Analyte sensor devices, connections, and methods

Description

BACKGROUND

Diabetes Mellitus is an incurable chronic disease in which the body does not produce or properly utilize insulin. Insulin is a hormone produced by the pancreas that regulates blood sugar (glucose). In particular, when blood sugar levels rise, e.g., after a meal, insulin lowers the blood sugar levels by facilitating blood glucose to move from the blood into the body cells. Thus, when the pancreas does not produce sufficient insulin (a condition known as Type 1 Diabetes) or does not properly utilize insulin (a condition known as Type II Diabetes), the blood glucose remains in the blood resulting in hyperglycemia or abnormally high blood sugar levels.

The vast and uncontrolled fluctuations in blood glucose levels in people suffering from diabetes cause long-term, serious complications. Some of these complications include blindness, kidney failure, and nerve damage. Additionally, it is known that diabetes is a factor in accelerating cardiovascular diseases such as atherosclerosis (hardening of the arteries), leading to stroke, coronary heart disease, and other diseases. Accordingly, one important and universal strategy in managing diabetes is to control blood glucose levels.

One element of managing blood glucose levels is the monitoring of blood glucose levels. Conventional in vitro techniques, such as drawing blood samples, applying the blood to a test strip, and determining the blood glucose level using colorimetric, electrochemical, or photometric test meters, may be employed. Another technique for monitoring glucose levels uses an in vivo analyte monitoring system, which measures and stores sensor data representative of glucose levels automatically over time.

Unlike conventional in vitro blood glucose monitoring approaches, in vivo analyte monitoring systems use an insertable or implantable in vivo sensor that is positioned to be in contact with interstitial fluid of a user for a period of time to detect and monitor glucose levels. Prior to use of an in vivo sensor, at least a portion of the sensor is positioned under the skin. An applicator assembly can be employed to insert the sensor into the body of the user. For insertion of the sensor, a sharp engaged with the sensor, pierces the skin of the user and is then removed from the body of the user leaving the sensor in place. The in vivo-positioned sensor can be connected to other system components such as sensor electronics contained in a unit that can be held onto the skin.

To realize fully the advantages associated with such systems, what is needed are applicator systems configured to handle insertion, as well as packaging and user interface issues, that are easy-to-use, reliable and minimize both user inconvenience and pain. The present invention provides such solutions and additional or alternative advantages as described below and/or as may be appreciated by those of skill in the art upon review of the subject disclosure.

SUMMARY

The present invention includes packaging, loading systems, applicators, and elements of the on-body devices themselves. According to embodiments of the present invention, an on-body device includes an electronics assembly and a sensor assembly. The sensor assembly includes a sensor and a connector for coupling the sensor to the electronics assembly. In addition, a sharp can be provided that supports the sensor and allows a distal end of the sensor to be placed under a user's skin. In some embodiments, the invention includes the connection of electrochemical analyte sensors to and/or within associated other monitoring components such as system devices that are configured to be held in place on body. The approaches variously involve the use of unique sensor and unique ancillary element arrangements to facilitate assembly of separate on-body devices and sensor assembly units that are kept apart until the user brings them together. Methods associated with such use also form part of the inventive subject matter.

Certain embodiments are described that include an analyte sensor (e.g., a glucose sensor) and an applicator assembly to position a portion of the sensor beneath a skin surface, as well as methods of positioning at least a portion of the sensor and methods of analyte testing or monitoring. Further methods include the manner of preparing the applicator assembly. Namely, such acts associated with user assembly and mating of the component parts of a monitoring system.

As mentioned above, such a monitoring system includes an electronics assembly adapted to adhere to a skin of a subject, a sensor assembly coupled to the electronics assembly to form an on-body device, and an insertion sharp having a longitudinal body including a longitudinal opening to receive at least a portion of the sensor body. The details of the sensor may vary. Exemplary chemistries and constructions are described in any of U.S. Pat. Nos. 5,593,852, 6,284,478, and 6,329,161, each incorporated by reference herein in its entirety. Exemplary form-factors or configurations (e.g., for associated use with an insertion “sharp”) are described in any of U.S. Pat. Nos. 6,175,752, 6,565,509, 6,134,461 and 6,990,366 and in U.S. Publication No. 2010/0230285, each incorporated by reference herein in its entirety.

Likewise, the details of the on-body device may vary. For instance, the on-body device may include sensor electronics and other adaptation to communicate with a monitoring device. Various options for communications facilities (e.g., wireless transmitters, transponders, etc.) are described in detail in U.S. Patent Publication Nos. 2010/0198034 and 2011/0213225, the entirety of the applications hereby incorporated by reference, including cited and incorporated references.

In some embodiments, systems and methods are provided for assembling and applying the on-body device including assembling the sensor assembly to the electronics assembly and inserting a portion of the sensor under the skin of a user. Thus, the sensor assembly includes a sensor that has a distal portion for operative contact with a fluid of the user. The on-body device also includes an electronics assembly including a housing defining a distal surface adapted for attachment to the skin of the user and a circuit coupleable to the sensor for detecting electrical signals from the sensor. In some embodiments, the system also includes an applicator assembly that has a sleeve defining a distal surface for placement on the skin of the subject, a handle for a user interface, and various internal support, coupling, guide, grasping, stop and detent features as well as driver elements. In some embodiments, the system may also include a container that stores one or more of the sensor, the sharp, and/or the mount/electronics assembly in a sealed environment within. The container is configured to releasably interface with the applicator assembly for the purpose of loading one or more of the sensor, the sharp, and/or the electronics assembly into the applicator assembly, and readying the applicator assembly for use.

The present disclosure includes the subject systems, devices, kits in which they are included, and methods of use and manufacture. A number of aspects of such manufacture are discussed herein. Further details can be appreciated in reference to the figures and/or associated description.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and may or may not be drawn to scale, with the possibility of some components and features being exaggerated for clarity. Similar components may be numbered identically or not. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

FIG. 1 is a flowchart, indicating user activity in handling the subject devices;

FIGS. 2A-2G illustrate such activity with additional detail;

FIG. 3 is an assembly view of an applicator or inserter;

FIG. 4 is an assembly view of a sensor container or loader;

FIGS. 5A and 5B are section views of the container in FIG. 4;

FIG. 6 is an assembly view of an alternative container;

FIG. 7 is a section view of the assembly of FIG. 6;

FIG. 8 is an assembly view of yet another sensor container set or loader;

FIGS. 9A and 9B are top and section views, respectively, of the container set assembly of FIG. 8 in stages of operation;

FIGS. 10A-10N variously illustrate the mechanics of preparing the applicator for use;

FIGS. 11A-11F illustrate the mechanics of applicator use;

FIGS. 12A-12D are perspectives illustrating another applicator/container set approach in which the container holds the electronics assembly;

FIGS. 13A-13C variously illustrate use of the applicator in FIGS. 12A-12D in connection with a locking-sleeve feature;

FIGS. 14A and 14B illustrate an applicator with a removable locking strip;

FIGS. 15A-15F variously illustrate use of the applicator in FIGS. 14A and 14B;

FIGS. 16A and 16B are sectional and detail to views, respectively, of features of the container in FIGS. 15A-15D;

FIGS. 17A and 17B are perspective assembly views illustrating alternative container configurations to that illustrated in FIGS. 16A and 16B;

FIG. 18 is a side-section view illustrating the features of the applicator and container sets variously shown in FIGS. 15A-15F;

FIGS. 19A and 19B are perspective views of a sensor assembly incorporated in the system shown in FIG. 18;

FIGS. 20A and 20B are perspective views of the operation of a sensor assembly retention unit incorporated in the system shown in FIG. 18;

FIGS. 21A-21C are perspective section views illustrating sensor assembly receipt by the sensor mount and sharp withdrawal from the assembled complex;

FIG. 22 is a perspective assembly view of advantageous sensor and sensor connector elements;

FIGS. 23A and 23B are perspective assembly and final-assembly views, respectively of the sensor components in FIG. 22;

FIGS. 24A and 24B are top and bottom perspective views, respectively of circuit board components to be used with the assembly shown in FIGS. 23A and 23B;

FIGS. 25A and 25B are perspective views illustrating assembly of the subject components in stages;

FIG. 26 is an assembly view of the on-body/sensor mount unit in FIGS. 25A and 25B illustrating an advantageous seal element;

FIGS. 27A and 27B are section views further illustrating the seal element and its relation to the mount in FIG. 26;

FIGS. 28A-F are perspective views of another advantageous sensor and sensor element arrangement;

FIGS. 29A-D are perspective views of another advantageous sensor and sensor connector arrangement;

FIGS. 30A-30B are perspective views illustrating yet another advantageous sensor approach with the sensor as originally produced and modified for use, respectively;

FIG. 30C is a perspective view illustrating the sensor as configured in FIGS. 30A and 30B coupled to a PCB;

FIG. 31 is a side-section view showing a comparative approach, in a final on-body sensor assembly;

FIGS. 32A and 32B are perspective views of still other advantageous sensor configurations, these figures illustrating split-sensor approaches;

FIGS. 33A-33G are plane, side, magnified, and sectional views of an additional sensor configuration;

FIGS. 33H-33J are plane views of various sensor designs;

FIGS. 34A-34D are perspective views illustrating combination electrical connector and sensor isolator in yet another advantageous sensor arrangement;

FIGS. 35A and 35B are side assembly and section views, respectively, of the system shown in FIGS. 34A-34D;

FIG. 35C is an end-section view, with detail view, FIG. 35D, illustrating additional sensor features;

FIG. 36 is a perspective assembly view illustrating a sensor connection approach related to that in FIGS. 34A-34D for a sensor with contacts on a single side;

FIG. 37 is a perspective partial assembly view illustrating a mount-and-socket interface for the sensor assembly employing the components in FIG. 36;

FIG. 38 is a complete assembly view of that illustrated in FIG. 37;

FIGS. 39A and 39B are perspective assembly and as-assembled views of a stacked non-directional sensor connect arrangement;

FIG. 40 is a side partial-sectional view of the sensor in FIG. 39 received within an on-body device;

FIGS. 41A and 41B are partial perspective assembly views of another stacked non-directional sensor connection arrangement;

FIG. 41C is a section view of the complete assembly of the components variously illustrated in FIGS. 41A and 41B;

FIG. 42 is an assembly view of an advantageous radial arrangement sensor connector assembly;

FIGS. 43A and 43B are reversed perspective views of the mount-side sensor connection component for use with an assembly as shown in FIG. 42;

FIG. 44 is a section view of the complete assembly of the components variously illustrated in FIGS. 42, 43A and 43B;

FIGS. 45A and 45B are reversed assembly views of an alternative advantageous sensor connection assembly that can be used like that in FIG. 42;

FIGS. 46A and 46B are assembly and sectional views, respectively of a complete on-body device employing the sensor and connection elements illustrated in FIGS. 45A and 45B;

FIG. 47A-47C are assembly and cross-sectional views of an on-body device including an integrated connector for the sensor assembly;

FIGS. 48A-48D are construction views of an on-body subassembly;

FIG. 48E is a perspective view of a complete on-body electronics subassembly;

FIGS. 49A-49D illustrate the process of co-molding/overmolding the assembly in FIG. 48E;

FIGS. 50A-50C are assembly and sectional views of an alternative snap-together approach with the assembly in FIG. 48E; and

FIGS. 51A-51B are assembly views illustrating adhesive backing application in producing a final on-body device ready for use as shown in perspective-view FIG. 51C.

