Pre-connected analyte sensors

Information

  • Patent Grant
  • 11160926
  • Patent Number
    11,160,926
  • Date Filed
    Wednesday, July 7, 2021
    3 years ago
  • Date Issued
    Tuesday, November 2, 2021
    3 years ago
Abstract
Pre-connected analyte sensors are provided. A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured for mechanical coupling of the sensor to testing, calibration, or wearable equipment. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the testing, calibration, or wearable equipment.
Description
INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, or any correction thereto, are hereby incorporated by reference under 37 CFR 1.57. This application claims the benefit of U.S. application Ser. No. 15/792,038, filed on Oct. 24, 2017, now U.S. Pat. No. 10,653,835, issued on May 19, 2020. The aforementioned application is incorporated by reference herein in its entirety, and is hereby expressly made a part of this specification.


TECHNICAL FIELD

The present disclosure generally relates to sensors and, more particularly, to analyte sensors such as continuous analyte sensors.


BACKGROUND

Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.


Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are spread so far apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. Glucose levels may be alternatively monitored continuously by a sensor system including an on-skin sensor assembly. The sensor system may have a wireless transmitter which transmits measurement data to a receiver which can process and display information based on the measurements.


This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above.


SUMMARY

There are various steps in the manufacturing process of an analyte sensor such as a continuous analyte sensor for which temporary mechanical and electrical connections between the sensor and manufacturing equipment such as testing and/or calibration equipment are used. These connections are facilitated by accurate placement and alignment of the sensor to mechanical and electrical interfaces of the testing and/or calibration equipment. A device such as an “interconnect”, “interposer” or “sensor carrier” can be attached to an elongated body of the sensor, as described hereinafter, to assist with handling, and both temporary and permanent, electrical and mechanical connections. A sensor carrier (also referred to as a “sensor interposer”) may also include features for tracking, data storage, and sealing sensor electrodes, from each other and from the environment. Without limiting the scope of the present embodiments as expressed by the claims that follow, their more prominent features now will be discussed briefly. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the present embodiments provide the advantages described herein.


In accordance with a first aspect, a method of manufacturing a sensor is provided. The method includes providing an analyte sensor having an elongated body, a first electrode, a second electrode coaxially located within the first electrode, and at least two electrical contacts longitudinally aligned and spaced along a longitudinal axis of the sensor. The method includes attaching a sensor carrier to the analyte sensor, the sensor carrier including an intermediate body, a first conductive portion disposed on the intermediate body, the first conductive portion in electrical communication with the first electrode, a second conductive portion disposed on the intermediate body, the second conductive portion in electrical communication with the second electrode. The first and second conductive portions form a connection portion configured to establish electrical connection between the sensor and a separate device.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the method further includes coupling an outer layer to the intermediate body. The outer layer includes an identifier. The outer layer, the sensor, and the intermediate body can form a laminated configuration. The identifier can be a QR code sheet. The identifier can include any of an optical identifier, a radio-frequency identifier, or a memory-encoded identifier. The identifier can identify the analyte sensor, calibration data for the analyte sensor, or a history of the analyte sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the method further includes coating the sensor with a membrane after attaching the sensor to the sensor carrier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the first conductive portion and the second conductive portion are traces. The traces can extend from a distal position of the sensor carrier and terminate at a proximal end of the sensor carrier. The traces can form exposed contact surfaces in the connection portion. The first and second conductive portions can be embedded into the intermediate body.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the first conductive portion and the second conductive portion are solder welds. The solder welds can attach the sensor to the sensor carrier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the first conductive portion and the second conductive portion are conductive tapes. The conductive tapes can attach the sensor to the sensor carrier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the connection portion is configured to mechanically mate with the separate device.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the separate device is an electronics unit configured to measure analyte data.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the separate device is a component of a manufacturing station. The method can further include performing at least one of a potentiostat measurement, a dipping process, a curing process, a calibration process, or a sensitivity measurement while the electrical connection is established between the sensor and the manufacturing station. The method can further include de-establishing electrical connection between the sensor and the calibration station. The method can further include establishing electrical connection between the sensor and at least one testing station via the connection portion of the sensor carrier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the intermediate body further includes a datum structure that controls a position and spatial orientation of the analyte sensor relative to a substrate of the intermediate body. The datum structure can include a flexible portion of the substrate that is folded over at least a portion of the analyte sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the first aspect, the first conductive portion and/or the second conductive portion comprise at least one of a coil spring, a leaf spring, or a conductive elastomer.


In accordance with a second aspect, an apparatus is provided that includes an analyte sensor having an elongated body, a first electrode in electrical communication with a first conductive contact, a second electrode in electrical communication with a second conductive contact. The sensor carrier can be attached to the analyte sensor. The sensor carrier can include an intermediate body, a first conductive portion disposed on the intermediate body, the first conductive portion in electrical communication with the first conductive contact, and a second conductive portion disposed on the intermediate body, the second conductive portion in electrical communication with the second conductive contact. The first and second conductive portions can form a connection portion configured to establish electrical communication between the first and second conductive contacts and a separate device.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the apparatus further includes an identifier coupled to the intermediate body. The identifier, the sensor, and the intermediate body can form a laminated configuration. The identifier can be a QR code sheet. The identifier can be any of an optical identifier, a radio-frequency identifier, or a memory-encoded identifier. The identifier can be configured to identify any of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first conductive portion and the second conductive portion are traces. The traces can form exposed contact surfaces in the connection portion. The first and second conductive portions can be at least partially embedded into the intermediate body.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first conductive portion and the second conductive portion include at least one of a solder weld, a conductive tape, a coil spring, a leaf spring, or a conductive elastomer.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the connection portion is configured to mechanically mate with the separate device.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the separate device is an electronics unit configured to measure analyte data.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the separate device is a component of a manufacturing station. At least one of a potentiostat measurement, a dipping process, a curing process, a calibration process, or a sensitivity measurement can be configured to be performed while the electrical connection is established between the sensor and the manufacturing station. The manufacturing station can comprise a calibration station configured to de-establish electrical connection between the sensor and the calibration station and establish electrical connection between the sensor and at least one testing station via the connection portion of the sensor carrier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the intermediate body further comprises a datum structure configured to control a position and spatial orientation of the analyte sensor relative to a substrate of the intermediate body.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first electrode may be positioned coaxially within the second electrode, and the first electrical contact and the second electrical contact may be longitudinally aligned and spaced along a longitudinal axis of the sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first electrode and the second electrode may be affixed to a flexible planar substrate. In addition, the first electrical contact and the second electrical contact may be affixed to the flexible planar substrate.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first conductive contact and the second conductive contact are affixed to the intermediate body with conductive adhesive.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the second aspect, the first conductive contact and the second conductive contact are affixed to the intermediate body with anisotropic conductive film.


In accordance with a third aspect, an array of pre-connected analyte sensors is provided. The array includes a substrate, a first plurality of electrical contacts disposed on the substrate, a second plurality of electrical contacts disposed on the substrate, and a plurality of analyte sensors disposed on the substrate. Each of the plurality of analyte sensors includes a first sensor electrical contact coupled to a corresponding one of the first plurality of electrical contacts on the substrate, and a second sensor electrical contact coupled to a corresponding one of the second plurality of electrical contacts on the substrate. The array may comprise one or more strips.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the first plurality of electrical contacts are aligned along the substrate. The first plurality of electrical contacts can be formed from an exposed contact surface.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the second plurality of electrical contacts are aligned along the substrate. The second plurality of electrical contacts can be formed from an exposed contact surface.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the first and second plurality of electrical contacts are configured to connect with a separate device. The separate device can be a component of a manufacturing station.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the substrate includes at least one singulation feature configured to facilitate singulation of the substrate into a plurality of sensor carriers, wherein each of the plurality of sensor carriers is attached to a corresponding one of the analyte sensors.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the strip further includes a plurality of identifiers disposed on the substrate.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the substrate includes an elongated dimension, wherein the plurality of analyte sensors extend beyond an edge of the substrate in a direction orthogonal to the elongated dimension. The strip can further include a feed-guide strip that runs along an opposing edge of the substrate in the elongated dimension. The substrate can further include a flexible substrate configured to be rolled onto a reel. The feed-guide strip can be removable from the substrate.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the substrate comprises a molded thermoplastic having a plurality of datum features that control a position and orientation of the plurality of analyte sensors, and wherein the a first plurality of electrical contacts and the second plurality of electrical contacts each comprise embedded conductive traces in the molded thermoplastic.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the strip further includes a first datum structure coupled to the strip, the first datum structure configured to position the plurality of analyte sensors. The first datum structure includes at least one singulation feature configured to facilitate singulation of the first datum structure into a plurality of second datum structures, wherein each of the plurality of second datum structures is coupled to a corresponding one of a plurality of sensor carriers formed by the substrate.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the third aspect, the strip further includes a carrier having processing circuitry configured to perform at least potentiostat measurements for the plurality of analyte sensors. The strip can further include communications circuitry operable by the processing circuitry to send and receive data associated with each of the analyte sensors together with an identifier for that analyte sensor.


In accordance with a fourth aspect, a method is provided. The method includes providing a pre-connected analyte sensor, the pre-connected analyte sensor comprising an intermediate body, an analyte sensor permanently attached to the intermediate body, and an identifier coupled to the intermediate body. The method includes communicatively coupling the analyte sensor to a processing circuitry of a manufacturing station by coupling the intermediate body to a corresponding feature of the manufacturing station. The method includes operating the processing circuitry of the manufacturing station to communicate with the pre-connected analyte sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, operating the processing circuitry includes obtaining a signal from the analyte sensor via the connection portion. Operating the processing circuitry can include operating an optical, infrared, or radio-frequency reader of the manufacturing station to obtain the identifier.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, the method further includes storing, with the processing circuitry of the manufacturing station and in connection with the identifier, sensor data corresponding to the signal. The identifier can identify any of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, the signal includes a glucose sensitivity signal.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, the method further includes removing the pre-connected analyte sensor from the manufacturing station and communicatively coupling the analyte sensor to processing circuitry of a wearable device by mechanically coupling an anchoring feature of the intermediate body to a corresponding feature of a wearable device. The method can further include obtaining in vivo measurement data from the analyte sensor with the processing circuitry of the wearable device.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, the analyte sensor is permanently attached to the intermediate body with conductive adhesive.


In a generally applicable embodiment (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fourth aspect, the analyte sensor is permanently attached to the intermediate body with anisotropic conductive film.


In accordance with a fifth aspect, a wearable device is provided. The wearable device comprises a housing and electronic circuitry configured to process analyte sensor signals. The electronic circuitry is enclosed within the housing. An analyte sensor has a distal portion positioned outside the housing. An intermediate body has an electrical connection to both a proximal portion of the analyte sensor and the electronics, wherein the electrical connection between the intermediate body and the proximal portion of the analyte sensor is external to the housing.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fifth aspect the intermediate body may be positioned adjacent to an exterior surface of the housing. The device may include electrical contacts coupled to both the electronics and the intermediate body. The intermediate body may be electrically connected to the electrical contacts with conductive epoxy. The intermediate body is electrically connected to the electrical contacts with anisotropic conductive film. The intermediate body may be sealed. The electrical contacts may extend through the housing. The intermediate body may be positioned in a recess on the exterior surface of the housing. The electrical contacts may extend through the housing in the recess to electrically couple the intermediate body to the electronic circuitry enclosed within the housing. The intermediate body may be covered with a polymer in the recess.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the fifth aspect the analyte sensor is formed as an elongated body with a distal portion configured for percutaneous implantation in a subject and a proximal portion configured for electrically connecting to the intermediate body. The distal portion of the analyte sensor may extend away from an opening through the housing. The electronic circuitry may comprise a potentiostat and/or a wireless transmitter.


In accordance with a sixth aspect, a method of making a pre-connected analyte sensor is provided. The method comprises mechanically and electrically connecting a proximal portion of an elongated conductor to a conductive portion of an intermediate body, and after the connecting, coating a distal portion of the elongated conductor with a polymer membrane to form an analyte sensor having a working electrode region configured to support electrochemical reactions for analyte detection in the distal portion of the elongated conductor.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the sixth aspect, the method additionally comprises testing the analyte sensor, wherein the testing comprises electrically coupling the intermediate body to a testing station. The method may additionally comprise calibrating the analyte sensor, wherein the calibrating comprises electrically coupling the intermediate body to a testing station. The coating may comprise dip coating.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the sixth aspect, the intermediate body may be part of an array formed by a plurality of coupled intermediate bodies, wherein the method further comprises mechanically and electrically connecting a proximal portion of each of a plurality of elongated electrodes to a conductive portion of each intermediate body of the array. The coating may be performed in parallel on each distal portion of each of the plurality of elongated electrodes connected to the intermediate bodies of the array. The method may comprise singulating one or more of the intermediate bodies of the array after the coating.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the sixth aspect, mechanically and electrically connecting comprises applying conductive paste to the elongated conductor and the conductive portion of the intermediate body. In some embodiments, mechanically and electrically connecting comprises compressing anisotropic conductive film between the proximal portion of the elongated conductor and the conductive portion of the intermediate body. The connecting may be performed at a location remote from the coating. In some embodiments, the coating, testing, and calibrating are all performed at a location remote from the connecting.


In accordance with a seventh aspect, a method of making an on-skin wearable percutaneous analyte sensor comprises assembling electronic circuitry into an internal volume of a housing, wherein the electronic circuitry is configured for (1) detecting signals generated from an electrochemical reaction under the skin of a subject at a working electrode of an analyte sensor, and (2) wirelessly transmitting data derived from the detected signals outside of the housing for processing and/or display by a separate device. After assembling the electronic circuitry into the internal volume of the housing, attaching a proximal portion of the analyte sensor to an external electrical interface coupled to the electronic circuitry such that the electronic circuitry becomes connected to the analyte sensor to receive signals therefrom without opening the housing.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the seventh aspect, the method comprises sealing the interface after attaching the proximal portion of the analyte sensor. The method may comprise testing the electronic circuitry for functionality prior to the attaching. The method may comprise testing the analyte sensor for functionality prior to the attaching. The assembling may be performed at a location remote from the attaching.


In generally applicable embodiments (i.e. independently combinable with any of the aspects or embodiments identified herein) of the seventh aspect, the method may comprise coupling an intermediate body to the proximal portion of the analyte sensor, and the attaching may comprise attaching the intermediate body to the external electrical interface. The method may then comprise performing at least one manufacturing or testing procedure on the working electrode using the intermediate body prior to the attaching. The performing may comprise coating the working electrode of the analyte sensor. The coupling may be performed at a first location, the assembling may be performed at a second location, and the performing may be performed at a third location, wherein the first, second, and third locations are remote from one another. The attaching and/or the coupling may be performed with anisotropic conductive film The method may further comprise attaching an inserter to the housing for implanting the working electrode into a subject.


It is understood that various configurations of the subject technology will become readily apparent to those skilled in the art from the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.





BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments now will be discussed in detail with an emphasis on highlighting the advantageous features. These embodiments are for illustrative purposes only and are not to scale, instead emphasizing the principles of the disclosure. These drawings include the following figures, in which like numerals indicate like parts:



FIG. 1 is a schematic view of an analyte sensor system attached to a host and communicating with a plurality of example devices, according to some embodiments.



FIG. 2 is a block diagram that illustrates electronics associated with the sensor system of FIG. 1, according to some embodiments.



FIGS. 3A-3C illustrate a wearable device having an analyte sensor, according to some embodiments.



FIG. 3D illustrates one implementation of an elongated sensor connected to a potentiostat.



FIG. 4A illustrates a schematic of a pre-connected analyte sensor, according to some embodiments.



FIG. 4B illustrates another schematic of a pre-connected analyte sensor, according to some embodiments.



FIG. 4C illustrates a layered view of a pre-connected analyte sensor, according to some embodiments.



FIG. 4D illustrates a schematic view of an array of pre-connected analyte sensors, according to some embodiments.



FIGS. 5A-5E illustrate block diagrams of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments.



FIG. 6 illustrates a cross-sectional schematic view of a wearable device with a pre-connected analyte sensor, according to some embodiments.



FIG. 7 illustrates a cross-sectional schematic view of a wearable device with a pre-connected analyte sensor, according to some embodiments.



FIG. 8 illustrates a cross-sectional schematic view of a wearable device with a pre-connected analyte sensor, according to some embodiments.



FIG. 9 illustrates a perspective view of an on-skin sensor assembly, according to some embodiments.



FIGS. 10 and 11 illustrate perspective views of sensor carriers that have springs, according to some embodiments.



FIG. 12 illustrates a cross-sectional perspective view of a portion of a sensor carrier, according to some embodiments.



FIGS. 13A-13B illustrate perspective views of a wearable sensor assembly, according to some embodiments.



FIG. 13C illustrates an exploded view of components of a wearable sensor assembly, according to some embodiments.



FIGS. 14A-14B illustrate perspective views of another wearable sensor assembly, according to some embodiments.



FIG. 14C illustrates an exploded view of components of another wearable sensor assembly, according to some embodiments, including an external electrical interface embodiment.



FIG. 14D illustrates a top plan view of the external electrical interface of FIG. 14C with a pre-connected sensor assembly installed.



FIG. 14E is a cross section along lines E-E in FIG. 14D.



FIG. 15A illustrates another embodiment of a printed circuit board substrate for a sensor carrier.



FIGS. 15B and 15C illustrate alternative embodiments for coupling a sensor and sensor carrier to an electrical interface of a wearable sensor assembly.



FIG. 16 illustrates a top view of a sensor carrier attached to an analyte sensor with conductive adhesive, according to some embodiments.



FIG. 17 illustrates an end view of a sensor carrier attached to an analyte sensor with conductive adhesive, according to some embodiments.



FIG. 18 illustrates an end view of a sensor carrier attached to an analyte sensor with conductive adhesive in a recess of a sensor carrier substrate, according to some embodiments.



FIG. 19 illustrates an end view of a sensor carrier attached to an analyte sensor with conductive adhesive in a corner of a sensor carrier substrate, according to some embodiments.



FIG. 20 illustrates an end view of a sensor carrier attached to an analyte sensor with conductive adhesive in a rounded recess of a sensor carrier substrate, according to some embodiments.



FIGS. 21A and 21B illustrate a perspective view and an end view respectively of an analyte sensor attached to a sensor carrier in guide structures.



FIG. 22 illustrates a top view of a sensor carrier attached to an analyte sensor with conductive tape, according to some embodiments.



FIG. 23 illustrates a top view of a sensor carrier having a substrate attached to and wrapped around an analyte sensor, according to some embodiments.



FIG. 24 illustrates a top view of a sensor carrier attached to an analyte sensor with welded conductive plastic, according to some embodiments.



FIGS. 25 and 26 illustrate manufacturing equipment for attaching a sensor carrier to an analyte sensor with conductive plastic, according to some embodiments.



FIG. 27 is a perspective-view schematic illustrating a proximal portion of an analyte sensor having flattened electrical connector portions, according to some embodiments.



FIG. 28 illustrates a side view of the analyte sensor of FIG. 24 attached to a sensor carrier, according to some embodiments.



FIG. 29 illustrates a top view of a sensor carrier having a flexible substrate configured to wrap around an analyte sensor, according to some embodiments.



FIG. 30 illustrates a perspective view of a sensor carrier having substrate with a flexible portion configured to wrap around an analyte sensor, according to some embodiments.



FIGS. 31A and 31B illustrate another embodiment of a sensor carrier attached to an analyte sensor.



FIG. 32 illustrates a top view of a sensor carrier having a movable fastener for attaching an analyte sensor, according to some embodiments.



FIG. 33 illustrates a perspective view of the movable fastener of FIG. 29, according to some embodiments.



FIG. 34 illustrates a perspective view of a sensor carrier implemented as a barrel fastener, according to some embodiments.



FIG. 35A illustrates a face-on view of a sensor carrier having a flexible substrate wrapped around an analyte sensor, according to some embodiments.



FIG. 35B illustrates a perspective view of a sensor carrier having a flexible substrate wrapped around multiple analyte sensors, according to some embodiments.



FIG. 36 illustrates an end view of a sensor carrier having a crimp connector, according to some embodiments.



FIG. 37 illustrates an end view of a sensor carrier attached to an analyte sensor by a crimp connector, according to some embodiments.



FIG. 38 illustrates a side view of a sensor carrier having crimp connectors, according to some embodiments.



FIG. 39 illustrates a perspective view of a sensor carrier, according to some embodiments.



FIG. 40 illustrates a perspective view of a sensor carrier formed from a molded interconnect device, according to some embodiments.



FIG. 41 illustrates a top view of a sensor carrier formed from a molded interconnect device, according to some embodiments.



FIG. 42 illustrates a side view of a sensor carrier attached to an analyte sensor by a conductive coupler, according to some embodiments.



FIG. 43 illustrates a side view of a sensor carrier having an elongated dimension for attachment to multiple analyte sensors, according to some embodiments.



FIG. 44 illustrates a top view of a sensor carrier having a flexible substrate for wrapping around an analyte sensor, according to some embodiments.



FIG. 45 illustrates a top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor, according to some embodiments.



FIG. 46 illustrates a top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor, according to some embodiments.



FIG. 47A illustrates a side view of a sensor carrier having a feed-guide strip on an elongated dimension for attachment to multiple analyte sensors, according to some embodiments.



FIG. 47B illustrates a perspective view of the sensor carrier of FIG. 47A wrapped on a reel, according to some embodiments.



FIG. 48 illustrates a top view of the sensor carrier of FIG. 47A with a sensor carrier singulated from the sensor carrier, according to some embodiments.



FIG. 49 illustrates a perspective view of a sensor carrier having spring-loaded receptacles for attachment of multiple analyte sensors, according to some embodiments.



FIG. 50 illustrates a perspective view of a sensor carrier having magnetic datum features for positioning and orientation of multiple analyte sensors, according to some embodiments.



FIG. 51A illustrates a top view of a sensor carrier having a rigid flex panel for attachment to multiple analyte sensors, according to some embodiments.



FIG. 51B illustrates a top view of a sensor carrier having a rigid flex panel for attachment to multiple analyte sensors having an edge card connector pad for electronic connection, according to some embodiments.



FIG. 52A illustrates a top view of a sensor carrier singulated from the sensor carrier of FIG. 48 and attached to an analyte sensor to form a pre-connected sensor, according to some embodiments.



FIG. 52B illustrates a sensor carrier having a rigid flex panel for attachment to multiple analyte sensors of FIG. 48B without the V-score portion, according to some embodiments.



FIG. 53A illustrates the pre-connected sensor to be installed in a wearable device, according to some embodiments.



FIG. 53B illustrates the pre-connected sensor in a folded position to be installed in a wearable device, according to some embodiments.



FIG. 54 illustrates a sensor carrier implemented as a daughter board for connection to an analyte sensor, according to some embodiments.



FIG. 55 illustrates a sensor carrier implemented with a pinch clip, according to some embodiments.



FIG. 56 illustrates a sensor carrier having clips for connection to an analyte sensor, according to some embodiments.



FIG. 57 is a flow chart of illustrative operations that may be performed for manufacturing and using a pre-connected sensor, according to some embodiments.



FIG. 58 illustrates a perspective view of a sensor-holding apparatus having a fluted flexible tube, according to some embodiments



FIG. 59 illustrates an exploded perspective view of the apparatus of FIG. 58, according to some embodiments.



FIG. 60 illustrates a device that includes a sensor mounted in the apparatus of FIG. 55, according to some embodiments.



FIG. 61 illustrates a diagram of a carrier for pre-connected sensors, according to some embodiments.





Like reference numerals refer to like elements throughout. Elements are not to scale unless otherwise noted.


DETAILED DESCRIPTION

The following description and examples illustrate some exemplary implementations, embodiments, and arrangements of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present invention.


Definitions


In order to facilitate an understanding of the various embodiments described herein, a number of terms are defined below.


The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensor heads, devices, and methods is analyte. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-ß hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; D-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free ß-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, ß); lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, Leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-Dihydroxyphenylacetic acid (DOPAC), Homovanillic acid (HVA), 5-Hydroxytryptamine (5HT), and 5-Hydroxyindoleacetic acid (FHIAA).


The terms “microprocessor” and “processor” as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to a computer system, state machine, and the like that performs arithmetic and logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.


The term “calibration” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the process of determining the relationship between the sensor data and the corresponding reference data, which can be used to convert sensor data into meaningful values substantially equivalent to the reference data, with or without utilizing reference data in real time. In some embodiments, namely, in analyte sensors, calibration can be updated or recalibrated (at the factory, in real time and/or retrospectively) over time as changes in the relationship between the sensor data and reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, and the like.


The terms “calibrated data” and “calibrated data stream” as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to data that has been transformed from its raw state to another state using a function, for example a conversion function, including by use of a sensitivity, to provide a meaningful value to a user.


The term “algorithm” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a computational process (for example, programs) involved in transforming information from one state to another, for example, by using computer processing.


The term “sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the component or region of a device by which an analyte can be quantified. A “lot” of sensors generally refers to a group of sensors that are manufactured on or around the same day and using the same processes and tools/materials. Additionally, sensors that measure temperature, pressure etc. may be referred to as a “sensor”.


The terms “glucose sensor” and “member for determining the amount of glucose in a biological sample” as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to any mechanism (e.g., enzymatic or non-enzymatic) by which glucose can be quantified. For example, some embodiments utilize a membrane that contains glucose oxidase that catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate, as illustrated by the following chemical reaction:

Glucose+O2→Gluconate+H2O2


Because for each glucose molecule metabolized, there is a proportional change in the co-reactant O2 and the product H2O2, one can use an electrode to monitor the current change in either the co-reactant or the product to determine glucose concentration.


The terms “operably connected” and “operably linked” as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to one or more components being linked to another component(s) in a manner that allows transmission of signals between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal, e.g., an electrical or electromagnetic signal; the signal can then be transmitted to an electronic circuit. In this case, the electrode is “operably linked” to the electronic circuitry. These terms are broad enough to include wireless connectivity.


The term “determining” encompasses a wide variety of actions. For example, “determining” may include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” may include resolving, selecting, choosing, calculating, deriving, establishing and/or the like. Determining may also include ascertaining that a parameter matches a predetermined criterion, including that a threshold has been met, passed, exceeded, and so on.


The term “substantially” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to being largely but not necessarily wholly that which is specified.


The term “host” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to mammals, particularly humans.


The term “continuous analyte (or glucose) sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a device that continuously or continually measures a concentration of an analyte, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor such as described in U.S. Pat. No. 6,001,067, which is incorporated herein by reference in its entirety.


The term “sensing membrane” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a permeable or semi-permeable membrane that can be comprised of two or more domains and is typically constructed of materials of a few microns thickness or more, which are permeable to oxygen and may or may not be permeable to glucose. In one example, the sensing membrane comprises an immobilized glucose oxidase enzyme, which enables an electrochemical reaction to occur to measure a concentration of glucose.


The term “sensor data,” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refers without limitation to any data associated with a sensor, such as a continuous analyte sensor. Sensor data includes a raw data stream, or simply data stream, of analog or digital signals directly related to a measured analyte from an analyte sensor (or other signal received from another sensor), as well as calibrated and/or filtered raw data. In one example, the sensor data comprises digital data in “counts” converted by an A/D converter from an analog signal (e.g., voltage or amps) and includes one or more data points representative of a glucose concentration. Thus, the terms “sensor data point” and “data point” refer generally to a digital representation of sensor data at a particular time. The terms broadly encompass a plurality of time spaced data points from a sensor, such as from a substantially continuous glucose sensor, which comprises individual measurements taken at time intervals ranging from fractions of a second up to, e.g., 1, 2, or 5 minutes or longer. In another example, the sensor data includes an integrated digital value representative of one or more data points averaged over a time period. Sensor data may include calibrated data, smoothed data, filtered data, transformed data, and/or any other data associated with a sensor.


The term “sensor electronics,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the components (for example, hardware and/or software) of a device configured to process data. As described in further detail hereinafter (see, e.g., FIG. 2) “sensor electronics” may be arranged and configured to measure, convert, store, transmit, communicate, and/or retrieve sensor data associated with an analyte sensor.


The terms “sensitivity” or “sensor sensitivity,” as used herein, are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refer without limitation to an amount of signal produced by a certain concentration of a measured analyte, or a measured species (e.g., H2O2) associated with the measured analyte (e.g., glucose). For example, in one embodiment, a sensor has a sensitivity from about 1 to about 300 picoAmps of current for every 1 mg/dL of glucose analyte.


The term “sample,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and it is not to be limited to a special or customized meaning), and refers without limitation to a sample of a host body, for example, body fluids, including, blood, serum, plasma, interstitial fluid, cerebral spinal fluid, lymph fluid, ocular fluid, saliva, oral fluid, urine, excretions, or exudates.


The term “distal to,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively far from the reference point than another element.


The term “proximal to,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively near to the reference point than another element.


The terms “electrical connection” and “electrical contact,” as used herein, are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to any connection between two electrical conductors known to those in the art. In one embodiment, electrodes are in electrical connection with (e.g., electrically connected to) the electronic circuitry of a device. In another embodiment, two materials, such as but not limited to two metals, can be in electrical contact with each other, such that an electrical current can pass from one of the two materials to the other material and/or an electrical potential can be applied.


The term “elongated conductive body,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an elongated body formed at least in part of a conductive material and includes any number of coatings that may be formed thereon. By way of example, an “elongated conductive body” may mean a bare elongated conductive core (e.g., a metal wire), an elongated conductive core coated with one, two, three, four, five, or more layers of material, each of which may or may not be conductive, or an elongated non-conductive core with conductive coatings, traces, and/or electrodes thereon and coated with one, two, three, four, five, or more layers of material, each of which may or may not be conductive.


The term “ex vivo portion,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a portion of a device (for example, a sensor) adapted to remain and/or exist outside of a living body of a host.


The term “in vivo portion,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a portion of a device (for example, a sensor) adapted for insertion into and/or existence within a living body of a host.


The term “potentiostat,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an electronic instrument that controls the electrical potential between the working and reference electrodes at one or more preset values.


The term “processor module,” as used herein, is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refers without limitation to a computer system, state machine, processor, components thereof, and the like designed to perform arithmetic or logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.


The term “sensor session,” as used herein, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a period of time a sensor is in use, such as but not limited to a period of time starting at the time the sensor is implanted (e.g., by the host) to removal of the sensor (e.g., removal of the sensor from the host's body and/or removal of (e.g., disconnection from) system electronics).


The terms “substantial” and “substantially,” as used herein, are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a sufficient amount that provides a desired function.


“Coaxial two conductor wire based sensor”: A round wire sensor consisting of a conductive center core, an insulating middle layer and a conductive outer layer with the conductive layers exposed at one end for electrical contact.


“Pre-connected sensor”: A sensor that has a “sensor interconnect/interposer/sensor carrier” attached to it. Therefore this “Pre-connected sensor” consists of two parts that are joined: the sensor itself, and the interconnect/interposer/sensor carrier. The term “pre-connected sensor” unit refers to the unit that is formed by the permanent union of these two distinct parts.


Other definitions will be provided within the description below, and in some cases from the context of the term's usage.


As employed herein, the following abbreviations apply: Eq and Eqs (equivalents); mEq (milliequivalents); M (molar); mM (millimolar) μM (micromolar); N (Normal); mol (moles); mmol (millimoles); μmol (micromoles); nmol (nanomoles); g (grams); mg (milligrams); μg (micrograms); Kg (kilograms); L (liters); mL (milliliters); dL (deciliters); μL (microliters); cm (centimeters); mm (millimeters); μm (micrometers); nm (nanometers); h and hr (hours); min. (minutes); s and sec. (seconds); ° C. (degrees Centigrade) ° F. (degrees Fahrenheit), Pa (Pascals), kPa (kiloPascals), MPa (megaPascals), GPa (gigaPascals), Psi (pounds per square inch), kPsi (kilopounds per square inch).


Overview/General Description of System


In vivo analyte sensing technology may rely on in vivo sensors. In vivo sensors may include an elongated conductive body having one or more electrodes such as a working electrode and a reference electrode.


For example, a platinum metal-clad, tantalum wire is sometimes used as a core bare sensing element with one or more reference or counter electrodes for an analyte sensor. This sensing element is coated in membranes to yield the final sensor.


Described herein are pre-connected sensors that include an analyte sensor attached to a sensor carrier (also referred to herein as a “sensor interposer”). The analyte sensor may include a working electrode and a reference electrode at a distal end of an elongated conductive body. The sensor carrier may include a substrate, one or more electrical contacts coupled to one or more electrical contacts of the sensor, and circuitry such as one or more additional or external electrical contacts for coupling the one or more electrical contacts that are coupled to the sensor contact(s) to external equipment such as a membrane dip coating station, a testing station, a calibration station, or sensor electronics of a wearable device. In some embodiments, the substrate can be referred to as an intermediate body.


The following description and examples described the present embodiments with reference to the drawings. In the drawings, reference numbers label elements of the present embodiments. These reference numbers are reproduced below in connection with the discussion of the corresponding drawing features.


Sensor System



FIG. 1 depicts an example system 100, in accordance with some example implementations. The system 100 includes an analyte sensor system 101 including sensor electronics 112 and an analyte sensor 138. The system 100 may include other devices and/or sensors, such as medicament delivery pump 102 and glucose meter 104. The analyte sensor 138 may be physically connected to sensor electronics 112 and may be integral with (e.g., non-releasably attached to) or releasably attachable to the sensor electronics. For example, continuous analyte sensor 138 may be connected to sensor electronics 112 via a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics. The sensor electronics 112, medicament delivery pump 102, and/or glucose meter 104 may couple with one or more devices, such as display devices 114, 116, 118, and/or 120.


In some example implementations, the system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and/or other patient-related data) provided via network 409 (e.g., via wired, wireless, or a combination thereof) from sensor system 101 and other devices, such as display devices 114, 116, 118, and/or 120 and the like, associated with the host (also referred to as a patient) and generate reports providing high-level information, such as statistics, regarding the measured analyte over a certain time frame. A full discussion of using a cloud-based analyte processing system may be found in U.S. patent application Ser. No. 13/788,375, entitled “Cloud-Based Processing of Analyte Data” and filed on Mar. 7, 2013, published as U.S. Patent Application Publication 2013/0325352, herein incorporated by reference in its entirety. In some implementations, one or more steps of the factory calibration algorithm can be performed in the cloud.


In some example implementations, the sensor electronics 112 may include electronic circuitry associated with measuring and processing data generated by the analyte sensor 138. This generated analyte sensor data may also include algorithms, which can be used to process and calibrate the analyte sensor data, although these algorithms may be provided in other ways as well. The sensor electronics 112 may include hardware, firmware, software, or a combination thereof, to provide measurement of levels of the analyte via an analyte sensor, such as a glucose sensor. An example implementation of the sensor electronics 112 is described further below with respect to FIG. 2.


In one implementation, the factory calibration algorithms described herein may be performed by the sensor electronics.


The sensor electronics 112 may, as noted, couple (e.g., wirelessly and the like) with one or more devices, such as display devices 114, 116, 118, and/or 120. The display devices 114, 116, 118, and/or 120 may be configured for presenting information (and/or alarming), such as sensor information transmitted by the sensor electronics 112 for display at the display devices 114, 116, 118, and/or 120.


In one implementation, the factory calibration algorithms described herein may be performed at least in part by the display devices.


In some example implementations, the relatively small, key fob-like display device 114 may comprise a wrist watch, a belt, a necklace, a pendent, a piece of jewelry, an adhesive patch, a pager, a key fob, a plastic card (e.g., credit card), an identification (ID) card, and/or the like. This small display device 114 may include a relatively small display (e.g., smaller than the large display device 116) and may be configured to display certain types of displayable sensor information, such as a numerical value, and an arrow, or a color code.


In some example implementations, the relatively large, hand-held display device 116 may comprise a hand-held receiver device, a palm-top computer, and/or the like. This large display device may include a relatively larger display (e.g., larger than the small display device 114) and may be configured to display information, such as a graphical representation of the sensor data including current and historic sensor data output by sensor system 100.


In some example implementations, the analyte sensor 138 may comprise a glucose sensor configured to measure glucose in the blood or interstitial fluid using one or more measurement techniques, such as enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, immunochemical, and the like. In implementations in which the analyte sensor 138 includes a glucose sensor, the glucose sensor may comprise any device capable of measuring the concentration of glucose and may use a variety of techniques to measure glucose including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring), to provide data, such as a data stream, indicative of the concentration of glucose in a host. The data stream may be sensor data (raw and/or filtered), which may be converted into a calibrated data stream used to provide a value of glucose to a host, such as a user, a patient, or a caretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor, a nurse, or any other individual that has an interest in the wellbeing of the host). Moreover, the analyte sensor 138 may be implanted as at least one of the following types of analyte sensors: an implantable glucose sensor, a transcutaneous glucose sensor, implanted in a host vessel or extracorporeally, a subcutaneous sensor, a refillable subcutaneous sensor, an intravascular sensor.


Although the disclosure herein refers to some implementations that include an analyte sensor 138 comprising a glucose sensor, the analyte sensor 138 may comprise other types of analyte sensors as well. Moreover, although some implementations refer to the glucose sensor as an implantable glucose sensor, other types of devices capable of detecting a concentration of glucose and providing an output signal representative of glucose concentration may be used as well. Furthermore, although the description herein refers to glucose as the analyte being measured, processed, and the like, other analytes may be used as well including, for example, ketone bodies (e.g., acetone, acetoacetic acid and beta hydroxybutyric acid, lactate, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, intermediaries in the citric acid cycle, choline, insulin, cortisol, testosterone, and the like.


In some manufacturing systems, sensors 138 are manually sorted, placed and held in fixtures. These fixtures are manually moved from station to station during manufacturing for various process steps including interfacing electrical measurement equipment for testing and calibration operations. However, manual handling of sensors can be inefficient, can cause delays due to non-ideal mechanical and electrical connections, and can risk damage to the sensor and/or testing and calibration equipment and can induce sensor variability that can lead to inaccurate verification data being collected in manufacturing. In addition, the process of packaging sensor 138 with the sensor electronics 112 into a wearable device involves further manual manipulation of the sensor that can damage the sensor 138.


Various systems, devices, and methods described herein help to reduce or eliminate manual interaction with a sensor. For example, a pre-connected sensor may be provided that includes a sensor interconnect or sensor carrier electrically coupled to sensor electrodes and having mechanical and electrical features configured to accurately interface with wearable electronics, automation equipment and/or robustly connect to measurement equipment.


Identification and other data associated with each sensor may be stored on the sensor carrier for logging and tracking of each sensor during manufacturing, testing, calibration, and in vivo operations. Following testing and calibration operations, the sensor carrier may be used to connect the sensor to sensor electronics of a wearable device, such as an on-skin sensor assembly, in an arrangement that is sealed and electrically robust.



FIG. 2 depicts an example of electronics 112 that may be used in sensor electronics 112 or may be implemented in a manufacturing station such as a testing station, a calibration station, a smart carrier, or other equipment used during manufacturing of device 101, in accordance with some example implementations. The sensor electronics 112 may include electronics components that are configured to process sensor information, such as sensor data, and generate transformed sensor data and displayable sensor information, e.g., via a processor module. For example, the processor module may transform sensor data into one or more of the following: filtered sensor data (e.g., one or more filtered analyte concentration values), raw sensor data, calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, rate of acceleration/deceleration information, sensor diagnostic information, location information, alarm/alert information, calibration information such as may be determined by factory calibration algorithms as disclosed herein, smoothing and/or filtering algorithms of sensor data, and/or the like.


In some embodiments, a processor module 214 is configured to achieve a substantial portion, if not all, of the data processing, including data processing pertaining to factory calibration. Processor module 214 may be integral to sensor electronics 112 and/or may be located remotely, such as in one or more of devices 114, 116, 118, and/or 120 and/or cloud 490. For example, in some embodiments, processor module 214 may be located at least partially within a cloud-based analyte processor 490 or elsewhere in network 409.


In some example implementations, the processor module 214 may be configured to calibrate the sensor data, and the data storage memory 220 may store the calibrated sensor data points as transformed sensor data. Moreover, the processor module 214 may be configured, in some example implementations, to wirelessly receive calibration information from a display device, such as devices 114, 116, 118, and/or 120, to enable calibration of the sensor data from sensor 138. Furthermore, the processor module 214 may be configured to perform additional algorithmic processing on the sensor data (e.g., calibrated and/or filtered data and/or other sensor information), and the data storage memory 220 may be configured to store the transformed sensor data and/or sensor diagnostic information associated with the algorithms. The processor module 214 may further be configured to store and use calibration information determined from a factory calibration, as described below.


In some example implementations, the sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and/or 120, and/or other components for signal processing and data storage (e.g., processor module 214 and data storage memory 220). Although FIG. 2 depicts ASIC 205, other types of circuitry may be used as well, including field programmable gate arrays (FPGA), one or more microprocessors configured to provide some (if not all of) the processing performed by the sensor electronics 112, analog circuitry, digital circuitry, or a combination thereof.


In the example depicted in FIG. 2, through a first input port 211 for sensor data the potentiostat 210 is coupled to an analyte sensor 138, such as a glucose sensor to generate sensor data from the analyte. The potentiostat 210 may be coupled to a working electrode 211 and reference electrode 212 that form a part of the sensor 138. The potentiostat may provide a voltage to one of the electrodes 211, 212 of the analyte sensor 138 to bias the sensor for measurement of a value (e.g., a current) indicative of the analyte concentration in a host (also referred to as the analog portion of the sensor). The potentiostat 210 may have one or more connections to the sensor 138 depending on the number of electrodes incorporated into the analyte sensor 138 (such as a counter electrode as a third electrode).


In some example implementations, the potentiostat 210 may include a resistor that translates a current value from the sensor 138 into a voltage value, while in some example implementations, a current-to-frequency converter (not shown) may also be configured to integrate continuously a measured current value from the sensor 138 using, for example, a charge-counting device. In some example implementations, an analog-to-digital converter (not shown) may digitize the analog signal from the sensor 138 into so-called “counts” to allow processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.


The telemetry module 232 may be operably connected to processor module 214 and may provide the hardware, firmware, and/or software that enable wireless communication between the sensor electronics 112 and one or more other devices, such as display devices, processors, network access devices, and the like. A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth, Bluetooth Low-Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access technologies, radio frequency (RF), infrared (IR), paging network communication, magnetic induction, satellite data communication, spread spectrum communication, frequency hopping communication, near field communications, and/or the like. In some example implementations, the telemetry module 232 comprises a Bluetooth chip, although Bluetooth technology may also be implemented in a combination of the telemetry module 232 and the processor module 214.


The processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data (e.g., counts), from the sensor, filter the data, calibrate the data, perform fail-safe checking, and/or the like.


Potentiostat 210 may measure the analyte (e.g., glucose and/or the like) at discrete time intervals or continuously, for example, using a current-to-voltage or current-to-frequency converter.


