Compact medical device inserters and related systems and methods

Information

  • Patent Grant
  • 10674944
  • Patent Number
    10,674,944
  • Date Filed
    Friday, May 13, 2016
    8 years ago
  • Date Issued
    Tuesday, June 9, 2020
    3 years ago
Abstract
Compact medical device inserters, systems incorporating the same, and related methods of use are described. The inserters can include a housing, a sharp support, a sharp body, and a shroud, and can apply a sensor control device to a recipient with a sensor implanted in the recipient's body. The shroud can extend from the sensor control device in a position that covers or protects the sensor and a sharp, and can be retracted by pressure placed upon the inserter against the recipient's body to cause the sharp and sensor to penetrate the body, after which the sharp can be automatically withdrawn with the aid of a biasing element.
Description
FIELD

The present subject matter relates to compact medical device inserters for inserting a medical device through the skin of a subject, as well as to systems incorporating or utilizing such inserters and methods for making and using the inserters and incorporating systems.


BACKGROUND

The detection and/or monitoring of glucose levels or other analytes, such as lactate, oxygen, A1C, or the like, in certain individuals is vitally important to their health. For example, the monitoring of glucose is particularly important to individuals with diabetes. Diabetics generally monitor glucose levels to determine if their glucose levels are being maintained within a clinically safe range, and may also use this information to determine if, and/or when, insulin is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their bodies.


Growing clinical data demonstrates a strong correlation between the frequency of glucose monitoring and glycemic control. Despite such correlation, many individuals diagnosed with a diabetic condition do not monitor their glucose levels as frequently as they should due to a combination of factors including convenience, testing discretion, pain associated with glucose testing, and cost.


Devices have been developed for the automatic monitoring of analyte(s), such as glucose, in bodily fluid such as in the blood stream or in interstitial fluid (“ISF”), or other biological fluid. Some of these analyte monitoring devices are configured so that at least a portion of the devices are positioned below a skin surface of a user, e.g., in a blood vessel or in the subcutaneous tissue of a user, so that the monitoring is accomplished in vivo.


The positioning of the analyte monitoring devices in the body is typically accomplished with the aid of an insertion device, or inserter, that includes a sharp for penetrating the skin and allowing simultaneous or subsequent placement of the sensor within the resulting skin puncture. Conventional inserters can be bulky and/or complex devices that are expensive to manufacture and burdensome to use. These complex inserters are typically stored in sterile packaging and are not reusable, thus increasing the costs for the consumer. Furthermore, many typical inserters require some degree of assembly prior to use, either assembly of the inserter or the sensor device to be placed on and in the body, or both.


Thus, with the continued development of analyte monitoring devices and systems, there is a need for improved inserters that, for example, are more compact, less complex, easier to use, and cheaper to manufacture.


SUMMARY

Provided herein are example embodiments of improved medical device inserters, systems incorporating the same, and related methods of use. The inserter embodiments can be used in a wide variety of medical device applications, one example of which is for the insertion of analyte monitoring devices into the human body. While the inserter embodiments will be described herein with reference to an example analyte monitoring application, these embodiments are not limited to only that application.


Other systems, devices, methods, features and advantages of the subject matter described herein will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. In no way should the features of the example embodiments be construed as limiting the appended claims, absent express recitation of those features in the claims.





BRIEF DESCRIPTION OF THE FIGURES

The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying figures, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be depicted schematically rather than literally or precisely.



FIG. 1 is a high level diagram depicting an example embodiment of an analyte monitoring system for real time analyte (e.g., glucose) measurement, data acquisition and/or processing.



FIGS. 2A and 2B are exploded bottom up and top down perspective views, respectively, depicting an example embodiment of an inserter and sensor control device.



FIG. 3A is a side view depicting an example embodiment of an inserter and a sensor control device in a first stage of operation.



FIG. 3B is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 3B-3B of FIG. 3A.



FIG. 3C is a side view, rotated by 90 degrees from the view of FIG. 3A, depicting an example embodiment of the inserter and the sensor control device.



FIG. 3D is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 3D-3D of FIG. 3C.



FIGS. 3E and 3F are bottom up and top down perspective views, respectively, of an example embodiment of the inserter and the sensor control device.



FIG. 4A is a side view depicting an example embodiment of an inserter and a sensor control device in a second stage of operation.



FIG. 4B is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 4B-4B of FIG. 4A.



FIG. 4C is a side view, rotated by 90 degrees from the view of FIG. 4A, depicting an example embodiment of the inserter and the sensor control device.



FIG. 4D is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 4D-4D of FIG. 4C.



FIG. 4E is a bottom up perspective view of an example embodiment of the inserter and the sensor control device.



FIG. 5A is a side view depicting an example embodiment of an inserter and a sensor control device in a second stage of operation.



FIG. 5B is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 5B-5B of FIG. 5A.



FIG. 5C is a side view, rotated by 90 degrees from the view of FIG. 5A, depicting an example embodiment of the inserter and the sensor control device.



FIG. 5D is a cross-sectional perspective view of the example embodiment of the inserter and the sensor control device taken along line 5D-5D of FIG. 5C.



FIG. 5E is a bottom up perspective view of an example embodiment of the inserter and the sensor control device.



FIG. 6A is a perspective view depicting an example embodiment of an inserter.



FIG. 6B is a cross-section view depicting an example embodiment of a sensor control device.



FIGS. 6C-D are perspective and top-down views, respectively, depicting an example embodiment of a sensor control device.



FIG. 7A is a side view depicting an example embodiment of a sharp support and a sharp body.



FIG. 7B is a perspective view depicting an example embodiment of a sharp body.



FIGS. 7C-D are top-down and bottom-up perspective views, respectively, depicting an example embodiment of a shroud.



FIG. 8 is a flow diagram depicting an example embodiment of a method of using example embodiments of an inserter.



FIG. 9 is a block diagram depicting an example embodiment of a sensor control device.





DETAILED DESCRIPTION

Before describing this medical device inserter subject matter in greater detail, it is worthwhile to describe example embodiments of systems, devices, and methods with which this subject matter can be implemented.


A number of systems have been developed for the automatic monitoring of the analyte(s), like glucose, in bodily fluid such as in the blood stream, in interstitial fluid (“ISF”), dermal fluid of the dermal layer, or in other biological fluid. Some of these systems are configured so that at least a portion of a sensor is positioned below a skin surface of a user or recipient, e.g., in a blood vessel or in the dermal or subcutaneous tissue of a user, to obtain information about at least one analyte of the body.


As such, these systems can be referred to as “in vivo” monitoring systems. FIG. 1 is a high-level diagram depicting an example embodiment of an in vivo analyte monitoring system 100, which in some embodiments can be a “Continuous Analyte Monitoring” system (or “Continuous Glucose Monitoring” (CGM) system) that can broadcast data from a sensor control device 102 having an in vivo sensor 104 to a reader device 120 continuously without prompting, e.g., automatically according to a broadcast schedule. System 100 can also (or alternatively) be configured as a “Flash Analyte Monitoring” system (or “Flash Glucose Monitoring” system or simply “Flash” system) that can transfer data from sensor control device 102 in response to a scan or request for data by reader device 120, such as with an Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocol. Some embodiments of system 100 can also operate without the need for finger stick calibration. In addition to CGM and Flash, system 100 can also be used with other types of in vivo analyte monitoring configurations.


The in vivo analyte monitoring system 100 can be differentiated from “in vitro” systems that contact a biological sample outside of the body (or rather “ex vivo”) and that typically include a meter device that has a port for receiving an analyte test strip carrying bodily fluid of the user, which can be analyzed to determine the user's blood sugar level. While in many of the present embodiments the monitoring is accomplished in vivo, the embodiments disclosed herein can be used with in vivo analyte monitoring systems that incorporate in vitro capability, as well has purely in vitro or ex vivo analyte monitoring systems.


Sensor 104 can be part of the sensor control device 102 that resides on the body of the recipient and that contains the electronics and power supply that enable and control the analyte sensing. Sensor control device 102, and variations thereof, can also be referred to as a “sensor control unit,” an “on-body electronics” device or unit, an “on-body” device or unit, or a “sensor data communication” device or unit, to name a few.


Reader device 120 can receive sensed analyte data from sensor control device 102 and processes and/or displays that sensed analyte data, in any number of forms, to the user. This device and variations thereof can be referred to, for example, as a “reader device” (or simply a “reader”), “handheld electronics” (or a handheld), a “portable data processing” device or unit, a “data receiver,” a “receiver” device or unit (or simply a receiver), or a “remote” device or unit.


Sensor control device 102 and/or reader device 120 can each be configured to communication with a drug delivery device 160 that is capable of injecting or infusing a drug, such as but not limited to insulin, into the body of the individual wearing sensor control device 102. Sensor control device 102, reader device 120, and drug delivery device 160 can each be configured to communicate with a local or remote computer system 170 (such as a personal or laptop computer, a tablet, or other suitable data processing device) and/or with a remote trusted computer system 180 (which can include one or more computers, servers, networks, databases, and the like).


Additional detail regarding these and other example embodiments of in vivo monitoring systems 100 is provided in the following sections.


Embodiments of Medical Device Inserters



FIGS. 2A-7D depict example embodiments of an inserter or insertion device 200. Generally, these embodiments of inserter 200 have a compact design that is simpler and less burdensome to use, and less costly to manufacture than conventional inserters. Inserter 200 can be adapted for inserting at least a portion of sensor 104 into a recipient's body (e.g., that of a patient or human subject) and/or for placing sensor control device 102 on the recipient's body. For example, sensor 104 is inserted through the outer skin surface of the recipient until one or more electrodes on sensor 104 are placed into contact with a bodily fluid (e.g., blood, interstitial fluid, dermal fluid of the dermal skin layer, etc.) where those electrodes can reside for use in sensing an analyte level of the recipient.


In another embodiment, insertion device 200 can be used with a medical device having a drug infusion (e.g., insulin) cannula, where insertion device 200 applies the device to the body of a recipient such that the drug infusion cannula is inserted into the body of the recipient with the aid of a sharp. In certain embodiments, this medical device can also include sensor control device 102 (or at least analyte sensor 104, which may be separate from the cannula such that two sharps are used to create two body punctures, or analyte sensor 104 may be integrated with or attached to the cannula such that both sensor 104 and the cannula are inserted into the same body puncture with the aid of the same sharp).


The operator performing the insertion process with inserter 200 can be the same individual as the recipient of sensor 104, or the operator and recipient can be different individuals. Whether the same or different, both the operator and recipient are users of inserter 200. Both can also be users of system 100, or components thereof.



FIGS. 2A and 2B are exploded assembly views, from a bottom perspective and top perspective, respectively, depicting an example embodiment of inserter 200 for use with sensor control device 102. As shown here, inserter 200 can include a housing 201 that can also be configured as a handle for the operator. Housing 201 has a posterior side 203 and an anterior side 204. A relatively wider or flared section 202 with a recess 222 for receiving and holding housing 103 of sensor control device 102 is located on the anterior side 204 of housing 201. Inserter 200 can further include a sharp support 205, a sharp body 210 coupled to sharp 211, a biasing element 215, and a shroud 220.


The relative terms “posterior” and “anterior” are used herein to denote the back and front of the device, respectively, where the anterior side is the side placed against the recipient's skin from which sensor 104 is deployed, and the opposite side is the posterior side that is generally held in the operator's hand. As used herein, the term “advancement” in its various forms generally refers to motion in a posterior to anterior direction, and the term “retraction” in its various forms generally refers to motion in an anterior to posterior direction.


Sharp body 210 can slidably receive sensor 104, which in turn can be coupled with sensor control device housing 103 by way of a sensor mount 112. Sensor control device 102 can be releasably coupled with inserter 200 in a number of different manners. For example, one or more deflectable elastic projections, snaps, clips, or shaped contours can be used to mechanically engage with housing 103 of sensor control device 102. The attachment mechanism can be self-releasing or can include an actuator mechanism (e.g., a trigger, lever, switch, and the like) to allow a user to manually unlock sensor control device 102 from housing 201. In the embodiment described with respect to FIGS. 2A-B, three deflectable arms 223 are spaced evenly about the anterior periphery of housing 201 with gaps 224 on both sides. These arms 223 project anteriorly and can have a contoured inner surface 225 that is complementary to the shape of sensor housing 103. For example, in this embodiment sensor housing 103 has a rounded convex outer surface and inner surface 225 has a matching concave shape.


In many embodiments it is desirable that sensor control device 102 be released from inserter 200 by pulling inserter 200 away from the user's body (i.e., posteriorly) after attaching sensor control device 102 to the user's skin, such as with adhesive layer 105. Thus the posteriorly directed force necessary to release sensor control device 102 from inserter 200 should be less than the force at which sensor control device 102 is detached from the user's body. Thus, for example, contoured surface 225 on the interior of each arm 223 provides a coupling mechanism that can be released with the exertion of a relatively low pulling force, as compared to standard mechanical catches with detents. In other embodiments, sensor control device 102 can be attached to inserter 200 with a low tack adhesive or with the use of one or more magnetic elements (e.g., a magnet on sensor control device 102 and/or a magnet on inserter 200, each adapted to attract another magnet or ferromagnetic material on the opposite structure).


As can be seen in FIGS. 2A-B, sensor 104 can include a posterior portion 106 from which extends an anterior projection 108 adapted for at least partial insertion into the recipient's body. Sensor projection 108 can include three electrodes (not shown) for electrochemically sensing the user's analyte level. In other embodiments, sensor 104 can include one or more electrodes. These electrodes are electrically connected to electrical contacts 107 on proximal portion 106. Contacts 107 can overlie and be placed in electrical contact with opposing contacts (not shown) in sensor control device 102, which are in electrical communication with the circuitry of device 102 that is responsible for electrically controlling sensor 104 and monitoring the electrical signals produced on the sensor electrodes in response to the detection of the analyte (e.g., glucose).



FIGS. 3A-5E depict an example embodiment of inserter 200 at various stages of operation and will be used to describe inserter 200 in greater detail. To apply sensor control device 102 and insert sensor 104 into the user's body, in many embodiments, while shroud 220 is fully or mostly extended from sensor control device 102, an anterior surface 221 (described below) of shroud 220 is placed against the skin of the user at the desired implantation site (e.g., the upper arm or lower back). FIGS. 3A-F depict inserter 200 at this first stage of operation where shroud 220 is fully or mostly extended. Housing 201 can then be advanced relative to shroud 220 in order to advance at least a portion of sensor projection 108, along with sharp 211, from shroud 220 into and through the skin and into the body of the recipient. FIGS. 4A-E depict inserter 200 at a second stage of operation where shroud 220 has been partially retracted from the fully extended position, exposing sharp 211 and sensor projection 108.