DETAILED DESCRIPTION

Before the present disclosure is further described, it is to be understood that this disclosure is not limited to the particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein includes discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.

As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

Various exemplary embodiments of the disclosure are described below. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the present disclosure. Various changes may be made to the disclosure described and equivalents may be substituted without departing from the true spirit and scope of the disclosure. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present disclosure. All such modifications are intended to be within the scope of the claims made herein.

Applicator and Container Overview

Turning to FIG. 1, a flowchart depicting an example method 100 of using various systems of the present invention is provided. In some embodiments, a user starts with unpacking the container (102) and unpacking the applicator (104). Unpacking the container (102) can include removing a cover that provides a sterile seal to the container contents and unpacking the applicator (104) can include removing an end cap that provides a sterile seal to the internal portion of the applicator. Next, in an assembly operation (106), the applicator is inserted into the container to merge or connect the sensor assembly and the electronics assembly together to form an on-body device and an insertion needle or sharp. In some embodiments, the user unlocks the applicator or removes a locking element to ready the applicator for use. The process of the assembly operation (106) and the constituent components are described in detail below.

Next, once the user has chosen an application site, an on-body device application operation (108) is performed. In the application operation (108), the user places the applicator on the skin of the insertion site and then applies a force to install the on-body device. The applicator is driven to insert the distal end of the sensor through the user's skin, adhere the on-body device to the skin surface, and retract the sharp into the applicator for disposal. In some embodiments, the user performs the application operation (108) by applying force to the applicator where the force applied is a single, continuous pushing motion along the longitudinal axis of the applicator that once started, causes the applicator to perform the application operation (108) such that the applicator does not stop operation until completion. The applicator is configured to relay action/audible cues to the user so that all three of the above listed actions happen automatically in response to applying the force to the applicator causing it to trigger. Advantageously, an adhesive of the on-body device does not contact the user until the application operation (108) is performed. So, the even after the applicator has been placed on the skin, the applicator can be moved to a different location up until the application operation (108) is performed without damage to the apparatus or other system components. In a post application stage (110), use of the sensor for monitoring the user's analyte level occurs during wear followed by appropriate disposal.

Details of method 100 are illustrated in the sequence of drawings shown in FIGS. 2A to 2G. In FIG. 2A, one of the highlighted application sites 202, 204 on a user 200 is selected. In some embodiments, other application sites may be used. In some embodiments, a site preparation operation may optionally be performed. The application site 202, 204 may be shaved, exfoliated, cleaned, or otherwise treated to better adhere the on-body device. More specifically, the skin at the site of the user's body where the on-body device will be adhered may be prepared to receive the on-body device. For example, the skin may be shaved with a razor, cleaned with isopropyl alcohol (IPA), and exfoliated with an abrasive. A mechanically exfoliating element can be used to remove an outer layer of dead skin and expose newer skin below. These elements include: microfiber exfoliating cloths; pumice or other abrasive mineral; metal-stamped components of a rasp/file type configuration; synthetic scouring material, e.g., Scotch-Brite®; an alternate adhesive tape or patch to be applied and stripped off to remove dead skin; and organic abrasive elements such as salt, crushed almond shells, apricot kernels, etc. Likewise, a chemically exfoliating element may be used to prepare the site, including: mild acids such as alpha hydroxyl acid, beta-hydroxyl acid and salicylic acid; and fruit enzymes. Such chemically abrasive element(s) may be incorporated in a preparation pad, towelette, swab or be supplied otherwise. In some embodiments, the end cap of the applicator may include one or more exfoliating elements. In some embodiments, the end cap may be textured or otherwise formed to provide a surface that can be used to exfoliate the skin of the site where the on-body device will be adhered. Exfoliating away an outer layer of dead skin before application may allow the on-body device to better adhere to the skin for a longer period of time.

FIG. 2B illustrates loader or container 206 preparation, including removing cover 208 from a casing 210. The container 206 includes the casing 210 which holds the sensor assembly and a sharp (or in some embodiments, the electronics assembly). FIG. 2C illustrates applicator 212 preparation including separating a removable applicator end cap 214 from applicator assembly 216. In some embodiments, container 206 and applicator 212 can initially be packaged connected together to simplify packaging and shipping. For example, the removable applicator end cap 214 may include a boss or other feature that couples or snaps to a corresponding feature on the exterior of the container 206. This connection is only operative to hold the two pieces together for shipping purposes and not for operation of the system. Thus, in some embodiments, before removing the cover 208 from the casing 210 and separating the removable end cap 214 from the applicator assembly 216, in an initial unpacking step, the container 206 and applicator 212 are separated from each other.

As shown in FIG. 2D, once alignment indicators 218, 220 are aligned, the user assembly operation 106 (FIG. 1) is achieved by pushing the applicator assembly 216 firmly into the container 206 to retrieve a sensor and a sharp from the container and to unlock a guide sleeve of the applicator assembly 216. In FIG. 2E, the assembled and unlocked applicator assembly 216 is placed on the application site 204 (or 202) and pushed down firmly to effect on-body device application 108 (FIG. 1). As shown in FIG. 2F, upon used applicator assembly 216 removal from the application site 204, on-body device 222 is adhered to the user. In some embodiments, as illustrated in FIG. 2G, analyte levels detected by the sensor of the on-body device 222 can be retrieved over a wireless communication link 224 via a communications facility (e.g., a transmitter, a transponder, etc.) within the on-body device 222 by a receiver unit 226 (referred to alternatively as a “reader unit” or “receiver device”, or in some contexts, depending on the usage, as a “display unit,” “handheld unit,” or “meter”). Relevant information (e.g., analyte level trend data, graphs, etc.) is presented on the receiver unit's display 228.

The applicator 212, container 206, and associated components shown in FIGS. 2A to 2G are illustrated in more detail in FIGS. 3 and 4. In addition, numerous other variations are described in detail below. These alternative embodiments may operate differently insofar as their internal workings, but may present no difference concerning user activity.

Turning to FIG. 3, applicator 212 includes a removable cap 214 and applicator assembly 216. The removable cap 214 can be secured to the applicator assembly 216 via complimentary threadings 306, 306′. End Cap 214 fits with the applicator 216 to create a sterile packaging for interior of the applicator 216. Therefore, no additional packaging is required to maintain sterility of the interior of the applicator 216. In some embodiments, the end (not visible) of the removable end cap 214 can include one or more openings, which can be sealed by a sterile barrier material such as DuPont™ Tyvek®, or other suitable material, to form seal 308. Such provision allows for ethylene oxide (ETO) sterilization of the applicator 212 through the seal 308 when closed. In some embodiments, the openings in the removable cap 214 may not be present and the removable cap 214 may be made from a sterile process-permeable material so that the interior of the applicator can be sterilized when the cap is mated to it, but that maintains sterility of the interior of the cap after exposure to the sterility process. In some embodiments, ETO sterilization is compatible with the electronics within the electronics assembly 310 and with the associated adhesive patch 312, both of which can be releasably retained within the applicator assembly 216 until applied to the user. As shown, the applicator assembly 216 includes a housing 314 including integrally formed grip features 316 and a translating sheath or guide sleeve 318.

In reference to FIG. 4, the container 206 includes a cover 402 (e.g., made of a removable material such as foil) and casing 404. Housed within the casing 404 is a desiccant body 412 and a table or platform 408. In some embodiments, the desiccant body 412 can have an annular shape so that the desiccant body 412 can be disposed within the casing 404 and a sensor assembly support (not visible in FIG. 4 but see 512 in FIGS. 5A and 5B) can extend up through the desiccant body 412. This arrangement allows the container 206 to include a desiccant without requiring any additional height to accommodate the desiccant. A sensor assembly 410 is snap-fit or otherwise held by the sensor assembly support 512. The sensor assembly 410 can also be snap-fit or otherwise held by the platform 408 (e.g., using fingers 414). With the cover 402 sealed, the container 206 can be subjected to gamma or radiation (e.g., e-beam) sterilization, an approach compatible with the chemistry of the sensor included in the sensor assembly 410. Like the applicator 212, the container 206 is its own sterile packaging so that no additional packaging, other than the casing 404 and the cover 402, is required to maintain sterility of the interior of the casing.

The container 206 and the applicator 212 may be sterilized by different sterilization approaches. For example, a sensor contained in a container 206 may require one type of sterilization process and the contents of an applicator 212—for example, electronics contained within the interior of the applicator 212—may require another type of sterilization process. The utility of a two-piece separable but combinable system (i.e., the container 206 and the applicator 212) enables the respective sterilization of the two pieces and sterility maintenance before the two are connected together for use. In other words, separately sealing the container 206 and the applicator 212 facilitates the use of otherwise incompatible sterilization methods for these two components. For example, one type of sterilization which could damage the chemistry of the sensor can be used to sterilize the applicator 212 including the electronics assembly 310 including the adhesive patch 312. Likewise, another sterilization process which could damage the electronics in the electronics assembly 310 (and/or the adhesive patch 312 used to adhere the electronics assembly 310 to the user's skin) can be used to sterilize the container 206 including the sensor therein. Still other advantages may exist, given different shelf-life attributes for the active (i.e., electronic, chemical, etc.) elements. In some embodiments, all components can be sterilized using the same sterilization technique, such as, but not limited to ETO and e-beam sterilization, etc.

