Systems and methods relating to analyte sensor system having battery located within disposable base

A disposable analyte sensor base with a reusable electronics module addresses battery power inconsistencies in continuous glucose monitoring by ensuring reliable power and communication through a secure electrical connection, enhancing diabetic health management.

JP2025138650APending Publication Date: 2025-09-25DEXCOM INC
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Patent Information

Application Number
JP2025091021
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2018-05-04
Filing Date
2025-05-30
Publication Date
2025-09-25

AI Technical Summary

Technical Problem

Existing analyte sensors, particularly those used by diabetics, face challenges in maintaining consistent battery power supply, which is crucial for continuous glucose monitoring and communication, leading to potential health risks due to unreliable glucose level detection.

Method used

A disposable analyte sensor base with an integrated battery and a reusable sensor electronics module that can be releasably coupled, ensuring a reliable power source through a secure electrical connection and sealing mechanism, allowing for continuous glucose monitoring and wireless communication.

Benefits of technology

The solution provides a reliable power source for continuous glucose monitoring, reducing the risk of health complications by ensuring consistent analyte concentration level sensing and communication, even with battery replacement and reuse of electronics modules.

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Abstract

To provide a disposable analyte sensor base having a battery disposed therein, and a reusable sensor electronics module configured to be releasably coupled to the base.SOLUTION: A system includes a base configured to attach to a skin of a host. The base includes: an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host; a battery; and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to make electrical contact with a respective contact of the first plurality of contacts, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. The system includes a first sealing member configured to provide a seal around the first and second pluralities of contacts within a first cavity.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 667,348, filed May 4, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present development relates generally to medical devices such as analyte sensors, and more particularly, but not by way of limitation, to systems, devices, and methods relating to a disposable analyte sensor base having a battery disposed therein, and a reusable sensor electronics module configured to releasably couple to the base. [Background technology]

[0003] Diabetes is a metabolic condition associated with the body's production or use of insulin, a hormone that enables the body to use glucose for energy or store it as fat.

[0004] When a person eats a meal containing carbohydrates, the food is processed by the digestive system, which produces glucose in the person's blood. Blood glucose can be used for energy or stored as fat. The body normally maintains blood glucose levels within a range that provides enough energy to support bodily functions and avoid problems that can occur if glucose levels are too high or too low. Blood glucose regulation depends on the production and use of insulin, which regulates the movement of blood glucose into cells.

[0005] If the body does not produce enough insulin or is unable to effectively use the insulin that is present, blood glucose levels can rise above the normal range. Higher-than-normal blood glucose levels are called "hyperglycemia." Chronic hyperglycemia can lead to many health problems, including cardiovascular disease, cataracts and other eye problems, nerve damage (neuropathy), and kidney damage. Hyperglycemia can also lead to acute problems, such as diabetic ketoacidosis, a condition in which the body becomes overly acidic due to the presence of blood glucose and ketones, which are produced when the body cannot use glucose. Lower-than-normal blood glucose levels are called "hypoglycemia." Severe hypoglycemia can cause acute attacks, which can result in seizures or death.

[0006] Diabetics can receive insulin to manage their blood glucose levels. Insulin can be received, for example, by manual injection with a needle. Wearable insulin pumps can also be utilized. Diet and exercise also affect blood glucose levels. Glucose sensors can provide estimated glucose concentration levels, which can be used as guidance by the patient or caregiver.

[0007] The condition of diabetes is sometimes referred to as "type 1" and "type 2." People with type 1 diabetes are usually able to use insulin when it is present, but because of problems with the insulin-producing beta cells in the pancreas, their bodies are unable to produce enough insulin. People with type 2 diabetes may produce some insulin, but their sensitivity to insulin is reduced, making them "insulin resistant." As a result, even though insulin is present in the body, the patient's body does not use enough of it to effectively regulate blood sugar levels.

[0008] Blood glucose concentration levels may be monitored using an analyte sensor, such as a continuous glucose monitor. Wearable continuous glucose monitors may be powered by a battery that powers the sensor and other components, such as wireless communication circuitry. It is important that battery power is consistently available to ensure that the analyte concentration level can be sensed and communicated by the analyte sensor.

[0009] This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. It is not intended as an aid in determining the scope of the claimed subject matter, nor is it to be construed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems discussed above. Summary of the Invention

[0010] According to some embodiments, an analyte sensor system is provided. The system includes a base configured to attach to the skin of a host. The base includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host, a battery, and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to electrically contact a respective one of the first plurality of contacts, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. The system includes a first seal member configured to provide a seal around the first and second plurality of contacts within a first cavity.

[0011] In some embodiments, the base is disposable. In some embodiments, the sensor electronics module is reusable. In some embodiments, a battery is configured to provide power to the analyte sensor and the sensor electronics module. In some embodiments, the first plurality of contacts includes first sensor contacts and second sensor contacts, each configured to be electrically coupled to a respective terminal of the analyte sensor. In some embodiments, the second plurality of contacts includes a first signal contact configured to be in electrical contact with the first sensor contact and a second signal contact configured to be in electrical contact with the second sensor contact.

[0012] In some embodiments, the first plurality of contacts further includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery. In some embodiments, the second plurality of contacts further includes a first power contact configured to be in electrical contact with the first battery contact and a second power contact configured to be in electrical contact with the second battery contact. In some embodiments, the first and second signal contacts are configured to receive a sensor signal via the first and second sensor contacts, and the first and second power contacts are configured to receive power from the battery.

[0013] In some embodiments, the base further includes a first retaining member and a second retaining member, and the sensor electronics module further includes an anchoring feature configured to mate with the first retaining member and an anchoring feature configured to mate with the second retaining member, thereby releasably coupling the sensor electronics module to the base. In some embodiments, the second retaining member is frangible and configured to be separable from the base.

[0014] In some embodiments, the base further includes a cover configured to securely attach to the base and to secure the battery within the base. In some embodiments, the cover includes a first plurality of conductive traces configured to couple at least some of the first plurality of contacts to one of the analyte sensor and the battery. In some embodiments, the cover includes a recess configured to receive the battery. In some embodiments, the cover includes a weld configured to secure the cover to the base. In some embodiments, the first seal member is configured as a part of the cover. In some embodiments, the cover is configured to be disposed between the base and the sensor electronics module. In some embodiments, the cover is configured to securely attach to a bottom of the base.

[0015] In some embodiments, the base includes a first plurality of conductive traces configured to couple at least some of the first plurality of contacts to one of the analyte sensor and the battery. In some embodiments, a first seal member extends over the first plurality of conductive traces, thereby sealing the first plurality of conductive traces from ingress of moisture. In some embodiments, the first seal member extends over the battery, thereby sealing the battery from ingress of moisture. In some embodiments, at least some of the second plurality of contacts are in direct electrical contact with the analyte sensor or the battery.

[0016] In some embodiments, a second plurality of contacts are disposed on the fixation feature. In some embodiments, the second plurality of contacts includes at least one signal contact configured to electrically connect with the analyte sensor and at least one power contact configured to electrically connect with the battery. In some embodiments, the second plurality of contacts includes at least two signal contacts configured to electrically connect with the analyte sensor and at least two power contacts configured to electrically connect with the battery. In some embodiments, the first retention member includes a hood, and the first plurality of contacts are disposed within the hood. In some embodiments, a first seal member is disposed around a periphery of the fixation feature such that the first cavity is disposed within the hood. In some embodiments, the first seal member is disposed on an inner surface of the hood. In some embodiments, the sensor electronics module is configured to releasably couple to the base by engaging the anchoring feature with a first retaining member while the sensor electronics module is disposed at a high angle relative to the base, and pivoting the sensor electronics module about the first retaining member toward the base until the retaining feature engages with the second retaining member.

[0017] In some embodiments, the sensor electronics module includes an opening, and the base includes a raised portion configured to fit within the opening, with the outer periphery of the raised portion complementing the inner periphery of the opening. In some embodiments, the first plurality of contacts are disposed on the raised portion. In some embodiments, the opening is symmetrical about at least one axis parallel to the top surface of the sensor electronics module and asymmetrical about at least one other axis parallel to the top surface of the sensor electronics module. In some embodiments, the top surface of the raised portion sits substantially flush with the top surface of the sensor electronics module. In some embodiments, the sensor electronics module is configured to releasably couple to the base by fitting the raised portion of the base into the opening of the sensor electronics module and pressing the sensor electronics module against the base in a direction substantially perpendicular to the bottom surface of the base until one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base. In some embodiments, the base includes a recess disposed on the top surface of the base, and the sensor electronics module includes a protrusion configured to mate with the recess, thereby aligning the sensor electronics module with the base.

[0018] In some embodiments, the base further includes a third plurality of contacts, the sensor electronics module further includes a fourth plurality of contacts, each configured to electrically contact a respective one of the third plurality of contacts, and the system further includes a second seal member configured to provide a continuous seal around the third and fourth plurality of contacts within the second cavity. In some embodiments, the third plurality of contacts includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery. In some embodiments, the fourth plurality of contacts includes a first power contact configured to electrically contact the first battery contact and a second power contact configured to electrically contact the second battery contact. In some embodiments, the second plurality of contacts includes concentric circular contacts. In some embodiments, the concentric circular contacts are arranged around a center of the sensor electronics module. In some embodiments, each of the second plurality of contacts is configured to be in electrical contact with a respective one of the first plurality of contacts when the sensor electronics module is secured to the base in any of a plurality of radial orientations.

[0019] In some embodiments, the base includes an opening, and the sensor electronics module includes a raised portion configured to fit within the opening, with an outer periphery of the raised portion complementing an inner periphery of the opening. In some embodiments, the opening and the raised portion each have a substantially circular shape. In some embodiments, the sensor electronics module is configured to be releasably coupled to the base by fitting the raised portion of the sensor electronics module within the opening in the base and pressing the sensor electronics module against the base in a direction substantially perpendicular to a bottom surface of the base until one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base.

[0020] In some embodiments, the base includes a raised rail and the sensor electronics module includes a channel having a shape that complements the shape of the raised rail. In some embodiments, the raised rail has a constant width along its length. In some embodiments, the width of the raised rail tapers along its length. In some embodiments, a first plurality of contacts is disposed on a sidewall of the raised rail and a second plurality of contacts is disposed on a sidewall of the channel. In some embodiments, a first and a third plurality of contacts are disposed on a sidewall of the base and a second and a fourth plurality of contacts are disposed on a sidewall of the sensor electronics module. In some embodiments, the sensor electronics module is configured to releasably couple to the base by aligning the channel of the sensor electronics module with the raised rail of the base and sliding the sensor electronics module along the raised rail in a direction parallel to the body of the host until the sensor electronics module is seated against the base and one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base.

[0021] According to some embodiments, an analyte sensor system is provided. The system includes a base configured to attach to the skin of a host. The base includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host, a battery, and a first plurality of contacts. The system includes a sensor electronics module configured to releasably couple to the base. The sensor electronics module includes a second plurality of contacts, each configured to electrically contact a respective one of the first plurality of contacts when the sensor electronics module is secured to the base in one of a plurality of radial orientations, and a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal.

[0022] In some embodiments, the second plurality of contacts are concentric and annularly spaced apart from one another. In some embodiments, each one of the second plurality of contacts is configured to make electrical contact with each one of the first plurality of contacts at any point along each one of the second plurality of contacts. In some embodiments, the second plurality of contacts is formed by laser direct structuring. In some embodiments, the system further includes a first seal member configured to provide a seal around the first and second plurality of contacts within the first cavity.

[0023] In some embodiments, the base is disposable. In some embodiments, the sensor electronics module is reusable. In some embodiments, the battery is configured to provide power to the analyte sensor and the sensor electronics module. In some embodiments, the first plurality of contacts includes a first sensor contact and a second sensor contact, each configured to be electrically coupled to a respective terminal of the analyte sensor. In some embodiments, the second plurality of contacts includes a first signal contact configured to be in electrical contact with the first sensor contact and a second signal contact configured to be in electrical contact with the second sensor contact. In some embodiments, the first plurality of contacts further includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery.

[0024] According to some embodiments, an analyte sensor base assembly is provided. The assembly includes a base configured to adhere to the skin of a host. The assembly includes an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host. The assembly includes at least one battery. The assembly includes at least one sensor contact. The assembly includes at least one battery contact. The assembly includes at least a seal member configured to provide a seal around the at least one battery contact.

[0025] In some embodiments, the seal member is further configured to provide a seal around at least one of the sensor contacts. In some embodiments, the assembly includes at least two sensor contacts and at least two battery contacts, and the seal member is configured to provide a seal around the at least two sensor contacts and the at least two battery contacts. In some embodiments, the base further includes a plurality of conductive traces configured to electrically connect the battery to the at least one battery contact. In some embodiments, the base further includes a plurality of conductive traces configured to electrically connect the analyte sensor to the at least one sensor contact. In some embodiments, the assembly is disposable. In some embodiments, the battery is configured to provide power to the analyte sensor and the sensor electronics module, which is coupleable to the base.

[0026] In some embodiments, the base further includes a first retaining member configured to mate with a securing feature of the dockable sensor electronics module and a second retaining member configured to mate with a securing feature of the dockable sensor electronics module. In some embodiments, the second retaining member is configured to be frangible and separable from the base. In some embodiments, the base further includes a cover configured to securely attach to the base and to secure the battery within the base. In some embodiments, the first retaining member includes a hood, and the at least one sensor contact and the at least one battery contact are disposed within the hood. In some embodiments, a seal member is disposed within the hood.

[0027] According to some embodiments, an analyte monitoring system is provided. The system may include a base configured to connect to a host, a reusable portion, and a battery assembly. The base may include an analyte sensor configured to detect a sensor signal indicative of an analyte concentration level in the host. The reusable portion may be configured to couple to the base and may include a wireless transceiver, such that the reusable portion receives a signal from the base and transmits a wireless signal based at least in part on the sensor signal. The battery assembly may include a battery housing and one or more batteries. The battery assembly is configured to mechanically and electrically couple to the base or the reusable portion, and the battery provides power to the analyte sensor and the wireless transceiver.

[0028] According to some embodiments, an analyte monitoring kit is provided. The kit may include a sensor electronics package including a processor and communications circuitry, and a plurality of sensor devices, each sensor device including a sensor device battery and a sensor configured to generate a signal indicative of an analyte concentration level in a host, the sensor electronics package electrically and mechanically couples to each of the plurality of sensor devices and draws power from the sensor device battery to power the processor and communications circuitry, and the sensor electronics package is reusable with multiple sensor devices.

[0029] According to some embodiments, a biosensor device is provided that may include an analyte sensor configured to generate a signal representative of a concentration level of a substance in a fluid of a host, the sensor signal, a processor configured to receive the sensor signal and determine a value based on the sensor signal, a communication circuit operably coupled to the processor and configured to transmit the value based on the sensor signal, a battery, and a supercapacitor electrically coupled to the battery, wherein the battery and the supercapacitor are configured to power the processor or the communication circuit, and the supercapacitor reduces load on the battery during periods of high load to reduce strain on the battery.

[0030] This Abstract is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive description of the disclosure. The Detailed Description is included to provide further information regarding this patent application. Other aspects of the present disclosure will be apparent to those skilled in the art upon reading and understanding the following Detailed Description and viewing the Drawings that form a part hereof, each of which should not be construed in a limiting sense. [Brief explanation of the drawings]

[0031] The present embodiments will now be described in detail, with an emphasis on highlighting advantageous features. These embodiments are for illustrative purposes only and are not to scale, instead emphasizing the principles of the present disclosure. These drawings include the following figures, in which like numerals may refer to like parts:

[0032] [Figure 1] 1 is a diagram of an exemplary medical device system, according to some embodiments. [Figure 2] 2 is a schematic diagram of various exemplary electronic components that may be part of the medical device system shown in FIG. 1, according to some embodiments. [Figure 3] FIG. 1 is a flowchart diagram of an exemplary method for managing power consumption in an analyte monitoring system, according to some embodiments. [Figure 4]FIG. 1 is a flowchart diagram of an exemplary method for managing power output based on monitored sensor values ​​or performance metrics, according to some embodiments. [Figure 5] FIG. 10 is a flowchart diagram of an exemplary method for selecting a communication protocol based on satisfying an analyte management condition, according to some embodiments. [Figure 6] FIG. 4 is a flowchart diagram of an exemplary method for managing power using operating parameters received from a peripheral device, according to some embodiments. [Figure 7A] FIG. 1 is a flowchart diagram of an exemplary method for managing power based on user input, according to some embodiments. [Figure 7B] FIG. 4 is a flowchart diagram of an exemplary method for managing power based on a sleep command, according to some embodiments. [Figure 8] FIG. 1 is a flowchart diagram of an exemplary method for determining an operating protocol to ensure battery life meets specified time parameters, according to some embodiments. [Figure 9] FIG. 1 is a flowchart diagram of an exemplary method for using information from non-volatile memory after a power reset, according to some embodiments. [Figure 10A] 1 is a cross-sectional view of an exemplary sensor assembly, according to some embodiments. [Figure 10B] 10B is a magnified portion of the sensor assembly of FIG. 10A. [Figure 11A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 11B] FIG. 11B is a perspective bottom view of the base shown in FIG. 11A. [Figure 12A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 12B] FIG. 12B is a perspective bottom view of the base shown in FIG. 12A. [Figure 13A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 13B]FIG. 13B is a perspective bottom view of the base shown in FIG. 13A. [Figure 14A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 14B] 14B. FIG. 14C is a perspective bottom view of the base shown in FIG. 14A and an exemplary sensor electronics module configured to mechanically and electrically couple with the base shown in FIGS. 14A and 14B. [Figure 15A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 15B] FIG. 15B is a perspective bottom view of the base shown in FIG. 15A. [Figure 16A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 16B] 16B. FIG. 16C is a perspective bottom view of the base shown in FIG. 16A and an exemplary sensor electronics module configured to mechanically and electrically couple with the base shown in FIGS. 16A and 16B. [Figure 17A] 1 is an exploded (disassembled) perspective top view of an exemplary sensor base and an exemplary sensor electronics module, according to some embodiments. [Figure 17B] FIG. 17B is a perspective view of the base shown in FIG. 17A assembled with a sensor electronics module. [Figure 18A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 18B] FIG. 17B is an enlarged perspective view of the base shown in FIG. 17A assembled with an exemplary sensor electronics module. [Figure 19A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 19B] 19B. FIG. 19C is a perspective bottom view of the base shown in FIG. 19A and an exemplary sensor electronics module configured to mechanically and electrically couple with the base shown in FIGS. 19A and 19B. [Figure 20A]FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 20B] 20B. FIG. 20C is a perspective bottom view of the base shown in FIG. 20A and an exemplary sensor electronics module configured to mechanically and electrically couple with the base shown in FIGS. 20A and 20B. [Figure 21A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 21B] 21B is a perspective bottom view of the base shown in FIG. 21A and an exemplary sensor electronics module configured to mechanically and electrically couple with the base shown in FIGS. 21A and 21B. [Figure 22A] FIG. 1 is a perspective top view of an exemplary sensor base, according to some embodiments. [Figure 22B] FIG. 22B is a perspective bottom view of the base shown in FIG. 22A. [Figure 23A] 1 is a perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 23B] FIG. 23B is a perspective view of the sensor electronics module secured to the base of FIG. 23A. [Figure 23C] FIG. 23B is a plan view of the sensor electronics module fixed to the base of FIG. 23A. [Figure 24A] FIG. 10 is a perspective view of a base including a cover having a frangible retaining member according to some embodiments. [Figure 24B] FIG. 24B is a close-up perspective view of a portion of the frangible retaining member of FIG. 24A retaining the sensor electronics module to the base, according to some embodiments. [Figure 24C] FIG. 24B is a perspective view of the cover of FIG. 24A. [Figure 24D] FIG. 24B is a perspective bottom view of the base of FIG. 24A. [Figure 25A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 25B] FIG. 25B is a plan view of the base of FIG. 25A. [Figure 26A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 26B] FIG. 26B is a plan view of the base of FIG. 26A. [Figure 27A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 27B] FIG. 27B is a plan view of the base of FIG. 27A. [Figure 28A] 1 is a perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 28B] FIG. 28B is a perspective view of the sensor electronics module secured to the base of FIG. 28A. [Figure 28C] FIG. 28B is a plan view of the sensor electronics module fixed to the base of FIG. 28A. [Figure 29A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured within the base, according to some embodiments. [Figure 29B] FIG. 29B is a perspective view of a portion of the base of FIG. 29A. [Figure 29C] FIG. 29B is a perspective view of the bottom of the base of FIG. 29A. [Figure 30A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 30B] FIG. 30B is a perspective assembly view of the sensor electronics module secured to the base of FIG. 30A. [Figure 31A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 31B]FIG. 31B is a perspective view of a battery disposed on the cover of the base of FIG. 31A. [Figure 31C] FIG. 31B is a perspective bottom view of the base and sensor electronics module of FIG. 31A. [Figure 32] 1 is a perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. FIG. [Figure 33A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 33B] FIG. 33B is a perspective view of a battery disposed on the cover of the base of FIG. 33A. [Figure 33C] FIG. 33C is an exploded perspective bottom view of the cover and base of FIG. 33B. [Figure 33D] FIG. 33C is a perspective bottom view of the cover fixed to the base of FIG. 33B. [Figure 34] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 35A] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 35B] FIG. 35B is an exploded perspective bottom view of the base and sensor electronics module of FIG. 35A. [Figure 35C] FIG. 35B is a plan view of the bottom of the base of FIG. 35A. [Figure 35D] 35B is a perspective cross-sectional view of the sensor electronics module fixed to the base of FIG. 35A. FIG. [Figure 36] FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 37A]FIG. 1 is an exploded perspective view of an exemplary base and a sensor electronics module configured to be secured over or on the base, according to some embodiments. [Figure 37B] FIG. 37B is an exploded perspective bottom view of the base and sensor electronics module of FIG. 37A. [Figure 37C] FIG. 37B is a plan view of the bottom of the base of FIG. 37A. [Figure 37D] 37B is a side cross-sectional view of the sensor electronics module secured to the base of FIG. 37A. FIG. [Figure 38A] 1 is a perspective view of an exemplary base and a sensor electronics module configured to slide over and be secured to the base, according to some embodiments. FIG. [Figure 38B] FIG. 38B is a perspective view of the sensor electronics module secured to the base of FIG. 38A. [Figure 39A] 1 is a perspective view of an exemplary base and a sensor electronics module configured to slide over and be secured to the base, according to some embodiments. FIG. [Figure 39B] FIG. 39B is another perspective view of the base of FIG. 39A. [Figure 39C] FIG. 39B is an exploded perspective bottom view of the base and sensor electronics module of FIG. 39A. [Figure 40] 1 is a flowchart of a method for fabricating and / or manufacturing an analyte sensor system, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0033] The following description and examples illustrate in detail several exemplary implementations, embodiments, and configurations. Those skilled in the art will recognize that there are many variations and modifications of the present disclosure that are encompassed by the scope of the present invention. Accordingly, the description of a particular exemplary embodiment should not be deemed to limit the scope of the present disclosure.

[0034] definition To facilitate understanding of the various embodiments described herein, several terms are defined below.

[0035] The term "analyte," as used herein, is a broad term and is to be given its ordinary and customary meaning to those skilled in the art (not limited to any special or customized meaning), and further refers to, but is not limited to, a substance or chemical constituent in a bodily fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine) that may be analyzed. Analytes may include naturally occurring substances, man-made substances, metabolites, or reaction products. In some embodiments, the analyte for measurement by the sensor head, devices, and methods is an analyte. However, other analytes are considered as well, including acarboxyprothrombin, acylcarnitines, adenine phosphoribosyltransferase, adenosine deaminase, albumin, α-fetoprotein, amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), andrenostenedione, antipyrine, arabinitol enantiomers, arginase, benzoylecgonine (cocaine), biotinidase, biopterin, c-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β-hydroxycholic acid, cortisol, creatine kinase, creatine kinase MM isoenzyme, cyclosporin A, and D-penicillin. Lamin, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylation polymorphism), alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus , HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sex differentiation, 21-deoxycortisol), desbutylhalofantrine, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte protoporphyrin, esterase D, fatty acids / acylglycines, free β-human chorionic gonadotropin, free erythrocyte porphyrin,Free thyroxine (FT4), free tri-iodothyronine (FT3), fumarylacetoacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, analyte-6-phosphate dehydrogenase, glutathione, glutathione peroxidase, glycocholate, glycosylated hemoglobin, halofantrine, hemoglobin variants, hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-α-hydroxyprogesterone, hypoxanthine phosphoribosyltransferase, immunoreactive trypsin, lactate, Lead, lipoproteins ((a), B / A-1, β), lysozyme, mefloquine, netilmicin, phenobarbitone, phenytoin, phytanic acid / pristanic acid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase, quinine, inverted tri-iodothyronine (rT3), selenium, serum pancreatic lipase, sisomicin, somatomedin C, specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, guinea worm, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia lamblia duodenalisa), Helicobacter pylori, Hepatitis B virus, Herpes virus, HIV-1, IgE (atopic disease), Influenza virus, Leishmania donovani, Leptospirosis, Measles / Mumps / Rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerciasis volvulus, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma cruzi / Langer, Vesicular stomatitis virus virus), Wuchereria bancrofti, Yellow fever virus), specific antigens (Hepatitis B virus, HIV-1), acetoacetate, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, leukocytes, and zinc protoporphyrin.The present invention is not limited to the above. Salts, sugars, proteins, fats, vitamins, and hormones naturally occurring in blood or interstitial fluid may also constitute analytes in certain embodiments. Analytes, such as metabolites, hormones, antigens, antibodies, etc., may naturally occur in bodily fluids. Alternatively, analytes, such as contrast agents for diagnostic imaging, radioisotopes, chemical agents, fluorocarbon-based artificial blood, or drugs or pharmaceutical compositions may be introduced into the body, including insulin, glucagon, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons), cocaine (crack cocaine), stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine), depressants (barbiturates, methaqualone, tranquilizers, Examples include, but are not limited to, Valium, Librium, Miltown, Serax, Equanil, Tranxene), hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil), designer drugs (fentanyl, meperidine, amphetamine, methamphetamine, and phencyclidine analogs, e.g., Ecstasy), anabolic steroids, and nicotine. Metabolites of drugs and pharmaceutical compositions are also contemplated as analytes. For example, analytes such as neurochemicals and other chemicals produced in the body, such as ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA), may be analyzed.

[0036] As used herein, the term "microprocessor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a computer system, state machine, or the like that performs arithmetic and logical operations using logic circuitry that responds to and processes the basic instructions that drive the computer.