Upon fully advancing housing 201 against the user's body, adhesive layer 105 of sensor control device 102 contacts and engages with the user's skin. Shroud 220 is fully (or mostly retracted) and sharp 211 and sensor projection 108 are advanced to the desired depth in the user's body. FIGS. 5A-E depict inserter 200 at this third stage of operation where shroud 220 has been fully or mostly retracted. At this point, sharp body 210 (along with sharp 211) can be released by internal components of inserter 200 and automatically retracted by biasing element 215 to a retracted position as discussed in further detail hereinafter. Inserter 200 can then be removed from the user's body and sensor control device 102 released from inserter 200 and left behind in position to monitor the user's analyte levels.


Referring back to the first stage of operation, FIGS. 3A-F depict inserter 200 with shroud 220 fully or mostly extended. Here, inserter 200 is shown in a loaded state coupled with sensor control device 102. With shroud 220 extended as shown, inserter 200 is ready to insert sensor 104 into the recipient's body and apply sensor control device housing 103 to the recipient's skin by way of adhesive layer 105. As will be described in more detail below, sharp 211 is positioned in close proximity with sensor projection 108 (FIGS. 3B, 3D) such that sharp 211 can create a puncture in the user's body and guide sensor projection 108 into the user's body. Sharp 211 is movable with respect to projection 108 and can be withdrawn from the user's body while leaving sensor projection 108 implanted therein.


In many embodiments, in the extended position, shroud 220 covers sharp 211 and sensor projection 108 thereby protecting users from sharp 211, and protecting sharp 211 and sensor projection 108 from external damage and/or contamination. Shroud 220 can include an anterior opening 276 (FIG. 3D, 3E), that may be the terminus of an interior lumen 277 (FIG. 3D, 7C), through which sharp 211 and sensor projection 108 can pass.


In the embodiments depicted, shroud 220 is a cylindrical or substantially cylindrical housing. Those of ordinary skill in the art, upon reading this description, will readily recognize those structures that are “substantially cylindrical,” as such structures are not limited to a pure geometric cylinder but include all variations of cylinder shapes, including those that are polygonal in cross-section, tapered, at least partially conical, hourglass-like, and so forth. Shroud 220 can also have a non-cylindrical shape that acts as a retractable cover or shield for one or both of sharp 211 and sensor projection 108.


Shroud 220 can be held in the extended position relative to device 102 by a lock mechanism 234 that engages shroud 220 with sensor control device 102. An embodiment of lock mechanism 234 is depicted, for example, in FIG. 3D. Here, lock mechanism 234 is implemented with a detent 235 that can extend radially outwardly from shroud 220 and engage with a corresponding recess 135 in device 102, which in this embodiment is formed between radially inwardly extending detents 136 and 137. Recess 135 and detents 136 and 137 are formed in sensor housing 103 (see also FIG. 6B), although these elements can be formed elsewhere on device 102. When detents 235 of shroud 220 are releasably engaged with recess 135 of sensor housing 103, shroud 220 is mechanically held in its position relative to sensor control device 102. It should be noted that all of the various detents described herein can also be implemented as a projection or an extending member.


Each detent 235 can be coupled with an elastic support 240 that is biased towards the position shown in FIGS. 3B, 3D, and 4D. Here, elastic support 240 is configured as an elastic arm and detent 235 (FIG. 3D) is integrally formed along the end of elastic arm 240 as a ledge that projects radially outwardly. Multiple elastic arms 240 can be present about the periphery of shroud 220, as described with respect to FIGS. 7C-D. Each detent 235 can be releasably maintained in recess 135 by elastic arm 240, which is deflectable inwardly from this position to allow disengagement of detent 235 from recess 135, and in turn to allow disengagement of shroud 220 from sensor housing 103. Alternatively, recess 135 can be implemented as a single groove that extends around substantially all of the periphery of sensor housing 103.


In other embodiments, the structures that form lock mechanism 234 can be reversed. For example, at least one recess or groove can be present on each elastic support 240 instead of a detents 235, and each such recess or groove can engage with a complementary detent or projection on sensor control device 102 or housing 103, similar to detent 136 or 137.


Angled surfaces can be present on detents 136, 137, and 235 and any portion of the other releasable lock mechanisms described herein in order to facilitate releasable engagement. The angle of these surfaces can be varied to obtain the desired resistance to engagement and/or disengagement. Angling of contact surfaces can facilitate translation of longitudinal motion (e.g., posterior-anterior motion) of one structure, e.g., the main body of shroud 220, into lateral motion (e.g., sideways motion) of another structure, e.g., elastic arms 240.


When anterior surface 221 of shroud 220 is placed against the recipient's body and sufficient force is applied to housing 201 in a direction towards the recipient's body, detents 235 will release from recess 135 and allow shroud 220 to retract into an opening 109 (FIG. 3B) within sensor control device 102. Thus, lock mechanism 234 can be released upon application of a predetermined manual force by the user.


Referring to FIG. 3B, inserter 200 can also include a second lock mechanism 254 that can releasably couple sharp support 205 with sharp body 210. Lock mechanism 254, which is shown in more detail in the embodiment depicted in FIG. 7A, can be implemented with one or more detents 255 and complementary recesses or grooves 256. Each detent 255 can radially outwardly extend from sharp body 210. Each detent 255 can be received within recess or groove 256 in sharp support 205. In this embodiment, recess 256 is formed by the space between optional projections 257 and 258, which extend radially inwardly from sharp support 205. More particularly, projections 257 and 258 extend from elastic supports 260 that, in this embodiment, are configured as elastic arms.


Any number of one or more elastic arms 260 can be utilized. In this embodiment, two elastic arms 260 are present, each in a position that opposes the other (e.g., present on opposite sides of sharp body 205). In some embodiments, sharp support 205 is a discrete component coupled with housing 201. In other embodiments, housing 201 and sharp support 205 are integral, e.g., molded from a single polymer. In either case, elastic arms 260 can be considered as coupled with housing 201.


Each recess 256 can be releasably maintained over detent 255 by elastic arm 260 to lock or secure sharp body 210 in position with respect to sharp support 205. Each elastic arm 260 is biased towards and deflectable outwardly from the position shown in FIGS. 3B and 7A to allow disengagement of recess 256 from detent 255, and in turn to allow disengagement of sharp body 210 from sharp support 205. One or more elastic arms 260 can be present and positioned as desired about the periphery of sharp support 205 to adequately engage and hold sharp body 210. Alternatively, and as described with respect to lock mechanism 234, the arrangement of lock mechanism 254 can be reversed such that recess 256, and projections 257 and 258 if present, are instead on sharp body 210 and detent 255 is on elastic arm 260.


Shroud 220 comprises a release mechanism 265 configured to unlock lock mechanism 254 and uncouple sharp support 205 from sharp body 210. In this embodiment, release mechanism 265 is a projection that extends away from surface 221 towards sharp support 205 when shroud 220 is in the extended position depicted in FIG. 3D. Release mechanism 265 can have an angled, rounded, beveled, or chamfered surface 266 that is positioned to contact an anterior surface 267 of arm 260, which can also be angled, rounded, beveled, or chamfered in a complementary (e.g., opposite) fashion. Retraction of shroud 220 causes surfaces 266 and 267 to contact (as will be described with respect to FIG. 4D) and translate the retracting force into a lateral or radially outward motion of arms 260, which in turn disengages each recess 256 from its respective detent 255 and release sharp body 205 from sharp support 210.


Biasing element 215 (FIGS. 3B, 4B, 5B; also referred to as a “bias” element) can be any structure or medium that can apply a bias or force to sharp body 205 and cause sharp body 205 to retract from the extended or advanced shroud position depicted in FIG. 3B. In the embodiments described herein, biasing element 215 is a helical coil spring, however other spring shapes can be used as well. Also, biasing element 215 can be configured as a structure that relies upon other media such as gas or fluid for the application of a retraction force.


Referring back to FIG. 3B, when shroud 220 is in the extended position, biasing element 215 is held in a relatively uncompressed state in an open chamber 269 within shroud 220. Biasing element 215 is laterally offset from a central axis 271 of inserter 200 and acts against two opposing surfaces 270 and 275, both of which can surround semi-cylindrical projections that can be received within the central lumen space of the helical coil and prevent the coil from sliding substantially out of position within chamber 269. In other embodiments, a center longitudinal axis of biasing element 215 can be aligned with central axis 271 of inserter 200. For example, a biasing element 215 configured as a helical coil spring can surround sharp 211 and sensor projection 108 such that the axis of withdrawal of sharp 211 can be within the central lumen of the helical spring along its central axis (generally the same position as central axis 271). The alignment of the axis of withdrawal of sharp 211 and the central axis of biasing element 215 can minimize the exertion of torque or a lateral moment on sharp body 205 during withdrawal.


Surface 270 faces anteriorly and is present on an extension or ledge 272 of sharp body 210 that is offset and extends away from sharp 211. This extension 272 is sized to fit and slide longitudinally within chamber 269, which has an open side to allow the extension's passage. Surface 275 faces posteriorly and is present on the anterior side of shroud 220, also in a position that is offset from sharp 211 itself.


The posterior side of sharp support 205 has a relatively large cylindrical portion that is coupled with an interior channel of housing 201, as shown in FIGS. 3B and 3D, and fixes sharp support 205 in place with respect to housing 201. Sharp support 205 may be coupled with housing 201 by a mechanical attachment such as welding, adhesive bonding, a snap or clip, a bayonet mount, an interference fit, or in another suitable manner that would allow it to be permanently or removably attached. As stated, sharp support 205 may also be formed as part of the housing such that they are one continuous component (e.g., monolithic).


Reference is now made to the second stage of operation, described with respect to FIGS. 4A-E, and the third stage of operation, described with respect to FIGS. 5A-E. The pressing of anterior shroud surface 221 against the skin (by the application of an anteriorly directed force by the user upon housing 201, i.e., pushing inserter 200 against the skin) causes shroud 220 to begin to retract upon disengagement of lock mechanism 234. Shroud 220 is shown in a partially retracted state in FIGS. 4A-E. The continued pressing of surface 221 against the skin causes shroud 220 to fully retract as shown in FIGS. 5A-E.


Because sharp support 205 is held in place by housing 201, and because sharp body 210 is held in place with respect to sharp support 205 by lock mechanism 254, the retraction of shroud 220 causes sharp 211 to pass through lumen or channel 277 (FIGS. 3D, 7C) and emerge from aperture 276 (FIG. 4B) in shroud 220. The retraction of shroud 220 also compresses biasing element 215 such that it transitions from a relatively uncompressed state to a relatively compressed state (FIG. 4B).


The continued retraction of shroud 220 causes release mechanism 265 to begin to disengage lock mechanism 254. As described earlier, the opposing angled or rounded surfaces 266 and 267 are pressed together (FIG. 4D) and the continued application of that force causes arms 260 to deflect outwards, disengaging recesses 256 from detents 255.


Upon disengagement of lock mechanism 254, sharp body 210 is no longer secured in place with respect to sharp support 205, and the pressure exerted by the now compressed biasing element 215 between surfaces 270 and 275 causes sharp body 210 to move posteriorly, i.e., to retract, into a space or cavity 278 (FIG. 5B) within sharp support 205. (Shroud 220 and surface 275 are prevented from moving anteriorly by the user's body.) This movement withdraws sharp 211 from the user's body without moving sensor 104, such that projection 108 remains fully extended (FIGS. 5A-E) in a position where the terminus of projection 108 would be at the desired depth within the user's body (e.g., within a dermal layer, subcutaneous layer, etc.).


In alternative embodiments, inserter 200 can be configured such that sharp 211 is manually withdrawn, e.g., the operator grasps sharp 211 and manually pulls it from the recipient's body. In other embodiments, sensor projection 108 can be configured, for example, with a sharp anterior terminus that pierces the user's body directly without the need for an additional sharp, thus also eliminating the need for withdrawal of an ancillary sharp.


Proximal portion 106 of sensor 104 can at least partially reside within an elongate opening or gap 279 in sharp body 210 (FIG. 4B). Elongate gap 279 can be shaped like a slit to allow sharp body 210 to slidably receive or pass over the planar-shaped proximal portion 206. When shroud 220 is retracted far enough to release lock mechanism 254, sharp body 210 is freed and forced posteriorly by biasing element 215. Sharp body 210 slides over sensor 104 into the fully retracted state (FIGS. 5B, 5D).


With reference to FIGS. 4D and 5D, sharp support 205 can include a stop 280 that is positioned so as to contact an opposing stop 285 on sharp body 210, which in this embodiment is the posterior surface of ledge 272. These opposing stops 280 and 285 define a position at which sharp body 210 is fully retracted and prevent further posterior motion of sharp body 210.


Biasing element 215 can cycle through three states during the insertion process. In the first state, shroud 220 is in the extended position and biasing element 215 is in a relatively uncompressed state (FIG. 3B). This relatively uncompressed state can be fully uncompressed or only partially compressed. In some embodiments, lock mechanism 234 can be omitted altogether and shroud 220 can be maintained in the extended proximal position by biasing element 215 itself in this first state.


As shroud 220 is retracted, biasing element 215 is compressed until shroud 220 reaches an intermediate position where shroud 220 is not yet fully retracted but the release of lock mechanism 254 is imminent (FIG. 4B). At this intermediate position biasing element 215 is in a second, relatively compressed state. In many embodiments, the amount of compression at this point is the maximum compression that biasing element 215 undergoes during the insertion process. Although when in a state of at least partial compression, biasing element 215 still exerts an expansive force against the surfaces that restrain it.


The intermediate position where sharp 211 begins retraction can be adjusted according the needs of the application and can be, for example, at the halfway distance between full extension of shroud 220 and full retraction of shroud 220 where shroud 220 is flush with surface 105 of sensor control device (FIGS. 5A-E). In other embodiments, the intermediate position can be relatively closer to the fully retracted position that the fully extended position of shroud 220, or vice versa. In some embodiments, lock mechanism 254 is released upon full retraction of shroud 220 such that the intermediate position and fully retracted position of shroud 220 are the same.


Once lock mechanism 254 is released, biasing element 215 begins to decompress from the relatively compressed state back towards a third relatively uncompressed state (FIG. 5B), which again may be fully uncompressed or partially compressed, either the same or different from the first state.


After reaching the fully retracted state, surface 221 of shroud can be generally flush with adhesive surface 105 of sensor control device 102 such that adhesive surface 105 is in contact with the recipient's skin. Once adequate adhesive contact is obtained, the operator can remove inserter 200 leaving sensor control device 102 behind on the recipient's body with sensor 104 at least partially in vivo.


In some embodiments, shroud 220 can be maintained or secured in the fully retracted position by a lock mechanism similar to those described herein, or otherwise. For example, upon reaching a fully retracted position, detent 235 of shroud 220 can enter a recess (not shown) on an inner surface of housing 201, such as inner wall 235 (FIG. 5D), and detent 235 can be maintained in that recess by the radially outward bias exerted by arms 240. In another embodiment, shroud 220 can be maintained in position solely by the friction between detent 235 and a smooth interior surface of inserter 200 (e.g., inner wall 235) that lacks a recess or other detent or catch.