The processor module 214 may further include a data generator (not shown) configured to generate data packages for transmission to devices, such as the display devices 114, 116, 118, and/or 120. Furthermore, the processor module 214 may generate data packets for transmission to these outside sources via telemetry module 232. In some example implementations, the data packages may include an identifier code for the sensor and/or sensor electronics 112, raw data, filtered data, calibrated data, rate of change information, trend information, error detection or correction, and/or the like.


The processor module 214 may also include a program memory 216 and other memory 218. The processor module 214 may be coupled to a communications interface, such as a communication port 238, and a source of power, such as a battery 234. Moreover, the battery 234 may be further coupled to a battery charger and/or regulator 236 to provide power to sensor electronics 112 and/or charge the battery 234.


The program memory 216 may be implemented as a semi-static memory for storing data, such as an identifier for a coupled sensor 138 (e.g., a sensor identifier (ID)) and for storing code (also referred to as program code) to configure the ASIC 205 to perform one or more of the operations/functions described herein. For example, the program code may configure processor module 214 to process data streams or counts, filter, perform the calibration methods described below, perform fail-safe checking, and the like.


The memory 218 may also be used to store information. For example, the processor module 214 including memory 218 may be used as the system's cache memory, where temporary storage is provided for recent sensor data received from the sensor. In some example implementations, the memory may comprise memory storage components, such as read-only memory (ROM), random-access memory (RAM), dynamic-RAM, static-RAM, non-static RAM, electrically erasable programmable read only memory (EEPROM), rewritable ROMs, flash memory, and the like.


The data storage memory 220 may be coupled to the processor module 214 and may be configured to store a variety of sensor information. In some example implementations, the data storage memory 220 stores one or more days of analyte sensor data. The stored sensor information may include one or more of the following: a time stamp, raw sensor data (one or more raw analyte concentration values), calibrated data, filtered data, transformed sensor data, and/or any other displayable sensor information, calibration information (e.g., reference BG values and/or prior calibration information such as from factory calibration), sensor diagnostic information, and the like.


The user interface 222 may include a variety of interfaces, such as one or more buttons 224, a liquid crystal display (LCD) 226, a vibrator 228, an audio transducer (e.g., speaker) 230, a backlight (not shown), and/or the like. The components that comprise the user interface 222 may provide controls to interact with the user (e.g., the host).


The battery 234 may be operatively connected to the processor module 214 (and possibly other components of the sensor electronics 112) and provide the necessary power for the sensor electronics 112. In other implementations, the receiver can be transcutaneously powered via an inductive coupling, for example.


A battery charger and/or regulator 236 may be configured to receive energy from an internal and/or external charger. In some example implementations, the battery 234 (or batteries) is configured to be charged via an inductive and/or wireless charging pad, although any other charging and/or power mechanism may be used as well.


One or more communication ports 238, also referred to as external connector(s), may be provided to allow communication with other devices, for example a PC communication (com) port can be provided to enable communication with systems that are separate from, or integral with, the sensor electronics 112. The communication port, for example, may comprise a serial (e.g., universal serial bus or “USB”) communication port, and allow for communicating with another computer system (e.g., PC, personal digital assistant or “PDA,” server, or the like). In some example implementations, factory information may be sent to the algorithm from the sensor or from a cloud data source.


The one or more communication ports 238 may further include an input port 237 in which calibration data may be received, and an output port 239 which may be employed to transmit calibrated data, or data to be calibrated, to a receiver or mobile device. FIG. 2 illustrates these aspects schematically. It will be understood that the ports may be separated physically, but in alternative implementations a single communication port may provide the functions of both the second input port and the output port.


In some analyte sensor systems, an on-skin portion of the sensor electronics may be simplified to minimize complexity and/or size of on-skin electronics, for example, providing only raw, calibrated, and/or filtered data to a display device configured to run calibration and other algorithms required for displaying the sensor data. However, the sensor electronics 112 (e.g., via processor module 214) may be implemented to execute prospective algorithms used to generate transformed sensor data and/or displayable sensor information, including, for example, algorithms that: evaluate a clinical acceptability of reference and/or sensor data, evaluate calibration data for best calibration based on inclusion criteria, evaluate a quality of the calibration, compare estimated analyte values with time corresponding measured analyte values, analyze a variation of estimated analyte values, evaluate a stability of the sensor and/or sensor data, detect signal artifacts (noise), replace signal artifacts, determine a rate of change and/or trend of the sensor data, perform dynamic and intelligent analyte value estimation, perform diagnostics on the sensor and/or sensor data, set modes of operation, evaluate the data for aberrancies, and/or the like.



FIGS. 3A, 3B, and 3C illustrate an exemplary implementation of analyte sensor system 101 implemented as a wearable device such as an on-skin sensor assembly 600. As shown in FIG. 3, on-skin sensor assembly comprises a housing 128. An adhesive patch 126 can couple the housing 128 to the skin of the host. The adhesive 126 can be a pressure sensitive adhesive (e.g. acrylic, rubber based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment. The housing 128 may include a through-hole 180 that cooperates with a sensor inserter device (not shown) that is used for implanting the sensor 138 under the skin of a subject.


The wearable sensor assembly 600 can include sensor electronics 112 operable to measure and/or analyze glucose indicators sensed by glucose sensor 138. Sensor electronics 112 within sensor assembly 600 can transmit information (e.g., measurements, analyte data, and glucose data) to a remotely located device (e.g., 114, 116, 118, 120 shown in FIG. 1). As shown in FIG. 3C, in this implementation the sensor 138 extends from its distal end up into the through-hole 180 and is routed to an electronics module 135 inside the enclosure 128. The working electrode 211 and reference electrode 212 are connected to circuitry in the electronics module 135 which includes the potentiostat.



FIG. 3D illustrates one exemplary embodiment of an analyte sensor 138 which includes an elongated body portion. The elongated body portion may be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than about 0.1 inches, 0.075 inches, 0.05 inches, 0.025 inches, 0.01 inches, 0.004 inches, or 0.002 inches. While the elongated conductive body is illustrated herein as having a circular cross-section, in other embodiments the cross-section of the elongated conductive body can be ovoid, rectangular, triangular, or polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, or the like.


In the implementation of FIG. 3D, the analyte sensor 138 comprises a wire core 139. At a distal, in vivo portion of the sensor 138, the wire core 139 forms an electrode 211a. At a proximal, ex vivo portion of the sensor 138, the wire core 139 forms a contact 211b. The electrode 211a and the contact 211b are in electrical communication over the length of the wire core 139 as it extends along the elongated body portion of the sensor 138. The wire core can be made from a single material such as platinum or tantalum, or may be formed as multiple layers, such as a conducting or non-conducting material with an outer coating of a different conducting material.


A layer 104 surrounds a least a portion of the wire core 139. The layer 104 may be formed of an insulating material, such as polyimide, polyurethane, parylene, or any other known insulating materials. For example, in one embodiment the layer 104 is disposed on the wire core 139 and configured such that the electrode 211a is exposed via window 106.


In some embodiments, the sensor 138 further comprises a layer 141 surrounding the insulating layer 104 like a sleeve that comprises a conductive material. At a distal, in vivo portion of the sensor 138, the sleeve layer 141 forms an electrode 212a. At a proximal, ex vivo portion of the sensor 138, the sleeve layer 141 forms a contact 212b. The electrode 212a and the contact 212b are in electrical communication over the length of the sleeve layer 141 as it extends along the elongated body portion of the sensor 138. This sleeve layer 141 may be formed of a silver-containing material that is applied onto the insulating layer 104. The silver-containing material may include any of a variety of materials and be in various forms, such as, Ag/AgCl-polymer pastes, paints, polymer-based conducting mixture, and/or inks that are commercially available, for example. This layer 141 can be processed using a pasting/dipping/coating step, for example, using a die-metered dip coating process. In one exemplary embodiment, an Ag/AgCl polymer paste is applied to an elongated body by dip-coating the body (e.g., using a meniscus coating technique) and then drawing the body through a die to meter the coating to a precise thickness. In some embodiments, multiple coating steps are used to build up the coating to a predetermined thickness.


The sensor 138 shown in FIG. 3D also includes a membrane 108 covering at least a portion of the distal in vivo portion of the sensor 138. This membrane is typically formed of multiple layers, which may include one or more of an interference domain, an enzyme domain, a diffusion resistance domain, and a bioprotective domain. This membrane is important to support the electrochemical processes that allow analyte detection and it is generally manufactured with great care by dip-coating, spraying, or other manufacturing steps. It is preferable for the distal in vivo portion of the sensor 138 to be subject to as little handling as possible from the time the membrane 108 is formed to the time the distal in vivo portion of the sensor 138 is implanted into a subject. In some embodiments, electrode 211a forms a working electrode of an electrochemical measuring system, and electrode 212a forms a reference electrode for that system. In use, both electrodes may be implanted into a host for analyte monitoring.


Although the above description is applicable specifically to a coaxial wire type structure, the embodiments herein are also applicable to other physical configurations of electrodes. For example, the two electrodes 211a and 212a could be affixed to a distal in vivo portion of an elongated flexible strip of a planar substrate such as a thin, flat, polymer flex circuit. The two contacts 211b and 212b could be affixed to the proximal ex vivo portion of this flexible planar substrate. Electrodes 211a, 212a could be electrically connected to their respective contacts 211b, 212b a circuit traces on the planar substrate. In this case, the electrodes 211a and 212a and the contacts 211b and 212b may be adjacent to one another on a flat surface rather than being coaxial as shown in FIG. 3D.


Also shown in FIG. 3D is an illustration of the contact 211b and the contact 212b electrically coupled to a simple current-to-voltage converter based potentiostat 210. The potentiostat includes a battery 320 that has an output coupled to an input of an operational amplifier 322. The output of the operational amplifier 322 is coupled to a contact 324 that is electrically coupled to the working electrode contact 211b through a resistor 328. The amplifier 322 will bias the contact 324 to the battery voltage Vb, and will drive the current im required to maintain that bias. This current will flow from the working electrode 211a through the interstitial fluid surrounding the sensor 138 and to the reference electrode 212a. The reference electrode contact 212b is electrically coupled to another contact 334 which is connected to the other side of the battery 320. For this circuit, the current im is equal to (Vb−Vm)/R, where Vm is the voltage measured at the output of the amplifier 322. The magnitude of this current for a given bias on the working electrode 211a is a measure of analyte concentration in the vicinity of the window 106.


The contacts 324 and 334 are typically conductive pads/traces on a circuit board. There is always some level of parasitic leakage current ip over the surface of this board during the test. If possible, this leakage current should not form part of the measurement of current due to analyte. To reduce the effect this leakage current has on the measured current, an optional additional pad/trace 336 may be provided between the biased contact 324 and the return contact 334 that is connected directly to the battery output. This optional additional pad/trace may be referred to as a “guard trace.” Because they are held at the same potential, there will be essentially no leakage current from the biased contact 324 and the guard trace 336. Furthermore, leakage current from the guard trace 336 to the return contact 334 does not pass through the amplifier output resistor 328, and therefore is not included in the measurement. Additional aspects and implementations of a guard trace may be found in paragraphs [0128] and [0129] of U.S. Patent Publication 2017/0281092, which are incorporated herein by reference.


During manufacturing, various coating, testing, calibration, and assembly operations are performed on the sensor 138. However, it can be difficult to transport individual sensors and electrically interface the sensors with multiple testing and calibration equipment installations. These processes also subject the sensors to damage from handling. To help address these issues, the sensor 138 may be provided as a part of a pre-connected sensor that includes a sensor carrier as described in greater detail below.



FIG. 4A shows a schematic illustration of a pre-connected sensor 400. As shown in FIG. 4A, pre-connected sensor 400 includes sensor carrier 402 permanently attached to sensor 138. In the example of FIG. 4A, sensor carrier 402 includes an intermediate body such as substrate 404, and also includes one or more contacts such as first internal contact 406, and second internal contact 408. First internal contact 406 is electrically coupled to a first contact on a proximal end of sensor 138 and contact internal contact 408 is electrically coupled to a second contact on the proximal end of sensor 138. The distal end of sensor 138 is a free end configured for insertion into the skin of the host. Contacts 406 and 408 may, for example, correspond to contacts 324 and 334 of FIG. 3D in some implementations.


As shown in FIG. 4A, first internal contact 406 may be electrically coupled to a first external contact 410 and second internal contact 408 may be electrically coupled to a second external contact 412. As described in further detail hereinafter, external contacts 410 and 412 may be configured to electrically interface with sensor electronics 112 in wearable device 600. Furthermore, external contacts 410 and 412 may be configured to electrically interface with processing circuitry of manufacturing equipment such one or more testing stations and/or one or more calibration stations. Although various examples are described herein in which two external contacts 410 and 412 on the sensor carrier are coupled to two corresponding contacts on sensor 138, this is merely illustrative. In other implementations, sensor carrier 402 and sensor 138 may each be provided with a single contact or may each be provided with more than two contacts, for example, any N number of external contacts (e.g., more than two external contacts 410 and 412) of the sensor carrier and any M number of contacts (e.g., more than two contacts 406 and 408) of sensor 138 that can be coupled. In some implementations, sensor carrier 402 and sensor 138 may have the same number of contacts (i.e., N=M). In some implementations, sensor carrier 402 and sensor 138 may have a different number of contacts (i.e., N≠M). For example, in some implementations, sensor carrier 402 may have additional contacts for coupling to or between various components of a manufacturing station.


As described in further detail hereinafter, substrate 404 may be configured to couple with sensor electronics 112 in wearable device 600. In some embodiments, substrate 404 may be sized and shaped to mechanically interface with housing 128 and electrically interface with sensor electronics 112 inside housing 128. Further, substrate 404 may be sized and shaped to mechanically interface with manufacturing equipment, assembly equipment, testing stations and/or one or more calibration stations. As described in further detail hereinafter, sensor carrier 402 may be attached and/or electrically coupled to sensor 138. Sensor 138 may be permanently coupled to a component of sensor carrier 402 (e.g. substrate 404) by using, for example, adhesive (e.g. UV cure, moisture cure, multi part activated, heat cure, hot melt, etc.), including conductive adhesive (e.g. carbon filled, carbon nanotube filled, silver filled, conductive additive, etc.), conductive ink, spring contacts, clips, wrapped flexible circuitry, a conductive polymer (e.g. conductive elastomer, conductive plastic, carbon filled PLA, conductive graphene PLA), conductive foam, conductive fabric, a barrel connector, a molded interconnect device structure, sewing, wire wrapping, wire bonding, wire threading, spot welding, swaging, crimping, stapling, clipping, soldering or brazing, plastic welding, or overmolding. In some embodiments, sensor 138 may be permanently coupled to substrate 404 by rivets, magnets, anisotropic conductive films, metallic foils, or other suitable structures or materials for mechanically and electrically attaching sensor carrier 402 to sensor 138 before or during assembly, manufacturing, testing and/or calibration operations. In some embodiments, sensor carrier 402 may be 3-D printed around sensor 138 to form pre-connected sensor 400. Additionally, sensor carrier 402 may include datum features 430 (sometimes referred to as datum structures) such as a recess, an opening, a surface or a protrusion for aligning, positioning, and orienting sensor 138 relative to sensor carrier 402. Sensor carrier 402 may also include, or may itself form, one or more anchoring features for securing and aligning the analyte sensor during manufacturing (e.g., relative to a manufacturing station). Additionally, sensor carrier 402 may include an identifier 450 configured to identify the sensor. In some embodiments, identifier 450 is formed on substrate 404. Identifier 450 will be explained further below.



FIG. 4B illustrates another schematic of a pre-connected analyte sensor 400. The pre-connected analyte sensor 400 shown in FIG. 4B may include similar components of pre-connected analyte sensor 400 shown in FIG. 4A. FIG. 4B is shown without optional cover 460 for clarity. FIG. 4C illustrated an exploded view of pre-connected analyte sensor 400 shown in FIG. 4B.


In the example of FIG. 4B, sensor carrier 402 includes an intermediate body such as a substrate 404, and also includes one or more traces such as first trace 414 and second trace 416. First trace 414 may include a first internal contact 406 and a first external contact 410. Second trace 416 may include a second internal contact 408 and a second external contact 412. In some embodiments, first internal contact 406 is electrically coupled to a first contact on a proximal end of sensor 138 and second internal contact 408 is electrically coupled to a second contact on the proximal end of sensor 138. The distal end of sensor 138 is a free end configured for insertion into the skin of the host. The electrical coupling is described in connection with various embodiments herein, such as clips, conductive adhesive, conductive polymer, conductive ink, metallic foil, conductive foam, conductive fabric, wire wrapping, wire threading or any other suitable methods. In some embodiments, a non-conductive adhesive 426 (e.g. epoxy, cyanoacrylate, acrylic, rubber, urethane, hot melt, etc.) can be used to attach the sensor 138 to substrate 404. Non-conductive adhesive 426 may be configured to affix, seal, insulate, or provide a strain relief to the sensor 138. Sensor 138 may be attached to substrate 404 by other methods, such as those described in FIG. 4A above.


As shown in FIG. 4C, a pressure sensitive adhesive 428 may be configured to isolate an exposed end of traces 414 and 416. For instance, pressure sensitive adhesive 428 may laminate sensor 138 between substrate 404 and cover 460. In such instances, sensor 138, substrate 404, pressure sensitive adhesive 428, and cover 460 may form a laminated configuration. In the laminated configuration, sensor 138 and its connection to one or more contacts (e.g. first internal contact 406 and second internal contact 408) are isolated from one or more exposed contacts (e.g. first external contact 410 and second external contact 412). Furthermore, the laminated configuration may create a moisture sealed region surrounding the sensor 138. The moisture seal may be created as embodied by a combination of a pressure sensitive adhesive 428 and a non-conductive adhesive 426. In other embodiments, the laminated structure can be created by one or a combination of the following materials and methods: A non-conductive adhesive, a pressure sensitive adhesive tape, an elastomer, heat bonding, hot plate welding, laser welding, ultrasonic welding, RF welding, or any suitable type of lamination method. The cover 460 may consist of a polymer sheet, structure, or film that at least partially covers the substrate 404. The cover 460 may optionally contain an identifier 450, which can identify the sensor 138. In some embodiments, identifier 450 may incorporate various identification protocols or techniques such as, but not limited to, NFC, RFID, QR Code, Bar code, Wi-Fi, Trimmed resistor, Capacitive value, Impedance values, ROM, Memory, IC, Flash memory, etc.


Guide fixture 420, which is an optional component, is an exemplary embodiment of an interface with a work station, such as a testing station, a calibration station, an assembly station, a coating station, manufacturing stations, or as part of the wearable assembly. The guide fixture 420 includes datum features (or datum structures) 430, such as a recess, an opening, a surface or a protrusion for aligning, positioning, and orienting sensor 138 relative to sensor carrier 402. Datum features 430 may be used in manufacturing and for assembly into a wearable electronic component. In some embodiments, datum features 430 are raised protrusions configured to align with corresponding datum features 432 of substrate 404. Corresponding datum features 432 of substrate 404 may feature cutouts, slots, holes, or recesses. The corresponding datum features 432 in the sensor carrier may be placement features that can interface with datum features 430 in a work station, such as a testing station, a calibration station, an assembly station, a coating station, or other manufacturing stations. Guide fixture 420 may be configured to ensure proper placement of the sensor carrier 402 to align the exposed external contacts 410 and 412 for connecting to a work station, such as a testing station, a calibration station, an assembly station, a coating station, or other manufacturing stations. In other embodiments, datum features 430 may consist of female features to engage with male corresponding datum features 432.



FIG. 4D illustrates a schematic view of an array 480 of pre-connected analyte sensors 400 having a plurality of pre-connected sensors 400 with optional identifiers 450. In FIG. 4D, an array formed as a one-dimensional strip of pre-connected analyte sensors 400 is shown, but a two-dimensional array could also be implanted. In some embodiments, the array 480 of pre-connected analyte sensors may be disposed in a cartridge. Each of the plurality of pre-connected sensors 400 can be singulated. In some embodiments, scoring 4020 may be provided to facilitate singulation into individual pre-connected sensors 400. In some embodiments, the array 480 can be used in facilitating manufacturing, testing and/or calibrating multiple sensors 138 individually in sequential or random manners. In some embodiments, the array 480 can be used in facilitating manufacturing, testing and/or calibrating multiple sensors 138 concurrently.



FIGS. 5A-5E show block diagrams of various machines and assemblies the pre-connected analyte sensor 400 may be associated with during its pre-implant lifetime. Such machines and assemblies may include manufacturing equipment such as one or more manufacturing stations 5091, one or more testing stations 5002 and/or one more calibration stations 5004, and an on-skin wearable assembly 600. At least some of these are configured to receive sensor carrier 402 and to communicatively couple the machines and assemblies to sensor 138 via sensor carrier 402.


It is one aspect of some embodiments that the sensor 138 is coupled to the sensor carrier 402 before the membrane 108 described above is applied. With the sensor 138 attached to the sensor carrier, and potentially with multiple carrier mounted sensors attached together as shown in FIG. 4D, subsequent device production steps such as membrane coating, testing, calibration, and assembly into a wearable unit can be performed with easier mounting and dismounting from manufacturing and testing equipment, less sensor handling, less chance of damaging the membrane, producing a significant overall improvement in production efficiency.


Another benefit of the pre-connected sensor construction is that it is easier to separate different kinds of manufacturing and testing among different facilities that are better equipped to handle them. For example, fabricating the electrodes may require various kinds of metal forming/extrusion machines, whereas membrane application, testing, and calibration requires a wet chemistry lab and sensitive electronic test equipment. Accordingly, the sensor electrodes may be formed and mounted on the carrier in one facility in one location, and then shipped to a different remote facility that is equipped for membrane application, testing, and calibration. Remote in this context means not in the same production facility in the same building. It can even be advantageous for different commercial entities to perform the different tasks that specialize in the appropriate manufacturing and testing technologies.


Manufacturing station 5091 may comprise a testing station as described herein, a calibration station as described herein, or another manufacturing station. Manufacturing station 5091 may include processing circuitry 5092 and/or mechanical components 5094 operable to perform testing operations, calibration operations, and/or other manufacturing operations such as sensor straightening operations, membrane application operations, curing operations, calibration-check operations, glucose sensitivity operations (e.g., sensitivity slope, baseline, and/or noise calibration operations), and/or visual inspection operations.


The pre-connected analyte sensor 400 may be connected to one or more testing stations 5002 having processing circuitry 5012 configured to perform testing operations with sensor 138 to verify the operational integrity of sensor 138. Testing operations may include verifying electrical properties of a sensor 138, verifying communication between a working electrode and contact 408, verifying communication between a reference electrode or additional electrodes and contact 406, and/or other electronic verification operations for sensor 138. Processing circuitry 5012 may be communicatively coupled with sensor 138 for testing operations by inserting substrate 404 into a receptacle 5006 (e.g., a recess in a housing of testing station 5002) until contact 410 is coupled to contact 5010 of testing station 5002 and contact 412 is coupled to contact 5008 of testing station 5002.


System 5000 may include one or more calibration stations 5004 having processing circuitry 5020 configured to perform calibration operations with sensor 138 to obtain calibration data for in vivo operation of sensor 138. Calibration data obtained by calibration equipment 5004 may be provided to on-skin sensor assembly 600 to be used during operation of sensor 138 in vivo. Processing circuitry 5020 may be communicatively coupled with sensor 138 for calibration operations by inserting substrate 404 into a receptacle 5014 (e.g., a recess in a housing of calibration station 5004) until contact 410 is coupled to contact 5018 of testing station 5002 and contact 412 is coupled to contact 5016 of testing station 5002.


In the examples of FIGS. 5A-5E, testing station 5002 and calibration station 5004 include receptacles 5006 and 5014. However, this is merely illustrative and sensor carrier 402 may be mounted to testing station 5002 and calibration station 5004 and/or manufacturing station 5091 using other mounting features such as grasping, clipping, or clamping figures. For example, manufacturing station 5091 includes grasping structures 5093 and 5095, at least one of which is movable to grasp sensor carrier 402 (or a carrier having multiple sensor carriers and sensors). Structure 5093 may be a stationary feature having one or more electrical contacts such as contact 5008. Structure 5095 may be a movable feature that moves (e.g., slides in a direction 5097) to grasp and secure sensor carrier 402 in an electrically coupled position for manufacturing station 5091. In other implementations, both features 5093 and 5095 are movable.


Sensor carrier 402 may also include an identifier 450 (see, e.g., FIGS. 4A-4D). Identifier 450 may be formed on or embedded within substrate 404. Identifier 450 may be implemented as a visual or optical identifier (e.g., a barcode or QR code pre-printed or printed on-the-fly on substrate 404 or etched in to substrate 404), a radio frequency (RF) identifier, or an electrical identifier (e.g., a laser-trimmed resistor, a capacitive identifier, an inductive identifier, or a micro storage circuit (e.g., an integrated circuit or other circuitry in which the identifier is encoded in memory of the identifier) programmable with an identifier and/or other data before, during, or after testing and calibration). Identifier 450 may be used for tracking each sensor through the manufacturing process for that sensor (e.g., by storing a history of testing and/or calibration data for each sensor). In other words, the identifier 450 identifies any of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor. For example, identifier 450 may be used for binning of testing and calibration performance data. Identifier 450 may be a discrete raw value or may encode information in addition to an identification number. Identifier 450 may be used for digitally storing data in non-volatile memory on substrate 404 or as a reference number for storing data external to sensor carrier 402.


Testing station 5002 may include a reader 5011 (e.g., an optical sensor, an RF sensor, or an electrical interface such as an integrated circuit interface) that reads identifier 450 to obtain a unique identifier of sensor 138. Testing data obtained by testing station 5002 may be stored and/or transmitted along with the identifier of sensor 138.


Calibration station 5004 may include a reader 5011 (e.g., an optical sensor, an RF sensor, or an electrical interface) that reads identifier 450 to obtain a unique identifier of sensor 138. Calibration data obtained by calibration station 5004 may be stored and/or transmitted along with the identifier of sensor 138. In some implementations, calibration data obtained by calibration station 5004 may be added to identifier 450 by calibration station 5004 (e.g., by programming the calibration data into the identifier). In some implementations, calibration data obtained by calibration station 5004 may be transmitted to a remote system or device along with identifier 450 by calibration station.


As shown in FIGS. 5A-5E and described in further detail hereinafter, on-skin sensor assembly 600 may include one or more contacts such as contact 5022 configured to couple internal electronic circuitry to contacts 410 and 412 of sensor carrier 402 and thus to sensor 138. Sensor carrier 402 may be sized and shaped to be secured within a cavity 5024 in or on the housing 128 such that sensor 138 is coupled to electronics in the housing 128 via sensor carrier 402, and sensor 138 may be positionally secured to extend from the housing 128 for insertion for in vivo operations.


Although one calibration station and one testing station are shown in FIGS. 5A-5E, it should be appreciated that more than one testing station and/or more than one calibration station may be utilized in the manufacturing and testing phase of production. Although calibration station 5004 and testing station 5002 are shown as separate stations in FIGS. 5A-5E, it should be appreciated that, in some implementations calibration stations and testing stations may be combined into one or more calibration/testing stations (e.g., stations in which processing circuitry for performing testing and calibration operations is provided within a common housing and coupled to a single interface 5006).


Wearable assembly 600 may also include a reader (e.g., an optical sensor, an RF sensor, or an electrical interface) positioned near the contacts 5022 that reads identifier 450 to obtain a unique identifier of sensor 138. Sensor electronics may obtain calibration data for in vivo operation of sensor 138 based on the read identifier 450. The calibration data may be stored in, and obtained, from identifier 450 itself, or identifier 450 may be used to obtain the calibration data for the installed sensor 138 from a remote system such as a cloud-based system.



FIGS. 6-8 are schematic illustrations of various implementations of securement of a pre-connected sensor 400 within wearable assembly 600. In the example of FIG. 6, sensor carrier 402 is in direct contact with a base wall 605 and housing 128, and contact 5022 includes multiple contacts on the housing 128 for contacting both contacts 410 and 412 of sensor carrier 402 (e.g., both located on a top surface of sensor carrier 402). In the example of FIG. 7, a mechanical receiver 700 is provided on base wall 605 for mechanically securing sensor carrier 402. In the example of FIG. 8, mechanical receiver 800 is provided on base wall 605 for mechanically securing sensor carrier 402 in cooperation with receiver 702. In the example of FIG. 8, receiver 702 includes an additional contact 704 for contacting contact 410 of sensor carrier 402 located on a rear surface of the sensor carrier.



FIG. 9 shows a detailed example of a sensor module 300 including a pre-connected sensor 400 and a sealing structure 192. As shown, sealing structure 192 may be disposed on a substrate 404, in which sealing structure 192 may be configured to prevent moisture ingress toward contacts 410 and 412. Furthermore, contacts 410 and 412 may be implemented as leaf spring contact for coupling to sensor electronics. In some embodiments, pre-connected sensor 400 includes at least one contact. In some embodiments, pre-connected sensor 400 includes at least two contacts. In some embodiments, pre-connected sensor 400 includes at least three contacts. In some embodiments, pre-connected sensor 400 includes at least four contacts. An adhesive 126 can couple the housing 128 to the skin 130 of the host. The adhesive 126 can be a pressure sensitive adhesive (e.g. acrylic, rubber based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type) for skin attachment. As shown in FIG. 9, substrate 404 may include at least one arm 202 or other mechanical features for interfacing with corresponding mating features on base 128 (e.g., mechanical interlocks such as snap fits, clips, and/or interference features) to mechanically secure substrate 404 to housing 128. Coupling features such as arm 902 and/or other features of substrate 404 may be sized and shaped for releasably mechanically attaching substrate 404 to a connector associated with manufacturing equipment such as one or more of connectors 5006, 5014, and/or 5093/5095 of FIGS. 5A-5E for testing and/or calibration operations during manufacturing and prior to attachment to features 900 of housing 128.



FIG. 10 illustrates a perspective view of the sensor module 400 in an implementation in which contacts 406 and 408 are implemented using coil springs 306. In the example of FIG. 10, protrusions 308 on substrate 404 can align sensor 138 and secure springs 306 to substrate 404. (Not all the protrusions 308 are labeled in order to increase the clarity of FIG. 10.) Protrusions 308 can protrude distally.


At least three, at least four, and/or less than ten protrusions 308 can be configured to contact a perimeter of a spring 306. Protrusions 308 can be separated by gaps. The gaps enable protrusions 308 to flex outward as spring 306 is inserted between protrusions 308. A downward force for coupling electronics unit 500 to base 128 can push spring 306 against sensor 138 to electrically couple spring 306 to the sensor 138. Sensor 138 can run between at least two of protrusions 308. Testing station 5002 and/or calibration station 5004 may also have a mating connector structure that, when substrate 404 is inserted into recess 5006 or 5014, compresses springs 306 to couple springs 306 electrically between sensor 138 and processing circuitry 5012 or 5020.


Sensor 138 may include a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to sensor carrier 402 having an electrical interconnect (e.g., springs 306) mechanically coupled to the substrate 404 and electrically coupled to proximal portion 138b. Springs 306 can be conical springs, helical springs, or any other type of spring mentioned herein or suitable for electrical connections.


Substrate 404 may have a base portion 312 that includes at least two proximal protrusions 308 located around a perimeter of spring 306. Proximal protrusions 308 are configured to help orient spring 306. A segment of glucose sensor 138 is located between the proximal protrusions 308 (distally to the spring 306).


Base portion 312 may be configured to be mechanically coupled to the housing 128, to manufacturing equipment 5091, testing equipment 5002, and/or calibration equipment 5004. For example, base portion 312 includes anchoring features such as arms 202. Anchoring features may include arms 202 and/or may include features such as one or more notches, recesses, protrusions, or other features in base 312, arms 202, and/or substrate 404 that mechanically interface with corresponding features of, for example, a receptacle such as one of receptacles 5006 of 5014 of FIGS. 5A-5E or a clamping connector formed by clamping connector features such as features 5093 and 5095 of FIGS. 5A-5E to secure and align sensor 138. In one suitable example, a slidable (or otherwise actuable or rotatable) feature such as feature 5095 of FIGS. 5A-5E may be arranged to slide over, around, or otherwise engage with one or more of arms 202, base 312, and/or sensor carrier 402 altogether to secure sensor carrier 402 to the manufacturing equipment. For example, in other implementations of sensor carrier 402 in which arms 202 are not provided, a receptacle connector such as one of receptacles 5006 of 5014 of FIGS. 5A-5E or a clamping connector formed by clamping connector features such as features 5093 and 5095 of FIGS. 5A-5E may include a clamshell component, a sliding component, or other movable component that bears against or covers sensor carrier 402 to latch sensor carrier 402 to the manufacturing, testing, and/or calibration equipment.


Referring now to FIGS. 11 and 12, another implementation of sensor module 400 is shown that includes a base portion 312d; a glucose sensor 138 having a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to base portion 312d; and an electrical interconnect (e.g., leaf springs 306d) mechanically coupled to substrate 404 and electrically coupled to the proximal portion 138b. Leaf springs 306d can be configured to bend in response to pressure from testing station contacts, calibration station contacts, and/or electronics unit 500 coupling with base 128 while pre-connected sensor 400 is disposed between electronics unit 500 coupling with base 128.


As used herein, cantilever springs are a type of leaf spring. As used herein, a leaf spring can be made of a number of strips of curved metal that are held together one above the other. As used herein in many embodiments, leaf springs only include one strip (e.g., one layer) of curved metal (rather than multiple layers of curved metal). For example, leaf spring 306d in FIG. 11 can be made of one layer of metal or multiple layers of metal. In some embodiments, leaf springs include one layer of flat metal secured at one end (such that the leaf spring is a cantilever spring).


As shown in FIGS. 11 and 12, base portion 312d includes a proximal protrusion 320d having a channel 322d in which at least a portion of proximal portion 138b is located. The channel 322d positions a first area of proximal portion 138b such that the area is electrically coupled to leaf spring 306d.


As shown in the cross-sectional, perspective view of FIG. 12, leaf spring 306d arcs away from the first area and protrudes proximally to electrically couple with testing station 5002, calibration station 5004, and/or wearable assembly 600. At least a portion of leaf spring 306d forms a “W” shape. At least a portion of leaf spring 306d forms a “C” shape. Leaf spring 306d bends around the proximal protrusion 320d. Leaf spring 306d protrudes proximally to electrically couple testing station 5002, calibration station 5004, and/or electronics unit 500. Seal 192 is configured to impede fluid ingress to leaf spring 306d.


Leaf spring 306d is oriented such that coupling sensor carrier 402 to testing station 5002, calibration station 5004, and/or electronics unit 500 presses leaf spring 306d against a first electrical contact of the testing station 5002, calibration station 5004, and/or electronics unit 500 and a second electrical contact of the glucose sensor 138 to electrically couple the glucose sensor 138 to the testing station 5002, calibration station 5004, and/or electronics unit 500. The proximal height of seal 192 may be greater than a proximal height of leaf spring 306d such that the testing station 5002, calibration station 5004, and/or electronics unit 500 contacts the seal 192 prior to contacting the leaf spring 306d. Springs 306 and/or leaf springs 306d may cooperate with underlying features on substrate 404 (e.g., features 308) and/or channel 322d, as shown, to form datum features that secure and align sensor 138 with respect to sensor carrier 402 (e.g., for manufacturing, calibration, testing, and/or in vivo operations).



FIGS. 13A and 13B show perspective views of an embodiment of a wearable assembly 600 including a pre-connected sensor 400. Wearable assembly 600 may include sensor electronics and an adhesive patch (not shown). Pre-connected sensor 400 may include a sensor carrier such as sensor carrier 402 described in FIGS. 4A-4D. The sensor carrier 402 may be placed in or on housing 128. Housing 128 may be composed of two housing components, top housing 520 and bottom housing 522. Top housing 520 and bottom housing 522 can be assembled together to form housing 128. Top housing 520 and bottom housing 522 can be sealed to prevent moisture ingress to an internal cavity of housing 128. The sealed housing may include an encapsulating material (e.g. epoxy, silicone, urethane, or other suitable material). In other embodiments, housing 128 is formed as a single component encapsulant (e.g. epoxy) configured to contain sensor carrier 402 and sensor electronics. FIG. 13A illustrates an aperture 524 within top housing 520 configured to allow for an insertion component (e.g. hypodermic needle, C-needle, V-needle, open sided needle, etc.) to pass through the wearable assembly 600 for insertion and/or retraction. Aperture 524 may be aligned with a corresponding aperture in bottom housing 522. In other embodiments, aperture 524 may extend through an off-center location of housing 128. In other embodiments, aperture 524 may extend through an edge of the housing 128, forming a C-shaped channel. In some embodiments the aperture 524 includes a sealing material such as a gel, adhesive, elastomer, or other suitable material located within aperture 524.



FIG. 13B shows a perspective view of the bottom of wearable assembly 600. As illustrated, pre-connected sensor 400 may be disposed within the housing 128. Pre-connected sensor 400 may be installed within an aperture 526 of bottom housing 522. As shown in the figure, sensor 138 may extend out from aperture 526. Aperture 526 may be sized and shaped to retain pre-connected sensor 400. Furthermore, aperture 526 may be sized and shaped to retain pre-connected sensor 400 in which sensor 138 extends approximately parallel to the skin surface and forms a 90 degree bend for insertion into the skin. It should be understood that the bottom surface of bottom housing 522 can contain an attachment member (e.g. an adhesive patch) for adhering the wearable assembly to the skin surface of a user.



FIG. 13C shows an exploded view of the wearable assembly 600. Various electronic components such as the potentiostat 210 and other components illustrated in FIG. 2 may be mounted on or to an electronics assembly substrate 530, typically some form of printed circuit board. It is contemplated that sensor carrier 402 has an electrical coupling with electronics assembly substrate 530. Various methods may be used to establish electrical connection (e.g. pins, solder, conductive elastomer, conductive adhesive, etc.) between one or more contacts of pre-connected sensor 400, such as external contacts 410 and 412 and electronics assembly substrate 530. Sensor carrier 402 may be configured to interface with electronics assembly substrate 530 through the bottom housing 522. In other implementations, the sensor carrier 402 may be configured to interface with the electronics assembly substrate 530 through top housing 520. In some other implementations, the sensor carrier 402 is configured to interface with the electronics assembly substrate 530 through the side of wearable assembly 600. Also shown in the figure, an optional sealing member 528 may be configured to insulate at least a portion of sensor carrier 402 from potential moisture ingress. In some instances, the sealing member 528 may be liquid dispensed (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 528 may be an assembled component that is welded (e.g., laser or ultrasonic, hot plate), or otherwise permanently attached (e.g., anisotropic adhesive film, pressure sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealed region. The sealing member 528 may be used to physically couple and/or provide a sealed region for the sensor carrier 402 to the wearable assembly 600.



FIGS. 14A-14E illustrate another implementation of a wearable assembly 600. The implementation of FIGS. 14A-14E share some similarities to the implementation shown in FIGS. 13A-13C. As illustrated in FIG. 14A, the wearable assembly 600 includes a housing formed as a top housing 520 and a bottom housing 522. The wearable assembly also includes a through hole 524 for use during interstitial insertion of the sensor 138 into a subject. Referring especially to FIGS. 14B, C, and D, the bottom housing 522 includes a recess 726 with a floor 704. The floor 704 may include locating pins 784 and 786 that extend upward from the floor 704 and two apertures 722 and 724. The locating pins may be formed as an integral part of the floor 704, during for example molding of the housing, or they may be separate parts that are coupled to the floor with friction fit, adhesive, or any other means. In some embodiments, there is at least one locating pin. In some embodiments, there are at least two locating pins. In some embodiments, there are at least three locating pins. On the opposite side of the floor 704 is a printed circuit board 530 (visible in FIG. 14E) with some or all of the sensor electronic circuitry (e.g. the potentiostat 210 or at least traces that connect to the potentiostat) mounted thereon. The printed circuit board 530 may also have conductive pins 712 and 714 mounted thereon which extend through apertures 722 and 724 in the floor 704, forming an external electrical interface that is accessible without opening the housing. The pre-connected sensor 400 drops into this recess 726. Holes 794 and 796 drop over locating pins 784 and 786 and conductive pins 712 and 714 extend through holes 706 and 708 in the sensor carrier substrate 404. These holes 706 and 708 extend through plated metal (e.g. copper) contacts 406 and 408 on the substrate 404, similar to those shown in a different embodiment in FIGS. 4A to 4C. Generally, the number of holes 706, 708 in the substrate 404 correspond to the number of electrodes present in the sensor 138, which may in turn correspond to the number of pins 712, 714. For example, a three-electrode system with a working, reference, and counter electrode may have three holes in the substrate corresponding to three pins extending up through floor 704. The pins 712 and 714 may be electrically connected to the contacts 408 and 406 in a variety of ways such as solder, swaging, or conductive glue, paste, adhesive, or film. After this connection is made, the electronic circuitry for detecting and/or processing analyte sensor signals that is placed inside the housing becomes connected to the analyte sensor to receive signals therefrom. The connection material bonding the sensor 138 to the sensor carrier 402 is designated 762 and 764 in FIGS. 14D and 14E. These connections may be established by any of the methods described above with reference to FIG. 4A.


Once the substrate 404 is placed over the pins 712, 714, the proximal portion of the sensor 138 can be secured to the floor 704 with a pressure sensitive adhesive 772 to retain the proximal portion of the sensor on or near the housing prior to extending downward at the inserter opening 524. This allows for accurate sensor insertion position and controls the bias force into the insertion needle. A variety of methods and/or structural features may be used to perform this retention function such as a protrusion or shelf in the floor 704, an overmolded part, a snap-fit additional plastic piece installed over the sensor, or any sort of glue or adhesive placed before or after the pre-connected sensor is placed in the recess 726. As is also shown in FIG. 13C, optional sealing members 528a and 528b may be configured to seal and insulate at least a portion of sensor carrier 402 from potential moisture ingress. In some instances, the sealing member 528 may be liquid dispensed (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 528 may be an assembled component that is welded (e.g., laser or ultrasonic, hot plate), or otherwise permanently attached (e.g., pressure sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealed region. The sealing member 528 may be used to physically couple and/or provide a sealed region for the sensor carrier 402 to the wearable assembly 600. The two sealing members 528a and 528b are partially separated by walls 766 and 768. These walls allow two different sealing methods to be used in the two different portions of the recess 726 that are separated by the walls. For example, 528b may be a solid polymer that is press fit into the recess portion with opening 524 on one side of the walls. The other portion of the recess 726 may then be filled with a liquid UV cured epoxy which hardens to form sealing member 528a. The depth of the two recess portions on either side of the walls may be the same or different.



FIG. 15A shows an alternative embodiment of a sensor carrier 402, also potentially taking the form of a printed circuit board. In this implementation, a guard trace 407 such as described above with reference to item 336 in FIG. 3D is provided on the substrate 404 of the sensor carrier 402. As explained above, this guard trace 407 is positioned between contacts 406 and 408 and is connected to the bias voltage by the sensor electronics. The guard trace 407 can be coupled to the sensor electronics with or more conductive pins 713 (not shown in FIGS. 14A to 14E) that extend through the floor 704 similar to pins 712 and 714. In FIG. 15A, the pins are shown connected to castellated contacts on the side of the substrate 404. An insulating layer 780 such as solder mask may be positioned over the guard trace 407 to eliminate the risk of the analyte sensor electrodes shorting to it.