[0037] As used herein, the term "calibration" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers, without limitation, to a process of determining a relationship between sensor data and corresponding reference data that can be used to convert the sensor data into a meaningful value substantially equivalent to the reference data, with or without utilizing the reference data in real time. In some embodiments, i.e., analyte sensors, the calibration can be updated or recalibrated over time (at the factory, in real time and / or retrospectively) as changes in the relationship between the sensor data and the reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, etc.

[0038] As used herein, the terms "calibrated data" and "calibrated data stream" are broad terms that have their ordinary and customary meaning given to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, data that has been transformed from its raw state to another state using a function, e.g., a transformation function, including through the use of sensitivities, to provide a meaningful value to a user.

[0039] As used herein, the term "algorithm" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a computational process (e.g., a program) involved in transforming information from one state to another, for example, using computer processing.

[0040] As used herein, the term "sensor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a component or region of a device that quantifies an analyte. A "lot" of sensors generally refers to a group of sensors manufactured on or about the same day and using the same processes and tools / materials. Additionally, sensors that measure temperature, pressure, etc. may be referred to as "sensors."

[0041] As used herein, the terms "glucose sensor" and "component for determining the amount of glucose in a biological sample" are broad terms that are given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings) and refer to, but are not limited to, any mechanism for quantifying glucose (e.g., enzymatic or non-enzymatic). For example, some embodiments utilize a membrane containing glucose oxidase, which catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate, as illustrated by the following chemical reaction: Glucose + O2 → Gluconic acid + H2O2

[0042] For each glucose molecule metabolized, there is a proportional change in the co-reactant O2 and product H2O2, so electrodes can be used to monitor the current change in the co-reactant or product to determine the glucose concentration.

[0043] As used herein, the terms "operably connected" and "operably coupled" are broad terms given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings), and refer, without limitation, to one or more components being coupled to another component(s) in a manner that allows for the transmission of a signal between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal, e.g., an electrical or electromagnetic signal, which can then be transmitted to an electronic circuit. In this case, the electrodes are "operably coupled" to the electronic circuit. These terms are broad enough to include wireless connections.

[0044] The term "determining" encompasses a variety of actions. For example, "determining" may include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, database, or other data structure), checking, etc. "Determining" may also include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc. "Determining" may also include resolving, selecting, choosing, calculating, deriving, establishing, etc. Determining may also include verifying that a parameter matches a predetermined criterion, including meeting, passing, exceeding, etc. a threshold.

[0045] As used herein, the term "substantially" is a broad term having its ordinary and customary meaning given to those of ordinary skill in the art (and is not limited to any special or customized meaning), including, but not limited to, most but not entirely of what is specified.

[0046] As used herein, the term "host" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, mammals, particularly humans.

[0047] As used herein, the term "continuous analyte (or glucose) sensor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a device that continuously or uninterruptedly measures the concentration of an analyte, for example, over time intervals ranging from a fraction of a second to, for example, 1, 2, or 5 minutes or more. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor such as those described in U.S. Pat. No. 6,001,067, which is incorporated herein by reference in its entirety.

[0048] As used herein, the term "sensing membrane" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers, without limitation, to a permeable or impermeable membrane that may be composed of two or more domains, typically several microns or more thick, and constructed of materials that are permeable to oxygen and permeable or impermeable to glucose. In one example, the sensing membrane contains immobilized glucose oxidase enzyme, which can cause an electrochemical reaction to occur to measure glucose concentration.

[0049] As used herein, the term “sensor data” is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to any data associated with a sensor, such as a continuous analyte sensor, without limitation. Sensor data includes a raw data stream, or simply a data stream, of an analog or digital signal directly related to the analyte being measured from an analyte sensor (or other signal received from another sensor), as well as calibrated and / or filtered raw data. In one example, sensor data includes digital data of “counts” converted from an analog signal (e.g., voltage or amperes) by an A / D converter and includes one or more data points representing glucose concentrations. Thus, the terms “sensor data point” and “data point” generally refer to a digital representation of sensor data at a particular time. The terms broadly encompass multiple time-interval data points from a sensor, such as a substantially continuous glucose sensor, including individual measurements taken at time intervals ranging from a fraction of a second to, for example, one, two, or five minutes or more. In another example, sensor data includes an integrated digital value representing one or more data points averaged over a period of time. The sensor data may include calibration data, smoothed data, filtered data, conversion data, and / or other data related to the sensor.

[0050] As used herein, the term "sensor electronics" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the components (e.g., hardware and / or software) of a device configured to process data. As described in more detail below (see, e.g., FIG. 2), "sensor electronics" may be arranged and configured to measure, convert, store, transmit, communicate, and / or retrieve sensor data associated with an analyte sensor.

[0051] As used herein, the terms "sensitivity" or "sensor sensitivity" are broad terms given their ordinary and customary meaning to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, the amount of signal produced by a given concentration of the analyte or sample being measured (e.g., HO) associated with the analyte being measured (e.g., glucose). For example, in one embodiment, the sensor has a sensitivity of about 1 to about 300 picoamps of current per 1 mg / dL of glucose analyte.

[0052] As used herein, the term "sample" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to a sample of a host body, e.g., a bodily fluid, including, but not limited to, blood, serum, plasma, interstitial fluid, cerebrospinal fluid, lymphatic fluid, ocular fluid, saliva, oral fluid, urine, excretions, or exudates.

[0053] As used herein, the term "distal to" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that one element is relatively farther from the reference point than another element.

[0054] As used herein, the term "proximal to" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that an element is relatively closer to the reference point than another element.

[0055] As used herein, the terms "electrical connection" and "electrical contact" are broad terms that are given their ordinary and customary meaning to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, any connection between two electrical conductors known to those skilled in the art. In one embodiment, an electrode is in electrical connection (e.g., electrically connected) with the electronic circuitry of a device. In another embodiment, two materials, such as, but not limited to, two metals, can be in electrical contact with each other such that current can flow from one of the two materials to the other and / or such that an electrical potential can be applied.

[0056] As used herein, the term "elongated conductor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, an elongated body formed at least in part on a conductive material and including any number of coatings that may be formed thereon. By way of example, "elongated conductive body" may refer to a bare elongated conductive core (e.g., a metal wire), an elongated conductive core coated with one, two, three, four, five, or more layers of material (each of which may or may not be conductive), a trace, and / or an electrode coated thereon with one, two, three, four, five, or more layers of material (each of which may or may not be conductive).

[0057] As used herein, the term "ex vivo component" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted to reside and / or exist outside the host's living body.

[0058] As used herein, the term "in vivo portion" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) adapted for insertion into and / or residing within the body of a host.

[0059] As used herein, the term "potentiostat" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, an electrical device that controls the potential between a working electrode and a reference electrode at one or more preset values.

[0060] As used herein, the term "processor module" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, computer systems, state machines, processors, components thereof, and the like, designed to perform arithmetic or logical operations using logic circuitry that responds to and processes the basic instructions that drive a computer.

[0061] As used herein, the term "sensor session" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the period from implantation of a sensor (e.g., by a host) until removal of the sensor (e.g., removal of the sensor from the host's body and / or removal of (e.g., disconnection from) the system electronics).

[0062] As used herein, the terms "substantial" and "substantially" are broad terms that are to be given their ordinary and customary meaning to those skilled in the art (and are not to be limited to any special or customized meaning), and refer to, but are not limited to, a sufficient amount to provide a desired function.

[0063] "Coaxial two-conductor based sensor": A round wire sensor consisting of a conductive central core, an insulating middle layer, and a conductive outer layer with an exposed conductive layer at one end for electrical contact.

[0064] "Pre-connected sensor": A sensor that has a "sensor interconnect / interposer / sensor carrier" connected to it. This "pre-connected sensor" therefore comprises two parts that are joined together: the sensor itself and the interconnect / interposer / sensor carrier. The term "pre-connected sensor" unit refers to the unit formed by the permanent joining of these two different parts.

[0065] Other definitions are provided within the description that follows and, in some cases, from the context of the use of a term.

[0066] As used herein, the following abbreviations apply: Eq and Eq (equivalent), mEq (milliequivalent), M (mole), mM (millimole), μM (micromole), N (normal), mol (mole), mmol (millimole), μmol (micromole), nmol (nanomole), g (gram), mg (milligram), μg (microgram), Kg (kilogram), (liter), mL (milliliter), dL (deciliter), μL (microliter), cm (centimeter), mm (millimeter), μm (micrometer), nm (nanometer), h and hr (hour), min. (minute), s and sec (second), °C (Celsius) °F (Fahrenheit), Pa (pascal), kPa (kilopascal), MPa (megapascal), GPa (gigapascal), Psi (pounds per square inch), kPsi (pounds per square inch).

[0067] overview The energy of an analyte sensor system can be managed by controlling energy outputs, such as the consumption of energy by communication or other circuits, and by controlling energy inputs, such as replacing or recharging batteries. A wearable analyte sensor system may include a battery, capacitor, or other power storage component that powers a sensor, processor, communication circuit, or other electrical components. Managing energy consumption (e.g., power management, i.e., managing the energy consumed per unit time) can be important to extend the life of a sensor component (e.g., a battery) and ensure that the analyte sensor continues to perform its intended function(s). For example, if a component (e.g., a sensor electronics module that may include relatively expensive wireless sensor electronics package components) has a battery that is not rechargeable or replaceable, the life of the component can be extended by managing the use of energy stored in the battery.

[0068] The sensor system may apply various real-time, systematic, trend, model, or algorithms that consider one or more of the following factors: wireless performance, analyte management (e.g., glucose management), battery status, power management trends or characteristics, patient or environmental risk factors, risk tolerance, location, or a combination thereof. For example, the system may perform an action in response to a condition. The system response may include changing system behavior to decrease or increase power consumption based on the determined condition. For example, the analyte management condition (e.g., an estimated glucose level that is within, below, above, or exhibiting a specified trend) may be used as an input to determine system behavior and energy consumption. In various examples, the condition may be predetermined and programmed or hardwired into the device, specified by a user, or determined by a processor (e.g., based on information learned from data).

[0069] In some examples, the sensor system may receive operating parameters for a peripheral device, which may be a therapeutic device such as an insulin pump or pen. The sensor system may receive the operating parameters from the peripheral device, from a remote resource based on the identification of the peripheral device (e.g., a pump model number or serial number), or from memory (e.g., retrieved from a lookup table). The sensor system may manage its operation based at least in part on the operating parameters. For example, based on the operating parameters, the system may communicate according to a schedule, communicate with a designated device or group of devices, or manage power consumption to extend the battery.

[0070] The system hardware may be configured to allow for battery replacement, and the system components (e.g., the sensor base and sensor electronics) may be configured to provide a watertight seal after the battery is replaced. Battery-assisted technologies such as supercapacitors may also be used to facilitate energy management.

[0071] Exemplary System 1 is a diagram of an exemplary system 100. System 100 may include an analyte sensor system 102 that may be coupled to a host 101. Host 101 may be a human patient. The patient may be subject to, for example, a temporary or permanent diabetic condition or other health condition for which analyte monitoring may be useful.

[0072] The analyte sensor system 102 may include an analyte sensor 104, which may be, for example, a glucose sensor. The glucose sensor may be any device capable of measuring the concentration of glucose. For example, the analyte sensor 104 may be fully implantable, the analyte sensor may be wearable on the body (e.g., on the body but not under the skin), or the analyte sensor may be a transcutaneous device (e.g., having a sensor that resides under or in the skin of the host). It should be understood that the devices and methods described herein may be applied to any device capable of detecting the concentration of glucose and providing an output signal representative of the concentration of glucose (e.g., as a form of analyte data).

[0073] The analyte sensor system 102 may also include sensor electronics 106. In some examples, the analyte sensor 104 and the sensor electronics 106 may be provided as an integrated package. In other examples, the analyte sensor 104 and the sensor electronics 106 may be provided as separate components or modules. For example, the analyte sensor system 102 may include a disposable (e.g., single-use) base that may include the analyte sensor 104, a component for attaching the sensor to a host (e.g., an adhesive pad), or a mounting structure configured to receive another component. The system may also include a sensor electronics package that may include some or all of the sensor electronics 106 shown in FIG. 2. The sensor electronics package may be reusable.

[0074] The analyte sensor may provide a data stream indicative of the concentration of the analyte in the host using any known method, including invasive, minimally invasive, or non-invasive sensing techniques (e.g., optically excited fluorescence, microneedles, transdermal monitoring of glucose). The data stream may be a raw data signal or may be converted into a calibrated and / or filtered data stream used to provide a useful value of the analyte (e.g., an estimated blood glucose concentration level) to a user, such as a patient or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual interested in the health of the host).

[0075] The analyte sensor 104 may be, for example, a continuous glucose sensor and may include, for example, a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device. In some embodiments, such a sensor or device may analyze sensor data repeatedly (e.g., periodically or intermittently). The glucose sensor may use any method of glucose measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, immunochemical, etc. In various examples, the analyte sensor system 102 may be or include a continuous glucose monitoring sensor available from DexCom™ (e.g., a DexCom G5™ sensor, or a Dexcom G6™ sensor, or any variant thereof).

[0076] In some examples, the analyte sensor 104 may be an implantable glucose sensor, such as those described with reference to U.S. Patent No. 6,001,067 and U.S. Patent Publication No. 2005 / 0027463(A1). In some examples, the analyte sensor 104 may be a transcutaneous glucose sensor, such as those described with reference to U.S. Patent Publication No. 2006 / 0020187(A1). In some examples, the analyte sensor 104 may be configured to be implanted in a blood vessel or outside a host's body, such as described in U.S. Patent Publication No. 2007 / 0027385(A1), co-pending U.S. Patent Publication No. 2008 / 0119703(A1), filed October 4, 2006, U.S. Patent Publication No. 2008 / 0108942(A1), filed March 26, 2007, and U.S. Patent Application No. 2007 / 0197890(A1), filed February 14, 2007. In some examples, the continuous glucose sensor may include a transcutaneous sensor, such as described in U.S. Patent No. 6,565,509 to Say et al. In some examples, the analyte sensor 104 may be a continuous glucose sensor including a subcutaneous sensor, such as those described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Say et al. In some examples, the continuous glucose sensor may include a refillable subcutaneous sensor, such as those described with reference to U.S. Pat. No. 6,512,939 to Colvin et al. The continuous glucose sensor may include an intravascular sensor, such as those described with reference to U.S. Pat. No. 6,477,395 to Schulman et al. The continuous glucose sensor may include an intravascular sensor, such as those described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al.

[0077] The system 100 may also include a second medical device 108, which may be, for example, a drug delivery device (e.g., an insulin pump or insulin pen). In some examples, the medical device 108 may be or include another analyte sensor, a heart rate sensor, a respiration sensor, a motion sensor (e.g., an accelerometer), a posture sensor (e.g., a three-axis accelerometer), an acoustic sensor (e.g., capturing ambient or internal sounds), or other sensor. In some examples, the medical device 108 may be wearable, for example, on a watch, eyeglasses, contact lenses, a patch, a wristband, an ankle band, or other wearable item, or may be incorporated into a handheld device (e.g., a smartphone). In some examples, the medical device 108 may include a multi-sensor patch that may detect, for example, one or more of an analyte level (e.g., glucose, lactate, insulin, or other substance), heart rate, respiration (e.g., using impedance), activity (e.g., using an accelerometer), posture (e.g., using an accelerometer), galvanic skin response, tissue fluid level (e.g., using impedance or pressure), etc.

[0078] The analyte sensor system 102 may communicate with the second medical device 108 via a wired connection or via a wireless communication signal 110. For example, the analyte sensor system may be configured to communicate using radio frequency (e.g., Bluetooth, Medical Implant Communication System (MICS), WiFi, NFC, RFID, Zigbee, Z-Wave, or other communication protocols), optical (e.g., infrared), sonic (e.g., ultrasound), or cellular protocols (e.g., CDMA (Code Division Multiple Access) or GSM (Global System for Mobile Communications)), or via a wired connection (e.g., serial, parallel, etc.). In some examples, an array or network of sensors may be associated with a patient. For example, the analyte sensor system 102, the medical device 108, and the additional sensor 130 may communicate with each other via wired or wireless (e.g., Bluetooth, MICS, or any of the other options discussed above) communication. The additional sensor 130 may be any of the examples discussed above with respect to the medical device 108. The analyte sensor system 102, medical device 108, and additional sensors 130 on the host 101 are provided for purposes of illustration and discussion and are not necessarily drawn to scale.

[0079] The system may also include one or more peripheral devices, such as a handheld smart device (e.g., a smartphone) 112, a tablet 114, a smart pen 116 (e.g., an insulin delivery pen with processing and communication capabilities), a computer 118, a watch 120, or a peripheral medical device 122, any of which may communicate with the analyte sensor system 102 via wireless communication signals and with a server system (e.g., a remote data center) 126 via a network 124 or with a remote terminal 128 to facilitate communication with remote users (not shown), such as technical support staff or clinicians.

[0080] System 100 may also include a wireless access point (WAP) 132 that may be used to communicatively couple one or more of analyte sensor system 102, network 124, server system 126, medical device 108, or any peripheral device described above. For example, WAP 132 may provide Wi-Fi and / or cellular connectivity within system 100. Other communication protocols (e.g., near field communication (NFC) or Bluetooth) may also be used between devices in system 100. In some examples, server system 126 may be used to collect analyte data from analyte sensor system 102 and / or multiple other devices, perform analyses on the collected data, generate or apply universal or individualized models of glucose levels, and communicate such analytes, models, or information based thereon back to one or more of the devices in system 100.

[0081] 2 is a schematic diagram of various exemplary electronic components that may be part of a medical device system 200. In one example, the system may include sensor electronics 106 and a base 290. While a particular example of division of components between the base and sensor electronics is shown, it will be understood that some examples may include additional components in the base 290 or in the sensor electronics 106, and that some of the components shown in the sensor electronics 106 (e.g., supercapacitor 284) may alternatively or additionally (e.g., redundantly) be provided in the base. In one example, the base 290 may include the analyte sensor 104 and a battery 292. In some examples, the base may be replaceable, and the sensor electronics 106 may include debouncing circuitry (e.g., a gate with hysteresis or delay) to, for example, avoid repeated power-on or power-down processes when the battery is repeatedly connected and disconnected, or to avoid processing noise signals associated with battery removal or replacement.

[0082] The sensor electronics 106 may include electronic components configured to process sensor information, such as sensor data, and generate converted sensor data and displayable sensor information. The sensor electronics 106 may include electronic circuitry associated with measuring, processing, storing, or communicating continuous analyte sensor data, including, for example, predictive algorithms associated with processing and calibrating the sensor data. The sensor electronics module 106 may include hardware, firmware, and / or software that enable the measurement of analyte levels via the glucose sensor. The electronic components may be affixed to a printed circuit board (PCB), or the like, and may take various forms. For example, the electronic components may take the form of integrated circuits (ICs), such as application-specific integrated circuits (ASICs), microcontrollers, and / or processors.

[0083] 2 , the sensor electronics 106 may include a potentiostat 202 coupled to the analyte sensor 104 and configured to repeatedly obtain analyte sensor readings using the analyte sensor, e.g., by continuously or repeatedly applying a voltage bias across the sensor electrodes and measuring a current indicative of the analyte concentration. The sensor electronics may also include a processor 204, which may retrieve instructions 206 from a memory 208 and execute the instructions to determine controlled application of a bias potential to the analyte sensor 104 via the potentiostat, interpret signals from the sensor, or compensate for environmental factors. The processor may also store information in or retrieve information from a data storage memory 210. In various examples, the data storage memory 210 may be integrated with the memory 208 or may be a separate memory circuit, such as a non-volatile memory circuit (e.g., flash RAM). Examples of systems and methods for processing sensor analyte data are described in more detail herein and in US Pat. Nos. 7,310,544 and 6,931,327.

[0084] The sensor electronics 106 may also include a sensor 212, which may be coupled to the processor. The sensor 212 may be, for example, a temperature sensor or an accelerometer. The sensor electronics 106 may also include a power source, such as a capacitor or battery 214, which may be integrated into the sensor electronics, removable, or part of a separate electronics package. The battery 214 (or other power storage component, e.g., a capacitor) may optionally be rechargeable via a wired or wireless (e.g., inductive or ultrasonic) recharging system 216. The recharging system may recover energy or may receive energy from an external or built-in source. In various examples, the recharging circuit may include a triboelectric charging circuit, a piezoelectric charging circuit, an RF charging circuit, an optical charging circuit, an ultrasonic charging circuit, a thermal charging circuit, a heat recovery circuit, or a circuit that recovers energy from a communications circuit. In some examples, the recharging circuit may recharge a rechargeable battery using power provided from a replaceable battery (e.g., a battery supplied with the base component).

[0085] The sensor electronics may also include one or more supercapacitors 284 within the sensor electronics package (as shown) or within the base. For example, the supercapacitor 284 may allow energy to be drawn from the battery in a highly consistent manner, extending the battery's life. The battery may recharge the supercapacitor after it provides energy to the communications circuitry or processor, so that the supercapacitor is ready to provide energy during subsequent periods of high load. In some examples, the supercapacitor may be configured in parallel with the battery. The device may be configured to preferentially draw energy from the supercapacitor rather than the battery. In some examples, the supercapacitor may be configured to receive energy from a rechargeable battery for short-term storage and transfer energy to the rechargeable battery for long-term storage.

[0086] The supercapacitor may extend the operating life of the battery by reducing the strain on the battery during periods of high load. In some examples, the supercapacitor removes at least 10% of the strain from the battery during a high load event. In some examples, the supercapacitor removes at least 20% of the strain from the battery during a high load event. In some examples, the supercapacitor removes at least 30% of the strain from the battery during a high load event. In some examples, the supercapacitor removes at least 50% of the strain from the battery during a high load event.

[0087] The sensor electronics 106 may also include wireless communication circuitry 218, which may include, for example, a wireless transceiver operably coupled to an antenna. The wireless communication circuitry 218 may be operably coupled to the processor and may be configured to wirelessly communicate with one or more peripheral devices or other medical devices, such as an insulin pump or smart insulin pen.

[0088] The peripheral device 250 may include a user interface 252, a memory circuit 254, a processor 256, a wireless communication circuit 258, a sensor 260, or any combination thereof. The user interface 252 may include, for example, a touch screen interface, a microphone (e.g., for receiving voice commands), a speaker, a vibration circuit, or any combination thereof, and the user interface 252 may receive information from a user (e.g., glucose values) or deliver information to the user, such as glucose values, glucose trends (e.g., arrows, graphs, or charts), or glucose alerts. The processor 256 may be configured to present information to the user or receive input from the user via the user interface 252. The processor 256 may also be configured to store and retrieve information in the memory circuit 254, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information. The wireless communication circuit 258 may include a transceiver and antenna configured to communicate via a wireless protocol, such as Bluetooth, MICS, or any of the other options discussed above. The sensors 260 may include, for example, an accelerometer, a temperature sensor, a location sensor, a biometric sensor, or a blood glucose sensor, a blood pressure sensor, a heart rate sensor, a respiration sensor, or other physiological sensor. The peripheral device 250 may be, for example, a device such as a handheld smart device (e.g., a smartphone or other device such as a dedicated handheld device available from Dexcom) 112, a tablet 114, a smart pen 116, a watch 120 or other wearable device, or a computer 118 shown in FIG. 1 .

[0089] The peripheral devices 250 may be configured to receive and display sensor information that may be transmitted by the sensor electronics module 106 (e.g., in customized data packages transmitted to a display device based on respective preferences). Sensor information (e.g., blood glucose concentration levels) or alerts or notifications (e.g., “high glucose level,” “low glucose level,” or “decline rate alert”) may be communicated via the user interface 252 (e.g., via a visual display, sound, or vibration). In some examples, the peripheral devices 250 may be configured to display or otherwise communicate the sensor information (e.g., in data packages transmitted to a respective display device) as it is communicated from the sensor electronics module. For example, the peripheral devices 250 may transmit processed data (e.g., estimated analyte concentration levels that may be determined by processing raw sensor data), such that a device receiving the data may not need to further process the data to determine usable information (such as an estimated analyte concentration level). In other examples, the peripheral device 250 may process or interpret the received information (e.g., to declare an alert based on the glucose value or glucose trend. In various examples, the peripheral device 250 may receive information directly from the sensor electronics 106 or over a network (e.g., over a cellular or Wi-Fi network that receives information from the sensor electronics or from a device communicatively coupled to the sensor electronics 106).

[0090] Referring again to FIG. 2 , medical device 270 may include a user interface 272, a memory circuit 274, a processor 276, a wireless communication circuit 278, a sensor 280, a therapy circuit 282, or any combination thereof. User interface 272 may include, for example, a touch screen interface, a microphone or speaker, a vibration circuit, or any combination thereof, and user interface 272 may receive information from a user (e.g., glucose values, alert preferences, calibration coding) or transmit information to a user, such as, for example, glucose values, glucose trends (e.g., arrows, graphs, or charts), glucose alerts, etc. Processor 276 may be configured to present information to or receive input from a user via user interface 272. Processor 276 may also be configured to store and retrieve information in memory circuit 274, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information. The wireless circuit communication circuitry 278 may include a transceiver and antenna configured to communicate via a wireless protocol such as Bluetooth, Medical Implant Communication System (MICS), Wi-Fi, Zigbee, or a cellular protocol (e.g., CDMA (Code Division Multiple Access) or GSM (Global System for Mobile Communications)). The sensors 280 may include, for example, an accelerometer, a temperature sensor, a location sensor, a biometric sensor, or a blood glucose sensor, a blood pressure sensor, a heart rate sensor, a respiration sensor, or other physiological sensor. Although only one is shown in the example of FIG. 2, the medical device 270 may include two or more sensors (or memory or other components). In various examples, the medical device 270 may be a smart handheld glucose sensor (e.g., a blood glucose meter), a drug pump (e.g., an insulin pump), or other physiological sensor device, a therapy device, or a combination thereof. The medical device 270 may be the device 122 shown in FIG. 1.

[0091] In examples where medical device 122 or medical device 270 is an insulin pump, the pump and analyte sensor system may be in bidirectional communication (e.g., so that the pump may request changes to the analyte transmission protocol, such as requesting data points or data on a more frequent schedule, and the analyte sensor system provides the requested data accordingly), or the pump and analyte sensor system may communicate using one-way communication (e.g., the pump may receive analyte concentration level information from the analyte sensor system without responding to a request. In one-way communication, glucose values ​​may be incorporated into announcement messages that may be encrypted with a pre-shared key. In two-way communication, the pump may request values ​​for the analyte system to share or obtain and share in response to a request from the pump, and any or all of these communications may be encrypted using one or more pre-shared keys. The insulin pump may receive and track analyte (e.g., glucose) values ​​transmitted from analyte sensor system 102 using one-way communication to the pump for one or more of a variety of reasons. For example, the insulin pump may pause or activate insulin administration based on glucose values ​​that are below or above a threshold.