FIG. 6A is a perspective view depicting an example embodiment of inserter 200 after removal, with shroud 220 in the retracted position and open recess 222 where sensor control device 102 had been previously housed. In this embodiment, inserter 200 is adapted to retain sensor control device by a friction fit between shroud 220 and housing 103 within opening 111. FIG. 6B is a cross-sectional view depicting an example embodiment of sensor control device 102 after removal of inserter 200 (the recipient's body is not shown). Here, adhesive surface 105 would be in contact with the exterior of the recipient's skin and sensor projection 108 would be mostly implanted within the recipient's body. If sensor 104 is a dermal sensor, then the distance by which projection 108 would extend into the body can be less than the full depth of the dermal layer, so that the electrodes on projection 108 are primarily in contact with dermal fluid and not interstitial fluid (ISF).


Also shown here is generally cylindrical opening 111 which receives shroud 220, sharp body 210, and sharp support 205. Located around the periphery of opening 111 are multiple detents 136 and 137. In this embodiment, each detent 136 is offset from each detent 137 such that the two detents are not directly above or below each other. In other embodiments the detents can be aligned such that they are directly above and below each other. In still other embodiments, detent 136 and/or detent 137 can be in the form of a ridge or lip that extends partially or entirely around the periphery of opening 111. Detent 136 is relatively anterior to detent 137, and detent 136 resists, and in many instances prevents, detent 235 of shroud 220 from passing in a posterior to anterior direction, which prevents shroud 220 from being removed in that same direction.



FIGS. 6C-D are top-down perspective and top-down views, respectively, of sensor control device 102 after removal of inserter 200. Here, a mount, support, or coupling 112 secures proximal portion 106 of sensor 104 to sensor control device 102. Mount 112 can include electrical connections to contacts 107 (not shown) on proximal portion 106. While sensor projection 108 is shown extending generally from the center of opening 111, in other embodiments projection 108 can be positioned adjacent the sidewall of opening 111.


In other embodiments, some or all of the inserter 200 may remain with sensor control device 102 on the recipient. For example, in some embodiments the recipient can wear the inserter for the entire lifetime of the sensor control device 102. In those cases, inserter 200 can be configured with a lower profile so as to minimize its noticeability. In other embodiments, housing 201 is removed but shroud 22, sharp 210, and sharp support 205 remain with sensor control device 102. In yet other embodiments housing 201, sharp 210, and sharp support 205 are removed but shroud 220 remains with device 102.



FIG. 7A is a side view depicting an example embodiment of sharp body 210 coupled with sharp support 205. FIG. 7B is a perspective view of an example embodiment of sharp body 210. In this embodiment, sharp 211 has a U-shaped configuration where opposing sidewalls 213 form a channel 212 therebetween. Sensor projection 108 (not shown) can reside within channel 212 such that sharp 211 can partially surround and protect sensor projection 108 during the insertion process. Also in this embodiment, detent 255 is configured as a rounded ledge that projects from a posterior mount 281 that is fastened to sharp 211. Elongate gap 279 is located within this posterior mount 281. A semi-cylindrical projection 282 is positioned on ledge 272 for engaging with an inner lumen of a helical spring biasing element 215 (not shown).



FIGS. 7C and 7D are top and bottom perspective views, respectfully, depicting an example embodiment of shroud 220. Although any number of one or more elastic arms 240 can be utilized, in this embodiment, shroud 220 includes three elastic arms 240, each with detent 235 in the form of a projecting ledge or lip. Release surface 266 for releasing elastic arms 240 has an angled or beveled configuration different from the embodiment shown in FIGS. 3D and 4D. Also shown is an elongate gap or opening 273 to allow the passage of planar proximal portion 106 of sensor 104 (not shown). A semi-cylindrical projection 274 is positioned near surface 275 for engaging with an inner lumen of a helical spring biasing element 215 (not shown).


Although not shown, to assist in guiding advancement and/or retraction of shroud 220, one or more elongate grooves, spaces, or channels can be implemented in which a projection or extension can slide. For example, the elongate groove, space, or channel can be present in shroud 220 with the longitudinal axis of that groove, space, or channel generally aligned with the direction of sliding motion, such that a projection or extension on the interior of housing 201 can be received into the groove, space, or channel and thereby guide the motion of shroud 220, preventing shroud 220 from rotating or tilting during advancement and/or retraction. Alternatively, the projection or extension can be present on shroud 220 and can be received in a groove, space, or channel in housing 201 with similar effect.



FIG. 8 is a flow diagram depicting an example method 800 of using certain embodiments of inserter 200 described herein. Inserter 200 and sensor control device 102, along with their various components, are described but not shown in FIG. 8, as these structures and their variants are shown in detail with respect to FIGS. 2A-7B.


At 802, inserter 200 can be mated with a sensor control device 102. This can be performed during manufacturing or by the user after distribution thereto. At 804, in a state where shroud 220, sharp 211, and sensor projection 108 are extended from an anterior surface 105 of sensor control device 102 and also where sharp 211 and sensor projection 108 are covered by shroud 220, inserter 200 is positioned in proximity with the recipient such that anterior surface 221 of shroud 200 contacts the skin of the recipient. At 806, the operator of inserter 200 can advance housing 201 towards the skin of the recipient, thereby also advancing sensor control device 102. In embodiments where shroud 220 is held in position by biasing element 215 alone, then this movement causes shroud 220 to retract. In embodiments that include lock mechanism 234, then the operator first exerts sufficient (in some embodiments predetermined) pressure in the direction of the recipient's skin to cause lock mechanism 234 to release shroud 220, at which point advancement of housing 201 towards the recipient's skin causes shroud 220 to retract.


The retraction of shroud 220 exposes sharp 211 and sensor projection 108 from anterior surface 221 of shroud 220. Because anterior surface 221 is pressed against the recipient's skin, sharp 211 pierces or punctures the exterior surface of the recipient's skin and travels into the recipient's body by a desired amount, generally equal to the remaining distance between anterior surface 221 and surface 105 of sensor control device 102. This distance can be set such that sensor projection 108 is placed subcutaneously in contact with the ISF and/or blood, or such that sensor projection 108 (and optionally sharp 211) do not exceed the depth of the dermal layer (i.e., do not pass out of the dermal layer into deeper tissue). The retraction of shroud 220 can also cause biasing element 215 to compress.


At 808, continued advancement of housing 201 towards the recipient's skin causes shroud 220 to continue to retract and, upon the exertion of sufficient (and in some embodiments predetermined) pressure then lock mechanism 254 is released. The release of lock mechanism 254 can release sharp body 205 from its secured position, and expansive force exerted by biasing mechanism 215 causes sharp body 205 to retract at 810, thereby removing sharp 211 from the body of the recipient.


At 812, if any distance remains between anterior surface 221 of shroud 220 and anterior surface 105 of sensor control device 102, then housing 201 can be advanced until surfaces 221 and 105 are at least flush. At 814, adequate pressure is exerted to secure adhesive layer 105 of sensor control device 102 to the recipient's skin. In other embodiments, alternative or additional techniques to secure sensor control device 102 can be performed. At 816, all or part of inserter 200 can be optionally removed. At 818, sensor control device 102 can be used to monitor the analyte level of the recipient, and transmit its collected data to another electronic device such as reader 120.


Embodiments of In Vivo Monitoring Systems


For purpose of illustration, and not limitation, the embodiments of inserter 200 and sensor control device 102 described herein may be used in connection with the example analyte monitoring system 100 previously described with respect to FIG. 1, which depicts an example in vivo analyte monitoring system 100 with which any and/or all of the embodiments described herein can be used. System 100 can have a sensor control device 102 and a reader device 120 that communicate with each other over a local communication path (or link) 140, which can be wired or wireless, and uni-directional or bi-directional. In embodiments where local communication path 140 is wireless, any near field communication (NFC) protocol, RFID protocol, Bluetooth or Bluetooth Low Energy protocol, Wi-Fi protocol, proprietary protocol, or the like can be used, including those communication protocols in existence as of the date of this filing or their later developed variants.


Reader device 120 can be a purpose specific device dedicated for use with analyte monitoring systems. Reader device 120 can also be a mobile communication device such as, for example, a Wi-Fi or internet enabled smartphone, tablet, or personal digital assistant (PDA). Reader device 120 can also be configured as a mobile smart wearable electronics assembly, such as an optical assembly that is worn over or adjacent to the user's eye (e.g., a smart glass or smart glasses, such as GOOGLE GLASSES). Other examples of wearable electronics include devices that are worn around or in the proximity of the user's wrist (e.g., a watch, etc.), neck (e.g., a necklace, etc.), head (e.g., a headband, hat, etc.), chest, or the like.


Reader device 120 is also capable of wired, wireless, or combined communication, either bidirectional or unidirectional, with either or all of: drug delivery device 160 over communication path (or link) 143, a local computer system 170 over communication path (or link) 141, and with a network 190 over communication path (or link) 142. The same wireless protocols described for link 140 can likewise be used for all or part of links 141, 142, and 143.


Reader device 120 can communicate with any number of entities through network 190, which can be part of a telecommunications network, such as a Wi-Fi network, a local area network (LAN), a wide area network (WAN), the internet, or other data network for uni-directional or bi-directional communication. A trusted computer system 180 can be accessed through network 190. In an alternative embodiment, communication paths 141 and 142 can be the same path which can include the network 190 and/or additional networks.


Variants of devices 102 and 120, as well as other components of an in vivo-based analyte monitoring system that are suitable for use with the system, device, and method embodiments set forth herein, are described in US Patent Application Publ. No. 2011/0213225 (the '225 Publication), which is incorporated by reference herein in its entirety for all purposes.


Sensor control device 102 can include a housing 103 containing in vivo analyte monitoring circuitry and a power source (not shown). The in vivo analyte monitoring circuitry can be electrically coupled with an analyte sensor 104 that can extend through an adhesive patch 105 and project away from housing 103. Adhesive patch 105 contains an adhesive layer (not shown) for attachment to a skin surface of the body of the user. Other forms of body attachment to the body may be used, in addition to or instead of adhesive.


Sensor 104 is adapted to be at least partially inserted into the body of the user, where it can make fluid contact with that user's body fluid (e.g., interstitial fluid (ISF), dermal fluid, or blood) and be used, along with the in vivo analyte monitoring circuitry, to measure analyte-related data of the user. Generally, sensor control device 102 and its components can be applied to the body with inserter 200 in one or more steps as described herein.


After activation, sensor control device 102 can wirelessly communicate the collected analyte data (such as, for example, data corresponding to monitored analyte level and/or monitored temperature data, and/or stored historical analyte related data) to reader device 120 where, in certain embodiments, it can be algorithmically processed into data representative of the analyte level of the user and then displayed to the user and/or otherwise incorporated into a diabetes monitoring regime.


Various embodiments disclosed herein relate to reader device 120, which can have a user interface including one or more of a display 122, keyboard, optional user interface component 121, and the like. Here, display 122 can output information to the user and/or accept an input from the user (e.g., if configured as a touch screen). Reader device 120 can include one or more optional user interface components 121, such as a button, actuator, touch sensitive switch, capacitive switch, pressure sensitive switch, jog wheel or the like. Reader device 120 can also include one or more data communication ports 123 for wired data communication with external devices such as local computer system 170. Reader device 120 may also include an integrated or attachable in vitro meter, including an in vitro test strip port (not shown) to receive an in vitro analyte test strip for performing in vitro blood analyte measurements.


Drug delivery device 160 is capable of injecting or infusing a drug, such as but not limited to insulin, into the body of the individual wearing sensor control device 102. Like reader device 120, drug delivery device 160 can include processing circuitry, non-transitory memory containing instructions executable by the processing circuitry, wireless or wired communication circuitry, and a user interface including one or more of a display, touchscreen, keyboard, an input button or instrument, and the like. Drug delivery device 160 can include a drug reservoir, a pump, an infusion tube, and an infusion cannula configured for at least partial implantation into the user's body. The pump can deliver insulin from the reservoir, through the tube, and then through the cannula into the user's body. Drug delivery device 160 can include instructions, executable by the processor, to control the pump and the amount of insulin delivered. These instructions can also cause calculation of insulin delivery amounts and durations (e.g., a bolus infusion and/or a basal infusion profile) based on analyte level measurements obtained directly or indirectly from sensor control device 102. The instructions can start drug delivery, stop drug delivery, increase or decrease the drug dosage, or modify a basal profile or a bolus dosage administered to the user. Embodiments of system 100 that include a drug delivery device 160 can be configured to operate as a semi-closed loop system or a fully closed loop system (sometimes referred to as an artificial pancreas).


Computer system 170 may be a personal or laptop computer, a tablet, or other suitable data processing device. Computer 170 can be either local (e.g., accessible via a direct wired connection such as USB) or remote to reader device 120 and can be (or include) software for data management and analysis and communication with the components in analyte monitoring system 100. Operation and use of computer 170 is further described in the '225 Publication incorporated herein by reference. Analyte monitoring system 100 can also be configured to operate with a data processing module (not shown), also as described in the incorporated '225 Publication.


Trusted computer system 180 can be used to perform authentication of sensor control device 102 and/or reader device 120, used to store confidential data received from devices 102 and/or 120, used to output confidential data to devices 102 and/or 120, or otherwise configured. Trusted computer system 180 can include one or more computers, servers, networks, databases, and the like. Trusted computer system 180 can be within the possession of the manufacturer or distributor of sensor control device 102, either physically or virtually through a secured connection, or can be maintained and operated by a different party (e.g., a third party).


The processing of data and the execution of software within system 100 can be performed by one or more processors of reader device 120, computer system 170, and/or sensor control device 102. For example, raw data measured by sensor 104 can be algorithmically processed into a value that represents the analyte level and that is readily suitable for display to the user, and this can occur in sensor control device 102, reader device 120, or computer system 170. This and any other information derived from the raw data can be displayed in any of the manners described above (with respect to display 122) on any display residing on any of sensor control device 102, reader device 120, or computer system 170. The information may be utilized by the user to determine any necessary corrective actions to ensure the analyte level remains within an acceptable and/or clinically safe range.



FIG. 9 is a block schematic diagram depicting an example embodiment of sensor control device 102 having analyte sensor 104 and sensor electronics 950 (including analyte monitoring circuitry). Although any number of chips can be used, here the majority of the sensor electronics 950 are incorporated on a single semiconductor chip 951 that can be, e.g., a custom application specific integrated circuit (ASIC). Shown within ASIC 951 are several high-level functional units, including an analog front end (AFE) 952, power management circuitry 954, processor 956, and communication circuitry 958 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol). In this embodiment shown here, both AFE 952 and processor 956 are used as analyte monitoring circuitry, but in other embodiments either circuit can perform the analyte monitoring function. Processor 956 can include one or more processors, microprocessors, controllers, and/or microcontrollers.