FIGS. 15B and 15C illustrated other implementations of connecting a sensor carrier 402 having an analyte sensor 138 mounted thereon to electronic circuitry internal to a wearable sensor. In FIG. 15B, the sensor 138 is coupled to the sensor carrier 402 with conductive adhesive 762 and 764 as shown above with reference to FIGS. 14C and 14D. On the other side of the sensor carrier substrate are conductive contact pads 812 and 814. The circuit board 530 also has contact pads 826 and 828 bonded thereto and which are accessible through the floor 704 of the recess 726. An anisotropic film 820 is used to electrically and mechanically bond the sensor carrier contact 812 to circuit board contact 826 and also sensor carrier contact 814 to circuit board contact 828. The anisotropic film 820 is compressed with heat between the contacts, which makes conductive particles in the film 820 bridge the gap vertically between the contact pairs 812/826 and 814/828. The conductive particles in the film 820 are spaced apart horizontally, so no shorting between the contact pairs occurs. This electrical and mechanical bonding technique has found widespread use in display applications for small electronics such as smart phones and lends itself to easy and consistent connections in production environments.


In FIG. 15C, the proximal region of sensor 138 is coupled to the sensor carrier 402 contacts 812 and 814 with anisotropic film 820. A different area of the same anisotropic film 820 may be used to connect the sensor carrier contacts 812 and 814 to circuit board contacts 826 and 828 respectively. In this implementation, the area of the film 820 that connects the sensor 138 to the contacts 812 and 814 may be horizontally adjacent to or otherwise separated from the area of the film 820 that connects the circuit board contacts 826 and 828 to the sensor carrier contacts 812 and 814.


In the examples of FIGS. 10-15, pre-connected sensor 400 can be installed as a standalone interface between sensor 138 and the sensor electronics. However, it should be appreciated that, in some implementations described herein, pre-connected sensor 400 may include a sensor carrier that couples to an additional interface between the sensor 138 and the sensor electronics inside the wearable assembly 600. For example, channel 322d and leaf spring 306d can be formed on separate substrate that, following calibration and testing operations, mechanically attaches to base portion 312d within seal 192 for installation into wearable assembly 600.


It is one benefit of the analyte sensor connection techniques described above that the fabrication of the pre-connected sensor 400 may be separated from the fabrication of the electronics enclosed within the housing. As described above with reference to the pre-connected sensor structure and the subsequent coating, testing and calibrating processes, the housing with the internally contained electronics can be manufactured in a separate facility from the one that attaches the pre-connected sensor 400 to the sensor electrical interface. This is made possible by providing an analyte sensor electronics interface that is accessible from outside the housing. The housing need not be opened to attach the sensor.


In some advantageous methods, the electrodes for the pre-connected sensor are fabricated and mounted on the substrate in a first location and are shipped to a second location for coating testing and calibrating. The housing with internal electronics is manufactured in a third location. The housing with the electronics is shipped from the third location to the second location, where the completed analyte sensor is attached to the external electrical interface. The three locations can all be remote from each other. This minimizes handling of the sensitive membrane coated sensor, but still allows separate manufacturing of the other components of the complete device.



FIG. 16 shows a top view of an implementation of sensor carrier 402 in which substrate 404 is a substantially planar substrate and sensor 138 is attached to substrate 404 with a conductive adhesive 1500. As shown in FIG. 16, conductive adhesive 1500 may be applied to contacts 1000 and 1002 of sensor 138 to mechanically attach sensor 138 to substrate 404. Once applied the conductive adhesive 1500 on contacts 1000 and 1002, may itself form contacts 408 and 406 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500. FIG. 17 shows an end view of sensor carrier 402 of FIG. 16 in which conductive adhesive 1500 can be seen covering a portion of sensor 138 at the proximal end. In other embodiments, sensor 138 may be attached to substrate 404 with a conductive adhesive 1500, or via any other suitable methods via the use of, for example, clips, conductive polymer, metallic foil, conductive foam, conductive fabric, wire wrapping, wire threading or via any other suitable methods.



FIGS. 18, 19, and 20 show examples of substrate 404 of FIG. 16, with additional datum features for controlling the position and spatial orientation of sensor 138 on substrate 404. In the example of FIG. 18, substrate 404 includes a v-shaped recess 1700. Sensor 138 is disposed partially within recess 1700 to orient sensor 138 in a direction along the recess, and conductive adhesive 1500 substantially covers sensor 138 and fills in portions of recess 1700 not filled by sensor 138 to secure sensor 138 within the recess. In the example of FIG. 19, substrate 404 includes a first planar portion 1800 and a second planar portion 1802 extending at a non-parallel (e.g., perpendicular) angle with respect to the first planar portion, and sensor 138 is attached at the interface of the first and second planar portions by conductive adhesive 1500. In the example of FIG. 20, substrate 404 includes a rounded recess 1900 in which sensor 138 is attached by conductive adhesive 1500 that substantially covers sensor 138 and fills in portions of recess 1700 not filled by sensor 138 to secure sensor 138 within the recess.



FIGS. 21A and 21B show an example sensor carrier 402 with at least one pair of guide structures 2106 and 2108 formed on the substrate 404, such as on one or both contacts 406 and 408. These guide structures can assist placement of the sensor body 138 on the appropriate location when applying conductive adhesive to bond the two together. This can eliminate the need for external guide fixtures when assembling the sensor to the sensor carrier during manufacturing. The structures 2106, 2108 can be made of solder or other conductive adhesive. Although not shown in FIGS. 21A and 21B, an additional adhesive bonding material can be provided between the guide structures to fix the sensor to the guide structures during manufacturing.


Conductive adhesive 1500 may be, for example, a conductive liquid dispensed glue. The conductive liquid dispensed glue may be a one or two-part adhesive that cures (e.g., at room temperate or an elevated curing temperate). The conductive liquid dispensed glue may be a snap-cure adhesive. A two-part conductive liquid dispensed glue may include a base adhesive (e.g., epoxy, polyurethane, etc.) and a conductive filler (e.g., silver, carbon, nickel, etc.). Conductive adhesive 1500 may include, for example, an adhesive resin with one or more embedded conductive materials such as silver, copper or graphite. Conductive adhesive 1500 may be a heat curable conductive adhesive.



FIG. 22 shows a top view of an implementation of sensor carrier 402 in which substrate 404 is a substantially planar substrate and sensor 138 is attached to substrate 404 with a conductive tape 2000. As shown in FIG. 22, conductive tape 2000 may be applied to one or more contacts (e.g. connection areas 1000 and 1002) of sensor 138 to mechanically attach sensor 138 to substrate 404. Once applied the conductive tape 2000 on contacts 1000 and 1002, may itself form contacts 408 and 406 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500. Tape 200 may be applied over sensor 138 as shown in FIG. 22, or may be interposed between substrate 404 and sensor 138. In implementations in which tape 2000 is disposed between substrate 404 and sensor 138, substrate 404 may be a flexible substrate that can be rolled or folded around sensor 138 as shown in the end view of FIG. 23. The rolled substrate of FIG. 23 includes extending portions 2100 that can form one or more contacts (e.g. 406 or 408).


Conductive tape 2000 may be configured for use as a multi-zoned tape with one or more conductive tapes 2000 and non-conductive tape sections. The combination of conductive and non-conductive regions can be used to electrically isolate connection regions. Using a multi-zoned tape may simplify the assembly of multiple connection regions in a single assembly step. The pitch of the conductive regions on the tape may be matched to the targeted connection area of the sensor wire 138. In other embodiments the pitch of the conductive region of the tape is significantly less than the spacing of the targeted connection area of the sensor wire 138. A shorter pitch may allow for more variability in tape placement while ensuring isolated connection between the sensor 138 and the substrate 404. Conductive tape 2000 may be formed from a polymer substrate with a conductive adhesive (e.g. carbon-impregnated adhesive, metal-impregnated adhesive). As another example, conductive tape 2000 may be a metallic substrate with conductive and non-conductive adhesive. Some examples of non-conductive substrates are polyimide, composite, polymers, etc. Some examples of conductive substrates are metals (e.g. Foils, plating, cladding, etc), conductive polymers, and conductive elastomers. Examples of non-conductive adhesive are epoxy, cyanoacrylate, acrylic, rubber, urethane, hot melt, etc. Examples of conductive adhesives are carbon filled adhesive, nano particle filled adhesive, metal filled adhesive (e.g. silver), conductive inks, etc.



FIG. 24 shows a top view of an implementation of sensor carrier 402 in which substrate 404 is a substantially planar substrate and sensor 138 is attached to substrate 404 with a conducive plastic 2200 welded or bonded to a non-conductive (e.g., plastic) substrate 404. As shown in FIG. 24, conductive plastic 2200 may be applied to contacts 1000 and 1002 of sensor 138 to mechanically attach sensor 138 to substrate 404. Once applied the conductive plastic 2200 on contacts 1000 and 1002, may itself form contacts 408 and 406 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500.



FIGS. 25 and 26 show an exemplary ultrasonic welding system for welding conductive plastic 2200 to substrate 404. As shown in FIG. 25, substrate 404 may be provided with a recess within which a protrusion on a conductive plastic member 2200 can be received. Sensor 138 may be disposed within a recess in the protrusion on conductive plastic member 2200 and conductive plastic member 2200 can be pressed in direction 2302 and vibrated by ultrasonic welding horn 2300 to form a melt region 2400 that, when horn 2300 is removed, solidifies to secure sensor 138 between substrate 404 and conductive plastic 2200 to form a conductive contact to sensor 138.


In some implementations, in order to provide a sensor 138 with additional surface area for clipping or soldering of contacts to substrate 404, the proximal end of sensor 138 may be rolled or otherwise flattened as shown in FIG. 27. As shown in FIG. 27, contacts 1000F and 1002F may be flat contacts that converge into a cylindrical wire sensor 138. As shown in the side view of sensor carrier 402 in FIG. 28, flattened contacts 1000F and 1002F may be attached to substrate 404 with conductive attachment members 2600 and 2602 such as clips, solder welds, an anisotropic conductive film, a conductive tape, a plastic member with embedded conductors, conductive springs, or elastomeric conductive members (as examples).


In one example, connectors such as contacts 1000F and 1002F (and/or other forms of contacts 1000 and 1002 described herein) may be laser soldered to corresponding contacts on substrate 404. In implementations in which sensor 138 is laser soldered to substrate 404, a trace surface of substrate 404 may be preheated by laser illumination at a soldering location. The surface heat emission may reflow a pre-deposited solder material on either side of sensor 139. A guide such as a borosilicate glass “angle” may be placed over the sensor and per-deposited solder to retain the solder, driving molten solder towards the sensor. A resulting “cradle” bond may then securely anchor the sensor to the trace on substrate 404 which may help increase or maximize a trace-to-solder-sensor contact wire bonding area. Use of a guide such as a borosilicate glass angle may also protect printed circuit board assembly electronics that may be included on and/or in the substrate from solder debris during the hot portion of the soldering process.


In another example, connectors such as contacts 1000F and 1002F (and/or other forms of contacts 1000 and 1002 described herein) may be soldered to corresponding contacts on substrate 404 without a laser. In these example, solder wire may be pre-fed onto a tip of a soldering iron to build up a blob of molten solder on the tip. The iron may then be moved down so the blob touches the sensor and conductive trace on the substrate. A coating on the sensor such as the Ag/AgCl coating described herein may be provided with a low thermal mass such that the sensor coating heats up quickly without freezing the solder. Once the coating is heated, the solder wets to the coating. The trace would also have minimal thermal mass so it will heat up quickly without freezing the solder. A solder mask may be provided around the trace that prevents the solder flowing off the edge of the trace.


In some implementations, substrate 404 may be formed, at least in part, by a flexible circuit (e.g., a polyimide substrate having conductive traces or other suitable flex circuit) that folds over and/or around at least a portion of sensor 138 to conductive traces of the flex circuit. FIG. 29 shows a top view of a flex circuit implementation of substrate 404 in which substrate 404 is a flexible circuit having a central, non-conductive, elongated portion 2702 along which sensor 138 is oriented and having upper and lower extensions 2700 and 2704 that extend from central portion in a directed perpendicular to the elongated dimension of central portion 2702. Extensions 2700 and 2704 respectively include conductive contacts 2706 and 2708 that form contacts 408 and 406. Conductive contacts 2706 and 2708 may be coupled, via traces and/or conductive vias on or within substrate 404 to external contacts that form contacts 412 and 410. In some instances, extensions 2700 and 2704 may allow for testing, calibration, sensor electronics or other equipment to connect to sensor carrier/sensor assembly in area that is not occupied by the sensor. This may allow for additional connection types and/or improve electrical coupling of connection.



FIG. 30 shows an implementation of sensor carrier 402 in which substrate 404 includes a wedge-shaped base portion 2800 and a foldable flexible portion 2802. Conductive contacts 2804 may extend from base portion 2800 to foldable portion 2802 so that, when sensor 138 is placed on base portion 2800 and optionally foldable portion 2802 is be folded over sensor 138 (e.g., in direction 2820) to wrap over and around sensor 138, contacts 410 and 412 electrically couple to sensor 138. Base portion 2800 may be rigid and may taper in a direction away from sensor 138. Base portion 2800 may include conductive contacts 410 and 412 at a narrow end. Base portion 2800 may, for example, be removably inserted into recesses 5006 and 5014 of testing station 5002 and calibration station 5004 for testing and calibration operations. In the examples of FIGS. 27 and 28, the flexible substrate may be folded over the sensor and secured (e.g., to the sensor and/or to itself to secure the sensor by a welding soldering, a mechanical crimp, spring contacts, rivets, adhesive such as epoxies, or the like.



FIGS. 31A and 31B illustrate another embodiment of a sensor carrier 402. In this embodiment, the sensor carrier 402 comprises a block 404 made of non-conducting material such as a polymer or ceramic. The block 404 includes a through-hole 1420 extending therethrough along the y-axis through which the proximal ex vivo portion of the analyte sensor 138 extends. Slots or blind holes 1410 and 1412 intersect the through-hole 1420 on an orthogonal z-axis to the through hole y-axis. Conductive contact material 406 and 408 is plated on the top surface and extends into the slots 1410 and 1412. Additional holes 1430 and 1432 extending along the x-axis intersect both the through-hole 1420 and the slots 1410 and 1412. Each hole 1430 and 1432 extends across its respective slot and partway into the block on the other side of each slot forming a blind hole or depression 1442, 1444 on the other side. Plugs 1451 and 1453, which may be conductive or non-conductive are inserted into the holes 1430 and 1432 and push the contacts 212b and 211b of the wire analyte sensor into the depressions 1442, 1444, causing the contacts 212b and 211b to come into electrical contact with the sensor carrier contacts 406 and 408.



FIG. 32 shows a top view of a sensor carrier having a substrate 404, a datum feature 2900, and a movable connector 2902 for each of contacts 406 and 408. Sensor 138 may be aligned against datum features 2900 and movable connectors 2902 may be moved to secure each of contacts 1000 and 1002 between the corresponding datum feature and movable connector. Movable connectors 2902 and/or datum features 2900 conductively couple to contacts 1000 and 1002. Movable connectors 2902 and/or datum features 2900 may be conductively coupled to other contacts (not shown) on substrate 404 that form contacts 410 and 412. FIG. 33 is a perspective view of one of datum features 2900 and an associate movable contact 2902, movable in a direction 2904 toward datum feature 2900 to secure sensor 138. Contacts 1000 and 1002 may be flattened to enhance contact with datum feature 2900 and contact 2902. Additional conductive material 2906 may be formed on substrate 404 between datum feature 2900 and contact 2902 to enhance electrical contact with sensor 138 if desired. The additional conductive material may be an exposed surface of a portion of an embedded conductive layer (e.g., a copper or other conductive metal layer) within substrate 404 or may be solder or a conductive adhesive (as examples).



FIG. 34 shows a perspective view of a pre-connected sensor formed from a sensor carrier implemented as a barrel connector that substantially surrounds sensor 138. In the example of FIG. 34, substrate 404 may be an insulating layer formed around sensor 138 with conductive bands that extend from an internal contact with contacts 1000 and 1002 to an external surface that forms contacts 410 and 412. As shown in FIG. 34, annular contacts 410 and 412 may be removable received by a press fit into conductive brackets 3102 and 3104 of a device 3100 (e.g., testing station 5002, calibration station 5004, and/or electronics unit 500). Conductive brackets 3102 and 3104 may establish electrical communication between sensor 138 and device 3100 (e.g., testing station 5002, calibration station 5004, and/or electronics unit 500).



FIG. 35A shows an implementation of sensor carrier 402 in which a flexible circuit is wrapped over an end of sensor 138 such that a top portion 3200 and a bottom portion 3202 of the flexible substrate are formed on opposing sides of sensor 138. As shown in FIG. 35B, top portion 3200 and bottom portion 3202 may be wrapped over the ends of multiple sensors 138 such that a flex circuit strip 3404 forms a common sensor carrier for multiple sensors. Flex circuit strip 3204 may include pairs of internal contacts for coupling to contacts 1000 and 1002 of each sensor 138 and pairs of external contacts, each pair of external contacts coupled to a corresponding pair of internal contacts and forming contacts for coupling to testing station 5002 and/or calibration station 5004. In this way, multiple sensors can be transported and coupled to testing and calibration equipment as a group. Strip sensor carrier 3204 may include identifiers for each sensor 138 so that testing and/or calibration data for each sensor can be logged and stored. Individual pre-connected sensors may be formed by singulating strip sensor carrier 3204 into individual sensor carriers for each sensor that can be installed in an electronics unit, such as the wearable sensor units of FIGS. 13 and 14. Strip 3204 may include singulation features 3220 (e.g., markings and/or scoring that facilitate singulation into individual pre-connected sensors.


Although FIGS. 35A and 35B show a flexible circuit strip that is wrapped around the ends of sensor 138, this is merely illustrative. It should be appreciated that a flex strip carrier for more one or more sensors 138 may be attached to the sensor(s) in other ways. For example, the ends or other portions of sensors 138 may extend into a substrate of flexible circuit strip 3204 to couple to internal conductive contacts in the strip or the ends or other portions of sensors 138 may be attached to a surface of flexible circuit strip 3204 (e.g., using an anisotropic conductive film (ACF) or other conductive adhesive, a laser solder or other solder, a clip or other attachment mechanisms and/or datum features that position and align the sensor).



FIG. 36 shows an implementation of sensor carrier 302 in which a crimp connector 3301 extends through a portion of substrate 404. As shown in FIG. 36, crimp connector 3301 may have a base portion 3300 that extends from a first side of substrate 404 (e.g., to form one of contacts 410 and 412). Crimp connector 3301 also includes arms 3302 extend from an opposing second side of substrate 404. As shown in FIG. 37, arms 3302 can be pressed together or crimped to mechanically secure and conductively couple to sensor 138, thereby forming, for example, contact 406. FIG. 38 shows a side view of the sensor carrier of FIGS. 36 and 37 and shows how two crimp connectors may be provided that extend through substrate 404 and form contacts 406 and 408 on a first side and contacts 410 and 412 on a second side. Although contacts 410 and 412 are formed on the second side of substrate 404 in FIG. 38, it should be appreciated that contacts 410 and 412 can be formed on the first side, or on a sidewall or edge of substrate 404 (e.g., by including one or more bends or other conductive couplings within substrate 404).



FIG. 39 shows an implementation of pre-connected sensor in which sensor carrier 402 includes a distally oriented channel 358 that directs sensor 138 distally such that sensor 138 includes a bend that is at least 45 degrees and/or less than 135 degrees. A channel cover 362 secures the glucose sensor 138 in the distally oriented channel 358. In the example of FIG. 39, one or more contacts (e.g. 408 and 406) are implemented using conductive elastomeric members 1400. In other embodiments contacts may be any suitable type (e.g. coil springs 306, leaf spring 306d). Contacts (e.g. conductive elastomeric members 1400) form a conductive coupling between sensor 138 and external equipment (e.g., testing station 5002, calibration station 5004, and/or on-skin sensor assembly 600). Contacts may cooperate with underlying features on substrate 404 (e.g., protrusions 308) and/or channel 322d, as shown, to form datum features that secure and align sensor 138 with respect to sensor carrier 402 (e.g., for manufacturing, calibration, testing, and/or in vivo operations). In some implementations, the sensor 138 maybe bent, glued, or bonded so as to be affixed within sensor carrier 402.



FIG. 40 shows an implementation of sensor carrier 402 in which substrate 404 is a molded interconnect device. In the example of FIG. 40, substrate 404 is formed from molded thermoplastic or thermoset (e.g., acrylonitrile butadiene styrene, a liquid crystal polymer, a polyimide/polyphthalamide plastic, or other thermoplastic or thermoset polymer materials) that includes conductive traces 3702. Conductive traces 3702 may be formed on a surface of substrate 404 and/or may pass into and/or through portions of substrate 404 to form suitable connections. Conductive traces may be formed on the molded substrate using a variety of techniques (e.g. selective plating via laser etching, combining platable and non platable substrate polymers, or other suitable methods). In other embodiments, a conductive material (e.g. conductive polymer, metal stamping, plated polymer, metallic structure) may be overmolded with a non-conductive material.


To create suitable electrical connections as shown in FIG. 40, conductive traces 3702 are electrically coupled between contacts (e.g. contact region 1000 and 1002 on sensor 138) and external contacts (e.g. contacts 410 and 412). Although contacts (e.g. 410 and 412) are formed on the same surface of substrate 404 to which sensor 138 is attached in the example of FIG. 37, this is merely illustrative. It should be appreciated that contacts (e.g. contacts 410 and 412) may be formed on an opposing surface or on an edge or sidewall of substrate 404 and coupled to contacts (e.g. contacts 408 and 406) by conductive materials (e.g. conductive layers, structures, adhesive, clips, solder, or interconnects) within or on substrate 404. For example, contacts (e.g. contacts 410 and 412) may form a designated area to interface electrical coupling on a different surface or region of substrate 404 on which sensor 138 is attached. The designated area may form a channel, groove, recess, slot, or similar alignment feature for orienting the sensor.


Molded thermoplastic substrate 404 may be an injection-molded substrate having features that facilitate various aspects of testing, calibration, and wearable device installation for sensor 138. For example, molded thermoplastic substrate 404 may include datum features or other locating features or positioning features such as a recess 3700 having a shape that is complementary to the shape of the proximal end of sensor 138. For example, recess 3700 may include three or more stepped regions that correspond to the steps between the different layers of the coaxial analyte sensor such as shown in FIG. 3D. In other configurations, molded thermoplastic substrate 404 may include a flat-walled recess as in the example of FIG. 18, a wall that forms a corner as in the example of FIG. 19, or a rounded recess as in the example of FIG. 20. In yet other configurations, molded thermoplastic substrate 404 may include raised features or protrusions on the surface that position and align sensor 138. For example, a raised channel having a shape corresponding to the shape of sensor 138 may be provided on the surface of molded thermoplastic substrate 404. As another example one more posts may extend from the surface of molded thermoplastic substrate 404. For example, one or more lines of protrusions can be formed on the surface of molded thermoplastic substrate 404 against which and/or between which sensor 138 can be positioned and aligned. In this way, various configurations can be provided for a molded thermoplastic substrate 404 including datum features that orient sensor 138 in a preferred direction at a preferred position.


Molded thermoplastic substrate 404 may also include other shaped features such as finger holds 3720 on opposing sides the substrate that facilitate grasping, holding, and transporting of sensor 138. Molded thermoplastic substrate 404 may also include other shaped features such as anchoring features corresponding to the shape of connectors for manufacturing equipment 5091, testing equipment 5004, and calibration equipment 5004 such as grasping connector features 5093/5095 of manufacturing equipment 5091 and/or recess connectors 5006 and 5014 of testing equipment 5002 and calibration equipment 5004. Anchoring features formed on molded thermoplastic substrate 404 and/or by molded thermoplastic substrate 404 itself may include one or more protrusions such as posts, snap-fit features, arms such as arms 202 (see, e.g., FIGS. 11-14), recesses, notches, hooks, and/or tapered portions similar to the tapered portions shown in FIG. 28 (as examples). In some examples, a portion of molded thermoplastic substrate 404 or the entire molded thermoplastic substrate 404 may have a shape that corresponds to the shape of a mounting receptacle on or within one or more of manufacturing equipment 5091, testing equipment 5002, calibration equipment 5004, carriers, and/or a wearable device.


Although substrate 404 is shown in FIG. 40 as being substantially rectilinear, a molded thermoplastic substrate 404 can be provided with features 3720 and/or an overall shape such as a handle shape for inserting, pulling, or otherwise manipulating sensor 138 during manufacturing and assembly operations. For example, molded thermoplastic substrate 404 may include a main portion configured to mechanically and electrically interface with manufacturing equipment 5091, testing equipment 5002, calibration equipment 5004, and/or a wearable device, and a gripping portion that extends from the main portion. The gripping portion may extend from the manufacturing equipment 5091, testing equipment 5002, or calibration equipment 5004 during manufacturing operations to facilitate removal of sensor carrier 402 and sensor 138 from the equipment after or between the manufacturing operations. The gripping portion may be integrally formed with the main portion or may be a separate component that extends from the surface of, or from within, molded thermoplastic substrate 404. The gripping component may be a post, a stock, a shaft, or an arched handle shaped for gripping by a gripping tool or by hand (e.g., by a technician).


As shown in FIG. 40, sensor 138 may be placed in recess 3700 and secured to substrate 404 using adhesive 3704 (e.g., a conductive adhesive as described herein). Adhesive 3704 may be applied to couple contact 1000 of sensor 138 to a first conductive trace 3702 on substrate 404 to form contact 408 between sensor 138 and sensor carrier 402. Adhesive 3704 may be also applied to couple contact 1002 of sensor 138 to a second conductive trace 3702 on substrate 404 to form contact 406 between sensor 138 and sensor carrier 402. In this way, molded thermoplastic substrate 404 can provide a handle and/or a strain relief member for moving and/or otherwise handling sensor 138.



FIG. 41 shows a top view of sensor carrier 402 of FIG. 40. As shown in FIGS. 40 and 41, the first conductive trace 3702 may extend from a contact portion with contact 1000 within recess 3700 to form one or more exposed portions on the surface of substrate 404 that form external contact 412 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500. The second conductive trace 3702 may extend from a contact portion with contact 1002 within recess 3700 to form one or more exposed portions on the surface of substrate 404 that form external contact 410 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500.



FIG. 42 shows a specific implementation of sensor carrier 402 as illustrated in FIGS. 40 and 41. In this implementation of sensor carrier 402, sensor 138 is attached to substrate 404 with a conductive coupler 3900, such as, for example, clips, conductive adhesive, conductive polymer, metallic foil, conductive foam, conductive fabric, wire wrapping, wire threading or via any suitable methods. As shown in FIG. 43, a substrate 4000 may have an elongated dimension along which parallel conductive strips 4001 and 4002 are formed. Multiple sensor 138 may be attached to substrate 4000 and extend beyond an edge of the substrate in a direction perpendicular to the elongated dimension of the substrate. Singulation features such as scoring 4020 may be provided that facilitate singulation of substrate 4000 into individual sensor carrier substrates 404 for each sensor and/or that electrically isolate portions of conductive strips 4001 and 4002 for each sensor. Each sensor may be attached to substrate 4000 using, for example clips 3900 or any other methods including, via the use of conductive adhesive, conductive polymer, metallic foil, conductive foam, conductive fabric, wire wrapping, wire threading or any other suitable methods. An identifier 450 for each sensor may be provided on a corresponding portion of substrate 4000.


Sensors 138 may each have a pair of sensor electrical contacts (e.g., contacts 1000 and 1002) coupled to a corresponding pair of electrical contacts formed from strips 4001 and 4002 on the substrate. Openings in substrate 4000 and/or vias that extend through substrate 4000 may provide exposed portions of strips 4001 and 4002 that form a plurality of pairs of electrical contacts for coupling each sensor 138 to testing station 5002, calibration station 5004, and/or electronics unit 500 (e.g., an electronics unit of a wearable device). Each of the plurality of pairs of electrical contacts is coupled to an associated pair of portions of strips 4001 and 4002 via the substrate.



FIGS. 44-46 show various contact configurations on sensor carriers that can be singulated from a sensor carrier strip of the type shown in FIG. 43. In the example of FIG. 44, a z-shaped contact configuration on substrate 4000 has been singulated to form a pre-connected sensor on a smaller portion of the substrate, referred to as substrate 404. In this instance, the z-shaped contact configuration may allow for greater distance between connectors (e.g., larger pitch connection) on testing, manufacturing, or calibration equipment, though a z-shaped substrate is not necessary to generate the greater distance and other substrate shapes can be used. In the example of FIG. 45, a square portion of substrate 4000 has been singulated to form a pre-connected sensor on the substrate 404. In the example of FIG. 46 a square portion of substrate 4000 has been singulated to form a pre-connected sensor and an opening 4300 (e.g., an air gap) is provided in the singulated substrate 404 to improve electrical isolation between singulated contact strip portions 4001 and 4002.


As shown in FIG. 47A, in some implementations, an elongate substrate 4000 that forms a sensor carrier for multiple sensor 138 can be provided with a feed-guide strip 4402 that runs along an elongated edge of the elongate substrate. Feed-guide strip 4402 may include locating features 4404 that can be accessed and manipulated to move and register a strip of pre-connected sensors through one or more manufacturing stations.


In the implementation of FIG. 47A, sensors 138 can be attached to substrate 4000 in bulk and singulated on substrate 404 after manufacturing or testing operations. As shown in FIG. 47B, a strip of pre-connected sensors as shown in FIG. 47A can be provided on a reel 4410 for bulk storage and/or transportation and optionally automatically pulled from the reel using feed-guide strip 4402 to be moved through one or more testing stations and/or one or more calibration stations. FIG. 48 shows a pre-connected sensor having a sensor carrier that has been singulated from substrate 4000 and separated from a singulated portion 4402 of feed-guide strip 4402. Alternatively, feed-guide strip 4402 can be separated as a strip prior to singulation of individual pre-connected sensors. In other embodiments, the feed guide is integrated into the final product configuration and not removed from the sensor carrier during or after singulation.



FIG. 49 shows an implementation of sensor carrier 402 in which a plurality of sets of contacts 406 and 408 are formed from receptacles 4600 having a slot for receiving a corresponding plurality of sensors 138. In some implementations, the receptacles 4600 may be an elongated member comprising a resilient or flexible material. The receptacles 4600 may have slots that optionally pierce through an insulation layer or deform a portion of the outer layer so as to make contact with the sensors 138.



FIG. 50 shows an implementation of a sensor carrier for multiple sensors 138 having recesses 4700 that form datum features to hold each sensor in an accurate alignment and position. Complementary magnetic features may be provided on sensor 138 and substrate 404 to hold each sensor in an accurate alignment and position and thereby facilitate accurate sensor processing.



FIG. 51A shows an implementation of an elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate, from which multiple sensor carriers 402 can be singulated. Flexible portion of the substrate may be manufactured from a material such as polyimide, PEEK, polyester or any suitable type. Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6, insulated metal substrate (IMS), PTFE, or any suitable type. As shown in FIG. 51A, each sensor carrier may include a sensor connection portion 4804 and an interface or processing portion 4802. In some implementations, each sensor carrier may include a sensor connection portion 4804 that extends from a rigid or flexible portion and an interface or processing portion 4802 that extends from a rigid or flexible portion. In these implementations, one or more contacts, such as contacts 406 and 408 can be formed on the sensor connection portion 4804 of each sensor carrier 402. Sensor connection portions 4804 of substrate 4800 may contain anchoring or datum features of sensor carriers 402.



FIG. 51B shows another implementation of an elongate substrate 4800 as shown in FIG. 51A with an optional electrical connection interface 4850 for connecting to a work station, such as a testing station, a calibration station, an assembly station, a coating station, or other manufacturing stations. The optional electrical connection interface 4850 may be coupled to one or more sensor carriers 402 through electrical traces configured on one or more layers of the circuit board. As shown in FIG. 51B, a plurality of sensor carriers 402 are assembled in a panel, and each of the sensor carrier 402 may include a sensor connection portion 4804 that extends from a flexible or rigid portion and an interface or processing portion 4802 that extends from a flexible or rigid portion. In these implementations, one or more contacts, such as contacts 406 and 408 can be formed on the sensor connection portion 4804 of each sensor carrier 402. Sensor connection portions 4804 of substrate 4800 may contain anchoring or datum features of sensor carriers 402. In some implementations, the elongate substrate 4800 shown in FIG. 51B may be configured to allow the sensor 138 to extend beyond the edge of the substrate. This may be accomplished by removing a portion of the elongated substrate 4860 for further processing. In some embodiments a perforation (e.g. V-score, mouse bites, or other suitable type) is included in elongated substrate 4800 for enabling the removal of the bottom portion of the panel 4860 for dipping or calibration. In this implementation, the elongated substrate 4800 can be configured for dipping or calibration, as described in FIG. 52B.


Now referring to FIG. 52A, an implementation of a sensor carrier 402 is shown with one or more sensor contacts (e.g. contacts 406 and 408) on sensor connection portion 4804 and one or more one or more interface contacts (e.g. contacts 410 and 412) on an interface or processing portion 4802. One or more interface contacts (e.g., 410 and 412) may be formed on sensor carrier 402 for coupling to testing station 5002, calibration station 5004, and/or electronics unit 500. In this configuration, testing and/or calibration operations can be performed by coupling portion 4802 to the testing and/or calibration equipment.



FIG. 52B shows an example panel implementation of a plurality of sensor carriers 402 with electrical connection interface 4850 for interfacing with electronics of a work station, such as a testing station, a calibration station, an assembly station, a coating station, or other manufacturing stations. The illustration of FIG. 52B shows the elongate substrate 4800 of FIG. 48B after the bottom panel portion 4860 has been removed (from the illustration of FIG. 51B) and with sensor 138 attached via one or more sensor contacts (e.g. contacts 406 and 408). In some implementations, the sensors can be permanently connected (e.g. conductive adhesive, conductive polymer, conductive ink, solder, welding, brazing, or other suitable methods) to the sensor carriers 402 and both components can be calibrated together or separately. In other implementations, the sensors can be releasably attached (e.g. via clips, metallic foil, conductive foam, conductive fabric, wire wrapping, wire threading or any other suitable methods).


Following testing and/or calibration operations, flexible portion 4802 may be folded around, folded over, wrapped around, wrapped over, or manipulated to envelope portion 4804 for installation into on-skin sensor assembly 600. In the example of FIG. 53A, portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112. In other implementations, portion 4802 may be coupled directly to signal processing circuit for assembly 600, to a system in package (SIP) implementation of the sensor electronics or a main printed circuit board for the sensor electronics. In the example of FIG. 53B, the flexible portion 4804 is folded to envelope portion 4802 for installation into on-skin sensor assembly 600 so as to have sensor 138 positionally secured to extend (e.g. through opening 4808) for insertion for in vivo operations.



FIG. 54 shows an implementation in which sensor carrier 402 is manufactured using printed circuit board technology as a daughter board for a main printed circuit board 5100 for the sensor electronics. As shown in FIG. 54, one or more contacts such as contacts 5104 (e.g., solder contacts) may be formed between sensor carrier 402 and main PCB 5100 to form sensor electronics unit for sensor 138 in on-skin sensor assembly 600. Conductive traces 5102 may couple contacts 5104 to sensor 138 via a conductive attachment mechanism 5103 (e.g., solder, conductive adhesive, a conductive tape, or other conductive attachment as discussed herein).



FIG. 55 shows an implementation of sensor carrier 402 in which a pinch clip 5200 is provided to close the arms 5204 of a crimp connector 5202 to secure sensor 138 to substrate 404. Connector 5204 may be formed form a conductive material that forms one of contacts 410 and 412. As shown in FIG. 55, pinch clip 5200 includes clasping arms 5208 with ramped surfaces that push the arms outward as pinch clip 5200 is move toward substrate 404 in direction 5206 and snap back to secure pinch clip 5200 to substrate 404. In other implementations, pinch clip 5200 may be provided without clasping arms 5208 so that pinch clip 5200 is removable after arms 5204 are pinched closed so that pinch clip 5200 does not form a part of the sensor carrier. As shown in FIG. 55, one or more electrode breakouts 5220 may be provided to form, for example, one or more of contacts 410 and 412 on substrate 404. Although breakout 5220 is formed on a surface of substrate 404 that is opposed to the surface to which sensor 138 is attached in the example of FIG. 55, this is merely illustrative. It should be appreciated that breakouts for contacts such as contacts 410 and 412 may be formed on the opposing surface, on the same surface as sensor 138, or on an edge or sidewall of substrate 404 and coupled to contacts 408 and 406 by conductive vias or other conductive layers, structures, or interconnects within or on substrate 404. In some implementations, a pinch clip 5200 may be used to apply bias force against sensor 138 in combination with crimp connector 5202 or directly against substrate without crimp connector 5202. Pinch clip 5202 may apply force radially, axially, or in a suitable direction to provide a biasing force on sensor 138 and conductive pathway.



FIG. 56 shows an implementation of sensor carrier 402 in which contacts 406 and 408 are formed from foldable conductive clips 5300. Sensor 138 may be inserted through openings 5302 in each clip 5300 and mechanically secured to substrate 404 and conductively coupled to clips 5300 by a folding a portion 5304 of each of clips 5300 over onto sensor 138.


Portions 5304 of clips 5300 may also form contacts 410 and 412 for coupling to external equipment such as a manufacturing station (e.g., a testing station, a calibration station, an assembly station, a coating station, or other manufacturing stations). However, this is merely illustrative. In other implementations, one or more electrode breakouts that are conductively coupled to clips 5300 may be provided to form, for example, one or more of contacts 410 and 412 on substrate 404. Such breakouts may be formed on a surface of substrate 404 that is opposed to the surface to which sensor 138 is attached, on the same surface as sensor 138, or on an edge or sidewall of substrate 404 and coupled to clips 5300 by conductive vias or other conductive layers, structures, or interconnects within or on substrate 404.


Clips 5300 also form datum features for positioning and aligning sensor 138 relative to substrate 404. Substrate 404 may be sized and shaped (or may include structural features) that form anchoring features for substrate 404 relative to manufacturing stations and/or a housing of a wearable device. In this way, sensor carrier 402 may be used to easily position and align sensor 138 for both manufacturing and assembly operations (e.g., using the datum features to align the sensor relative to substrate 404 and the anchoring features to align the substrate relative to the manufacturing or wearable equipment).


The conductive components of the sensor carrier 402 in the various embodiments described herein are electrically isolated from each other and the environment when installed in on-skin sensor assembly 600. For example, contacts 406, 408, 410, and 412 may be electrically isolated from each other and the environment, using a non-conductive adhesive such as a one or two-part epoxy, using a polyurethane, using a low pressure overmolding such as a moldable polyamide or a moldable polyolefin, using an injection overmolded thermoplastic or thermoset, using a non-elastomer such as welded clamshell plastic, adhesively bonded clamshell, single or 2-sided cavity potted with sealant, e.g., epoxy, urethane, silicone, etc., or using a factory pre-compressed elastomer such as a constrained two-part cavity that holds an elastomer in a compressed state. The two-part cavity may hold the elastomer in the compressed state by a snap fit, a bonding such as an ultrasonic weld, a laser weld, a solvent bond, or a heat stake, or a mechanical fastener such as a screw, rivet, clip, or other fastener.


Illustrative operations that may be performed for manufacturing and using a pre-connected analyte sensor are shown in FIG. 57.


At block 5400, an analyte sensor such as analyte sensor 138 may be provided. As described herein the analyte sensor may have an elongated body (e.g., an elongated conductive body with an elongated conductive core), and a working electrode on the elongated body (e.g., at a distal end of the elongated body). The analyte sensor may also include one or more electrical contacts at a proximal end or elsewhere along the elongated body and coupled, respectively, to the working electrode and/or the reference electrode.


At block 5402, a sensor carrier such as one of the implementations of sensor carrier 402 described herein may be attached, for example, to the proximal end of the elongated body. Attaching the sensor carrier includes coupling one or more contacts (e.g., on a substrate) of the sensor carrier to one or more corresponding electrical contacts on the elongated body.


At block 5403, a work station such as a manufacturing station is provided. As described herein, a manufacturing station can be configured to perform one or more dip coating processes to form the membrane 108 described above on the working electrode.


At block 5404, the analyte sensor may be coupled to at least one testing station (e.g., testing station 5002) by coupling the sensor carrier to circuitry of the at least one test station. Coupling the sensor carrier to the circuitry of the at least one test station may include mechanically coupling one or more anchoring features such as a substrate of the sensor carrier to a mating interface of the test station such that one or more external contacts on the substrate are coupled to one or more corresponding contacts at the test station. An identifier for the sensor on the sensor carrier may be read by the testing station. Test data obtained by the test station may be stored and/or transmitted, in association with the identifier, by the test station.


At block 5406, the analyte sensor may be coupled to at least one calibration station (e.g., calibration station 5004) by coupling the sensor carrier to circuitry of the at least one calibration station. Coupling the sensor carrier to the circuitry of the at least one calibration station may include mechanically coupling the one or more anchoring features such as the substrate of the sensor carrier to a mating interface of the calibration station such that one or more external contacts on the substrate is coupled to one or more corresponding contacts at the calibration station. An identifier for the sensor on the sensor carrier may be read by the calibration station. Calibration data obtained by the calibration station may be stored and/or transmitted, in association with the identifier, by the calibration station. Calibration data may be stored on the sensor carrier or transmitted for later use by an on-skin sensor assembly 600 during in vivo use of sensor 138.


Sensor carrier 402 may be coupled to one or more additional manufacturing stations as desired. The additional manufacturing stations may include potentiostat measurement stations, sensor straightening stations, membrane dipping stations, curing stations, analyte sensitivity measurement stations, and/or inspection stations.


At block 5408, the sensor carrier may be coupled to sensor electronics (e.g., sensor electronics 112 of electronics unit 500) of a wearable device such as on-skin sensor assembly 600. Coupling the sensor carrier to the sensor electronics may include coupling the one or more external contacts on the sensor carrier to corresponding contacts of the sensor electronics. In some embodiments, coupling the sensor carrier to the sensor electronics may include securing the sensor carrier between a base such as base 128 and electronics unit 500 as described herein. A reader in the on-skin sensor assembly 600 may obtain an identifier of the sensor from the sensor carrier. Calibration data for the sensor may be obtained based on the identifier.


At block 5410, in vivo signals from the working electrode (e.g., and a reference electrode) may be obtained and processed with the sensor electronics. The in vivo signals from the working electrode (e.g., and a reference electrode) may be received by the sensor electronics from the sensor through the circuitry of the sensor carrier.