In some embodiments, the platform 408 in the container 206 functions as an anti-tamper barrier for the sensor assembly 410 and prevents direct handling of the sensor assembly 410 by the user. More specifically, the platform 408 is disposed to protect and assist in the retention of the sensor, a sharp, and an associated connector. In some embodiments, the platform 408 is locked in place within the casing 404 until released by a longitudinally directed force from the applicator assembly 216 during the user assembly operation 106 (FIG. 1). In other words, as the guide sleeve 318 of the applicator assembly 216 is inserted down against the platform 408, the sleeve 318 releases a locking mechanism (e.g., a catch) and allows the platform to translate deeper into the casing 404. Additionally, features of the casing 404 can be employed to unlock a guide sleeve lock feature of the applicator assembly 216. In some embodiments, the platform 408 in the container 206 can only be unlocked if the guide sleeve 318 of the applicator assembly 216 is inserted into the container 206 with alignment marks on the applicator assembly 216 and the container 206 properly aligned. (See FIG. 10C and associated text below).

FIG. 5A is an isometric, cross-sectional view of the casing 404 of FIG. 4. FIG. 5B is an assembled, isometric, cross-sectional view of the container 206 of FIG. 4 including the component parts. As can be seen in FIGS. 5A and 5B, platform 408 is surrounded by multiple locking features 502 (at least one is advantageously provided in some embodiments). Each of locking features 502 includes a cantilevered arm 504 with a tongue 506 received in a slot or groove 508. So disposed, the platform 408 is locked in place. When the arm(s) 504 are urged inward, in the direction represented by arrows P and P′, from a concentrically disposed sleeve 318 (not shown) of the applicator assembly 216 riding over ramp(s) 510, the locking feature(s) 502 are released and the platform 408 can translate in direction B along a longitudinal axis of the combined applicator assembly 216 interfaced with the container 206. The translation of the platform 408 into the casing 404 provides access to sensor assembly 410 by the applicator assembly 216. Until the platform 408 is unlocked and driven down into the casing 404, the sensor assembly 410 is otherwise isolated from being touched or otherwise handled/accessed by a user. In some embodiments, additional detent ramp features can be provided to hold the platform 408 until depressed with force applied by a user. In addition, various key-and-way or slot-and-groove guidance features can be provided to control such motion and ensure that it is smooth and linear (i.e., to avoid platform canting, binding, etc.)

In some embodiments, the sleeve/ramp interface with associated locks relies only on detent features to maintain the platform's position. So configured, inadvertent handling of the sensor assembly can be avoided. The detent(s) can be tuned to require deliberate action to clear the platform 408.

In some embodiments, alternative mechanisms and arrangements may be employed to provide a platform 408 that collapses upon application of force via the applicator assembly 216 by the user. For example, FIGS. 6 and 7 depict an alternative container 600 embodiment including an alternative platform 602 arrangement. Here, a collapsible armature or linkage 604 supports the platform 602. This linkage 604 is integrally guided and spring-loaded by virtue of the living hinge design of the linkage 604. Alternatively, a coil spring could be employed along with guides for the platform 602. A sleeve 318 (FIG. 3) (FIG. 3) of an applicator 216 or the base of sensor mount unit 606 itself, can be used to translate the platform 602 to provide clearance for sensor assembly 608 access and pick-up by the applicator 216 and incorporation as a complete assembled on-body device 222. The container 600 includes a casing 610 and can also include a desiccant ring 612 to protect the sensor assembly 608 from moisture.

Another embodiment for sensor storage and protection is illustrated in FIG. 8 with container 800. As with the prior embodiments, this embodiment can also include an annular desiccant ring 612. Casing 802 is provided in connection with a support base 804. The support base 804 receives sensor assembly 608 and a frame 806. The frame 806 includes a pivoting door 808. As shown, the support base 804 incorporates three channels 810 for receipt of frame legs 812 to serve as guidance. In its up/closed position shown in FIG. 9A, door 808 protects the sensor assembly 608 from contact by the user. Spiral ramp features interacting between the support base 804 and the frame 806 cause the door 808 to swing open as the frame 806 is moved down as shown in FIG. 9B. Likewise, features of the frame 806 can hold the sensor assembly 608 against the support base 804 until the frame 806 is pushed down by user activity.

Similar to the container embodiment 206 shown in FIGS. 5A and 5B, the frame 806 in container 800 can be locked in place and released by applicator sleeve introduction. A support ring 902 may lock against boss or tang 814 until the boss 814 is urged inward by the action of an applicator sleeve along angled interface surface 904 of each leg 812. In some embodiments, the legs 812 can be biased outward with a preload but in other embodiments, the locking/unlocking function can operate without such biasing. FIG. 9A illustrates the locked configuration, whereas FIG. 9B illustrates unlocked/translated relation of components.

FIGS. 10A to 10N illustrate example details of embodiments of the internal device mechanics of preparing the applicator 212 for use, using the container 206. All together, these drawings represent an example sequence of assembling an on-body device 222 by connecting a sensor assembly 410 stored in the container 206 with an electronics assembly 310 stored in the applicator 212. In addition, the sequence prepares the applicator 212 to apply the assembled on-body device 222 to the user. Modification of such activity for use with the alternative container embodiments (as described above or others) can be appreciated in reference to the same by those with skill in the art.

FIGS. 10A and 10B show container 206 and applicator 212 with their constituent parts, along with arrows indicating the manner of cover 402 and cap 214 removal, respectively. Upon peeling off foil cover 402 from the casing 404, the platform 408 within is locked, thus protecting the sensor assembly 410 (not visible but see FIG. 4) which includes a sensor, a sensor support (also referred to as a plug), a connector, and a sharp. (These components are discussed in detail below.) Likewise, upon removal of cap 214 from the applicator assembly 216, the applicator 212 is locked. As a result of being locked, a guide sleeve 318 (not visible but see FIG. 3) cannot be collapsed into the applicator's housing 314.

In FIG. 10C, applicator assembly 216 is set within container 206. The two components 206, 216 are rotated and advanced until mechanical alignment features M and M′ engage, allowing the applicator assembly 216 to register and sit level within the container 206. Visual alignment indicators A and A′ assist or guide the user to quickly find the proper alignment position. Note that in some embodiments, the platform 408 cannot be unlocked to translate into the container 206 unless the alignment features M and M′ are properly aligned. FIG. 10D depicts the components 206, 216 with the mechanical alignment features M, M′ engaged. Sleeve 318 passes over platform 408, with the platform 408 nested concentrically inside the inner diameter of sleeve 318.

Cross-sectional views FIGS. 10E and 10F illustrate the relationship of parts overviewed in FIGS. 10C and 10D. When the sleeve 318 of applicator assembly 216 is seated onto the platform 408 of the container 206 and pushed downward, platform locking features 502 disposed around the platform 408 on locking ribs 1002 are unlocked to allow the platform 408 to translate along a longitudinal axis (labeled “Z”) of the interfaced components 206, 216. More specifically, a portion of platform 408 bends and platform locking arms 504 are displaced inward as indicated by arrow P to clear locking grooves 508 in the locking ribs 1002 of casing 404, thus unlocking the platform 408. At this point, the platform 408 is held in place by guide ribs 1004 each providing a detent feature 1006 between the platform 408 and the guide ribs 1004 that can be overcome by further downward pressure applied by the user upon further depression of the applicator assembly 216 in the direction of the longitudinal axis Z.

Turning now to FIGS. 10G and 10H, the dropping of the unlocked platform 418 is illustrated. FIG. 10G depicts further depression of the applicator assembly 216 in the direction of the longitudinal axis Z. The force from the sleeve 318 causes inward, radial deflection of a portion of the platform 408. The effect is that detent arms 1008 are flexed down, inward and away from the detent feature 1006 of guide ribs 1004 as shown. This action releases the platform 418 and the applicator assembly 216 into freefall into the container 206. In some embodiments, the force to flex detent arms 1008, or in other words, the force to overcome the resistance from the detent features 1006, is selected to create a predetermined amount of momentum sufficient to ultimately properly mate the electronics assembly 310 with the sensor assembly 410 and unlock the sleeve 318. In some embodiments, the force to overcome the resistance from the detent features 1006 is from approximately 1 N to approximately 23 N. Other practicable values are possible.

In FIG. 10H, once detent arms 1008 of the platform 418 are past the detent features 1006, a relieve or undercut 1010 in each of the guide ribs 1004 provides increased clearance for the platform 418 to reduce sliding friction as the sleeve 318 and platform 418 slide or telescope further into the container's casing 404 along the longitudinal axis Z (FIG. 10F). Also, one or more flexible grasping arms 1012 previously in contact with the sensor assembly 410, particularly through sharp boss 1014, are moved from a stabilizing configuration in FIG. 10G to a freed state or configuration in FIG. 10H. In other words, as the platform 418 translates further into the container 206, the sharp boss 1014 of the sensor assembly 410 protrudes through a central opening in the platform 418 and pushes the flexible grasping arms 1012 out of the way.

Turning now to FIGS. 10I and 10J, a cross-sectional view depicting a slightly different cut plane than the prior views is provided to illustrate additional features. In FIG. 10I, sleeve lock arms are shown engaged with a sleeve lock ledge 1018. This engagement locks the applicator assembly 216 and prevents the sleeve 318 from being able to be retracted or pushed into the housing 314 of the applicator assembly 216. In FIG. 10J, as the applicator assembly 216 is further advanced into the container 206 along the longitudinal axis Z (FIG. 10F), sleeve unlock features contact and bend the sleeve lock arms 1016 clear of the sleeve lock ledge 1018 thereby unlocking the applicator assembly 216. Note that in the particular example embodiment depicted in FIGS. 10I and 10J, the sleeve lock ledge 1018 is formed in a carrier 1022 of the electronics assembly 310.

When the platform 418 bottoms-out in the container 206 as shown in FIG. 10J, the sleeve 318 of the applicator assembly 216 is fully unlocked/released and ready to move. Note that while the sleeve lock arms 1016 are shown flexing outward to unlock, in some embodiments, the sleeve lock arms 1016 can be oriented to flex radially inward to free the elements. The same may hold true for the various locking/unlocking features of the present invention. However, the present arrangement offers advantages in terms of a coordinated whole providing an advantageous form factor and minimized container casing size (a factor that affects the user experience) in which the carrier 1022 of the electronics assembly 310 is coaxially arranged. Regarding the carrier 1022, it is advantageously designed with unique carrier arm features as detailed in, for example, U.S. patent application Ser. No. 13/071,461, the disclosure of which is incorporated herein by reference.