A non-transitory memory 953 is also included within ASIC 951 and can be shared by the various functional units present within ASIC 951, or can be distributed amongst two or more of them. Memory 953 can be volatile and/or non-volatile memory. In this embodiment, ASIC 951 is coupled with power source 960, which can be a coin cell battery, or the like. AFE 952 interfaces with in vivo analyte sensor 104 and receives measurement data therefrom and outputs the data to processor 956 in digital form, which in turn processes the data to arrive at the end-result analyte discrete and trend values, etc. This data can then be provided to communication circuitry 958 for sending, by way of antenna 961, to reader device 120 (not shown) where further processing can be performed by, e.g., the sensor interface application. It should be noted that the functional components of ASIC 951 can also be distributed amongst two or more discrete semiconductor chips.


Performance of the data processing functions within the electronics of the sensor control device 102 provides the flexibility for system 100 to schedule communication from sensor control device 102 to reader device 120, which in turn limits the number of unnecessary communications and can provide further power savings at sensor control device 102.


Information may be communicated from sensor control device 102 to reader device 120 automatically and/or continuously when the analyte information is available, or may not be communicated automatically and/or continuously, but rather stored or logged in a memory of sensor control device 102, e.g., for later output.


Data can be sent from sensor control device 102 to reader device 120 at the initiative of either sensor control device 102 or reader device 120. For example, in many example embodiments sensor control device 102 can communicate data periodically in an unprompted or broadcast-type fashion, such that an eligible reader device 120, if in range and in a listening state, can receive the communicated data (e.g., sensed analyte data). This is at the initiative of sensor control device 102 because reader device 120 does not have to send a request or other transmission that first prompts sensor control device 102 to communicate. Broadcasts can be performed, for example, using an active Wi-Fi, Bluetooth, or BTLE connection. The broadcasts can occur according to a schedule that is programmed within device 102 (e.g., about every 1 minute, about every 5 minutes, about every 10 minutes, or the like). Broadcasts can also occur in a random or pseudorandom fashion, such as whenever sensor control device 102 detects a change in the sensed analyte data. Further, broadcasts can occur in a repeated fashion regardless of whether each broadcast is actually received by a reader device 120.


System 100 can also be configured such that reader device 120 sends a transmission that prompts sensor control device 102 to communicate its data to reader device 120. This is generally referred to as “on-demand” data transfer. An on-demand data transfer can be initiated based on a schedule stored in the memory of reader device 120, or at the behest of the user via a user interface of reader device 120. For example, if the user wants to check his or her analyte level, the user could perform a scan of sensor control device 102 using an NFC, Bluetooth, BTLE, or Wi-Fi connection. Data exchange can be accomplished using broadcasts only, on-demand transfers only, or any combination thereof.


Accordingly, once a sensor control device 102 is placed on the body so that at least a portion of sensor 104 is in contact with the bodily fluid and electrically coupled to the electronics within device 102, sensor derived analyte information may be communicated in on-demand or unprompted (broadcast) fashion from the sensor control device 102 to a reader device 120. On-demand transfer can occur by first powering on reader device 120 (or it may be continually powered) and executing a software algorithm stored in and accessed from a memory of reader device 120 to generate one or more requests, commands, control signals, or data packets to send to sensor control device 102. The software algorithm executed under, for example, the control of processing hardware 206 of reader device 120 may include routines to detect the position of the sensor control device 102 relative to reader device 120 to initiate the transmission of the generated request command, control signal and/or data packet.


It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combinable and substitutable with those from any other embodiment. If a certain feature, element, component, function, or step is described with respect to only one embodiment, then it should be understood that that feature, element, component, function, or step can be used with every other embodiment described herein unless explicitly stated otherwise. This paragraph therefore serves as antecedent basis and written support for the introduction of claims, at any time, that combine features, elements, components, functions, and steps from different embodiments, or that substitute features, elements, components, functions, and steps from one embodiment with those of another, even if the following description does not explicitly state, in a particular instance, that such combinations or substitutions are possible. It is explicitly acknowledged that express recitation of every possible combination and substitution is overly burdensome, especially given that the permissibility of each and every such combination and substitution will be readily recognized by those of ordinary skill in the art.


To the extent the embodiments disclosed herein include or operate in association with memory, storage, and/or computer readable media, then that memory, storage, and/or computer readable media are non-transitory. Accordingly, to the extent that memory, storage, and/or computer readable media are covered by one or more claims, then that memory, storage, and/or computer readable media is only non-transitory.


In many instances entities are described herein as being coupled to other entities. It should be understood that the terms “coupled” and “connected” (or any of their forms) are used interchangeably herein and, in both cases, are generic to the direct coupling of two entities and the indirect coupling of two entities. Where entities are shown as being directly coupled together, or described as coupled together without description of any intervening entity, it should be understood that those entities can be indirectly coupled together as well unless the context clearly dictates otherwise.


The subject matter described herein and in the accompanying figures is done so with sufficient detail and clarity to permit the inclusion of claims, at any time, in means-plus-function format pursuant to 35 U.S.C. section 112, part (f). However, a claim is to be interpreted as invoking this means-plus-function format only if the phrase “means for” is explicitly recited in that claim.


As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.


While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. These embodiments are not to be limited to the particular form disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any features, functions, steps, or elements of the embodiments may be recited in or added to the claims, as well as negative limitations that define the scope of the claims by features, functions, steps, or elements that are not within that scope.

Claims
  • 1. A method for inserting an analyte sensor into a human body with an inserter, the inserter comprising a posterior housing, a sensor control device coupled with the housing, the analyte sensor, a sharp, and a shroud, the method comprising: placing an anterior surface of the shroud against a recipient's skin, wherein the shroud, the analyte sensor, and the sharp are extended with respect to an anterior surface of the sensor control device, wherein the shroud covers the analyte sensor and the sharp, and wherein the shroud is held extended with respect to the anterior surface of the sensor control device by a first lock mechanism comprising a structure on the shroud that locks with a structure on the sensor control device;advancing the sensor control device towards the recipient's skin such that the shroud retracts with respect to the sensor control device and the sharp and analyte sensor are inserted into the recipient's body; andwithdrawing the sharp while leaving the analyte sensor within the recipient's body.
  • 2. The method of claim 1, wherein the sharp and analyte sensor are inserted into the recipient's body through an aperture in the shroud.
  • 3. The method of claim 1, wherein the structure on the shroud is a detent and the structure on the sensor control device is a recess.
  • 4. The method of claim 1, wherein the inserter further comprises a biasing element, the method further comprising automatically withdrawing the sharp from the recipient's body with a force applied by the biasing element.
  • 5. The method of claim 4, wherein the sharp is coupled with a posterior mount, the method comprising automatically withdrawing the sharp from the recipient's body with the force applied by the biasing element against the posterior mount.
  • 6. The method of claim 5, wherein the biasing element contacts a base of the shroud and a surface on the posterior mount, and is adapted to apply the force therebetween.
  • 7. The method of claim 5, wherein the biasing element is in a uncompressed state when the shroud is extended, the method further comprising advancing the sensor control device towards the recipient's skin such that the shroud retracts with respect to the sensor control device and the biasing element transitions from the uncompressed state to a compressed state.
  • 8. The method of claim 7, further comprising releasing a second lock mechanism wherein, upon release, the biasing element decompresses from the compressed state and causes withdrawal of the sharp from the recipient's body.
  • 9. The method of claim 8, wherein the second lock mechanism comprises an elastic arm coupled with the housing and adapted to releasably hold the posterior mount in position with respect to the sensor control device.
  • 10. The method of claim 9, wherein retraction of the shroud causes a release surface of the shroud to deflect the elastic arm and thereby release the second lock mechanism.
  • 11. The method of claim 7, wherein the inserter further comprises two elastic arms coupled with the housing and adapted to releasably hold the posterior mount in position with respect to the sensor control device.
  • 12. The method of claim 11, wherein upon placement of the anterior surface of the shroud against the recipient's skin, the two elastic arms are holding the posterior mount in position with respect to the sensor control device and, wherein retraction of the shroud causes a release surface of the shroud to deflect the two elastic arms and thereby release the posterior mount from the elastic arms.
  • 13. The method of claim 12, wherein after release of the posterior mount from the elastic arms, the biasing element decompresses from the compressed state and causes withdrawal of the sharp from the recipient's body.
  • 14. The method of claim 1, further comprising adhesively coupling an anterior surface of the sensor control device to the recipient's skin.
  • 15. The method of claim 14, further comprising withdrawing the inserter such that the sensor control device is separated from the inserter and the sensor control device remains adhesively coupled to the recipient's skin with the analyte sensor at least partially implanted within the recipient's body.
  • 16. The method of claim 15, wherein, after withdrawal of the inserter, an electrode on the analyte sensor is in contact with a fluid of the recipient and capable of measuring a level of an analyte in the fluid, wherein the fluid is only interstitial fluid or only dermal fluid.
  • 17. The method of claim 16, wherein the analyte is glucose.
  • 18. The method of claim 1, wherein the sensor control device is coupled with the housing of the inserter and advancing the sensor control device towards the recipient's skin comprises grasping the housing of the inserter and advancing the housing towards the recipient's skin.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and the benefit of, U.S. Provisional Patent Application 62/161,787 filed May 14, 2015, the contents of which are incorporated by reference herein in its entirety and for all purposes.