[0092] 1 may include two or more peripheral devices, each receiving information directly or indirectly from the analyte sensor system 102. Because different display devices may provide different user interfaces, the content of the data package (e.g., the amount, format, and / or type of data to be displayed, alarms, etc.) may be customized to each particular device (e.g., programmed differently by the manufacturer and / or end user). For example, in the embodiment of FIG. 1, multiple different peripheral devices may wirelessly communicate directly with the sensor electronics module (e.g., the skin-mounted sensor electronics module 106 physically connected to the continuous analyte sensor 104) during a sensor session to enable multiple different types and / or levels of display and / or functionality associated with the displayable sensor information or to conserve battery power of the sensor system 102, and one or more designated devices may communicate with the analyte sensor system and relay (i.e., share) information to other devices directly or via a server system (e.g., a networked data center) 126.

[0093] Exemplary Methods 3 is a flowchart diagram of an example method 300 for managing power consumption in an analyte monitoring system. The method may include, for example, modulating the power output from the first communication circuit to increase range or bandwidth by increasing the power output and to conserve energy by decreasing the power output from the first communication circuit. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2. The method may be repeated continuously or recurringly (e.g., periodically) or in response to one or more events to manage power in an ongoing manner.

[0094] At 302, a signal representing an analyte (e.g., glucose) concentration level may be received. The signal may be received, for example, from an analyte sensor, which may be part of a continuous glucose monitoring system, such as those described above.

[0095] At 304, a determination is made as to whether the first condition is met. In some examples, a processor (e.g., a CGM processor) operably coupled to the analyte sensor may determine whether the first condition is met. In some examples, a processor within a peripheral device (e.g., a smartphone or other display device) may determine whether the first condition is met. In response to the condition not being met, the method may return to step 302 and continue to receive the analyte concentration level.

[0096] In some examples, the first condition may be a connectivity condition, and step 304 may include determining whether the connectivity condition is met. The connectivity condition may include, for example, the existence of a connection (e.g., a Bluetooth connection), the reliability of the connection (e.g., based on the occurrence of a successful connection attempt or based on a connection failure), or the quality of the connection based on one or more signal strength measurement parameters (e.g., a received signal strength indicator (RSSI)). Determining whether the first condition is met may include applying the connectivity parameter to a model. The model may include multiple communication states. The communication state may be based, for example, on the reliability of communication, the elapsed time between consecutive successful communication sessions, the elapsed time since a failed attempt (or series of attempts) to establish communication, or other measures of the effectiveness or reliability of communication.

[0097] The first condition may additionally or alternatively include an analyte control condition, such as a range (e.g., a glucose value range) or a trend (e.g., one or more analyte (glucose) levels above or below a specified value, or within a specified range, or a rate of change of analyte concentration levels above or below a rate of change threshold). In various examples, determining whether the first condition is met may include analyzing the analyte signal, or an analyte parameter based on the analyte signal, to determine whether the analyte control condition is met.

[0098] In some examples, determining whether a first condition is met may include, for example, applying the analyte parameters to a model (e.g., a state model). In some examples, the condition may correspond to the recognition of a disease management condition clinically relevant to a user of the peripheral device. The condition may be based, for example, on an analyte level (e.g., an estimated low glucose level or an estimated high glucose level), a trend (e.g., a rate of change or forecast data of an analyte concentration level), a deviation from a trend (e.g., a reversal of a trend), or the likelihood of a clinically relevant condition occurring in the future (e.g., an imminent hypoglucose).

[0099] In some examples, the conditions may correspond to or be based on one or more requirements of a peripheral device, such as an insulin pump. For example, the connection state may transition from a low power usage model to a high power usage model based on basal or bolus insulin delivery conditions (e.g., a high power usage model or more reliable or frequent communication may be used when insulin is being delivered to avoid loss of connection).

[0100] In some examples, a state model may include multiple analyte concentration level states, which may be defined or determined by an analyte concentration range or trend (e.g., glucose below a target range, glucose within a target range, or glucose above a target range).

[0101] In some examples, the state model may additionally or alternatively include multiple communication states (e.g., a low power state, a high power state, or a high reliability state; a partnered state for working with peripheral devices such as pumps; an extended battery life state for ensuring that predicted battery life meets battery life criteria).

[0102] In response to the condition being satisfied, the method 300 may include, at 306, transitioning from the first wireless communication mode to a second wireless communication mode in response to the condition being satisfied. In some examples, transitioning from the first wireless communication mode to the second wireless communication mode includes reducing power output from the communication circuitry to conserve energy. In some examples, the first wireless communication mode may consume more power than the second wireless communication mode. This transition to the second wireless communication mode may allow the analyte monitoring system to conserve power when the first condition is satisfied by transitioning to the second wireless communication mode. In some examples, the system may balance communication needs with power consumption. For example, satisfaction of a first condition may be associated with a lower urgency for communication (e.g., a determination that the analyte concentration level and / or trend is in a "controlled" range or state), in which case less frequent (e.g., 15-minute intervals instead of 5-minute intervals), lower power demands (e.g., lower transmit power or a lower power protocol), or less automatic or on-demand communication (e.g., NFC instead of Bluetooth) may be permitted. In some examples, the processor may intermittently monitor power consumption continuously or repeatedly, or may increase or decrease power consumption in response to meeting a protocol or condition.

[0103] In some examples, the second wireless communication mode uses less power than the first wireless communication mode. In some examples, the first wireless communication mode may be a continuous connection mode defined by a connection protocol (e.g., Bluetooth), and the second wireless communication mode may be a periodic connection mode. The periodic connection mode may require fewer wireless transmissions than the continuous connection mode to stay awake (e.g., based on a minimum connection interval). In some examples, the first wireless communication mode may be a two-way communication mode, and the second wireless communication mode may be a one-way communication mode that includes data transmission from the first communication circuit. For example, the one-way communication mode may be a broadcast mode (e.g., of the Bluetooth protocol). The one-way communication protocol may require a shorter time for active transmission and reception and therefore use less power.

[0104] In some examples, the first wireless communication mode has a longer range than the second wireless communication mode. For example, the first communication mode may include a medium- to long-range wireless communication method or technology (e.g., Bluetooth or MICS communication), and the second communication mode may use a short-range wireless method or technology (e.g., NFC or inductive communication). Bluetooth tends to have a relatively long range (e.g., up to 100 m). MICS also tends to have a relatively long range (e.g., up to about 6 m), but the MICS range is usually shorter than Bluetooth. NFC and other inductive communication technologies tend to have a relatively short range (e.g., 4 cm to a maximum of about 30 cm), but require less power, do not require power, and in some examples may reclaim power.

[0105] In some examples, the authentication process may be performed in a first communication mode (e.g., a two-way communication scheme that enables key exchange), and the system may transition to a second communication mode after authentication. In some examples, the system may transmit encrypted broadcast data over the second wireless communication mode. The encrypted broadcast data may include, for example, analyte concentration level information, trend information, or status information. In some examples, the encrypted broadcast data may be used to determine whether to transition from the second wireless communication mode to the first wireless communication mode (e.g., determine whether a second condition is met). In some examples, the encrypted broadcast data may include instructions for transitioning from the second wireless communication mode back to the first wireless communication mode. For example, the analyte system processor (e.g., a CGM processor) may apply an algorithm to determine whether to transition back to the first mode (e.g., back to two-way communication), and the peripheral device may transmit a bit flag in the broadcast packet. In some examples, a peripheral device (e.g., a smartphone or other handheld display device) may apply an algorithm to determine whether to transition from a first mode to a second mode (e.g., to save power).

[0106] After transitioning to the second wireless communication mode, the method may include, at 308, transmitting using the second wireless communication mode for a period of time or until a second condition (e.g., as determined in step 310) is met.

[0107] At 310, the method may include determining whether a second condition is met. The second condition may be a different condition or the opposite of the first condition (e.g., the analyte level or trend moves out of range, or otherwise meets or fails to meet a glucose control condition, or fails to meet a communication condition). If the second condition is not met, the method may return to transmitting a wireless signal using a second (e.g., low power) wireless communication mode at 308.

[0108] In response to the second condition being satisfied, the method may include ceasing to use the second wireless communication mode. For example, when the second condition is satisfied, the method may include transitioning from the second wireless communication mode to the first wireless communication mode at 312. In some examples, the method 300 may include transitioning from the second communication mode back to the first communication mode, increasing power output to increase communication range or bandwidth, and communicating using the first wireless communication mode at 314. Alternatively, the method may include transitioning to a third wireless communication mode at 310 (e.g., an intermediate power consumption mode (e.g., intermittent two-way communication) or a high priority communication mode (e.g., continuous connection) that may consume more power than the first mode) and communicating using the third wireless communication mode at 314.

[0109] In some examples, the method 300 may include transitioning from a one-way communication mode (e.g., broadcast) to a two-way communication mode when sensor calibration is required or to confirm that a warning or alarm has been received.

[0110] 4 is a flowchart diagram of an example method 400 for managing power output based on monitored sensor values ​​or performance metrics. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2.

[0111] The method 400 may include, at 402, monitoring one or more physiological sensor values ​​(e.g., an analyte concentration level, a temperature, an activity level, a heart rate). The physiological sensor values ​​may be received, for example, from a wearable sensor device including an analyte sensor (e.g., an analyte sensor) and a communication circuit. The wearable sensor device may include, for example, an analyte monitor, and the one or more physiological sensor values ​​include an estimated analyte concentration level.

[0112] The method may also include monitoring one or more communication performance metrics related to communications to or from the wearable sensor device, at 404. The communication performance metrics may include, for example, a packet capture rate or a received signal strength indicator value.

[0113] The method may further include determining whether a condition is met, at 406. The determination may be based, for example, at least in part, on monitored physiological sensor values ​​(e.g., meeting an analyte management condition) or communication performance metrics (e.g., meeting a communication reliability condition), or both or a combination. For example, the method may include determining whether an analyte management condition is met based, at least in part, on an estimated analyte concentration level. The analyte risk management condition may include, for example, a range, trend, planned analyte level, or other analyte management information. As described in detail above, the condition may correspond to a recognition of a disease management status that is clinically relevant to a user of the peripheral device.

[0114] The method may additionally or alternatively include determining whether a communication reliability condition is met based at least in part on the communication performance metric, and, in response to determining that the communication reliability condition is met, conserving power by transitioning to a more energy-efficient communication scheme or maintaining the current communication scheme (e.g., inhibiting increases in power output). The communication reliability condition may be based, for example, on signal strength or packet rate below a threshold, or a combination thereof.

[0115] In some examples, the system may maintain the status quo (e.g., make no changes) if the condition is met. In some examples, the condition may be a negative condition, e.g., a negative condition may be met when some combination of requirements is not met.

[0116] In response to satisfying the condition, the method may further include increasing or decreasing the power output of the communication circuitry at 408. In some examples, the method may include transitioning to a lower power protocol. For example, the method may include transitioning from a long-range communication protocol to a short-range communication protocol (e.g., from MICS or Bluetooth to NFC), or from a continuously connected mode to a repetitively (e.g., periodically) connected mode, or from a two-way communication protocol to a one-way communication mode (e.g., broadcast mode). In some examples, the method may include changing one or more communication parameters (e.g., transitioning communication modes). In some examples, the method may include periodically communicating the estimated analyte concentration level to another device, and the increase or decrease in power output may include decreasing the frequency of communication of the estimated analyte concentration level.

[0117] In some examples, increasing or decreasing power output may include frequency transitions, mode transitions, power level transitions, or transitions in the period between communications to increase communication range or reliability or to conserve energy. For example, the system may transition between communications one or more of once per minute, once every five minutes, once every ten minutes, or once every thirty minutes.

[0118] In some examples, increasing or decreasing power output may include limiting communication to a designated peripheral device of a plurality of available peripheral devices (e.g., increasing power to a pump but not a smartwatch). In some examples, the method may further include determining the designated peripheral device based on a schedule, a priority scheme, or a location. In some examples, the method may further include determining a battery status, wherein the communication scheme is modified based at least in part on the monitored physiological sensor values, the communication performance metrics, and the battery status.

[0119] 5 is a flowchart diagram of an example method 500 for selecting a communication protocol based on satisfying an analyte control condition. Method 500 may be applied, for example, to an analyte monitoring system that includes a communication circuit and an analyte sensor configured to generate a signal representative of an analyte concentration level, a processor configured to control operation of the system, and a battery configured to power the system. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2.

[0120] The method may include receiving analyte management conditions from a partner device, such as an insulin pump or insulin pen, at 502. The analyte management conditions may include, for example, a range, rate, or change of an analyte concentration level (e.g., a glucose concentration level), or other parameters based on one or more analyte concentration levels. In various examples, the analyte management conditions may be determined by the partner device or may be input by a user of the partner device.

[0121] At 504, method 500 may further include receiving an analyte signal representing an analyte concentration level (e.g., a glucose concentration level), for example, from an analyte sensor. Method 500 may also include determining an analyte parameter, at 506, based at least in part on the analyte signal. For example, an estimated analyte concentration level (e.g., an estimated glucose concentration level) may be determined. Method 500 may further include determining whether an analyte management condition is met, at 508. The determination may be based at least in part on the analyte parameter. For example, the method may include determining whether the estimated analyte concentration level is below a threshold, above a threshold, a rate of change exceeds a rate of change threshold, or whether a predicted analyte concentration level meets a condition (e.g., above or below a threshold). In some examples, determining whether an analyte management condition is met may include applying the analyte parameter to a model (e.g., a state model). The model may be predefined or may be learned from data and may reside within the system (e.g., in the sensor electronics) or locally (e.g., on a smart device at or near the patient (host) or may reside on a remote system (e.g., a networked resource). One or more parameters (e.g., analyte parameters) may be applied to the model (e.g., provided as inputs), and a state may be determined by applying the one or more parameters to the model. The state may be related to the host, such as, for example, glucose status (e.g., in range, out of range, or trending), or may be related to communication (e.g., trusted or unreliable), or a combination thereof.

[0122] Method 500 may further include determining a communication protocol for communicating with the partner device based at least in part on whether an analyte management condition is met. For example, the method may include, at 510, communicating via a first communication mode (e.g., power level, frequency, protocol) when the condition is met and, at 512, communicating via a second communication mode when the condition is not met. In one example, when the estimated analyte level (e.g., an estimated glucose level) falls within a safety zone (e.g., 80-140 mg / DL) that may be specified by the partner device (e.g., an insulin pump) or based on the requirements or characteristics of the partner device, the analyte monitor (e.g., CGM) may communicate (e.g., announce in a Bluetooth protocol) less frequently to conserve power (e.g., continuously or every 15 or 30 minutes instead of every 1 or 5 minutes), transition to a one-way communication scheme, or otherwise control the operation of the system to conserve power as described herein.

[0123] 6 is a flowchart diagram of an example method 600 for managing power using operating parameters received from a peripheral device. Method 600 may be implemented within an analyte monitoring system (e.g., a CGM) that includes a communications circuit, an analyte sensor configured to generate a signal representative of an analyte concentration level, a processor configured to control operation of the system, and a battery configured to power the system. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2.

[0124] Method 600 may include, at 602, receiving operating parameters related to a peripheral device via a communications circuit. The peripheral device may include, for example, a drug pump, a smart pen, a handheld device (e.g., a smartphone), or another type of display device configured to communicate with the analyte monitoring system. The operating parameters may be received from the peripheral device, or the operating parameters may be received from a remote resource (e.g., a server) or a local device (e.g., a smartphone app). In some examples, the operating parameters may be retrieved from a memory circuit (e.g., retrieved from a lookup table) based on identification information or characteristics of the peripheral device. In one example, a system may communicate with a peripheral device and receive (or exchange) device identification information, which may then provide the device identification information (e.g., via a device such as a smartphone) and receive operating parameters, which may be received from or determined by a remote resource (e.g., a network server) or smart device.

[0125] In various examples, the operational parameters may include, for example, battery management parameters, calibration schedule parameters, sensor accuracy parameters, or context information. In some examples, the operational parameters may include context information from the peripheral device (e.g., information about the peripheral device's interaction with another device or the network environment). For example, the operational parameters may include information about the peripheral device's connection status (such as network or remote server (“cloud”) connection, RSSI, or missed communication). In some examples, the operational parameters may include battery level, activity level (e.g., determined using the peripheral device's accelerometer), location (e.g., based on GPS or network connection status or strength), display status (e.g., on or off), alert state (e.g., alert activated or not activated), alert acknowledgement (e.g., input received from a user to acknowledge receipt of the alert), use mode (e.g., open loop or closed loop), or the status of a pending event or action (e.g., waiting for an action or event).

[0126] The method may further include, at 604, operating a system (e.g., an analyte monitoring system such as a CGM) based at least in part on the operating parameter. In various examples, a determination may be made based on the operating parameter, and the system may operate based at least in part on the determination. For example, the system may determine whether the operating parameter is within an acceptable range. In some examples, the system may determine whether the analyte concentration meets trend criteria, such as, for example, being within a defined analyte concentration range or having an average rate of change below a threshold.

[0127] In some examples, the operational parameters may include operational requirements of a peripheral device. Method 600 may include controlling operation of the system to satisfy the operational requirements.

[0128] In one example, the operational requirements may include sensor accuracy requirements, and the system may be controlled to meet the sensor accuracy requirements (e.g., calibrate or replace sensors that do not meet the sensor accuracy requirements). In one example, the operational requirements may include a calibration schedule, and the system may operate to meet the calibration schedule (e.g., the system may prompt a user to calibrate to meet a schedule received from a partner device).

[0129] In one example, the operational requirement may include a battery life requirement, and the system may operate to meet the battery life requirement (e.g., the system may suggest replacing the battery, or a transceiver or other component containing the battery, to ensure that the battery life requirement is met). In some examples, the operational parameter may include a specified time period (e.g., pump session time), and the operation of the system (e.g., a continuous analyte sensor) may be controlled to manage energy consumption from a battery (e.g., an analyte sensor battery) so that the energy stored in the battery is not depleted before the specified time period has elapsed; for example, the processor may control the operation of the communication circuitry in a manner calculated to ensure that the energy stored in the battery is not depleted before the specified time period has elapsed. For example, the processor may modify the communication scheme to conserve battery energy during the specified time period. For example, the processor may transition to a communication mode that consumes less energy (e.g., transition from MICS or Bluetooth to NFC, transition from a constantly connected mode to a repetitive (e.g., periodic) communication mode, or transition from a two-way communication mode to a one-way (e.g., broadcast) communication mode.

[0130] In some examples, the system (e.g., the analyte monitoring system) may be configured to communicate with a second device (e.g., in addition to a peripheral device such as a pump or smart pen), and the method may include restricting communication through the communication circuitry so that the system communicates only with the peripheral device during a specified period of time. For example, the system may receive a whitelist (e.g., from the peripheral device or from a smart device or network resource) that the system may use during a specified period of time. In another example, the system (e.g., the analyte monitoring system) may receive operational parameters indicating that the system may communicate only with the peripheral device during a specified period of time (e.g., the parameters may define a communication schedule to reduce the need to broadcast). In another example, the system (e.g., the analyte monitoring system) may receive operational parameters indicating that the system may communicate only with the peripheral device (and not with other devices) during a specified period of time (e.g., to ensure successful communication to the pump). In another example, the system may receive operational parameters to blacklist communication devices, such as devices previously connected to the system (e.g., a previous pump that has been replaced may be blacklisted).

[0131] In some examples, the operating parameters may include a specified number of additional peripheral devices, and the method may include communicating with only the peripheral devices and the specified number of additional devices, wherein excessive consumption of energy stored in the battery is avoided by limiting the number of devices with which the analyte monitoring system communicates.

[0132] In some examples, the operating parameters may include identification information of one or more additional peripheral devices, and the method may include communicating with only the identified one or more additional devices, where excessive consumption of energy stored in the battery is avoided by limiting the number of devices with which the analyte monitoring system communicates. For example, the analyte monitoring system may communicate with a default or user-specified primary device. In some examples, the identification information may specify a particular device, for example, using a device ID. In some examples, the identification information may specify a type of device (e.g., a watch). Types of peripheral devices may include, for example, a handheld device (e.g., a smartphone), a watch, a tablet, a pen, a pump, or a desktop computer.

[0133] In some examples, a system (e.g., an analyte monitoring system) may receive information regarding connections between peripheral devices. For example, the analyte system may receive information that a smartphone is communicating with a watch. In response to receiving information that a first peripheral device is communicating with a second peripheral device, the system may limit communication to a designated device or group of devices (e.g., the analyte monitoring system may communicate with the smartphone, or the smartphone and the pump), and, depending on the designated device, may communicate with a third device (e.g., the smartphone may pass information to a smartwatch to reduce battery consumption by the analyte sensor system).

[0134] In some examples, the operating parameters may be a schedule for providing information such as analyte levels or trends (or both), and the system may communicate according to the schedule. For example, an analyte signal representing an analyte concentration level may be received from an analyte sensor, processed to determine an estimated analyte concentration level, and transmitted via wireless signals (e.g., using communications circuitry) according to the schedule specified by the operating parameters.

[0135] In some examples, a system (e.g., an analyte monitoring system) may receive identities (e.g., a list) of one or more authorized peripheral devices. The system may accept operating parameters or communication requests from the one or more peripheral devices based on the identities of the authorized devices.

[0136] 7A is a flowchart diagram of an example method 700 for managing power based on user input. In some examples, the method 800 may be implemented in a system that may include an analyte sensor configured to generate a signal indicative of an analyte concentration level in a host, a processor configured to determine an estimated analyte concentration level based on the signal, and a communication circuit configured to transmit the estimated analyte concentration level, or information based on the estimated analyte concentration level, via a transmitted communication signal and receive user input via a detected communication signal. The system may be configured to control a communication mode of the communication circuit based at least in part on the user input. The system may be, for example, the system 200 shown in FIG. 2.

[0137] At 702, user input is received. The user input may be received, for example, directly via a user interface (e.g., a graphical user interface GUI) or from another device (e.g., a smartphone or other smart device) that may receive user input via a user interface. In one example, the user interface may include menus and buttons (e.g., providing various options as described below), and a user may provide input via selecting an option from a menu and pressing a button. In some examples, the user input may be received over a network. For example, a host (e.g., a child) to which an analyte sensor (e.g., a glucose sensor) is attached may be at a first location, and a user (e.g., a caregiver) may provide user input (e.g., via a smartphone) at a second location, and the input may be relayed over a network (e.g., a cellular network or the Internet) to a smart device near the host.

[0138] The user input may include, for example, a request to enter an energy-saving mode. The user input may also relate to energy management, for example, the user input may include a request to align an estimated battery life with parameters of a partner device (e.g., pump sessions). In some examples, the user input may include a specified condition. In some examples, in response to meeting the specified condition, the system may communicate less frequently or take other steps to consume less energy. In other examples, the system may enter a low power consumption mode and disable the low power consumption mode in response to meeting a specified condition (e.g., an estimated glucose level moving outside a safe range or the pump starting to deliver basal or bolus insulin).

[0139] At 704, a sensor signal may be received from the analyte sensor. The sensor signal may be indicative of, for example, an analyte concentration level of the host (e.g., indicative of a glucose concentration). The sensor signal may be received, for example, from the analyte sensor 104 by the processor 204 as shown in FIG.

[0140] At 706, an estimated analyte concentration level (eg, an estimated glucose concentration level) is determined based on the sensor signal.

[0141] At 708, an operating mode of the communications circuitry may be determined based at least in part on the user input. The determined operating mode may be, for example, an energy-saving mode in which power consumption by the communications circuitry or the system may be reduced. The system may invoke any of the methods described herein to conserve or manage energy consumption (e.g., the system may communicate less frequently than in a normal operating mode, limit the number of devices with which the system communicates, or communicate using low-power technology (e.g., NFC) for non-critical communications, all communications, or all communications).

[0142] At 710, the estimated analyte concentration level, or information based on the estimated analyte concentration level, may be transmitted via the communications circuitry using the determined operating mode. Transmitting using an energy-saving mode may include, for example, transmitting information less frequently than in a normal operating mode, transmitting using a low-power intensive communications mode (e.g., NFC rather than Bluetooth), communicating with fewer devices (e.g., communicating with a pump rather than a watch), or communicating via a peripheral device (e.g., communicating with a watch via a smartphone).

[0143] In some examples, the communication circuitry can be controlled based at least in part on the analyte concentration level.

[0144] In some examples, the system (e.g., a CGM system) may determine whether a condition is met based at least in part on the analyte concentration level and control operation of the communication circuitry to reduce power consumption by the communication circuitry based on the determination of whether the condition is met. For example, the condition may include a range of analyte concentration levels, and determining whether the condition is met may include determining whether the determined analyte concentration level falls within the range of analyte concentration levels. In one example, the system may communicate when the analyte concentration level is sufficiently controlled (e.g., the estimated glucose level is between 80 and 150 mg / dL and stable (e.g., without a rapid rate of change)) and less frequently when the analyte concentration level is not sufficiently controlled (e.g., the estimated glucose level exceeds a specified threshold, e.g., below 70 mg / dL, above 150 mg / dL, 200 mg / dL or 250 mg / dL, rising or falling rapidly, or a combination thereof).

[0145] In some examples, the condition may include a trend condition, and determining whether the condition is met may include determining whether the trend condition is met using multiple analyte concentration levels. For example, the trend condition may include a rate of change of the analyte concentration level being below a specified threshold (e.g., an estimated glucose rate of change of 2 mg / dL / min or less or 3 mg / dL / min or less). The trend condition may also include an analyte concentration level (e.g., a rate of change of an estimated glucose concentration level of 2 mg / dL / min or less when the estimated glucose concentration level is less than 120 mg / dL).

[0146] In some examples, transmitting using the determined mode of operation may include reducing power consumption by suppressing automatic transmission of analyte concentration information or transmitting analyte concentration information less frequently. In some examples, transmitting using the determined mode of operation may include transmitting only in response to a request (e.g., transitioning to a "pull" mode instead of a "push" mode), or transmitting less frequently unless a request is received (e.g., a request from a partner device or a user).

[0147] In some examples, the determined operating mode may be disabled to communicate in response to the analyte concentration level falling below a threshold or falling outside of a range.

[0148] In some examples, the user input may include a specification of a condition, and the operation of the communications circuitry may be modified in response to satisfying the condition. The condition may include, for example, an analyte concentration level range or an analyte trend condition, or any other condition discussed herein.

[0149] In some examples, the patient state may be determined based on one or more analyte concentration levels, and operation of the communication circuitry may be modified to reduce power consumption in response to a patient state that meets a safety condition. For example, the patient state may be determined by applying one or more analyte concentration levels to a model, such as a state model, which may include one or more states determined by the model responsive to the analyte concentration level(s), and optionally also by contextual factors, information about the device (e.g., battery level), or information about a partner device (e.g., a pump).