In FIGS. 10K and 10L, now that the sleeve 318 of the applicator assembly 216 is fully unlocked, the momentum along the longitudinal axis Z (FIG. 10F) from the force used to overcome the resistance of the detent features 1006 (FIG. 10H) causes three additional concurrent actions. First, even though the sleeve 318 cannot descend any further into the container 206 (since it is in contact with the platform 418 which is bottomed-out), the housing 314 of the applicator assembly 216, the carrier 1022, and the electronics assembly 310 are free to continue to descend into the container 206, now that the sleeve 318 is unlocked as shown in FIG. 10L.

Second, as the electronics assembly 310 descends further along the longitudinal axis Z (FIG. 10F), the sensor assembly 410 is forced into an opening in the electronics assembly 310 which couples the sensor to the electronics and completes assembly of the on-body device 222 (FIG. 2F). In some embodiments, mating snap features on the sensor assembly 410 and the electronics assembly 310 can be used to compel the components to remain locked and compressed together to insure a sealed, reliable connection. As an alternative to mating snap features, in some embodiments, the sensor assembly 410 and the electronics assembly 310 may be coupled by a light press fit or other connection method. However, the positive interaction and lock of snap features is an advantage. So too is the minimal force used to deflect fine locking features that spring back for engagement.

Third, along with the housing 314, the carrier 1022, and the electronics assembly 310, a sharp retraction assembly 1024 also continues to descend into the container 206 along the longitudinal axis Z (FIG. 10F) and is forced to receive the sharp boss 1014 of the sensor assembly 410. The conical head of the sharp boss 1014 is pushed past a radial arrangement of flexible arms 1026 of the sharp retraction assembly 1024. The flexible arms 1026 bend outwardly, as they are forced to ride against the passing conical surface of the head of the sharp boss 1014. The sharp is thus thereby engaged by the sharp retraction assembly 1024 as the flexible arms 1026 snap back into place once the head of the sharp boss 1014 has passed by, securely grasping the head at the narrowed neck portion of the sharp boss 1014. Note that a base of the sharp boss 1014 may be included to limit insertion into the sharp retraction assembly 1024 through interference with a stop limit or shoulder of the flexible arms 1026. FIG. 10K illustrates the arrangement immediately before the above three actions have completed and FIG. 10L illustrates the resulting arrangement immediately after the actions have completed.

In some embodiments, the connection features between the sharp boss 1014 of the sensor assembly 410 and the sharp retraction assembly 1024 can be otherwise configured. For example, the sharp retraction assembly 1024 can include a conical channel formed from a radial arrangement of inwardly biased flexible finger members configured to receive the head of sharp boss 1014 such that once the head has passed through the channel, the flexible fingers conform to the narrowed neck of the sharp boss 1014. With the fingers so conformed, the sharp boss 1014 is captured by the sharp retraction assembly 1024. Retention force is limited only by material strength because the self-energizing lock is not prone to slip between the pieces.

Turning to FIG. 10M, a slightly rotated view, relative to FIG. 10L, is shown. When the sharp boss 1014 is engaged in the sharp retraction assembly 1024, the sensor assembly 410 is coupled to the electronics assembly 310 completing assembly of the on-body-device 222, and the sleeve 318 is unlocked, platform locking arms 504 and detent arms 1008 have engaged undercut grooves 1028 in the container 206, thereby locking the platform 418 in the casing 404. This engagement between the platform 418 and the casing 404 marks the final position of the container 206 from which the loaded applicator assembly 216 is withdrawn for use to apply the on-body device 222 to the user.

Now, once removed from the container 206, the applicator assembly 216 is ready to “fire” as illustrated in FIG. 10N. As such, the applicator assembly 216 is ready to use as in application 108 described in connection with FIG. 2E. Here, the applicator assembly 216 has already been unlocked by interaction with the container 206, and the sensor assembly 410 is coupled to the electronics assembly 310. The sharp 1030 extends from the on-body device 222 which is held in the sleeve 318 of the applicator assembly 216 as shown.

FIGS. 11A to 11F illustrate example details of embodiments of the internal device mechanics of “firing” the applicator assembly 216 to apply the on-body device 222 to a user and including retracting the sharp 1030 safely back into the used applicator assembly 216. All together, these drawings represent an example sequence of driving the sharp 1030 (supporting a sensor coupled to the on-body device 222) into the skin of a user, withdrawing the sharp while leaving the sensor behind in operative contact with interstitial fluid of the user, and adhering the on-body device to the skin of the user with an adhesive. Modification of such activity for use with the alternative applicator assembly embodiments and components can be appreciated in reference to the same by those with skill in the art.

Turning now to FIG. 11A, a sensor 1102 is supported within sharp 1030, just above the skin 1104 of the user. Rails 1106 (optionally three of them) of an upper guide section 1108 may be provided to control applicator assembly 216 motion relative to the sleeve 318. The sleeve 318 is held by detent features 1110 within the applicator assembly 216 such that appropriate downward force along the longitudinal axis of the applicator assembly 216 will cause the resistance provided by the detent features 1110 to be overcome so that the sharp 1030 and on-body device 222 can translate along the longitudinal axis into (and onto) the skin 1104 of the user. In addition, catch arms 1112 of carrier 1022 engage the sharp retraction assembly 1024 to maintain the sharp 1030 in a position relative to the on-body device 222.

In FIG. 11B, user force is applied to overcome or override detent features 1110 and sleeve 318 collapses into housing 314 driving the on-body device 222 (with associated parts) to translate down as indicated by the arrow L along the longitudinal axis. An inner diameter of the upper guide section 1108 of the sleeve 318 constrains the position of carrier arms 1112 through the full stroke of the sensor/sharp insertion process. The retention of the stop surfaces 1114 of carrier arms 1112 against the complimentary faces 1116 of the sharp retraction assembly 1024 maintains the position of the members with return spring 1118 fully energized.

In FIG. 11C, sensor 1102 and sharp 1030 have reached full insertion depth. In so doing, the carrier arms 1112 clear the upper guide section 1108 inner diameter. Then, the compressed force of the coil return spring 1118 drives angled stop surfaces 1114 radially outward, releasing force to drive the sharp carrier 1120 of the sharp retraction assembly 1024 to pull the (slotted or otherwise configured) sharp 1030 out of the user and off of the sensor 1102 as indicated by the arrow R in FIG. 11D.

With the sharp 1030 fully retracted as shown in FIG. 11E, the upper guide section 1108 of the sleeve 318 is set with a final locking feature 1120. As shown in FIG. 11F, the spent applicator assembly 216 is removed from the insertion site, leaving behind the on-body device 222, and with the sharp 1030 secured safely inside the applicator assembly 216. The spent applicator assembly 216 is now ready for disposal.

Operation of the applicator 216 when applying the on-body device 222 is designed to provide the user with a sensation that both the insertion and retraction of the sharp 1030 is performed automatically by the internal mechanisms of the applicator 216. In other words, the present invention avoids the user experiencing the sensation that he is manually driving the sharp 1030 into his skin. Thus, once the user applies sufficient force to overcome the resistance from the detent features of the applicator 216, the resulting actions of the applicator 216 are perceived to be an automated response to the applicator being “triggered.” The user does not perceive that he is supplying additional force to drive the sharp 1030 to pierce his skin despite that all the driving force is provided by the user and no additional biasing/driving means are used to insert the sharp 1030. As detailed above in FIG. 11C, the retraction of the sharp 1030 is automated by the coil return spring 1118 of the applicator 216.

As for further details of the operation, alternative embodiments may be appreciated in view of related approaches discussed below, others in review of the incorporated subject matter and still more appreciated by those with skill in the art based upon further review of the figures which depict actual hardware produced according to various aspects of the subject disclosure.

Turning to FIGS. 12A to 12D an alternative applicator/container set approach is now described. As shown in FIG. 12A, the container 1200 holds the electronics assembly 1202. This is in contrast to the above embodiments wherein the relationship between the sensor assembly and the electronics assembly was reversed. Upon aligning markers M and M′, the applicator 1204 is inserted in the container 1200. In FIG. 12B, the units are merged. In FIG. 12C, the parts are separated. Finally, in FIG. 12D the applicator 1204 is unlocked (e.g., in some embodiments by twisting the sleeve 1206 within the applicator 1204, in some embodiments by the act of loading the electronics assembly 1202 into the applicator 1204, or in some embodiment by the act of removing a locking strip from the sleeve 1206) and ready for use with the assembled on-body device (not visible) including the sensor assembly loaded therein. These various alternative embodiments are illustrated in FIG. 13A to 15F.

FIGS. 13A to 13C variously illustrate use of the applicator 1204 of FIGS. 12A to 12D in connection with a locking-sleeve feature 1206. FIG. 13A shows the sleeve 1206 locked as indicated by the closed window 1208. After twisting the sleeve 1206 relative to the rest of the applicator 1204 to unlock the sleeve 1206, a visual indication (e.g., open window 1208′) is seen when the applicator 1204 is ready for use as presented in FIG. 13B. Upon use, as shown in FIG. 13C, the unit is compressed with the sleeve 1206 collapsed into the applicator 1204.

FIGS. 14A and 14B illustrate an alternative applicator 1400 embodiment with a removable locking strip 1402. With the locking strip 1402 in place around the sleeve 1406, the sleeve 1406 cannot be pushed into the applicator 1400. The strip 1402 includes a pull-tab 1404 and adhesive or other fastening member to keep it in place until removed and the applicator 1400 is ready for use.

FIGS. 15A to 15F illustrate preparation of the applicator 1400 of FIGS. 14A and 14B for use with a container 1500. Once the cover 1502 has been removed from the container 1500 and the cap 1506 removed from the applicator 1400, the applicator 1400 is inserted into container 1500 to load the electronics assembly 1504 into the applicator 1400 and mate the sensor assembly (not shown) with the electronics assembly 1504 as shown in FIGS. 15B and 15C. Once loaded, the applicator 1400 is removed from the container 1500 as shown in FIG. 15D. FIG. 15E shows the applicator 1400 loaded with the assembled on-body device 222 and ready for sensor/sharp insertion. The locking strip 1402 is removed from the sleeve 1406 and the open ready indicator 1208′ signals that the applicator 1400 is ready to be used. FIG. 15F illustrates the system after such action has been taken in transferring the on-body device 222 from the applicator 1400 onto the skin of a user.