The methods disclosed herein comprise one or more steps or actions for achieving the described methods. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims. For example, the operations described above in connection with blocks 5404 and 5406 may be reversed and/or may be performed in parallel.


In some scenarios, it may be desirable to couple sensor 138 to one or more contacts on a substrate in a preferred position and orientation. FIG. 58 shows an exemplary apparatus 5531 in which sensor 138 is oriented to substrate 5530 using an elastomeric tube. As shown in FIG. 58, apparatus 5531 may include a substrate 5530 having one or more conductive contacts such as contacts 5532 and 5534 (e.g., exposed copper pads on a printed circuit substrate), and an elastomeric tube 5500. Elastomeric tube 5500 may be formed from a non-conductive elastomer.


As shown, elastomeric tube 5500 may be formed with a “D”, “O”, oval, pyramidal, or hemispherical shaped cross-section having an elongated cutout 5503 in the bottom portion of the elastomeric tube 5500 within which sensor 138 is disposed. In this way, sidewalls of the elongated cutout of elastomeric tube 5500 can align sensor 138 relative to substrate 5530.


Bottom portions 5502 on either side of cutout 5503 may be attached to substrate 5530. The bottom portions 5502 may be attached to substrate using adhesive 5504 such as a pressure-sensitive adhesive. The elongated opening 5501 and cutout 5503 in the elastomeric tube 5500 provides sufficient space that, in order to assemble the apparatus, tube 5500 can be placed over sensor 138 while sensor 138 is in place on substrate 5530.



FIG. 59 shows an exploded perspective view of the apparatus of FIG. 55 in which contacts 5532 and 5534 can be seen on substrate 5530. Sensor 138 may be positioned over one or more contacts such as contacts 5532 and 5534.


Sensor 138 may be loosely held within opening 5501 of tube 5500 during initial placement of the tube over the sensor, and then be fixed to the substrate 5530 by the tube when the tube is compressed (e.g., by an upper housing of a wearable device). In this way, sensor 138 may be communicatively coupled and mechanically fixed to a substrate without soldering or other bonding operations.


During manufacturing operations and/or during in-vivo use of sensor 138, sensor 138 may be held in place on substrate 404 by external compression of tube 5500. FIG. 60 shows an example in which sensor 138 is held in place by compression of tube 5500 by a housing structure. For example, housing 5700 (e.g., a housing of a wearable device or a lid or clip for a manufacturing station) may include a protruding member 5702 that, in an assembled configuration, compresses tube 5500 to secure sensor 138.


As noted above in connection with, for example, FIGS. 35B, 43, 47A, 47B, 50, and 51, during manufacturing operations, multiple sensors 138 may be carried by a common sensor carrier. However, in some scenarios, a common carrier such as an intelligent carrier may be provided for manufacturing operations for multiple pre-connected sensors. FIG. 61 shows an example of a carrier for multiple pre-connected sensors. As shown in FIG. 58, a carrier 5800 may include a housing 5802 with interfaces 5804 for multiple pre-connected sensors. Housing 5802 may be a substantially solid substrate or may be a housing that forms an interior cavity within which other components are mounted and/or connected.


Each interface 5804 may be configured to receive a sensor carrier 402 in any of the implementations described herein. For example, each interface 5804 may include one or more features that interface with one or more corresponding anchoring features of a sensor carrier as described herein in accordance with various implementations. Carrier 5800 may include circuitry 5806 (e.g., one or more processors and/or memory) configured to communicate with sensors 138 and/or external computing equipment. Circuitry 5806 may include communications circuitry such as one or more antennas for transmitting and/or receiving data from external equipment. Housing 5802 may include one or more structures 5810 (e.g., clips, clasps, protrusions, recesses, notches, posts, or the like) for mechanically coupling carrier 5800 to manufacturing equipment. One or more conductive contacts 5808 may be provided on housing 5802 that communicatively couple manufacturing equipment to sensors 138 through the carrier.


As shown, each interface 5804 may be associated with a particular identification number (represented, as an example, in FIG. 58 as I1, I2 . . . IN-1, and IN). Circuitry 5806 may electronically identify sensors mounted in interfaces 5804 of carrier 5800 with the identification number associated with that interface. However, this is merely illustrative. In other implementations, sensors 138 may be uniquely identified by circuitry 5806 using a reader in each of interfaces 5804 that reads an identifier such as identifier 450 on the sensor carrier. Testing and/or calibration data may be gathered by processing circuitry 5806 and stored and/or transmitted along with an identifier for each sensor.


During manufacturing, one or more pre-connected sensors may be loaded carrier 5800. Carrier 5800 may secure the pre-connected sensors therein and perform potentiostat measurements for each sensor (e.g., using circuitry 5806). Sensors 138 may be secured to interfaces 5804 by individual mounting features or carrier 5800 may be provided with a locking mechanism such as a slidable bar 5812. Slidable bar 5812 may be slidable (e.g., by a handle 5814) between an open position as shown, in which sensor carriers can be inserted into and removed from interfaces 5804, to a closed position in which bar 5812 blocks removal of the sensor carriers from the interfaces.


In some scenarios, an initial measurement test may be performed by carrier 5800 to test the potentiostat connection through the sensor interconnect electrodes and the sensor surfaces. Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may include physical manipulation of the sensor such as straightening of the sensors. Carrier 5800 may facilitate more efficient manufacturing by allowing multiple sensors to be straightened in a single operation using automated straightening equipment.


Carrier 5800 may facilitate potentiostat and/or other measurements at various stages of manufacturing for sensors 138. Potentiostat measurements may be performed before, during, and/or after straightening operations and information regarding sensor damage or any other mechanical stress that might be introduced by the straightening may be saved and/or transmitted along with associated sensor ID's.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include a membrane process in which dipping operations are performed to form a membrane such as membrane 508 for each sensor. Straightened sensors 138 mounted in carrier 5800 may be concurrently dipped. Potentiostat measurements may be performed before, during, and/or after membrane operations and information associated with the electrochemistry of the sensors and dipping process may be gathered, processed, stored, and/or transmitted by carrier 5800.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include a curing process. Performing curing for groups of sensors 138 mounted in carrier 5800 may allow the curing process to take less space, which can reduce the footprint of the manufacturing area used by curing equipment. Potentiostat measurements may be performed before, during, and/or after curing operations and information associated with the electrochemistry of the sensors and curing process may be gathered, processed, stored, and/or transmitted by carrier 5800.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include calibration operations. Because carrier 5800 can perform connection testing early in the manufacturing process, improved analyte/electrochemical calibration can be performed by carrier 5800 itself and/or in cooperation with external manufacturing equipment. Calibration data may be gathered, processed, stored, and/or transmitted by carrier 5800.


Gathering calibration and/or testing data with carrier 5800 can save time in connecting and disconnecting additional external equipment. Gathering calibration and/or testing data with carrier 5800, particularly when data is gathered and stored automatically in connection with sensor ID's, can also reduce calibration/testing errors because the data is gathered by the same equipment throughout various processes.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include analyte concentration measurements. For example, carrier 5800 may be moved by manufacturing equipment (e.g., a robotic arm) to expose the sensors 138 mounted in the carrier through various analyte baths (e.g., glucose baths). Carrier 5800 may gather electrical potential measurements during the various bath exposures. Information associated with the electrical potential measurements during the various bath exposures may be gathered, processed, stored, and/or transmitted by carrier 5800.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include analyte sensitivity measurements. Sensitivity measurements that may be performed by carrier 5800 may include baseline measurements that indicate the signal from each sensor without analyte exposure, slope measurements that indicate the signal change for a given amount of an analyte, and/or noise measurements. These sensitivity measurements may be stored, and/or transmitted by carrier 5800.


Manufacturing operations that may be performed for sensors 138 coupled to carrier 5800 may also include visual inspection operations (e.g., by a technician). Providing a group of pre-connected sensors, mounted in carrier 5800, that have already been through all of the testing/calibration/manufacturing operations described above may allow a more efficient and/or more automated visual inspection and rejection (e.g., because the exact physical location of each sensor within carrier 5800 is known). Sensors 138 that have exhibited unusual electrochemistry or mechanical stress during manufacturing operations can be flagged by carrier 5800 (e.g., using a display, a visual indicator, or transmission of flag information to an external device) for retesting or rejection.


The connections between the elements shown in some figures illustrate exemplary communication paths. Additional communication paths, either direct or via an intermediary, may be included to further facilitate the exchange of information between the elements. The communication paths may be bi-directional communication paths allowing the elements to exchange information.


Various operations of methods described above may be performed by any suitable means capable of performing the operations, such as various hardware and/or software component(s), circuits, and/or module(s). Generally, any operations illustrated in the figures may be performed by corresponding functional means capable of performing the operations.


The various illustrative logical blocks, modules and circuits described in connection with the present disclosure (such as the blocks of FIG. 2) may be implemented or performed with a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array signal (FPGA) or other programmable logic device (PLD), discrete gate or transistor logic, discrete hardware components or any combination thereof designed to perform the functions described herein. A processor may be a microprocessor, but in the alternative, the processor may be any commercially available processor, controller, microcontroller or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.


In one or more aspects, various functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. Computer-readable media includes both computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another. A storage media may be any available media that can be accessed by a computer. By way of example, and not limitation, such computer-readable media can comprise various types of RAM, ROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of instructions or data structures and that can be accessed by a computer. Also, any connection is properly termed a computer-readable medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, WiFi, Bluetooth®, RFID, NFC, and microwave are included in the definition of medium. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray® disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. Thus, in some aspects a computer readable medium may comprise non-transitory computer readable medium (e.g., tangible media). In addition, in some aspects a computer readable medium may comprise transitory computer readable medium (e.g., a signal). Combinations of the above should also be included within the scope of computer-readable media.


Certain aspects may comprise a computer program product for performing the operations presented herein. For example, such a computer program product may comprise a computer readable medium having instructions stored (and/or encoded) thereon, the instructions being executable by one or more processors to perform the operations described herein. For certain aspects, the computer program product may include packaging material.


Software or instructions may also be transmitted over a transmission medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of transmission medium.


Further, it should be appreciated that modules and/or other appropriate means for performing the methods and techniques described herein can be downloaded and/or otherwise obtained by a user terminal and/or base station as applicable. For example, such a device can be coupled to a server to facilitate the transfer of means for performing the methods described herein. Alternatively, various methods described herein can be provided via storage means (e.g., RAM, ROM, a physical storage medium such as a compact disc (CD) or floppy disk, etc.), such that a user terminal and/or base station can obtain the various methods upon coupling or providing the storage means to the device. Moreover, any other suitable technique for providing the methods and techniques described herein to a device can be utilized.


It is to be understood that the claims are not limited to the precise configuration and components illustrated above. Various modifications, changes and variations may be made in the arrangement, operation and details of the methods and apparatus described above without departing from the scope of the claims.


Unless otherwise defined, all terms (including technical and scientific terms) are to be given their ordinary and customary meaning to a person of ordinary skill in the art, and are not to be limited to a special or customized meaning unless expressly so defined herein. It should be noted that the use of particular terminology when describing certain features or aspects of the disclosure should not be taken to imply that the terminology is being re-defined herein to be restricted to include any specific characteristics of the features or aspects of the disclosure with which that terminology is associated. Terms and phrases used in this application, and variations thereof, especially in the appended claims, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing, the term ‘including’ should be read to mean ‘including, without limitation,’ ‘including but not limited to,’ or the like; the term ‘comprising’ as used herein is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps; the term ‘having’ should be interpreted as ‘having at least;’ the term ‘includes’ should be interpreted as ‘includes but is not limited to;’ the term ‘example’ is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; adjectives such as ‘known’, ‘normal’, ‘standard’, and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass known, normal, or standard technologies that may be available or known now or at any time in the future; and use of terms like ‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words of similar meaning should not be understood as implying that certain features are critical, essential, or even important to the structure or function of the invention, but instead as merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Likewise, a group of items linked with the conjunction ‘and’ should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as ‘and/or’ unless expressly stated otherwise. Similarly, a group of items linked with the conjunction ‘or’ should not be read as requiring mutual exclusivity among that group, but rather should be read as ‘and/or’ unless expressly stated otherwise.


Where a range of values is provided, it is understood that the upper and lower limit and each intervening value between the upper and lower limit of the range is encompassed within the embodiments.


With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. The indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope.


It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention, e.g., as including any combination of the listed items, including single members (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”


All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification are to be understood as being modified in all instances by the term ‘about.’ Accordingly, unless indicated to the contrary, the numerical parameters set forth herein are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to the present application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.


All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.


Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.


Furthermore, although the foregoing has been described in some detail by way of illustrations and examples for purposes of clarity and understanding, it is apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the description and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather to also cover all modification and alternatives coming with the true scope and spirit of the invention.


Various system and methods described may be fully implemented and/or controlled in any number of computing devices. Typically, instructions are laid out on computer readable media, generally non-transitory, and these instructions are sufficient to allow a processor in the computing device to implement the method of the invention. The computer readable medium may be a hard drive or solid state storage having instructions that, when run, are loaded into random access memory. Inputs to the application, e.g., from the plurality of users or from any one user, may be by any number of appropriate computer input devices. For example, users may employ a keyboard, mouse, touchscreen, joystick, trackpad, other pointing device, or any other such computer input device to input data relevant to the calculations. Data may also be input by way of an inserted memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of file-storing medium. The outputs may be delivered to a user by way of a video graphics card or integrated graphics chipset coupled to a display that maybe seen by a user. Alternatively, a printer may be employed to output hard copies of the results. Given this teaching, any number of other tangible outputs will also be understood to be contemplated by the invention. For example, outputs may be stored on a memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of output. It should also be noted that the invention may be implemented on any number of different types of computing devices, e.g., personal computers, laptop computers, notebook computers, net book computers, handheld computers, personal digital assistants, mobile phones, smart phones, tablet computers, and also on devices specifically designed for these purpose. In one implementation, a user of a smart phone or wi-fi-connected device downloads a copy of the application to their device from a server using a wireless Internet connection. An appropriate authentication procedure and secure transaction process may provide for payment to be made to the seller. The application may download over the mobile connection, or over the WiFi or other wireless network connection. The application may then be run by the user. Such a networked system may provide a suitable computing environment for an implementation in which a plurality of users provide separate inputs to the system and method. In the below system where factory calibration schemes are contemplated, the plural inputs may allow plural users to input relevant data at the same time.