[0150] In some examples, the user input may include a request to operate the system in a manner that ensures that the estimated battery life meets or exceeds an operational parameter for the partner device. For example, the operational parameter may be a period of time (e.g., pump session time), and the system may operate in a manner that extends the life of batteries in the system so that the batteries do not expire (e.g., deplete to a charge level insufficient to perform their function) before the period expires.

[0151] In some examples, the system may monitor for an alert condition based at least in part on the estimated analyte concentration level, and the system may disable an energy saving mode and communicate an alert.

[0152] In some examples, the determined communication operating mode may include a dormant mode (e.g., a low power consumption mode). In the dormant mode, the system may stop communicating, communicate very infrequently, only list and not transmit, transmit very infrequently, one or more non-communication operations (e.g., sensing) may be suspended, or any combination thereof. In some examples, the system may enter the dormant mode in response to a user input including a request to stop a sensor session or in response to a request to start a sensor session (e.g., because the sensor may not be used after the session starts during a warm-up period during which the host / sensor is adapted for insertion of the sensor into the host). In some examples, the system may transition out of the dormant mode after a specified period of time (e.g., after the expiration of the warm-up period).

[0153] 7B is a flowchart diagram of an example method 700 for managing power based on a sleep command (e.g., an instruction to enter a hibernate mode or other low-power consumption state). The method may be applied, for example, to an analyte monitoring system including an analyte sensor configured to generate a communication circuit and a signal representative of an analyte concentration level, a processor configured to control operation of the system, and a battery configured to power the system. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2.

[0154] Method 770 may include, at 772, receiving a sleep command from the peripheral device via the communications circuitry. For example, it may be desirable to put the analyte monitoring system to sleep during a warm-up period (e.g., after application of a sensor to a host, a warm-up period may be required before sensor readings begin). Method 770 may include, at 774, transitioning the system to a low-power state in response to receiving the sleep command. In some examples, the system may cease communications in the sleep state. For example, the communications circuitry may completely cease transmitting and receiving for a period of time, or the communications circuitry may enter a standby-only mode, which may optionally involve a lower-power standby mode (e.g., a longer duty cycle, or scheduled wake-up and standby) than normal operation. In some examples, other portions of the system may also stop consuming energy or enter a low-power mode. For example, the analyte sensor may stop applying sensing voltage to the electrodes, or the processor may stop collecting or processing data. In another example, when the system is in a low power mode, the analyte sensor may still continue to apply voltage for analyte measurement purposes, but the transmission / communication circuitry may remain in a sleep or low power mode. Furthermore, in another example, when the sensor electronics is removed from the host (e.g., when the transmitter is disconnected from the sensor), the sensor electronics may stop processing or communicating (e.g., because the sensor electronics is not receiving any sensor data).

[0155] The method may include waking the system from the low power state at 776. In some examples, the system may include a clock that triggers a wake-up event upon expiration of a period of time (e.g., a warm-up period), for example, using a timer or at a specified time. In some examples, the method may include waking the analyte monitoring system in response to a wake-up command, for example, in response to a command from a peripheral device such as a pump or a smart device (e.g., a smartphone or dedicated handheld device).

[0156] 8 is a flowchart diagram of an example method 800 for determining an operating protocol to ensure battery life meets specified time parameters. The method may be applied, for example, to an analyte monitoring system including an analyte sensor configured to generate a communication circuit and a signal representative of an analyte concentration level, a processor configured to control operation of the system, and a battery configured to power the system. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG. 2.

[0157] Method 800 may include, at 802, receiving a specified time parameter from a peripheral device. The specified time parameter may be, for example, a specified time, such as a particular date (e.g., day, week, or month), or an amount of time, such as a number of days, weeks, or months. Method 800 may further include, at 804, determining an amount of energy remaining in the battery, for example, based on a voltage measurement, a current measurement, a coulomb counter, or any combination thereof. Method 800 may further include, at 806, determining a system operating protocol calculated to ensure planned energy consumption by providing an estimated battery life that meets the specified time parameter. For example, the planned energy consumption rate may be determined based on one or more communication parameters (e.g., strength of transmission, frequency with which the system communicates, or number of devices with which the system will communicate), one or more data processing parameters (e.g., amount and frequency with which data processing will occur), one or more sensing parameters (e.g., frequency with which sensor readings will be taken), or any combination thereof. In one example, the life or expiration of the analyte sensor system (e.g., CGM) may be aligned or extended to exceed the life or expiration of the pump, e.g., the CGM may operate to ensure that the CGM's battery life outlasts the pump's battery life or a change in pump insertion site. In some examples, the system may ensure that there is enough battery remaining at the end of a session to perform one or more end-of-session tasks, such as transferring data to an external device such as a smartphone. In some examples, a notification may be delivered to the user to change or check the analyte sensor system battery to coordinate the battery change with a pump replacement or insertion site change.

[0158] 9 is a flow chart diagram of an example method 900 of using information from non-volatile memory after a power reset. The method may be implemented, for example, in a system such as that shown in FIG. 1 or a device such as that shown in FIG.

[0159] Method 900 may include, at 902, receiving a sensor signal representing an analyte concentration level from a wearable analyte monitor. Method 900 may further include, at 904, repeatedly storing information in non-volatile memory in preparation for an unplanned power reset, such as when a removable battery is removed from the device. The stored information may include, for example, an estimated analyte concentration level determined from the sensor signal and an associated timestamp. In some examples, method 900 may also include storing time data, session data, pairing information, a reset count, or the effect of a battery reset in non-volatile memory. The reset count and the effect of a reset may be considered in estimating remaining battery life.

[0160] In some examples, periodically storing information may include storing critical information that may be used to re-establish a session after a power reset and continue the session according to the operating parameters used before the power reset. For example, a mode (e.g., a communication mode, a device operating mode, or a mode of interaction with a peripheral device such as a pump) or a status (e.g., an analyte trend or patient status) may be resumed after a power reset.

[0161] Method 900 may further include, at 906, retrieving the stored information from the non-volatile memory after a power reset. In some examples, the method may further include initiating a power-on mode after the power reset and evaluating device status or analyte status in the power-on mode using the stored information. In some examples, a debouncing circuit (e.g., a gate with hysteresis) may be used to avoid repeated execution of a power-on or power-off process when a battery is repeatedly connected and disconnected, or to avoid processing noise signals associated with battery removal or replacement. In some examples, the system may execute instructions to remove noise associated with battery removal or insertion. For example, the system or device may detect a battery connection or disconnection, and the system may delay the power-on or power-off process or processing of a signal for a specified period of time after a connection or disconnection from the battery is detected. In some examples, the system or device may delay the power-down process for a specified period of time after a connection to a battery is detected, which may allow the system or device to avoid continuously performing the power-up and power-down process when the battery is connected and disconnected multiple times in a short window of time.

[0162] The method may further include resuming operation using the retrieved information, at 908. In some examples, the method may further include determining an operational mode based at least in part on the stored information. In some examples, the determined operational mode may include one or more of a power consumption mode or a communication mode. For example, the system may use the stored information to determine whether to operate in a low-power operational mode, a normal operational mode (e.g., default), or a high-power operational mode (e.g., high-frequency communication or high power to ensure range or high likelihood of successful communication, which may be useful, for example, when the patient is in an uncontrolled state, e.g., in or prone to a high-glucose or low-glucose state).

[0163] In some examples, the low power mode may be initiated based on battery conditions (e.g., based on current, voltage, or remaining energy) or the amount of remaining battery life (e.g., time to expiration or estimated time until an end-of-life condition is met). In various examples, the low power mode may conserve power by communicating less frequently, transitioning from a first communication mode or protocol to a second mode or protocol that uses lower power (e.g., transitioning from Bluetooth to NFC), communicating with fewer devices, relying on peripheral devices to communicate with other devices (e.g., linking a smartphone to communicate with a watch, pump, or smart pen), performing infrequent, non-communication operations (e.g., sensing), or offloading processing to peripheral devices (e.g., relying on the smartphone for complex processing). In some examples, the determination of whether to operate in low power mode after a power reset may be based on battery power after the reset (e.g., detecting whether a battery with sufficient power (e.g., a new battery) has been inserted, or whether a low-power battery (e.g., the same battery as the one removed or another low-power battery) has been inserted). In some examples, a power level evaluation (e.g., a decision on whether to operate in a low power mode) may be triggered after a power reset based on information stored before the reset (e.g., based on one or more of the operating modes before the reset, analyte management conditions (e.g., glucose level or trend), communication conditions (e.g., reliable or not), or communication mode (e.g., two-way or one-way)).

[0164] In some examples, the method may include determining an analyte trend based at least in part on the estimated analyte concentration level retrieved from the non-volatile memory.

[0165] In some examples, the method may include periodically saving first information on a first schedule and periodically saving additional information on a second schedule, the first information being saved more frequently than the additional information. For example, information that is important for resuming a session after a power reset may be saved more frequently than other types of information.

[0166] Battery and Device Construction Examples 10A is a cross-sectional view of an exemplary sensor assembly 1000. The sensor assembly 1000 may include a base 1002 that may include a mounting unit 1004 configured to couple with a sensor electronics module 1006, which may be or include the sensor electronics module 106 of FIGS. 1 and 2. The sensor assembly 1000 may also include one or more batteries 1018, which may be removable or replaceable. The battery 1018 may be electrically coupled to electrical contacts 1028, which may be sized and shaped to electrically couple with electrical contacts 1030 on the sensor electronics module 1006, as described further below.

[0167] The base 1002 may include contacts 1008, which may be part of a contact subassembly 1010. The contacts 1008 may be configured to electrically and mechanically contact respective contacts (not shown) on the sensor electronics module, for example, to enable signal or power transfer. The contact subassembly 1010 may include a hinge 1012 configured to enable the contact subassembly 1010 to pivot between a first position (for insertion) and a second position (for use) relative to the mounting unit 1004. As used herein, the term “hinge” is a broad term and is used in its original sense inclusively and without limitation to refer to any of a variety of pivot, articulation, and / or hinge mechanisms, such as adhesive hinges, sliding joints, etc., and the term hinge does not necessarily imply a fulcrum or fixed point at which articulation occurs. In some examples, the contacts 1008 may be formed from a conductive elastomeric material, such as a carbon-filled elastomer, that is in electrical communication with the sensor 1016.

[0168] In some examples, the mounting unit 1004 may include an adhesive pad 1014 disposed on a back surface of the mounting unit. The adhesive pad may include a peelable backing layer. The mounting unit 1004 may be adhered to the host's skin by pressing the mounting unit's base 1002 and adhesive pad 1014 against the skin. A suitable adhesive pad may be selected and designed to stretch, stretch, conform to, and / or vent an area (e.g., the host's skin). Various configurations and arrangements may provide water-resistant, waterproof, and / or sealed properties associated with the mounting unit / sensor electronics module embodiments described herein. Any of the examples discussed herein may be sealed to avoid, for example, exposure to water or excessive exposure to moisture.

[0169] 10B is an enlarged view of a portion of the sensor assembly of FIG. 10A. The base 1002 may be configured to receive one or more batteries 1018, which may be, for example, coin cell batteries (e.g., silver oxide, lithium, alkaline, zinc-air, etc.). A sealed region 1020 may extend over the batteries 1018 to isolate and secure the batteries 1018 within the base 1002. In various embodiments, the sealed region may be coupled to the base using a mechanical connection (e.g., a snap fit), an adhesive, a welded joint, or any combination thereof.

[0170] The base 1002 may include one or more protrusions 1024 (e.g., seal members or sealing features) that extend upward to the sensor electronics module 1006. An electrical connector 1026 may extend through the protrusion 1024 and electrically connect with a second electrical contact 1030 on the sensor electronics module 1006 via an electrical contact 1028. In some examples, an end face 1034 (e.g., seal member) of the protrusion 1024 may seal against an opposing surface of the sensor electronics module to form a seal (e.g., a face seal). In some examples, an outer surface 1036 of the protrusion 1024 may seal against a corresponding surface (e.g., an inner surface on a cavity of the sensor electronics module 1006) to form a radial seal (e.g., an O-ring or lip seal against the sensor electronics module).

[0171] 10A and 10B, protrusion 1024 and electrical connector 1026 are laterally offset from one or more batteries (i.e., to the right of the battery in FIG. 10B), in which case electrical connector 1026 can be electrically coupled to the battery via electrical connector 1032. In some alternative examples, such as the embodiment shown in FIG. 13A, the protrusion can extend upward from the battery, for example, as shown in FIG. 11A.

[0172] The protrusion 1024 may form a seal with the sensor electronics module 1006 when the sensor electronics module is assembled with the base 1002. For example, the protrusion may form a radial seal or a face seal with the sensor electronics module 1006. The protrusion may be overmolded to the base or on or around the electrical contacts 1028. Alternatively, a sealing component may be coupled to the protrusion (e.g., the protrusion itself may be integral with the base and a sealing component may be overmolded to the base or otherwise coupled to or disposed around the protrusion). The protrusion or seal may be formed of a material that forms a watertight seal, such as an elastomer or a compliant material (e.g., silicone, TPE, polypropylene, etc.).

[0173] Each of the example bases shown in FIGS. 10A-39C may include one or more electrical contacts 1028, 1029 that can be configured to deliver battery power to a sensor electronics module (e.g., sensor electronics module 106 or sensor electronics module 1006, not shown in FIGS. 11A-39C). While some of the examples are shown with two batteries, other examples may include a single battery or three or more batteries (e.g., three, four, or more batteries). In various examples, the batteries may all be the same, or the batteries may be differently sized or have different electrical or electrochemical properties to provide desired performance characteristics (e.g., current capacity or battery life). In examples with two or more batteries, the batteries may be arranged in series or parallel, but are preferably arranged in series, so that one contact 1028 is positive and the other contact 1029 is negative (or vice versa), thereby forming a closed circuit when coupled with a sensor electronics module. The base may also include electrical contacts 1008, 1010, which may be configured to interface with the sensor electronics module to operably couple one or more sensor system components (e.g., potentiostat 202 shown in FIG. 2 ) to provide power and generate a sensor signal (e.g., to apply a bias via sensor 1016 to generate a signal indicative of an analyte concentration level). In some examples, a cover, film, flex circuit board, potting material (e.g., epoxy), or other component may be provided and configured to extend over the battery and seal with the base. The sealed interface may be created using one or more of a sealing member (e.g., an O-ring or elastomer), ultrasonic welding, laser, radio frequency (RF), or thermal welding. A sensor electronics sealing member may also be provided between the sensor electronics module 1006 and the base.10A-39C, the battery may be coupled to the sensor electronics package via conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure, which may be secured to the base or to the sensor electronics module in various configurations. Any of the structural elements shown in Figures 10A-39C may be combined with those shown in another example of Figures 10A-39C, and many of the examples may have similar or identical components as shown in the figures.

[0174] A battery seal may be provided between the sensor electronics module and the battery or battery contacts to prevent contact between the battery and the external environment (e.g., water during swimming or bathing), which may corrode, wear, or damage the battery or electronic components. The battery seal may be, for example, a face seal, a radial seal (e.g., an O-ring), or an irregular seal. The seal may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature that may be bonded to or assembled with the base or sensor electronics module, or other overmolded or assembled sealing component or feature. The one or more seals may create one continuous seal around the perimeter of both batteries (see, for example, FIGS. 12A, 15A, 16A, 18A, and 19A), or may create individual seals around each battery (see, for example, FIGS. 11A, 13A, 14A, and 23A-39C). In various configurations, the battery 1018 can be assembled to the base through the bottom of the base (see, e.g., Figures 11A, 11B, 13A-16B, 20A-25B, 28A-34, and 38A-39C) or through the top of the base (see, e.g., Figures 12A, 12B, 17A-19B, 26A-37B, and 35A-37D).

[0175] Any of the examples shown in Figures 11A-39C may be coupled to an adhesive component such as the adhesive pad 1014 shown in Figures 10A, 23A-23C, 28A-28C, 30A-30B, 32, 34, 36 and / or 38A, 38B, or alternatively or additionally may include an adhesive on the bottom surface 1052 of the base for coupling the base to a host.

[0176] FIG. 11A is a perspective top view of an exemplary sensor base 1102 having two protruding seal members 1124, 1125 that may be offset from the battery 1018. FIG. 11A shows the electrical contacts 1128, 1129 as conductive elastomer puck-type contacts that may press against corresponding contacts (not shown) on the sensor electronics module when the sensor electronics module is assembled with the base 1102. Battery power may be supplied to the sensor electronics module via the electrical contacts 1128, 1129. The seal members 1124, 1125 may be configured to seal against the sensor electronics module (not shown), such that the electrical contacts 1128, 1129 may be sealed from exposure to potential environmental elements, such as water. The seal members 1124, 1125 may be, for example, overmolded elastomer seals (e.g., overmolded onto the base). The seal member 1124 may form a face seal when pressed against the sensor electronics module. In one example, the outer surfaces 1130, 1131 of the sensor electronics module may seal against one or more inner surfaces of corresponding cavities in the sensor electronics module. Alternatively, or additionally, the end faces 1132, 1133 may form a seal against an opposing surface on the sensor electronics module.

[0177] 11B is a perspective bottom view of the base 1102. The battery 1018 may be sealed within the base. In some examples, the analyte sensor 1016 (not shown in FIG. 11B) may be delivered to the host through the bottom surface 1104 of the base 1102, for example, through a hole (not shown in FIG. 11B) in the sealed region 1020 (e.g., a cover). The analyte sensor 2016 may be delivered, for example, via a mechanical or electrical delivery system (e.g., an applicator, not shown), which may be configured, for example, to insert the needle / sensor assembly into the host and withdraw the needle, leaving the sensor within the host for sensing the analyte (e.g., glucose) concentration. Exemplary sensor delivery systems are shown and described in U.S. Patent No. 7,949,381, U.S. Patent Application No. 15 / 387,088 (published as US20170188910(A1)), and U.S. Patent Application No. 15 / 298,721 (published as US20170112534(A1)), which are incorporated by reference. Any of the examples shown in Figures 11A-39C can be similarly configured to receive a sensor 1016 and a sensor delivery system.

[0178] The base 1102 and the base shown in Figures 12A-39C may include the mounting unit 1004, electrical contacts 1008, 1010, and sealed area 1020 as described with reference to at least Figures 10A and 10B.

[0179] 12A and 12B illustrate an exemplary base 1202 in which the battery can be loaded from the top side, rather than the bottom side as shown in FIG. 11B. A seal member 1224 can extend around both batteries 1218, 1219 and, optionally, around battery contacts 1228, 1229. The battery contacts 1228, 1229 can be separate components or can be part of the battery. The seal member 1224 can be overmolded to the base or assembled with the base and disposed around the battery contacts 1228, 1229, or around the battery contacts 1228, 1229 and the battery 1018. An outer surface 1230 of the seal member 1224 can be configured to seal against an opposing inner surface on the sensor electronics module (e.g., the inner surface of a cavity) (e.g., sealed against inner surface 1952 on the sensor electronics module 1904 of FIG. 19B). Additionally or alternatively, an inner surface 1231 of the seal member 1224 can be configured to seal against an opposing surface on the sensor electronics module. As shown in FIG. 12B, the batteries 1218, 1219 can be electrically coupled via connector 1232. A sensor (e.g., sensor 104 or sensor 1016) can be delivered through a passage in the base, such as hole 1240 shown in FIG. 12B.

[0180] 13A and 13B illustrate an example base 1302 including sealing members 1324, 1325 having side surfaces 1330, 1331 that can form a face seal with a corresponding surface on the sensor electronics module (e.g., a seal against the interior surface of a cavity on the sensor electronics module) to seal the battery electrical contacts 1328, 1329 against exposure to water or moisture. Additionally or alternatively, end surfaces 1332, 1333 can form a seal against the sensor electronics module.

[0181] 13B shows a film 1310 (or alternatively a flex circuit board) that may be laser or heat bonded (e.g., glued or welded) to the mounting unit 1304 to seal the battery within the mounting unit 1304. For example, a sealed path 1312 may be laser or heat bonded around the periphery of the battery to create an isolated area around the battery. A sensor (e.g., sensor 104 or sensor 1016) may be delivered through a passage in the base, such as hole 1340 shown in FIG. 13B.

[0182] 14A and 14B illustrate an example base 1402 and sensor electronics module 1450. The sensor electronics module may include one or more protrusions 1452 (e.g., a second protrusion is at the rear of the base and therefore not shown) that include one or more electrical contacts 1454 configured to electrically couple with electrical contacts 1428, 1429 on the base 1402. The protrusions 1452 may be configured to fit into corresponding recesses 1434, 1435 in the seal members 1424, 1425, such that one or more outer surfaces 1456 on the protrusions form a radial seal with the seal members.

[0183] The seal members 1424, 1425 may also optionally have end faces 1432, 1433 that may be sized and shaped to form a seal against the opposite surface 1458 of the sensor electronics module to further seal the battery electrical contacts 1428, 1429 against exposure to water or moisture.

[0184] 14B shows a film 1410 (or alternatively a flex circuit board) that can be laser or heat bonded to the mounting unit 1404 to seal the battery within the mounting unit 1404. For example, a sealed weld path 1412 can be laser or heat bonded around the perimeter of the battery to create an isolated area around the battery.

[0185] 15A and 15B illustrate an example base 1502 having a seal member 1524 that can extend around one or more battery contacts 1528, 1529. The outer surface 1530, the inner surface 1531, or both, can be configured to seal against a corresponding opposing surface of the sensor electronics module (not shown in FIGS. 15A, 15B) to form a seal around both battery contacts. The seal member 1524 can be, for example, an overmolded elastomeric gasket.

[0186] 16A and 16B illustrate an example base 1602 having a seal member 1624 that can extend around one or more battery contacts 1628, 1629. An outer surface 1630 of the seal member can include one or more ribs 1631 that can form a radial seal (e.g., similar to an O-ring) with an inner surface 1652 of a cavity 1654 formed by the sensor electronics module 1650. The seal member 1624 can be, for example, a molded elastomeric seal disposed over the battery contacts 1628, 1629. In another example, the seal member 1624 can be overmolded onto the base.

[0187] 17A and 17B illustrate an example base 1702 that includes a radial seal (e.g., an O-ring seal) that extends around the periphery of the base's bottom component 1704. The radial seal 1724 and the top component 1706 (which may be part of the sensor electronics module) may be configured to form a fluid-tight seal to avoid exposure to water or moisture.

[0188] 18A and 18B illustrate an example base 1802 including a radial seal extending around a bottom component 1804 of the base. The radial seal 1824 and a portion 1806 of the sensor electronics module can be configured to form a fluid-tight seal to avoid exposure to water or moisture. The radial seal 1824 can be, or can include, for example, an overmolded elastomeric feature (e.g., overmolded onto the base to extend around an inserted battery or battery contacts).

[0189] 19A and 19B illustrate an example base 1902 including a seal member 1924 that extends around both batteries 1918, 1919. The seal member 1924 may be overmolded to the base and sized and shaped to extend around the batteries 1918, 1919 (or around battery contacts (not shown) and the batteries). An outer surface 1930 of the seal member 1924 may include a ring feature 1931 that may be configured to seal against an opposing inner surface 1954 within a cavity on the sensor electronics module 1950.

[0190] 20A and 20B illustrate another example base 2002 including a single seal member 2024 that may include a cavity 2126 that may be configured to receive a protrusion 2052 extending from a bottom side 2054 of a sensor electronics module 2050. The seal member 2024 may be configured to seal against an outer surface 2058 of the protrusion. In some examples, the seal member 2024 may form a face seal with the protrusion 2052 or may form a radial seal (e.g., via an internal rib (not shown) in the cavity 2026 of the seal member). The protrusion 2052 may include one or more electrical contacts 2056 (e.g., a second contact, not shown, may be on the other side of the protrusion to complete a circuit; see, e.g., FIG. 21B ). The electrical contacts 2056 may electrically couple with corresponding contacts (not shown) on an inner surface of the seal member 2024 (eg, on the inner wall of the cavity 2026 of the seal member 2024 that receives the protrusion).

[0191] 21A and 21B illustrate another example base 2102 including a single seal member 2124 that may include a cavity 2126 that may be configured to receive a protrusion 2152 extending from a bottom side 2154 of the sensor electronics module 2150. The seal member 2124 may be configured to seal against an outer surface 2158 of the protrusion. In various examples, the seal member 2124 may form a face seal with the protrusion 2152 or a radial seal (e.g., via internal ribs (not shown) in the seal member cavity 2126). The protrusion 2152 may include one or more electrical contacts 2156, 2160. The electrical contacts 2156, 2160 may be electrically coupled to corresponding contacts (not shown) on an inner surface of the seal member 2124 (e.g., on an inner wall of the seal member cavity 2126 that receives the protrusion).

[0192] 22A and 22B illustrate another exemplary base 2202 similar to the example 1102 shown in FIG. 11A, but with seal members 2224, 2225 seated on a front portion 2204 of the base 2202. As shown in FIG.

[0193] Toe-in embodiment Several embodiments that utilize protrusions or "toes" on the sensor electronics module to secure the sensor electronics module to a base are described below in connection with Figures 23A-29C.

[0194] Although not shown in Figures 23A-29C, the base 2302-2902 may include an analyte sensor (e.g., analyte sensor 104 of Figure 1, analyte sensor 212 of Figure 2, analyte sensor 1016 of Figure 10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration in the host, while the sensor electronics module 2350-2950 may include sensor electronics described herein (e.g., sensor electronics 106 of Figures 1 and / or 2) and may include at least a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal generated by the analyte sensor.

[0195] In some embodiments, the analyte sensor base assembly may include a base 2302-2902 configured to adhere to the skin of a host and one or more of the analyte sensors as described above and configured to generate a sensor signal indicative of an analyte concentration level in the host, at least one battery as will be described below, at least one sensor contact 2308-2908 and / or 2310-2910, at least one battery contact 2328-2938 and / or 2329-2929, at least a seal member 2324-2924 configured to provide a seal around the at least one battery contact 2328-2938 and / or 2329-2929, and / or any other features configured to be associated with and / or coupled to the base 2302-2902 as will be described below.

[0196] Figure 23A is a perspective view of an exemplary base 2302 and a sensor electronics module 2350 configured to be fixedly mounted to the base 2302, according to some embodiments. Figure 23B is a perspective view of the sensor electronics module 2350 fixedly mounted to the base 2302 of Figure 23A. Figure 23C is a top view of the sensor electronics module 2350 fixedly mounted to the base 2302 of Figure 23A. The discussion continues with respect to Figures 23A-23C.