FIGS. 16A and 16B are sectional and detail views, respectively, of features of the container 1500 in FIGS. 15A-15F. Specifically, the on-body device 1604 is shown in the container 1500 with an adhesive patch 1602 and its backing 1606. The backing 1606 is spiral-cut and attached to a boss so that when the on-body device 1604 is transferred from the container 1500, the peel-away backing 1606 is left behind. In this fashion, the adhesive patch 1602 remains covered by the backing 1606 so it does not inadvertently adhere to the container 1500.

As an alternative to the spiral peel-around backing approach of FIGS. 16A and 16B, FIGS. 17A and 17B are perspective assembly views illustrating alternative container 1702 configurations for capturing separate peel-off “butterfly” wings or bilateral liner panels from the adhesive-backed patch of the on-body device 1706. In each case, a two-part base 1704 is provided for gripping the peel-away backing liner pieces. Naturally, the base 1704 is adapted to fit in the container casing. In some embodiments, the container 1702 can be configured differently. In the version depicted in FIG. 17A, traction/tread 1708 is provided to assist with grip of the backing. In the version depicted in FIG. 17B, ramps 1710 are provided to assist in removing the backing. In another version, the base can be a one-piece molding incorporating a living hinge in a “clamshell” arrangement. The backing liner piece(s) may be captured along a center line or at an offset location. However configured, the base 1704 may snap into place with complementary band and rib interface features associated with each of the base 1704 and container 1702, snaps, or other features. As with other assemblies described herein, these features may alternatively be press fit, ultrasonically welded or otherwise secured in place.

FIG. 18 is a cross-sectional view illustrating features of the applicator and container sets shown in FIGS. 15A-15F. The embodiment shown in FIG. 18 includes several of the features described in connection with the alternative loading approach above. However, it is simplified in approach. Most notably, the container 1806 includes no active/mobile components. Once the applicator 1800 is pressed down into the container 1806, the on-body device 1808 is assembled (e.g., the sensor assembly is mated with the electronics assembly), released from the container 1806 (e.g., using releasable latches), and held by the applicator 1800 (e.g., using latching arms). This embodiment offers an advantage of not having to expose the adhesive of the on-body device 1808 as in other embodiments. Furthermore, the position of the on-body device 1808 provides a stable surface for the sensor assembly insertion. Other embodiments where the applicator is pre-loaded with the on-body device do provide the advantage of not having to perform the above-described hand-off. Also, the use or inclusion of a protector for the sharp is avoided.

FIGS. 19A and 19B show a sensor assembly 1902 in association with a needle guard 1904. In use, a distal interface feature (e.g., a barb) of the needle guard 1904 is captured by a complimentary split ring or other feature in the container during the assembly of the on-body device. Then, when the applicator is separated from the container, the needle guard 1904 is retained in the container and the sharp is unsheathed. In some embodiments, the needle guard 1904 may be made from polypropylene with a thermoplastic elastomer (TPE) insert to releasably secure the sharp. Other materials may be selected.

Other materials may be selected for construction of other elements of the present invention. For example, the applicator housing may be made of polycarbonate or any other practicable material. The guide sleeve, container, etc. may be constructed from acetyl (for reason of lubricity of sliding parts). Any number of the parts may be injected molded, thermoformed or otherwise produced.

Regarding the sensor assembly hand-off to the electronics assembly, FIGS. 20A and 20B illustrate a manner of holding a sensor assembly boss 2006 to the element 2002 that will pick up the electronics assembly 2004 to form the on-body device. Spring armatures 2008 clip to a lip of the sensor assembly 2006 and hold the sensor assembly 2006 within the applicator during shipping and handling. When the applicator and the container are brought together, lever arms 2010 contact the on-body device 2004, causing the associated spring armatures (or “spring arms”) to twist and rotate the connection away from the lip of the sensor assembly, thereby releasing the sensor assembly. A chamfer on the sensor assembly boss can help ensure alignment and proper actuation of the one or more (e.g., three) torqueing spring armatures 2008.

FIGS. 21A-21C illustrate an alternative hand-off approach. In this embodiment, a sensor assembly gripper 2106, with a light snap fit, grabs and orients the sensor assembly 2104 for connection to the electronics assembly 2102. After the sensor assembly 2104 is firmly snapped into the electronics assembly 2102, the sensor assembly gripper 2106 is retracted with an amount of force that overcomes its grip. Such an approach offers simplicity by reducing the number of parts required (given that the snap features may be incorporated in the sharp hub/boss).

Electrical Connections Details

The selection of various hardware options from the above alternative embodiments will depend, at least in part, on the sensor assembly configuration. Sensor assembly configuration, in turn, depends on the mechanism selected for establishing electrical contact between the sensor assembly and the electronics assembly, as well as the method used to seal the contacts. A number of advantageous alternative embodiments are illustrated in FIGS. 22 through 48.

A first example is presented in FIG. 22. Here a sensor 2202 is provided with an elongate “tail” section. The distal portion of the tail is to be inserted through the skin surface guided by a sharp. The proximal portion of the sensor 2202 includes a “flag” type connector region. Three carbon-doped (for conductivity) silicone electrical connectors 2204 are provided to interface with the electrical contacts of the sensor 2202. A split “V” portion of each connector 2204 receives the electrical contacts of the sensor 2202. A flexible nubbin on the opposite side of each connector 2204 is provided for electrical contact with the circuit board incorporated in the electronics assembly. When inserted in a housing 2210, the sensor 2202 and the connector 2204 are advantageously sealed, encased or potted with an adhesive. Epoxy, a UV cure or another type of dielectric (non-conductive) compound may be used. Generally, the compound selected is of such viscosity that it is able to flow around features and fully seal the sensor 2202 within its housing 2210 to avoid leakage. Such an approach avoids contamination and/or current leakage due to fluid intrusion. FIGS. 23A and 23B are perspective assembly and final-assembly cross-sectional views, respectively of the sensor components of FIG. 22. The tail of the sensor 2202 is supported within the sharp 2206 and the sharp 2206 extends through the connector housing 2210. The electrical contacts of the sensor 2202 are seated in the connector 2204 and the assembly is sealed within the housing 2210 including the housing top 2208.

FIGS. 24A and 24B are top and bottom perspective views, respectively of circuit board components to be used with the sensor assembly 2300 of FIGS. 23A and 23B. In each, a custom printed circuit board (PCB) 2402 is shown. The PCB 2402 includes a battery 2406 with mount 2408, an application specific integrated circuit (ASIC) 2410, or other appropriate processing unit, and various other circuitry, including a thermocouple. On its face, the PCB 2402 includes a housing 2404 with snap features for receiving the sensor assembly 2300 of FIGS. 23A and 23B. On the reverse side of the PCB 2402, heat stakes 2412 show the mode of attaching the housing 2404.

Turning to FIGS. 25A and 25B, in some embodiments, the on-body device 2502 is formed by over molding with a polymer “macromelt” (e.g., a thermoplastic hot-melt based on polyamide) or other compound and then affixing an adhesive patch with a releasable liner thereto. A completed on-body device 2502 is provided once fitted with a complimentary sensor assembly 2300, as illustrated in FIGS. 25A and 25B. Internal to such assembly, it may be desirable to include a seal or gasket 2604 as shown in assembly view FIG. 26. As shown in cross section, in FIG. 27A, and magnified in FIG. 27B, the gasket 2604 advantageously includes discrete ring/rim elements to compress and ensure sealing in critical areas, including around each circuit connection/nubbin.

FIGS. 28A-28F illustrate another advantageous sensor 2802 and sensor mount or connector 2804 arrangement. This embodiment resembles the previous approach, but is configured with a bend and a curve imparted to the sensor connection “flag.” This permits package and sealing within in a roughly triangular envelope to shorten the length of the connector. Doing so results in a generally more compact sensor assembly body and the ability to downsize all associated components. Yet, it does not significantly complicate manufacture. FIG. 28A depicts the sensor 2802 before it is shaped to fit within the connector 2804. FIG. 28B depicts the bent and curved sensor connection “flag.” FIG. 28C depicts the relative orientation of the sensor 2802 as it is inserted into the connector 2804. FIG. 28D depicts a wedge 2806 that is press-fit into the connector 2804 to retain the sensor 2802 and press the connector's electrical contacts against the electrical contacts of the sensor 2802. FIG. 28E depicts the relative orientation of the sharp 2808 as it is inserted into the connector 2804 and FIG. 28F depicts the completed sensor assembly including potting 2810 (e.g., UV potting) used to seal the electrical contacts.

An alternative embodiment is contemplated in connection with the sensor approach illustrated in FIGS. 29A-29D. Using a sensor 2902 with a vertically disposed “flag” connector portion that is supported by coupling 2904, coupling 2904 is configured to snap into connector block 2908 which is attached to PCB 2914. Connector block 2908 includes a connector socket 2910 to receive the contacts portion of the sensor 2902. Connector block 2908 also includes a coupling feature 2912 to receive snap-fit tab 2906 on the coupling 2904 which retains the sensor 2902 in the connector socket 2910.

Another alternative embodiment is contemplated in connection with the sensor approach illustrated in FIGS. 30A-30C. Here, a design is provided that eliminates a connection element and the need for separate spring contacts (be they metal or elastomeric as above). In addition, the approach offers the advantage of effectively converting a sensor with contacts on two sides into a sensor with contacts on a single side after folding. The sensor 3004 shown in FIG. 30A initially has two electrical contacts facing a first direction on the split contact area and one contact facing in a second, opposite direction (obscured by the view). When folded and optionally clamped, glued or otherwise affixed in the orientation shown in FIG. 30B, all of the electrical contacts lie in a single plane, facing the same direction (e.g., downward in the drawing). Set within a housing (not shown) to restrain and/or seal the sensor 3004, the sensor 3004 is coupled to electrical contacts on the PCB 3002 as shown in FIG. 30C.

Such an approach in some embodiments includes a thinner (e.g., lower profile) on-body device relative to the on-body device 3102 variation shown in FIG. 31. The reduced thickness dimension is represented by height H. In FIG. 31, a flag type sensor is shown in a housing with separate electrical connectors. The “stack height” in FIG. 31 includes these connectors as well as the housing. The approach shown in FIG. 30 enables eliminating the connector height above the sensor 3004. Thus, elements are eliminated without losing functionality. Moreover, the elimination of parts reduces cost, and impedance (relative at least to the inclusion of elastomeric connectors as shown in FIG. 22, etc.) between the sensor 3004 and the PCB. Another useful aspect is allowing a sensor with contacts on two sides to connect to the PCB without requiring vias or holes in the sensor, thereby helping with sealing considerations and ease of electrical connection.