Claims
  • 1. A wearable device for measuring an analyte concentration in a host, the wearable device comprising: a housing;a transcutaneous analyte sensor comprising: an in vivo portion configured to be inserted in a living body of a host during a sensor session, wherein the in vivo portion comprises an electrode, wherein the electrode is configured to generate a signal indicative of an analyte concentration; andan ex vivo portion configured to remain outside the living body of the host during the sensor session;a substrate located in the housing, wherein the substrate comprises: a first portion; anda second portion, wherein the second portion is folded over the first portion; andsensor electronics operably connected to the transcutaneous analyte sensor, wherein the sensor electronics is configured to process the signal generated by the electrode, wherein at least a portion of the sensor electronics is located on the first portion of the substrate.
  • 2. The wearable device of claim 1, wherein the substrate comprises a foldable portion positioned between and connecting the first portion of the substrate to the second portion of the substrate.
  • 3. The wearable device of claim 2, wherein the foldable portion of the substrate has a width that is less than a width of both the first portion of the substrate and the second portion of the substrate.
  • 4. The wearable device of claim 1, wherein the first portion comprises an opening, and wherein the transcutaneous analyte sensor extends into the opening.
  • 5. The wearable device of claim 1, wherein the first portion of the substrate is substantially parallel to the second portion of the substrate when the second portion of the substrate is folded over the first portion of the substrate.
  • 6. The wearable device of claim 1, wherein the first portion of the substrate lies in a common plane with the second portion of the substrate when the substrate is in an unfolded state.
  • 7. The wearable device of claim 1, wherein the substrate comprises a flexible circuit board.
  • 8. The wearable device of claim 1, wherein the sensor electronics comprises a battery, a processor, conductive traces, and wireless communication circuitry.
  • 9. The wearable device of claim 8, wherein a portion of the sensor electronics is located on the second portion of the substrate.
  • 10. The wearable device of claim 9, wherein the portion of the sensor electronics is the conductive traces.
  • 11. The wearable device of claim 1, wherein the sensor electronics comprises interface circuitry, and wherein the interface circuitry is configured to connect to calibration equipment during manufacture.
  • 12. The wearable device of claim 11, wherein the interface circuitry is configured to connect to traces on a test panel circuit board during manufacture.
  • 13. The wearable device of claim 12, wherein the substrate is configured to be integrally connected to the test panel circuit board during manufacture.
  • 14. The wearable device of claim 1, wherein the transcutaneous analyte sensor is removably attached to the substrate.
  • 15. The wearable device of claim 1, wherein the sensor electronics is configured to wirelessly transmit sensor data to an external device.
  • 16. The wearable device of claim 1, comprising an electrical contact, wherein the transcutaneous analyte sensor is operably connected to the sensor electronics via the electrical contact.
  • 17. The wearable device of claim 16, wherein the electrical contact is attached to the substrate.
  • 18. The wearable device of claim 17, wherein the electrical contact is located in or on a sensor carrier.
  • 19. A method for manufacturing a wearable device, the method comprising: providing a substrate in a first state, wherein the substrate comprises a first portion and a second portion, wherein at least a portion of sensor electronics is located on the first portion of the substrate, wherein the sensor electronics are configured to process a signal generated by an electrode during a sensor session, and wherein the signal is indicative of an analyte concentration;operably connecting a transcutaneous analyte sensor to the sensor electronics, wherein the transcutaneous analyte sensor comprises: an in vivo portion configured to be inserted in a living body of a host during a sensor session, wherein the in vivo portion comprises the electrode; andan ex vivo portion configured to remain outside the living body of the host during the sensor session, wherein the ex vivo portion of the transcutaneous analyte sensor is operably connected to the sensor electronics; andtransforming the substrate from the first state to a second state, wherein the transforming is performed by folding the substrate, wherein in the second state, the second portion is folded over the first portion.
  • 20. The method of claim 19, comprising placing the transformed substrate into a housing.
  • 21. The method of claim 20, comprising placing a portion of the transcutaneous analyte sensor into an opening in the substrate.
  • 22. The method of claim 21, comprising placing a portion of the transcutaneous analyte sensor through an opening in the housing.
  • 23. The method of claim 22, wherein the transforming comprises folding the substrate at a foldable portion having a width that is less than both the first portion and the second portion.
  • 24. The method of claim 19, comprising connecting the sensor electronics to calibration equipment when the substrate is in the first state.
  • 25. The method of claim 24, comprising detaching the substrate from a test panel when the substrate is in the first state.
  • 26. The method of claim 19, comprising singulating the substrate away from an array of other substrates.
  • 27. The method of claim 19, comprising attaching the transcutaneous analyte sensor to the substrate.
  • 28. The method of claim 27, comprising attaching the transcutaneous analyte sensor to the substrate via a sensor module.
  • 29. The method of claim 19, wherein transforming the substrate from the first state to the second state comprises folding the substrate from a common plane into a pair of substantially parallel planes.
  • 30. The method of claim 19, wherein the substrate comprises a flexible circuit board.
US Referenced Citations (1566)
Number Name Date Kind
52641 Gates Feb 1866 A
62334 Holmes Feb 1867 A
65604 Reynolds Jun 1867 A
1954643 Neuhaus Apr 1934 A
2719797 Rosenblatt et al. Oct 1955 A
3210578 Sherer Oct 1965 A
3219533 Mullins Nov 1965 A
3381371 Russell May 1968 A
3506032 Eveleigh et al. Apr 1970 A
3556950 Dahms et al. Jan 1971 A
3610226 Albisser Oct 1971 A
3775182 Patton et al. Nov 1973 A
3780727 King Dec 1973 A
3826244 Salcman et al. Jul 1974 A
3837339 Aisenberg et al. Sep 1974 A
3838682 Clark et al. Oct 1974 A
3874850 Sorensen et al. Apr 1975 A
3898984 Mandel et al. Aug 1975 A
3910256 Clark et al. Oct 1975 A
3929971 Roy Dec 1975 A
3933593 Sternberg Jan 1976 A
3943918 Lewis Mar 1976 A
3957613 Macur May 1976 A
3964974 Banauch et al. Jun 1976 A
3979274 Newman Sep 1976 A
4008717 Kowarski Feb 1977 A
4016866 Lawton Apr 1977 A
4024312 Korpman May 1977 A
4040908 Clark, Jr. Aug 1977 A
4052754 Homsy Oct 1977 A
4055175 Clemens et al. Oct 1977 A
4073713 Newman Feb 1978 A
4076656 White et al. Feb 1978 A
4109505 Clark et al. Aug 1978 A
4119406 Clemens Oct 1978 A
4136250 Mueller et al. Jan 1979 A
4151845 Clemens May 1979 A
4172770 Semersky et al. Oct 1979 A
4176659 Rolfe Dec 1979 A
4197840 Beck et al. Apr 1980 A
4197852 Schindler et al. Apr 1980 A
4206755 Klein Jun 1980 A
4215703 Willson Aug 1980 A
4240438 Updike et al. Dec 1980 A
4240889 Yoda et al. Dec 1980 A
4245634 Albisser et al. Jan 1981 A
4253469 Aslan Mar 1981 A
4255500 Hooke Mar 1981 A
4259540 Sabia Mar 1981 A
4265249 Schindler et al. May 1981 A
4319578 Enger Mar 1982 A
4327725 Cortese et al. May 1982 A
4366040 Marsoner et al. Dec 1982 A
4369785 Rehkopf et al. Jan 1983 A
4374013 Enfors Feb 1983 A
4388166 Suzuki et al. Jun 1983 A
4403984 Ash et al. Sep 1983 A
4415666 D'Orazio et al. Nov 1983 A
4431004 Bessman et al. Feb 1984 A
4432366 Margules Feb 1984 A
4436094 Cerami Mar 1984 A
4442841 Uehara et al. Apr 1984 A
4454295 Wittmann et al. Jun 1984 A
4457339 Juan et al. Jul 1984 A
4477314 Richter et al. Oct 1984 A
4478222 Koning et al. Oct 1984 A
4486290 Cahalan et al. Dec 1984 A
4492575 Mabille Jan 1985 A
4494950 Fischell Jan 1985 A
4506680 Stokes Mar 1985 A
4519973 Cahalan et al. May 1985 A
RE31916 Oswin et al. Jun 1985 E
4526569 Bernardi Jul 1985 A
4534825 Koning et al. Aug 1985 A
4535786 Kater Aug 1985 A
4538616 Rogoff Sep 1985 A
4545382 Higgins et al. Oct 1985 A
4554927 Fussell Nov 1985 A
4565665 Fogt Jan 1986 A
4565666 Cahalan et al. Jan 1986 A
4568444 Nakamura et al. Feb 1986 A
4571292 Liu et al. Feb 1986 A
4573968 Parker Mar 1986 A
4577642 Stokes Mar 1986 A
4583976 Ferguson Apr 1986 A
4592824 Smith et al. Jun 1986 A
4600495 Fogt Jul 1986 A
4614514 Carr et al. Sep 1986 A
4619793 Lee Oct 1986 A
4625730 Fountain et al. Dec 1986 A
4626104 Pointon et al. Dec 1986 A
4632968 Yokota et al. Dec 1986 A
RE32361 Duggan Feb 1987 E
4655880 Liu Apr 1987 A
4663824 Kenmochi May 1987 A
4671288 Gough Jun 1987 A
4672970 Uchida et al. Jun 1987 A
4680268 Clark, Jr. Jul 1987 A
4685463 Williams Aug 1987 A
4685903 Cable et al. Aug 1987 A
4694861 Goodale et al. Sep 1987 A
4702732 Powers et al. Oct 1987 A
4703756 Gough et al. Nov 1987 A
4705503 Dorman et al. Nov 1987 A
4711245 Higgins et al. Dec 1987 A
4711251 Stokes Dec 1987 A
4721677 Clark, Jr. Jan 1988 A
4726381 Jones Feb 1988 A
4731726 Allen, III Mar 1988 A
4736748 Nakamura et al. Apr 1988 A
4747822 Peabody May 1988 A
4750496 Reinhart et al. Jun 1988 A
4753652 Langer et al. Jun 1988 A
4755168 Romanelli et al. Jul 1988 A
4757022 Shults et al. Jul 1988 A
4759828 Young et al. Jul 1988 A
4763648 Wyatt Aug 1988 A
4763658 Jones Aug 1988 A
4777953 Ash et al. Oct 1988 A
4781798 Gough Nov 1988 A
4784157 Halls et al. Nov 1988 A
4786394 Enzer et al. Nov 1988 A
4787398 Garcia et al. Nov 1988 A
4789467 Lindsay et al. Dec 1988 A
4791932 Margules Dec 1988 A
4803243 Fujimoto et al. Feb 1989 A
4805624 Yao et al. Feb 1989 A
4805625 Wyler Feb 1989 A
4807632 Liess et al. Feb 1989 A
4808089 Buchholtz et al. Feb 1989 A
4808292 Kessler et al. Feb 1989 A
4809704 Sogawa et al. Mar 1989 A
4810243 Howson Mar 1989 A
4810470 Burkhardt et al. Mar 1989 A
4815471 Stobie Mar 1989 A
4820281 Lawler, Jr. Apr 1989 A
4822336 DiTraglia Apr 1989 A
4823808 Clegg et al. Apr 1989 A
4828544 Lane et al. May 1989 A
4830013 Maxwell May 1989 A
4831070 McInally et al. May 1989 A
4832005 Takamiya et al. May 1989 A
4832034 Pizziconi et al. May 1989 A
4834101 Collison et al. May 1989 A
4838281 Rogers et al. Jun 1989 A
4841974 Gumbrecht et al. Jun 1989 A
4849458 Reed et al. Jul 1989 A
4852573 Kennedy Aug 1989 A
4854322 Ash et al. Aug 1989 A
4858615 Meinema Aug 1989 A
4867741 Portnoy Sep 1989 A
4871440 Nagata et al. Oct 1989 A
4874363 Abell Oct 1989 A
4883057 Broderick Nov 1989 A
4883467 Franetzki et al. Nov 1989 A
4889528 Nadai et al. Dec 1989 A
4889744 Quaid Dec 1989 A
4890620 Gough Jan 1990 A
4890621 Hakky Jan 1990 A
4900305 Smith et al. Feb 1990 A
4902294 Gosserez Feb 1990 A
4907857 Giuliani et al. Mar 1990 A
4908208 Lee et al. Mar 1990 A
4909786 Gijselhart et al. Mar 1990 A
4919114 Miyazaki Apr 1990 A
4919141 Zier et al. Apr 1990 A
4919649 Timothy et al. Apr 1990 A
4921477 Davis May 1990 A
4921480 Sealfon May 1990 A
4925444 Orkin et al. May 1990 A
4927407 Dorman May 1990 A
4927516 Yamaguchi et al. May 1990 A
4928694 Maxwell May 1990 A
4934369 Maxwell Jun 1990 A
4934375 Cole et al. Jun 1990 A
4944299 Silvian Jul 1990 A
4946439 Eggers Aug 1990 A
4950246 Muller Aug 1990 A
4951657 Pfister et al. Aug 1990 A
4951669 Maxwell et al. Aug 1990 A
4953552 DeMarzo Sep 1990 A
4957483 Gonser et al. Sep 1990 A
4963595 Ward et al. Oct 1990 A
4966579 Polaschegg Oct 1990 A
4967940 Blette et al. Nov 1990 A
4970145 Bennetto et al. Nov 1990 A
4973320 Brenner et al. Nov 1990 A
4974592 Branco Dec 1990 A
4974929 Curry Dec 1990 A
4975636 Desautels Dec 1990 A
4976687 Martin Dec 1990 A
4979509 Hakky Dec 1990 A
4984929 Rock et al. Jan 1991 A
4986671 Sun et al. Jan 1991 A
4988341 Columbus Jan 1991 A
4989607 Keusch et al. Feb 1991 A
4992794 Brouwers Feb 1991 A
4994026 Fecondini Feb 1991 A
4994167 Shults et al. Feb 1991 A
4997627 Bergkuist et al. Mar 1991 A
5002055 Merki et al. Mar 1991 A
5002572 Picha Mar 1991 A
5006050 Cooke et al. Apr 1991 A
5006111 Inokuchi et al. Apr 1991 A
5007929 Quaid Apr 1991 A
5009251 Pike et al. Apr 1991 A
5019974 Beckers May 1991 A
5026348 Venegas Jun 1991 A
5030199 Barwick et al. Jul 1991 A
5030333 Clark, Jr. Jul 1991 A
5034112 Murase et al. Jul 1991 A
5035711 Aoki et al. Jul 1991 A
5041092 Barwick Aug 1991 A
5045057 Van Driessche et al. Sep 1991 A
5046496 Betts et al. Sep 1991 A
5048525 Maxwell Sep 1991 A
5050612 Matsumura Sep 1991 A
5055171 Peck Oct 1991 A
5055198 Shettigar Oct 1991 A
5059654 Hou et al. Oct 1991 A
5067491 Taylor, II et al. Nov 1991 A
5068536 Rosenthal Nov 1991 A
5070169 Robertson et al. Dec 1991 A
5077476 Rosenthal Dec 1991 A
5088981 Howson et al. Feb 1992 A
5089421 Dieffenbach Feb 1992 A
5096669 Lauks et al. Mar 1992 A
5097834 Skrabal Mar 1992 A
5098377 Borsanyi et al. Mar 1992 A
5101814 Palti Apr 1992 A
5108819 Heller et al. Apr 1992 A
5109850 Blanco et al. May 1992 A
5112301 Fenton, Jr. et al. May 1992 A
5116313 McGregor May 1992 A
5127405 Alcala et al. Jul 1992 A
5137028 Nishimura Aug 1992 A
5140985 Schroeder et al. Aug 1992 A
5145565 Kater et al. Sep 1992 A
5152746 Atkinson et al. Oct 1992 A
5160418 Mullen Nov 1992 A
5161532 Joseph Nov 1992 A
5165406 Wong Nov 1992 A
5165407 Wilson et al. Nov 1992 A
5174291 Schoonen et al. Dec 1992 A
5176632 Bernardi Jan 1993 A
5176658 Ranford Jan 1993 A
5178142 Harjunmaa et al. Jan 1993 A
5182004 Kohno Jan 1993 A
5188591 Dorsey, III Feb 1993 A
5190041 Palti Mar 1993 A
5195963 Yafuso et al. Mar 1993 A
5196025 Ranalletta et al. Mar 1993 A
5198771 Fidler et al. Mar 1993 A
5208147 Kagenow et al. May 1993 A
5208313 Krishnan May 1993 A
5220917 Cammilli et al. Jun 1993 A
5220920 Gharib Jun 1993 A
5224929 Remiszewski Jul 1993 A
5225063 Gumbrecht et al. Jul 1993 A
5232434 Inagaki et al. Aug 1993 A
5235003 Ward et al. Aug 1993 A
5243982 Mostl et al. Sep 1993 A
5243983 Tarr et al. Sep 1993 A
5249576 Goldberger Oct 1993 A
5251126 Kahn et al. Oct 1993 A
5254102 Ogawa Oct 1993 A
5262305 Heller et al. Nov 1993 A
5265594 Olsson et al. Nov 1993 A
5266179 Nankai et al. Nov 1993 A
5269891 Colin Dec 1993 A
5271736 Picha Dec 1993 A
5271815 Wong Dec 1993 A
5279294 Anderson et al. Jan 1994 A
5281319 Kaneko et al. Jan 1994 A
5282848 Schmitt Feb 1994 A
5284140 Allen et al. Feb 1994 A
5284570 Savage et al. Feb 1994 A
5285513 Kaufman et al. Feb 1994 A
5287753 Routh et al. Feb 1994 A
5298022 Bernardi Mar 1994 A
5299571 Mastrototaro Apr 1994 A
5302093 Owens et al. Apr 1994 A
5304468 Phillips et al. Apr 1994 A
5307263 Brown Apr 1994 A
5310469 Cunningham et al. May 1994 A
5311908 Barone et al. May 1994 A
5312361 Zadini et al. May 1994 A
5314441 Cusack et al. May 1994 A
5314471 Brauker et al. May 1994 A
5316008 Suga et al. May 1994 A
5316452 Bogen et al. May 1994 A
5318511 Riquier et al. Jun 1994 A
5318583 Rabenau et al. Jun 1994 A
5322063 Allen et al. Jun 1994 A
5324322 Grill, Jr. et al. Jun 1994 A
5326356 Della Valle et al. Jul 1994 A
5326449 Cunningham Jul 1994 A
5330521 Cohen Jul 1994 A
5330634 Wong et al. Jul 1994 A
5331555 Hashimoto et al. Jul 1994 A
5335658 Bedingham Aug 1994 A
5337747 Neftel Aug 1994 A
5342409 Mullett Aug 1994 A
5342789 Chick et al. Aug 1994 A
5343869 Pross et al. Sep 1994 A
5344454 Clarke et al. Sep 1994 A
5345932 Yafuso et al. Sep 1994 A
5348788 White Sep 1994 A
5352348 Young et al. Oct 1994 A
5352351 White et al. Oct 1994 A
5354272 Swendson et al. Oct 1994 A
5354449 Band et al. Oct 1994 A
5356375 Higley Oct 1994 A
5356378 Doan Oct 1994 A
5356786 Heller et al. Oct 1994 A
5360405 Yoon Nov 1994 A
5368028 Palti Nov 1994 A
5368224 Richardson et al. Nov 1994 A
5368562 Blomquist et al. Nov 1994 A
5372133 Hogen Esch Dec 1994 A
5372135 Mendelson et al. Dec 1994 A
5372709 Hood Dec 1994 A
5376070 Purvis et al. Dec 1994 A
5378229 Layer et al. Jan 1995 A
5380268 Wheeler Jan 1995 A
5380491 Carver, Jr. et al. Jan 1995 A
5380536 Hubbell et al. Jan 1995 A
5380665 Cusack et al. Jan 1995 A
5384028 Ito Jan 1995 A
5390671 Lord et al. Feb 1995 A
5391250 Cheney, II et al. Feb 1995 A
5397848 Yang et al. Mar 1995 A
5405510 Betts et al. Apr 1995 A
5411052 Murray May 1995 A
5411647 Johnson et al. May 1995 A
5411866 Luong et al. May 1995 A
5417206 Kaneyoshi May 1995 A
5421328 Bedingham Jun 1995 A
5421923 Clarke et al. Jun 1995 A
5423738 Robinson et al. Jun 1995 A
5423749 Merte et al. Jun 1995 A
5428123 Ward et al. Jun 1995 A
5429485 Dodge Jul 1995 A
5429602 Hauser Jul 1995 A
5429735 Johnson et al. Jul 1995 A
5431160 Wilkins Jul 1995 A
5431174 Knute Jul 1995 A
5431921 Thombre Jul 1995 A
5434412 Sodickson et al. Jul 1995 A
5437635 Fields et al. Aug 1995 A
5438984 Schoendorfer Aug 1995 A
5443508 Giampapa Aug 1995 A
5445610 Evert Aug 1995 A
5448992 Kupershmidt Sep 1995 A
5451260 Versteeg et al. Sep 1995 A
5453278 Chan et al. Sep 1995 A
5458631 Xavier Oct 1995 A
5462051 Oka et al. Oct 1995 A
5462064 D'Angelo et al. Oct 1995 A
5466356 Schneider et al. Nov 1995 A
5469846 Khan Nov 1995 A
5474552 Palti Dec 1995 A
5476776 Wilkins Dec 1995 A
5482008 Stafford et al. Jan 1996 A
5482446 Williamson et al. Jan 1996 A
5482473 Lord et al. Jan 1996 A
5484404 Schulman et al. Jan 1996 A
5491474 Suni et al. Feb 1996 A
5494562 Maley et al. Feb 1996 A
5496453 Uenoyama et al. Mar 1996 A
5497772 Schulman Mar 1996 A
5502396 Desarzens et al. Mar 1996 A
5505828 Wong et al. Apr 1996 A
5507288 Bocker et al. Apr 1996 A
5508203 Fuller et al. Apr 1996 A
5509888 Miller Apr 1996 A
5512046 Pusinelli et al. Apr 1996 A
5512055 Domb et al. Apr 1996 A
5512248 Van Apr 1996 A
5513636 Palti May 1996 A
5514253 Davis et al. May 1996 A
5515851 Goldstein May 1996 A
5518601 Foos et al. May 1996 A
5527288 Gross et al. Jun 1996 A
5527334 Kanner et al. Jun 1996 A
5531679 Schulman et al. Jul 1996 A
5531878 Vadgama et al. Jul 1996 A
5538511 Van Antwerp Jul 1996 A
5540828 Yacynych Jul 1996 A
5545220 Andrews et al. Aug 1996 A
5545223 Neuenfeldt et al. Aug 1996 A
5549547 Cohen et al. Aug 1996 A
5549548 Larsson Aug 1996 A
5549569 Lynn et al. Aug 1996 A
5549651 Lynn Aug 1996 A
5551850 Williamson et al. Sep 1996 A
5553616 Ham et al. Sep 1996 A
5554339 Cozzette et al. Sep 1996 A
5561615 Kuo et al. Oct 1996 A
5562614 O'Donnell Oct 1996 A
5562615 Nassif Oct 1996 A
5564439 Picha Oct 1996 A
5568806 Cheney, II et al. Oct 1996 A
5569186 Lord et al. Oct 1996 A
5569188 Mackool Oct 1996 A
5569219 Hakki et al. Oct 1996 A
5569462 Martinson et al. Oct 1996 A
5575293 Miller et al. Nov 1996 A
5575930 Tietje-Girault et al. Nov 1996 A
5577499 Teves Nov 1996 A
5582184 Erickson et al. Dec 1996 A
5582593 Hultman Dec 1996 A
5584813 Livingston et al. Dec 1996 A
5584876 Bruchman et al. Dec 1996 A
5586553 Halili et al. Dec 1996 A
5589133 Suzuki Dec 1996 A
5590651 Shaffer et al. Jan 1997 A
5593440 Brauker et al. Jan 1997 A
5609572 Lang Mar 1997 A
5611900 Worden et al. Mar 1997 A
5624409 Seale Apr 1997 A
5624537 Turner et al. Apr 1997 A
5626563 Dodge et al. May 1997 A
5628619 Wilson May 1997 A
5628890 Carter et al. May 1997 A
5637083 Bertrand et al. Jun 1997 A
5640470 Iyer et al. Jun 1997 A
5643195 Drevet et al. Jul 1997 A
5651767 Schulman et al. Jul 1997 A
5653756 Clarke et al. Aug 1997 A
5653863 Genshaw et al. Aug 1997 A
5658250 Blomquist et al. Aug 1997 A
5660163 Schulman Aug 1997 A
5660565 Williams Aug 1997 A
5665061 Antwiler Sep 1997 A
5665065 Colman et al. Sep 1997 A
5667504 Baumann et al. Sep 1997 A
5673694 Rivers Oct 1997 A
5674289 Fournier et al. Oct 1997 A
5676651 Larson, Jr. et al. Oct 1997 A
5676820 Wang et al. Oct 1997 A
5681572 Seare, Jr. Oct 1997 A
5682884 Hill et al. Nov 1997 A
5683562 Schaffar et al. Nov 1997 A
5686829 Girault Nov 1997 A
5688239 Walker Nov 1997 A
5688244 Lang Nov 1997 A
5695623 Michel et al. Dec 1997 A
5696314 McCaffrey et al. Dec 1997 A
5697366 Kimball et al. Dec 1997 A
5697899 Hillman et al. Dec 1997 A
5704354 Preidel et al. Jan 1998 A
5706807 Picha Jan 1998 A
5711861 Ward et al. Jan 1998 A
5713888 Neuenfeldt et al. Feb 1998 A
5730654 Brown Mar 1998 A
5733259 Valcke et al. Mar 1998 A
5733336 Neuenfeldt et al. Mar 1998 A
5743262 Lepper, Jr. et al. Apr 1998 A
5749832 Vadgama et al. May 1998 A
5749907 Mann May 1998 A
5755692 Manicom May 1998 A
5756632 Ward et al. May 1998 A
5758643 Wong et al. Jun 1998 A
5763760 Gumbrecht et al. Jun 1998 A
5771890 Tamada Jun 1998 A
5773286 Dionne et al. Jun 1998 A
5776324 Usala Jul 1998 A
5779665 Mastrototaro et al. Jul 1998 A
5781455 Hyodo Jul 1998 A
5782880 Lahtinen et al. Jul 1998 A
5782912 Brauker et al. Jul 1998 A
5787900 Butler et al. Aug 1998 A
5791344 Schulman et al. Aug 1998 A
5791880 Wilson Aug 1998 A
5795453 Gilmartin Aug 1998 A
5795774 Matsumoto et al. Aug 1998 A
5798065 Picha Aug 1998 A
5800383 Chandler et al. Sep 1998 A
5800420 Gross et al. Sep 1998 A
5800529 Brauker et al. Sep 1998 A
5806517 Gerhardt et al. Sep 1998 A
5807274 Henning et al. Sep 1998 A
5807312 Dzwonkiewicz Sep 1998 A
5807375 Gross et al. Sep 1998 A
5807406 Brauker et al. Sep 1998 A
5810770 Chin et al. Sep 1998 A
5811487 Schui, Jr. et al. Sep 1998 A
5814599 Mitragotri et al. Sep 1998 A
5820589 Torgerson et al. Oct 1998 A
5820622 Gross et al. Oct 1998 A
5822715 Worthington et al. Oct 1998 A
5836887 Oka et al. Nov 1998 A
5836989 Shelton Nov 1998 A
5837454 Cozzette et al. Nov 1998 A
5837728 Purcell Nov 1998 A
5840026 Uber, III et al. Nov 1998 A
5840148 Campbell et al. Nov 1998 A
5848991 Gross et al. Dec 1998 A
5851197 Marano et al. Dec 1998 A
5851229 Lentz et al. Dec 1998 A
5858365 Faller Jan 1999 A
5858747 Schinstine et al. Jan 1999 A
5861019 Sun et al. Jan 1999 A
5863400 Drummond et al. Jan 1999 A
5871514 Wiklund et al. Feb 1999 A
5873862 Lopez Feb 1999 A
5879713 Roth et al. Mar 1999 A
5882494 Van Antwerp Mar 1999 A
5895235 Droz Apr 1999 A
5897525 Dey et al. Apr 1999 A
5897578 Wiklund et al. Apr 1999 A
5899855 Brown May 1999 A
5904666 DeDecker et al. May 1999 A
5904708 Goedeke May 1999 A
5911219 Aylsworth et al. Jun 1999 A
5913998 Butler et al. Jun 1999 A
5914026 Blubaugh, Jr. Jun 1999 A
5917346 Gord Jun 1999 A
5919215 Wiklund et al. Jul 1999 A
5919216 Houben et al. Jul 1999 A
5921951 Morris Jul 1999 A
5925021 Castellano et al. Jul 1999 A
5928155 Eggers et al. Jul 1999 A
5928182 Kraus et al. Jul 1999 A
5928189 Phillips et al. Jul 1999 A
5928195 Malamud et al. Jul 1999 A
5931814 Alex et al. Aug 1999 A
5932175 Knute et al. Aug 1999 A
5933136 Brown Aug 1999 A
5935785 Reber et al. Aug 1999 A
5938636 Kramer et al. Aug 1999 A
5944661 Swette et al. Aug 1999 A
5947911 Wong et al. Sep 1999 A
5954643 VanAntwerp et al. Sep 1999 A
5954954 Houck et al. Sep 1999 A
5957854 Besson et al. Sep 1999 A
5957903 Mirzaee et al. Sep 1999 A
5961451 Reber et al. Oct 1999 A
5963132 Yoakum Oct 1999 A
5964745 Lyles et al. Oct 1999 A
5964993 Blubaugh, Jr. et al. Oct 1999 A
5965125 Mineau-Hanschke Oct 1999 A
5965380 Heller et al. Oct 1999 A
5971922 Arita et al. Oct 1999 A
5972369 Roorda et al. Oct 1999 A
5976085 Kimball et al. Nov 1999 A
5984940 Davis et al. Nov 1999 A
5987352 Klein et al. Nov 1999 A
5995208 Sarge et al. Nov 1999 A
5995860 Sun et al. Nov 1999 A
5997501 Gross et al. Dec 1999 A
5999848 Gord et al. Dec 1999 A
6001067 Shults et al. Dec 1999 A
6001471 Bries et al. Dec 1999 A
6002954 Van Antwerp et al. Dec 1999 A
6007845 Domb et al. Dec 1999 A
6011984 Van Antwerp et al. Jan 2000 A
6014577 Henning et al. Jan 2000 A
6016448 Busacker et al. Jan 2000 A
6017435 Hassard et al. Jan 2000 A
6023629 Tamada Feb 2000 A
6024720 Chandler et al. Feb 2000 A
6027445 Von Bahr Feb 2000 A
6027479 Alei et al. Feb 2000 A
6032059 Henning et al. Feb 2000 A
6032667 Heinonen Mar 2000 A
6036924 Simons et al. Mar 2000 A
6043328 Domschke et al. Mar 2000 A
6045671 Wu et al. Apr 2000 A
6048691 Maracas Apr 2000 A
6049727 Crothall Apr 2000 A
6059946 Yukawa et al. May 2000 A
6063637 Arnold et al. May 2000 A
6066088 Davis May 2000 A
6066448 Wohlstadter et al. May 2000 A
6071391 Gotoh et al. Jun 2000 A
6077299 Adelberg et al. Jun 2000 A
6080583 Von Bahr Jun 2000 A
6081735 Diab et al. Jun 2000 A
6081736 Colvin et al. Jun 2000 A
6083523 Dionne et al. Jul 2000 A
6083710 Heller et al. Jul 2000 A
6088608 Schulman et al. Jul 2000 A
6090087 Tsukada et al. Jul 2000 A
6091975 Daddona et al. Jul 2000 A
6093172 Funderburk et al. Jul 2000 A
6099511 Devos et al. Aug 2000 A
6103033 Say et al. Aug 2000 A
6103533 Hassard et al. Aug 2000 A
6107083 Collins et al. Aug 2000 A
6115634 Donders et al. Sep 2000 A
6117290 Say et al. Sep 2000 A
6120676 Heller et al. Sep 2000 A
6121009 Heller et al. Sep 2000 A
6122536 Sun et al. Sep 2000 A
6123827 Wong et al. Sep 2000 A
6127154 Mosbach et al. Oct 2000 A
6128519 Say Oct 2000 A
6129891 Rolander et al. Oct 2000 A
6134461 Say et al. Oct 2000 A
6135978 Houben et al. Oct 2000 A
6142939 Eppstein et al. Nov 2000 A
6144869 Berner et al. Nov 2000 A
6159186 Wickham et al. Dec 2000 A
6162201 Cohen et al. Dec 2000 A
6162611 Heller et al. Dec 2000 A
6163720 Gyory et al. Dec 2000 A
6164921 Moubayed et al. Dec 2000 A
6165154 Gray et al. Dec 2000 A
6167614 Tuttle et al. Jan 2001 B1
6168568 Gavriely Jan 2001 B1
6169155 Alvarez et al. Jan 2001 B1
6171276 Lippe et al. Jan 2001 B1
6175752 Say et al. Jan 2001 B1
6180416 Kurnik et al. Jan 2001 B1
6183437 Walker Feb 2001 B1
6186982 Gross et al. Feb 2001 B1
6187062 Oweis et al. Feb 2001 B1
6189536 Martinez et al. Feb 2001 B1
6191860 Klinger et al. Feb 2001 B1
6192891 Gravel et al. Feb 2001 B1
6201980 Darrow et al. Mar 2001 B1
6201993 Kruse et al. Mar 2001 B1
6206856 Mahurkar Mar 2001 B1
6208894 Schulman Mar 2001 B1
6212416 Ward et al. Apr 2001 B1
6212424 Robinson Apr 2001 B1
6213739 Phallen et al. Apr 2001 B1
6214185 Offenbacher et al. Apr 2001 B1
6219574 Cormier et al. Apr 2001 B1
6223080 Thompson Apr 2001 B1
6223083 Rosar Apr 2001 B1
6230059 Duffin May 2001 B1
6231879 Li et al. May 2001 B1
6232783 Merrill May 2001 B1
6233080 Brenner et al. May 2001 B1
6234964 Iliff May 2001 B1
6241863 Monbouquette Jun 2001 B1
6248067 Causey, III et al. Jun 2001 B1
6248077 Elson et al. Jun 2001 B1
6248093 Moberg Jun 2001 B1
6254586 Mann et al. Jul 2001 B1
6256522 Schultz Jul 2001 B1
6259937 Schulman Jul 2001 B1
6263222 Diab et al. Jul 2001 B1
6264825 Blackburn et al. Jul 2001 B1
6270478 Mernoee Aug 2001 B1
6271332 Lohmann et al. Aug 2001 B1
6272364 Kurnik Aug 2001 B1
6272382 Faltys et al. Aug 2001 B1
6272480 Tresp et al. Aug 2001 B1
6274285 Gries et al. Aug 2001 B1
6275717 Gross et al. Aug 2001 B1
6280408 Sipin Aug 2001 B1
6281015 Mooney et al. Aug 2001 B1
6284478 Heller et al. Sep 2001 B1
6293925 Safabash et al. Sep 2001 B1
6298254 Tamada Oct 2001 B2
6299578 Kurnik et al. Oct 2001 B1
6299583 Eggers et al. Oct 2001 B1
6300002 Webb et al. Oct 2001 B1
6302855 Lav et al. Oct 2001 B1
6309351 Kurnik et al. Oct 2001 B1
6309384 Harrington et al. Oct 2001 B1
6309884 Cooper et al. Oct 2001 B1
6312388 Marcovecchio et al. Nov 2001 B1
6315738 Nishikawa et al. Nov 2001 B1
6325978 Labuda et al. Dec 2001 B1
6326160 Dunn et al. Dec 2001 B1
6329161 Heller et al. Dec 2001 B1
6329929 Weijand et al. Dec 2001 B1
6330464 Colvin, Jr. et al. Dec 2001 B1
6343225 Clark, Jr. Jan 2002 B1
6356776 Berner et al. Mar 2002 B1
6358225 Butterfield Mar 2002 B1
6365670 Fry Apr 2002 B1
6366794 Moussy et al. Apr 2002 B1
6368141 VanAntwerp et al. Apr 2002 B1
6368274 Van Antwerp et al. Apr 2002 B1
6370941 Nakamura et al. Apr 2002 B2
6372244 Antanavich et al. Apr 2002 B1
6379301 Worthington et al. Apr 2002 B1
6379317 Kintzig et al. Apr 2002 B1
6383478 Prokop et al. May 2002 B1
6387709 Mason et al. May 2002 B1
6391019 Ito May 2002 B1
6400974 Lesho Jun 2002 B1
6402703 Kensey et al. Jun 2002 B1
6403944 Mackenzie et al. Jun 2002 B1
6406066 Uegane Jun 2002 B1
6407195 Sherman et al. Jun 2002 B2
6409674 Brockway et al. Jun 2002 B1
6413393 Van Antwerp et al. Jul 2002 B1
6416651 Millar Jul 2002 B1
6424847 Mastrototaro et al. Jul 2002 B1
6430437 Marro Aug 2002 B1
6438397 Bosquet Aug 2002 B1
6447448 Ishikawa et al. Sep 2002 B1
6447542 Weadock Sep 2002 B1
6459917 Gowda et al. Oct 2002 B1
6461496 Feldman et al. Oct 2002 B1
6464849 Say et al. Oct 2002 B1
6466810 Ward et al. Oct 2002 B1
6467480 Meier et al. Oct 2002 B1
6471689 Joseph et al. Oct 2002 B1
6474360 Ito Nov 2002 B1
6475750 Han et al. Nov 2002 B1
6477392 Honigs et al. Nov 2002 B1
6477395 Schulman et al. Nov 2002 B2
6481440 Gielen et al. Nov 2002 B2
6484045 Holker et al. Nov 2002 B1
6484046 Say et al. Nov 2002 B1
6485449 Ito Nov 2002 B2
6488652 Weijand et al. Dec 2002 B1
6494830 Wessel Dec 2002 B1
6494879 Lennox et al. Dec 2002 B2
6497729 Moussy et al. Dec 2002 B1
6498043 Schulman et al. Dec 2002 B1
6498941 Jackson Dec 2002 B1
6501976 Sohrab Dec 2002 B1
6510239 Wieres et al. Jan 2003 B1
6510329 Heckel Jan 2003 B2
6512939 Colvin et al. Jan 2003 B1
6514718 Heller et al. Feb 2003 B2
6517508 Utterberg et al. Feb 2003 B1
6520326 McIvor et al. Feb 2003 B2
6520477 Trimmer Feb 2003 B2
6520937 Hart et al. Feb 2003 B2
6520997 Pekkarinen et al. Feb 2003 B1
6526298 Khalil et al. Feb 2003 B1
6527729 Turcott Mar 2003 B1
6534711 Pollack Mar 2003 B1
6536433 Cewers Mar 2003 B1
6537318 Ita et al. Mar 2003 B1
6541266 Modzelewski Apr 2003 B2
6542765 Guy et al. Apr 2003 B1
6544212 Galley et al. Apr 2003 B2
6545085 Kilgour et al. Apr 2003 B2
6546268 Ishikawa et al. Apr 2003 B1
6546269 Kurnik Apr 2003 B1
6549796 Sohrab Apr 2003 B2
6551496 Moles et al. Apr 2003 B1
6553241 Mannheimer et al. Apr 2003 B2
6553244 Lesho et al. Apr 2003 B2
6554805 Hiejima Apr 2003 B2
6554822 Holschneider et al. Apr 2003 B1
6558320 Causey, III et al. May 2003 B1
6558321 Burd et al. May 2003 B1
6558347 Jhuboo et al. May 2003 B1
6558351 Steil et al. May 2003 B1
6558955 Kristal et al. May 2003 B1
6560471 Heller et al. May 2003 B1
6561978 Conn et al. May 2003 B1
6562001 Lebel et al. May 2003 B2
6565509 Say et al. May 2003 B1
6565535 Zaias et al. May 2003 B2
6565807 Patterson et al. May 2003 B1
6569195 Yang et al. May 2003 B2
6569521 Sheridan et al. May 2003 B1
6571128 Lebel et al. May 2003 B2
6572545 Knobbe et al. Jun 2003 B2
6572579 Raghavan et al. Jun 2003 B1
6574490 Abbink et al. Jun 2003 B2
6575905 Knobbe et al. Jun 2003 B2
6577899 Lebel et al. Jun 2003 B2
6579257 Elgas et al. Jun 2003 B1
6579498 Eglise Jun 2003 B1
6579690 Bonnecaze et al. Jun 2003 B1
6585644 Lebel et al. Jul 2003 B2
6585675 O'Mahony et al. Jul 2003 B1
6585763 Keilman et al. Jul 2003 B1
6587705 Kim et al. Jul 2003 B1
6589229 Connelly et al. Jul 2003 B1
6591125 Buse et al. Jul 2003 B1
6594514 Berner et al. Jul 2003 B2
6595756 Gray et al. Jul 2003 B2
6595919 Berner et al. Jul 2003 B2
6602221 Saravia et al. Aug 2003 B1
6605072 Struys et al. Aug 2003 B2
6607509 Bobroff et al. Aug 2003 B2
6607543 Purcell et al. Aug 2003 B2
6609071 Shapiro et al. Aug 2003 B2
6612984 Kerr, II Sep 2003 B1
6613379 Ward et al. Sep 2003 B2
6615061 Khalil et al. Sep 2003 B1
6615078 Burson et al. Sep 2003 B1
6618603 Varalli et al. Sep 2003 B2
6618934 Feldman et al. Sep 2003 B1
6620138 Marrgi et al. Sep 2003 B1
6633772 Ford et al. Oct 2003 B2
6635014 Starkweather et al. Oct 2003 B2
6641533 Causey, III et al. Nov 2003 B2
6642015 Vachon et al. Nov 2003 B2
6645181 Lavi et al. Nov 2003 B1
6648821 Lebel et al. Nov 2003 B2
6653091 Dunn et al. Nov 2003 B1
6654625 Say et al. Nov 2003 B1
6656157 Duchon et al. Dec 2003 B1
6663615 Madou et al. Dec 2003 B1
6673022 Bobo et al. Jan 2004 B1
6673596 Sayler et al. Jan 2004 B1
6679865 Shekalim Jan 2004 B2
6679872 Turovskiy et al. Jan 2004 B2
6683535 Utke Jan 2004 B1
6684904 Ito Feb 2004 B2
6685668 Cho et al. Feb 2004 B1
6687522 Tamada Feb 2004 B2
6689089 Tiedtke et al. Feb 2004 B1
6689265 Heller et al. Feb 2004 B2
6694191 Starkweather et al. Feb 2004 B2
6695860 Ward et al. Feb 2004 B1
6699188 Wessel Mar 2004 B2
6699218 Flaherty et al. Mar 2004 B2
6699383 Lemire et al. Mar 2004 B2
6702249 Ito Mar 2004 B2
6702857 Brauker et al. Mar 2004 B2
6702972 Markle Mar 2004 B1
6711424 Fine et al. Mar 2004 B1
6712796 Fentis et al. Mar 2004 B2
6721587 Gough Apr 2004 B2
6723086 Bassuk et al. Apr 2004 B2
6731976 Penn et al. May 2004 B2
6736783 Blake et al. May 2004 B2
6740072 Starkweather et al. May 2004 B2
6740075 Lebel et al. May 2004 B2
6741877 Shults et al. May 2004 B1
6742635 Hirshberg Jun 2004 B2
6743635 Neel et al. Jun 2004 B2
6749587 Flaherty Jun 2004 B2
6750055 Connelly et al. Jun 2004 B1
6770030 Schaupp et al. Aug 2004 B1
6770067 Lorenzen et al. Aug 2004 B2
6773565 Kunimoto et al. Aug 2004 B2
6780297 Matsumoto et al. Aug 2004 B2
6793632 Sohrab Sep 2004 B2
6801041 Karinka et al. Oct 2004 B2
6802957 Jung et al. Oct 2004 B2
6804002 Fine et al. Oct 2004 B2
6805693 Gray et al. Oct 2004 B2
6809653 Mann et al. Oct 2004 B1
6810290 Lebel et al. Oct 2004 B2
6811548 Jeffrey Nov 2004 B2
6813519 Lebel et al. Nov 2004 B2
6832200 Greeven et al. Dec 2004 B2
6850790 Berner et al. Feb 2005 B2
6858020 Rusnak Feb 2005 B2
6862465 Shults et al. Mar 2005 B2
6869413 Langley et al. Mar 2005 B2
6875195 Choi Apr 2005 B2
6887228 McKay May 2005 B2
6892085 McIvor et al. May 2005 B2
6893552 Wang et al. May 2005 B1
6895263 Shin et al. May 2005 B2
6895265 Silver May 2005 B2
6902544 Ludin et al. Jun 2005 B2
6925393 Kalatz et al. Aug 2005 B1
6926691 Miethke Aug 2005 B2
6931327 Goode, Jr. et al. Aug 2005 B2
6932584 Gray et al. Aug 2005 B2
6936006 Sabra Aug 2005 B2
6936029 Mann et al. Aug 2005 B2
6945965 Whiting Sep 2005 B2
6948492 Wermeling et al. Sep 2005 B2
6952604 Denuzzio et al. Oct 2005 B2
6954662 Freger et al. Oct 2005 B2
6960192 Flahertv et al. Nov 2005 B1
6965791 Hitchcock et al. Nov 2005 B1
6966325 Erickson Nov 2005 B2
6975893 Say et al. Dec 2005 B2
6979315 Rogers et al. Dec 2005 B2
6989891 Braig et al. Jan 2006 B2
6997921 Gray et al. Feb 2006 B2
6998247 Monfre et al. Feb 2006 B2
7003341 Say et al. Feb 2006 B2
7008979 Schottman et al. Mar 2006 B2
7011630 Desai et al. Mar 2006 B2
7016713 Gardner et al. Mar 2006 B2
7022072 Fox et al. Apr 2006 B2
7022219 Mansouri et al. Apr 2006 B2
7025727 Brockway et al. Apr 2006 B2
7025743 Mann et al. Apr 2006 B2
7027848 Robinson et al. Apr 2006 B2
7029444 Shin et al. Apr 2006 B2
7033322 Silver Apr 2006 B2
7044911 Drinan et al. May 2006 B2
7048727 Moss May 2006 B1
7058437 Buse et al. Jun 2006 B2
7060059 Keith et al. Jun 2006 B2
7061593 Braig et al. Jun 2006 B2
7063086 Shahbazpour Jun 2006 B2
7066884 Custer et al. Jun 2006 B2
7070577 Haller et al. Jul 2006 B1
7074307 Simpson et al. Jul 2006 B2
7081195 Simpson Jul 2006 B2
7097775 Greenberg et al. Aug 2006 B2
7098803 Mann et al. Aug 2006 B2
7100628 Izenson et al. Sep 2006 B1
7108778 Simpson et al. Sep 2006 B2
7120483 Russell et al. Oct 2006 B2
7131967 Gray et al. Nov 2006 B2
7134999 Brauker et al. Nov 2006 B2
7136689 Shults et al. Nov 2006 B2
7144404 Whitson et al. Dec 2006 B2
7146202 Ward et al. Dec 2006 B2
7150741 Erickson et al. Dec 2006 B2
7150755 Levaughn et al. Dec 2006 B2
7162290 Levin Jan 2007 B1
7166074 Reghabi et al. Jan 2007 B2
7168597 Jones et al. Jan 2007 B1
7169289 Schuelein et al. Jan 2007 B2
7183102 Monfre et al. Feb 2007 B2
7184810 Caduff et al. Feb 2007 B2
7207968 Harcinske Apr 2007 B1
7211074 Sansoucy May 2007 B2
7221970 Parker May 2007 B2
7223253 Hogendijk May 2007 B2
7223276 List et al. May 2007 B2
7225535 Feldman et al. Jun 2007 B2
7228162 Ward et al. Jun 2007 B2
7229288 Stuart et al. Jun 2007 B2
7238165 Vincent et al. Jul 2007 B2
7247138 Reghabi et al. Jul 2007 B2
7254450 Christopherson et al. Aug 2007 B2
7255690 Gray et al. Aug 2007 B2
7258681 Houde Aug 2007 B2
7261690 Teller et al. Aug 2007 B2
7266400 Fine et al. Sep 2007 B2
7267665 Steil et al. Sep 2007 B2
7276029 Goode, Jr. et al. Oct 2007 B2
7278983 Ireland et al. Oct 2007 B2
7279174 Pacetti et al. Oct 2007 B2
7282029 Poulsen et al. Oct 2007 B1
7288085 Olsen Oct 2007 B2
7291114 Mault Nov 2007 B2
7295867 Berner et al. Nov 2007 B2
7297136 Wyrick Nov 2007 B2
7299082 Feldman et al. Nov 2007 B2
7303549 Flaherty et al. Dec 2007 B2
7311690 Burnett Dec 2007 B2
7313425 Finarov et al. Dec 2007 B2
7314452 Madonia Jan 2008 B2
7315767 Caduff et al. Jan 2008 B2
7316662 Delnevo et al. Jan 2008 B2
7317939 Fine et al. Jan 2008 B2
7318814 Levine et al. Jan 2008 B2
7327273 Hung et al. Feb 2008 B2
7329234 Sansoucy Feb 2008 B2
7334594 Ludin Feb 2008 B2
7335179 Burnett Feb 2008 B2
7335195 Mehier Feb 2008 B2
7338464 Blischak et al. Mar 2008 B2
7344500 Talbot et al. Mar 2008 B2
7354420 Steil et al. Apr 2008 B2
7357793 Pacetti Apr 2008 B2
7359723 Jones Apr 2008 B2
7361155 Sage, Jr. et al. Apr 2008 B2
7364562 Braig et al. Apr 2008 B2
7367942 Grage et al. May 2008 B2
7396353 Lorenzen et al. Jul 2008 B2
7399277 Saidara et al. Jul 2008 B2
7402153 Steil et al. Jul 2008 B2
7417164 Suri Aug 2008 B2
7426408 Denuzzio et al. Sep 2008 B2
7433727 Ward et al. Oct 2008 B2
7481819 Koeppel et al. Jan 2009 B2
7519408 Rasdal et al. Apr 2009 B2
7519478 Bartkowiak et al. Apr 2009 B2
7523004 Bartkowiak et al. Apr 2009 B2
7530964 Lavi et al. May 2009 B2
7569030 Lebel et al. Aug 2009 B2
7583990 Goode, Jr. et al. Sep 2009 B2
7591801 Brauker et al. Sep 2009 B2
7599726 Goode, Jr. et al. Oct 2009 B2
7604593 Parris et al. Oct 2009 B2
7615007 Shults et al. Nov 2009 B2
7618368 Brown Nov 2009 B2
7618369 Hayter et al. Nov 2009 B2
7624028 Brown Nov 2009 B1
7640032 Jones Dec 2009 B2
7640048 Dobbles et al. Dec 2009 B2
7647237 Malave et al. Jan 2010 B2
7654955 Polidori et al. Feb 2010 B2
7657297 Simpson et al. Feb 2010 B2
7670288 Sher Mar 2010 B2
7695434 Malecha Apr 2010 B2
7727147 Osorio et al. Jun 2010 B1
7731659 Malecha Jun 2010 B2
7761126 Gardner et al. Jul 2010 B2
7766830 Fox et al. Aug 2010 B2
7846132 Gravesen et al. Dec 2010 B2
7850652 Liniger et al. Dec 2010 B2
7857760 Brister et al. Dec 2010 B2
7901394 Ireland et al. Mar 2011 B2
7905833 Brister et al. Mar 2011 B2
7927274 Rasdal et al. Apr 2011 B2
7946985 Mastrototaro et al. May 2011 B2
7976492 Brauker et al. Jul 2011 B2
8000901 Brauker et al. Aug 2011 B2
8005524 Brauker et al. Aug 2011 B2
8005525 Goode, Jr. et al. Aug 2011 B2
8010174 Goode, Jr. et al. Aug 2011 B2
8025658 Chong et al. Sep 2011 B2
8079961 Saikley et al. Dec 2011 B2
8298172 Nielsen et al. Oct 2012 B2
8366682 Wyrick Feb 2013 B2
8366729 Levaughn et al. Feb 2013 B2
8409140 Ejlersen et al. Apr 2013 B2
8409145 Raymond et al. Apr 2013 B2
8439838 Mogensen et al. May 2013 B2
8460231 Brauker et al. Jun 2013 B2
8483792 Slomski et al. Jul 2013 B2
8500654 Goldenberg Aug 2013 B2
8512276 Talbot et al. Aug 2013 B2
8562567 Gundberg Oct 2013 B2
8615281 Yodfat et al. Dec 2013 B2
8721585 Brauker et al. May 2014 B2
8747363 Nielsen et al. Jun 2014 B2
8808228 Brister et al. Aug 2014 B2
8870822 Thalmann et al. Oct 2014 B2
8882741 Brauker et al. Nov 2014 B2
8920401 Brauker et al. Dec 2014 B2
8926585 Brauker et al. Jan 2015 B2
9050413 Brauker et al. Jun 2015 B2
9155843 Brauker et al. Oct 2015 B2
9295786 Gottlieb et al. Mar 2016 B2
9380975 Karbowniczek et al. Jul 2016 B2
9399094 Krag et al. Jul 2016 B2
9451908 Kamath et al. Sep 2016 B2
9452258 Dobbles et al. Sep 2016 B2
9452259 Dobbles et al. Sep 2016 B2
9457146 Dobbles et al. Oct 2016 B2
9463277 Dobbles et al. Oct 2016 B2
9533092 Gyrn Jan 2017 B2
9572935 Dobbles et al. Feb 2017 B2