[0197] As shown in the figure, analyte sensor system 2300 includes a base 2302 and a sensor electronics module 2350. The base 2302 can be configured to adhere to the host's skin utilizing adhesive pads 2314, which can be disposed on a back surface of the base 2302, for example. In some embodiments, the adhesive pads 2314 can include a peelable backing layer. The base 2302 can be adhered to the host's skin by pressing the base 2302 and adhesive pads 2314 onto the skin. Suitable adhesive pads can be selected and designed to stretch, stretch, conform to, and / or vent the area of ​​the host's skin. Various configurations and arrangements can provide the water-resistant, waterproof, and / or sealing properties associated with the base / sensor electronics module embodiments described herein.

[0198] In some embodiments, the base 2302 may be configured to utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 2350. For example, the base 2302 may have a raised perimeter 2304 configured to at least partially surround the sensor electronics module 2350 when the sensor electronics module 2350 is physically and / or mechanically coupled to the base 2302, thereby guiding the sensor electronics module 2350 into position during such physical and / or mechanical coupling.

[0199] To achieve, act on and / or support such physical and / or mechanical coupling, the base 2302 may further include a first retaining member 2342 and a second retaining member 2344, while the sensor electronics module 2350 may further include an anchoring feature 2352 configured to mate with the first retaining member 2342 and a retaining feature 2356 configured to mate with the second retaining member 2344.

[0200] The first retaining member 2342 of the base 2302 may include a recess, ridge, hook, slit, or any other type of suitable retaining member. The first retaining member 2342 may be disposed, for example, at a first end of the base 2302. The second retaining member 2344 of the base 2302 may include a snap, hook, button, or any other suitable retaining member. The second retaining member 2344 may be disposed, for example, at a second end of the base 2302 opposite the first end.

[0201] The anchoring feature 2352 of the sensor electronics module 2350 may include a protrusion, a toe, or any other type of suitable retaining feature configured to mate with and be substantially secured by the first retaining member 2342 of the base 2302. The retaining feature 2356 of the sensor electronics module 2350 may include a recess, a ridge, a hook, a slit, or any other type of suitable retaining feature configured to mate with, fit within, and / or otherwise be suitably secured by the second retaining member 2344 of the base 2302.

[0202] For example, to secure the sensor electronics module 2350 to the base 2302, the securement feature 2352 of the sensor electronics module 2350 may be inserted into the first retaining member 2342 of the base 2302 such that the sensor electronics module 2350 is disposed at a high angle relative to the base 2302, as shown in FIG. 23A. The sensor electronics module 2350 may then be pivoted toward the base 2302 substantially about the mated first retaining member 2342 and first retaining feature 2352 until the retaining feature 2356 and the second retaining member 2344 mate with one another (e.g., fit together in a retaining orientation), thereby securing the sensor electronics module 2350 to the base 2302 as shown in FIGS. 23B-23C.

[0203] In some embodiments, the second retaining member 2344 is an integral part of the base 2302 and is not configured to be separable from the base 2302. In such embodiments, the second retaining member 2344 may be configured to release the retaining feature 2356, for example, by applying a sufficient force to the second retaining member 2344 to sufficiently deflect it, thereby decoupling it from the second retaining feature 2356. However, in other embodiments, similar to those described in more detail below in connection with at least FIGS. 24A-24D , the second retaining member 2344 may be disposed on a frangible tab 2362 of the base 2302 that is configured to separate from the base 2302, thereby decoupling the second retaining member 2344 from the retaining feature 2356 and decoupling the sensor electronics module 2350 from the base 2302.

[0204] Although not shown in Figures 23A-23C, base 2302 may include at least a battery (e.g., battery 292 of Figure 2) configured to power the analyte sensor and / or sensor electronics module 2350, a first sensor contact (e.g., similar to contact 2408 of Figure 24A) and a second sensor contact (e.g., similar to contact 2410 of Figure 24A), each electrically coupled to a respective terminal of the analyte sensor, and a first battery contact (e.g., similar to contact 2428 of Figure 24A) and a second battery contact (e.g., similar to contact 2429 of Figure 24A), each electrically coupled to a respective terminal of the battery.

[0205] 23A-23C, the sensor electronics module 2350 may include a plurality of contacts (e.g., similar to contact 2554 of FIG. 25A) that may include a first signal contact configured to make electrical contact with the first sensor contact, a second signal contact configured to make electrical contact with the second sensor contact, a first power contact configured to make electrical contact with the first battery contact, and a second power contact configured to make electrical contact with the second battery contact (see, e.g., FIGS. 24A-29C). Such first and second power contacts may be configured to receive power from the battery, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor.

[0206] Although not shown in Figures 23A-23C, the analyte sensor assembly 2300 may further include a first seal member (see, e.g., Figures 24A-29C) configured to surround and seal the first and second sensor contacts, the first and second battery contacts, the first and second signal contacts, and the first and second power contacts within the first cavity.

[0207] 24A-27B illustrate several variations and / or embodiments of analyte sensor systems similar to those of FIGS. 23A-23C and are described in more detail below. Where appropriate, the sensor electronics module 2350 and base 2302 of FIGS. 23A-23C can be considered to include at least some or all of the features described in connection with any of FIGS. 24A-27B.

[0208] Figure 24A is a perspective view of a base 2402 including a cover 2460 having a frangible tab 2462 with a retention member 2444 disposed thereon, according to some embodiments. Figure 24B is an enlarged perspective view of the frangible tab 2462 and retention member 2444 of Figure 24A shown retaining a sensor electronics module 2450 to the base 2402. Figure 24C is a perspective view of the cover 2460 of Figure 24A. And Figure 24D is a perspective bottom view of the base 2402. The discussion continues with respect to Figures 24A-24D.

[0209] The analyte sensor system 2400 may include a base 2402 and a sensor electronics module 2450. As illustrated in the figure, the base 2402 includes a cover 2460 configured to be attached to and / or disposed on a bottom side of the base 2402. The cover 2460 may include a plurality of conductive traces 2466, which may be formed using any suitable process, such as laser direct structuring (LDS) of the cover 2460 or overmolding of a conductive elastomer. The conductive traces 2466 may ultimately be used to transmit electrical signals from the analyte sensor to the sensor electronics module 2450 and / or power from a battery 2418 to the sensor electronics module 2450 and the analyte sensor. The cover 2460 may further include a recess 2468 configured to receive the battery 2418. It is believed that fabricating the traces 2466 on the cover 2460 instead of on the base 2402 may provide manufacturability benefits due to the small size of the base 2402 and the manufacturing process for LDS traces.

[0210] The cover 2460 is further illustrated as having a frangible tab 2462 coupled to the body of the cover 2460 by a break line 2464. The frangible tab 2462 is configured to separate from the cover 2460 along the break line 2464 when the frangible tab 2462 is sufficiently bent, flexed, or otherwise deflected from its rest position shown in FIG. 24C . The cover 2460 may be secured to the bottom surface of the base 2402 using any suitable method, such as snaps, adhesive, friction fit, heat staking, and / or laser, heat, or ultrasonic welding along the weld line 2412. As shown in FIG. 24D , when secured to the base 2402, the cover 2460 may secure the battery 2418 within a cavity in the bottom surface of the base 2402.

[0211] 24A, the base 2402 includes a seal member 2424. A first sensor contact 2408 and a second sensor contact 2410 are disposed within the seal member 2424 and each is electrically coupled to a respective terminal of an analyte sensor (not shown in FIGS. 24A-24D) within the base 2402 via at least some of the conductive traces 2466a on the cover 2460, as shown in FIG. 24C. For example, when the cover 2460 is properly secured to the bottom surface of the base 2402, a first portion of the conductive traces 2466a may be configured to contact the first and second sensor contacts 2408, 2410, and a second portion of the conductive traces 2466a (e.g., the portion including the raised post-like feature illustrated in FIG. 24C) may be further configured to contact a respective terminal or electrode of the analyte sensor.

[0212] A first battery contact 2428 and a second battery contact 2429 are also disposed within the seal member 2424, and each is electrically coupled to a respective terminal of the battery 2418 via at least some of the conductive traces 2466b on the cover 2460, as also shown in FIG. 24C. For example, when the cover 2460 is properly secured to the base 2402, a first portion of the conductive traces 2466b may be configured to contact the first and second battery contacts 2428, 2429, and a second portion of the conductive traces 2466b (e.g., a portion abutting and / or contacting the cavity 2468 for receiving the battery 2418 illustrated in FIG. 24C) may be further configured to contact a respective terminal or electrode of the battery 2418. In some embodiments, when the cover 2460 is properly secured to the base 2402, a current-limiting diode 2498 (see FIG. 24C) may be disposed in series between at least two portions of the conductive traces 2466b to electrically connect the conductive traces 2466b and may be configured to limit the amount of current that may be drawn from the battery 2418, thereby improving the useful life of the battery 2418. Such a current-limiting diode 2498 may be disposed in a pocket 2499 in the base 2402 (see FIG. 24D).

[0213] In some embodiments, as shown in at least FIG. 24A , the first and second sensor contacts 2408, 2410 may be disposed a predetermined distance from the first and second battery contacts 2428, 2429, which may substantially reduce signal interference compared to embodiments in which the first and second sensor contacts 2508, 2510 and the first and second battery contacts 2528, 2529 are disposed immediately adjacent to one another (see, e.g., FIGS. 25A, 25B ). The predetermined distance may be a distance sufficient to substantially reduce signal interference (e.g., leakage current, ionic contamination) from the sensor contacts and / or battery contacts. The predetermined distance may be determined by the resistance of the PCB substrate material and / or the solder mask on the contacts. In some embodiments, the predetermined distance is at least 1 millimeter. In some embodiments, the predetermined distance is at least 2 millimeters. In some embodiments, the predetermined distance is at least 3 millimeters. In some embodiments, the predetermined distance is at least 4 millimeters. In some embodiments, the predetermined distance is at least 5 millimeters. In some embodiments, the predetermined distance is at least 10 millimeters. In some embodiments, the predetermined distance is at least 15 millimeters. The contacts 2408, 2410, 2428, 2429 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0214] 24A-24D , the opposing (e.g., bottom) surface of the sensor electronics module 2450 may further comprise a plurality of contacts, including a first signal contact configured to make electrical contact with the first sensor contact 2408, a second signal contact configured to make electrical contact with the second sensor contact 2410, a first power contact configured to make electrical contact with the first battery contact 2428, and a second power contact configured to make electrical contact with the second battery contact 2429. Thus, the first and second signal contacts on the bottom surface of the sensor electronics module 2450 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 2418 when the sensor electronics module 2450 is properly secured to the base 2402. Such contacts on the sensor electronics module 2450 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0215] When the sensor electronics module 2450 is secured to the base 2402, the seal member 2424 is configured to press against an opposing surface of the sensor electronics module 2450, thereby forming a first cavity 2420 between the base 2402 and the sensor electronics module 2450. The single seal member 2424 is thus configured to surround each of the first and second sensor contacts 2408, 2410, the first and second battery contacts 2428, 2429, the first and second signal contacts, and the first and second power contacts of the sensor electronics module 2450, creating one continuous seal within the first cavity 2420. The seal member 2424 may be composed of or include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or ultraviolet curable silicone that may be bonded to or assembled with the base 2402.

[0216] In some embodiments, the base 2402 may be configured to utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 2450. For example, the base 2402 may have a raised perimeter 2404 configured to at least partially surround the sensor electronics module 2450 when the sensor electronics module 2450 is physically and / or mechanically coupled to the base 2402, thereby guiding the sensor electronics module 2450 into position during such physical and / or mechanical coupling.

[0217] To achieve, affect, and / or support such physical and / or mechanical coupling, base 2402 may further include a first retaining member 2442 and a second retaining member 2444, while sensor electronics module 2450 may further include a first retaining feature (not shown in FIGS. 24A-24D , but having a similar structure, function, and location as anchoring feature 2352 of FIGS. 23A-23C ) configured to mate with first retaining member 2442, and a retaining feature 2456 configured to mate with second retaining member 2444. First and second retaining members 2442, 2444, anchoring feature, and retaining feature 2456 may have a similar or the same structure, function, and location as first and second retaining members 2342, 2344, anchoring feature 2352, and retaining feature 2356 of FIGS. 23A-23C , respectively.

[0218] To secure the sensor electronics module 2450 to the base 2402, a first retention feature (not shown in FIGS. 24A-24D) of the sensor electronics module 2450 may be inserted into the first retention member 2442 of the base 2402 such that the sensor electronics module 2450 is disposed at a high angle relative to the base 2402, similar to that shown in FIG. 23A. The sensor electronics module 2450 may then be pivoted toward the base 2402 substantially about the mated first retention member 2442 and first retention feature until the retention feature 2456 and the second retention member 2444 mate with one another, thereby securing the sensor electronics module 2450 to the base 2402 in an orientation as shown in FIGS. 23B, 23C, and 24B.

[0219] 24A-24C , the second retaining member 2444 of the base 2402 can be disposed on a frangible tab 2462 of the cover 2460. The frangible tab 2462 is configured to separate from the base 2402 along a break line 2464. Thus, the reusable sensor electronics module 2450 can be decoupled from the disposable base 2402 by sufficiently bending, flexing, or otherwise altering the frangible tab 2462 from its resting position to decouple the second retaining member 2444 from the second retaining feature 2456. The reusable sensor electronics module 2450, which includes relatively more expensive components than the disposable base 2302, can then be secured and / or installed in a new disposable base 2402 with a new analyte sensor and a charged battery 2418 in preparation for a subsequent sensor session for the host. Such an arrangement, in which the sensor electronics (e.g., including a wireless transceiver) are disposed within a housing or module that is mechanically separable from the analyte sensor and / or battery, advantageously allows for replacement of inexpensive components of the analyte sensor system 2400 (e.g., base 2402) and reuse of relatively more expensive components of the analyte sensor system 2400 (e.g., sensor electronics module 2450).

[0220] Figure 25A is an exploded perspective view of an exemplary base 2502 and a sensor electronics module 2550 configured to be fixedly mounted within the base 2502, according to some embodiments. Figure 25B is a top view of the base 2502 of Figure 25A. The discussion continues with respect to Figures 25A and 25B.

[0221] The analyte sensor system 2500 may include a base 2502 and a sensor electronics module 2550. Similar to the base 2402 of FIGS. 24A-24D , the base 2502 is configured to receive a battery 2518 within a cavity in the bottom surface of the base 2502. The base 2502 may also include a cover 2560 configured to be attached to and / or disposed on the bottom side of the base 2502. However, unlike the cover 2460 of FIGS. 24A-24D , the cover 2560 may not cover a substantial portion of the bottom surface of the base 2502, but instead may be shaped and sized to secure the battery 2518 within the base 2502. The cover 2560 may be secured to the bottom surface of the base 2502 using any suitable method, such as snaps, adhesive, friction fit, heat staking, and / or laser, heat, or ultrasonic welding along a weld line 2512.

[0222] 25B, the base 2502 may include a plurality of conductive traces 2566, which may be formed using any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer of the base 2502. The conductive traces 2566 may ultimately be utilized to transmit electrical signals from the analyte sensors to the sensor electronics module 2550 and / or power from the battery 2518 to the sensor electronics module 2550 and the analyte sensors. Fabricating the traces 2566 directly on the base 2502 could reduce the part count and the size and / or volume of the overall sensor electronics module.

[0223] The base 2502 further includes a first sensor contact 2508 and a second sensor contact 2510, each electrically coupled to a respective terminal of an analyte sensor within the base 2502 via at least some of the conductive traces 2566. The base 2502 further includes a first battery contact 2528 and a second battery contact 2529, each electrically coupled to a respective terminal of the battery 2518 via at least some of the conductive traces 2566. As shown in the figure, the contacts 2508, 2510, 2528, 2529 may be disposed immediately adjacent to one another (e.g., along a straight or curved line) and may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0224] Base 2502 further includes a seal member 2524 that may extend over conductive traces 2566, thereby sealing them from moisture ingress, and that surrounds the periphery of contacts 2508, 2510, 2528, 2529 on base 2302 to form a single continuous seal. Seal member 2524 may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or UV-curable silicone that may be bonded to or assembled with base 2502.

[0225] The opposing (e.g., bottom) surface of the sensor electronics module 2550 further comprises a plurality of contacts 2544, the plurality of contacts 2544 may include a first signal contact configured to make electrical contact with the first sensor contact 2508, a second signal contact configured to make electrical contact with the second sensor contact 2510, a first power contact configured to make electrical contact with the first battery contact 2528, and a second power contact configured to make electrical contact with the second battery contact 2529. Thus, the first and second signal contacts on the bottom surface of the sensor electronics module 2550 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 2518 when the sensor electronics module 2550 is properly secured to the base 2502. Such contacts 2554 on the sensor electronics module 2550 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0226] When the sensor electronics module 2550 is secured to the base 2502, the seal member 2524 is configured to press against a facing surface of the sensor electronics module 2550, thereby forming a first cavity 2520 between the base 2502 and the sensor electronics module 2550. Thus, when the sensor electronics module 2550 is secured to the base 2502, the seal member 2524 is configured to surround each of the first and second sensor contacts 2508, 2510, the first and second battery contacts 2528, 2529, the first and second signal contacts, and the first and second power contacts of the sensor electronics module 2550, creating a continuous seal.

[0227] In some embodiments, the base 2502 may be configured to utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 2550. For example, the base 2502 may have a raised perimeter 2504 configured to at least partially surround the sensor electronics module 2550 when the sensor electronics module 2550 is physically and / or mechanically coupled to the base 2502, thereby guiding the sensor electronics module 2550 into position during such physical and / or mechanical coupling.

[0228] To achieve, act on and / or support such physical and / or mechanical coupling, the base 2502 may further include a first retaining member 2542 and a second retaining member (not shown in Figures 25A and 25B, but having a structure, function and location similar to the second retaining members 2344, 2444 of Figures 23A to 24D), while the sensor electronics module 2550 may further include an anchoring feature 2552 configured to mate with the first retaining member 2542 and a retaining feature 2556 configured to mate with the second retaining member. The first and second retaining members 2542, anchoring feature 2552 and retaining feature 2556 may have similar or identical structure, function and location to the first and second retaining members 2342, 2344, anchoring feature 2352 and retaining feature 2356 of Figures 23A-23C, respectively, except that anchoring feature 2552 may be wider than anchoring feature 2352 of Figures 23A-23C.

[0229] Although not shown in FIGS. 25A and 25B, the second retaining member may be disposed on the base 2502, for example, as described in connection with FIGS. 23A-23C, rather than a cover, as described in connection with FIGS. 24A-24D. In some embodiments, the second retaining member is an integral part of the base 2502 and is not configured to be separable from the base 2302. In other embodiments, the base 2502 may include a frangible tab similar to that previously described in connection with at least FIGS. 24A-24D, and the second retaining member may be disposed on the frangible tab. The sensor electronics module 2550 may be secured to and detached from the base 2502, substantially as previously described in connection with at least FIGS. 23A-24D.

[0230] Figure 26A is an exploded perspective view of an exemplary base 2602 and a sensor electronics module 2650 configured to be fixedly mounted within the base 2602, according to some embodiments. Figure 26B is a top view of the base 2602 of Figure 26A. The discussion continues with respect to Figures 26A and 26B.

[0231] 26B , the base 2602 may include a plurality of conductive traces 2666, which may be formed using any suitable process, such as laser direct structuring (LDS) of the base 2602 or overmolding of a conductive elastomer. The conductive traces 2666 may ultimately be utilized to transmit electrical signals from the analyte sensor to the sensor electronics module 2650 and / or power from the battery 2618 to the sensor electronics module 2650 and / or the analyte sensor.

[0232] The base 2602 further includes a first sensor contact 2608 and a second sensor contact 2610, each electrically coupled to a respective terminal of an analyte sensor in the base 2602 via at least some of the conductive traces 2666. The base 2602 further includes a first battery contact 2628 and a second battery contact 2629, each electrically coupled to a respective terminal of the battery 2618 via at least some of the conductive traces 2666. In some embodiments, at least one terminal of the battery 2618 can be a radially conductive connection including conductive material disposed on a sidewall of a portion of the base 2602 configured to hold the battery 2618. Such a radially conductive terminal can be configured to physically secure the battery 2618 to the base 2602 and provide an electrical connection from one battery terminal to one of the battery contacts 2628, 2629.

[0233] As shown in the figures, and similar to the embodiment illustrated by Figures 25A and 25B, the contacts 2608, 2610, 2628, 2629 may be disposed immediately adjacent to one another (e.g., disposed along a straight or curved line) and may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0234] Base 2602 further includes a cover 2660 with a seal member 2624 that may extend over, thereby sealing, conductive traces 2666 and battery 2618, and also surround the periphery of each of contacts 2608, 2610, 2628, 2629 on base 2302, creating a continuous seal. Cover 2660 and / or seal member 2624 may include overmolded components such as an overmolded gasket, overmolded elastomeric features, and / or UV-curable silicone, which may be bonded to a surface of base 2602 using any suitable method, for example, adhesive, heat staking, and / or laser, thermal, or ultrasonic welding along weld line 2612. The cover 2660 may also extend over the through-hole 2640 of the base 2602, and the cover 2660 may also include a second seal 2625 surrounding the through-hole 2640. Due to the cover 2660 extending over substantially all or a significant portion of the top surface of the base 2602, the cover 2660 may act as an isolation cover for all or at least some of the components of the base 2602 disposed therebelow.

[0235] An opposing (e.g., bottom) surface of the sensor electronics module 2650 may further comprise a plurality of contacts 2654, the plurality of contacts 2654 may include a first signal contact configured to make electrical contact with the first sensor contact 2608, a second signal contact configured to make electrical contact with the second sensor contact 2610, a first power contact configured to make electrical contact with the first battery contact 2628, and a second power contact configured to make electrical contact with the second battery contact 2629. Thus, when the sensor electronics module 2650 is properly secured to the base 2602, the first and second signal contacts on the bottom surface of the sensor electronics module 2650 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 2618. Such contacts on the sensor electronics module 2650 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0236] When the sensor electronics module 2650 is secured to the base 2602, a portion of the seal member 2624 on the cover 2660 and around the contacts 2608, 2610, 2628, 2629 is configured to press against an opposing surface of the sensor electronics module 2650, thereby forming a first cavity 2620 between the base 2602 and the sensor electronics module 2650. Thus, when the sensor electronics module 2650 is secured to the base 2602, the seal member 2624 is configured to surround and create a continuous seal around the first and second sensor contacts 2608, 2610, the first and second battery contacts 2628, 2629, and the plurality of contacts 2654 (e.g., the first and second signal contacts and the first and second power contacts) of the sensor electronics module 2650.

[0237] In some embodiments, base 2602 can be configured to physically and / or mechanically couple to sensor electronics module 2650 using one or more retention features. For example, base 2602 can have a raised outer perimeter 2604 configured to at least partially surround sensor electronics module 2650 when sensor electronics module 2650 is physically and / or mechanically coupled to base 2602, thereby guiding sensor electronics module 2650 to a fixed position during such physical and / or mechanical coupling.

[0238] To achieve, actuate, and / or support such physical and / or mechanical coupling, base 2602 can further include a first retention member 2642 and a second retention member (not shown in FIGS. 26A and 26B, but having a structure, function, and location similar to second retention members 2344 (FIG. 23A), 2444 (FIG. 24D)). Meanwhile, sensor electronics module 2650 can further include a fixed feature 2652 configured to mate with first retention member 2642, and a retention feature 2656 configured to mate with the second retention member. The first and second retention members 2642, fixed feature 2652, and retention feature 2656 can each have a structure, function, and location similar or identical to the first and second retention members 2342, 2344, fixed feature 2352, and retention feature 2356 of FIGS. 23A-23C, except that fixed feature 2652 can be wider than fixed feature 2352 of FIGS. 23A-23C and can be similar to fixed feature 2552 of FIGS. 25A and 25B, but having a substantially rounded leading edge.

[0239] Although not shown in FIGS. 26A and 26B , the second retention member may be disposed on the base 2602, for example, as described in connection with FIGS. 23A-23C and 25A-25B , rather than being a cover as described in connection with FIGS. 24A-24D . In some embodiments, the second retention member is an integral part of the base 2602 and is not configured to be separable from the base 2602. In other embodiments, the base 2602 may include a frangible tab similar to that previously described in connection with at least FIGS. 24A-24D , and the second retention member may be disposed on the frangible tab. The sensor electronics module 2650 may be secured to and detached from the base 2602 substantially as previously described in connection with at least FIGS. 23A-24D .

[0240] Figure 27A is an exploded perspective view of an exemplary base 2702 and a sensor electronics module 2750 configured to be fixedly mounted within the base 2702, according to some embodiments. Figure 27B is a top view of the base 2702 of Figure 27A. The discussion continues with respect to Figures 27A and 27B.

[0241] Analyte sensor system 2700 may include a base 2702 and a sensor electronics module 2750. Although some features are not shown in Figures 27A-27B, base 2702 and sensor electronics module 2750 may include substantially the same features as already described for base 2602 and sensor electronics module 2650 in connection with Figures 26A-26B, with the following differences.

[0242] The securing feature 2752 of the sensor electronics module 2750, configured to mate with the first retaining member 2742 of the base 2702, may include protrusions or "toes" similar to those previously described for the first retaining member 2342 of FIGS. 23A-23C. Additionally, rather than the first seal member 2724 covering most of the top surface of the base 2702, the first seal member 2724 may instead form a continuous perimeter seal extending around the battery 2718 disposed in a cavity in the top surface of the base 2702 and each of the contacts on the base 2302. A separate second seal member 2725 may surround the through-hole 2740 in the base 2702. The seal members 2724, 2725 may include, for example, overmolded components such as an overmolded gasket, an overmolded elastomeric feature, and / or ultraviolet-curable silicone, which may be bonded to the surface of the base 2702 using any suitable method. Additionally, in some embodiments, the power and signal contacts 2754 on the underside of the sensor electronics module 2750 may be in direct contact with the respective terminals on the battery 2718 and the respective leads of the analyte sensor (not shown in FIGS. 27A, 27B), and are not connected via multiple conductive traces located away from such terminals and leads.

[0243] Figures 28A-29C illustrate several variations and / or embodiments of analyte sensor systems that are at least similar to those of Figures 23A-27B but that provide electrical contacts on the first retention feature of the sensor electronics module, and are described in more detail below.

[0244] Figure 28A is a perspective view of an exemplary base 2802 and a sensor electronics module 2850 configured to be secured within the base 2802, according to some embodiments. Figure 28B is a perspective view of the sensor electronics module 2850 secured to the base 2802 of Figure 28A. Figure 28C is a top view of the sensor electronics module 2850 secured to the base 2802 of Figure 28A.

[0245] As shown, analyte sensor system 2800 includes a base 2802 and a sensor electronics module 2850. Base 2802 can be configured to adhere to the skin of a host utilizing adhesive pad 2814, which can be disposed on a back surface of base 2802, for example. Adhesive pad 2814 can have substantially similar features and functionality as previously described for adhesive pad 2314 of FIGS. 23A-23C.