FIGS. 32A and 32B illustrate two additional sensor configurations. In these embodiments, sensors 3202, 3212 with contacts on two sides are split and bent in opposite directions to orient the electrical contacts 3204, 3214 onto a single face or plane. As above, orienting the electrical contacts 3204, 3214 onto a single plane facilitates ease of sealing the electrical connections. Moreover, overall sensor assembly height can be reduced relative to other approaches. Any of conductive adhesives, conductive films and/or mechanical contacts may be used to electrically connect with the sensor contacts so arranged.

FIGS. 33A-33G depict a low-profile multilayer sensor configuration with the electrical contacts all on one side and some details of its construction. FIGS. 33A and 33B illustrate the two sides of this embodiment of a sensor 3300 and its overall shape. The example sensor 3300 includes a tail portion 3302 that is initially supported by a sharp and then disposed within the user's interstitial fluid or dermal space below the skin upon application of the on-body device. The tail portion 3302 includes electrodes 3304, 3306, 3308 that are used to contact the interstitial fluid and to sense (e.g., transmit and receive) the electrical signals used to measure the analyte concentration within the interstitial fluid. The sensor 3300 also includes an electrical contacts portion 3310 which includes electrical contacts 3312, 3314, 3316 that are disposed all on one side of the sensor 3300 and are in electrical communication with the electrodes 3304, 3306, 3308 via conductive traces (not visible in FIGS. 33A and 33B but see FIG. 33F). Note also that the electrical contacts portion 3310 is shaped to facilitate being securely held and sealed into a connector support that will be described below. For example, the electrical contacts portion 3310 includes securement features that hold the sensor to be secured to the connector support by friction fit, interference fit, etc., herein shown as tabs 3310A and notches 3310B that allow the electrical contacts portion 3310 to be held securely in the connector support which includes mating features.

The sensor 3300 also includes a bendable portion 3318 that allows the electrical contacts portion 3310 to be arranged parallel to the circuit board of the electronics assembly to facilitate a relatively flat or low profile within the electronics assembly. The bendable portion 3318 also allows the tail portion 3302 to extend down from the electronics assembly so that it can be inserted below the skin of the user while the electrical contacts portion 3310 lays parallel to the circuit board. Lastly, the sensor 3300 includes an armature portion 3320 that allows the sensor 3300 to be held securely to the connector support of the sensor assembly. The armature portion 3320 also provides a leverage point to apply a biasing force to compel the tail portion 3302 into a channel of the sharp as described below in FIG. 35D and the associated text.

FIG. 33C depicts a side view of the sensor 3300. The encircled portion labeled D is shown in more detail in FIG. 33D. FIG. 33D provides a magnified side view of the distal most part of the tail portion 3302 of the sensor 3300. The encircled portion labeled E is shown in more detail in FIG. 33E. FIG. 33E provides an even further magnified view of the electrodes 3304, 3306, 3308 of the tail portion 3302. As can be seen in FIG. 33E, the electrodes 3304, 3306, 3308 are formed as layers on a substrate 3322. The substrate 3322 is made of a flexible, non-conductive dielectric material. In some embodiments, a clear, high-gloss, heat stabilized polyester film may be used for the substrate 3322 and conductive carbon ink can be used to create the trace layers used for the electrodes 3304, 3306, 3308. In other embodiments, other materials may be used for the substrate 3322 such as polymeric or plastic materials and ceramic materials and for the trace layers such as carbon or gold.

Dielectric layers 3324, 3326, 3328 are disposed between and upon the electrodes 3304, 3306, 3308 to insulate the electrodes 3304, 3306, 3308 from each other. In some embodiments, an ultraviolet (UV) light curable dielectric material may be used for the dielectric layers 3324, 3326, 3328. In other embodiments, other practicable materials may be used. In the particular example embodiment shown, electrode 3304 is a counter electrode, electrode 3306 is a working electrode, and electrode 3308 is a reference electrode. Note that reference electrode 3308 also includes a secondary conductive layer 3330, e.g., an Ag/AgCl layer. In certain embodiments, the lateral surface of the secondary conducive layer 3330 is covered by a dielectric layer 3328 resulting in only the side edges the secondary conductive layer 3330, which extend along the side edges of the substrate 3322, being uncovered by dielectric layer 3328 and, as such, are exposed to the environment when in operative use. In such embodiments, dielectric layer 3328 covers the entire lateral surface of the secondary conducive layer 3330, i.e., 100% of the lateral surface of the secondary conducive layer 3330 is covered by dielectric layer 3328. As such, dielectric layer 3328 has at least the same lateral width and at least the same length as conductive layer 3330.

Further details of the arrangement, dimensions, chemistry, and manufacturing methods of the sensor 3300 may be found in U.S. patent application Ser. No. 13/526,136, entitled “Connectors For Making Connections Between Analyte Sensors And Other Devices,” which was filed Jun. 18, 2012, and which is incorporated by reference herein in its entirety and for all purposes.

FIG. 33F depicts a view of the sensor 3300 of FIGS. 33A and 33B including hidden lines representing different layers of electrically conductive trace lines 3332, 3334, 3336 connecting the electrical contacts 3312, 3314, 3316 to the electrodes 3304, 3306, 3308. The electrical contacts 3314, 3316 for the electrodes on the opposite side of the sensor 3300 are coupled to the respective conductive traces 3334, 3336 using vias 3338, 3340 (only two labeled). FIG. 33G is a cross-sectional view of the sensor 3300 taken along line GG of FIG. 33F. As can be seen, conductive trace 3332 covered by dielectric layer 3324 is on one side of the substrate 3322 while conductive traces 3334, 3336 separated by dielectric layer 3326 and covered by dielectric layer 3328 is on the opposite side on the substrate 3322. The electrical contacts 3314, 3316 are accessible via openings in the dielectric layer 3328.

FIGS. 33H to 33J depict three alternative sensor designs 3342, 3344, 3300 side by side for comparison. Notably sensor 3342 includes an aperture 3346 to receive a rivet or other fastener for physical attachment to the PCB of the electronics assembly. Details of sensor 3342 are provided in previously incorporated U.S. patent application Ser. No. 13/526,136, entitled “Connectors For Making Connections Between Analyte Sensors And Other Devices,” which was filed Jun. 18, 2012. Sensors 3344 and 3300 are suitable for use with the alternative connector arrangements described below with respect to FIGS. 34A-35D.

Turning now to FIGS. 34A-35D, an alternative connector arrangement for connecting a circuit board to a sensor 3300 such as depicted in FIGS. 33A, 33B, and 33J is described. As shown in FIG. 34A, a flexible one-piece seal or connector 3402 is molded in silicone or other practicable elastic material. Separate doped silicone conductive elements are set therein which provide electrical contacts 3410 for connection to a circuit board. In some embodiments, the conductive elements can alternatively be over molded or insert-molded into place. The result is a generally malleable/flexible hybrid connection and sealing unit or connector 3402 incorporating a living hinge joining two (as-shown) symmetrical sections. Alternatively, a two-piece design is possible. Yet, with the unitary design, the arrangement can be neatly secured using a single catch boss or post 3412 opposite the hinged section. In some embodiments, two or more posts can be used to secure the connector 3402 folded around and sealing both sides of the contacts portion of the sensor 3300. Thus, even if a dielectric coating on the sensor 3300 fails (e.g., pinhole leaks), the connector 3402 insures that the sensor contacts 3312, 3314, 3316 are protected from moisture or any contaminants. The one-piece design also facilitates assembly as illustrated, in which the flexible connector 3402 is set in a rigid or semi-rigid housing or connector support 3404 with one side located on the post 3412. Then a sensor 3300 is inserted, and bent approximately ninety degrees at the bendable portion 3318 of the sensor 3300. Once bent, the sensor 3300 is then captured with the upper part of the connector 3402 by folding over the connector 3402 as indicated by arrow S in FIG. 34C. The connector 3402 is illustrated as bilaterally symmetrical, however, the connector 3402 can be formed in a direction-specific orientation because in some embodiments, certain of the electrical contacts 3410 may not be necessary. In some embodiments, all the sensor's electrical contacts 3312, 3314, 3316 can be provided on a single side of the sensor 3300 or, in other embodiments, both sides of the sensor 3300.

As shown in FIG. 34D, in some embodiments, the top surface of the connector 3402 includes a raised lip 3418 disposed at the top surface edge of the connector 3402 that encircles the electrical contacts 3410 of the connector 3402. The raised lip 3418 can be integrally formed in the elastomeric material that forms the connector 3402 and is thus compressible when the sensor assembly is inserted into the electronics assembly. Alternatively, the raised lip can be embodied as gasket or O-ring on the top surface of the connector 3402. The raised lip 3418 functions to ensure that a seal is formed around the electrical contacts 3410 of the connector 3402 and the electrical contacts of the PCB before any electrical connectivity between the sensor and the electronics assembly is established. Thus, the raised lip 3418 provides a failsafe against a short by insuring the order of assembly includes creating a seal and then creating electrical connectivity as the sensor assembly is mated with the electronics assembly.

In any case, with the sensor 3300 captured within the seal 3402, a sharp 3408 is then introduced, with its hub 3414 contacting the connector support 3404 as shown in FIG. 34D. FIG. 35A illustrates the orientation of the sharp 3408 prior to the insertion of the sharp 3408 into the connector support 3404. FIGS. 35B and 35C provide a cross-sectional overview of the relationship of the sharp 3408 to the sensor 3300. Notably, once inserted in the connector support 3404, the sharp 3408 surrounds and supports the tail portion 3302 of the sensor 3300. In FIG. 35D, further details of the sensor configuration are visible. Particularly, biasing features are shown that abut surfaces of the connector support 3404 in order to center and bias the sensor 3300 into the channel of the sharp 3408. Specifically, armature portion 3320 abuts the surface at arrow 3502 of the connector support 3404 which causes the biasing feature 3508 to act as a fulcrum at arrow 3504 to push the tail portion 3302 of the sensor 3300 into the sharp 3408 at arrow 3506.