9572936 Dobbles et al. Feb 2017 B2
9586004 Dobbles et al. Mar 2017 B2
9597453 Dobbles et al. Mar 2017 B2
9675285 Christian Jun 2017 B2
9788771 Stafford Oct 2017 B2
9808574 Yodfat et al. Nov 2017 B2
9827372 Dobbles et al. Nov 2017 B2
9937293 Brauker et al. Apr 2018 B2
10076606 Ambruzs et al. Sep 2018 B2
10278580 Brister et al. May 2019 B2
10376637 Gyrn et al. Aug 2019 B2
10653835 Dobbles et al. May 2020 B2
11051725 Pace et al. Jul 2021 B2
20010007950 North et al. Jul 2001 A1
20010016682 Berner et al. Aug 2001 A1
20010021817 Brugger et al. Sep 2001 A1
20010039053 Liseo et al. Nov 2001 A1
20010041830 Varalli et al. Nov 2001 A1
20010044588 Mault Nov 2001 A1
20010051768 Schulman et al. Dec 2001 A1
20020009810 O'Connor et al. Jan 2002 A1
20020016535 Martin et al. Feb 2002 A1
20020018843 Van Antwerp et al. Feb 2002 A1
20020019022 Dunn et al. Feb 2002 A1
20020019330 Murray et al. Feb 2002 A1
20020022883 Burg Feb 2002 A1
20020023852 McIvor et al. Feb 2002 A1
20020026110 Parris et al. Feb 2002 A1
20020026111 Ackerman Feb 2002 A1
20020029058 Levaughn et al. Mar 2002 A1
20020042090 Heller et al. Apr 2002 A1
20020042561 Schulman et al. Apr 2002 A1
20020043471 Ikeda et al. Apr 2002 A1
20020045808 Ford et al. Apr 2002 A1
20020060692 Broemmelsiek May 2002 A1
20020065453 Lesho et al. May 2002 A1
20020068860 Clark Jun 2002 A1
20020071776 Bandis et al. Jun 2002 A1
20020084196 Liamos et al. Jul 2002 A1
20020099282 Knobbe et al. Jul 2002 A1
20020099997 Piret Jul 2002 A1
20020111547 Knobbe et al. Aug 2002 A1
20020119711 VanAntwerp et al. Aug 2002 A1
20020123048 Gau Sep 2002 A1
20020133224 Bajgar et al. Sep 2002 A1
20020151796 Koulik Oct 2002 A1
20020155615 Novikov et al. Oct 2002 A1
20020161288 Shin et al. Oct 2002 A1
20020182241 Borenstein et al. Dec 2002 A1
20020188185 Sohrab Dec 2002 A1
20020193679 Malave et al. Dec 2002 A1
20020193885 Legeay et al. Dec 2002 A1
20020198513 Lebel et al. Dec 2002 A1
20030004432 Assenheimer Jan 2003 A1
20030006669 Pei et al. Jan 2003 A1
20030021729 Moller et al. Jan 2003 A1
20030023171 Sato et al. Jan 2003 A1
20030023317 Brauker et al. Jan 2003 A1
20030028089 Galley et al. Feb 2003 A1
20030028126 List Feb 2003 A1
20030031699 Van Antwerp Feb 2003 A1
20030032874 Rhodes et al. Feb 2003 A1
20030050546 Desai et al. Mar 2003 A1
20030054428 Monfre et al. Mar 2003 A1
20030060692 Ruchti et al. Mar 2003 A1
20030060753 Starkweather et al. Mar 2003 A1
20030060765 Campbell et al. Mar 2003 A1
20030070548 Clausen Apr 2003 A1
20030072741 Berglund et al. Apr 2003 A1
20030076082 Morgan et al. Apr 2003 A1
20030078481 McIvor et al. Apr 2003 A1
20030078560 Miller et al. Apr 2003 A1
20030091433 Tam et al. May 2003 A1
20030097082 Purdy et al. May 2003 A1
20030099682 Moussy et al. May 2003 A1
20030100040 Bonnecaze et al. May 2003 A1
20030100821 Heller et al. May 2003 A1
20030114836 Estes et al. Jun 2003 A1
20030117296 Seely Jun 2003 A1
20030119208 Yoon et al. Jun 2003 A1
20030120152 Omiya Jun 2003 A1
20030125612 Fox et al. Jul 2003 A1
20030125613 Enegren et al. Jul 2003 A1
20030130616 Steil et al. Jul 2003 A1
20030132227 Geisler et al. Jul 2003 A1
20030134347 Heller et al. Jul 2003 A1
20030143746 Sage Jul 2003 A1
20030153821 Berner et al. Aug 2003 A1
20030176183 Drucker et al. Sep 2003 A1
20030187338 Say et al. Oct 2003 A1
20030187470 Chelak et al. Oct 2003 A1
20030188427 Say et al. Oct 2003 A1
20030199744 Buse et al. Oct 2003 A1
20030199745 Burson et al. Oct 2003 A1
20030208113 Mault et al. Nov 2003 A1
20030211050 Majeti et al. Nov 2003 A1
20030211625 Cohan et al. Nov 2003 A1
20030212317 Kovatchev et al. Nov 2003 A1
20030212346 Yuzhakov et al. Nov 2003 A1
20030212347 Sohrab Nov 2003 A1
20030225324 Anderson et al. Dec 2003 A1
20030225437 Ferguson Dec 2003 A1
20030231550 MacFarlane Dec 2003 A1
20030235817 Bartkowiak et al. Dec 2003 A1
20040006263 Anderson et al. Jan 2004 A1
20040010207 Flaherty et al. Jan 2004 A1
20040011671 Shults et al. Jan 2004 A1
20040015063 Denuzzio et al. Jan 2004 A1
20040015134 Lavi et al. Jan 2004 A1
20040023253 Kunwar et al. Feb 2004 A1
20040023317 Motamedi et al. Feb 2004 A1
20040024327 Brodnick Feb 2004 A1
20040030285 Lavi et al. Feb 2004 A1
20040030294 Mahurkar Feb 2004 A1
20040039298 Abreu Feb 2004 A1
20040039406 Jessen Feb 2004 A1
20040040840 Mao et al. Mar 2004 A1
20040044272 Moerman et al. Mar 2004 A1
20040045879 Shults et al. Mar 2004 A1
20040052689 Yao Mar 2004 A1
20040054352 Adams et al. Mar 2004 A1
20040068230 Estes et al. Apr 2004 A1
20040074785 Holker et al. Apr 2004 A1
20040078219 Kaylor et al. Apr 2004 A1
20040106857 Gough Jun 2004 A1
20040122297 Stahmann et al. Jun 2004 A1
20040122353 Shahmirian et al. Jun 2004 A1
20040133164 Funderburk et al. Jul 2004 A1
20040138543 Russell et al. Jul 2004 A1
20040138588 Saikley et al. Jul 2004 A1
20040143173 Reghabi et al. Jul 2004 A1
20040146909 Duong et al. Jul 2004 A1
20040152187 Haight et al. Aug 2004 A1
20040152622 Keith et al. Aug 2004 A1
20040162678 Hetzel et al. Aug 2004 A1
20040167801 Say et al. Aug 2004 A1
20040173472 Jung et al. Sep 2004 A1
20040176672 Silver et al. Sep 2004 A1
20040180391 Gratzl et al. Sep 2004 A1
20040186362 Brauker et al. Sep 2004 A1
20040186365 Jin et al. Sep 2004 A1
20040193025 Steil et al. Sep 2004 A1
20040199059 Brauker et al. Oct 2004 A1
20040204687 Mogensen et al. Oct 2004 A1
20040219664 Heller et al. Nov 2004 A1
20040220517 Starkweather et al. Nov 2004 A1
20040224001 Pacetti et al. Nov 2004 A1
20040248282 Sobha et al. Dec 2004 A1
20040253365 Warren et al. Dec 2004 A1
20040254433 Bandis et al. Dec 2004 A1
20050003399 Blackburn et al. Jan 2005 A1
20050010265 Baru et al. Jan 2005 A1
20050026689 Marks Feb 2005 A1
20050027180 Goode, Jr. et al. Feb 2005 A1
20050027181 Goode, Jr. et al. Feb 2005 A1
20050027182 Siddiqui et al. Feb 2005 A1
20050027462 Goode, Jr. et al. Feb 2005 A1
20050027463 Goode, Jr. et al. Feb 2005 A1
20050031689 Shults et al. Feb 2005 A1
20050033132 Shults et al. Feb 2005 A1
20050038332 Saidara et al. Feb 2005 A1
20050043598 Goode, Jr. et al. Feb 2005 A1
20050049472 Manda et al. Mar 2005 A1
20050051427 Brauker et al. Mar 2005 A1
20050051440 Simpson et al. Mar 2005 A1
20050054909 Petisce et al. Mar 2005 A1
20050056552 Simpson et al. Mar 2005 A1
20050065464 Talbot et al. Mar 2005 A1
20050077584 Uhland et al. Apr 2005 A1
20050090607 Tapsak et al. Apr 2005 A1
20050090850 Thoes et al. Apr 2005 A1
20050096519 Denuzzio et al. May 2005 A1
20050101847 Routt et al. May 2005 A1
20050107677 Ward et al. May 2005 A1
20050112169 Brauker et al. May 2005 A1
20050113653 Fox et al. May 2005 A1
20050113744 Donoghue et al. May 2005 A1
20050115832 Simpson et al. Jun 2005 A1
20050118344 Pacetti Jun 2005 A1
20050119720 Gale et al. Jun 2005 A1
20050121322 Say et al. Jun 2005 A1
20050124873 Shults et al. Jun 2005 A1
20050131305 Danielson et al. Jun 2005 A1
20050139489 Davies et al. Jun 2005 A1
20050143635 Kamath et al. Jun 2005 A1
20050143675 Neel et al. Jun 2005 A1
20050149089 Trissei et al. Jul 2005 A1
20050154271 Rasdal et al. Jul 2005 A1
20050176136 Burd et al. Aug 2005 A1
20050177036 Shults et al. Aug 2005 A1
20050177398 Watanabe et al. Aug 2005 A1
20050181012 Saint et al. Aug 2005 A1
20050182451 Griffin et al. Aug 2005 A1
20050183954 Hitchcock et al. Aug 2005 A1
20050187720 Goode, Jr. et al. Aug 2005 A1
20050192557 Brauker et al. Sep 2005 A1
20050197554 Polcha Sep 2005 A1
20050203360 Brauker et al. Sep 2005 A1
20050211571 Schulein et al. Sep 2005 A1
20050215871 Feldman et al. Sep 2005 A1
20050215872 Berner et al. Sep 2005 A1
20050239154 Feldman et al. Oct 2005 A1
20050242479 Petisce Nov 2005 A1
20050245795 Goode, Jr. et al. Nov 2005 A1
20050245799 Brauker et al. Nov 2005 A1
20050245904 Estes et al. Nov 2005 A1
20050251083 Carr-Brendel et al. Nov 2005 A1
20050261563 Zhou et al. Nov 2005 A1
20050283114 Bresina et al. Dec 2005 A1
20050288596 Eigler et al. Dec 2005 A1
20060001550 Mann et al. Jan 2006 A1
20060007017 Mann et al. Jan 2006 A1
20060015020 Neale et al. Jan 2006 A1
20060015024 Brister et al. Jan 2006 A1
20060016700 Brister et al. Jan 2006 A1
20060019327 Brister et al. Jan 2006 A1
20060020186 Brister et al. Jan 2006 A1
20060020187 Brister et al. Jan 2006 A1
20060020188 Kamath et al. Jan 2006 A1
20060020189 Brister et al. Jan 2006 A1
20060020190 Kamath et al. Jan 2006 A1
20060020191 Brister et al. Jan 2006 A1
20060020192 Brister et al. Jan 2006 A1
20060036139 Brister et al. Feb 2006 A1
20060036140 Brister et al. Feb 2006 A1
20060036141 Kamath et al. Feb 2006 A1
20060036142 Brister et al. Feb 2006 A1
20060036143 Brister et al. Feb 2006 A1
20060036144 Brister et al. Feb 2006 A1
20060036145 Brister et al. Feb 2006 A1
20060040402 Brauker et al. Feb 2006 A1
20060047095 Pacetti Mar 2006 A1
20060052745 Van Antwerp et al. Mar 2006 A1
20060067908 Ding Mar 2006 A1
20060078908 Pitner et al. Apr 2006 A1
20060079740 Silver et al. Apr 2006 A1
20060079809 Goldberger et al. Apr 2006 A1
20060094946 Kellogg et al. May 2006 A1
20060100588 Brunnberg et al. May 2006 A1
20060134165 Pacetti Jun 2006 A1
20060171980 Helmus et al. Aug 2006 A1
20060173406 Hayes et al. Aug 2006 A1
20060177379 Asgari Aug 2006 A1
20060183871 Ward et al. Aug 2006 A1
20060183984 Dobbles et al. Aug 2006 A1
20060183985 Brister et al. Aug 2006 A1
20060189863 Peyser et al. Aug 2006 A1
20060195029 Shults et al. Aug 2006 A1
20060222566 Brauker et al. Oct 2006 A1
20060224141 Rush et al. Oct 2006 A1
20060229512 Petisce et al. Oct 2006 A1
20060235285 Brister et al. Oct 2006 A1
20060241517 Fowler et al. Oct 2006 A1
20060241669 Stout et al. Oct 2006 A1
20060247671 LeVaughn Nov 2006 A1
20060253085 Geismar et al. Nov 2006 A1
20060258929 Goode, Jr. et al. Nov 2006 A1
20060258939 Pesach et al. Nov 2006 A1
20060258990 Weber Nov 2006 A1
20060263839 Ward et al. Nov 2006 A1
20060269586 Pacetti Nov 2006 A1
20060275857 Kjaer et al. Dec 2006 A1
20060281985 Ward et al. Dec 2006 A1
20060287630 Hommann Dec 2006 A1
20070007133 Mang et al. Jan 2007 A1
20070016381 Kamath et al. Jan 2007 A1
20070027381 Stafford Feb 2007 A1
20070027385 Brister et al. Feb 2007 A1
20070032706 Kamath et al. Feb 2007 A1
20070038044 Dobbles et al. Feb 2007 A1
20070049873 Hansen et al. Mar 2007 A1
20070060814 Stafford Mar 2007 A1
20070066873 Kamath et al. Mar 2007 A1
20070066956 Finkel Mar 2007 A1
20070073129 Shah et al. Mar 2007 A1
20070078322 Stafford Apr 2007 A1
20070085995 Pesach et al. Apr 2007 A1
20070100222 Mastrototaro et al. May 2007 A1
20070106135 Sloan et al. May 2007 A1
20070112298 Mueller, Jr. et al. May 2007 A1
20070116600 Kochar et al. May 2007 A1
20070129619 Ward et al. Jun 2007 A1
20070129621 Kellogg et al. Jun 2007 A1
20070135698 Shah et al. Jun 2007 A1
20070135699 Ward et al. Jun 2007 A1
20070151869 Heller et al. Jul 2007 A1
20070167907 Deslierres et al. Jul 2007 A1
20070173706 Neinast et al. Jul 2007 A1
20070173710 Petisce et al. Jul 2007 A1
20070173761 Kanderian, Jr. et al. Jul 2007 A1
20070179434 Weinert et al. Aug 2007 A1
20070191702 Yodfat et al. Aug 2007 A1
20070197889 Brister et al. Aug 2007 A1
20070200254 Curry Aug 2007 A1
20070200267 Tsai Aug 2007 A1
20070203407 Hoss et al. Aug 2007 A1
20070203410 Say et al. Aug 2007 A1
20070203966 Brauker et al. Aug 2007 A1
20070206193 Pesach Sep 2007 A1
20070208244 Brauker et al. Sep 2007 A1
20070208245 Brauker et al. Sep 2007 A1
20070208246 Brauker et al. Sep 2007 A1
20070213610 Say et al. Sep 2007 A1
20070218097 Heller et al. Sep 2007 A1
20070219441 Carlin et al. Sep 2007 A1
20070225579 Lucassen et al. Sep 2007 A1
20070225675 Robinson et al. Sep 2007 A1
20070227907 Shah et al. Oct 2007 A1
20070233013 Schoenberg Oct 2007 A1
20070233167 Weiss et al. Oct 2007 A1
20070235331 Simpson et al. Oct 2007 A1
20070240497 Robinson et al. Oct 2007 A1
20070244381 Robinson et al. Oct 2007 A1
20070244382 Robinson et al. Oct 2007 A1
20070249916 Pesach et al. Oct 2007 A1
20070249922 Peyser et al. Oct 2007 A1
20070255126 Moberg et al. Nov 2007 A1
20070255302 Koeppel et al. Nov 2007 A1
20070275193 DeSimone et al. Nov 2007 A1
20070293742 Simonsen et al. Dec 2007 A1
20070299409 Whitbourne et al. Dec 2007 A1
20080007141 Deck Jan 2008 A1
20080009805 Ethelfeld Jan 2008 A1
20080021666 Goode, Jr. et al. Jan 2008 A1
20080021668 Son Jan 2008 A1
20080027301 Ward et al. Jan 2008 A1
20080027474 Curry et al. Jan 2008 A1
20080029390 Roche et al. Feb 2008 A1
20080029391 Mao et al. Feb 2008 A1
20080033254 Kamath et al. Feb 2008 A1
20080034972 Gough et al. Feb 2008 A1
20080045824 Tapsak et al. Feb 2008 A1
20080051714 Moberg et al. Feb 2008 A1
20080071157 McGarraugh et al. Mar 2008 A1
20080071158 McGarraugh et al. Mar 2008 A1
20080072663 Keenan et al. Mar 2008 A1
20080086040 Heller et al. Apr 2008 A1
20080086041 Heller et al. Apr 2008 A1
20080086042 Brister et al. Apr 2008 A1
20080086043 Heller et al. Apr 2008 A1
20080086044 Brister et al. Apr 2008 A1
20080086273 Shults et al. Apr 2008 A1
20080091094 Heller et al. Apr 2008 A1
20080091095 Heller et al. Apr 2008 A1
20080097246 Stafford Apr 2008 A1
20080097289 Steil et al. Apr 2008 A1
20080108942 Brister et al. May 2008 A1
20080114227 Haar et al. May 2008 A1
20080119703 Brister et al. May 2008 A1
20080119704 Brister et al. May 2008 A1
20080119706 Brister et al. May 2008 A1
20080125751 Fjield et al. May 2008 A1
20080139903 Bruce et al. Jun 2008 A1
20080139910 Mastrototaro et al. Jun 2008 A1
20080154101 Jain et al. Jun 2008 A1
20080161656 Bruce et al. Jul 2008 A1
20080167641 Hansen et al. Jul 2008 A1
20080183061 Goode et al. Jul 2008 A1
20080183399 Goode et al. Jul 2008 A1
20080187655 Markle et al. Aug 2008 A1
20080188722 Markle et al. Aug 2008 A1
20080188725 Markle et al. Aug 2008 A1
20080188731 Brister et al. Aug 2008 A1
20080188798 Weber Aug 2008 A1
20080189051 Goode et al. Aug 2008 A1
20080193936 Squirrell Aug 2008 A1
20080194837 Kim et al. Aug 2008 A1
20080194935 Brister et al. Aug 2008 A1
20080194936 Goode et al. Aug 2008 A1
20080194937 Goode et al. Aug 2008 A1
20080195967 Goode et al. Aug 2008 A1
20080197024 Simpson et al. Aug 2008 A1
20080200788 Brister et al. Aug 2008 A1
20080200789 Brister et al. Aug 2008 A1
20080200791 Simpson et al. Aug 2008 A1
20080208025 Shults et al. Aug 2008 A1
20080210557 Heller et al. Sep 2008 A1
20080214915 Brister et al. Sep 2008 A1
20080249383 Sass et al. Oct 2008 A1
20080249473 Rutti et al. Oct 2008 A1
20080262469 Brister et al. Oct 2008 A1
20080269723 Mastrototaro et al. Oct 2008 A1
20080281270 Cross et al. Nov 2008 A1
20080287764 Rasdal et al. Nov 2008 A1
20080287765 Rasdal et al. Nov 2008 A1
20080287766 Rasdal et al. Nov 2008 A1
20080296155 Shults et al. Dec 2008 A1
20080300572 Rankers et al. Dec 2008 A1
20080305009 Gamsey et al. Dec 2008 A1
20080305506 Suri Dec 2008 A1
20080306368 Goode, Jr. et al. Dec 2008 A1
20080306433 Cesaroni Dec 2008 A1
20080306434 Dobbles et al. Dec 2008 A1
20080306435 Kamath et al. Dec 2008 A1
20080306444 Brister et al. Dec 2008 A1
20090005666 Shin et al. Jan 2009 A1
20090012379 Goode, Jr. et al. Jan 2009 A1
20090012472 Ahm et al. Jan 2009 A1
20090018418 Markle et al. Jan 2009 A1
20090018424 Kamath et al. Jan 2009 A1
20090018426 Markle et al. Jan 2009 A1
20090036758 Brauker et al. Feb 2009 A1
20090043181 Brauker et al. Feb 2009 A1
20090043182 Brauker et al. Feb 2009 A1
20090043525 Brauker et al. Feb 2009 A1
20090043541 Brauker et al. Feb 2009 A1
20090043542 Brauker et al. Feb 2009 A1
20090054812 Mace Feb 2009 A1
20090061528 Suri Mar 2009 A1
20090062635 Brauker et al. Mar 2009 A1
20090062645 Fehre et al. Mar 2009 A1
20090076356 Simpson et al. Mar 2009 A1
20090076360 Brister et al. Mar 2009 A1
20090076361 Kamath et al. Mar 2009 A1
20090081803 Gamsey et al. Mar 2009 A1
20090088689 Carter Apr 2009 A1
20090099434 Liu et al. Apr 2009 A1
20090124877 Goode, Jr. et al. May 2009 A1
20090124878 Goode, Jr. et al. May 2009 A1
20090124964 Leach et al. May 2009 A1
20090124979 Raymond et al. May 2009 A1
20090131768 Simpson et al. May 2009 A1
20090131769 Leach et al. May 2009 A1
20090131776 Simpson et al. May 2009 A1
20090131777 Simpson et al. May 2009 A1
20090137886 Shariati et al. May 2009 A1
20090137887 Shariati et al. May 2009 A1
20090143659 Li et al. Jun 2009 A1
20090156924 Shariati et al. Jun 2009 A1
20090177143 Markle et al. Jul 2009 A1
20090178459 Li et al. Jul 2009 A1
20090182217 Li et al. Jul 2009 A1
20090192366 Mensinger et al. Jul 2009 A1
20090192380 Shariati et al. Jul 2009 A1
20090192722 Shariati et al. Jul 2009 A1
20090192724 Brauker et al. Jul 2009 A1
20090192745 Kamath et al. Jul 2009 A1
20090192751 Kamath et al. Jul 2009 A1
20090203981 Brauker et al. Aug 2009 A1
20090204341 Brauker et al. Aug 2009 A1
20090216103 Brister et al. Aug 2009 A1
20090240120 Mensinger et al. Sep 2009 A1
20090240128 Mensinger et al. Sep 2009 A1
20090240193 Mensinger et al. Sep 2009 A1
20090242399 Kamath et al. Oct 2009 A1
20090242425 Kamath et al. Oct 2009 A1
20090264719 Markle et al. Oct 2009 A1
20090264856 Lebel et al. Oct 2009 A1
20090287074 Shults et al. Nov 2009 A1
20090299155 Yang et al. Dec 2009 A1
20090299156 Simpson et al. Dec 2009 A1
20090299162 Brauker et al. Dec 2009 A1
20090299276 Brauker et al. Dec 2009 A1
20100010324 Brauker et al. Jan 2010 A1
20100010331 Brauker et al. Jan 2010 A1
20100010332 Brauker et al. Jan 2010 A1
20100010529 Shi Jan 2010 A1
20100016687 Brauker et al. Jan 2010 A1
20100022855 Brauker et al. Jan 2010 A1
20100025174 Dayton Feb 2010 A1
20100030053 Goode, Jr. et al. Feb 2010 A1
20100030484 Brauker et al. Feb 2010 A1
20100030485 Brauker et al. Feb 2010 A1
20100036215 Goode, Jr. et al. Feb 2010 A1
20100036216 Goode, Jr. et al. Feb 2010 A1
20100036222 Goode, Jr. et al. Feb 2010 A1
20100036223 Goode, Jr. et al. Feb 2010 A1
20100036224 Goode, Jr. et al. Feb 2010 A1
20100036225 Goode, Jr. et al. Feb 2010 A1
20100041971 Goode, Jr. et al. Feb 2010 A1
20100045465 Brauker et al. Feb 2010 A1
20100049024 Saint et al. Feb 2010 A1
20100076283 Simpson et al. Mar 2010 A1
20100081908 Dobbles et al. Apr 2010 A1
20100081910 Brister et al. Apr 2010 A1
20100145377 Lai et al. Jun 2010 A1
20100161269 Kamath et al. Jun 2010 A1
20100179401 Rasdal et al. Jul 2010 A1
20100179407 Goode, Jr. et al. Jul 2010 A1
20100179408 Kamath et al. Jul 2010 A1
20100179409 Kamath et al. Jul 2010 A1
20100185178 Sharp et al. Jul 2010 A1
20100228226 Nielsen Sep 2010 A1
20100234707 Goode, Jr. et al. Sep 2010 A1
20100235106 Kamath et al. Sep 2010 A1
20100240975 Goode, Jr. et al. Sep 2010 A1
20100240976 Goode, Jr. et al. Sep 2010 A1
20100331642 Bruce et al. Dec 2010 A1
20100331656 Mensinger et al. Dec 2010 A1
20100331657 Mensinger et al. Dec 2010 A1
20110009727 Mensinger et al. Jan 2011 A1
20110060287 Ambruzs et al. Mar 2011 A1
20110082484 Saravia et al. Apr 2011 A1
20110098656 Burnell et al. Apr 2011 A1
20110106126 Love et al. May 2011 A1
20110118579 Goode, Jr. et al. May 2011 A1
20110124997 Goode, Jr. et al. May 2011 A1
20110130970 Goode, Jr. et al. Jun 2011 A1
20110137601 Goode, Jr. et al. Jun 2011 A1
20110144463 Pesach et al. Jun 2011 A1
20110144683 Butz Jun 2011 A1
20110201910 Rasdal et al. Aug 2011 A1
20110218414 Kamath et al. Sep 2011 A1
20110230735 Wolfe et al. Sep 2011 A1
20110231107 Brauker et al. Sep 2011 A1
20110231140 Goode, Jr. et al. Sep 2011 A1
20110231141 Goode, Jr. et al. Sep 2011 A1
20110231142 Goode, Jr. et al. Sep 2011 A1
20110257895 Brauker et al. Oct 2011 A1
20110270158 Brauker et al. Nov 2011 A1
20120059673 Cohen et al. Mar 2012 A1
20120097289 Chun et al. Apr 2012 A1
20120150123 Lawrence et al. Jun 2012 A1
20120186581 Brauker et al. Jul 2012 A1
20120190953 Brauker et al. Jul 2012 A1
20120191063 Brauker et al. Jul 2012 A1
20120215201 Brauker et al. Aug 2012 A1
20120220979 Brauker et al. Aug 2012 A1
20120227737 Mastrototaro et al. Sep 2012 A1
20120238852 Brauker et al. Sep 2012 A1
20120259278 Hayes et al. Oct 2012 A1
20120265042 Neinast et al. Oct 2012 A1
20120296311 Brauker et al. Nov 2012 A1
20120323098 Moein et al. Dec 2012 A1
20130172695 Nielsen et al. Jul 2013 A1
20170127982 Larson et al. May 2017 A1
20180043096 Dobbles et al. Feb 2018 A1
20180185587 Brauker et al. Jul 2018 A1
20190070360 Sloan et al. Mar 2019 A1
20190209009 Brister et al. Jul 2019 A1
20190357818 Pryor et al. Nov 2019 A1
Foreign Referenced Citations (162)
Number Date Country
2127172 Jul 1998 CA
0098592 Jan 1984 EP
0107634 May 1984 EP
0127958 Dec 1984 EP
0286118 Oct 1988 EP
0288793 Nov 1988 EP
0320109 Jun 1989 EP
0352610 Jan 1990 EP
0352631 Jan 1990 EP
0353328 Feb 1990 EP
0390390 Oct 1990 EP
0396788 Nov 1990 EP
0406473 Jan 1991 EP
0440044 Aug 1991 EP
0441252 Aug 1991 EP
0441394 Aug 1991 EP
0467078 Jan 1992 EP
0534074 Mar 1993 EP
0535898 Apr 1993 EP
0539751 May 1993 EP
0563795 Oct 1993 EP
0323605 Jan 1994 EP
0647849 Apr 1995 EP
0424633 Jan 1996 EP
0729366 Sep 1996 EP
0747069 Dec 1996 EP
0776628 Jun 1997 EP
0817809 Jan 1998 EP
0838230 Apr 1998 EP
0880936 Dec 1998 EP
0885932 Dec 1998 EP
0967788 Dec 1999 EP
0995805 Apr 2000 EP
1077634 Feb 2001 EP
1078258 Feb 2001 EP
1102194 May 2001 EP
0789540 Sep 2001 EP
1153571 Nov 2001 EP
0817809 Jul 2002 EP
1266607 Dec 2002 EP
1338295 Aug 2003 EP
1 475 113 Nov 2004 EP
1498067 Jan 2005 EP
1571582 Sep 2005 EP
2223710 Sep 2010 EP
2226086 Sep 2010 EP
2228642 Sep 2010 EP
2656423 Jun 1991 FR
2760962 Sep 1998 FR
1442303 Jul 1976 GB
2149918 Jun 1985 GB
S6283649 Apr 1987 JP
S6283849 Apr 1987 JP
H0783871 Mar 1995 JP
2000060826 Feb 2000 JP
2002515302 May 2002 JP
2002189015 Jul 2002 JP
2003108679 Apr 2003 JP
2004000555 Jan 2004 JP
2006-346160 Dec 2006 JP
WO-8902720 Apr 1989 WO
WO-9000738 Jan 1990 WO
WO-9010861 Sep 1990 WO
WO-9013021 Nov 1990 WO
WO-9116416 Oct 1991 WO
WO-9213271 Aug 1992 WO
WO-9314693 Aug 1993 WO
WO-9323744 Nov 1993 WO
WO-9422367 Oct 1994 WO
WO-9507109 Mar 1995 WO
WO-9513838 May 1995 WO
WO-9601611 Jan 1996 WO
WO-9603117 Feb 1996 WO
WO-9614026 May 1996 WO
WO-9625089 Aug 1996 WO
WO-9630431 Oct 1996 WO
WO-9632076 Oct 1996 WO
WO-9637246 Nov 1996 WO
WO-9701986 Jan 1997 WO
WO-9706727 Feb 1997 WO
WO-9719188 May 1997 WO
WO-9728737 Aug 1997 WO
WO-9743633 Nov 1997 WO
WO-9824358 Jun 1998 WO
WO-9838906 Sep 1998 WO
WO-9948419 Sep 1999 WO
WO-9956613 Nov 1999 WO
WO-9958051 Nov 1999 WO
WO-9958973 Nov 1999 WO
WO-9959657 Nov 1999 WO
WO-0012720 Mar 2000 WO
WO-0013002 Mar 2000 WO
WO-0013003 Mar 2000 WO
WO-0019887 Apr 2000 WO
WO-0032098 Jun 2000 WO
WO-0033065 Jun 2000 WO
WO-0049941 Aug 2000 WO
WO-0059373 Oct 2000 WO
WO-0074753 Dec 2000 WO
WO-0078210 Dec 2000 WO
WO-0112158 Feb 2001 WO
WO-0116579 Mar 2001 WO
WO-0120019 Mar 2001 WO
WO-0120334 Mar 2001 WO
WO-0134243 May 2001 WO
WO-0143660 Jun 2001 WO
WO-0152727 Jul 2001 WO
WO-0158348 Aug 2001 WO
WO-0168901 Sep 2001 WO
WO-0169222 Sep 2001 WO
WO-0188524 Nov 2001 WO
WO-0188534 Nov 2001 WO
WO-0205702 Jan 2002 WO
WO-0224065 Mar 2002 WO
WO-0078210 May 2002 WO
WO-02082989 Oct 2002 WO
WO-02089666 Nov 2002 WO
WO-02100266 Dec 2002 WO
WO-03000127 Jan 2003 WO
WO-03022125 Mar 2003 WO
WO-03022327 Mar 2003 WO
WO-03063700 Aug 2003 WO
WO-03072269 Sep 2003 WO
WO-03101862 Dec 2003 WO
WO-2004009161 Jan 2004 WO
WO-2004110256 Dec 2004 WO
WO-2005011489 Feb 2005 WO
WO-2005012873 Feb 2005 WO
WO-2005026689 Mar 2005 WO
WO-2005032400 Apr 2005 WO
WO 2005046780 May 2005 WO
WO-2005057168 Jun 2005 WO
WO-2005057175 Jun 2005 WO
WO-2005078424 Aug 2005 WO
WO-2005026689 Oct 2005 WO
WO-2005093629 Oct 2005 WO
WO-2006017358 Feb 2006 WO
WO-2006021430 Mar 2006 WO
WO 2006038044 Apr 2006 WO
WO-2006050405 May 2006 WO
WO 2006067217 Jun 2006 WO
WO 2006075016 Jul 2006 WO
WO 2006077262 Jul 2006 WO
WO-2006105146 Oct 2006 WO
WO-2006118713 Nov 2006 WO
WO-2006131288 Dec 2006 WO
WO-2007002209 Jan 2007 WO
WO-2007002579 Jan 2007 WO
WO 2007031125 Mar 2007 WO
WO-2007065285 Jun 2007 WO
WO-2007097754 Aug 2007 WO
WO-2007114943 Oct 2007 WO
WO-2007127606 Nov 2007 WO
WO-2007137286 Nov 2007 WO
WO-2007143225 Dec 2007 WO
WO-2008001091 Jan 2008 WO
WO 2008065646 Jun 2008 WO
WO-2008076868 Jun 2008 WO
WO 2008078319 Jul 2008 WO
WO 2008083379 Jul 2008 WO
WO 2008115409 Sep 2008 WO
WO 2008124597 Oct 2008 WO
Non-Patent Literature Citations (632)
Entry
US 7,530,950 B2, 05/2009, Brister et al. (withdrawn)
Aalders, et al., “Development of a Wearable Glucose Sensor; Studies in Healthy Volunteers and in Diabetic Patients,” The International Journal Of Artificial Organs, 1991, vol. 14, No. 2, pp. 102-108.
Abe, et al., “Characterization of Glucose Microsensors for Intracellular Measurements,” Analytical Chemistry, 1992, vol. 64, No. 18, pp. 2160-2163.
Abel, et al., “Biosensors For in Vivo Glucose Measurements: Can We Cross the Experimental Stage,” Biosensors & Bioelectronics, 2002, vol. 17, pp. 1059-1070.
Abel, et al., “Experience With An Implantable Glucose Sensor as a Prerequisite of an Artificial Beta Cell,” Biomed. Biochim. Actan, 1984, vol. 43, No. 5, pp. 577-584.
Adilman, et al., “Videogames: Knowing The Score, Creative Computing,” Dec. 1983, Dialog: File 148; IAC Trade & Industry Database, vol. 9, p. 224(5) (9 pages).
Alcock S.J., et al., “Continuous Analyte Monitoring To Aid Clinical Practice,” IEEE Engineering in Medicine & Biology, 1994, vol. 13, pp. 319-325.
Amer M.M.B., “An Accurate Amperometric Glucose Sensor Based Glucometer with Eliminated Cross-Sensitivity,” Journal of Medical Engineering & Technology, vol. 26 (5), Sep./Oct. 2002, pp. 208-213.
American Diabetes Association., “Position Statement: Diagnosis and Classification of Diabetes Mellitus,” Diabetes Care, vol. 30, Supplement 01, Jan. 2007, pp. S42-S47.
American Diabetes Association., “Position Statement: Standards of Medical Care in Diabetes,” Diabetes Care, vol. 30, Supplement 01, Jan. 2007, pp. S4-S41.
American Diabetes Association., “Summary of Revisions for the 2007 Clinical Practice Recommendations,” Diabetes Care, vol. 30, Supplement 01, Jan. 2007, pp. S3.
Amin R., et al., “Hypoglycemia Prevalence in Prepubertal Children With Type 1 Diabetes on Standard Insulin Regimen: Use of Continuous Glucose Monitoring System,” Diabetes Care, 2003, vol. 26, No. 3, pp. 662-667.
Armour J.C., et al., “Application of Chronic Intravascular Blood Glucose Sensor in Dogs,” Diabetes, Dec. 1990, vol. 39, pp. 1519-1526.
Assolant-Vinet C.H., et al., “New Immobilized Enzyme Membranes for Tailor-Made Biosensors,” Analytical Letters, 1986, vol. 19(788), pp. 875-885.
Atanasov P., et al., “Biosensor for Continuous Glucose Monitoring,” Biotechnology and Bioengineering, John Wiley & sons Inc, 1994, vol. 43, pp. 262-266.
Atanasov P., et al., “Implantation of a Refillable Glucose Monitoring-Telemetry Device,” Biosensors and Bioelectronics, vol. 12 (7), 1997, pp. 669-680.
Aussedat B., et al., “A User-Friendly Method For Calibrating a Subcutaneous Glucose Sensor-Based Hypoglycaemic Alarm,” Elsevier Science Limited, Biosensors & Bioelectronic, 1997, vol. 12, No. 11, pp. 1061-1071.
Aussedat B., et al., “Interstitial Glucose Concentration and Glycemia: Implications for Continuous Subcutaneous Glucose Monitoring,” American Journal of Physiology—Endocrinology and Metabolism, vol. 278 (4), Apr. 1, 2000, pp. E716-E728.
Bailey T.S., et al., “Reduction in Hemoglobin A1C with Real-Time Continuous Glucose Monitoring: Results from a 12-Week Observational Study,” Diabetes Technology & Therapeutics, vol. 9 (3), 2007, pp. 203-210.
Baker D.A., et al., “Dynamic Concentration Challenges for Biosensor Characterization,” Biosensors & Bioelectronics, vol. 8, 1993, pp. 433-441.
Baker D.A., et al., “Dynamic Delay and Maximal Dynamic Error in Continuous Biosensors,” Analytical Chemistry, vol. 68 (8), Apr. 15, 1996, pp. 1292-1297.
Bard A.J., et al., “Electrochemical Methods,” Fundamentals and Applications, John Wiley & Sons, New York, 1980, pp. 173-175.
Bardeletti G., et al., “A Reliable L-Lactate Electrode with a New Membrane for Enzyme Immobilization for Amperometric Assay of Lactate,” Analytica Chemica Acta, vol. 187, 1986, pp. 47-54.
Beach R.D., et al., “Subminiature Implantable Potentiostat and Modified Commercial Telemetry Device for Remote Glucose Monitoring,” IEEE Transactions on Instrumentation and Measurement, vol. 48 (6), Dec. 1999, pp. 1239-1245.
Bellucci F., et al., “Electrochemical Behaviour of Graphite-Epoxy Composite Materials (GECM) in Aqueous Salt Solutions,” Journal of Applied Electrochemistry, vol. 16 (1), Jan. 1986, pp. 15-22.
Berger M., et al., “Computer Programs to Assist the Physician in the Analysis of Self-Monitored Blood Glucose Data,” Proceedings of the Annual Symposium on Computer Applications in Medical Care, 1988, pp. 52-57.
Bertrand C., et al., “Multipurpose Electrode with Different Enzyme Systems Bound to Collagen Films,” Analytica Chemica Acta, 1981, vol. 126, pp. 23-34.
Bessman S.P., et al., “Progress toward a Glucose Sensor for the Artificial Pancreas,” Proceedings of a Workshop on Ion-Selective Microelectrodes, Jun. 4-5, 1973, Boston University, 1973, pp. 189-197.
Biermann E., et al., “How Would Patients Behave if they were Continually Informed of their Blood Glucose Levels? A Simulation Study Using a “Virtual” Patient,” Diabetes Technology & Therapeutics, vol. 10 (3), 2008, pp. 178-187.
Bindra D.S., et al., “Design and in Vitro Studies of a Needle-Type Glucose Sensor for Subcutaneous Monitoring,” Analytical Chemistry, vol. 63, Sep. 1, 1991, pp. 1692-1696.
Bindra D.S., et al., “Pulsed Amperometric Detection of Glucose in Biological Fluids at a Surface-Modified Gold Electrode,” Analytical Chemistry, vol. 61 (22), Nov. 15, 1989, pp. 2566-2570.
Bisenberger M., et al., “A Triple-Step Potential Waveform at Enzyme Multisensors with Thick-Film Gold Electrodes for Detection of Glucose and Sucrose,” Sensors and Actuators B, vol. 28, 1995, pp. 181-189.
Bland J.M., et al., “A Note on the Use of the Intraclass Correlation Coefficient in the Evaluation of Agreement between Two Methods of Measurement,” Computers in Biology and Medicine, vol. 20 (5), 1990, pp. 337-340.
Bland J.M., et al., “Statistical Methods for Assessing Agreement Between Two Methods of Clinical Measurement,” The Lancet, Feb. 8, 1986, pp. 307-310.
Bobbioni-Harsch E., et al., “Lifespan of Subcutaneous Glucose Sensors and their Performances during Dynamic Glycaemia Changes in Rats,” J. Biomed. Eng., vol. 15, 1993, pp. 457-463.
Bode B.W., “Clinical Utility of the Continuous Glucose Monitoring System,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1,2000, pp. S35-S41.
Bode B.W., et al., “Continuous Glucose Monitoring Used to Adjust Diabetes Therapy Improves Glycosylated Hemoglobin: A Pilot Study,” Diabetes Research and Clinical Practice, vol. 46, 1999, pp. 183-190.
Bode B.W., et al., “Using the Continuous Glucose Monitoring System to Improve the Management of Type 1 Diabetes,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1, 2000, pp. S43-S48.
Boedeker Plastics Inc, “Polyethylene Specifications,” Polyethylene Data Sheet, Retrieved from http://www.boedeker.com/polye.sub.--p.htm on Aug. 19, 2009, 4 pages.
Boland E., et al., “Limitations of Conventional Methods of Self-Monitoring of Blood Glucose,” Diabetes Care, vol. 24 (11), Nov. 2001, pp. 1858-1862.
Bolinder J., et al., “Self-Monitoring of Blood Glucose in Type I Diabetic Patients: Comparison with Continuous Microdialysis Measurements of Glucose in Subcutaneous Adipose Tissue during Ordinary Life Conditions,” Diabetes Care, vol. 20 (1), Jan. 1997, pp. 64-70.
Bolinder J., et al., “Microdialysis Measurement of the Absolute Glucose Concentration in Subcutaneous Adipose Tissue Allowing Glucose Monitoring in Diabetic Patients,” Rapid Communication, Diabetologia, vol. 35, 1992, pp. 1177-1180.
Bott A.W., “A Comparison of Cyclic Voltammetry and Cyclic Staircase Voltammetry,” Current Separations, vol. 16 (1), 1997, pp. 23-26.
Bott A.W., “Electrochemical Methods for the Determination of Glucose,” Current Separations, vol. 17 (1), 1998, pp. 25-31.
Bowman L., et al., “The Packaging of Implantable Integrated Sensors,” IEEE Transactions in Biomedical Engineering, vol. BME-33 (2), Feb. 1986, pp. 248-255.
Brauker J., et al., “Local Inflammatory Response Around Diffusion Chambers Containing Xenografts,” Transplantation, vol. 61 (12), Jun. 27, 1996, pp. 1671-1677.
Braunwald E., “Biomarkers in Heart Failure,” Medical Progress, The New England Journal of Medicine, vol. 358, May 15, 2008, pp. 2148-2159.
Bremer T., et al., “Is Blood Glucose Predictable from Previous Values? A Solicitation for Data,” Perspectives in Diabetes, vol. 48, Mar. 1999, pp. 445-451.
Bremer T.M., et al., “Benchmark Data from the Literature for Evaluation of New Glucose Sensing Technologies,” Diabetes Technology & Therapeutics, vol. 3 (3), 2001, pp. 409-418.
Brooks S.L., et al., “Development of an On-line Glucose Sensor for Fermentation Monitoring,” Biosensors, vol. 3, 1987/1988, pp. 45-56.
Bruckel J., et al., “In Vivo Measurement of Subcutaneous Glucose Concentrations with an Enzymatic Glucose Sensor and a Wick Method,” Klin Wochenschr, vol. 67, 1989, pp. 491-495.
Brunstein E., et al., “Preparation and Validation of Implantable Electrodes for the Measurement of Oxygen and Glucose,” Biomed Biochim. Acta, vol. 48 (11/12), 1989, pp. 911-917.
Cai Q., et al., “A Wireless, Remote Query Glucose Biosensor Based on a pH-Sensitive Polymer,” Analytical Chemistry, vol. 76 (14), Jul. 15, 2004, pp. 4038-4043.
Cameron T., et al., “Micromodular Implants to Provide Electrical Stimulation of Paralyzed Muscles and Limbs,” IEEE Transactions on Biomedical Engineering, vol. 44 (9), Sep. 1997, pp. 781-790.
Campanella L., et al., “Biosensor for Direct Determination of Glucose and Lactate in Undiluted Biological Fluids,” Biosensors & Bioelectronics, vol. 8, 1993, pp. 307-314.
Candas B., et al., “An Adaptive Plasma Glucose Controller Based on a Nonlinear Insulin/Glucose Model,” IEEE Transactions on Biomedical Engineering, vol. 41 (2), Feb. 1994, pp. 116-124.
Cass A.E.G., et al., “Ferrocene-Mediated Enzyme Electrodes for Amperometric Determination of Glucose,” Analytical Chemistry, vol. 56 (4), Apr. 1984, pp. 667-671.
Cassidy J.F., et al., “Novel Electrochemical Device for the Detection of Cholesterol or Glucose,” Analyst, vol. 118, Apr. 1993, pp. 415-418.
Chase H.P., et al., “Continuous Subcutaneous Glucose Monitoring in Children with Type 1 Diabetes,” Pediatrics, vol. 107 (2), Feb. 2001, pp. 222-226.
Chase J.G., et al., “Targeted Glycemic Reduction in Critical Care Using Closed-Loop Control,” Diabetes Technology & Therapeutics, vol. 7 (2), 2005, pp. 274-282.
Chen T., et al., “Defining the Period of Recovery of the Glucose Concentration after its Local Perturbation by the Implantation of a Miniature Sensor,” Clinical Chemistry and Laboratory Medicine, vol. 40 (8), 2002, pp. 786-789.
Chia C.W., et al., “Glucose Sensors: Toward Closed Loop Insulin Delivery,” Endocrinology and Metabolism Clinics of North America, vol. 33, 2004, pp. 175-195.
Choleau C., et al., “Calibration of a Subcutaneous Amperometric Glucose Sensor Implanted for 7 Days in Diabetic Patients Part 2. Superiority of the One-point Calibration Method,” Biosensors and Bioelectronics, vol. 17 (8), 2002, pp. 647-654.
Choleau C., et al., “Calibration of a Subcutaneous Amperometric Glucose Sensor Part 1. Effect of Measurement Uncertainties on the Determination of Sensor Sensitivity and Background Current,” Biosensors and Bioelectronics, vol. 17, 2002, pp. 641-646.
Ciba Specialty Chemicals, “Ciba® IRGACURE® 2959,” Coating Effects Segment, Photoinitiator Product Description, Basel Switzerland, Apr. 2, 1998, 3 pages.
Claremont D.J., et al., “Potentially-lmplantable, Ferrocene-Mediated Glucose Sensor,” Journal of Biomedical Engineering, vol. 8, Jul. 1986, pp. 272-274.
Claremont D.J., et al., “Subcutaneous Implantation of a Ferrocene-Mediated Glucose Sensor in Pigs,” Diabetologia, vol. 29, 1986, pp. 817-821.
Clark L.C., et al., “Configurational Cyclic Voltammetry: Increasing the Specificity and Reliability of Implanted Electrodes,” IEEE/Ninth Annual Conference of the Engineering in Medicine and Biology Society, 1987, pp. 0782-0783.
Clark L.C., et al., “Long-Term Stability of Electroenzymatic Glucose Sensors Implanted in Mice,” vol. XXXIV, Transactions—American Society for Artificial Internal Organs, 1988, vol. 34, pp. 259-265.
Clark L.C., et al., “One-Minute Electrochemical Enzymic Assay for Cholesterol in Biological Materials,” Clinical Chemistry, vol. 27 (12), 1981, pp. 1978-1982.
Clarke W.L., et al., “Evaluating Clinical Accuracy of Systems for Self Monitoring of Blood Glucose,” Technical Articles, Diabetes Care, vol. 10 (5), Sep.-Oct. 1987, pp. 622-628.
Colangelo V.J., et al., “Corrosion Rate Measurements in Vivo,” Journal of Biomedical Materials Research, vol. 1, 1967, pp. 405-414.
Colowick S.P., et al., “Methods in Enzymology,” vol. XLIV, Immobilized Enzymes, Edited by Mosbach K, New York Academic Press, 1976, 11 pages.
Coulet P.R., et al., “Enzymes Immobilized on Collagen Membranes: A Tool for Fundamental Research and Enzyme Engineering,” Journal of Chromatography, vol. 215, 1981, pp. 65-72.
Coulet P.R., “Polymeric Membranes and Coupled Enzymes in the Design of Biosensors,” Journal of Membrane Science, 1992, vol. 68, pp. 217-228.
Cox D.J., et al., “Accuracy of Perceiving Blood Glucose in IDDM,” Diabetes Care, vol. 8 (6), Nov.-Dec. 1985, pp. 529-536.
Csoregi E., et al., “Amperometric Microbiosensors for Detection of Hydrogen Peroxide and Glucose Based on Peroxidase-Modified Carbon Fibers,” Electroanalysis, vol. 6, 1994, pp. 925-933.
Csoregi E., et al., “Design, Characterization and One-Point in Vivo Calibration of a Subcutaneously Implanted Glucose Electrode,” American Chemical Society, Analytical Chemistry, vol. 66 (19), Oct. 1, 1994, pp. 3131-3138.
Currie J.F., et al., “Novel Non-lntrusive Trans-Dermal Remote Wireless Micro-Fluidic Monitoring System Applied to Continuous Glucose and Lactate Assays for Casualty Care and Combat Readiness Assessment,” RTO HFM Symposium, RTO-MP-HFM-109, Aug. 16-18, 2004, pp. ‘24-1’-‘24-18’.
Danielsson B., et al., “Enzyme Thermistors,” Methods in Enzymology, vol. 137, 1988, pp. 181-197.
Dassau E., et al., “In Silico Evaluation Platform for Artificial Pancreatic β-Cell Development—A Dynamic Simulator for Closed-Loop Control with Hardware-in-the-loop,” Diabetes Technology & Therapeutics, vol. 11 (3), 2009, pp. 1-8.
Davies M.L., et al., “Polymer Membranes in Clinical Sensor Applications,” An overview of membrane function, Biomaterials, vol. 13 (14), 1992, pp. 971-978.
Davis G., et al., “Bioelectrochemical Fuel Cell and Sensor Based on a Quinoprotein, Alcohol Dehydrogenase,” Enzyme and Microbial Technology, vol. 5 (5), Sep. 1983, pp. 383-388.
De Vos P., et al., “Considerations for Successful Transplantation of Encapsulated Pancreatic Islets,” Diabetologia, vol. 45, 2002, pp. 159-173.
Deutsch T., et al., “Time Series Analysis and Control of Blood Glucose Levels in Diabetic Patients,” Computer Methods and Programs in Biomedicine, Elsevier Scientific Publishers, vol. 41, 1994, pp. 167-182.
Dixon B.M., et al., “Characterization in Vitro and in Vivo of the Oxygen Dependence of an Enzyme/Polymer Biosensor for Monitoring Brain Glucose,” Journal of Neuroscience Methods, vol. 119, 2002, pp. 135-142.
Dupont, “Dimension® AR Clinical Chemistry System,” The Chemistry Analyzer that Makes the most of your Time, Money and Effort, Dade International, Chemistry Systems, Newark, 1998, 18 pages.
Durliat H., et al., “Spectrophotometric and Electrochemical Determinations of L( +)-Lactate in Blood by Use of Lactate Dehydrogenase from Yeast,” Clinical Chemistry, vol. 22 (11), 1976, pp. 1802-1805.
Edwards Lifesciences, “Accuracy for You and Your Patients,” Marketing materials, 2002, 4 pages.