[0246] The base 2802 may be configured to utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 2850. For example, the base 2802 may have a raised perimeter 2804 configured to at least partially surround the sensor electronics module 2850 when the sensor electronics module 2850 is physically and / or mechanically coupled to the base 2802, thereby guiding the sensor electronics module 2850 into position during such physical and / or mechanical coupling.

[0247] To achieve, act on and / or support such physical and / or mechanical coupling, the base 2802 may further include a first retaining member 2842 and a second retaining member 2844, while the sensor electronics module 2850 may further include an anchoring feature 2852 configured to mate with the first retaining member 2842 and a retaining feature 2856 configured to mate with the second retaining member 2844.

[0248] The first retaining member 2842 of the base 2802 may include a cap or hood and may be disposed, for example, at a first end of the base 2802. The second retaining member 2844 of the base 2802 may include a snap, hook, button, or any other type of suitable retaining member. The second retaining member 2844 may be disposed, for example, at a second end of the base 2802 opposite the first end.

[0249] The anchoring feature 2852 of the sensor electronics module 2850 may include a protrusion, a toe, or any other type of suitable retaining feature configured to mate with and be substantially secured by the first retaining member 2842 of the base 2802. The retaining feature 2856 of the sensor electronics module 2850 may include a recess, a ridge, a hook, a slit, or any other type of suitable retaining feature configured to mate with, fit within, and / or otherwise be suitably secured by the second retaining member 2844 of the base 2802.

[0250] The sensor electronics module 2850 may include a plurality of contacts 2854, which may include first and second signal contacts and first and second power contacts, each disposed on the first retention feature 2852. Such first and second power contacts may be configured to receive power from a battery (not shown in FIGS. 28A, 28B ) disposed within the base 2802, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. Thus, the anchoring feature 2852 is configured to anchor the sensor electronics module 2850 to the base 2802 and provide an electrical connection therebetween, utilizing the same structure for both different functions.

[0251] The sensor electronics module 2850 may further include a first seal member 2824 configured to surround and seal each of the first and second sensor contacts and the first and second battery contacts within a first cavity 2820 located within a cap or hood formed by the first retaining member 2842 of the base 2802. For example, the first seal member 2824 may be a radial or slot seal disposed around a periphery of the fastening feature 2852 and configured to press against an inner surface formed by the first retaining member 2842 and / or of the cap or hood of the base 2802 when the sensor electronics 2850 is properly secured to the base 2802.

[0252] Although not shown in Figures 28A-28C, base 2802 further includes a plurality of electrical contacts (see, e.g., contacts 2908, 2910, 2928, 2929 in Figures 29A-29C) disposed within a cap or hood formed by first retaining member 2842 of base 2802, including, for example, first and second sensor contacts each electrically coupled to a respective terminal of an analyte sensor, and first and second battery contacts each electrically coupled to a respective terminal of a battery (see, e.g., battery 2918 in Figures 29A-29C). The first and second signal contacts and the first and second power contacts (e.g., collectively contacts 2954) of the sensor electronics module 2850 are configured to electrically contact the first and second sensor contacts and the first and second battery contacts (e.g., see contacts 2908, 2910, 2928, 2929 in Figures 29A-29C), respectively, of the base 2802 when the sensor electronics module 2850 is properly secured to the base 2802.

[0253] To secure the sensor electronics module 2850 to the base 2802, the anchoring feature 2852 of the sensor electronics module 2850 may be inserted into the first retaining member 2842 of the base 2802 such that the sensor electronics module 2850 is disposed at a high angle relative to the base 2802, as shown in FIG. 28A. The sensor electronics module 2850 may then be pivoted toward the base 2802 substantially about the mated first retaining member 2842 and anchoring feature 2852 until the retaining feature 2856 and the second retaining member 2844 mate with one another (e.g., fit together in a retaining orientation), thereby securing the sensor electronics module 2850 to the base 2802, as shown in FIGS. 28B-28C. In some embodiments, the force required to securely mount the sensor electronics module 2850 to the base 2802, thereby sealing the contacts 2908, 2910, 2928, 2929 within the first cavity 2820, may be less than with some other toe-in concepts (e.g., see Figures 23A-27B), at least because the first seal member 2824 is disposed around the periphery of the mounting feature 2852, rather than on a portion of the base 2802 or on a cover that is laterally spaced from the mounting feature 2852.

[0254] In some embodiments, the second retaining member 2844 is an integral part of the base 2802 and is not configured to be separable from the base 2802. In such embodiments, the second retaining member 2844 may be configured to release the retaining feature 2856, for example, by applying a sufficient force to the second retaining member 2844 to sufficiently deflect it, thereby decoupling it from the second retaining feature 2856. However, in other embodiments, similar to those previously described in connection with at least FIGS. 23A-24D , the second retaining member 2844 may be disposed on a frangible tab 2862 of the base 2802 that is configured to separate from the base 2802, thereby decoupling the second retaining member 2844 from the retaining feature 2856 and decoupling the sensor electronics module 2850 from the base 2802.

[0255] 29A-29C illustrate variations and / or embodiments of analyte sensor systems similar to those of FIGS. 28A-28C, which are described in more detail below. FIG. 29A is an exploded perspective view of an exemplary base 2902 and a sensor electronics module 2950 configured to be secured within the base 2902, according to some embodiments. FIG. 29B is a perspective view of a portion of the base 2902 of FIG. 29A. FIG. 29C is a perspective view of the bottom of the base 2902 of FIG. 29A. The discussion continues with respect to FIGS. 29A-29C.

[0256] Analyte sensor system 2900 may include a base 2902 and a sensor electronics module 2950. Base 2902 is configured to receive battery 2918 within a cavity in a bottom surface of base 2902. Base 2902 may also include cover 2960 (shown transparent for illustrative purposes) configured to be attached to and / or disposed on the bottom surface of base 2902 and shaped and sized to secure battery 2918 within base 2902. Cover 2960 may be secured to the bottom surface of base 2902 using any suitable method, such as, for example, snaps, adhesive, friction fit, heat staking, and / or laser, heat or ultrasonic welding along weld line 2912.

[0257] 29B , the base 2902 may include a plurality of conductive traces 2966, which may be formed using any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer of the base 2902. The conductive traces 2966 may ultimately be used to transmit electrical signals from the analyte sensors to the sensor electronics module 2950 and / or power from the battery 2918 to the sensor electronics module 2950 and / or the analyte sensors. As illustrated in at least FIG. 29B , according to some embodiments, conductive traces of the conductive traces 2966 utilized to ultimately transmit electrical signals from the analyte sensors to the sensor electronics module 2950 may be disposed at least a predetermined distance away from conductive traces of the conductive traces 2966 utilized to ultimately transmit power from the battery 2918 to the sensor electronics module 2950 and / or the analyte sensors. At least one advantage of such placement of the conductive traces 2966 is reduced signal interference between the electrical signal traces and the power traces. Base 2902 further includes a first plurality of conductive contacts 2937, each in electrical contact with a respective one of conductive traces 2966. Conductive contacts 2937 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or other suitable conductive materials and / or structures. Seal member 2925 (shown transparent in FIG. 29B for illustrative purposes) is disposed over conductive traces 2966 and around at least a portion of conductive contacts 2937. Seal member 2925 may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or UV-curable silicone that may be bonded to or assembled with base 2902.

[0258] 28A-28B , the first retaining member 2942 may include a cap or hood and may be disposed at a first end of the base 2902, for example. Further, in some examples, the first retaining member 2942 may be a separate component from the base 2902, as shown in FIG. 29A . As shown in FIG. 29B , the first retaining member 2942 further includes a second plurality of conductive contacts 2938, each of which is configured to electrically contact a respective one of the conductive contacts 2937 of the base 2902 when the first retaining member 2942 is fixed to the base 2902, for example, by adhesive, welding, or any other suitable method. First retaining member 2942 may further include a second plurality of conductive traces 2967, which, like conductive traces 2966 of base 2902, may be formed utilizing any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer, of first retaining member 2942. First retaining member 2942 may further include a sensor contact 2908, a second sensor contact 2910, a first battery contact 2928, and a second battery contact 2929, each electrically coupled to a respective one of the conductive contacts 2938 via a respective one of the conductive traces 2967. As shown in the figure, contacts 2908, 2910, 2928, 2929 may be disposed immediately adjacent to one another (e.g., along a straight or curved line) and may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0259] First retaining member 2942 further includes a seal member 2924 (e.g., disposed on an inner surface of first retaining member 2942) that extends over conductive traces 2967, thereby sealing them around each of conductive contacts 2937, and seal member 2924 also surrounds the periphery of contacts 2908, 2910, 2928, 2929, creating one continuous seal. Seal member 2924 may be composed of or include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or ultraviolet curable silicone, for example, that may be coupled to or assembled with first retaining member 2942.

[0260] The sensor electronics module 2950 includes an anchoring feature 2952 configured to mate with the first retaining member 2942. The anchoring feature 2952 comprises a plurality of contacts 2954, which may include a first signal contact configured to make electrical contact with the first sensor contact 2908, a second signal contact configured to make electrical contact with the second sensor contact 2910, a first power contact configured to make electrical contact with the first battery contact 2928, and a second power contact configured to make electrical contact with the second battery contact 2929. Thus, when the sensor electronics module 2950 is properly secured to the base 2902, the first and second signal contacts of the anchoring feature 2952 of the sensor electronics module 2950 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 2918. Such contacts 2954 on the fixed features 2952 of the sensor electronics module 2950 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure. It is believed that including the signal contacts 2954 on the fixed features 2952 may improve the space efficiency of the sensor electronics module 2950 and minimize the overall height and / or area of ​​the sensor electronics module 2950.

[0261] When the sensor electronics module 2950 is secured to the base 2902, the seal member 2924 is configured to press against an opposing surface of the securing feature 2952 of the sensor electronics module 2950, ​​thereby forming a first cavity 2920 between the base 2902 (e.g., first retaining member 2942) and the sensor electronics module 2950 (e.g., first retaining feature 2952). Thus, when the sensor electronics module 2950 is secured to the base 2902, the seal member 2924 is configured to surround the first and second sensor contacts 2908, 2910, the first and second battery contacts 2928, 2929, the first and second signal contacts and the first and second power contacts of the sensor electronics module 2950 (e.g., contacts 2854) and create a continuous seal.

[0262] The base 2902 may be configured to utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 2950. For example, the base 2902 may have a raised perimeter 2904 configured to at least partially surround the sensor electronics module 2950 when the sensor electronics module 2950 is physically and / or mechanically coupled to the base 2902, thereby guiding the sensor electronics module 2950 into position during such physical and / or mechanical coupling.

[0263] To achieve, affect, and / or support such physical and / or mechanical coupling, base 2902 may further include a second retaining member (not shown in FIGS. 29A-29C , but having a structure, function, and location similar to second retaining members 2344, 2444 of FIGS. 23A-24D ), while sensor electronics module 2950 may further include a retaining feature 2956 configured to mate with the second retaining member. Second retaining member 2942 and retaining feature 2956 may have a structure, function, and location similar to second retaining member 2344 and retaining feature 2356 of FIGS. 23A-23C , respectively.

[0264] Although not shown in FIGS. 29A and 29B , the second retaining member may be disposed on the base 2902, for example, as described in connection with FIGS. 23A-23C , rather than being a cover, for example, as described in connection with FIGS. 24A-24D . In some embodiments, the second retaining member is an integral part of the base 2902 and is not configured to be separable from the base 2902. In other embodiments, the base 2902 may include a frangible tab similar to that previously described in connection with at least FIGS. 23A-24D , and the second retaining member may be disposed on the frangible tab. The sensor electronics module 2950 may be secured to and detached from the base 2902, substantially as previously described in connection with at least FIGS. 23A-24D .

[0265] Exemplary Over-the-Top Embodiment Several "over-the-top" embodiments utilizing a sensor electronics module configured to be disposed over, surround, and / or obscure an underlying base are described in connection with Figures 30A-37D.

[0266] Although not shown in Figures 30A-37D, the bases 3002-3702 may include an analyte sensor (e.g., analyte sensor 104 of Figure 1, analyte sensor 212 of Figure 2, analyte sensor 1016 of Figure 10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration in the host, while the sensor electronics modules 3050-3750 may include sensor electronics described herein (e.g., sensor electronics 106 of Figures 1 and / or 2) and may include at least a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal generated by the analyte sensor.

[0267] In some embodiments, the analyte sensor base assembly may include a base 3002-3702 configured to adhere to the skin of a host and one or more of the analyte sensors as described above and configured to generate a sensor signal indicative of an analyte concentration level in the host, at least one battery as will be described below, at least one sensor contact 3008-3708 and / or 3010-3710, at least one battery contact 3028-3738 and / or 3029-3729, at least a seal member 3024-3724 and / or 3325, 3525, 3725 configured to provide a seal around the at least one battery contact 3028-3738 and / or 3029-3729, and / or any other features configured to be associated with and / or coupled to the base 3002-3702 as will be described below.

[0268] Figure 30A is an exploded perspective view of an exemplary base 3002 and a sensor electronics module 3050 configured to be secured over or on the base 3002, according to some embodiments. Figure 30B is a perspective assembly view of the sensor electronics module 3050 secured to the base 3002 of Figure 30A. A discussion follows below with respect to Figures 30A and 30B.

[0269] As shown, analyte sensor system 3000 includes a base 3002 and a sensor electronics module 3050. Base 3002 can be configured to adhere to the skin of a host utilizing adhesive pad 3014, which can be disposed on a back surface of base 3002, for example. Adhesive pad 3014 can have substantially similar features and functionality as previously described for adhesive pad 2314 of FIGS. 23A-23C.

[0270] As shown in the figure, the sensor electronics module 3050 may have a raised perimeter 3004 configured to at least partially surround the base 3002 when the sensor electronics module 3050 is physically and / or mechanically coupled to the base 3002, thereby guiding the sensor electronics module 3050 into position during such physical and / or mechanical coupling.

[0271] The sensor electronics module 3050 may further include an opening 3070. In some embodiments, the opening 3070 may be shaped such that there are a limited number of orientations between the sensor electronics module 3050 and the base 3002 that allow the sensor electronics module 3050 to be secured to the base 3002. For example, the opening 3070 may have a shape that is symmetrical about at least one axis parallel to the top surface of the sensor electronics module 3050, but asymmetrical about at least one other axis parallel to the top surface of the sensor electronics module 3050. Such a partially symmetrical shape of the opening 3070 may make it easier for a host to secure the sensor electronics module 3050 to the base 3002 in the proper orientation.

[0272] The base 3002 may have a perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3004 of the sensor electronics module 3050. The base 3002 may further have a raised portion 3005 that has a perimeter or shape that compliments the inner perimeter or shape of the opening 3070. Thus, when the sensor electronics module 3050 is secured over the top of the base 3002, the base 3002 is configured to fit securely within the raised perimeter 3004 of the sensor electronics module 3050, and the raised portion 3005 is configured to fit securely within the opening 3070. In some embodiments, a battery may be located in a cavity (not shown in FIGS. 30A-30B ) within the raised portion 3005 of the base 3002. In some embodiments, when properly secured, the top surface of the raised portion 3005 may sit substantially flush with the top surface of the sensor electronics module 3050, thereby providing tactile feedback that the sensor electronics module 3050 is properly secured to the base 3002. However, the present disclosure is not so limited, and the top surface of the raised portion 3005 may sit higher or lower compared to the top surface of the sensor electronics module 3050. Thus, the use of the opening 3070 in the sensor electronics module 3050 and the raised portion 3005 in the base 3002 allows the analyte sensor system 3000 to have a significantly reduced thickness or depth compared to other analyte sensor systems.

[0273] The base 3002 may further include first and second sensor contacts 3008, 3010, each electrically connected to a respective terminal of the analyte sensor, and first and second battery contacts 3028, 3029, each electrically connected to a respective terminal of the battery. FIG. 30A illustrates the contacts 3008, 3010, 3028, 3029 disposed on an inclined surface 3097 of the raised portion 3005 of the base 3002. Advantages of arranging the contacts 3008, 3010, 3028, 3029 on the inclined surface 3097 include, but are not limited to, space efficiency and a lower profile of the sensor electronics module 3050. However, the present disclosure is not so limited, and the contacts 3008, 3010, 3028, 3029 may be disposed on any suitable surface of the base 3002. The base 3002 may further include a first seal member 3024 configured to surround and seal each of the contacts 3008, 3010, 3028, 3029 within a first cavity 3020 formed between the opposing surface of the base 3002 and the sensor electronics module 3050 and the first seal member 3024. The seal member 3024 may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or UV-curable silicone.

[0274] The sensor electronics module 3050 may include a plurality of contacts 3054 disposed on an inner surface facing the base 3002, the plurality of contacts 3054 may include a first signal contact configured to make electrical contact with the first sensor contact 3008, a second signal contact configured to make electrical contact with the second sensor contact 3010, a first power contact configured to make electrical contact with the first battery contact 3028, and a second power contact configured to make electrical contact with the second battery contact 3029. Such first and second power contacts may be configured to receive power from the battery, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. In some alternative embodiments, the first seal member 3024 may alternatively be disposed on the same surface of the sensor electronics module 3050 as the contacts 3054 facing the base 3002 to form the first cavity 3020.

[0275] The sensor electronics module 3050 may be secured to the base 3002 by pressing the sensor electronics module 3050 against the base 3002 in a direction substantially perpendicular to the bottom surface of the base 3002 until one or more retention features (not shown in FIGS. 30A, 30B ) of the sensor electronics module 3050 mate with one or more corresponding retention members (not shown in FIGS. 30A, 30B ) of the base 3002. In some embodiments, the retention members of the base 3002 may be the same members or features utilized to secure the base 3002 to an applicator (not shown) for initial deployment to the host's skin. The sensor electronics module 3050 may be uncoupled from the base 3002 by pulling the sensor electronics module 3050 vertically away from the base 3002 while pressing with sufficient force to uncouple the raised portions 3005 of the base 3002.

[0276] Similar embodiments to those described in connection with Figures 30A-30C are shown in Figures 31A-31C and described below. Figure 31A is an exploded perspective view of an exemplary base 3102 and a sensor electronics module 3150 configured to cover or be secured onto the base 3102, according to some embodiments. Figure 31B is a perspective view of a battery 3118 disposed on a cover 3160 of the base 3102 of Figure 31A. Figure 31C is a perspective bottom view of the base 3102 and sensor electronics module 3150 of Figure 31A. A discussion follows below with respect to Figures 31A-31C.

[0277] As shown in the figure, the analyte sensor system 3100 comprises a base 3102 and a sensor electronics module 3150. As shown in the figure, the sensor electronics module 3150 may have a raised perimeter 3104 configured to at least partially surround the base 3102 when the sensor electronics module 3150 is physically and / or mechanically coupled to the base 3102, thereby guiding the sensor electronics module 3150 into position during such physical and / or mechanical coupling.

[0278] The sensor electronics module 3150 further includes an opening 3170. Similar to the opening 3070 of Figures 30A-30C, the opening 3170 may be shaped such that there are a limited number of orientations between the sensor electronics module 3150 and the base 3102 that allow the sensor electronics module 3150 and the base 3102 to be secured to one another, which makes it easy for a host to secure the sensor electronics module 3150 to the base 3102 in the proper orientation.

[0279] The base 3102 may have a perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3104 of the sensor electronics module 3150. The base 3102 may further have a raised portion 3105 that has a perimeter or shape that compliments the inner perimeter or shape of the opening 3170. Thus, when the sensor electronics module 3150 is secured over the top of the base 3102, the base 3102 is configured to fit securely within the raised perimeter 3104 of the sensor electronics module 3150, and the raised portion 3105 is configured to fit securely within the opening 3170.

[0280] 31A, the battery 3118 may be located in a cavity in the raised portion 3105 of the base 3102. As previously described in connection with FIGS. 30A-30C, when properly secured, the top surface of the raised portion 3105 may sit substantially flush with the top surface of the sensor electronics module 3150, sit elevated relative to the top surface of the sensor electronics module 3150, or sit elevated relative to the top surface of the sensor electronics module 3150, thereby providing tactile feedback that the sensor electronics module 3150 is properly secured to the base 3102.

[0281] The base 3102 is shown with a cover 3160 configured to be attached to and / or disposed on a bottom side of the base 3102. The cover 3160 may include a plurality of conductive traces 3166, which may be formed using any suitable process, such as laser direct structuring (LDS) of the cover 3160 or overmolding of a conductive elastomer. The conductive traces 3166 may ultimately be used to transmit electrical signals from the analyte sensor to the sensor electronics module 3150 and / or power from the battery 3118 to the sensor electronics module 3150 and the analyte sensor. The cover 3160 may be further configured to receive the battery 3118. The cover 3160 may be secured to the bottom surface of the base 3102 using any suitable method, such as snaps, adhesive, friction fit, heat staking, and / or laser, thermal, or ultrasonic welding along weld seam 3112. As shown in FIG. 31D, when secured to the base 3102, the cover 3160 may secure the battery 3118 within a cavity in the bottom surface of the base 3102.

[0282] 31A-31B, the first sensor contact 3108 and the second sensor contact 3110 are each electrically coupled to respective terminals of the analyte sensor in the base 3102 via at least some of the conductive traces 3166 on the cover 3160. The first battery contact 3128 and the second battery contact 3129 are also each electrically coupled to respective terminals of the battery 3118 via at least some of the conductive traces 3166 on the cover 3160. The contacts 3108, 3110, 3128, 3129 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0283] The base 3102 further includes a first seal member 3124. When the cover 3160 is fixedly attached to the base 3102, each of the contacts 3108, 3110, 3128, 3129 can protrude through the first seal member 3124.

[0284] 31C , the opposing (e.g., bottom) surface of the sensor electronics module 3150 may further comprise a plurality of contacts 3154, the plurality of contacts 3154 may include a first signal contact configured to make electrical contact with the first sensor contact 3108, a second signal contact configured to make electrical contact with the second sensor contact 3110, a first power contact configured to make electrical contact with the first battery contact 3128, and a second power contact configured to make electrical contact with the second battery contact 3129. Thus, when the sensor electronics module 3150 is properly secured to the base 3102, the first and second signal contacts on the bottom surface of the sensor electronics module 3150 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 3118. Such contacts on the sensor electronics module 3150 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0285] When the sensor electronics module 3150 is secured to the base 3102, the seal member 3124 is configured to press against a facing surface of the sensor electronics module 3150, thereby forming a first cavity 3120 between the base 3102 and the sensor electronics module 3150. The seal member 3124 is thus configured to surround the first and second sensor contacts 3108, 3110, the first and second battery contacts 3128, 3129, the first and second signal contacts, and the first and second power contacts of the sensor electronics module 3150, creating a continuous seal within the first cavity 3120. The seal member 3124 may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or UV-curable silicone that may be bonded to or assembled with the base 3102.

[0286] The sensor electronics module 3150 can be secured to and decoupled from the base 3102 in a manner similar to that previously described in connection with Figures 30A-30C.

[0287] 32 is a perspective view of an exemplary base 3202 and a sensor electronics module 3250 configured to be secured over or on the base 3202, according to some embodiments. The analyte sensor system 3200 comprises a base 3202 and a sensor electronics module 3250.

[0288] The base 3202 can be configured to adhere to the skin of the host utilizing an adhesive pad 3214, which can be disposed on a back surface of the base 3202, for example. The adhesive pad 3214 can have substantially similar features and functionality as previously described for the adhesive pad 2314 of Figures 23A-23C.

[0289] The sensor electronics module 3250 is illustrated as having a raised perimeter 3204 configured to at least partially surround the base 3202 when the sensor electronics module 3250 is physically and / or mechanically coupled to the base 3202, thereby guiding the sensor electronics module 3250 into position during such physical and / or mechanical coupling.

[0290] The sensor electronics module 3250 may further include a protrusion 3252 extending away from the underside of the sensor electronics module 3250 and configured to fit within a corresponding recess 3242 in the top surface of the base 3204 when the sensor electronics module 3250 is properly oriented and secured to the base 3202. Utilizing the protrusion 3252 and recess 3242 may allow the host to properly orient and align the sensor electronics module 3250 relative to the base 3202 without direct aim of the alignment / securing process.

[0291] When the sensor electronics module 3250 is secured over the top of the base 3202, the base 3202 is configured to fit securely within the raised perimeter 3204 of the sensor electronics module 3250, and the protrusion 3252 is configured to fit securely within the recess 3242.

[0292] Further aspects of analyte sensor system 3200 are discussed in connection with similar embodiments as shown in Figures 33A-33C below. Thus, analyte sensor system 3200 can be considered to have similar or identical features as those described for analyte sensor system 3300 of Figures 33A-33D.

[0293] Figure 33A is an exploded perspective view of an exemplary base 3302 and a sensor electronics module 3350 configured to cover or be secured to the base 3302, according to some embodiments. Figure 33B is a perspective view of a battery 3318 disposed on a cover 3360 of the base 3302 of Figure 33A. Figure 33C is an exploded perspective bottom view of the cover 3360 and base 3302 of Figure 33A. And Figure 33D is a perspective bottom view of the cover 3360 secured to the base 3302 of Figure 33A. A discussion follows below with respect to Figures 33A-33D.

[0294] As shown in the figure, the analyte sensor system 3300 comprises a base 3302 and a sensor electronics module 3350. The sensor electronics module 3350 may have a raised perimeter 3304 configured to at least partially surround the base 3302 when the sensor electronics module 3350 is physically and / or mechanically coupled to the base 3302, thereby guiding the sensor electronics module 3350 into position during such physical and / or mechanical coupling.

[0295] The sensor electronics module 3350 further includes a protrusion 3352 and the base 3202 further includes a recess 3342, which are similar to the protrusion 3252 and recess 3242 of FIG. 32, respectively, and have substantially the same function.

[0296] In some embodiments, the base 3302 may have a perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3304 of the sensor electronics module 3350. However, the present disclosure is not so limited and the base 3302 may have any perimeter or shape that will fit securely within the raised perimeter 3304 of the sensor electronics module 3350.

[0297] The base 3302 is shown with a cover 3360 configured to be attached to and / or disposed on a bottom side of the base 3302. The cover 3360 may include a plurality of conductive traces 3366, which may be formed using any suitable process, such as laser direct structuring (LDS) of the cover 3360 or overmolding of a conductive elastomer. The conductive traces 3366 may ultimately be used to transmit electrical signals from the analyte sensors to the sensor electronics module 3350 and / or power from the battery 3318 to the sensor electronics module 3350 and / or analyte sensors. The cover 3360 may be secured to the bottom surface of the base 3302 using any suitable method, such as snaps, adhesive, friction fit, heat staking, and / or laser, thermal, or ultrasonic welding along weld seam 3312. When secured to the base 3302 , the cover 3360 may secure the battery 3318 within a cavity in the bottom surface of the base 3302 .