In some embodiments, the curved section 3508 of the sensor 3300 can overlie a corresponding surface of the connector support 3404 to help limit the insertion depth (i.e., provide a depth stop) for the sensor 3300. Sensor 3300 vertical placement, including insertion depth, is also controlled based on the relationship between the seal 3402 halves. As noted with respect to the other sensor assembly housings/supports discussed herein, the sensor assembly of FIG. 35C can also include various clip or snap features for its precise associations with a socket in the electronics assembly within the on-body device.

A related arrangement to that described in connection with FIGS. 34A-34D and 35A-35D is presented in FIGS. 36 to 38. In FIG. 36, a sensor 3300 with all electrical contacts on the same side is shown with a sharp 3602 for insertion in a connector support 3604. The connector support 3604 includes an elastomeric (e.g., silicone) seal backing. Once such a sensor assembly set is in a container (or alternatively in an applicator), the sensor assembly can be coupled to the sensor electronics to form an on-body device 222. As shown in FIG. 37, the sensor assembly 3702 is shaped to fit within a socket 3704 that includes a second elastomeric unit with electrical contacts in the elastomer body of the socket 3704. Note that in FIG. 37, the enclosure of the electronics assembly is not shown so that the socket can be more clearly displayed. The socket 3704 is affixed to a circuit board 3706 via any practicable method. The socket 3704 and/or the connector support 3604 can include various coupling features (e.g., a snap fit lip and hook arrangement) to ensure that the electrical contacts are pressed tightly together and sealed within the socket 3704 and sensor assembly 3702. Once the sensor assembly 3702 is received within the socket 3704, the on-body device (e.g., with the complete over-mold enclosure around the circuit board 3706 and adhesive patch 3802 as shown in FIG. 38) is ready for use.

The electrical contacts/connector approaches described above are “directional.” In other words, before the sensor assembly is mated with the electronics assembly, the two are aligned relative to each other both longitudinally and rotationally. In some embodiments, the coupling arrangement is “non-directional” and the sensor assembly can be mated with the electronics assembly without aligning the two rotationally. For example, the sensor assembly construction shown in FIGS. 39A and 39B offers such an approach. Separate conductive (e.g., optionally metal) bands 3904 mounted on a core support 3906 connect to sensor electrical contacts 3908 as shown in FIGS. 39A and 39B. The assembled unit (i.e., the sensor assembly 3910), with sharp 3902 in place, is received in the socket of an electronics assembly 4002 to form an on-body device as illustrated in FIG. 40. In some embodiments, brush-type connectors 4004 on the circuit board in the electronics assembly 4002 reach up to the individual levels of the conductive bands 3904. Such a sensor assembly 3910 can be inserted into the socket of the electronics assembly 4002 in any radial/rotational orientation.

A “reversed” approach is illustrated in the sensor assembly 4100 of FIGS. 41A-41C. Here, the circuit board 4102 includes a socket connector 4104 that has an arrangement of stacked conductive elastomeric O-rings 4106 disposed within the inner diameter of the socket connector 4104. A sensor support 4108 is adapted to hold the electrical contacts 4110 of the sensor 4112 in a corresponding stack facing radially outward. When the sensor support 4108 is inserted into the socket connector 4104, the conductive elastomeric O-rings 4106 align vertically with the electrical contacts of the sensor as shown in FIG. 41B (with the socket connector 4104 not shown so that the conductive elastomeric O-rings 4106 are more clearly visible) and in the cross-sectional view of FIG. 41C. In some embodiments, the electrical contacts 4110 of the sensor 4112 can be formed by rolling up a sensor with contacts all on the same side or using the oppositely directed folding/rolling approach shown in connection with FIG. 40—but oriented vertically. Other approaches may be utilized as well. In any case, the electrical contacts of the sensor subtend less than 360 degrees while the conductive elastomeric O-rings on the circuit board provide a multi-level encircling relationship. As with the approach associated with FIGS. 39A to 40, such a sensor assembly 4100 can be inserted into the socket connector 4104 of the electronics assembly 4102 in any radial/rotational orientation.

The sensor connections associated with the circuit board 4404 in the embodiment shown in FIGS. 42 to 44 are arranged in concentric rings. The sensor 4202 includes electrical contacts 4204 held within housing member 4206 and base 4208. The electrical contacts 4204 include “micro-spring” wireform connectors. These springs provide compliance as well as a discrete top loop. Each electrical contact 4204 is disposed at a different radial distance from the center corresponding to a different concentric conductive track 4304 on a circuit board coupling 4302. Thus, no matter the rotational orientation of the sensor assembly 4200 relative to the circuit board coupling 4302, the electrical contacts 4204 of the sensor 4202 align with the correct concentric conductive tracks 4304. Very fine wire can be used for the springs, thus producing an easily miniaturized system.

Turning now to FIGS. 45A and 45B, another non-directional sensor assembly connection approach that can be employed with a concentric electronics assembly connection is depicted. As illustrated in the isometric top and bottom views of FIGS. 45A and 45B, a sensor 4504 bent approximately ninety degrees with contacts positioned along different radial paths or arcs, connects with conductive elastomeric contacts 4508 supported by two opposing discs 4502, 4506. Two of the elastomeric contacts 4508 are set on one disc 4506, and a third, configured to pass through a sensor via, is set on the other disc 4502. As shown in FIG. 46A, this sensor assembly 4500 can then be received by a circuit board coupling 4604 which includes concentric tracks for connecting the radially disposed conductive elastomeric contacts 4508 of the sensor assembly 4500 to the circuit board 4606. The enclosure 4608 snap fits or is otherwise adhered to (e.g., using adhesive/welding) a base supporting the circuit board 4606. The as-assembled on-body device 4600 is depicted in FIG. 46B.

Turning now to FIGS. 47A to 47C, an alternative sensor assembly/electronics assembly connection approach is illustrated. As shown, the sensor assembly 4702 includes sensor 4704, connector support 4706, and sharp 4708. Notably, sensor assembly 4702 does not include a separate connector or seal to enclose the sensor's connectors within the connector support 4706 as in the embodiment depicted in FIGS. 34A to 34D (i.e., no seal 3402). Instead, a recess 4710 formed directly in the enclosure of the electronics assembly 4712 includes an elastomeric sealing member 4714 (including conductive material coupled to the circuit board and aligned with the electrical contacts of the sensor 4704). Thus, when the sensor assembly 4702 is snap fit or otherwise adhered to the electronics assembly 4712 by driving the sensor assembly 4702 into the integrally formed recess 4710 in the electronics assembly 4712, the on-body device 4714 depicted in FIG. 47C is formed. This embodiment provides an integrated connector for the sensor assembly 4702 within the electronics assembly 4712.

On-Body Device Construction Details

Certain elements of the on-body device fabrication may apply to any or all of the above electrical connection configurations. FIGS. 48A-48D provide top (FIG. 48A) and bottom (FIG. 48B-48D) construction views of an exemplary on-body device subassembly. A socket 4802 or mount is fit through vias in a printed circuit board 4800 along with other associated components including a processor 4804 (e.g., an ASIC including a communications facility), thermistor/thermocouple 4806, a battery mount 4808, etc. Once the circuit board 4800 has been populated with these components as shown in FIG. 48C, the socket 4802 is adhered to the circuit board 4800 (e.g., using heat stakes). Once a battery 4810 is set in place, the circuit board 4800 as shown in FIG. 48E is prepared for incorporation into an on-body device.

The circuit board 4800 is ready for an over-mold process or other sealing method. As illustrated in FIGS. 49A-49D, the circuit board 4800 is first set in the two-piece mold 4902, 4904. With the mold slide 4906 inserted and mold 4902, 4904 closed as shown in FIG. 49B. As depicted in FIG. 49C, a thermoplastic material is injected into the mold 4902, 4904, encasing the circuit board 4800. The mold 4902, 4904 is opened and the near-final part ejected as shown in FIG. 49D.

Alternatively, the enclosure of the electronics assembly of the on-body device 222 may include elements snap-fit (or welded/adhered) together as illustrated in the assembly view of FIG. 50A, the as-assembled view of FIG. 50B, and in cross-sectional perspective view of FIG. 50C. An enclosure including a top shell 5002 and a mounting base 5004 can be used to sealably enclose and protect the circuit board 4800. When snap-fit, various interference or snap fit elements (e.g., annular rims 5006) may be provided around the entirety of the periphery of the enclosure or as discrete snap-fit connectors (not shown). Notably, such an approach may benefit from additional O-ring sealing elements to avoid fluid intrusion. Alternatively or additionally, adhesive set at the snap junction(s) may be used to ensure good sealing, especially in connection with continuous annular snap-fit features 5006. As seen in FIG. 50C, a trough 5008 or other features can be provided to insure that adhesive 5010 that may be squeezed out during assembly is not forced into areas that could interfere with operation or assembly of the on-body device 222. In some embodiments, when a top shell 5002 and a mounting base 5004 are fit together with a bead of adhesive 5010 in place as shown, the trough 5008 not only provides space to capture the adhesive 5010 squeezed out but also provides additional surface area for a thicker layer of adhesive 5010 to seal the joint.

However constructed, final assembly of the electronics assembly of on-body device 222 involves adhesive patch installation. An exemplary approach is illustrated in FIGS. 51A-51C. First, a double-sided adhesive patch 5104 has the inner liner 5102 removed. This exposed adhesive is set over the on-body device body 5106 (with the temperature sensor 4806 folded to seat within a complimentary pocket) and adhered with a first window 5108 aligned for temperature sensing and second window 5110 for sensor assembly receipt. As such, it is ready for placement in an applicator assembly upon removal of the outer release liner, or alternatively ready for placement in a container with or without the outer liner in place, depending on the presence or absence of any liner-puller features provided therein.

Various other modifications and alterations in the structure and method of operation of the embodiments of the present disclosure will be apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. Although the present disclosure has been described in connection with certain embodiments, it should be understood that the present disclosure as claimed should not be unduly limited to such embodiments. It is intended that the following claims define the scope of the present disclosure and that structures and methods within the scope of these claims and their equivalents be covered thereby.