US Referenced Citations (1100)
Number Name Date Kind
3132123 Harris, Jr. et al. May 1964 A
3260656 Ross, Jr. Jul 1966 A
3522807 Millenbach Aug 1970 A
3581062 Aston May 1971 A
3653841 Klein Apr 1972 A
3670727 Reiterman Jun 1972 A
3719564 Lilly, Jr. et al. Mar 1973 A
3776832 Oswin et al. Dec 1973 A
3837339 Aisenberg et al. Sep 1974 A
3926760 Allen et al. Dec 1975 A
3949388 Fuller Apr 1976 A
3972320 Kalman Aug 1976 A
3979274 Newman Sep 1976 A
4008717 Kowarski Feb 1977 A
4016866 Lawton Apr 1977 A
4036749 Anderson Jul 1977 A
4055175 Clemens et al. Oct 1977 A
4059406 Fleet Nov 1977 A
4076596 Connery et al. Feb 1978 A
4098574 Dappen Jul 1978 A
4100048 Pompei et al. Jul 1978 A
4120292 LeBlanc, Jr. et al. Oct 1978 A
4129128 McFarlane Dec 1978 A
4151845 Clemens May 1979 A
4168205 Danniger et al. Sep 1979 A
4172770 Semersky et al. Oct 1979 A
4178916 McNamara Dec 1979 A
4206755 Klein Jun 1980 A
4224125 Nakamura et al. Sep 1980 A
4240438 Updike et al. Dec 1980 A
4245634 Albisser et al. Jan 1981 A
4247297 Berti et al. Jan 1981 A
4294258 Bernard Oct 1981 A
4327725 Cortese et al. May 1982 A
4340458 Lerner et al. Jul 1982 A
4344438 Schultz Aug 1982 A
4349728 Phillips et al. Sep 1982 A
4352960 Dormer et al. Oct 1982 A
4353888 Sefton Oct 1982 A
4356074 Johnson Oct 1982 A
4365637 Johnson Dec 1982 A
4366033 Richter et al. Dec 1982 A
4373527 Fischell Feb 1983 A
4375399 Havas et al. Mar 1983 A
4384586 Christiansen May 1983 A
4390621 Bauer Jun 1983 A
4401122 Clark, Jr. Aug 1983 A
4404066 Johnson Sep 1983 A
4418148 Oberhardt Nov 1983 A
4425920 Bourland et al. Jan 1984 A
4427004 Miller et al. Jan 1984 A
4427770 Chen et al. Jan 1984 A
4431004 Bessman et al. Feb 1984 A
4436094 Cerami Mar 1984 A
4440175 Wilkins Apr 1984 A
4450842 Zick et al. May 1984 A
4458686 Clark, Jr. Jul 1984 A
4461691 Frank Jul 1984 A
4469110 Slama Sep 1984 A
4477314 Richter et al. Oct 1984 A
4478976 Goertz et al. Oct 1984 A
4484987 Gough Nov 1984 A
4494950 Fischell Jan 1985 A
4509531 Ward Apr 1985 A
4522690 Venkatsetty Jun 1985 A
4524114 Samuels et al. Jun 1985 A
4526661 Steckhan et al. Jul 1985 A
4527240 Kvitash Jul 1985 A
4534356 Papadakis Aug 1985 A
4538616 Rogoff Sep 1985 A
4543955 Schroeppel Oct 1985 A
4545382 Higgins et al. Oct 1985 A
4552840 Riffer Nov 1985 A
4560534 Kung et al. Dec 1985 A
4571292 Liu et al. Feb 1986 A
4573994 Fischell et al. Mar 1986 A
4581336 Malloy et al. Apr 1986 A
4595011 Phillips Jun 1986 A
4619754 Niki et al. Oct 1986 A
4619793 Lee Oct 1986 A
4627445 Garcia et al. Dec 1986 A
4627842 Katz Dec 1986 A
4627908 Miller Dec 1986 A
4633878 Bombardien Jan 1987 A
4637403 Garcia et al. Jan 1987 A
4650547 Gough Mar 1987 A
4654197 Lilja et al. Mar 1987 A
4655880 Liu Apr 1987 A
4655885 Hill et al. Apr 1987 A
4663824 Kenmochi May 1987 A
4671288 Gough Jun 1987 A
4679562 Luksha Jul 1987 A
4680268 Clark, Jr. Jul 1987 A
4682602 Prohaska Jul 1987 A
4684537 Graetzel et al. Aug 1987 A
4685463 Williams Aug 1987 A
4685466 Rau Aug 1987 A
4698057 Joishy Oct 1987 A
4703756 Gough et al. Nov 1987 A
4711245 Higgins et al. Dec 1987 A
4711247 Fishman Dec 1987 A
4717673 Wrighton et al. Jan 1988 A
4721601 Wrighton et al. Jan 1988 A
4721677 Clark, Jr. Jan 1988 A
4726378 Kaplan Feb 1988 A
4726716 McGuire Feb 1988 A
4729672 Takagi Mar 1988 A
4731726 Allen, III Mar 1988 A
4749985 Corsberg Jun 1988 A
4755173 Konopka Jul 1988 A
4758323 Davis et al. Jul 1988 A
4759371 Franetzki Jul 1988 A
4759828 Young et al. Jul 1988 A
4764416 Ueyama et al. Aug 1988 A
4776944 Janata et al. Oct 1988 A
4777953 Ash et al. Oct 1988 A
4779618 Gough Oct 1988 A
4781683 Wozniak et al. Nov 1988 A
4781798 Gough Nov 1988 A
4784736 Lonsdale et al. Nov 1988 A
4795707 Niiyama et al. Jan 1989 A
4796634 Huntsman et al. Jan 1989 A
4805624 Yao et al. Feb 1989 A
4813424 Wilkins Mar 1989 A
4815469 Cohen et al. Mar 1989 A
4820399 Senda et al. Apr 1989 A
4822337 Newhouse et al. Apr 1989 A
4830959 McNeil et al. May 1989 A
4832797 Vadgama et al. May 1989 A
RE32947 Dormer et al. Jun 1989 E
4840893 Hill et al. Jun 1989 A
4848351 Finch Jul 1989 A
4854322 Ash et al. Aug 1989 A
4871351 Feingold Oct 1989 A
4871440 Nagata et al. Oct 1989 A
4874500 Madou et al. Oct 1989 A
4890622 Gough Jan 1990 A
4894137 Takizawa et al. Jan 1990 A
4895147 Bodicky et al. Jan 1990 A
4897162 Lewandowski et al. Jan 1990 A
4897173 Nankai et al. Jan 1990 A
4909908 Ross et al. Mar 1990 A
4911794 Parce et al. Mar 1990 A
4917800 Lonsdale et al. Apr 1990 A
4919141 Zier et al. Apr 1990 A
4919767 Vadgama et al. Apr 1990 A
4921199 Villavecs May 1990 A
4923586 Katayama et al. May 1990 A
4925268 Iyer et al. May 1990 A
4927516 Yamaguchi et al. May 1990 A
4934369 Maxwell Jun 1990 A
4935105 Churchouse Jun 1990 A
4935345 Guibeau et al. Jun 1990 A
4938860 Wogoman Jul 1990 A
4944299 Silvian Jul 1990 A
4950378 Nagara Aug 1990 A
4953552 DeMarzo Sep 1990 A
4954129 Giuliani et al. Sep 1990 A
4969468 Byers et al. Nov 1990 A
4970145 Bennetto et al. Nov 1990 A
4974929 Curry Dec 1990 A
4986271 Wilkins Jan 1991 A
4988341 Columbus et al. Jan 1991 A
4994167 Shults et al. Feb 1991 A
4995402 Smith et al. Feb 1991 A
5000180 Kuypers et al. Mar 1991 A
5001054 Wagner Mar 1991 A
5013161 Zaragoza et al. May 1991 A
5019974 Beckers May 1991 A
5035860 Kleingeld et al. Jul 1991 A
5036860 Leigh et al. Aug 1991 A
5047044 Smith et al. Sep 1991 A
5050612 Matsumura Sep 1991 A
5055171 Peck Oct 1991 A
5058592 Whisler Oct 1991 A
5070535 Hochmair et al. Dec 1991 A
5082550 Rishpon et al. Jan 1992 A
5082786 Nakamoto Jan 1992 A
5089112 Skotheim et al. Feb 1992 A
5095904 Seligman et al. Mar 1992 A
5101814 Palti Apr 1992 A
5106365 Hernandez Apr 1992 A
5108564 Szuminsky et al. Apr 1992 A
5108889 Smith et al. Apr 1992 A
5109850 Blanco et al. May 1992 A
5120420 Nankai et al. Jun 1992 A
5122925 Inpyn Jun 1992 A
5126034 Carter et al. Jun 1992 A
5133856 Yamaguchi et al. Jul 1992 A
5135003 Souma Aug 1992 A
5140985 Schroeder et al. Aug 1992 A
5141868 Shanks et al. Aug 1992 A
5161532 Joseph Nov 1992 A
5165407 Wilson et al. Nov 1992 A
5174291 Schoonen et al. Dec 1992 A
5190041 Palti Mar 1993 A
5192416 Wang et al. Mar 1993 A
5198367 Aizawa et al. Mar 1993 A
5202261 Musho et al. Apr 1993 A
5205920 Oyama et al. Apr 1993 A
5208154 Weaver et al. May 1993 A
5209229 Gilli May 1993 A
5217595 Smith et al. Jun 1993 A
5229282 Yoshioka et al. Jul 1993 A
5234835 Nestor et al. Aug 1993 A
5238729 Debe Aug 1993 A
5246867 Lakowicz et al. Sep 1993 A
5250439 Musho et al. Oct 1993 A
5262035 Gregg et al. Nov 1993 A
5262305 Heller et al. Nov 1993 A
5264103 Yoshioka et al. Nov 1993 A
5264104 Gregg et al. Nov 1993 A
5264105 Gregg et al. Nov 1993 A
5264106 McAleer et al. Nov 1993 A
5271815 Wong Dec 1993 A
5279294 Anderson Jan 1994 A
5284156 Schramm et al. Feb 1994 A
5285792 Sjoquist et al. Feb 1994 A
5286362 Hoenes et al. Feb 1994 A
5286364 Yacynych et al. Feb 1994 A
5288636 Pollmann et al. Feb 1994 A
5293546 Tadros et al. Mar 1994 A
5293877 O'Hara et al. Mar 1994 A
5299571 Mastrototaro Apr 1994 A
5320098 Davidson Jun 1994 A
5320725 Gregg et al. Jun 1994 A
5322063 Allen et al. Jun 1994 A
5337747 Neftei Aug 1994 A
5340722 Wolfbeis et al. Aug 1994 A
5342789 Chick et al. Aug 1994 A
5352348 Young et al. Oct 1994 A
5356786 Heller et al. Oct 1994 A
5360404 Novacek et al. Nov 1994 A
5368028 Palti Nov 1994 A
5372133 Hogen Esch Dec 1994 A
5372427 Padovani et al. Dec 1994 A
5376251 Kaneko et al. Dec 1994 A
5378628 Gratzel et al. Jan 1995 A
5379238 Stark Jan 1995 A
5387327 Khan Feb 1995 A
5390671 Lord et al. Feb 1995 A
5391250 Cheney, II et al. Feb 1995 A
5395504 Saurer et al. Mar 1995 A
5400782 Beaubiah Mar 1995 A
5408999 Singh et al. Apr 1995 A
5411647 Johnson et al. May 1995 A
5425361 Fenzlein et al. Jun 1995 A
5431160 Wilkins Jul 1995 A
5431921 Thombre Jul 1995 A
5437999 Dieboid et al. Aug 1995 A
5462645 Albery et al. Oct 1995 A
5469846 Khan Nov 1995 A
5472317 Field et al. Dec 1995 A
5489414 Schreiber et al. Feb 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 et al. Mar 1996 A
5507288 Bocker et al. Apr 1996 A
5509410 Hill et al. Apr 1996 A
5514718 Lewis et al. May 1996 A
5527288 Gross et al. Jun 1996 A
5531878 Vadgama et al. Jul 1996 A
5545191 Mann et al. Aug 1996 A
5549368 Shields Aug 1996 A
5551427 Altman Sep 1996 A
5560357 Faupei et al. Oct 1996 A
5562713 Silvian Oct 1996 A
5565085 Ikeda et al. Oct 1996 A
5567302 Song et al. Oct 1996 A
5568806 Cheney, II et al. Oct 1996 A
5569186 Lord et al. Oct 1996 A
5575563 Chiu et al. Nov 1996 A
5582184 Erickson et al. Dec 1996 A
5582697 Ikeda et al. Dec 1996 A
5582698 Flaherty et al. Dec 1996 A
5584813 Livingston et al. Dec 1996 A
5586553 Halli et al. Dec 1996 A
5589326 Deng et al. Dec 1996 A
5593852 Heller et al. Jan 1997 A
5596150 Arndt et al. Jan 1997 A
5601435 Quy Feb 1997 A
5609575 Larson et al. Mar 1997 A
5613978 Harding Mar 1997 A
5617851 Lipkovker Apr 1997 A
5628310 Rao et al. May 1997 A
5628890 Carter et al. May 1997 A
5632557 Simons May 1997 A
5638832 Singer et al. Jun 1997 A
5640954 Pfeiffer et al. Jun 1997 A
5651869 Yoshioka et al. Jul 1997 A
5653239 Pompei et al. Aug 1997 A
5660163 Schulman et al. Aug 1997 A
5665071 Wyrick Sep 1997 A
5665222 Heller et al. Sep 1997 A
5670031 Hintsche et al. Sep 1997 A
5680858 Hansen et al. Oct 1997 A
5682233 Brinda Oct 1997 A
5695623 Michel et al. Dec 1997 A
5708247 McAleer et al. Jan 1998 A
5711001 Bussan et al. Jan 1998 A
5711297 Iliff et al. Jan 1998 A
5711861 Ward et al. Jan 1998 A
5711862 Sakoda et al. Jan 1998 A
5733044 Rose et al. Mar 1998 A
5735285 Albert et al. Apr 1998 A
5741211 Renirie et al. Apr 1998 A
5749656 Boehm et al. May 1998 A
5766131 Kondo et al. Jun 1998 A
5771001 Cobb Jun 1998 A
5772586 Heinonen et al. Jun 1998 A
5779665 Mastrototaro et al. Jul 1998 A
5791344 Schulman et al. Aug 1998 A
5800420 Gross et al. Sep 1998 A
5807375 Gross et al. Sep 1998 A
5814020 Gross Sep 1998 A
5820551 Hill et al. Oct 1998 A
5820622 Gross et al. Oct 1998 A
5822715 Worthington et al. Oct 1998 A
5827184 Netherly et al. Oct 1998 A
5840020 Heinonen et al. Nov 1998 A
5842983 Abel et al. Dec 1998 A
5851197 Marano et al. Dec 1998 A
5858001 Tsals et al. Jan 1999 A
5865804 Bachynsky Feb 1999 A
5885211 Eppstein et al. Mar 1999 A
5899855 Brown May 1999 A
5924979 Sedlow et al. Jul 1999 A
5925021 Castellano et al. Jul 1999 A
5931814 Alex et al. Aug 1999 A
5948006 Mann Sep 1999 A
5951521 Mastrototaro et al. Sep 1999 A
5954643 Van Antwerp Sep 1999 A
5954685 Tierny Sep 1999 A
5957854 Besson et al. Sep 1999 A
5961451 Reber et al. Oct 1999 A
5964993 Blubaugh, Jr. et al. Oct 1999 A
5965380 Heller et al. Oct 1999 A
5971922 Arita et al. Oct 1999 A
5972199 Heller et al. Oct 1999 A
5987353 Khatchatrian et al. Nov 1999 A
5993411 Choi Nov 1999 A
5995860 Sun et al. Nov 1999 A
5997501 Gross et al. Dec 1999 A
6001067 Shults et al. Dec 1999 A
6004278 Botich et al. Dec 1999 A
6017335 Burnham Jan 2000 A
6022368 Gavronsky et al. Feb 2000 A
6024699 Surwit et al. Feb 2000 A
6026321 Miyata et al. Feb 2000 A
6027459 Shain et al. Feb 2000 A
6049727 Crothall Apr 2000 A
6056718 Funderburk et al. May 2000 A
6068399 Tseng May 2000 A
6083710 Heller et al. Jul 2000 A
6088608 Schulman et al. Jul 2000 A
6091975 Daddona et al. Jul 2000 A
6091976 Pfeiffer et al. Jul 2000 A
6093172 Funderbunk et al. Jul 2000 A
6102896 Roser Aug 2000 A
6103033 Say et al. Aug 2000 A
6117290 Say et al. Sep 2000 A
6119028 Schulman et al. Sep 2000 A
6120676 Heller et al. Sep 2000 A
6121009 Heller et al. Sep 2000 A
6121611 Lindsay et al. Sep 2000 A
6122351 Schlueter, Jr. et al. Sep 2000 A
6134461 Say et al. Oct 2000 A
6143164 Heller et al. Nov 2000 A
6159147 Lichter et al. Dec 2000 A
6162611 Heller et al. Dec 2000 A
6175752 Say et al. Jan 2001 B1
6186982 Gross et al. Feb 2001 B1
6200265 Walsh et al. Mar 2001 B1
6212416 Ward et al. Apr 2001 B1
6219574 Cormier et al. Apr 2001 B1
6248067 Causey, III et al. Jun 2001 B1
6254536 DeVito Jul 2001 B1
6254586 Mann et al. Jul 2001 B1
6275717 Gross et al. Aug 2001 B1
6283761 Joao Sep 2001 B1
6283982 Levaughn et al. Sep 2001 B1
6284478 Heller et al. Sep 2001 B1
6293925 Safabash et al. Sep 2001 B1
6295506 Heinonen et al. Sep 2001 B1
6306104 Cunningham et al. Oct 2001 B1
6309884 Cooper et al. Oct 2001 B1
6329161 Heller et al. Dec 2001 B1