[0298] 33A-33B, the first sensor contact 3308 and the second sensor contact 3310 are each electrically coupled to a respective terminal of the analyte sensor in the base 3302 via at least some of the conductive traces 3366 on the cover 3360. The first battery contact 3328 and the second battery contact 3329 are also each electrically coupled to a respective terminal of the battery 3318 via at least some of the conductive traces 3366 on the cover 3360. The contacts 3308, 3310, 3328, 3329 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0299] The base 3302 further includes a first seal member 3324 and a second seal member 3325. When the cover 3360 is fixedly attached to the base 3302, the contacts 3308 and 3310 can protrude through the first seal member 3324 and the contacts 3328 and 3329 can protrude through the second seal member 3325.

[0300] 33A , the opposing (e.g., bottom) surface of the sensor electronics module 3350 may further comprise a plurality of contacts 3354, the plurality of contacts 3354 may include a first signal contact configured to make electrical contact with the first sensor contact 3308, a second signal contact configured to make electrical contact with the second sensor contact 3310, a first power contact configured to make electrical contact with the first battery contact 3328, and a second power contact configured to make electrical contact with the second battery contact 3329. Thus, when the sensor electronics module 3350 is properly secured to the base 3302, the first and second signal contacts on the bottom surface of the sensor electronics module 3350 are configured to receive a sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from the battery 3318. Such contacts on the sensor electronics module 3350 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or contacts, or any other suitable conductive material.

[0301] When the sensor electronics module 3350 is fixed to the base 3302, the first seal member 3324 is configured to press against the opposing surface of the sensor electronics module 3350, thereby forming a first cavity 3320a between the base 3302 and the sensor electronics module 3350, while the second seal member 3325 is configured to press against the opposing surface of the sensor electronics module 3350, thereby forming a second cavity 3320b between the base 3302 and the sensor electronics module 3350. Thus, the first seal member 3324 is configured to surround and create a continuous seal around the first and second sensor contacts 3308, 3310, and the first and second signal contacts 3354 in the first cavity 3320a, and the first and second power contacts of the sensor electronics module 3350 in the first cavity 3320a, while the second seal member 3325 is configured to surround and create a continuous seal around the first and second battery contacts 3328, 3329, and the first and second power contacts 3354 in the second cavity 3320b. The first and second seal members 3324, 3325 may include overmolded components such as overmolded gaskets, overmolded elastomeric features, and / or UV-curable silicone, for example, that may be coupled to or assembled with the base 3302.

[0302] The sensor electronics module 3350 can be secured to and decoupled from the base 3302 in a manner similar to that previously described in connection with Figures 30A-30C.

[0303] Omnidirectional Over-the-Top Embodiment 34-37D illustrate several embodiments of an analyte sensor system in which a sensor electronics module having a substantially circular outer shape is configured to be omnidirectionally secured to a base having a substantially circular outer shape.

[0304] FIG. 34 is an exploded perspective view of an exemplary base 3402 and a sensor electronics module 3450 configured to be secured over or on the base 3402, according to some embodiments.

[0305] Analyte sensor system 3400 includes a base 3402 and a sensor electronics module 3450. As illustrated, base 3402 and sensor electronics module 3450 can each have a substantially circular outline, which allows one to be aligned with the other in all directions.

[0306] The base 3402 can be configured to adhere to the skin of the host utilizing an adhesive pad 3414, which can be disposed on a back surface of the base 3402, for example. The adhesive pad 3414 can have substantially similar features and functionality as previously described for the adhesive pad 2314 of Figures 23A-23C.

[0307] The base 3402 may have a raised perimeter 3404 configured to at least partially surround the sensor electronics module 3450 when the sensor electronics module 3450 is physically and / or mechanically coupled to the base 3402, thereby guiding the sensor electronics module 3450 into position during such physical and / or mechanical coupling. In some embodiments, the raised perimeter 2404 may have a substantially circular outline. The base 3402 may further include an opening 3470, which in some embodiments may have a substantially circular shape.

[0308] The sensor electronics module 3450 may have a substantially circular perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3404 of the base 3450. The sensor electronics module 3450 may further have a raised portion 3405 that has a substantially circular perimeter or shape that compliments the inner perimeter or shape of the opening 3470. Thus, when the sensor electronics module 3450 is secured over the top of the base 3402, the sensor electronics module 3450 is configured to fit securely within the raised perimeter 3404 of the base 3402, and the raised portion 3405 is configured to fit securely within the opening 3470. In some embodiments, when properly secured, the bottom surface of the raised portion 3405 may sit substantially flush with the bottom surface of the base 3402. However, the present disclosure is not so limited, and the bottom surface of the raised portion 3405 may sit at a higher or lower position compared to the bottom surface of the base 3402. Thus, at least some of the substantially circular shapes and / or perimeters of the sensor electronics module 3450, raised portion 3405, base 3402, and / or raised perimeter 3404 of opening 3470 allow for omnidirectional mounting of the sensor electronics module 3450 to the base 3402. It is believed that omnidirectional mounting may improve user convenience when installing the sensor electronics module 3450 without the need to first align the sensor electronics module 3450.

[0309] The base 3402 may further include a first sensor contact 3408 and a second sensor contact (not shown in FIG. 34 but substantially similar to the first sensor contact 3408), each configured to be electrically connected to a respective terminal of an analyte sensor, and a first battery contact 3428 and a second battery contact 3429, each configured to be electrically connected to a respective terminal of a battery (not shown in FIG. 34) disposed within the base 3402. The base 3402 may further include a first seal member (not shown in FIG. 34 but substantially similar to the first seal member 3524 of FIGS. 35A-35D), configured to surround and seal the first and second sensor contacts 3408 and the first and second battery contacts 3428 within a first cavity 3420 formed between facing surfaces of the base 3402, the sensor electronics module 3450, and the first seal member. The first seal member may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or a UV-curable silicone.

[0310] The sensor electronics module 3450 may include a plurality of concentric circular contacts 3454 disposed on an inner surface facing the base 3402. In some embodiments, the contacts 3454 may each have a substantially ring-like configuration and may each be annularly spaced apart from one another. As shown, the contacts 3454 may be centered on the raised portion 3405, which allows the contacts 3454 to make electrical contact with a respective one of the first and second sensor contacts 3408 and the first and second battery contacts 3428 of the base 3402 when the sensor electronics module 3450 is attached to the base 3402. Due to the annular configuration of each of the contacts 3454, it is contemplated that the sensor electronics module 3450 may be mounted on the base 3402 in any orientation. Each contact 3454 may be configured to contact one of the sensor contacts or battery contacts at any point along the respective contact 3454. The contacts 3454 may be formed utilizing any suitable process, such as laser direct structuring (LDS) of the base 3502 or overmolding of a conductive elastomer. The contacts 3454 may include a first signal contact configured to make electrical contact with the first sensor contact 3408, a second signal contact configured to make electrical contact with the second sensor contact (not shown in FIG. 34 ), a first power contact configured to make electrical contact with the first battery contact 3428, and a second power contact configured to make electrical contact with the second battery contact (not shown in FIG. 34 ). Such first and second power contacts may be configured to receive power from the battery, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. In some alternative embodiments, a first seal member (not shown in FIG. 34) may alternatively be disposed on a surface of the sensor electronics module 3450 at the same surface as or adjacent to the contact 3454 facing the base 3402 to form a first cavity 3420.

[0311] The sensor electronics module 3450 may be secured to the base 3402 by pressing the sensor electronics module 3450 against the base 3402 in a direction substantially perpendicular to the bottom surface of the base 3402 until one or more retention features of the sensor electronics module 3450 fit into one or more corresponding retention members of the base 3402. In some embodiments, the retention members of the base 3402 may be the same members or features utilized to secure the base 3402 to an applicator (not shown) for initial deployment to the host's skin. The sensor electronics module 3450 may be uncoupled from the base 3402 by pulling the sensor electronics module 3450 perpendicularly away from the base 3402 while anchoring the base 3402 with sufficient force to uncouple the base 3402.

[0312] Similar embodiments to those described in connection with Figure 34 are shown in Figures 35A-35D and described below. Figure 35A is an exploded perspective view of an exemplary base 3502 and a sensor electronics module 3550 configured to be secured over or on the base 3502, according to some embodiments. Figure 35B is an exploded perspective bottom view of the base 3502 and sensor electronics module 3550 of Figure 35A. Figure 35C is a plan view of the bottom of the base 3502 of Figure 35A. Figure 35D is a perspective cross-sectional view of the sensor electronics module 3550 secured to the base 3502 of Figure 35A.

[0313] The analyte sensor system 3500 includes a base 3502 and a sensor electronics module 3550. As illustrated, the base 3502 and the sensor electronics module 3550 may each have a substantially circular outline, allowing for omnidirectional alignment therebetween. The base 3502 includes a battery 3518 configured to power the analyte sensor and / or the sensor electronics module 3550. The battery 3518 may be disposed within a cavity through an upper side of the base 3502. In some embodiments, the battery 3518 may be secured within the cavity utilizing a conductive epoxy or another suitable adhesive compound.

[0314] The base 3502 may have a raised perimeter 3504 configured to at least partially surround the sensor electronics module 3550 when the sensor electronics module 3550 is physically and / or mechanically coupled to the base 3502, thereby guiding the sensor electronics module 3550 into position during such physical and / or mechanical coupling. In some embodiments, the raised perimeter 2404 may have a substantially circular outline. In contrast to the base 3402 of FIG. 34 , in some embodiments, the base 3502 may not include an opening similar to opening 3470.

[0315] The sensor electronics module 3550 may have a substantially circular perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3504 of the base 3500. In contrast to the sensor electronics module 3450 of FIG. 34 , in some embodiments, the sensor electronics module 3550 may not have a raised portion similar to the raised portion 3405 because the base 3502 may not include an opening similar to the opening 3470. However, when the sensor electronics module 3550 is secured over the top of the base 3502, the sensor electronics module 3550 is similarly configured to fit securely within the raised perimeter 3504 of the base 3502. The substantially circular shape and / or perimeter of the sensor electronics module 3550 and the raised perimeter 3504 of the base 3502 allows for omnidirectional mounting of the sensor electronics module 3550 to the base 3502.

[0316] The base 3502 may further include a first sensor contact 3508 and a second sensor contact 3510, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact 3528 and a second battery contact 3529, each electrically connected to a respective terminal of the battery 3518. The base 3502 may further include a first seal member 3524 configured to surround and seal each of the first and second sensor contacts 3508, 3510 and the first and second battery contacts 3528, 3529 within a first cavity 3520 formed between opposing surfaces of the base 3502 and the sensor electronics module 3550 and the first seal member 3524. In some embodiments, the first seal member 3524 may be disposed on a surface of the base 3202 facing the sensor electronics module 3550, on a sidewall of the raised perimeter 3504 of the base 3202, or both. In some embodiments, the base 3502 may further include a second seal member 3525 disposed within the perimeter of the first seal member 3524 and around the through-hole 3540 of the base 3202. The first and second seal members 3524, 3525 may include overmolded components such as, for example, overmolded gaskets, overmolded elastomeric features, and / or UV-curable silicone.

[0317] The base 3502 is further illustrated as including a plurality of conductive contacts 3566, which may be formed utilizing any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer of the base 3502. The conductive traces 3566 may ultimately be used to transmit electrical signals from the analyte sensor to the sensor electronics module 3550 and / or power from the battery 3518 to the sensor electronics module 3550 and the analyte sensor.

[0318] The sensor electronics module 3550 may include a plurality of concentric circular contacts 3554 disposed on an inner surface facing the base 3502. In some embodiments, the contacts 3554 may each have a substantially ring-like configuration and each may be annularly spaced apart from one another, which allows the contacts 3554 to make electrical contact with a respective one of the first and second sensor contacts 3508, 3510 and the first and second battery contacts 3528, 3529 of the base 3502 when the sensor electronics module 3550 is mounted to the base 3502. Due to the annular configuration of each of the contacts 3554, it is contemplated that the sensor electronics module 3550 may be mounted on the base 3502 in any orientation. Each contact 3554 may be configured to contact one of the sensor contacts or battery contacts at any point along the respective contact 3554. The contacts 3554 may be formed utilizing any suitable process, such as laser direct structuring (LDS) of the base 3502 or overmolding of a conductive elastomer. The contacts 3554 may include a first signal contact configured to make electrical contact with the first sensor contact 3508, a second signal contact configured to make electrical contact with the second sensor contact 3510, a first power contact configured to make electrical contact with the first battery contact 3528, and a second power contact configured to make electrical contact with the second battery contact 3529. Such first and second power contacts may be configured to receive power from the battery, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. In some alternative embodiments, one or both of the first and second seal members 3524, 3525 may alternatively be disposed on a surface of the sensor electronics module 3550 at the same surface as or adjacent to the contact 3554 facing the base 3502 to form the first cavity 3520.

[0319] The sensor electronics module 3550 may be secured to the base 3502 by pressing the sensor electronics module 3550 against the base 3502 in a direction substantially perpendicular to the bottom surface of the base 3502 until one or more retention features of the sensor electronics module 3550 fit into one or more corresponding retention members of the base 3502. In some embodiments, the retention members of the base 3502 may be the same members or features utilized to secure the base 3502 to an applicator (not shown) for initial deployment to the host's skin. The sensor electronics module 3550 may be uncoupled from the base 3502 by pulling the sensor electronics module 3550 vertically away from the base 3502 while anchoring the base 3502 with sufficient force to uncouple the base 3502.

[0320] FIG. 36 is an exploded perspective view of an exemplary base 3602 and a sensor electronics module 3650 configured to be secured over or on the base 3602, according to some embodiments.

[0321] Analyte sensor system 3600 includes a base 3602 and a sensor electronics module 3650. As illustrated, base 3602 and sensor electronics module 3650 can each have a substantially circular outline, which allows for omnidirectional alignment therebetween.

[0322] The base 3602 can be configured to adhere to the skin of the host utilizing an adhesive pad 3614, which can be disposed on a back surface of the base 3602, for example. The adhesive pad 3614 can have substantially similar features and functionality as previously described for the adhesive pad 2314 of Figures 23A-23C.

[0323] The sensor electronics module 3650 may have a raised perimeter 3604 configured to at least partially surround the base 3602 when the sensor electronics module 3650 is physically and / or mechanically coupled to the base 3602, thereby guiding the sensor electronics module 3650 into position during such physical and / or mechanical coupling. In some embodiments, the raised perimeter 3604 may have a substantially circular outline. The sensor electronics module 3650 may further include an opening 3670, which in some embodiments may have a substantially circular shape.

[0324] The base 3602 may have a substantially circular perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3604 of the sensor electronics module 3650. The base 3602 may further have a raised portion 3605 having a substantially circular perimeter or shape that compliments the inner perimeter or shape of the opening 3670. Thus, when the sensor electronics module 3650 is secured over the top of the base 3602, the base 3602 is configured to fit securely within the raised perimeter 3604 of the sensor electronics module 3650, and the raised portion 3605 is configured to fit securely within the opening 3670. In some embodiments, when properly secured, the top surface of the raised portion 3605 may sit substantially flush with the top surface of the sensor electronics module 3650. However, the present disclosure is not so limited, and the top surface of the raised portion 3605 may sit higher or lower compared to the top surface of the sensor electronics module 3650. Thus, at least some of the substantially circular shapes and / or perimeters of the sensor electronics module 3650, the raised portion 3605 of the base 3602, the raised perimeter 3604 of the sensor electronics module 3650 and / or the opening 3670 allow for omnidirectional mounting of the sensor electronics module 3650 to the base 3602.

[0325] The base 3602 may further include a first sensor contact 3608 and a second sensor contact 3610, each electrically connected to a respective terminal of an analyte sensor, and a first battery contact 3628 and a second battery contact 3629, each electrically connected to a respective terminal of a battery (not shown in FIG. 36 ) disposed within the base 3602. The base 3602 may further include a first seal member (not shown in FIG. 36 but substantially similar to the first seal member 3724 of FIGS. 37A-37D ) configured to surround and seal each of the first and second sensor contacts 3608 and the first and second battery contacts 3628 within a first cavity 3620 formed between opposing surfaces of the base 3602, the sensor electronics module 3650, and the first seal member. The first seal member may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or a UV-curable silicone.

[0326] The sensor electronics module 3650 may include a plurality of concentric circular contacts 3654 disposed on an inner surface facing the base 3602. In some embodiments, the contacts 3654 may each have a substantially ring-like configuration and may each be annularly spaced apart from one another. As shown, the contacts 3654 may be centered about an opening 3670, which allows the contacts 3654 to make electrical contact with a respective one of the first and second sensor contacts 3608, 3610 and the first and second battery contacts 3628, 3729 of the base 3602 when the sensor electronics module 3650 is mounted to the base 3602. Due to the annular configuration of each of the contacts 3654, it is contemplated that the sensor electronics module 3650 may be mounted on the base 3602 in any orientation. Each contact 3654 may be configured to contact one of the sensor contacts or battery contacts at any point along the respective contact 3654. The contacts 3654 may be formed utilizing any suitable process, such as laser direct structuring (LDS) of the base 3502 or overmolding of a conductive elastomer. The contacts 3654 may include a first signal contact configured to make electrical contact with the first sensor contact 3608, a second signal contact configured to make electrical contact with the second sensor contact 3610, a first power contact configured to make electrical contact with the first battery contact 3628, and a second power contact configured to make electrical contact with the second battery contact 3629. Such first and second power contacts may be configured to receive power from the battery, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. In some alternative embodiments, a first seal member (not shown in FIG. 36) may alternatively be disposed on a surface of the sensor electronics module 3650 at the same surface as or adjacent to the contact 3654 facing the base 3602 to form a first cavity 3620.

[0327] The sensor electronics module 3650 may be secured to the base 3602 by pressing the sensor electronics module 3650 against the base 3602 in a direction substantially perpendicular to the bottom surface of the base 3602 until one or more retention features of the sensor electronics module 3650 fit into one or more corresponding retention members of the base 3602. In some embodiments, the retention members of the base 3602 may be the same members or features utilized to secure the base 3602 to an applicator (not shown) for initial deployment to the host's skin. The sensor electronics module 3650 may be uncoupled from the base 3602 by pulling the sensor electronics module 3650 vertically away from the base 3602 while pressing down with sufficient force to uncouple the raised portion 3605 of the base 3602.

[0328] Similar embodiments to those described in connection with Figure 36 are shown in Figures 37A-37D and described below. Figure 37A is an exploded perspective view of an exemplary base 3702 and a sensor electronics module 3750 configured to be secured over or on the base 3702, according to some embodiments. Figure 37B is an exploded perspective bottom view of the base 3702 and sensor electronics module 3750 of Figure 37A. Figure 37C is a plan view of the bottom of the base 3702 of Figure 37A. Figure 37D is a side cross-sectional view of the sensor electronics module 3750 secured to the base 3702 of Figure 37A.

[0329] The analyte sensor system 3700 includes a base 3702 and a sensor electronics module 3750. As illustrated, the base 3702 and the sensor electronics module 3750 may each have a substantially circular outline, allowing for omnidirectional alignment therebetween. Although not shown in FIGS. 37A-35D , the base 3702 may include an analyte sensor (e.g., analyte sensor 104 of FIG. 1 , analyte sensor 212 of FIG. 2 , analyte sensor 1016 of FIG. 10A ) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration in the host. The base 3702 further includes a battery 3718 configured to power the analyte sensor and / or the sensor electronics module 3750. The battery 3718 may be disposed within a cavity through an upper side of the base 3702. In some embodiments, the battery 3718 may be secured within the cavity utilizing a conductive epoxy or another suitable adhesive compound.

[0330] Although not shown in Figures 37A-37D, the sensor electronics module 3750 may include sensor electronics as described herein (e.g., sensor electronics 106 of Figures 1 and / or 2) and may include at least a wireless transceiver configured to transmit a wireless signal based at least in part on a sensor signal generated by the analyte sensor.

[0331] The sensor electronics module 3750 may have a raised perimeter 3704 configured to at least partially surround the base 3702 when the sensor electronics module 3750 is physically and / or mechanically coupled to the base 3702, thereby guiding the sensor electronics module 3750 into position during such physical and / or mechanical coupling. In some embodiments, the raised perimeter 2404 may have a substantially circular outline. The sensor electronics module 3750 may further include an opening 3770, which in some embodiments may have a substantially circular shape.

[0332] The base 3702 may have a substantially circular perimeter or shape that compliments the inner perimeter or shape of the raised perimeter 3704 of the sensor electronics module 3750. The base 3702 may further have a raised portion 3405 having a substantially circular perimeter or shape that compliments the inner perimeter or shape of the opening 3770. Thus, when the sensor electronics module 3750 is secured over the top of the base 3702, the sensor electronics module 3750 is configured to fit securely within the raised perimeter 3704 of the base 3702, while the raised portion 3705 of the base 3702 is configured to fit securely within the opening 3770. The substantially circular shapes and / or perimeters of at least some of the sensor electronics module 3750, the opening 3770, the raised perimeter 3704 of the sensor electronics module 3750, and the raised portion 3705 of the base 3702 allow for omnidirectional mounting of the sensor electronics module 3750 to the base 3702.

[0333] The base 3702 may further include a first sensor contact 3708 and a second sensor contact 3710, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact 3728 and a second battery contact 3729, each electrically connected to a respective terminal of the battery 3718. The base 3702 may further include a first seal member 3724 configured to surround and seal each of the first and second sensor contacts 3708, 3710 and the first and second battery contacts 3728, 3729 within a first cavity 3720 formed between an opposing surface of the base 3702 and the sensor electronics module 3750 and the first seal member 3724. In some embodiments, the first seal member 3724 may be disposed on a surface of the base 3202 facing the sensor electronics module 3750, on a sidewall of the base 3202, or both. In some embodiments, the base 3703 may further include a second seal member 3725 disposed within the perimeter of the first seal member 3724 and around the sidewall of the raised portion 3705 of the base 3702. In some embodiments, the base 3702 may further include a third seal member 3727 disposed within the perimeter of the first seal member 3724 and around the through-hole 3740 of the base 3202. The first, second and / or third seal members 3724, 3725, 3727 may include overmolded components such as, for example, overmolded gaskets, overmolded elastomeric features, and / or UV-curable silicone.

[0334] The base 3702 is further illustrated as including a plurality of conductive contacts 3766, which may be formed utilizing any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer of the base 3702. The conductive traces 3766 may ultimately be used to transmit electrical signals from the analyte sensor to the sensor electronics module 3750 and / or power from the battery 3718 to the sensor electronics module 3750 and the analyte sensor.

[0335] The sensor electronics module 3750 may include a plurality of concentric circular contacts 3754 disposed on an inner surface facing the base 3702. In some embodiments, the contacts 3754 may each have a substantially ring-like configuration and each may be annularly spaced apart from one another about the opening 3770, which allows the contacts 3754 to make electrical contact with a respective one of the first and second sensor contacts 3708, 3710 and the first and second battery contacts 3728, 3729 of the base 3702 when the sensor electronics module 3750 is mounted on the base 3702. Due to the annular configuration of each of the contacts 3754, it is contemplated that the sensor electronics module 3750 may be mounted on the base 3702 in any orientation. Each contact 3754 may be configured to contact one of the sensor contacts or battery contacts at any point along the respective contact 3754. The contacts 3754 may be formed utilizing any suitable process, such as laser direct structuring (LDS) of the base 3702 or overmolding of a conductive elastomer. The contacts 3754 may include a first signal contact configured to make electrical contact with the first sensor contact 3708, a second signal contact configured to make electrical contact with the second sensor contact 3710, a first power contact configured to make electrical contact with the first battery contact 3728, and a second power contact configured to make electrical contact with the second battery contact 3729. Such first and second power contacts may be configured to receive power from the battery 3718, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor. In some alternative embodiments, one or more of the first, second and third seal members 3724, 3725, 3727 may alternatively be disposed on a surface of the sensor electronics module 3750 at the same surface as or adjacent to the contact 3754 facing the base 3702 to form the first cavity 3720.

[0336] The sensor electronics module 3750 may be secured to the base 3702 by pressing the sensor electronics module 3750 against the base 3702 in a direction substantially perpendicular to the bottom surface of the base 3702 until one or more retention features of the sensor electronics module 3750 fit into one or more corresponding retention members of the base 3702. In some embodiments, the retention members of the base 3702 may be the same members or features utilized to secure the base 3702 to an applicator (not shown) for initial deployment to the host's skin. The sensor electronics module 3750 may be uncoupled from the base 3702 by pulling the sensor electronics module 3750 vertically away from the base 3702 while pressing down with sufficient force to uncouple the raised portion 3705 of the base 3702.

[0337] Slider embodiment 38A-39C illustrate several embodiments of analyte sensor systems in which a base includes rails along which a sensor electronics module having channels configured to accommodate the rails can be slid and secured onto the base.

[0338] Although not shown in Figures 38A-39C, the bases 3802-3902 may include an analyte sensor (e.g., analyte sensor 104 of Figure 1, analyte sensor 212 of Figure 2, analyte sensor 1016 of Figure 10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration in the host, while the sensor electronics modules 3850-3950 may include sensor electronics described herein (e.g., sensor electronics 106 of Figures 1 and / or 2) and may include at least a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal generated by the analyte sensor.

[0339] In some embodiments, the analyte sensor base assembly may include a base 3802-3902 configured to adhere to the skin of a host and one or more of the analyte sensors as described above and configured to generate a sensor signal indicative of an analyte concentration level in the host, at least one battery as will be described below, at least one sensor contact 3808-3908 and / or 3810-3910, at least one battery contact 3828-3938 and / or 3829-3929, at least a seal member 3824-3924 and / or 3925 configured to provide a seal around the at least one battery contact 3828-3938 and / or 3829-3929, and / or any other features configured to be associated with and / or coupled to the base 3802-3902 as will be described below.

[0340] Figure 38A is a perspective view of an exemplary base 3802 and a sensor electronics module 3850 configured to be slidably mounted to the base 3802, according to some embodiments. Figure 38B is a perspective view of the sensor electronics module 3850 mounted to the base 3802 of Figure 38A. A discussion follows below with respect to Figures 38A and 38B.

[0341] As shown, analyte sensor system 3800 includes a base 3802 and a sensor electronics module 3850. Base 3802 can be configured to adhere to the skin of a host utilizing an adhesive pad 3814, which can be disposed on a back surface of base 3802, for example. Adhesive pad 3814 can have substantially similar features and functionality as previously described for adhesive pad 2314 of FIGS. 23A-23C.