Claims

1. A method for assembling an on-body device comprising a glucose sensor assembly, a housing, and sensor electronics, wherein the glucose sensor assembly comprises a proximal section comprising a connector support coupled with a proximal portion of a glucose sensor,wherein the housing comprises a top portion, a base portion, and a first space defined by the top portion and the base portion, wherein the base portion comprises a recess in a bottom exterior surface, wherein the recess comprises a distal-facing opening, and wherein the recess defines a second space different from the first space,the method comprising: positioning the sensor electronics within the first space of the on-body device, wherein the sensor electronics comprise a processor, a wireless communications facility, a battery, and a printed circuit board;after positioning the sensor electronics within the first space, inserting the connector support through the distal-facing opening of the recess in the bottom exterior surface of the base portion and into the recess, causing the glucose sensor to electrically couple with the sensor electronics.
2. The method of claim 1, wherein positioning the sensor electronics within the first space comprises injecting a thermoplastic material into a mold to form a single integral unit configured to seal the sensor electronics within the first space.
3. The method of claim 2, wherein the mold is a two-piece mold.
4. The method of claim 3, wherein the two-piece mold comprises a first mold piece corresponding with the top portion of the housing and a second mold piece corresponding with the base portion of the housing.
5. The method of claim 1, wherein positioning the sensor electronics within the first space comprises coupling the top portion with the base portion by a snap-fit mechanism such that the sensor electronics are sealed within the first space.
6. The method of claim 1, wherein positioning the sensor electronics within the first space comprises welding the top portion and the base portion together such that the sensor electronics are sealed within the first space.
7. The method of claim 1, wherein positioning the sensor electronics within the first space comprises coupling the top portion with the base portion using an adhesive such that the sensor electronics are sealed within the first space.
8. The method of claim 1, further comprising applying an adhesive patch to the base portion, wherein the adhesive patch comprises a window aligned with the distal-facing opening.
9. The method of claim 1, further comprising causing a first set of mating features of the sensor electronics to couple with a second set of mating features of the glucose sensor assembly when the connector support is inserted into the recess.
10. The method of claim 1, further comprising causing a first set of mating features contained in the recess to couple with a second set of mating features of the glucose sensor assembly when the connector support is inserted into the recess.
11. The method of claim 1, further comprising causing the connector support to come into contact with an elastomeric sealing member when the connector support is disposed in the recess.
12. The method of claim 1, further comprising aligning a polygonal shape of the connector support with a corresponding polygonal cross-sectional area of the distal-facing opening before inserting the connector support through the distal-facing opening.
13. The method of claim 12, wherein the connector support comprises a planar surface.
14. The method of claim 1, wherein the glucose sensor assembly further comprises a distal tail section comprising a distal portion of the glucose sensor configured to be positioned under a skin surface and in contact with a bodily fluid of a subject.
15. The method of claim 14, wherein the distal portion of the glucose sensor of the distal tail section is external to the recess after the connector support is inserted into the recess.
16. The method of claim 14, wherein the glucose sensor assembly further comprises a bent section between the proximal section and the distal tail section, wherein the proximal section and the distal tail section are approximately perpendicular to each other.
17. The method of claim 1, wherein causing the glucose sensor to electrically couple with the sensor electronics comprises causing the connector support to electrically couple with the sensor electronics.
18. The method of claim 17, wherein the connector support is electrically coupled with the sensor electronics via an interface that is external to the first space.
19. The method of claim 18, wherein the interface between the connector support and the sensor electronics is disposed within the recess.
20. The method of claim 1, wherein the housing further comprises a plurality of engagement recesses circumferentially disposed thereon, wherein the plurality of engagement recesses comprises a first engagement recess in a spaced relation to a second engagement recess, and wherein the plurality of engagement recesses is configured to be detachably engaged to an applicator.
21. The method of claim 20, wherein each of the plurality of engagement recesses comprises a concave portion.
22. The method of claim 20, wherein each of the plurality of engagement recesses is disposed on a side wall of the housing.
23. The method of claim 1, wherein the housing further comprises a side wall, wherein the top portion of the housing comprises a top exterior surface, and wherein the side wall is located between the top exterior surface of the top portion of the housing and the bottom exterior surface of the base portion of the housing.
24. The method of claim 23, wherein the side wall comprises a first portion and a second portion, wherein the first portion of the side wall is substantially orthogonal to the bottom exterior surface of the base portion of the housing, and wherein the second portion of the side wall is non-orthogonal to the top exterior surface of the top portion of the housing.
25. The method of claim 1, wherein the top portion of the housing comprises an aperture, and wherein a longitudinal insertion axis extends through the aperture and the recess of the base portion.
26. The method of claim 25, wherein the printed circuit board comprises an aperture, and wherein the longitudinal insertion axis extends through the aperture of the printed circuit board.
27. The method of claim 1, wherein the connector support comprises a planar surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent application Ser. No. 15/908,616, filed Feb. 28, 2018, which is a continuation of U.S. patent application Ser. No. 15/610,334, filed May 31, 2017, now U.S. Pat. No. 9,931,066, which is a continuation of U.S. patent application Ser. No. 15/193,499, filed Jun. 27, 2016, now U.S. Pat. No. 9,693,713, which is a continuation of U.S. patent application Ser. No. 13/710,460, filed Dec. 11, 2012, now U.S. Pat. No. 9,402,570, which claims priority to U.S. Provisional Application No. 61/569,287, filed Dec. 11, 2011, all of which are incorporated herein by reference in their entireties for all purposes.

US Referenced Citations (1084)

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
4757022	Shults et al.	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
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	Netherty 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	Funderburk 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
6129666	DeLuca et al.	Oct 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	Roques	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
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
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
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
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
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	Cabiri 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
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
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
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
20050222599	Czernecki et al.	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
20060036145	Brister et al.	Feb 2006	A1
20060047220	Sakata et al.	Mar 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, Jr. 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
20080255440	Eilersen 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
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
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
20090118592	Klitgaard	May 2009	A1
20090124877	Shariati 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
20100004597	Glyn 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
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
20100256471	Say et al.	Oct 2010	A1
20100261987	Kamath 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
20110040256	Bobroff et al.	Feb 2011	A1
20110040263	Hordum et al.	Feb 2011	A1
20110046456	Hordum et al.	Feb 2011	A1
20110046467	Simpson 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
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
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	Curry	Nov 2011	A1
20110290645	Brister et al.	Dec 2011	A1
20110313543	Brauker et al.	Dec 2011	A1
20110319729	Donnay 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 et al.	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
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

Foreign Referenced Citations (60)

Number	Date	Country
2291105	Dec 1998	CA
1202872	May 2005	CN
4401400	Jul 1995	DE
0320109	Jun 1989	EP
0353328	Feb 1990	EP
0390390	Oct 1990	EP
0396788	Nov 1990	EP
0286118	Jan 1995	EP
1048264	Nov 2000	EP
1177802	Feb 2002	EP
0987982	Jan 2007	EP
2060284	May 2009	EP
2201969	Jun 2010	EP
2327362	Jun 2011	EP
2335587	Jun 2011	EP
11-506629	Jun 1999	JP
2004-520103	Jul 2004	JP
2004520898	Jul 2004	JP
WO-1991015993	Oct 1991	WO
WO-1992013271	Aug 1992	WO
WO-1994020602	Sep 1994	WO
WO-1996025089	Aug 1996	WO
WO-1998035053	Aug 1998	WO
WO-1998056293	Dec 1998	WO
WO-1999033504	Jul 1999	WO
WO-1999056613	Nov 1999	WO
WO-2000049940	Aug 2000	WO
WO-2000059370	Oct 2000	WO
WO-2000078992	Dec 2000	WO
WO-2001052935	Jul 2001	WO
WO-2001054753	Aug 2001	WO
WO-2002016905	Feb 2002	WO
WO-2002050534	Jun 2002	WO
WO-2002058537	Aug 2002	WO
WO-2003028784	Apr 2003	WO
WO-2003076893	Sep 2003	WO
WO-2003082091	Oct 2003	WO
WO-2004028337	Apr 2004	WO
WO-2004060436	Jul 2004	WO
WO-2004061420	Jul 2004	WO
WO-2004098684	Nov 2004	WO
WO-2004112602	Dec 2004	WO
WO-2005084534	Sep 2005	WO
WO-2005089103	Sep 2005	WO
WO-2006024671	Mar 2006	WO
WO-2006042811	Apr 2006	WO
WO-2006108809	Oct 2006	WO
WO-2007002189	Jan 2007	WO
WO-2007089738	Aug 2007	WO
WO-2007140783	Dec 2007	WO
WO-2008014792	Feb 2008	WO
WO-2008065646	Jun 2008	WO
WO-2008133702	Nov 2008	WO
WO-2009062675	May 2009	WO
WO-2009068661	Jun 2009	WO
WO-2010112521	Oct 2010	WO
WO-2011002815	Jan 2011	WO
WO-2011015659	Feb 2011	WO
WO 2011025549	Mar 2011	WO
WO 2011119896	Sep 2011	WO

Non-Patent Literature Citations (83)

Entry
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. 29-45.
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.
Csoregi, 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.
Csoregi, 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 Miniatureized 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.
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. 19889.
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.
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 Sensor Implanted for Several Days in Rat Subcutaneous Tissue”, Diabetologia, vol. 35, 1992, pp. 224-330.
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 Electrodes”, Pflugers 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 Angeiogenesis 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 implantable glucose 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.
Shults, M. C., et al., “A Telemety-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.
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.
EP 17182379.2 Extended Search Report dated Feb. 21, 2018.
AU, 2011269796 Examination Report, dated Apr. 3, 2014.
EP, 10739015.5 Extended Search Report, dated May 10, 2013.
EP, 11760268.0 Extended Search Report, dated Apr. 14, 2014.
WO, PCT/US2016/032485 ISR and Written Opinion, dated Sep. 12, 2016.
Heller, A., “Electrical Wiring of Redox Enzymes”, Accounts of Chemical Research, 1990, vol. 23, No. 5, pp. 128-134.
Shichiri, M., et al., “Wearable Artificial Endocrine Pancreas With Needle-Type Glucose Sensor”, The Lancet, 1982, pp. 1129-1131.
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.
EP 21152231.3 Extended Search Report dated May 11, 2021.

Related Publications (1)

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	20210068722 A1	Mar 2021	US

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	61569287	Dec 2011	US

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	Number	Date	Country
Parent	15908616	Feb 2018	US
Child	16951656		US
Parent	15610334	May 2017	US
Child	15908616		US
Parent	15193499	Jun 2016	US
Child	15610334		US
Parent	13710460	Dec 2012	US
Child	15193499		US

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