6331244 Lewis et al. Dec 2001 B1
6338790 Feldman et al. Jan 2002 B1
6348640 Navot et al. Feb 2002 B1
6359444 Grimes Mar 2002 B1
6360888 McIvor et al. Mar 2002 B1
6368141 Van Antwerp et al. Apr 2002 B1
6368274 Van Antwerp et al. Apr 2002 B1
6377828 Chaiken et al. Apr 2002 B1
6379301 Worthington et al. Apr 2002 B1
6409740 Kuhr et al. Jun 2002 B1
6413393 Van Antwerp et al. Jul 2002 B1
6418332 Mastrototaro et al. Jul 2002 B1
6424847 Mastrototaro et al. Jul 2002 B1
6427088 Bowman, IV et al. Jul 2002 B1
6437679 Rogues Aug 2002 B1
6440068 Brown et al. Aug 2002 B1
6445374 Albert et al. Sep 2002 B2
6478736 Mault Nov 2002 B1
6482176 Wich Nov 2002 B1
6484045 Holker et al. Nov 2002 B1
6484046 Say et al. Nov 2002 B1
6514718 Heller et al. Feb 2003 B2
6520326 McIvor et al. Feb 2003 B2
6522927 Bishay et al. Feb 2003 B1
6551494 Heller et al. Apr 2003 B1
6554798 Mann et al. Apr 2003 B1
6558320 Causey, III et al. May 2003 B1
6558321 Burd 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
6564105 Starkweather et al. May 2003 B2
6565509 Say et al. May 2003 B1
6571128 Lebel et al. May 2003 B2
6572566 Effenhauser Jun 2003 B2
6576101 Heller et al. Jun 2003 B1
6577899 Lebel et al. Jun 2003 B2
6579690 Bonnecaze et al. Jun 2003 B1
6585644 Lebel et al. Jul 2003 B2
6589229 Connelly et al. Jul 2003 B1
6591125 Buse et al. Jul 2003 B1
6595919 Berner et al. Jul 2003 B2
6605200 Mao et al. Aug 2003 B1
6605201 Mao et al. Aug 2003 B1
6607509 Bobroff et al. Aug 2003 B2
6610012 Mault Aug 2003 B2
6613015 Sandstrom et al. Sep 2003 B2
6633772 Ford et al. Oct 2003 B2
6635014 Starkweather et al. Oct 2003 B2
6648821 Lebel et al. Nov 2003 B2
6654625 Say et al. Nov 2003 B1
6659948 Lebel et al. Dec 2003 B2
6666849 Marshall et al. Dec 2003 B1
6668196 Villegas et al. Dec 2003 B1
6675030 Ciurczak et al. Jan 2004 B2
6676290 Lu Jan 2004 B1
6687546 Lebel et al. Feb 2004 B2
6689056 Kilcoyne et al. Feb 2004 B1
6694191 Starkweather et al. Feb 2004 B2
6695860 Ward et al. Feb 2004 B1
6702857 Brauker et al. Mar 2004 B2
6733446 Lebel et al. May 2004 B2
6740075 Lebel et al. May 2004 B2
6741877 Shults et al. May 2004 B1
6746582 Heller et al. Jun 2004 B2
6758810 Lebel et al. Jul 2004 B2
6770030 Schaupp et al. Aug 2004 B1
6790178 Mault et al. Sep 2004 B1
6809653 Mann et al. Oct 2004 B1
6810290 Lebel et al. Oct 2004 B2
6811533 Lebel et al. Nov 2004 B2
6811534 Bowman, IV et al. Nov 2004 B2
6813519 Lebel et al. Nov 2004 B2
6830551 Uchigaki et al. Dec 2004 B1
6837858 Cunningham et al. Jan 2005 B2
6837885 Koblish et al. Jan 2005 B2
6837988 Leong et al. Jan 2005 B2
6849052 Uchigaki et al. Feb 2005 B2
6854882 Chen Feb 2005 B2
6862465 Shults et al. Mar 2005 B2
6873268 Lebel et al. Mar 2005 B2
6881551 Heller et al. Apr 2005 B2
6892085 McIvor et al. May 2005 B2
6895265 Silver May 2005 B2
6931327 Goode, Jr. et al. Aug 2005 B2
6932894 Mao et al. Aug 2005 B2
6936006 Sabra Aug 2005 B2
6942518 Liamos et al. Sep 2005 B2
6950708 Bowman, IV et al. Sep 2005 B2
6958705 Lebel et al. Oct 2005 B2
6959211 Rule et al. Oct 2005 B2
6968294 Gutta et al. Nov 2005 B2
6971274 Olin Dec 2005 B2
6971999 Py et al. Dec 2005 B2
6974437 Lebel et al. Dec 2005 B2
6990366 Say et al. Jan 2006 B2
6997907 Safabash et al. Feb 2006 B2
6998247 Monfre et al. Feb 2006 B2
7003336 Holker et al. Feb 2006 B2
7003340 Say et al. Feb 2006 B2
7003341 Say et al. Feb 2006 B2
7005857 Stiene et al. Feb 2006 B2
7024245 Lebel et al. Apr 2006 B2
7025743 Mann et al. Apr 2006 B2
7041068 Freeman et al. May 2006 B2
7041468 Drucker et al. May 2006 B2
7052483 Wojcik May 2006 B2
7056302 Douglas Jun 2006 B2
7074307 Simpson et al. Jul 2006 B2
7081195 Simpson et al. Jul 2006 B2
7097637 Triplett et al. Aug 2006 B2
7098803 Mann et al. Aug 2006 B2
7108778 Simpson et al. Sep 2006 B2
7110803 Shults et al. Sep 2006 B2
7113821 Sun et al. Sep 2006 B1
7134999 Brauker et al. Nov 2006 B2
7136689 Shults et al. Nov 2006 B2
7171274 Starkweather et al. Jan 2007 B2
7190988 Say et al. Mar 2007 B2
7192450 Brauker et al. Mar 2007 B2
7198606 Boecker et al. Apr 2007 B2
7207974 Safabash et al. Apr 2007 B2
7226978 Tapsak et al. Jun 2007 B2
7276029 Goode, Jr. et al. Oct 2007 B2
7278983 Ireland et al. Oct 2007 B2
7297151 Boecker et al. Nov 2007 B2
7299082 Feldman et al. Nov 2007 B2
7310544 Brister et al. Dec 2007 B2
7318816 Bobroff et al. Jan 2008 B2
7324012 Mann et al. Jan 2008 B2
7329239 Safabash et al. Feb 2008 B2
7335294 Heller et al. Feb 2008 B2
7340287 Mason et al. Mar 2008 B2
7340309 Miazga et al. Mar 2008 B2
7354420 Steil et al. Apr 2008 B2
7364592 Carr-Brendel et al. Apr 2008 B2
7366556 Brister et al. Apr 2008 B2
7379765 Petisce et al. May 2008 B2
7381184 Funderburk et al. Jun 2008 B2
7402153 Steil et al. Jul 2008 B2
7407493 Cane Aug 2008 B2
7416541 Yuzhakov et al. Aug 2008 B2
7424318 Brister et al. Sep 2008 B2
7455663 Bikovsky Nov 2008 B2
7460898 Brister et al. Dec 2008 B2
7467003 Brister et al. Dec 2008 B2
7471972 Rhodes et al. Dec 2008 B2
7494465 Brister et al. Feb 2009 B2
7497827 Brister et al. Mar 2009 B2
7519408 Rasdal et al. Apr 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
7604592 Freeman et al. Oct 2009 B2
7613491 Boock et al. Nov 2009 B2
7615007 Shults et al. Nov 2009 B2
7632228 Brauker et al. Dec 2009 B2
7637868 Saint et al. Dec 2009 B2
7640048 Dobbles et al. Dec 2009 B2
7651596 Petisce et al. Jan 2010 B2
7654956 Brister et al. Feb 2010 B2
7657297 Simpson et al. Feb 2010 B2
7666149 Simons et al. Feb 2010 B2
7682338 Griffin Mar 2010 B2
7697967 Stafford Apr 2010 B2
7699807 Faust et al. Apr 2010 B2
7711402 Shults et al. May 2010 B2
7713574 Brister et al. May 2010 B2
7715893 Kamath et al. May 2010 B2
7727147 Osorio et al. Jun 2010 B1
7731657 Stafford Jun 2010 B2
7736344 Moberg et al. Jun 2010 B2
7757022 Kato et al. Jul 2010 B2
7763042 Iio et al. Jul 2010 B2
7822454 Alden et al. Oct 2010 B1
7850652 Liniger et al. Dec 2010 B2
7896844 Thalmann et al. Mar 2011 B2
7955297 Radmer et al. Jun 2011 B2
7985203 Haueter et al. Jul 2011 B2
8172805 Mogensen et al. May 2012 B2
8262618 Scheurer Sep 2012 B2
8409145 Raymond et al. Apr 2013 B2
8641674 Bobroff et al. Feb 2014 B2
8870822 Thalmann et al. Oct 2014 B2
8880138 Cho Nov 2014 B2
9007781 Moein et al. Apr 2015 B2
9215992 Donnay et al. Dec 2015 B2
9295786 Gottlieb et al. Mar 2016 B2
20010056262 Cabin et al. Dec 2001 A1
20020013538 Teller Jan 2002 A1
20020019022 Dunn et al. Feb 2002 A1
20020019606 Lebel et al. Feb 2002 A1
20020022855 Bobroff et al. Feb 2002 A1
20020023852 McIvor et al. Feb 2002 A1
20020042090 Heller et al. Apr 2002 A1
20020055711 Lavi et al. May 2002 A1
20020057993 Maisey et al. May 2002 A1
20020066764 Perry et al. Jun 2002 A1
20020076966 Carron et al. Jun 2002 A1
20020082487 Kollias et al. Jun 2002 A1
20020103499 Perez et al. Aug 2002 A1
20020106709 Potts et al. Aug 2002 A1
20020119711 Van Antwerp et al. Aug 2002 A1
20020124017 Mault Sep 2002 A1
20020128594 Das et al. Sep 2002 A1
20020130042 Moerman et al. Sep 2002 A1
20020151796 Koulik Oct 2002 A1
20020151816 Rich et al. Oct 2002 A1
20020154050 Krupp et al. Oct 2002 A1
20020161288 Shin et al. Oct 2002 A1
20020165462 Westbrook et al. Nov 2002 A1
20020169369 Ward et al. Nov 2002 A1
20020198444 Ughigaki et al. Dec 2002 A1
20030023317 Brauker et al. Jan 2003 A1
20030023461 Quintanilla et al. Jan 2003 A1
20030032867 Crothall et al. Feb 2003 A1
20030042137 Mao et al. Mar 2003 A1
20030060753 Starkweather et al. Mar 2003 A1
20030065308 Lebel et al. Apr 2003 A1
20030069510 Semler Apr 2003 A1
20030078481 McIvor et al. Apr 2003 A1
20030078560 Miller et al. Apr 2003 A1
20030083686 Freeman et al. May 2003 A1
20030097092 Flaherty May 2003 A1
20030100040 Bonnecaze et al. May 2003 A1
20030109775 O'Neil et al. Jun 2003 A1
20030134347 Heller et al. Jul 2003 A1
20030135333 Aceti et al. Jul 2003 A1
20030144581 Conn et al. Jul 2003 A1
20030144608 Kojima et al. Jul 2003 A1
20030155656 Chiu et al. Aug 2003 A1
20030168338 Gao et al. Sep 2003 A1
20030176933 Lebel et al. Sep 2003 A1
20030187338 Say et al. Oct 2003 A1
20030199790 Boecker et al. Oct 2003 A1
20030199910 Boecker et al. Oct 2003 A1
20030212379 Bylund et al. Nov 2003 A1
20030217966 Tapsak et al. Nov 2003 A1
20030225361 Sabra Dec 2003 A1
20040002382 Kovelman et al. Jan 2004 A1
20040010207 Flaherty et al. Jan 2004 A1
20040011671 Shults et al. Jan 2004 A1
20040040840 Mao et al. Mar 2004 A1
20040045879 Shults et al. Mar 2004 A1
20040054263 Moerman et al. Mar 2004 A1
20040064068 DeNuzzio et al. Apr 2004 A1
20040064133 Miller et al. Apr 2004 A1
20040096959 Stiene et al. May 2004 A1
20040106858 Say et al. Jun 2004 A1
20040106859 Say et al. Jun 2004 A1
20040116847 Wall Jun 2004 A1
20040116865 Bengtsson Jun 2004 A1
20040116866 Gorman et al. Jun 2004 A1
20040122353 Shahmirian et al. Jun 2004 A1
20040122489 Mazar et al. Jun 2004 A1
20040133164 Funderbunk et al. Jul 2004 A1
20040135684 Steinthal et al. Jul 2004 A1
20040138544 Ward et al. Jul 2004 A1
20040138588 Saikley et al. Jul 2004 A1
20040138688 Giraud Jul 2004 A1
20040147996 Miazga et al. Jul 2004 A1
20040152622 Keith et al. Aug 2004 A1
20040158207 Hunn et al. Aug 2004 A1
20040167801 Say et al. Aug 2004 A1
20040171910 Moore-Steele Sep 2004 A1
20040171921 Say et al. Sep 2004 A1
20040176672 Silver et al. Sep 2004 A1
20040186362 Brauker et al. Sep 2004 A1
20040186365 Jin et al. Sep 2004 A1
20040193090 Lebel et al. Sep 2004 A1
20040199059 Brauker et al. Oct 2004 A1
20040204687 Mogensen et al. Oct 2004 A1
20040210122 Sleburg Oct 2004 A1
20040223985 Dunfield et al. Nov 2004 A1
20040225262 Fathallah et al. Nov 2004 A1
20040225338 Lebel et al. Nov 2004 A1
20040236200 Say et al. Nov 2004 A1
20040236251 Roe et al. Nov 2004 A1
20040254433 Bandis et al. Dec 2004 A1
20040254434 Goodnow et al. Dec 2004 A1
20040267300 Mace et al. Dec 2004 A1
20050003470 Nelson et al. Jan 2005 A1
20050004494 Perez et al. Jan 2005 A1
20050006122 Burnette Jan 2005 A1
20050010269 Lebel et al. Jan 2005 A1
20050022599 Suzuki Feb 2005 A1
20050027177 Shin et al. Feb 2005 A1
20050027180 Goode, Jr. et al. Feb 2005 A1
20050031689 Shults et al. Feb 2005 A1
20050043598 Goode, Jr. et al. Feb 2005 A1
20050070819 Poux et al. Mar 2005 A1
20050085872 Yanagihara et al. Apr 2005 A1
20050090607 Tapsak et al. Apr 2005 A1
20050090850 Thoes et al. Apr 2005 A1
20050101912 Faust May 2005 A1
20050106713 Phan et al. May 2005 A1
20050112169 Brauker et al. May 2005 A1
20050114068 Chey et al. May 2005 A1
20050121322 Say et al. Jun 2005 A1
20050131346 Douglas Jun 2005 A1
20050143635 Kamath et al. Jun 2005 A1
20050154410 Conway et al. Jul 2005 A1
20050165404 Miller Jul 2005 A1
20050173245 Feldman et al. Aug 2005 A1
20050176136 Burd et al. Aug 2005 A1
20050182306 Sloan Aug 2005 A1
20050187720 Goode, Jr. et al. Aug 2005 A1
20050192557 Brauker et al. Sep 2005 A1
20050195930 Spital et al. Sep 2005 A1
20050197554 Polcha Sep 2005 A1
20050199494 Say et al. Sep 2005 A1
20050203360 Brauker et al. Sep 2005 A1
20050222518 Dib Oct 2005 A1
20050235156 Drucker et al. Oct 2005 A1
20050236277 Imran et al. Oct 2005 A9
20050239154 Feldman et al. Oct 2005 A1
20050241957 Mao et al. Nov 2005 A1
20050245795 Goode, Jr. et al. Nov 2005 A1
20050245799 Brauker et al. Nov 2005 A1
20050245844 Mace et al. Nov 2005 A1
20050277164 Drucker et al. Dec 2005 A1
20050283114 Bresina et al. Dec 2005 A1
20050287620 Heller et al. Dec 2005 A1
20060001538 Kraft et al. Jan 2006 A1
20060004303 Weidenhaupt et al. Jan 2006 A1
20060009727 O'Mahony et al. Jan 2006 A1
20060010098 Goodnow 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
20060047220 Sakata et al. Mar 2006 A1
20060036145 Chambers et al. Apr 2006 A1
20060081469 Lee Apr 2006 A1
20060129173 Wilkinson Jun 2006 A1
20060155210 Beckman et al. Jul 2006 A1
20060155317 List et al. Jul 2006 A1
20060166629 Reggiardo Jul 2006 A1
20060173444 Choy et al. Aug 2006 A1
20060189863 Peyser et al. Aug 2006 A1
20060189939 Gonnelli et al. Aug 2006 A1
20060195029 Shults et al. Aug 2006 A1
20060200181 Fukuzawa et al. Sep 2006 A1
20060200970 Brister et al. Sep 2006 A1
20060222566 Brauker et al. Oct 2006 A1
20060224171 Sakata et al. Oct 2006 A1
20060226985 Goodnow et al. Oct 2006 A1
20060247508 Fennell Nov 2006 A1
20060253086 Moberg et al. Nov 2006 A1
20060258929 Goode et al. Nov 2006 A1