El Degheidy M.M., et al., “Optimization of an Implantable Coated Wire Glucose Sensor,” Journal of Biomedical Engineering, vol. 8, Apr. 1986, pp. 121-129.
ELCO Diagnostics Company, “Direct 30/30® Blood Glucose Sensor,” Markwell Medical Catalog, 1990, 1 page.
El-Khatib F.H., et al., “Adaptive Closed-Loop Control Provides Blood-Glucose Regulation Using Dual Subcutaneous Insulin and Glucagon Infusion in Diabetic Swine,” Journal of Diabetes Science and Technology, Diabetes Technology Society, vol. 1 (2), 2007, pp. 181-192.
El-Sa'ad L., et al., “Moisture Absorption by Epoxy Resins: The Reverse Thermal Effect,” Journal of Materials Science, vol. 25, 1990, pp. 3577-3582.
Ernst H., et al., “Reliable Glucose Monitoring Through the Use of Microsystem Technology,” Analytical Bioanalytical Chemistry, vol. 373, 2002, pp. 758-761.
European Search Report for Application No. 98908875.2 dated Apr. 29, 2004, 5 pages.
Extended European Search Report for Application No. 07844038.5 dated Dec. 21, 2012, 9 pages.
Extended European Search Report for Application No. 10163654.6 dated Aug. 3, 2010, 10 pages.
Extended European Search Report for Application No. 10163675.1, dated Aug. 3, 2010, 10 pages.
Fabietti P.G., et al., “Clinical Validation of a New Control-Oriented Model of Insulin and Glucose Dynamics in Subjects with Type 1 Diabetes,” Diabetes Technology & Therapeutics, vol. 9 (4), 2007, pp. 327-338.
Fahy B.G., et al., “An Analysis: Hyperglycemic Intensive Care Patients Need Continuous Glucose Monitoring—Easier Said Than Done,” Journal of Diabetes Science and Technology, Diabetes Technology Society, vol. 2 (2), Mar. 2008, pp. 201-204.
Fare T.L., et al., “Functional Characterization of a Conducting Polymer-Based Immunoassay System,” Biosensors & Bioelectronics, vol. 13 (3-4), 1998, pp. 459-470.
Feldman B., et al., “A Continuous Glucose Sensor Based on Wired EnzymeTM Technology—Results from a 3-Day Trial in Patients with Type 1 Diabetes,” Diabetes Technology & Therapeutics, vol. 5 (5), 2003, pp. 769-779.
File History of U.S. Appl. No. 09/447,227, filed Nov. 22, 1999, 1184 pages.
File History of U.S. Appl. No. 10/789,359, filed Feb. 26, 2004, 361 pages.
File History of U.S. Appl. No. 10/838,658, filed May 3, 2004, 748 pages.
File History of U.S. Appl. No. 10/838,909, filed May 3, 2004, 356 pages.
File History of U.S. Appl. No. 10/838,912, filed May 3, 2004, 1288 pages.
File History of U.S. Appl. No. 10/885,476, filed Jul. 6, 2004, 226 pages.
File History of U.S. Appl. No. 10/897,312, filed Jul. 21, 2004, 139 pages.
File History of U.S. Appl. No. 11/157,365, filed Jun. 21, 2005, 977 pages.
File History of U.S. Appl. No. 12/133,738, filed Jun. 5, 2008, 557 pages.
File History of U.S. Appl. No. 12/133,761, filed Jun. 5, 2008, 585 pages.
File History of U.S. Appl. No. 12/133,786, filed Jun. 5, 2008, 814 pages.
File History of U.S. Appl. No. 12/133,820, filed Jun. 5, 2008, 1273 pages.
File History of U.S. Appl. No. 12/536,852, filed Aug. 6, 2009, 480 pages.
File History of U.S. Appl. No. 12/579,385, filed Oct. 14, 2009, 558 pages.
File History of U.S. Appl. No. 95/001,818, filed Nov. 11, 2011, 1238 pages.
Fischer U., et al., “Assessment of Subcutaneous Glucose Concentration: Validation of the Wick Technique as a Reference for Implanted Electrochemical Sensors in Normal and Diabetic Dogs,” Diabetologia, vol. 30, 1987, pp. 940-945.
Fischer U., et al., “Hypoglycaemia-Warning by Means of Subcutaneous Electrochemical Glucose Sensors: An Animal Study,” Horm. Metab. Res, vol. 27, 1995, p. 53. (Abstract Only).
Fischer U., et al., “Oxygen Tension at the Subcutaneous Implantation Site of Glucose Sensors,” Biomed. Biochim. Acta, vol. 48 (11/12), 1989, pp. 965-971.
Freedman D., et al., “Statistics,” Second Edition, W.W. Norton & Company, New York & London, 1991, p. 74 (3 pages).
Freiberger P., “Video Game Takes on Diabetes Superhero ‘Captain Novolin’ Offers Treatment Tips,” Fourth Edition, Jun. 26, 1992, Business Section, 2 pages.
Frohnauer M.K., et al., “Graphical Human Insulin Time-Activity Profiles Using Standardized Definitions,” Diabetes Technology & Therapeutics, vol. 3 (3), 2001, pp. 419-429.
Frost M.C., et al., “Implantable Chemical Sensors for Real-Time Clinical Monitoring: Progress and Challenges,” Current Opinion in Chemical Biology, Analytical Techniques, vol. 6, 2002, pp. 633-641.
Gabby R.A., et al., “Optical Coherence Tomography-Based Continuous Noninvasive Glucose Monitoring in Patients with Diabetes,” Diabetes Technology & Therapeutics, vol. 10, Nov. 3, 2008, pp. 188-193.
Ganesan N., et al., “Gold Layer-Based Dual Crosslinking Procedure of Glucose Oxidase with Ferrocene Monocarboxylic Acid Provides a Stable Biosensor,” Analytical Biochemistry, Notes & Tips, vol. 343, 2005, pp. 188-191.
Ganesh A., et al., “Evaluation of the VIA® Blood Chemistry Monitor for Glucose in Healthy and Diabetic Volunteers,” Journal of Diabetes Science and Technology, vol. 2 (2), Mar. 2008, pp. 182-193.
Garg S.K., et al., “Correlation of Fingerstick Blood Glucose Measurements With GlucoWatch Biographer Glucose Results in Young Subjects With Type 1 Diabetes,” Emerging Treatments and Technologies, Diabetes Care, vol. 22 (10), Oct. 1999, pp. 1708-1714.
Garg S.K., et al., “Improved Glucose Excursions Using an Implantable Real-Time Continuous Glucose Sensor in Adults With Type 1 Diabetes,” Emerging Treatments and Technologies, Diabetes Care, vol. 27 (3), 2004, pp. 734-738.
Garg S.K., “New Insulin Analogues,” Diabetes Technology & Therapeutics, vol. 7 (5), 2005, pp. 813-817.
Gerritsen M., et al., “Performance of Subcutaneously Implanted Glucose Sensors for Continuous Monitoring,” The Netherlands Journal of Medicine, vol. 54, 1999, pp. 167-179.
Gerritsen M., et al., “Problems Associated with Subcutaneously Implanted Glucose Sensors,” Diabetes Care, vol. 23 (2), Feb. 2000, pp. 143-145.
Gilligan B.J., et al., “Evaluation of a Subcutaneous Glucose Sensor Out to 3 Months in a Dog Model” Diabetes Care, vol. 17 (8), Aug. 1994, pp. 882-887.
Gilligan B.J., et al., “Feasibility of Continuous Long-Term Glucose Monitoring from a Subcutaneous Glucose Sensor in Humans,” Diabetes Technology & Therapeutics, vol. 6 (3), 2004, pp. 378-386.
Godsland I.F., et al., “Maximizing the Success Rate of Minimal Model Insulin Sensitivity Measurement in Humans: The Importance of Basal Glucose Levels,” The Biochemical Society and the Medical Research Society, Clinical Science, vol. 101,2001, pp. 1-9.
Gouda M.D., et al., “Thermal Inactivation of Glucose Oxidase,” The Journal of Biological Chemistry, vol. 278 (27), Issue of Jul. 4, 2003, pp. 24324-24333.
Gough D.A., et al., “Frequency Characterization of Blood Glucose Dynamics,” Annals of Biomedical Engineering, vol. 31, 2003, pp. 91-97.
Gough D.A., et al., “Immobilized Glucose Oxidase in Implantable Glucose Sensor Technology,” Diabetes Technology & Therapeutics, vol. 2 (3), 2000, pp. 377-380.
Gough D.A., “The implantable Glucose Sensor: An Example of Bioengineering Design,” Introduction to Bioengineering, 2001, Chapter 3, pp. 57-66.
Gross, et al., “Diabetes Technology & Therapeutics,” Letters to the Editor, Diabetes Technology & Therapeutics, vol. 3 (1), 2001, pp. 129-131.
Gross T.M., et al., “Efficacy and Reliability of the Continuous Glucose Monitoring System,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1, 2000, pp. S19-S26.
Gross T.M., et al., “Performance Evaluation Of The Minimed® Continuous Glucose Monitoring System During Patient Home Use,” Diabetes Technology & Therapeutics, vol. 2(1), 2000, pp. 49-56.
Guerci B., et al., “Clinical Performance of CGMS in Type 1 Diabetic Patients Treated by Continuous Subcutaneous Insulin Infusion Using Insulin Analogs,” Diabetes Care, vol. 26, 2003, pp. 582-589.
Hagvik J., “Glucose Measurement: Time for a Gold Standard,” Journal of Diabetes Science and Technology, vol. 1 (2), Mar. 2007, pp. 169-172.
Hall S.B., et al., “Electrochemical Oxidation of Hydrogen Peroxide at Platinum Electrodes. Part 1. An Adsorption-controlled Mechanism,” Electrochimica Acta, vol. 43, Nos. 5/6, 1998, pp. 579-588.
Hall S.B., et al., “Electrochemical Oxidation of Hydrogen Peroxide at Platinum Electrodes. Part II: Effect of potential,” Electrochimica Acta, vol. 43 (14-15), 1998, pp. 2015-2024.
Hall S.B., et al., “Electrochemical Oxidation of Hydrogen Peroxide at Platinum Electrodes. Part III: Effect of Temperature,” Electrochimica Acta, vol. 44, 1999, pp. 2455-2462.
Hall S.B., et al., “Electrochemical Oxidation of Hydrogen Peroxide at Platinum Electrodes. Part IV: Phosphate Buffer Dependence,” Electrochimica Acta, vol. 44, 1999, pp. 4573-4582.
Hall S.B., et al., “Electrochemical Oxidation of Hydrogen Peroxide at Platinum Electrodes. Part V: Inhibition by Chloride,” Electrochimica Acta, vol. 45, 2000, pp. 3573-3579.
Hamilton, “Complete Guide to Selecting the Right Hamilton Gastight, Microliter, and Specialty Syringe for your Application,” Syringe Selection, http://www.hamiltoncompany.com 2006, 20 pages.
Hashiguchi Y., et al., “Development of a Miniaturized Glucose Monitoring System by Combining a Needle-Type Glucose Sensor with Microdialysis Sampling Method: Long-term subcutaneous tissue glucose monitoring in ambulatory diabetic patients,” Diabetes Care, vol. 17, No. 5, May 1994, pp. 387-396.
Heinemann L., et al., “Review: Measurement of Insulin Absorption and Insulin Action,” Diabetes Technology & Therapeutics, vol. 6 (5), 2004, pp. 698-718.
Heinemann L., “Measurement Quality of Blood Glucose Meters: Is There a Need for an Institution with an Unbiased View?,” Journal of Diabetes Science and Technology, vol. 1 (2), Mar. 2007, pp. 178-180.
Heinemann L., “Review: Variability of Insulin Absorption and Insulin Action,” Diabetes Technology & Therapeutics, vol. 4 (5), 2002, pp. 673-682.
Heise T., et al., “Hypoglycemia warning signal and glucose sensors: Requirements and concepts,” Diabetes Technology & Therapeutics, vol. 5, No. 4, 2003, pp. 563-571.
Heller A., “Electrical Connection of Enzyme Redox Centers to Electrodes,” J. Phys. Chern., vol. 96, 1992, pp. 3579-3587.
Heller A., “Electrical Wiring of Redox Enzymes,” Ace. Chem. Res., vol. 23, 1990, pp. 128-134.
Heller A., “Implanted Electrochemical Glucose Sensors for the Management of Diabetes,” Annu. Rev., Biomed Eng., vol. 1, 1999, pp. 153-175.
Heller A., “Plugging Metal Connectors into Enzymes,” Nature Biotechnology, vol. 21, No. 6, Jun. 2003, pp. 631-632.
Hicks J.M., “In Situ Monitoring,” Clinical Chemistry, vol. 31 (12), 1985, pp. 1931-1935.
Hitchman M.L., “Measurement of Dissolved Oxygen,” Edited by ELVING P.J et al., Chemical Analysis, New York, John Wiley & Sons, vol. 49, Chapter 3, 1978, pp. 34-49 and 59-123.
Hoel P.G., “Elementary Statistics,” Fourth Edition, John Wiley & Sons, Inc., 1976, pp. 113-114.
Houghton Mifflin Company, “American Heritage Dictionary,” 4th Edition, 2000, pp. 82.
Houghton Mifflin Company, “Xenogenic, the American Heritage Stedman's Medical Dictionary,” 2002, Answers.Com, retrieved from http://www.answers.com/topic/xenogenic, on Nov. 7, 2006, 2 Pages.
Hovorka R., et al., “Closing the Loop: The Adicol Experience,” Diabetes Technology & Therapeutics, vol. 6 (3), 2004, pp. 307-318.
Hrapovic S., et al., “Picoamperometric Detection of Glucose at Ultrasmall Platinum-Based Biosensors Preparation and Characterization,” Anal. Chern, vol. 75, 2003, pp. 3308-3315.
Hu Y., et al., “A Needle-Type Enzyme-Based Lactate Sensor for In Vivo Monitoring,” Analytica Chimica Acta, vol. 281, 1993, pp. 503-511.
Huang C., et al., “Electrochemical Generation of Oxygen. 1: The Effects of Anions and Cations on Hydrogen Chemisorption and Anodic Oxide Film Formation on Platinum Electrode. 2: The Effects of Anions and Cations on Oxygen Generation on Platinum Electrode,” U.S. Department of Commence/NTIS, 1975, 126 pages.
Huang Q., et al., “A 0.5mW Passive Telemetry IC for Biomedical Applications,” Proceedings of the 23rd European Solid-State Circuits Conference (ESSCIRC '97), Southampton, UK, Sep. 16-18, 1997, pp. 172-175.
Hunsley B., et al.,“Whole Blood Glucose Standard Is Key to Accurate Insulin Dosages,” Journal of Diabetes Science and Technology, vol. 1 (2), Mar. 2007, pp. 173-177.
Hunter I., et al., “Minimally Invasive Glucose Sensor and Insulin Delivery System,” MIT Home Automation and Healthcare Consortium, Mar. 31, 2000, Progress Report No. 25, 17 pages.
International Preliminary Reporton Patentability for Application No. PCT/US2005/006301, dated Aug. 30, 2006, 4 pages.
International Preliminary Reporton Patentability for Application No. PCT/US2007/080848 dated Apr. 13, 2010, 6 pages.
International Preliminary Reporton Patentability for Application No. PCT/US2008/058158, dated Sep. 29, 2009, 9 pages.
International Search Report and Written Opinion for Application No. PCT/US2005/006301, dated Jun. 22, 2005, 4 pages.
International Search Report and Written Opinion for Application No. PCT/US2007/080848 dated Aug. 28, 2008, 6 pages.
International Search Report and Written Opinion for Application No. PCT/US2008/058158, dated Aug. 8, 2008, 10 pages.
Ishikawa M., et al., “Initial Evaluation of A 290-Mm Diameter Subcutaneous Glucose Sensor: Glucose Monitoring With A Biocompatible, Flexible-Wire, Enzyme-Based Amperometric Microsensor in Diabetic and Nondiabetic Humans,” Journal of Diabetes and Its Complications, vol. 12, 1998, pp. 295-301.
Jablecki M., et al., “Simulations of the Frequency Response of Implantable Glucose Sensors,” Analytical Chemistry, vol. 72, 2000, 1853-1859.
Jaffari S.A., et al., “Recent Advances in Amperometric Glucose Biosensors for In Vivo Monitoring,” Physiological Measurement, 1995, vol. 16, pp. 1-15.
Jaremko J., et al., “Advances Toward the Implantable Artificial Pancreas for Treatment of Diabetes,” Diabetes Care, vol. 21 (3), Mar. 1998, pp. 444-450.
Jensen M.B., et al., “Fast Wave Forms for Pulsed Electrochemical Detection of Glucose by Incorporation of Reductive Desorption of Oxidation Products,” Analytical Chemistry, vol. 69 (9), May 1997, pp. 1776-1781.
Jeong R.A., et al., “In Vivo Calibration of the Subcutaneous Amperometric Glucose Sensors Using a Non-Enzyme Electrode,” Biosensors and Bioelectronics, Elsevier, vol. 19, 2003, pp. 313-319.
Jeutter D.C., “A Transcutaneous Implanted Battery Recharging and Biotelemeter Power Switching System,” IEEE Transactions on Biomedical Engineering, vol. BME-29 (5), May 1982, pp. 314-321.
Jeutter D.C., et al., “Design of a Radio-Linked Implantable Cochlear Prosthesis Using Surface Acoustic Wave Devices,” IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control, vol. 40 (5), Sep. 1993, pp. 469-477.
Jobst G., et al., “Thin-Film Microbiosensors for Glucose-Lactate Monitoring,” Anal Chern, Sep. 15, 1996, vol. 68(18), pp. 3173-3179.
Johnson K.W., et al., “In Vivo Evaluation of an Electroenzymatic Glucose Sensor Implanted in Subcutaneous Tissue,” Biosensors and Bioelectronics, 1992, vol. 7, pp. 709-714.
Johnson K.W., “Reproducible Electrodeposition of Biomolecules for the Fabrication of Miniature Electroenzymatic Biosensors,” Sensors and Actuators B, vol. 5, 1991, pp. 85-89.
Jones S.M., et al., “Optimal Insulin Pump Dosing and Postprandial Glycemia Following a Pizza Meal Using the Continuous Glucose Monitoring System,” Diabetes Technology & Therapeutics, vol. 7 (2), Apr. 2005, pp. 233-240.
Joung G.B., et al., “An Energy Transmission System for an Artificial Heart Using Leakage Inductance Compensation of Transcutaneous Transformer,” IEEE Transactions on Power Electronics, vol. 13 (6), Nov. 1998, pp. 1013-1022.
Jovanovic L.M.D., “The Role of Continuous Glucose Monitoring in Gestational Diabetes Mellitus,” Diabetes Technology and Therapeutics, vol. 2 (1), 2000, pp. S67-S71.
Kacaniklic V., et al., “Amperometric Biosensors for Detection of L- and D-Amino Acids Based on Coimmoblized Peroxidase and L- and D-Amino Acid Oxidases in Carbon Paste Electrodes,” Electroanalysis, vol. 6, May-Jun. 1994, pp. 381-390.
Kamath A., et al., “Calibration of a Continuous Glucose Monitor: Effect of Glucose Rate of Change,” Eighth Annual Diabetes Technology Meeting, Nov. 13-15, 2008, pp. A88 (2 pages).
Kang S.K., et al., “In Vitro and Short-Term in Vivo Characteristics of a Kel-F Thin Film Modified Glucose Sensor,” Analytical Sciences, vol. 19, Nov. 2003, pp. 1481-1486.
Kaplan S.M., “Wiley Electrical and Electronics Engineering Dictionary,” IEEE Press, John Wiley & Sons, Inc., 2004, pp. 141,142, 548 & 549.
Kaufman F.R., et al., “A Pilot Study of the Continuous Glucose Monitoring System,” Diabetes Care, vol. 24 (12), Dec. 2001, pp. 2030-2034.
Kaufman F.R., “Role of the Continuous Glucose Monitoring System in Pediatric Patients,” Diabetes Technology and Therapeutics, vol. 2 (1), 2000, S49-S52.
Kawagoe J.L., et al., “Enzyme-Modified Organic Conducting Salt Microelectrode,” Analytical Chemistry, vol. 63, 1991, pp. 2961-2965.
Keedy F.H., et al., “Determination of Urate in Undiluted Whole Blood by Enzyme Electrode,” Biosensors and Bioelectronics, vol. 6, 1991, pp. 491-499.
Kerner, et al., “A Potentially Implantable Enzyme Electrode for Amperometric Measurement of Glucose,” Hormone and Metabolic Research Supplement, vol. 20, 1988, pp. 8-13.
Kerner W., et al., “The Function of a Hydrogen Peroxide-Detecting Electroenzymatic Glucose Electrode is Markedly Impaired in Human Sub-Cutaneous Tissue and Plasma,” Biosensors and Bioelectronics, vol. 8, 1993, pp. 473-482.
Kerner W., “Implantable Glucose Sensors: Present Status and Future Developments,” Experimental and Clinical Endocrinol Diabetes, vol. 109 (2), 2001, pp. S341-S346.
Kiechle F.L., “The Impact of Continuous Glucose Monitoring on Hospital Point-of-Care Testing Programs,” Diabetes Technology and Therapeutics, vol. 3 (4), 2001, pp. 647-649.
Kizilel S., et al., “Review: The Bioartificial Pancreas: Progress and Challenges,” Diabetes Technology & Therapeutics, vol. 7 (6), 2005, pp. 968-985.
Klonoff D., et al., “Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline,” Clinical and Laboratory Standards Institute, POCT05-A, vol. 28 (33), 2008, 72 pages.
Klonoff D.C., “Editorial: Current, Emerging, and Future Trends in Metabolic Monitoring,” Diabetes Technology & Therapeutics, vol. 4 (5), 2002, pp. 583-588.
Klueh U., et al., “Use of Vascular Endothelial Cell Growth Factor Gene Transfer to Enhance Implantable Sensor Function in Vivo,” Biosensor Function and VEGF-Gene Transfer, vol. 67 (4), 2003, pp. 1072-1086.
Kondo T., et al., “A Miniature Glucose Sensor, Implantable in the Blood Stream,” Diabetes Care, vol. 5 (3), May-Jun. 1982, 218-221.
Koschinsky T., et al., “Sensors For Glucose Monitoring: Technical And Clinical Aspects,” Diabetes Metabolism Research and Reviews, vol. 17, No. 2, Jan. 1, 2001, pp. 113-123.
Koschinsky T., et al., “New Approach to Technical and Clinical Evaluation of Devices for Self-Monitoring of Blood Glucose,” Diabetes Care, vol. 11 (8), Sep. 1988, pp. 619-629.
Koschinsky T., et al., “Review: Glucose Sensors and the Alternate Site Testing-like Phenomenon: Relationship Between Rapid Blood Glucose Changes and Glucose Sensor Signals,” Diabetes Technology & Therapeutics, vol. 5 (5), 2003, pp. 829-842.
Kost J., et al., “Glucose-Sensitive Membranes Containing Glucose Oxidase: Activity, Swelling, And Permeability Studies,” Journal of Biomedical Materials Research, vol. 19, 1985, pp. 1117-1133.
Koudelka M., et al., “In Vivo Response of Microfabricated Glucose Sensors to Glycemia Changes in Normal Rats,” Biomed. Biochim. Acta, vol. 48 (11/12), Nov.-Dec. 1989, pp. 953-956.
Koudelka M., et al., “In-Vivo Behaviour of Hypodermically Implanted Microfabricated Glucose Sensors,” Biosensors and Bioelectronics, vol. 6, 1991, pp. 31-36.
Kovatchev B.P., et al., “Evaluating the Accuracy of Continuous Glucose-Monitoring Sensors: Continuous Glucose-Error Grid Analysis Illustrated by TheraSense Freestyle Navigator Data,” Diabetes Care, vol. 27 (8), Aug. 2004, pp. 1922-1928.
Kraver., et al., “A Mixed-Signal Sensor Interface Microinstrument,” Sensors and Actuators A, Physical 2001, vol. 91, pp. 266-277.
Krouwer J.S., “Setting Performance Goals and Evaluating Total Analytical Error for Diagnostic Assays,” Clinical Chemistry, vol. 48 (6), 2002, pp. 919-927.
Kruger D., et al., “Psychological Motivation and Patient Education: A Role for Continuous Glucose Monitoring,” Diabetes Technology and Therapeutics, vol. 2 (1), 2000, pp. S93-S97.
Kulys J., et al., “Carbon-Paste Biosensors Array for Long-Term Glucose Measurement,” Biosensors & Bioelectronics, vol. 9, 1994, pp. 491-500.
Kunjan K., et al., “Automated Blood Sampling and Glucose Sensing in Critical Care Settings,” Journal of Diabetes Science and Technology, vol. 2 (2), Mar. 2008, pp. 194-200.
Kurnik R.T., et al., “Application of the Mixtures of Experts Algorithm for Signal Processing in a Noninvasive Glucose Monitoring System,” Sensors and Actuators B, vol. 60, 1999, pp. 19-26.
Kuriz T.W., et al., “Recommendations for Blood Pressure Measurement in Humans and Experimental Animals, Part 2: Blood Pressure Measurement In Experimental Animals: A Statement for Professionals From the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research,” Hypertension, Feb. 2005, vol. 45, pp. 299-310.
Lacourse W.R., et al., “Optimization of Waveforms for Pulsed Amperometric Detection of Carbohydrates Based on Pulsed Voltammetry,” Analytical Chemistry, vol. 65, 1993, pp. 50-52.
Ladd M.F.C., et al., “Structure Determination By X-Ray Crystallography,” 3rd Edition, Plenum Press, 1994, Ch. 1, pp. xxi-xxiv and 1-58.
Lee S.W., et al., “Combined Insulin Pump Therapy with Real-Time Continuous Glucose Monitoring Significantly Improves Glycemic Control Compared to Multiple Daily Injection Therapy in Pump Naive Patients with Type 1 Diabetes; Single Center Pilot Study Experience,” Journal of Diabetes Science and Technology, vol. 1 (3), May 2007, pp. 400-404.
Lehmann E.D., et al., Retrospective Validation of a Physiological Model of Glucose-lnsulin Interaction in Type 1 Diabetes Mellitus. Medical Engineering & Physics, vol. 16, May 1994, pp. 193-202.
Lerner., et al., “An Implantable Electrochemical Glucose Sensor,” Ann. N. Y. Acad. Sci., vol. 428, May 1984, pp. 263-278.
Lewandowski J.J., et al., “Evaluation of a Miniature Blood Glucose Sensor,” Transactions—American Society for Artificial Internal Organs, vol. 34, 1988, pp. 255-258.
Leypoldt J.K., et al., “Model of a Two-Substrate Enzyme Electrode for Glucose,” Analytical Chemistry, vol. 56, 1984, pp. 2896-2904.
Linke B., et al., “Amperometric Biosensor for In Vivo Glucose Sensing Based on Glucose Oxidase Immobilized In A Redox Hydrogel,” Biosensors and Bioelectronics, vol. 9, 1994, pp. 151-158.
Lohn A., et al., “A Knowledge-Based System for Real-Time Validation of Calibrations and Measurements,” Chemometrics and Intelligent Laboratory Systems, vol. 46, 1999, pp. 57-66.
Lowe C.R., “Biosensors,” Trends in Biotechnology, vol. 2 (3), 1984, pp. 59-65.
Luong J.H.T., et al., “Solubilization of Multiwall Carbon Nanotubes by 3-Aminopropyltriethoxysilane towards the Fabrication of Electrochemical Biosensors with Promoted Electron Transfer,” Electroanalysis, vol. 16 (1-2), 2004, pp. 132-139.
Lyandres O., et al. “Progress toward an In Vivo Surface-Enhanced Raman Spectroscopy Glucose Sensor,” Diabetes Technology and Therapeutics, vol. 10 (4), 2008, pp. 257-265.
Lynch S.M., et al., “Estimation-Based Model Predictive Control of Blood Glucose in Type 1 Diabetics: A Simulation Study,” Proceedings of the IEEE 27th Annual Northeast Bioengineering Conference, 2001, pp. 79-80.
Lynn P.A., “Recursive Digital Filters for Biological Signals,” Med. & Biol. Engineering, vol. 9, 1971, pp. 37-43.
Maidan R., et al., “Elimination of Electrooxidizable Interferent-Produced Currents in Amperometric Biosensors,” Analytical Chemistry, vol. 64, 1992, pp. 2889-2896.
Makale M.T., et al., “Tissue Window Chamber System for Validation of Implanted Oxygen Sensors,” American Journal of Physiology—Heart and Circulatory Physiology, vol. 284, Feb. 21, 2003, pp. 1-27.
Malin S.F., et al., “Noninvasive Prediction of Glucose by Near-Infrared Diffuse Reflectance Spectroscopy,” Clinical Chemistry, vol. 45 (9), 1999, pp. 1651-1658.
Mancy K.H., et al., “A Galvanic Cell Oxygen Analyzer,” Journal of Electroanalytical Chemistry, vol. 4, 1962, pp. 65-92.
Maran A., et al., “Continuous Subcutaneous Glucose Monitoring in Diabetic Patients,” A Multicenter Analysis, Diabetes Care, vol. 25 (2), Feb. 2002, pp. 347-352.
March W.F., “Dealing with the Delay,” Diabetes Technology & Therapeutics, vol. 4 (1), 2002, pp. 49-50.
Marena S., et al., “The Artificial Endocrine Pancreas in Clinical Practice and Research,” Panminerva Medica, vol. 35 (2), 1993, pp. 67-74.
Martin R.F., “General Deming Regression for Estimating Systematic Bias and its Confidence Interval in Method-Comparison Studies,” Clinical Chemistry, vol. 46 (1), 2000, pp. 100-104.
Mascini M., et al., “Glucose Electrochemical Probe with Extended Linearity for Whole Blood,” Journal Pharmaceutical and Biomedical Analysis, vol. 7 (12), 1989, pp. 1507-1512.
Mastrototaro J.J., et al., “An Electroenzymatic Glucose Sensor Fabricated on a Flexible Substrate,” Sensors and Actuators B, vol. 5, 1991, pp. 139-144.
Mastrototaro J.J., et al., “Reproducibility of the Continuous Glucose Monitoring System Matches Previous Reports and the Intended Use of the Product,” Diabetes Care, vol. 26 (1), Jan. 2003, pp. 256-257.
Mastrototaro J.J., “The MiniMed Continuous Glucose Monitoring System,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1, 2000, pp. S13-S18.
Matsuki H., “Energy Transfer System Utilizing Amorphous Wires For Implantable Medical Devices,” IEEE Transactions on Magnetics, vol. 31 (2), 1994, pp. 1276-1282.
Matsumoto T., et al., “A Micro-Planar Amperometric Glucose Sensor Unsusceptible to Interference Species,” Sensors and Actuators B, 49, 1998, pp. 68-72.
Matthews D.R., et al., “An Amperometric Needle-Type Glucose Sensor Testing in Rats and Man,” Diabetic Medicine, vol. 5, 1988, pp. 248-252.
Mazze R.S., et al., “Characterizing Glucose Exposure for Individuals with Normal Glucose Tolerance Using Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis,” Diabetes Technology & Therapeutics, vol. 10 (3), 2008, pp. 149-159.
Mazzola F., et al., “Video Diabetes: A Teaching Tool for Children with Insulin-Dependent Diabetes,” IEEE, Proceedings 7th Annual Symposium on Computer Applications in Medical Care, Oct. 1983, 1 page Abstract.
McCartney L.J., et al., “Near-Infrared Fluorescence Lifetime Assay for Serum Glucose Based on Allophycocyanin-Labeled Concanavalin A,” Analytical Biochemistry, vol. 292, 2001, pp. 216-221.
McGrath M.J., et al., “The Use of Differential Measurements with a Glucose Biosensor for Interference Compensation During Glucose Determinations by Flow Injection Analysis,” Biosens Bioelectron, vol. 10, 1995, pp. 937-943.
McKean B.D., et al., “A Telemetry Instrumentation System for Chronically Implanted Glucose and Oxygen Sensors,” IEEE Transactions on Biomedical Engineering, vol. 35 (7), Jul. 1988, pp. 526-532.
Memoli A., et al., “A Comparison between Different Immobilised Glucoseoxidase-Based Electrodes,” Journal of Pharmaceutical and Biomedical Analysis, vol. 29, 2002, pp. 1045-1052.
Merriam Webster Online Dictionary, Definition for “Aberrant,” retrieved from https://www.merriam-webster.com/dictionary/aberrant Aug. 19, 2008, 1 page.
Merriam-Webster Online Dictionary, Definition of “Acceleration” retrieved from http://www.merriam-webster.com/dictionary/Acceleration Jan. 11, 2010, 1 page.
Merriam-Webster Online Dictionary, Definition of “Nominal” retrieved from http://www.merriam-webster.com/dictionary/nominal Apr. 23, 2007, 1 page.
Merriam-Webster Online Dictionary, Definition of “System”. http://www.merriamwebster.com/dictionary/System Jan. 11, 2010, 2 pages.
Metzger M., et al., “Reproducibility of Glucose Measurements using the Glucose Sensor,” Diabetes Care, vol. 25 (6), Jul. 2002, pp. 1185-1191.
Meyerhoff C., et al., “On Line Continuous Monitoring of Subcutaneous Tissue Glucose in Men by Combining Portable Glucosensor With Microdialysis,” Diabetologia, vol. 35 (11), 1992, pp. 1087-1092.
Miller J.A., et al., “Development of an Autotuned Transcutaneous Energy Transfer System,” ASAIO Journal, vol. 39, 1993, pp. M706-M710.
Moatti-Sirat D., et al., “Evaluating In Vitro and In Vivo the Interference of Ascorbate and Acetaminophen on Glucose Detection by a Needle-Type Glucose Sensor,” Biosensors and Bioelectronics, vol. 7, 1992, pp. 345-352.
Moatti-Sirat D., et al., “Reduction of Acetaminophen Interference in Glucose Sensors by a Composite Nation Membrane: Demonstration in Rats and Man,” Diabetologia, vol. 37 (6), Jun. 1994, pp. 610-616.
Moatti-Sirat., et al., “Towards Continuous Glucose Monitoring: In Vivo Evaluation of a Miniaturized Glucose Sensor Implanted for Several Days in Rat Subcutaneous Tissue,” Diabetologia, vol. 35, 1992, pp. 224-230.
Monsod T.P., et al., “Do Sensor Glucose Levels Accurately Predict Plasma Glucose Concentrations During Hypoglycemia And Hyperinsulinemia?, ” Diabetes Care, vol. 25 (5), 2002, pp. 889-893.
Morff R.J., et al., “Microfabrication of Reproducible, Economical, Electroenzymatic Glucose Sensors,” Annual International Conference of the IEEE Engineering in Medicine and Biology Society, vol. 12 (2), 1990, pp. 0483-0484.
Mosbach K., et al., “Determination of Heat Changes in the Proximity of Immobilized Enzymes with an Enzyme Thermistor and its Use for the Assay of Metabolites,” Biochimica Biophysica Acta, vol. 403, 1975, pp. 256-265.
Motonaka J., et al., “Determination of Cholesterol and Cholesterol Ester with Novel enzyme Microsensors,” Anal. Chern., vol. 65, 1993, pp. 3258-3261.
Moussy F., et al., “A Miniaturized Nafion-Based Glucose Sensor: In Vitro and In Vivo Evaluation in Dogs,” International Journals of Artificial Organs, vol. 17 (2), 1994, pp. 88-94.
Moussy F., et al., “Performance of Subcutaneously Implanted Needle-Type Glucose Sensors Employing a Novel Trilayer Coating,” Analytical Chemistry, vol. 65, Aug. 1, 1993, pp. 2072-2077.
Moussy F., “Implantable Glucose Sensor: Progress and Problems,” IEEE, Nov. 2002, pp. 270-273.
Murphy S.M., et al., “Polymer Membranes in Clinical Sensor Applications, II. The Design and Fabrication of Permselective Hydrogels for Electrochemical Devices,” Biomaterials, 1992, vol. 13(14), pp. 979-990.
Muslu, “Trickling Filter Performance,” Applied Biochemistry and Biotechnology, vol. 37, 1992, pp. 211-224.
Neuburger G.G., et al., “Pulsed Amperometric Detection of Carbohydrates at Gold Electrodes with a Two-Step Potential Waveform,” Anal. Chern., vol. 59, 1987, pp. 150-154.
Newsrx, “Glucose Monitoring: FDA OKs New Device to Manage Diabetes,” Medical Letter on the CDC & FDA via NewsRx.com, Aug. 3, 2003, 1 page.
Nintendo Healthcare, Wired, Dec. 1993, 1 page.
Novo Nordisk Pharmaceuticals Inc., “Diabetes Educational Video Game Recognized by Software Publishers Association,” Press Release, Mar. 14, 1994, 4 pages.
Office Action for European Application No. 05723951.9, dated Feb. 20, 2012, 4 pages.
Office Action for European Application No. 05723951.9, dated Jan. 28, 2011, 6 pages.
Office Action for European Application No. 05723951.9, dated Jun. 28, 2012, 9 pages.
Office Action for European Application No. 05723951.9, dated Nov. 21, 2007, 5 pages.
Office Action for European Application No. 05723951.9, dated Oct. 10, 2008, 3 pages.
Office Action for European Application No. 10163654.6, dated Oct. 11, 2012, 6 pages.
Office Action for European Application No. 10163675.1, dated Mar. 17, 2011, 5 pages.
Office Action for Japanese Application No. 2007-500777, dated Aug. 17, 2010, 6 pages.
Office Action for Japanese Application No. 2007-500777, dated Jul. 24, 2012, 27 pages.
Office Action for Japanese Application No. 2007-500777, dated Jun. 28, 2011, 3 pages.
Office Action for U.S. Appl. No. 09/636,369, dated Sep. 30, 2002, 4 pages.
Office Action for U.S. Appl. No. 10/632,537, dated Dec. 21, 2004, 7 pages.
Office Action for U.S. Appl. No. 10/632,537, dated Oct. 20, 2004, 7 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Apr. 27, 2010, 5 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Dec. 18, 2008, 9 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Feb. 4, 2008, 7 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Jul. 30, 2007, 9 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Jun. 11, 2009, 8 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Jun. 12, 2008, 7 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Mar. 26, 2007, 05 pages.
Office Action for U.S. Appl. No. 10/633,329, dated Oct. 5, 2006, 6 pages.
Office Action for U.S. Appl. No. 10/633,367, dated Jul. 15, 2008, 8 pages.
Office Action for U.S. Appl. No. 10/633,367, dated Jun. 11, 2009, 7 pages.
Office Action for U.S. Appl. No. 10/633,404, dated Feb. 12, 2007, 14 pages.
Office Action for U.S. Appl. No. 10/648,849, dated Jun. 23, 2009, 10 pages.
Office Action for U.S. Appl. No. 10/896,772, dated Dec. 14, 2005, 10 pages.
Office Action for U.S. Appl. No. 10/896,772, dated Jan. 11, 2005, 16 pages.
Office Action for U.S. Appl. No. 10/896,772, dated Jul. 19, 2005, 17 pages.
Office Action for U.S. Appl. No. 10/896,772, dated May 22, 2006, 31 pages.
Office Action for U.S. Appl. No. 10/991,966, dated Jul. 22, 2008, 12 pages.
Office Action for U.S. Appl. No. 10/991,966, dated Nov. 28, 2007, 13 pages.
Office Action for U.S. Appl. No. 11/007,635, dated Jan. 27, 2006, 9 pages.
Office Action for U.S. Appl. No. 11/007,920, dated Jun. 24, 2008, 10 pages.
Office Action for U.S. Appl. No. 11/034,344, dated Jan. 15, 2008, 5 pages.
Office Action for U.S. Appl. No. 11/038,340, dated Feb. 2, 2010, 18 pages.
Office Action for U.S. Appl. No. 11/038,340, dated Jan. 5, 2009, 13 pages.
Office Action for U.S. Appl. No. 11/038,340, dated Jun. 7, 2010, 18 pages.
Office Action for U.S. Appl. No. 11/038,340, dated Jun. 17, 2008, 11 pages.
Office Action for U.S. Appl. No. 11/038,340, dated May 19, 2009, 14 pages.
Office Action for U.S. Appl. No. 11/038,340, dated Nov. 9, 2009, 16 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Apr. 10, 2007, 16 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Apr. 16, 2009, 12 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Dec. 31, 2009, 8 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Jan. 10, 2008, 18 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Jan. 27, 2010, 9 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Jul. 27, 2007, 13 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Oct. 11, 2006, 9 pages.
Office Action for U.S. Appl. No. 11/077,714, dated Sep. 16, 2008, 16 pages.
Office Action for U.S. Appl. No. 11/077,739, dated Dec. 29, 2009, 7 pages.
Office Action for U.S. Appl. No. 11/077,739, dated Jul. 21, 2009, 8 pages.
Office Action for U.S. Appl. No. 11/077,739, dated Mar. 1, 2010, 9 pages.
Office Action for U.S. Appl. No. 11/077,740, dated Apr. 28, 2009, 27 pages.
Office Action for U.S. Appl. No. 11/077,740, dated Feb. 7, 2008, 16 pages.
Office Action for U.S. Appl. No. 11/077,740, dated Jul. 25, 2008, 24 pages.
Office Action for U.S. Appl. No. 11/077,740, dated Jun. 1, 2007, 14 pages.
Office Action for U.S. Appl. No. 11/077,740, dated Nov. 1, 2007, 13 pages.
Office Action for U.S. Appl. No. 11/077,759, dated Jul. 10, 2008, 10 pages.
Office Action for U.S. Appl. No. 11/077,759, dated Mar. 31, 2008, 16 pages.
Office Action for U.S. Appl. No. 11/077,759, dated May 17, 2007, 13 pages.
Office Action for U.S. Appl. No. 11/077,759, dated May 26, 2009, 8 pages.
Office Action for U.S. Appl. No. 11/077,765, dated Dec. 31, 2007, 10 pages.
Office Action for U.S. Appl. No. 11/077,765, dated Feb. 3, 2010, 10 pages.
Office Action for U.S. Appl. No. 11/077,765, dated Jan. 23, 2009, 11 pages.
Office Action for U.S. Appl. No. 11/077,765, dated May 16, 2008, 9 pages.
Office Action for U.S. Appl. No. 11/077,765, dated Sep. 19, 2008, 9 pages.
Office Action for U.S. Appl. No. 11/078,072, dated Feb. 18, 2010, 6 pages.
Office Action for U.S. Appl. No. 11/078,072, dated Jun. 10, 2010, 8 pages.
Office Action for U.S. Appl. No. 11/078,072, dated Sep. 2, 2009, 13 pages.
Office Action for U.S. Appl. No. 11/078,232, dated Apr. 27, 2010, 18 pages.
Office Action for U.S. Appl. No. 11/078,232, dated Jan. 5, 2010, 15 pages.
Office Action for U.S. Appl. No. 11/078,232, dated Jul. 21, 2009, 13 pages.
Office Action for U.S. Appl. No. 11/078,232, dated Mar. 5, 2009, 14 pages.
Office Action for U.S. Appl. No. 11/078,232, dated May 5, 2008, 21 pages.
Office Action for U.S. Appl. No. 11/078,232, dated Nov. 12, 2008, 28 pages.
Office Action for U.S. Appl. No. 11/333,837, dated Apr. 12, 2010, 10 pages.
Office Action for U.S. Appl. No. 11/333,837, dated Jul. 2, 2010, 7 pages.
Office Action for U.S. Appl. No. 11/333,837, dated Jun. 29, 2009, 13 pages.
Office Action for U.S. Appl. No. 11/333,837, dated Nov. 28, 2008, 11 pages.
Office Action for U.S. Appl. No. 11/334,876, dated Aug. 25, 2009, 18 pages.
Office Action for U.S. Appl. No. 11/334,876, dated Aug. 26, 2008, 8 pages.
Office Action for U.S. Appl. No. 11/334,876, dated May 2, 2008, 18 pages.
Office Action for U.S. Appl. No. 11/334,876, dated Oct. 4, 2006, 9 pages.
Office Action for U.S. Appl. No. 11/334,876, dated Sep. 25, 2007, 14 pages.
Office Action for U.S. Appl. No. 11/360,252, dated Jan. 29, 2009, 15 pages.
Office Action for U.S. Appl. No. 11/360,252, dated Jul. 23, 2009, 10 pages.
Office Action for U.S. Appl. No. 11/360,252, dated Jun. 30, 2008, 10 pages.
Office Action for U.S. Appl. No. 11/360,819, dated Apr. 7, 2010, 10 pages.
Office Action for U.S. Appl. No. 11/360,819, dated Aug. 11, 2008, 10 pages.
Office Action for U.S. Appl. No. 11/360,819, dated Dec. 26, 2008, 12 pages.
Office Action for U.S. Appl. No. 11/360,819, dated Oct. 29, 2009, 15 pages.
Office Action for U.S. Appl. No. 12/055,098, dated Oct. 5, 2010, 12 pages.
Office Action for U.S. Appl. No. 12/098,359, dated Jul. 7, 2010, 18 pages.
Office Action for U.S. Appl. No. 12/102,654, dated Jul. 30, 2009, 9 pages.
Office Action for U.S. Appl. No. 12/102,654, dated Mar. 10, 2010, 6 pages.
Office Action for U.S. Appl. No. 12/102,745, dated Dec. 23, 2008, 4 pages.
Office Action for U.S. Appl. No. 12/113,508, dated Feb. 23, 2010, 9 pages.
Office Action for U.S. Appl. No. 12/113,724, dated Jun. 24, 2010, 12 pages.
Office Action for U.S. Appl. No. 12/182,073, dated Jun. 28, 2010, 20 pages.
Office Action for U.S. Appl. No. 12/182,083, dated Jun. 24, 2010, 8 pages.
Office Action for U.S. Appl. No. 12/264,160, dated Jun. 3, 2010, 5 pages.
Office Action for U.S. Appl. No. 12/364,786, dated Jul. 29, 2010, 6 pages.
Office Action for U.S. Appl. No. 95/001,038, dated Jun. 17, 2008, 32 pages.
Office Action for U.S. Appl. No. 95/001,038, dated May 28, 2010, 32 pages.
Office Action for U.S. Appl. No. 95/001,039, dated May 29, 2008, 21 pages.
Office Action from European Patent Application No. 05723951.9, dated Sep. 7, 2010, 5 pages.
Ohara T.J., et al., “Glucose Electrodes Based On Cross-Linked [Os(bpy)2Cl](+/2+) Complexed Poly(1-Vinylimidazole) Films,” Analytical Chemistry, vol. 65, Dec. 1993, pp. 3512-3517.
Ohara T.J., et al., ““Wired” Enzyme Electrodes for Amperometric Determination of Glucose or Lactate in the Presence of Interfering Substances,” Anal Chern, vol. 66, 1994, pp. 2451-2457.