20060264888 Moberg et al. Nov 2006 A1
20060276724 Freeman et al. Dec 2006 A1
20060282042 Walters et al. Dec 2006 A1
20060287591 Ocvirk et al. Dec 2006 A1
20070016381 Kamath et al. Jan 2007 A1
20070027381 Stafford Feb 2007 A1
20070038044 Dobbles et al. Feb 2007 A1
20070060814 Stafford Mar 2007 A1
20070073129 Shah et al. Mar 2007 A1
20070078320 Stafford Apr 2007 A1
20070078321 Mazza et al. Apr 2007 A1
20070078322 Stafford Apr 2007 A1
20070088377 Levaughn et al. Apr 2007 A1
20070106135 Sloan et al. May 2007 A1
20070110124 Zaragoza et al. May 2007 A1
20070123819 Mernoe et al. May 2007 A1
20070149875 Ouyang et al. Jun 2007 A1
20070156094 Safabash et al. Jul 2007 A1
20070163880 Woo et al. Jul 2007 A1
20070173706 Neinast et al. Jul 2007 A1
20070173741 Deshmukh et al. Jul 2007 A1
20070191701 Feldman et al. Aug 2007 A1
20070203407 Hoss et al. Aug 2007 A1
20070203966 Brauker et al. Aug 2007 A1
20070213611 Simpson et al. Sep 2007 A1
20070235331 Simpson et al. Oct 2007 A1
20070244368 Bayloff et al. Oct 2007 A1
20070244398 Lo et al. Oct 2007 A1
20070249922 Peyser et al. Oct 2007 A1
20070255302 Koeppel et al. Nov 2007 A1
20080004512 Funderburk et al. Jan 2008 A1
20080004573 Kaufmann et al. Jan 2008 A1
20080009692 Stafford Jan 2008 A1
20080009805 Ethelfeld Jan 2008 A1
20080017522 Heller et al. Jan 2008 A1
20080021666 Goode, Jr. et al. Jan 2008 A1
20080027474 Curry et al. Jan 2008 A1
20080029391 Mao et al. Feb 2008 A1
20080031941 Pettersson Feb 2008 A1
20080033254 Kamath et al. Feb 2008 A1
20080033268 Stafford Feb 2008 A1
20080033318 Mace et al. Feb 2008 A1
20080039702 Hayter et al. Feb 2008 A1
20080045824 Tapsak et al. Feb 2008 A1
20080064937 McGarraugh et al. Mar 2008 A1
20080064941 Funderburk et al. Mar 2008 A1
20080064944 VanAntwerp et al. Mar 2008 A1
20080065646 Zhang et al. Mar 2008 A1
20080071156 Brister et al. Mar 2008 A1
20080083617 Simpson et al. Apr 2008 A1
20080086042 Brister et al. Apr 2008 A1
20080086044 Brister et al. Apr 2008 A1
20080086273 Shults et al. Apr 2008 A1
20080097246 Stafford Apr 2008 A1
20080108942 Brister et al. May 2008 A1
20080112848 Huffstodt et al. May 2008 A1
20080114280 Stafford May 2008 A1
20080119707 Stafford May 2008 A1
20080133702 Sharma et al. Jun 2008 A1
20080154205 Wojcik Jun 2008 A1
20080161664 Mastrototaro et al. Jul 2008 A1
20080167578 Bryer et al. Jul 2008 A1
20080183061 Goode, Jr. et al. Jul 2008 A1
20080183399 Goode, Jr. et al. Jul 2008 A1
20080188731 Brister et al. Aug 2008 A1
20080189051 Goode, Jr. et al. Aug 2008 A1
20080194935 Brister et al. Aug 2008 A1
20080194936 Goode, Jr. et al. Aug 2008 A1
20080194937 Goode, Jr. et al. Aug 2008 A1
20080194938 Brister et al. Aug 2008 A1
20080195049 Thalmann et al. Aug 2008 A1
20080195232 Carr-Brendel et al. Aug 2008 A1
20080195967 Goode, Jr. 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
20080200897 Hoss et al. Aug 2008 A1
20080208025 Shults et al. Aug 2008 A1
20080214481 Challoner et al. Sep 2008 A1
20080214915 Brister et al. Sep 2008 A1
20080214918 Brister et al. Sep 2008 A1
20080228051 Shults et al. Sep 2008 A1
20080228054 Shults et al. Sep 2008 A1
20080242961 Brister et al. Oct 2008 A1
20080262469 Brister et al. Oct 2008 A1
20080269673 Butoi et al. Oct 2008 A1
20080275313 Brister et al. Nov 2008 A1
20080283396 Wang 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
20080294096 Uber et al. Nov 2008 A1
20080296155 Shults et al. Dec 2008 A1
20080300476 Stafford Dec 2008 A1
20080306368 Goode, Jr. et al. Dec 2008 A1
20080306434 Dobbles et al. Dec 2008 A1
20080306435 Kamath et al. Dec 2008 A1
20080306444 Brister et al. Dec 2008 A1
20080312859 Skyggebjerg et al. Dec 2008 A1
20090005659 Kollias et al. Jan 2009 A1
20090012377 Jennewine et al. Jan 2009 A1
20090012379 Goode, Jr. et al. Jan 2009 A1
20090018424 Kamath et al. Jan 2009 A1
20090030294 Petisce et al. Jan 2009 A1
20090036758 Brauker et al. Feb 2009 A1
20090036763 Brauker et al. Feb 2009 A1
20090036915 Karbowniczek 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
20090045055 Rhodes et al. Feb 2009 A1
20090048499 Glejbol Feb 2009 A1
20090054866 Teisen-Simony et al. Feb 2009 A1
20090062633 Brauker et al. Mar 2009 A1
20090062635 Brauker et al. Mar 2009 A1
20090069658 Say et al. Mar 2009 A1
20090069750 Schraga Mar 2009 A1
20090076356 Simpson et al. Mar 2009 A1
20090076359 Peyser Mar 2009 A1
20090076360 Brister et al. Mar 2009 A1
20090076361 Kamath et al. Mar 2009 A1
20090088614 Taub Apr 2009 A1
20090088787 Koike et al. Apr 2009 A1
20090099436 Brister et al. Apr 2009 A1
20090102678 Mazza et al. Apr 2009 A1
20090105569 Stafford Apr 2009 A1
20090124877 Goode, Jr. et al. May 2009 A1
20090124878 Goode, Jr. et al. May 2009 A1
20090124879 Brister 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
20090131860 Nielson May 2009 A1
20090137886 Shariati et al. May 2009 A1
20090137887 Shariati et al. May 2009 A1
20090143659 Li et al. Jun 2009 A1
20090143660 Brister et al. Jun 2009 A1
20090156919 Brister et al. Jun 2009 A1
20090156924 Shariati et al. Jun 2009 A1
20090163790 Brister et al. Jun 2009 A1
20090163791 Brister et al. Jun 2009 A1
20090171182 Stafford 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
20090198215 Chong et al. Aug 2009 A1
20090203981 Brauker et al. Aug 2009 A1
20090204341 Brauker et al. Aug 2009 A1
20090212766 Olson 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
20090247855 Boock et al. Oct 2009 A1
20090247856 Boock et al. Oct 2009 A1
20090259118 Feldman et al. Oct 2009 A1
20090259201 Hwang et al. Oct 2009 A1
20090259202 Leeflang et al. Oct 2009 A1
20090270765 Ghesquire et al. Oct 2009 A1
20090287073 Boock et al. Nov 2009 A1
20090287074 Shults et al. Nov 2009 A1
20090292184 Funderburk et al. Nov 2009 A1
20090292185 Funderburk 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
20090299167 Seymour Dec 2009 A1
20090299276 Brauker et al. Dec 2009 A1
20090299301 Gottlieb Dec 2009 A1
20100004597 Gryn et al. Jan 2010 A1
20100010324 Brauker et al. Jan 2010 A1
20100010331 Brauker et al. Jan 2010 A1
20100010332 Brauker et al. Jan 2010 A1
20100016687 Brauker et al. Jan 2010 A1
20100016698 Rasdal et al. Jan 2010 A1
20100022855 Brauker et al. Jan 2010 A1
20100022863 Mogensen et al. Jan 2010 A1
20100030038 Brauker et al. 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
20100036225 Goode, Jr. et al. Feb 2010 A1
20100036281 Doi Feb 2010 A1
20100041971 Goode, Jr. et al. Feb 2010 A1
20100045465 Brauker et al. Feb 2010 A1
20100049014 Funderburk et al. Feb 2010 A1
20100049024 Saint et al. Feb 2010 A1
20100063373 Kamath et al. Mar 2010 A1
20100076283 Simpson et al. Mar 2010 A1
20100081908 Dobbles et al. Apr 2010 A1
20100081910 Brister et al. Apr 2010 A1
20100087724 Brauker et al. Apr 2010 A1
20100096259 Zhang et al. Apr 2010 A1
20100099970 Shults et al. Apr 2010 A1
20100099971 Shults et al. Apr 2010 A1
20100106088 Yodfat et al. Apr 2010 A1
20100113894 Brenneman et al. May 2010 A1
20100119693 Tapsak et al. May 2010 A1
20100121169 Petisce et al. May 2010 A1
20100152674 Kavazov et al. Jun 2010 A1
20100168677 Gabriel et al. Jul 2010 A1
20100174157 Brister et al. Jul 2010 A1
20100174158 Kamath et al. Jul 2010 A1
20100174163 Brister et al. Jul 2010 A1
20100174164 Brister et al. Jul 2010 A1
20100174165 Brister et al. Jul 2010 A1
20100174166 Brister et al. Jul 2010 A1
20100174167 Kamath et al. Jul 2010 A1
20100174168 Goode, Jr. et al. Jul 2010 A1
20100179401 Rasdal et al. Jul 2010 A1
20100179402 Goode, Jr. et al. Jul 2010 A1
20100179404 Kamath et al. Jul 2010 A1
20100179408 Kamath et al. Jul 2010 A1
20100179409 Kamath et al. Jul 2010 A1
20100185065 Goode, Jr. et al. Jul 2010 A1
20100186069 Brister et al. Jul 2010 A1
20100186070 Brister et al. Jul 2010 A1
20100186071 Simpson et al. Jul 2010 A1
20100186072 Goode, Jr. et al. Jul 2010 A1
20100186075 Brister et al. Jul 2010 A1
20100191082 Brister et al. Jul 2010 A1
20100198033 Krulevitch et al. Aug 2010 A1
20100198034 Thomas et al. Aug 2010 A1
20100198035 Kamath et al. Aug 2010 A1
20100198036 Kamath et al. Aug 2010 A1
20100204653 Gryn et al. Aug 2010 A1
20100212583 Brister et al. Aug 2010 A1
20100214104 Goode, Jr. et al. Aug 2010 A1
20100217105 Yodfat et al. Aug 2010 A1
20100217557 Kamath et al. Aug 2010 A1
20100223013 Kamath et al. Sep 2010 A1
20100223022 Kamath et al. Sep 2010 A1
20100223023 Kamath et al. Sep 2010 A1
20100228109 Kamath et al. Sep 2010 A1
20100228497 Kamath et al. Sep 2010 A1
20100240975 Goode, Jr. et al. Sep 2010 A1
20100240976 Goode, Jr. et al. Sep 2010 A1
20100151987 Kamath et al. Oct 2010 A1
20100256471 Say et al. Oct 2010 A1
20100262201 He et al. Oct 2010 A1
20100274107 Boock et al. Oct 2010 A1
20100280341 Boock et al. Nov 2010 A1
20100286496 Simpson et al. Nov 2010 A1
20100298684 Leach et al. Nov 2010 A1
20100324392 Yee et al. Dec 2010 A1
20100324403 Brister et al. Dec 2010 A1
20100331642 Bruce et al. Dec 2010 A1
20100331644 Neale et al. Dec 2010 A1
20100331647 Shah et al. Dec 2010 A1
20100331648 Kamath et al. Dec 2010 A1
20100331653 Stafford Dec 2010 A1
20100331656 Mensinger et al. Dec 2010 A1
20100331657 Mensinger et al. Dec 2010 A1
20110004085 Mensinger et al. Jan 2011 A1
20110009727 Mensinger et al. Jan 2011 A1
20110021889 Hoss et al. Jan 2011 A1
20110024043 Boock et al. Feb 2011 A1
20110024307 Simpson et al. Feb 2011 A1
20110027127 Simpson et al. Feb 2011 A1
20110027453 Boock et al. Feb 2011 A1
20110027458 Boock et al. Feb 2011 A1
20110028815 Simpson et al. Feb 2011 A1
20110028816 Simpson et al. Feb 2011 A1
20110046456 Hordum et al. Feb 2011 A1
20110046467 Simpson et al. Feb 2011 A1
20110240256 Bobroff et al. Feb 2011 A1
20110240263 Hordum et al. Feb 2011 A1
20110054275 Stafford Mar 2011 A1
20110060196 Stafford Mar 2011 A1
20110073475 Kastanos et al. Mar 2011 A1
20110077490 Simpson et al. Mar 2011 A1
20110082484 Saravia et al. Apr 2011 A1
20110106126 Love et al. May 2011 A1
20110118579 Goode, Jr. et al. May 2011 A1
20110118580 Goode, Jr. et al. May 2011 A1
20110124992 Brauker et al. May 2011 A1
20110124997 Goode, Jr. et al. May 2011 A1
20110125410 Goode, Jr. et al. May 2011 A1
20110130970 Goode, Jr. et al. Jun 2011 A1
20110130971 Goode, Jr. et al. Jun 2011 A1
20110130998 Goode, Jr. et al. Jun 2011 A1
20110137257 Gyrn et al. Jun 2011 A1
20110144465 Shults et al. Jun 2011 A1
20110172510 Chickering, III et al. Jul 2011 A1
20110178378 Brister et al. Jul 2011 A1
20110178461 Chong et al. Jul 2011 A1
20110184258 Stafford Jul 2011 A1
20110190603 Stafford Aug 2011 A1
20110190614 Brister et al. Aug 2011 A1
20110191044 Stafford Aug 2011 A1
20110201910 Rasdal et al. Aug 2011 A1
20110201911 Johnson et al. Aug 2011 A1
20110213225 Bernstein et al. Sep 2011 A1
20110218414 Kamath 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
20110253533 Shults et al. Oct 2011 A1
20110257521 Fraden Oct 2011 A1
20110257895 Brauker et al. Oct 2011 A1
20110263958 Brauker et al. Oct 2011 A1
20110270062 Goode, Jr. et al. Nov 2011 A1
20110270158 Brauker et al. Nov 2011 A1
20110275919 Petisce et al. Nov 2011 A1
20110288574 Donnay et al. Nov 2011 A1
20110290645 Brister et al. Dec 2011 A1
20110313543 Brauker et al. Dec 2011 A1
20110319729 Curry et al. Dec 2011 A1
20110319733 Stafford Dec 2011 A1
20110319738 Woodruff et al. Dec 2011 A1
20110319739 Kamath et al. Dec 2011 A1
20110320130 Valdes et al. Dec 2011 A1
20120010642 Lee Jan 2012 A1
20120035445 Boock et al. Feb 2012 A1
20120040101 Tapsak et al. Feb 2012 A1
20120046534 Simpson et al. Feb 2012 A1
20120078071 Bohm et al. Mar 2012 A1
20120095406 Gym et al. Apr 2012 A1
20120108934 Valdes et al. May 2012 A1
20120108983 Banet et al. May 2012 A1
20120123385 Edwards et al. May 2012 A1
20120143135 Cole et al. Jun 2012 A1
20120184909 Gyrn et al. Jul 2012 A1
20120296327 Hutchins et al. Nov 2012 A1
20130047981 Bacon Feb 2013 A1
20130150691 Pace et al. Jun 2013 A1
20130317323 Fujiwara et al. Nov 2013 A1
20140228760 Ethelfeld Aug 2014 A1
20150025338 Lee et al. Jan 2015 A1
20150073238 Matsumoto et al. Mar 2015 A1
20150164545 Gyrn Jun 2015 A1
Foreign Referenced Citations (14)
Number Date Country
1202872 May 2005 CN
0320109 Jun 1989 EP
0390390 Oct 1990 EP
0396788 Nov 1990 EP
2060284 May 2009 EP
2201969 Jun 2010 EP
2335587 Jun 2011 EP