Okuda, et al., “Mutarotase Effect on Micro Determinations of D-Glucose and its Anomers with β D-Glucose Oxidase,” Anal Biochem, vol. 43 (1), 1971, pp. 312-315.
Oxford English Dictionary Online, Definition of “Impending,” http://www.askoxford.com/results/?view=devdict&field-12668446_Impending&branch Jan. 11, 2010, 1 page.
Palmisano F., et al., “Simultaneous Monitoring of Glucose and Lactate by an Interference and Cross-Talk Free Dual Electrode Amperometric Biosensor Based on Electropolymerized Thin Films,” Biosensors & Bioelectronics, vol. 15, 2000, pp. 531-539.
Panteleon A.E., et al., “The Role of the Independent Variable to Glucose Sensor Calibration,” Diabetes Technology & Therapeutics, vol. 5 (3), 2003, pp. 401-410.
Parker R.S., et al., “A Model-Based Algorithm for Blood Glucose Control In Type I Diabetic Patients,” IEEE Trans Biomed Engg (BME), vol. 46(2), 1999, pp. 148-157.
Patel H., et al., “Amperometric Glucose Sensors Based on Ferrocene Containing Polymeric Electron Transfer Systems—A Preliminary Report,” Biosensors & Bioelectronics, vol. 18, 2003, pp. 1073-1076.
Peacock W.F., et al., “Cardiac Troponin and Outcome in Acute Heart Failure,” N. Engl. J. Med., vol. 358, 2008, pp. 2117-2126.
Peguin S., et al., “Pyruvate Oxidase and Oxaloacetate Decarboxylase Enzyme Electrodes—Simultaneous Determination of Transaminases with a Two-electrode-based Analyzer,” Analytica Chimica Acta, vol. 222, 1989, pp. 83-93.
Pfeiffer E.F., et al., “On Line Continuous Monitoring of Subcutaneous Tissue Glucose is Feasible by Combining Portable Glucosensor with Microdialysis,” Horm. Metab. Res., vol. 25, 1993, pp. 121-124.
Pfeiffer E.F., “The Glucose Sensor: The Missing Link in Diabetes Therapy,” Horm Metab Res Suppl., vol. 24, 1990, pp. 154-164.
Phillips R.P., “A High Capacity Transcutaneous Energy Transmission System,” ASIAO Journal, vol. 41, 1995, pp. M259-M262.
Pichert J.W., et al., “Issues for the Coming Age of Continuous Glucose Monitoring,” Diabetes Educator, vol. 26 (6), Nov.-Dec. 2000, pp. 969-980.
Pickup J.C., et al., “Developing Glucose Sensors for In Vivo Use,” Elsevier Science Publishers Ltd (Uk), Tibtech, vol. 11, 1993, pp. 285-291.
Pickup J.C., et al., “Implantable Glucose Sensors: Choosing the Appropriate Sensor Strategy,” Biosensors, vol. 3, (1987/1988), pp. 335-346.
Pickup J.C., et al., “In Vivo Molecular Sensing in Diabetes Mellitus: An Implantable Glucose Sensor with Direct Electron Transfer,” Diabetologia, vol. 32, 1989, pp. 213-217.
Pickup J.C., et al., “Potentially-lmplantable, Amperometric Glucose Sensors with Mediated Electron Transfer: Improving the Operating Stability,” Biosensors, vol. 4, 1989, pp. 109-119.
Pickup J.C., et al., “Responses and Calibration of Amperometric Glucose Sensors Implanted in the Subcutaneous Tissue of Man,” ACTA Diabetol, vol. 30, 1993, pp. 143-148.
Pinner S.H., et al., “Cross-Linking of Cellulose Acetate by Ionizing Radiation,” Nature, vol. 184, Oct. 24, 1959, pp. 1303-1304.
Pishko M.V., et al., “Amperometric Glucose Microelectrodes Prepared Through Immobilization of Glucose Oxidase in Redox Hydrogels,” Analytical Chemistry, vol. 63 (20), 1991, pp. 2268-2272.
Pitzer K.R., et al., “Detection of Hypoglycemia with the Glucowatch Biographer,” Diabetes Care, vol. 24 (5), 2001, pp. 881-885.
Poirier J.Y., et al., “Clinical and Statistical Evaluation of Self-Monitoring Blood Glucose Meters,” Diabetes Care, vol. 21 (11), Nov. 1998, pp. 1919-1924.
Poitout V., et al., “A Glucose Monitoring System for on Line Estimation in Man of Blood Glucose Concentration Using a Miniaturized Glucose Sensor Implanted in the Subcutaneous Tissue and a Wearable Control Unit,” Diabetologia, vol. 36, 1993, pp. 658-663.
Poitout V., et al., “Development of a Glucose Sensor for Glucose Monitoring in Man: The Disposable Implant Concept,” Clinical Materials, vol. 15, 1994, pp. 241-246.
Poitout V., et al., “In Vitro and In Vivo Evaluation in Dogs of a Miniaturized Glucose Sensor,” ASAIO Transactions, vol. 37, 1991, pp. M298-M300.
Postlethwaite T.A., et al., “Interdigitated Array Electrode as an Alternative to the Rotated Ring-Disk Electrode for Determination of the Reaction Products of Dioxygen Reduction,” Analytical Chemistry, vol. 68 (17), Sep. 1996, pp. 2951-2958.
Prabhu V.G., et al., “Electrochemical Studies of Hydrogen Peroxide at a Platinum Disc Electrode,” Electrochimica Acta, vol. 26 (6), 1981, pp. 725-729.
Quinn C.A.P., et al., “Biocompatible, Glucose-Permeable Hydrogel for In situ Coating of Implantable Biosensors,” Biomaterials, vol. 18 (24), 1997, pp. 1665-1670.
Quinn C.P., et al., “Kinetics of Glucose Delivery to Subcutaneous Tissue in Rats Measured with 0.3-mm Amperometric Microsensors,” The American Physiological Society, vol. 269, 1995, pp. E155-E161.
Rabah M.A., et al., “Electrochemical Wear of Graphite Anodes During Electrolysis of Brine,” Carbon, vol. 29 (2), 1991, pp. 165-171.
Rafael E., “Cell Transplantation and Immunoisolation: Studies on a Macroencapsulation Device,” Departments of Transplantation Surgery and Pathology, Karolinska Institutet, Huddinge Hospital, Stockholm, Sweden, 1999, pp. 1-83.
RAYA Systems Pioneers, “Raya Systems Pioneers Healthy Video Games,” Play Right, Nov. 1993, pp. 14-15.
Reach G., “A Method for Evaluating in vivo the Functional Characteristics of Glucose Sensors,” Biosensors, vol. 2, 1986, pp. 211-220.
Reach G., et al., “Can Continuous Glucose Monitoring Be Used for the Treatment of Diabetes?,” Analytical Chemistry, vol. 64 (6), Mar. 15, 1992, pp. 381A-386A.
Reach G., “Which Threshold to Detect Hypoglycemia? Value of Receiver-Operator Curve Analysis to Find a Compromise Between Sensitivity and Specificity,” Diabetes Care, vol. 24 (5), May 2001, pp. 803-804.
Rebrin K., et al., “Automated Feedback Control of Subcutaneous Glucose Concentration in Diabetic Dogs,” Diabetologia, vol. 32, 1989, pp. 573-576.
Rebrin K., et al., “Subcutaneous Glucose Monitoring by Means of Electrochemical Sensors: Fiction or Reality?,” Journal of Biomedical Engineering, vol. 14, Jan. 1992, pp. 33-40.
Rebrin K., et al., “Subcutaneous Glucose Predicts Plasma Glucose Independent of Insulin: Implications for Continuous Monitoring,” The American Physiological Society, vol. 277, 1999, pp. E561-E571.
Renard E., “Implantable Closed-Loop Glucose Sensing and Insulin Delivery: The Future for Insulin Pump Therapy,” Current Opinion in Pharmacology, vol. 2 (6), 2002, pp. 708-716.
Reush, “Organometallic Compounds,” Chemical Reactivity, Virtual Textbook of Organic Chemistry, Retrieved from http://www.cem.msu.edu/-reuschlVirtualText/orgmetal.htm 2004, pp. 1-16.
Rhodes R.K., et al., “Prediction of Pocket-Portable and Implantable Glucose Enzyme Electrode Performance from Combined Species Permeability and Digital Simulation Analysis,” Analytical Chemistry, vol. 66 (9), May 1, 1994, pp. 1520-1529.
Rigla M., et al., “Real-Time Continuous Glucose Monitoring Together with Telemedical Assistance Improves Glycemic Control and Glucose Stability in Pump-Treated Patients,” Diabetes Technology & Therapeutics, vol. 10 (3), 2008, pp. 194-199.
Rinken T., et al., “Calibration of Glucose Biosensors By Using Pre-Steady State Kinetic Data,” Biosensors & Bioelectronics, vol. 13, 1998, pp. 801-807.
Ristic S., et al., “Review: Effects of Rapid-Acting Insulin Analogs on Overall Glycemic Control in Type 1 and Type 2 Diabetes Mellitus,” Diabetes Technology & Therapeutics, vol. 5 (1), 2003, pp. 57-66.
Rivers E.P., et al., “Central Venous Oxygen Saturation Monitoring in the Critically Ill Patient,” Current Opinion in Critical Care, 2001, vol. 7, pp. 204-211.
Sakakida M., et al., “Development of Ferrocene-Mediated Needle-Type Glucose Sensor as a Measure of True Subcutaneous Tissue Glucose Concentrations,” Artif. Organs Today, vol. 2 (2), 1992, pp. 145-158.
Sakakida M., et al., “Ferrocene-Mediated Needle Type Glucose Sensor Covered with Newly Designed Biocompatible Membrane,” Sensors and Actuators B, vol. 13-14, 1993, pp. 319-322.
Salardi S., et al., “The Glucose Area Under the Profiles Obtained with Continuous Glucose Monitoring System Relationships with HbA1C in Pediatric Type 1 Diabetic Patients,” Diabetes Care, vol. 25 (10), Oct. 2002, pp. 1840-1844.
Samuels M.P., “The Effects of Flight and Altitude,” Arch Dis Child, vol. 89, 2004, pp. 448-455.
San Diego Plastics Inc, “Polyethylene,” Datasheet, Retrieved from http://www.sdplastics.com/polyeth.html on Aug. 19, 2009, 7 pages.
Sansen W., et al., “A Smart Sensor for the Voltammetric Measurement of Oxygen or Glucose Concentrations,” Sensors and Actuators B1, 1990, pp. 298-302.
Sansen W., et al., “Glucose Sensor with Telemetry System,” In Implantable Sensors for Closed Loop Prosthetic Systems edited by Ko W.H, Chapter 12, 1985, pp. 167-175.
Schaffar B.P.H., “Thick Film Biosensors for Metabolites in Undiluted Whole Blood and Plasma Samples,” Analytical Bioanalytical Chemistry, Dec. 2001, vol. 372, pp. 254-260.
Schmidt F.J., et al., “Calibration of a Wearable Glucose Sensor,” The International Journal of Artificial Organs, Wichtig Publishing, IT, vol. 15(1), Jan. 1, 1992, pp. 55-61.
Schmidt F.J., et al., “Glucose Concentration in Subcutaneous Extracellular Space,” Diabetes Care, vol. 16 (5), May 1993, pp. 695-700.
Schmidtke D.W., et al., “Accuracy of the One-Point in Vivo Calibration of “Wired” Glucose Oxidase Electrodes Implanted in Jugular Veins of Rats in Periods of Rapid Rise and Decline of the Glucose Concentration,” Analytical Chemistry, vol. 70 (10), May 15, 1998, pp. 2149-2155.
Schmidtke D.W., et al., “Measurement and Modeling of the Transient Difference Between Blood and Subcutaneous Glucose Concentrations in the Rat After Injection of Insulin,” Proceedings of the National Academy of Sciences, vol. 95, Jan. 1998, pp. 294-299.
Schoemaker M., et al., “The SCGMI System: Subcutaneous Continuous Glucose Monitoring Based on Microdialysis Technique,” Diabetes Technology & Therapeutics, vol. 5 (4), 2003, pp. 599-608.
Schoonen A.J.M., et al., “Development of a Potentially Wearable Glucose Sensor for Patients with Diabetes Mellitus: Design and In-vitro Evaluation,” Biosensors & Bioelectronics, vol. 5, 1990, pp. 37-46.
Selam J.L., “Management of Diabetes with Glucose Sensors and Implantable Insulin Pumps,” From the Dream of the 60s to the Realities of the 90s, ASAIO Journal 1997, vol. 43, pp. 137-142.
Service F.J., et al., “Mean Amplitude of Glycemic Excursions, A Measure of Diabetic Instability,” Diabetes, vol. 19 (9), Sep. 1970, pp. 644-655.
Service F.J., et al., “Measurements of Glucose Control,” Diabetes Care, vol. 10 (2), Mar.-Apr. 1987, pp. 225-237.
Service R.F., “Can Sensors Make a Home in the Body?,” Science, Materials Science: Soft Surface, vol. 297, Aug. 9, 2002, pp. 962-963.
Sharkawy A.A., et al., “Engineering the Tissue Which Encapsulates Subcutaneous Implants. I. Diffusion Properties,” Journal of Biomedical Materials Research, vol. 37, 1996, pp. 401-412.
Shaw G.W., et al., “In Vitro Testing of a Simply Constructed, Highly Stable Glucose Sensor Suitable for Implantation in Diabetic Patients,” Biosensors & Bioelectronics, vol. 6, 1991, pp. 401-406.
Shichiri M., et al., “Glycaemic Control in Pancreatectomized Dogs with a Wearable Artificial Endocrine Pancreas,” Diabetologia, vol. 24, 1983, pp. 179-184.
Shichiri M., et al., “Membrane Design for Extending the Long-Life of an Implantable Glucose Sensor,” Diabetes Nutrition & Metabolism, vol. 2 (4), 1989, pp. 309-313.
Shichiri M., et al., “Needle Type Glucose Sensor for Wearable Artificial Endocrine Pancreas,” In Implantable Sensors for Closed-Loop Prosthetic Systems edited by Ko W.H, Chapter 15, 1985, pp. 197-210.
Shichiri M., et al., “Telemetry Glucose Monitoring Device with Needle-Type Glucose Sensor: A Useful Tool for Blood Glucose Monitoring in Diabetic Individuals,” Diabetes Care, vol. 9 (3), May-Jun. 1986, pp. 298-301.
Shichiri M., et al., “Wearable Artificial Endocrine Pancreas with Needle-Type Glucose Sensor,” Preliminary Communication, Lancet, vol. 2, Nov. 20, 1982, pp. 1129-1131.
Shults M.C., et al., “A Telemetry-Instrumentation System for Monitoring Multiple Subcutaneously Implanted Glucose Sensors,” IEEE Transactions on Biomedical Engineering, vol. 41 (10), Oct. 1994, pp. 937-942.
Sigma-Aldrich Corp. “Nafion® 117 Solution Product Description, Product No. 70160,” retrieved from https//:http://www.sigmaaldrich.com/cgi-bin/hsrun/Suite7/Suite/HAHTpage/Suite.HsExternalProd on Apr. 7, 2005, 1 page.
Skyler U.S., “The Economic Burden of Diabetes and the Benefits of Improved Glycemic Control: The Potential Role of a Continuous Glucose Monitoring System,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1,2000, pp. S7-S12.
Slater-MacLean L., et al., “Accuracy of Glycemic Measurements in the Critically Ill,” Diabetes Technology and Therapeutics, vol. 10 (3), 2008, pp. 169-177.
Smith B., et al., “An Externally Powered, Multichannel, Implantable Stimulator-Telemeter for Control of Paralyzed Muscle,” IEEE Transactions on Biomedical Engineering, vol. 45 (4), Apr. 1998, pp. 463-475.
Smith, et al.,“A Comparison of Islet Transplantation and Subcutaneous Insulin Injections for the Treatment of Diabetes Mellitus,” Computers in Biology and Medicine, 1991, vol. 21 (6), pp. 417-427.
Sokol L., et al., “Immobilized-Enzyme Rate-Determination Method for Glucose Analysis,” Clinical Chemistry, vol. 26 (1), 1980, pp. 89-92.
Sokolov S., et al., “Metrological Opportunities of the Dynamic Mode of Operating an Enzyme Amperometric Biosensor,” Medical Engineering & Physics, vol. 17 (6), 1995, pp. 471-476.
Sparacino G., et al., “Continuous Glucose Monitoring Time Series and Hypo-Hyperglycemia Prevention: Requirements, Methods, Open Problems,” Current Diabetes Reviews, vol. 4 (3), 2008, pp. 181-192.
Sproule B.A., et al., “Fuzzy Pharmacology: Theory and Applications,” Trends in Pharmacological Sciences, vol. 23 (9), Sep. 2002, pp. 412-417.
Sriyudthsak M., et al., “Enzyme-Epoxy Membrane Based Glucose Analyzing System and Medical Applications,” Biosensors & Bioelectronics, vol. 11 (8), 1996, pp. 735-742.
Steil G.M., et al., “Determination of Plasma Glucose During Rapid Glucose Excursions with a Subcutaneous Glucose Sensor,” Diabetes Technology & Therapeutics, vol. 5 (1), 2003, pp. 27-31.
Stern M., et al., “Electrochemical Polarization: I. A Theoretical Analysis of the Shape of Polarization Curves,” Journal of the Electrochemical Society, vol. 104 (1), Jan. 1957, pp. 56-63.
Sternberg F., et al., “Does Fall in Tissue Glucose Precede Fall in Blood Glucose?,” Diabetologia, vol. 39, 1996, pp. 609-612.
Sternberg R., et al., “Study and Development of Multilayer Needle-type Enzyme Based Glucose Microsensors,” Biosensors, vol. 4, 1988, pp. 27-40.
Street, et al., “Islet Graft Assessment in the Edmonton Protocol: Implications for Predicting Long-Term Clinical Outcome,” Diabetes, 2004, vol. 53, pp. 3107-3114.
Street J.O., et al., “A Note on Computing Robust Regression Estimates Via Iteratively Reweighted Least Squares,” The American Statistician, vol. 42 (2), May 1988, pp. 152-154.
Sumino T., et al., “Preliminary Study of Continuous Glucose Monitoring with a Microdialysis Technique,” Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, vol. 20 (4), 1998, pp. 1775-1778.
Supplementary European Search Report for Application No. 05723951.9 dated May 2, 2007, 3 pages.
Takatsu I., et al., “Solid State Biosensors Using Thin-Film Electrodes,” Sensors and Actuators, 1987, vol. 11, pp. 309-317.
Takegami S., et al., “Pervaporation of Ethanol/Water Mixtures Using Novel Hydrophobic Membranes Containing Polydimethylsiloxane,” Journal of Membrane Science, vol. 75, 1992, pp. 93-105.
Tamura T., et al., “Preliminary Study of Continuous Glucose Monitoring with a Microdialysis Technique and a Null Method—A Numerical Analysis,” Frontiers of Medical & Biological Engineering, vol. 10 (2), 2000, pp. 147-156.
Tanenberg R.J., et al., “Continuous Glucose Monitoring System: A New Approach to the Diagnosis of Diabetic Gastroparesis,” Diabetes Technology & Therapeutics, vol. 2, Supplement 1, 2000, pp. S73-S80.
Tatsuma T., et al., “Oxidase/Peroxidase Bilayer-Modified Electrodes as Sensors for Lactate, Pyruvate, Cholesterol and Uric Acid,” Analytica Chimica Acta, vol. 242, 1991, pp. 85-89.
Thennadil S.N., et al., “Comparison of Glucose Concentration in Interstitial Fluid, and Capillary and Venous Blood During Rapid Changes in Blood Glucose Levels,” Diabetes Technology & Therapeutics, vol. 3 (3), 2001, pp. 357-365.
Thijssen, et al., “A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems,” Part 1,Theory and Simulations, Analytica chimica Acta, 1984, vol. 156, pp. 87-101.
Thijssen, et al., “A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems,” Part 3,Variance Reduction ,Analytica chimica Acta, 1985, vol. 173, pp. 265-272.
Thijssen, et al., “A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems,” Part 4,Flow Injection Analysis, Analytica chimica Acta, 1985, vol. 174, pp. 27-40.
Thijssen P.C.,“A Kalman Filter for Calibration, Evaluation of Unknown Samples and Quality Control in Drifting Systems,” Part 2,Optimal Designs, Analytica chimica Acta, vol. 162, 1984, pp. 253-262.
Thome V., et al., “(Abstract) Can the Decrease in Subcutaneous Glucose Concentration Precede the Decrease in Blood Glucose Level? Proposition for a Push-Pull Kinetics Hypothesis,” Horm. metab. Res., vol. 27, 1995, p. 53.
Thome-Duret V., et al., “Continuous Glucose Monitoring in the Free-Moving Rat,” Metabolism, vol. 47 (7), Jul. 1998, pp. 799-803.
Thome-Duret V., et al., “Modification of the Sensitivity of Glucose Sensor Implanted into Subcutaneous Tissue,” Diabetes & Metabolism, vol. 22, 1996, pp. 174-178.
Thome-Duret V., et al., “Use of a Subcutaneous Glucose Sensor to Detect Decreases in Glucose Concentration Prior to Observation in Blood,” Analytical Chemistry, vol. 68 (21), Nov. 1, 1996, pp. 3822-3826.
Thompson M., et al., “In Vivo Probes: Problems and Perspectives,” Clinical Biochemistry, vol. 19 (5), Oct. 1986, pp. 255-261.
Tierney M.J., et al., “Effect of Acetaminophen on the Accuracy of Glucose Measurements Obtained with the GlucoWatch Biographer,” Diabetes Technology & Therapeutics, vol. 2 (2), 2000, pp. 199-207.
Tierney M.J., et al., “The Gluco Watch® Biographer: A Frequent, Automatic and Noninvasive Glucose Monitor,” Annals of Medicine, vol. 32, 2000, pp. 632-641.
Tilbury J.B., et al., “Receiver Operating Characteristic Analysis for Intelligent Medical Systems—A New Approach for Finding Confidence Intervals,” IEEE Transactions on Biomedical Engineering, vol. 47 (7), Jul. 2000, pp. 952-963.
Torjman M.C., et al., “Glucose Monitoring in Acute Care: Technologies on the Horizon,” Journal of Diabetes Science and Technology, vol. 2 (2), Mar. 2008, pp. 178-181.
Trajanoski Z., et al., “Neural Predictive Controller For Insulin Delivery Using The Subcutaneous Route,” IEEE Transactions on Biomedical Engineering, vol. 45(9), 1998, pp. 1122-1134.
Trecroci D., “A Glimpse into the Future-Continuous Monitoring of Glucose with a Microfiber,” Diabetes Interview, Jul. 2002, pp. 42-43.
Tse P.S.H., et al., “Time-Dependent Inactivation of Immobilized Glucose Oxidase and Catalase,” Biotechnology & Bioengineering, vol. 29, 1987, pp. 705-713.
Turner A.P.F., et al., “Carbon Monoxide: Acceptor Oxidoreductase from Pseudomonas Thermocarboxydovorans Strain C2 and its Use in a Carbon Monoxide Sensor,” Analytica Chimica Acta, vol. 163, 1984, pp. 161-174.
Turner A.P.F., et al., “Diabetes Mellitus: Biosensors for Research and Management,” Biosensors, vol. 1, 1985, pp. 85-115.
Unger J., et al., “Glucose Control in the Hospitalized Patient,” Emergency Medicine, vol. 36 (9), 2004, pp. 12-18.
Updike S.J., et al., “A Subcutaneous Glucose Sensor with Improved Longevity, Dynamic Range, and Stability of Calibration,” Diabetes Care, vol. 23 (2), Feb. 2000, pp. 208-214.
Updike S.J., et al., “Continuous Glucose Monitor Based on an Immobilized Enzyme Electrode Detector,” Journal of Laboratory and Clinical Medicine, vol. 93(4), 1979, pp. 518-527.
Updike S.J., et al., “Enzymatic Glucose Sensor: Improved Long-Term Performance in Vitro and In Vivo,” ASAIO Journal, vol. 40 (2), Apr.-Jun. 1994, pp. 157-163.
Updike S.J., et al., “Implanting the Glucose Enzyme Electrode: Problems, Progress, and Alternative Solutions,” Diabetes Care, vol. 5 (3), May-Jun. 1982, pp. 207-212.
Updike S.J., et al., “Laboratory Evaluation of New Reusable Blood Glucose Sensor,” Diabetes Care, vol. 11 (10), Nov.-Dec. 1988, pp. 801-807.
Updike S.J., et al., “Principles of Long-Term Fully Implanted Sensors with Emphasis on Radiotelemetric Monitoring of Blood Glucose Form Inside a Subcutaneous Foreign Body Capsule (FBC),” Edited by Fraser D M, Biosensors in the Body: Continuous in vivo Monitoring, John Wiley & Sons Ltd., New York, 1997, Chapter 4, pp. 117-137.
Updike S.J., et al., “The Enzyme Electrode,” Nature, vol. 214, Jun. 3, 1967, pp. 986-988.
Utah Medical Products Inc., “Deltran—Disposable Blood Pressure Transducers,” Product Specifications, 2003-2006, 6 pages.
Vadgama P., “Diffusion Limited Enzyme Electrodes,” NATO ASI Series: Series C, Math and Phys. Sci, vol. 226, 1988, pp. 359-377.
Vadgama P., “Enzyme Electrodes as Practical Biosensors,” Journal of Medical Engineering & Technology, vol. 5 (6), Nov. 1981, pp. 293-298.
Valdes T.I., et al., “In Vitro and In Vivo Degradation of Glucose Oxidase Enzyme used for an Implantable Glucose Biosensor,” Diabetes Technology & Therapeutics, vol. 2 (3), 2000, pp. 367-376.
Van Den Berghe, “Tight Blood Glucose Control with Insulin in “Real-Life” Intensive Care,” Mayo Clinic Proceedings, vol. 79 (8), Aug. 2004, pp. 977-978.
Velho G., et al., “In Vitro and In Vivo Stability of Electrode Potentials in Needle-Type Glucose Sensors,” Influence of Needle Material, Diabetes, vol. 38, Feb. 1989, pp. 164-171.
Velho G., et al., “Strategies for Calibrating a Subcutaneous Glucose Sensor,” Biomed Biochim Acta, vol. 48 (11/12), 1989, pp. 957-964.
Vesper H.W., et al., “Assessment of Trueness of a Glucose Monitor Using Interstitial Fluid and Whole Blood as Specimen Matrix,” Diabetes Technology & Therapeutics, vol. 8 (1), 2006, pp. 76-80.
Von Woedtke T., et al., “In Situ Calibration of Implanted Electrochemical Glucose Sensors,” Biomed. Biochim. Acta 48 vol. 11/12, 1989, pp. 943-952.
Wagner, et al., “Continuous Amperometric Monitoring of Glucose in a Brittle Diabetic Chimpanzee with a Miniature Subcutaneous Electrode,” Proc. Natl. Acad. Sci. USA, vol. 95, May 1998, pp. 6379-6382.
Wang J., et al., “Highly Selective Membrane-Free Mediator-Free Glucose Biosensor,” Analytical Chemistry, vol. 66 (21), Nov. 1, 1994, pp. 3600-3603.
Wang X., et al., “Improved Ruggedness for Membrane-Based Amperometric Sensors using a Pulsed Amperometric Method,” Analytical Chemistry, vol. 69 (21), Nov. 1, 1997, pp. 4482-4489.
Ward W.K., et al., “A New Amperometric Glucose Microsensor: In Vitro and Short-Term In Vivo Evaluation,” Biosensors & Bioelectronics, vol. 17, 2002, pp. 181-189.
Ward W.K., et al., “Assessment of Chronically Subcutaneous Glucose Sensors in Dogs: The Effect of Surrounding Fluid Masses,” ASAIO Journal, 1999, vol. 45 (6), pp. 555-561.
Ward W.K., et al., “Rise in Background Current Over Time in a Subcutaneous Glucose Sensor in the Rabbit,” Relevance to Calibration and Accuracy, Biosensors & Bioelectronics, vol. 15, 2000, pp. 53-61.
Ward W.K., et al., “Understanding Spontaneous Output Fluctuations of an Amperometric Glucose Sensor: Effect of Inhalation Anesthesia and Use of a Nonenzyme Containing Electrode,” ASAIO Journal, 2000, pp. 540-546.
Wentholt I.M.E., et al., “Relationship between Interstitial and Blood Glucose in Type 1 Diabetes Patients: Delay and the Push-pull Phenomenon Revisited,” Diabetes Technology & Therapeutics, vol. 9 (2), 2007, pp. 169-175.
Wientjes K.J.C., “Development of a Glucose Sensor for Diabetic Patients,” (Ph.D. Thesis), 2000, 212 pages.
Wikipedia., “Intravenous Therapy,” http://en.wikipedia.org/wiki/Intravenous_therapy, Aug. 15, 2006, 6 pages.
Wilkins E., et al., “Glucose Monitoring: State of the Art and Future Possibilities,” Med. Eng. Phys., vol. 18 (4), 1996, pp. 273-288.
Wilkins E., et al., “Integrated Implantable Device for Long-Term Glucose Monitoring,” Biosensors & Bioelectronics, vol. 10, 1995, pp. 485-494.
Wilkins E.S., et al., “The Coated Wire Electrode Glucose Sensor,” Horm Metab Res Suppl., vol. 20, 1988, pp. 50-55.
Wilson G.S., et al., “Enzyme-Based Biosensors for In Vivo Measurements,” Chern. Rev., vol. 100, 2000, pp. 2693-2704.
Wilson G.S., et al., “Progress Toward the Development of an Implantable Sensor for Glucose,” Clinical Chemistry, vol. 38 (9), 1992, pp. 1613-1617.
Wolpert H., “Establishing a Continuous Glucose Monitoring Program,” Journal of Diabetes Science and Technology, Mar. 2008, vol. 2 (2), pp. 307-310.
Wolpert H.A., “Commentary: A Clinician's Perspective on Some of the Challenges in Closed Loop,” Diabetes Technology & Therapeutics, vol. 5 (5), 2003, pp. 843-846.
Wood W D., et al., “Hermetic Sealing with Epoxy,” Pave Technology—Mechanical Engineering, Mar. 1990, 3 pages.
Woodward S.C., “How Fibroblasts and Giant Cells Encapsulate Implants: Considerations in Design of Glucose Sensors,” Diabetes Care, vol. 5 (3) May-Jun. 1982, pp. 278-281.
Worsley G.J et al., “Measurement of Glucose in Blood with a Phenylboronic Acid Optical Sensor,” Journal of Diabetes Science and Technology, vol. 2 (2), Mar. 2008, pp. 213-220.
Wright M., et al., “Bioelectrochemical Dehalogenations Via Direct Electrochemistry of Poly(ethylene oxide)-Modified Myoglobin,” Electrochemistry Communications, vol. 1, 1999, pp. 609-613.
Wu H., et al., “In Situ Electrochemical Oxygen Generation with an Immunoisolation Device,” Annals New York Academy of Sciences, vol. 875, 1999, pp. 105-125.
Yamasaki Y., et al., “Direct Measurement of Whole Blood Glucose by a Needle-Type Sensor,” Clinica Chimica Acta. 93, 1989, pp. 93-98.
Yamasaki Y., “The Development of a Needle-Type Glucose Sensor for Wearable Artificial Endocrine Pancreas,” Medical Journal of Osaka University, vol. 35 (1-2), Sep. 1984, pp. 25-34.
Yang C., et al., “A Comparison of Physical Properties and Fuel Cell Performance of Nafion and Zirconium Phosphate/Nation Composite Membranes,” Journal of Membrane Science, vol. 237, 2004, pp. 145-161.
Yang Q., et al., “Development of Needle-Type Glucose Sensor with High Selectivity,” Science and Actuators B, vol. 46, 1998, pp. 249-256.
Yang S., et al., “A Glucose Biosensor Based On an Oxygen Electrode: In-Vitro Performances in a Model Buffer Solution and in Blood Plasma,” Biomedical Instrumentation & Technology, vol. 30 (1), 1996, pp. 55-61.
Yang S., et al., “Glucose Biosensors with Enzyme Entrapped in Polymer Coating,” Biomedical Instrument and Technology, Mar./Apr. 1995, vol. 29 (2), pp. 125-133.
Ye L., et al., “High Current Density Wired' Quinoprotein Glucose Dehydrogenase Electrode,” Analytical Chemistry, vol. 65, 1993, pp. 238-241.
Zamzow K.L., et al., “Development and Evaluation of a Wearable Blood Glucose Monitor,” ASAIO Transactions, vol. 36 (3), 1990, pp. M588-M591.
Zavalkoff S.R., et al., “Evaluation Of Conventional Blood Glucose Monitoring as An Indicator of Integrated Glucose Values Using a Continuous Subcutaneous Sensor,” Diabetes Care, vol. 25(9), 2002, pp. 1603-1606.
Zethelius B., et al., “Use Of Multiple Biomarkers to Improve the Prediction of Death From Cardiovascular Causes,” N. Engl. J. Med., vol. 358, May 2008, pp. 2107-2116.
Zhang, et al., “Elimination of the Acetaminophen Interference in an Implantable Glucose Sensor,” Analytical Chemistry, 1994, vol. 66 (7), pp. 1183-1188.
Zhang Y., et al., “Electrochemical Oxidation Of H2O2 On Pt and Pt + Ir Electrodes in Physiological Buffer and its Applicability to H2O2-Based Biosensors,” J. Electro Analytical Chemistry, vol. 345, 1993, pp. 253-271.
Zhang Y., et al., “In Vitro and In Vivo Evaluation of Oxygen Effects on a Glucose Oxidase Based Implantable Glucose Sensor,” Analytica Chimica Acta, vol. 281, 1993, pp. 513-520.
Zhu, et al., “Fabrication and Characterization of Glucose Sensors Based on a Microarray H2O2 Electrode,” Biosensors & Bioelectronics, 1994, vol. 9, pp. 295-300.
Zhu, et al., “Planar Amperometric Glucose Sensor Based on Glucose Oxidase Immobilized by Chitosan Film on Prussian blue Layer,” Sensors, 2002, vol. 2, pp. 127-136.
Ziaie, et al., “A Single-Channel Implantable Microstimulator for Functional Neuromuscular Stimulation,” IEEE Transactions on Biomedical Engineering, 1997, vol. 44(10), pp. 909-920.
Asberg P., et al., “Hydrogels of a Conducting Conjugated Polymer as 3-D Enzyme Electrode,” Biosensors Bioelectronics, 2003, vol. 19, pp. 199-207.
Brauker, et al., “Sustained Expression of High Levels of Human Factor IX from Human Cells Implanted within an Immunoisolation Device into Athymic Rodents,” Human Gene Therapy, Apr. 10, 1998, vol. 9, pp. 879-888.
Brauker J H., et al., “Neovascularization of Synthetic Membranes Directed by Membrane Microarchitecture,” Journal of Biomedical Material Research, 1995, vol. 29, pp. 1517-1524.
Brauker J., “Unraveling Mysteries at the Biointerface: Molecular Mediator of Inhibition of Blood Vessel Formation in the Foreign Body Capsule Revealed,” SurFACTS in Biomaterials, vol. 6 (3), 2001, pp. 1,5.
Brunner G.A., et al., “Validation of Home Blood Glucose Meters with Respect to Clinical and Analytical Approaches,” Diabetes Care, vol. 21, No. 4, Apr. 1998, pp. 585-590.
Chen C., et al., “A Noninterference Polypyrrole Glucose Biosensor,” Biosensors and Bioelectronics, vol. 22, 2006, pp. 639-643.
Dai W.S., et al., “Hydrogel Membranes with Mesh Size Asymmetry based on the Gradient Crosslinking of Poly(Vinyl Alcohol),” Journal of Membrane Science, 1999, vol. 156, pp. 67-79.
D'Arrigo G., et al., “Porous-Si Based Bio Reactors for Glucose Monitoring and Drugs Production,” Proceedings of SPIE, 2003, vol. 4982, pp. 178-184.
Extended European Search Report for Application No. 08756743.4 dated Feb. 26, 2013, 7 pages.
File History of U.S. Appl. No. 10/632,537, filed Aug. 1, 2003, 211 pages.
File History of U.S. Appl. No. 10/633,329, filed Aug. 1, 2003, 711 pages.
File History of U.S. Appl. No. 10/633,367, filed Aug. 1, 2003, 432 pages.
File History of U.S. Appl. No. 10/896,772, filed Jul. 21, 2004, 210 pages.
File History of U.S. Appl. No. 10/991,966, filed Nov. 17, 2004, 446 pages.
File History of U.S. Appl. No. 11/038,340, filed Jan. 18, 2005, 653 pages.
File History of U.S. Appl. No. 11/077,714, filed Mar. 10, 2005, 320 pages.
File History of U.S. Appl. No. 11/077,740, filed Mar. 10, 2005, 921 pages.
File History of U.S. Appl. No. 11/077,759, filed Mar. 10, 2005, 596 pages.
File History of U.S. Appl. No. 11/077,765, filed Mar. 10, 2005, 932 pages.
File History of U.S. Appl. No. 11/078,232, filed Mar. 10, 2005, 256 pages.
File History of U.S. Appl. No. 11/333,837, filed Jan. 17, 2006, 672 pages.
File History of U.S. Appl. No. 11/360,819, filed Feb. 22, 2006, 778 pages.
File History of U.S. Appl. No. 11/691,432, filed Mar. 26, 2007, 659 pages.
File History of U.S. Appl. No. 11/334,876, filed Jan. 18, 2006, 751 pages.
File History of U.S. Appl. No. 11/360,252, filed Feb. 22, 2006, 594 pages.
Geller R.I., et al., “Use of an Immunoisolation Device for Cell Transplantation and Tumor Immunotherapy,” Annals of the New York Academy of Science, 1997, vol. 831, pp. 438-451.
Gerritsen M., et al., “Influence of Inflammatory Cells and Serum on the Performance of Implantable Glucose Sensors,” Journal of Biomedical Material Research, 2001, vol. 54, pp. 69-75.
Gregg B A., et al., “Cross-Linked Redox Gels Containing Glucose Oxidase for Amperometric Biosensor Applications,” Anal Chem, 1990, vol. 62, pp. 258-263.
Harrison, et al., “Characterization of Perfluorosulfonic Acid Polymer Coated Enzyme Electrodes and a Miniaturized Integrated Potentiostat for Glucose Analysis in Whole Blood,” Analytical Chemistry, 1988, vol. 60, pp. 2002-2007.
International Preliminary Reporton Patentability for Application No. PCT/US2008/065978 dated Jun. 19, 2008, 14 pages.
International Search Report and Written opinion for Application No. PCT/US2008/065978 dated Oct. 2, 2008, 14 pages.
Kargol M., et al., “Studies on the Structural Properties of Porous Membranes: Measurement of Linear Dimensions of Solutes,” Biophysical Chemistry, 2001, vol. 91, pp. 263-271.
Karube I., et al., “Microbiosensors for Acetylcholine and Glucose,” Biosensors & Bioelectronics, 1993, vol. 8, pp. 219-228.
Klueh U., et al., “Inflammation and Glucose Sensors: Use of Dexamethasone to Extend Glucose Sensor Function and Life Span in Vivo,” Journal of Diabetes Science and Technology, vol. 1 (4), Jul. 2007, pp. 496-504.
Kunzler J., et al.,“Hydrogels based on Hydrophilic Side Chain Siloxanes,” Poly Mat Sci and Eng, 1993, vol. 69, pp. 226-227.
Kunzler J F., et al., “Contact Lens Materials,” Chemistry & Industry, Aug. 21, 1995, pp. 651-655.
Lee E., et al., “Effects of Pore Size, Void Volume, and Pore Connectivity on Tissue Responses to Porous Silicone Implants,” Society for Biomaterials, 25th Annual Meeting, 1999, p. 171.
Loffler P., et al., “Separation and Determination of Traces of Ammonia in Air by Means of Chromatomembrane Cells,” Fresenius Journal of Analytical Chemistry, 1995, vol. 352, pp. 613-614.
Lyman D J., “Polyurethanes. I. The Solution Polymerization of Diisocyanates with Ethylene Glycol,” Journal of Polymer Science, 1960, vol. XLV, pp. 49-59.
Madaras M B., et al., “Microfabricated Amperometric Creatine and Creatinine Biosensors,” Analytica Chimica Acta, 1996, vol. 319, pp. 335-345.
Matsumoto T., et al., “A long-Term Lifetime Amperometric Glucose Sensor with a Perfluorocarbon Polymer Coating,” Biosensors & Bioelectronics, vol. 16, 2001, pp. 271-276.
Miller K.M., et al., “Generation of IL-1 like Activity in Response to Biomedical Polymer Implants: a Comparison of in Vitro and in Vivo Models,” Journal of Biomedical Materials Research, vol. 23(9), 1989, pp. 1007-1026.
Miller K.M., et al., “Human monocyte/macrophage activation and interleukin 1 generation by biomedical polymers,” Journal of Biomedical Materials Research, vol. 22 (8), 1988, pp. 713-731.
Miller K.M., et al., “In Vitro Stimulation of Fibroblast Activity by Factors Generated from Human Monocytes Activated by Biomedical Polymers,” Journal of Biomedical Materials Research, vol. 23(8), 1989, pp. 911-930.
Moussy F., et al., “Biomaterials community examines biosensor biocompatibility,” Diabetes Technology & Therapeutics, vol. 2(3), 2000, pp. 473-477.
Mowery K.A., et al., “Preparation and Characterization by Hydrophobic Polymeric Films that are Thromboresistant via Nitric Oxide Release,” Biomaterials, vol. 21, 2000, pp. 9-21.
Myler S., et al., “Ultra-Thin-Polysiloxane-Film-Composite Membranes for the Optimisation of Amperometric Oxidase Enzyme Electrodes,” Biosensors & Bioelectronics, vol. 17, 2002, pp. 35-43.
Nakayama Y., et al., “Surface Fixation of Hydrogels: Heparin and Glucose Oxidase Hydrogelated Surfaces” ASAIO Journal, 1992, pp. M421-M424.
Nam Y.S., et al., “A Novel Fabrication Method of Macroporous Biodegradable Polymer Scaffolds Using Gas Foaming Salt as a Porogen Additive,” J Biomed Mater Res, 2000, vol. 53, pp. 1-7.
Office Action for European Application No. 07844038.5 dated Jun. 4, 2020, 14 pages.
Office Action for U.S. Appl. No. 11/691,424, dated Jun. 11, 2009, 21 pages.
Office Action for U.S. Appl. No. 11/691,424, dated Sep. 25, 2008, 15 pages.
Office Action for U.S. Appl. No. 11/691,466, dated Oct. 3, 2008, 15 pages.
Office Action for U.S. Appl. No. 12/102,729, dated Jul. 7, 2009, 7 pages.
Office Action for U.S. Appl. No. 12/133,738, dated Sep. 10, 2010, 11 pages.
Office Action for U.S. Appl. No. 12/133,761, dated Sep. 7, 2010, 11 pages.
Panetti T.S., “Differential Effects of Sphingosine 1-Phosphate and Lysophosphatidic Acid on Endothelial Cells,” Biochimica et Biophysica Acta, vol. 1582, 2002, pp. 190-196.
Phillips R.E., et al., “Biomedical Applications of Polyurethanes: Implications of Failure Mechanisms,” Journal of Biomedical application, vol. 3, Oct. 1988, pp. 206-227.
Pickup J.C., et al., “Progress Towards in Vivo Glucose Sensing with a Ferrocene-Mediated Amperometric Enzyme Electrode,” Horm Metab Res Suppl, vol. 20, 1988, pp. 34-36.
Pineda L.M., et al., “Bone Regeneration with Resorbable Polymeric Membranes. III. Effect of Poly(L-lactide) Membrane Pore Size on the Bone Healing Process in Large Defects,” Journal of Biomedical Materials Research, vol. 31, 1996, pp. 385-394.
Ratner B.D., “Reducing Capsular Thickness and Enhancing Angiogenesis around Implant Drug Release Systems,” Journal of Controlled Release, vol. 78, 2002, pp. 211-218.
Sachlos E., et al., “Making Tissue Engineering Scaffolds Work Review on the Application of Solid Freeform Fabrication Technology to the Production of Tissue Engineering Scaffolds,” European Cells and Materials, vol. 5, 2003, pp. 29-40.
Sanders E., et al., “Fibrous Encapsulation of Single Polymer Microfibers Depends on their Vertical Dimension in Subcutaneous Tissue Polymer Microfibers,” Journal of Biomedical Material Research, vol. 67A, 2003, pp. 1181-1187.
Schuler, et al., “Modified Gas-Permeable Silicone Rubber Membranes for Covalent Immobilisation of Enzymes and their Use in Biosensor Development,” Analyst, 1999, vol. 124, pp. 1181-1184.
Sieminski, et al., “Biomaterial-Microvasculature Interactions,” Biomaterials, 2000, vol. 21, pp. 2233-2241.
Sigma-Aldrich Corp., “Cellulose Acetate,” Product Description, Product No. 419028, St. Louis, MO, 2005, 1 page.
Sternberg, et al., “Covalent Enzyme Coupling on Cellulose Acetate Membranes for Glucose Sensor Development,” Anal Chem, Dec. 1988, vol. 60(24), pp. 2781-2786.
Stokes, “Polyether Polyurethanes: Biostable or Not,” Journal of Biomaterials Applications, Oct. 1988, vol. 3, pp. 228-259.
Suh, et al., “Behavior of Fibroblasts on a Porous Hyaluronic Acid Incorporated Collagen Matrix,” Yonsei Medical Journal, 2002, vol. 43 (2), pp. 193-202.
Tang, et al., “Fibrin(ogen) Mediates Acute Inflammatory Responses to Biomaterials,” J.Exp.Med, 1993, vol. 178, pp. 2147-2156.
Tang, et al., “Inflammatory Responses to Biomaterials,” Am J Clin Pathol, 1995, vol. 103, pp. 466-471.
Tang, et al., “Mast Cells Mediate Acute Inflammatory Responses to Implanted Biomaterials,” Proceedings of the National Academy of Sciences of the USA, 1998, vol. 95, pp. 8841-8846.
Tang, et al., “Molecular Determinants of Acute Inflammatory Responses to Biomaterials,” J Clin Invest, 1996, vol. 97, pp. 1329-1334.
Tibell, et al., “Survival of Macroencapsulated Allogeneic Parathyroid Tissue One Year after Transplantation in Nonimmunosuppressed Humans,” Cell Transplantation, 2001, vol. 10, pp. 591-599.
Turner A.P.F., “Amperometric Biosensor based on Mediator-Modified Electrodes,” Methods in Enzymology, 1988, vol. 137, pp. 90-103.
Wade L.G., “Reactions of Aromatic Compounds,” Organic Chemistry, Chapter 17, 5th edition, 2003, pp. 762-763.
Office Action from Australian Patent Application No. 2018295116, dated Jul. 5, 2021, 3 pages.
Communication pursuant to Article 94(3) EPC for European Application No. 18869622.3, dated Aug. 17, 2021, 9 pages.
Provisional Applications (1)
Number Date Country
62576660 Oct 2017 US
Continuations (1)
Number Date Country
Parent 16167976 Oct 2018 US
Child 17369535 US