WO-1992013271 Aug 1992 WO
WO-1994020602 Sep 1994 WO
WO-2000059370 Oct 2000 WO
WO-2001052935 Jul 2001 WO
WO-2001054753 Aug 2001 WO
WO-2003082091 Oct 2003 WO
WO-2009068661 Jun 2009 WO
Non-Patent Literature Citations (82)
Entry
EP, 16793637.6 Extended Search Report, dated Oct. 9, 2018.
Alcock, S. J., et al., “Continuous Analyte Monitoring to Aid Clinical Practice”, IEEE Engineering in Medicine and Biology Magazine, 1994, pp. 319-325.
Armour, J. C., et al., “Application of Chronic Intravascular Blood Glucose Sensor in Dogs”, Diabetes, vol. 39, 1990, pp. 1519-1526.
Aussedat, B., et al., “A User-Friendly Method for Calibrating a Subcutaneous Glucose Sensor-Based Hypoglycaemic Alarm”, Biosensors & Bioelectronics, vol. 12, No. 11, 1997, pp. 1061-1071.
Bennion, N., et al., “Alternate Site Glucose Testing: A Crossover Design”, Diabetes Technology & Therapeutics, vol. 4, No. 1, 2002, pp. 25-33.
Bindra, D. S., et al., “Design and in Vitro Studies of a Needle-Type Glucose Sensor for Subcutaneous Monitoring”, Analytical Chemistry, vol. 63, No. 17, 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, No. 22, 1989, pp. 2566-2570.
Bobbioni-Harsch, E., et al., “Lifespan of Subcutaneous Glucose Sensors and Their Performances During Dynamic Glycaemia Changes in Rats”, Journal of Biomedical Engineering, vol. 15, 1993, pp. 457-463.
Cass, A. E., et al., “Ferrocene-Medicated Enzyme Electrode for Amperometric Determination of Glucose”, Analytical Chemistry, vol. 56, No. 4, 1984, pp. 667-671.
Claremont, D. J., et al., “Biosensors for Continuous In Vivo Glucose Monitoring”, Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, vol. 10, 1988.
Clark Jr., L. C., et al., “Electrode Systems for Continuous Monitoring in Cardiovascular Surgery”, Annals New York Academy of Sciences, 1962, pp. 29-43.
Clark Jr., L. C., et al., “Long-term Stability of Electroenzymatic Glucose Sensors Implanted in Mice”, American Society of Artificial Internal Organs Transactions, vol. XXXIV, 1988, pp. 259-265.
Csöregi, E., et al., “Design and Optimization of a Selective Subcutaneously Implantable Glucose Electrode Based on ‘Wired’ Glucose Oxidase”, Analytical Chemistry, vol. 67, No. 7, 1995, pp. 1240-1244.
Csöregi, E., et al., “Design, Characterization, and One-Point in Vivo Calibration of a Subcutaneously Implanted Glucose Electrode”, Analytical Chemistry, vol. 66, No. 19, 1994, pp. 3131-3138.
Feldman, B., et al., “A Continuous Glucose Sensor Based on Wired Enzyme™ Technology—Results from a 3-Day Trial in Patients with Type 1 Diabetes”, Diabetes Technology & Therapeutics, vol. 5, No. 5, 2003, pp. 769-779.
Feldman, B., et al., “Correlation of Glucose Concentrations in Interstitial Fluid and Venous Blood During Periods of Rapid Glucose Change”, Abbott Diabetes Care Inc. Freestyle Navigator Continuous Glucose Monitor Pamphlet, 2004.
Gregg, B. A., et al., “Cross-Linked Redox Gels Containing Glucose Oxidase for Amperometric Biosensor Applications”, Analytical Chemistry, vol. 62, No. 3, 1990, pp. 258-263.
Gunasingham, et al., “Electrochemically Modulated Optrode for Glucose”, Biosensors & Bioelectronics, vol. 7, 1992, pp. 353-359.
Harrison, D. J., et al., “Characterization of Perfluorosulfonic Acid Polymer Coated Enzyme Electrodes and a Miniaturized Integrated Potentiostat for Glucose Analysis in Whole Blood”, Analytical Chemistry, vol. 60, No. 19, 1988, pp. 2002-2007.
Heller, A., “Electrical Connection Enzyme Redox Centers to Electrodes”, Journal of Physical Chemistry, vol. 96, No. 9, 1990, pp. 3579-3587.
Heller, A., “Electrical Wiring of Redox Enzymes”, Accounts of Chemical Research, 1990, vol. 23, No. 5, pp. 128-134.
Ikeda, T., et al., “Artificial Pancreas—Investigation of the Stability of Glucose Sensors Using a Telemetry System” (English translation of abstract), Jpn. J. Artif. Organs, vol. 19, No. 2, 1990, pp. 889-892.
Isermann, R., “Supervision, Fault-Detection and Fault-Diagnosis Methods—An Introduction”, Control Engineering Practice, vol. 5, No. 5, 1997, pp. 639-652.
Isermann, R., et al., “Trends in the Application of Model-Based Fault Detection and Diagnosis of Technical Processes”, Control Engineering Practice, vol. 5, No. 5, 1997, pp. 709-719.
Johnson, K. W., “Peripheral Circulation”, John Wiley & Sons, 1978, pp. 1989.
Johnson, K. W., et al., “In vivo evaluation of an electroenzymatic glucose sensor implanted in subcutaneous tissue”, Biosensors & Bioelectronics, vol. 7, 1992, pp. 709-714.
Jungheim, K., et al., “How Rapid Does Glucose Concentration Change in Daily Life of Patients with Type 1 Diabetes?”, Diabetologia, 2002, pp. 250.
Jungheim, K., et al., “Risky Delay of Hypoglycemia Detection by Glucose Monitoring at the Arm”, Diabetes Care, vol. 24, No. 7, 2001, pp. 1303-1304.
Koudelka, M., et al., “In-Vivo Behaviour of Hypodermically Implanted Microfabricated Glucose Sensors”, Biosensors & Bioelectronics, vol. 6, 1991, pp. 31-36.
Lager, W., et al., “Implantable Electrocatalytic Glucose Sensor”, Hormone Metabolic Research, vol. 26, 1994, pp. 526-530.
Maidan, R., et al “Elimination of Electrooxidizable Interferant-Produced Currents in Amperometric Biosensors”, Analytical Chemistry, vol. 64, No. 23, 1992, pp. 2889-2896.
Mastrototaro, J. J., et al., “An Electroenzymatic Glucose Sensor Fabricated on a Flexible Substrate”, Sensors and Actuators B, vol. 5, 1991, pp. 139-144.
Mckean, B. D., et al., “A Telemetry-Instrumentation System for Chronically Implanted Glucose and Oxygen Sensors”, IEEE Transactions on Biomedical Engineering, vol. 35, No. 7, 1988, pp. 526-532.
Minimed Technologies, “Tape Tips and Other Infusion Site Information”, 1995, pp. 1-10.
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 & Bioelectronics, vol. 7, 1992, pp. 345-352.
Moatti-Sirat, D., et al., “Reduction of acetaminophen interference in glucose sensors by a composite Nafion membrane: demonstration in rats and man”, Diabetologia, vol. 37, 1994, pp. 610-616.
Moatti-Sirat, D., et al., “Towards continuous glucose monitoring: in vivo evaluation of a miniaturized glucose sensoriImplanted for several days in rat subcutaneous tissue”, Diabetologia, vol. 35, 1992, pp. 224-230.
Ohara, T. J., et al., “Glucose Electrodes Based on Cross-Linked [Os(bpy)2Cl]+/2+ Complexed Poly(1-vinylimidazole) Films”, Analytical Chemistry, vol. 65, No. 23, 1993, pp. 3512-3517.
Olievier, C. N., et al., “In vivo Measurement of Carbon Dioxide Tension with a Miniature Electrode”, Pflügers Archiv: European Journal of Physiology, vol. 373, 1978, pp. 269-272.
Pickup, J., et al., “Implantable Glucose Sensors: Choosing the Appropriate Sensing Strategy”, Biosensors, vol. 3, 1987/88, pp. 335-346.
Pickup, J., “Developing glucose sensors for in vivo use”, Tibtech, vol. 11, 1993, pp. 285-291.
Pickup, J., et al., “Potentially-Implantable, Amperometric Glucose Sensors with Mediated Electron Transfer: Improving the Operating Stability”, Biosensors, vol. 4, 1989, pp. 109-119.
Pickup, J., et al., “In vivo molecular sensing in diabetes mellitus: an implantable glucose sensor with direct electron transfer”, Diabetologia, vol. 32, 1989, pp. 213-217.
Pishko, M. V., et al., “Amperometric Glucose Microelectrodes Prepared through Immobilization of Glucose Oxidase in Redox Hydrogels”, Analytical Chemistry, vol. 63, No. 20, 1991, pp. 2268-2272.
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”, Diabetolgia, vol. 36, 1993, pp. 658-663.
Poitout, V., et al., “Calibration in dogs of a subcutaneous miniaturized glucose sensor using a glucose meter for blood glucose determination”, Biosensors & Bioelectronics, vol. 7, 1992, pp. 587-592.
Poitout, V., et al., “In Vitro and In Vivo Evaluation in Dogs of a Miniaturized Glucose Sensor”, ASAIO Transactions, vol. 37, No. 3, 1991, pp. M298-M300.
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, 1995, pp. E155-E161.
Ratner, B. D., “Reducing capsular thickness and enhancing angiogenesis around implant drug release systems”, Journal of Controlled Release, vol. 78, 2002, pp. 211-218.
Reach, G., et al., “Can Continuous Glucose Monitoring Be Used for the Treatment of Diabetes?”, Analytical Chemistry, vol. 64, No. 6, 1992, pp. 381-386.
Rebrin, K., et al., “Automated feedback control of subcutaneous glucose concentration in diabetic dogs”, Diabetologia, vol. 32, 1989, pp. 573-576.
Roe, J. N., et al., “Bloodless Glucose Measurements”, Critical Review in Therapeutic Drug Carrier Systems, vol. 15, No. 3, 1998, pp. 199-241.
Sakakida, M., et al., “Development of ferrocene-mediated needle-type glucose sensor as a measure of true subcutaneous tissue glucose concentrations,” Artificial Organs Today, vol. 2, No. 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.
Salehi, C., et al., “A Telemetry-Instrumentation System for Long-Term Implantable Glucose and Oxygen Sensors”, Analytical Letters, vol. 29, No. 13, 1996, pp. 2289-2308.
Scheller, F., et al., “Enzyme electrodes and their application”, Philosophical Transactions of the Royal Society of London B, vol. 316, 1987, pp. 85-94.
Schmidt, F. J., et al., “Calibration of a wearable glucose sensor”, The International Journal of Artificial Organs, vol. 15, No. 1, 1992, pp. 55-61.
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, 1998, pp. 294-299.
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., “In Vivo Characteristics of Needle-Type Glucose Sensor—Measurements of Subcutaneous Glucose Concentrations in Human Volunteers”, Hormone and Metabolic Research Supplement Series, vol. 20, 1988, pp. 17-20.
Shichiri, M., et al., “Membrane design for extending the long-life of an implantableglucose sensor”, Diabetes Nutrition and Metabolism, vol. 2, 1989, pp. 309-313.
Shichiri, M., et al., “Needle-type Glucose Sensor for Wearable Artificial Endocrine Pancreas”, Implantable Sensors for Closed-Loop Prosthetic Systems, 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, No. 3, 1986, pp. 298-301.
Shichiri, M., et al., “Wearable Artificial Endocrine Pancreas With Needle-Type Glucose Sensor”, The Lancet, 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, No. 10, 1994, pp. 937-942.
Sternberg, R., et al., “Study and Development of Multilayer Needle-type Enzyme-based Glucose Microsensors”, Biosensors, vol. 4, 1988, pp. 27-40.
Thompson, M., et al., “In Vivo Probes: Problems and Perspectives”, Clinical Biochemistry, vol. 19, 1986, pp. 255-261.
Turner, A.P.F., et al., “Diabetes Mellitus: Biosensors for Research and Management”, Biosensors, vol. 1, 1985, pp. 85-115.
Updike, S. J., et al., “Principles of Long-term Fully Implanted Sensors with Emphasis on Radiotelemetric Monitoring of Blood Glucose from inside a Subcutaneous Foreign Body Capsule (FBC)”, Biosensors in the Body: Continuous in vivo Monitoring, Chapter 4, 1997, pp. 117-137.
Updike, S. J., et al., “A Subcutaneous Glucose Sensor With Improved Longevity, Dynamic Range, and Stability of Calibration”, Diabetes Care, 2000, vol. 23, pp. 208-214.
Velho, G., et al., “Strategies for calibrating a subcutaneous glucose sensor”, Biomedica Biochimica Acta, vol. 48, 1989, pp. 957-964.
Velho, G., et al., “In Vitro and in Vivo Stability of Electrode Potentials in Needle-Type Glucose Sensors”, Diabetes, vol. 38, No. 2, 1989, pp. 164-171.
Von Woedtke, T., et al., “In situ calibration of implanted electrochemical glucose sensors”, Biomedica Biochimica Acta, vol. 48, 1989, pp. 943-952.
Wilson, G. S., et al., “Progress toward the Development of an Implantable Sensor for Glucose”, Clinical Chemistry, vol. 38, No. 9, 1992, pp. 1613-1617.
Ye, L., et al., “High Current Density ‘Wired’ Quinoprotein Glucose Dehydrogenase Electrode”, Analytical Chemistry, vol. 65, No. 3, 1993, pp. 238-241.
PCT/US2012/068839 ISR and Written Opinion dated Feb. 22, 2013.
NL 2009963 Search Report and Written Opinion dated Aug. 12, 2013.
AU 2011269796 Examination Report dated Apr. 3, 2014.
EP 11760268.0 Extended Search Report dated Apr. 14, 2014.
EP 10739015.5 Extended Search Report dated May 10, 2013.
WO, PCT/US2016/032485 ISR and Written Opinion, dated Sep. 12, 2016.
Related Publications (1)
Number Date Country
20160331284 A1 Nov 2016 US
Provisional Applications (1)
Number Date Country
62161787 May 2015 US