[0342] In some embodiments, the base 3802 may be configured to be slid onto and physically and / or mechanically couple to the sensor electronics module 3850 utilizing one or more retention features. For example, the base 3802 may have a raised central rail 3872 configured to guide the sensor electronics module 3850 into position during physical and / or mechanical coupling to the base 3802. In some embodiments, the rail 3872 may have a substantially constant width along its length. However, the present disclosure is not so limited, and the rail 3872 may have a width that tapers along its length such that the rail 3872 is substantially wedge-shaped, having a first width at a first end of the rail 3872 and a second width, smaller than the first width, at a second end of the rail 3872 opposite the first end. Such a tapered width of the rail 3872 may facilitate easy mating of the sensor electronics module 3850 with the base 3802 and a good seal around one or more components and / or electrical contacts disposed thereon. The sensor electronics module 3850 may further include a channel 3874 having a shape that compliments the perimeter or shape of the rail 3872 of the base 3802 .

[0343] 38A-38B, to achieve, act on, and / or support such physical and / or mechanical coupling, the base 3802 may further include at least one of first and second retaining members (e.g., see at least retaining member 3944 in FIGS. 39A-39C), while the sensor electronics module 3850 may further include at least one of first and second retaining features configured to mate with the first and second retaining members, respectively (e.g., see at least retaining feature 3956 in FIGS. 39A-39C). Such at least one retaining member(s) and retaining mechanism(s) may prevent the sensor electronics module 3850 from undesirably backing out of a fixed position relative to the base 3802, as shown in FIG. 38 and further described below in connection with FIGS. 39A-39C.

[0344] FIG. 38A illustrates base 3802 as having first and second sensor contacts 3808 and 3810, each electrically connected to a respective terminal of an analyte sensor, and first and second battery contacts 3828 and 3829, each electrically connected to a respective terminal of a battery (not shown in FIGS. 38A and 38B, but see, for example, battery 3918 in FIGS. 39A-39C).

[0345] The sensor electronics module 3850 may include a plurality of contacts 3854 disposed on an interior surface of the channel 3874. In some embodiments, the contacts 3854 may include a first signal contact configured to make electrical contact with the first sensor contact 3808, a second signal contact configured to make electrical contact with the second sensor contact 3810, a first power contact configured to make electrical contact with the first battery contact 3828, and a second power contact configured to make electrical contact with the second battery contact 3829. Such first and second power contacts may be configured to receive power from the battery, and such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor.

[0346] The base 3802 may further include a first seal member 3824 configured to surround and seal the first and second sensor contacts 3808, 3810, the first and second battery contacts 3828, 3829, the first and second signal contacts, and the first and second power contacts within the first cavity 3820. While the first seal member 3824 is shown as being disposed on a sidewall of the rail 3874, the present disclosure is not limited to such and the first seal member 3824 may alternatively be similarly configured to surround the contacts 3854 and be disposed on an inner surface of the channel 3874 of the sensor electronics module 3850 to form the first cavity 3820.

[0347] The sensor electronics module 3850 may be secured to the base 3802 by aligning the channels 3874 of the sensor electronics module 3850 with the rails 3872 of the base 3802 and sliding the sensor electronics module 3850 in a direction parallel to the host's body until the sensor electronics module 3850 reaches the end of its travel along the rails 3872 and seats against at least a portion of the base 3802, and at least one retention member(s) and retention feature(s) (not shown in FIGS. 38A, 38B ) are engaged with one another. In some embodiments, such alignment and securing of the sensor electronics module 3850 to the base 3802 may be accomplished one-handed by the host by holding at least one finger against the base 3802 and at least one other finger against the sensor electronics module 3850 and pressing the fingers toward each other until the sensor electronics module 3850 is properly secured to the base 3802.

[0348] Similar embodiments to those described in connection with Figures 38A and 38B are shown in Figures 39A-39C and described below. Figure 39A is a perspective view of an exemplary base 3902 and a sensor electronics module 3950 configured to be slidably mounted to the base 3902, according to some embodiments. Figure 39B is another perspective view of the base 3902 of Figure 39A. Figure 39C is an exploded perspective bottom view of the base 3902 and sensor electronics module 3950 of Figure 39A. The discussion continues with respect to Figures 39A-39C.

[0349] As shown in the figure, the analyte sensor system 3900 includes a base 3902 and a sensor electronics module 3950. The base 3902 is configured to receive a battery 3918 within a cavity in a bottom surface of the base 3902. The base 3902 may also include a cover 3960 configured to be attached to and / or disposed on the bottom side of the base 3902. The cover 3960 may be shaped and sized to secure the battery 3918 within the base 3902. The cover 3960 may be secured to the bottom surface of the base 3902 using any suitable method, for example, snaps, adhesive, friction fit, heat staking, and / or laser, heat or ultrasonic welding along a weld line 3912.

[0350] 39B, the base 3902 may include a plurality of conductive traces 3966, which may be formed using any suitable process, such as laser direct structuring (LDS) or overmolding of a conductive elastomer, of the base 3902. The conductive traces 3966 may ultimately be used to transmit electrical signals from the analyte sensor to the sensor electronics module 3950 and / or power from the battery 3918 to the sensor electronics module 3950 and the analyte sensor.

[0351] The base 3902 further includes a first sensor contact 3908 and a second sensor contact 3910, each electrically coupled to a respective terminal of an analyte sensor in the base 3902 via at least some of the conductive traces 3966. The contacts 3908, 3910 may be disposed immediately adjacent to one another. The base 3902 further includes a first battery contact 3928 and a second battery contact 3929, each electrically coupled to a respective terminal of the battery 3918 via at least some of the conductive traces 3966 on the cover 3960. The contacts 3928, 3929 may likewise be disposed immediately adjacent to one another. The contacts 3908, 3910, 3928, 3929 are illustrated as being disposed on a sidewall of the base 3902 and configured to face a mating surface of the sensor electronics module 3950. However, the present disclosure is not so limited and the contacts 3908, 3910, 3928, 3929 may be disposed on any suitable surface of the base 3902. The contacts 3908, 3910, 3938, 3929 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive material and / or structure.

[0352] The base 3902 further includes a seal member 3924 that extends over and seals the conductive traces 3966 and that also creates a single continuous seal around the contacts 3908, 3910 to form a first cavity 3920a and another single continuous seal around the contacts 3928, 3929 on the base 3902 to form a second cavity 3920b. The seal member 3924 may include, for example, an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and / or UV-curable silicone, which may be bonded to the surface of the base 3902 using any suitable method.

[0353] The sensor electronics module 3950 may include a plurality of contacts 3954 disposed on a surface (e.g., a sidewall) of the sensor electronics module 3950 configured to face a mating surface of the sensor electronics module 3950 on which the contacts 3908, 3910, 3928, 3929 are disposed. The contacts 3954 may include conductive elastomeric contacts (e.g., pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or other suitable conductive materials and / or structures. In some embodiments, the contacts 3954 may include a first signal contact configured to make electrical contact with the first sensor contact 3908, a second signal contact configured to make electrical contact with the second sensor contact 3910, a first power contact configured to make electrical contact with the first battery contact 3928, and a second power contact configured to make electrical contact with the second battery contact 3929. Such first and second power contacts may be configured to receive power from the battery 3918, while such first and second signal contacts may be configured to receive a sensor signal from the analyte sensor.

[0354] In some embodiments, the base 3902 may be configured to be slid onto and utilize one or more retention features to physically and / or mechanically couple with the sensor electronics module 3950. For example, the base 3902 may have a raised central rail 3972 configured to guide the sensor electronics module 3950 into position during physical and / or mechanical coupling to the base 3902. In some embodiments, the rail 3972 may have a substantially constant width along its length. However, the present disclosure is not so limited, and the rail 3972 may have any suitable shape, width(s) along its length. To achieve, actuate, and / or support such physical and / or mechanical coupling, the base 3902 may further include at least one retention member 3944. The retention member 3944 may include snaps, hooks, deflectable tabs, or any other suitable type of retention member(s).

[0355] The sensor electronics module 3950 may further comprise a channel 3974 having a shape that complements the periphery or shape of the rail 3972 of the base 3902, and at least one retention feature 3956 configured to mate with the retention member(s) 3944. In some embodiments, the retention feature(s) 3956 may include a recess configured to receive the retention member 3944. Such retention member(s) 3944 and retention feature(s) 3956 may substantially secure the sensor electronics module 3950 to the base 3902 and prevent the sensor electronics module 3950 from undesirably backing out of such secured position.

[0356] In some embodiments, the base 3902 may have a break line 3964 that defines a first portion of the base 3902 at which the retention member 3944 is disposed, and from a second portion of the base 3902 disposed on the opposite side of the break line 3964 from the first portion. Thus, the first portion of the base 3902 may include a frangible tab, similar to that previously described in connection with FIGS. 24A-24D , configured to separate from the second portion of the base 3902 along the break line 3964 when the first portion of the base 3902 is sufficiently bent, flexed, or otherwise deflected from its rest position shown in FIG.

[0357] The sensor electronics module 3950 may be secured to the base 3902 by aligning the channel 3974 of the sensor electronics module 3950 with the rail 3972 of the base 3902 and sliding the sensor electronics module 3950 in a direction parallel to the host's body until the sensor electronics module 3950 reaches the end of its travel along the rail 3972 and seats against at least a portion of the base 3902, and the retention member(s) 3944 and retention feature(s) 3956 are engaged with one another. In some embodiments, such alignment and securing of the sensor electronics module 3950 to the base 3902 may be accomplished one-handed by the host by holding at least one finger against the base 3902 and at least one other finger against the sensor electronics module 3950 and pressing the fingers toward each other until the sensor electronics module 3950 is properly secured to the base 3902.

[0358] Manufacturing method for the above embodiment Some exemplary methods for fabricating a disposable analyte sensor base having one or more batteries disposed therein and a reusable sensor electronics module configured to releasably couple to the base are provided below in connection with FIG. 40.

[0359] The methods disclosed herein include one or more steps or actions for achieving the described method. The steps and / or actions of the methods may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0360] An exemplary method 4000 for fabricating an analyte sensing device and / or system will now be described below with reference to Figure 40. Method 4000 may correspond at least to the description above with reference to Figures 1-39C.

[0361] Block 4002 includes forming a base configured to adhere to the skin of a host. For example, the base may be formed according to the description of at least one of bases 1002-3902, as previously described in connection with any of Figures 10A-39C.

[0362] Block 4004 includes disposing a first plurality of contacts on the base. For example, as already described in connection with Figures 23A-39C, any of the bases 2302-3902 may have at least a first plurality of contacts disposed thereon, including first sensor contacts 2308-3908 and second sensor contacts 2310-3910. In some embodiments, the first plurality of contacts may further include first battery contacts 2328-3228, 3428-3828 and second battery contacts 2329-3229, 3429-3829, as already described in connection with Figures 23A-32 and 34-38B.

[0363] Block 4006 includes attaching an analyte sensor to the base, the analyte sensor configured to generate a sensor signal indicative of an analyte concentration level of the host. For example, the analyte sensor 104 may be attached to at least any of the bases 2302-3902. As previously described, the analyte sensor 104 is configured to generate a sensor signal indicative of an analyte concentration level of the host.

[0364] Block 4008 includes attaching a battery to the base. For example, a battery, such as any of the batteries described in connection with at least Figures 10A-39C, may be attached to the respective base 1002-3902 as previously described in connection with at least Figures 10A-39C.

[0365] Block 4010 includes forming a sensor electronics module configured to releasably couple to the base, the sensor electronics module comprising a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal. For example, the sensor electronics module may be formed according to the description of at least any of sensor electronics modules 2350-3950, as previously described in connection with any of Figures 23A-39C.

[0366] Block 4012 includes disposing a second plurality of contacts at respective locations on the sensor electronics module, whereby each of the second plurality of contacts is configured to make electrical contact with a respective one of the first plurality of contacts when the sensor electronics module is secured to the base. For example, any of the sensor electronics modules 2350-3950 may have at least the second plurality of contacts 2354-3954 disposed thereon, including a first signal contact configured to make electrical contact with the first sensor contact 2308-3908 and a second signal contact configured to make electrical contact with the second sensor contact 2310-3910 when the sensor electronics module 2350-3950 is secured to the base 2302-3902, as previously described in connection with FIGS. In some embodiments, the second plurality of contacts 2354-3954 may further include a first power contact configured to be in electrical contact with the first battery contacts 2328-3228, 3428-3828 and a second power contact configured to be in electrical contact with the second battery contacts 2329-3229, 3429-3829 when the sensor electronics module 2350-3950 is fixed to the base 2302-3902, as already described in connection with Figures 23A-32 and 34-38B.

[0367] Block 4014 includes disposing a first seal member on one of the base and the sensor electronics module, the first seal member configured to form a first cavity and provide a continuous seal around the first and second plurality of contacts within the first cavity when the sensor electronics is secured to the base. For example, the first seal member 2324-3924 may be disposed on at least one of the base 2302-3902 and the sensor electronics module 2350-3950, as previously described in connection with at least FIGS. 23A-39C , whereby the first seal member 2324-3924 is configured to form the first cavity 2320-3920 and provide a continuous seal around the first and second plurality of contacts within the first cavity when the sensor electronics module 2350-3950 is secured to the base 2302-3902.

[0368] In some embodiments, the base 2302-3902 is configured to be disposable. In some embodiments, the sensor electronics module 2350-3950 is configured to be reusable. In some embodiments, the battery is configured to provide power to the analyte sensor 104 and the sensor electronics module 2350-3950. In some embodiments, when the sensor electronics module 2350-3950 is secured to the base 2302-3902, the first and second signal contacts are configured to receive a sensor signal via the first sensor contacts 2308-3908 and the second sensor contacts 2310-3910, and the first and second power contacts are configured to receive power from the battery. In some embodiments, each of the second plurality of contacts 2654 is in direct electrical contact with one of the analyte sensor 104 and the battery.

[0369] In some embodiments, the method 4000 may further include electrically coupling the first sensor contacts 2308-3908 and the second sensor contacts 2310-3910 to respective terminals of the analyte sensor 104. In some embodiments, the method 400 may further include electrically coupling the first battery contacts 2328-3228, 3428-3828 and the second battery contacts 2329-3229, 3429-3829 to respective terminals of the battery.

[0370] In some embodiments, the method 4000 may further include forming a first retaining member 2342-3942 and a second retaining member 2344-3944 on the base 2302-3902, and forming a first retaining feature 2352-3952 on the sensor electronics module 2350-3950 configured to mate with the first retaining member 2342-3942 and a second retaining feature 3956 configured to mate with the second retaining member 2344-3944 when the sensor electronics module 2350-3950 is secured to the base 2302-3902, thereby releasably coupling the sensor electronics module 2350-3950 to the base 2302-3902. In some embodiments, the second retaining member 2344-3944 is frangible and configured to be separable from the base 2302-3902. In some embodiments, the second plurality of contacts 2854-2954 are disposed on the first retention feature 2852, 2952. In some embodiments, the first retention member 2842, 2942 includes a hood, and the first plurality of contacts 2908, 2910, 2928, 2929 are disposed within the hood. In some embodiments, the first seal member 2824 is disposed around a periphery of the anchoring mechanism 2852 such that the first cavity 2820 is disposed within the hood. In some embodiments, the first seal member 2924 is disposed on an inner surface of the hood.

[0371] In some embodiments, the method 4000 may further include securing a cover 2460, 2560, 2960, 3160, 3360, 3960 to a bottom of the base 2402, 2502, 2902, 3160, 3360, 3902. Such a cover may be configured to secure a battery within the respective base. In some embodiments, the method 4000 may further include disposing a first plurality of conductive traces 2466, 3166, 3366 on the cover 2460, 3160, 3360 such that, when the cover 2460, 3160, 3360 is secured to the bottom of the base 2402, 3102, 3302, at least some of the first plurality of contacts are coupled to one of the analyte sensor 104 and the battery via the first plurality of conductive traces 2466, 3166, 3366.

[0372] In some embodiments, the method 4000 may further include disposing a first plurality of conductive traces 2366, 2566-2666, 2866-3066, 3466-3966 on the base 2302, 2502-2026, 2802-3002, 3402-3902, such that at least some of the first plurality of contacts are electrically coupled to one of the analyte sensor 104 and the battery via the first plurality of conductive traces 2366, 2566-2666, 2866-3066, 3466-3966. In some embodiments, the first seal member 2524-2624, 2924, 3824-3924 extends over the first plurality of conductive traces 2566-2666, 2966, 3866-3966, thereby sealing the first plurality of conductive traces 2566-2666, 2966, 3866-3966 from the ingress of moisture. In some embodiments, the first seal member 2666 extends over the battery 2618, thereby sealing the battery 2618 from the ingress of moisture.

[0373] In some embodiments, the method 4000 may further include forming an opening 3070-3170, 3670-3770 in the sensor electronics module 3050-3150, 3650-3750, and forming a raised portion 3005-3105, 3605-3705 on the base 3002-3102, 3602-3702 configured to fit within the opening 3070-3170, 3670-3770, wherein an outer periphery of the raised portion complements an inner periphery of the opening. In some embodiments, the first plurality of contacts 3008, 3010, 3028, 3029 are disposed on the raised portion 3005. In some embodiments, the openings 3070-3170 are symmetrical about at least one axis parallel to the top surface of the sensor electronics module 3050-3150 and asymmetrical about at least one other axis parallel to the top surface of the sensor electronics module 3050-3150. In some embodiments, the battery is disposed within the raised portion 3005-3105, 3605 of the base 3002-3102, 3602. In some embodiments, the top surface of the raised portion 3005-3105, 3605-3705 sits substantially flush with the top surface of the sensor electronics module 3050-3150, 3650-3750 when the sensor electronics module is secured to the base 3002-3102, 3602-3702.

[0374] In some embodiments, the method 4000 may include forming recesses 3242-3342 on an upper surface of the base 3202-3302 and forming protrusions 3252-3352 configured to mate with the recesses 3242-3342, whereby the mating of the protrusions 3252-3352 with the recesses 3242-3342 aligns the sensor electronics modules 3250-3350 for fastening to the base 3202-3302.

[0375] In some embodiments, the method 4000 may further include forming a third plurality of contacts on the base 3302, 3902 and forming a fourth plurality of contacts at locations on the sensor electronics module 3350, 3950 such that when the sensor electronics module 3350, 3950 is fixed to the base 3302, 3902, each of the fourth plurality of contacts is configured to be in electrical contact with a respective one of the third plurality of contacts; and disposing a second seal member 3325, 3925 on the base 3302, 3902 and one of the sensor electronics modules 3350, 3950. The second seal member 3325, 3925 is configured to form a second cavity 3320b, 3920b and provide a continuous seal around the third and fourth plurality of contacts within the second cavity when the sensor electronics module 3350, 3950 is fixedly attached to the base 3302, 3902. In some embodiments, the third plurality of contacts includes a first battery contact 3328, 3928 and a second battery contact 3329, 3929. In some embodiments, the method 4000 further includes electrically coupling the first battery contact 3328, 3928 and the second battery contact 3329, 3929 to respective terminals of the battery. In some embodiments, the fourth plurality of contacts 3354, 3954 includes a first power contact configured to be in electrical contact with the first battery contact 3328, 3928 and a second power contact configured to be in electrical contact with the second battery contact 3329, 3929 when the sensor electronics module 3350, 3950 is fixed to the base 3302, 3902.

[0376] In some embodiments, the second plurality of contacts 3454-3754 includes concentric circular contacts. In some embodiments, the concentric circular contacts 3454-3754 are arranged around a center of the sensor electronics module 3450-3750. In some embodiments, each of the second plurality of contacts 3454-3754 is configured to make electrical contact with a respective one of the first plurality of contacts when the sensor electronics module 3450-3750 is fixedly mounted to the base 3402-3702 in any of a plurality of radial orientations.

[0377] In some embodiments, the method 4000 further includes forming an opening 3470 in the base 3402 and forming a raised portion 3405 on the sensor electronics module 3450 configured to fit within the opening 3470, wherein an outer periphery of the raised portion 3405 complements an inner periphery of the opening 3470. In some embodiments, the opening 3470 and the raised portion 3405 each have a substantially circular shape.

[0378] In some embodiments, the method 4000 may further include forming a raised rail 3872-3972 on the base 3802-3902 and forming a channel 3874-3974 having a shape that complements the shape of the raised rail 3872-3972 on the sensor electronics module 3850-3950. In some embodiments, the raised rail 3872-3972 may have a constant width along its length. In some embodiments, the width of the raised rail 3872-3972 tapers along its length. In some embodiments, the first plurality of contacts 3808, 3810, 3828, 3829 are disposed on a sidewall of the raised rail 3872, and the second plurality of contacts 3854 are disposed on a sidewall of the channel 3874. In some embodiments, the first plurality of contacts 3908, 3910 and the third plurality of contacts 3928, 3929 are disposed on the sidewalls of the base 3902, and the second and fourth plurality of contacts 3954 are disposed on the sidewalls of the sensor electronics module 3950.

[0379] Each of these non-limiting examples can stand alone by itself or can be combined in various permutations or combinations with one or more of the other examples.

[0380] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples using any combination or permutation of the elements shown or described (or one or more aspects thereof), either with respect to the particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0381] In the event of inconsistent usage between this document and any documents incorporated by reference, the usage in this document takes precedence.

[0382] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, regardless of other instances or uses of "at least one" or "one or more." In this document, the term "or" is used to refer to a non-exclusive "or," such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise specified. In this document, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "comprising" and "comprising" are intended to be open-ended, i.e., systems, devices, articles, compositions, formulations, or processes that include elements in addition to those listed after such terms in a claim are still considered to be within the scope of that claim. Furthermore, in the following claims, terms such as "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0383] Geometric terms such as "parallel," "perpendicular," "circular," or "square" do not require absolute mathematical precision unless the context dictates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as "circular" or "generally circular," components that are not exactly circular (e.g., somewhat rectangular or multi-sided polygonal) are also encompassed by this description.

[0384] The example methods described herein can be at least partially machine- or computer-implemented. Some examples include computer-readable or machine-readable media encoded with instructions operable to configure an electronic device to perform the methods described in the examples above. Implementations of such methods can include code, such as, for example, microcode, assembly language code, higher-level language code, etc. Such code can include computer-readable instructions for performing various methods. The code can form part of a computer program product. Furthermore, in one example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), etc.

[0385] The above description is intended to be illustrative, not limiting. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Upon reviewing the above description, for example, one of ordinary skill in the art may utilize other embodiments. The Abstract is provided to comply with 37 C.F.R. §1.72(b) to enable the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed disclosed feature is essential to the scope of a claim. Rather, inventive subject matter may comprise less than all features of a particular disclosed embodiment. Accordingly, the following claims are incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full range of equivalents to which such claims are entitled.

Claims

1. 1. An analyte sensor system comprising: A base configured to adhere to the skin of a host, said base comprising: an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level in the host; Battery, and a base including a first plurality of contacts; a sensor electronics module configured to releasably couple to the base, the sensor electronics module comprising: a second plurality of contacts, each configured to make electrical contact with a respective one of the first plurality of contacts; and a sensor electronics module including a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal; a first seal member configured to provide a seal within the first cavity around the first and second pluralities of contacts.

2. The system of claim 1 , wherein the base is disposable.

3. The system of claim 1 or 2, wherein the sensor electronics module is reusable.

4. The system of any of claims 1 to 3, wherein the battery is configured to provide power to the analyte sensor and the sensor electronics module.

5. 5. The system of claim 1, wherein the first plurality of contacts includes a first sensor contact and a second sensor contact, each configured to be electrically coupled to a respective terminal of the analyte sensor.

6. 6. The system of claim 5, wherein the second plurality of contacts includes a first signal contact configured to be in electrical contact with the first sensor contact and a second signal contact configured to be in electrical contact with the second sensor contact.

7. 6. The system of claim 5, wherein the first plurality of contacts further includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery.

8. 8. The system of claim 7, wherein the second plurality of contacts further includes a first power contact configured to be in electrical contact with the first battery contact and a second power contact configured to be in electrical contact with the second battery contact.

9. 9. The system of claim 8, wherein the first and second signal contacts are configured to receive the sensor signal via the first and second sensor contacts, and the first and second power contacts are configured to receive power from the battery.

10. the base further includes a first retaining member and a second retaining member; 10. The system of claim 1, wherein the sensor electronics module further includes an anchoring feature configured to mate with the first retaining member and a retention feature configured to mate with the second retaining member, thereby releasably coupling the sensor electronics module to the base.

11. The system of claim 10 , wherein the second retaining member is frangible and configured to be separable from the base.

12. The system of any preceding claim, wherein the base further comprises a cover configured to be secured to the base and configured to secure the battery within the base.

13. 13. The system of claim 12, wherein the cover includes a first plurality of conductive traces configured to couple at least some of the first plurality of contacts to one of the analyte sensor and the battery.

14. The system of claim 12 or 13, wherein the cover includes a recess configured to receive the battery.

15. The system of any of claims 12 to 14, wherein the cover includes a weld configured to secure the cover to the base.

16. 16. The system of claim 12, 14, or 15, wherein the first seal member is configured as a part of the cover.

17. The system of any of claims 12 and 14-16, wherein the cover is configured to be disposed between the base and the sensor electronics module.

18. The system of any one of claims 12 to 15, wherein the cover is configured to be fixed to the bottom of the base.

19. 19. The system of any of claims 1-12 and 14-18, wherein the base includes a first plurality of conductive traces configured to couple at least some of the first plurality of contacts to one of the analyte sensor and the battery.

20. 20. The system of claim 19, wherein the first seal member extends over the first plurality of conductive traces, thereby sealing the first plurality of conductive traces from the ingress of moisture.

21. A system according to any preceding claim, wherein the first sealing member extends over the battery, thereby sealing the battery from the ingress of moisture.

22. The system of any preceding claim, wherein at least some of the second plurality of contacts are in direct electrical contact with the analyte sensor or the battery.

23. The system of claim 10 or 11, wherein the second plurality of contacts are disposed on the anchoring feature.

24. 24. The system of claim 10, 11, or 23, wherein the second plurality of contacts includes at least one signal contact configured to electrically connect with the analyte sensor and at least one power contact configured to electrically connect with the battery.

25. 25. The system of claim 10, 11, 23, and 24, wherein the second plurality of contacts includes at least two signal contacts configured to electrically connect with the analyte sensor and at least two power contacts configured to electrically connect with the battery.

26. 26. The system of any of claims 10, 11, and 23-25, wherein the first retaining member includes a hood, and the first plurality of contacts are disposed within the hood.

27. 27. The system of any of claims 10, 11, and 23-26, wherein the first seal member is disposed around a periphery of the fastening feature such that the first cavity is disposed within the hood.

28. 28. The system of claim 26 or 27, wherein the first seal member is disposed on an interior surface of the hood.

29. The sensor electronics module includes: engaging the fastening feature with the first retention member while the sensor electronics module is disposed at a high angle relative to the base; 29. The system of any of claims 10, 11, and 23-28, configured to releasably couple to the base by pivoting the sensor electronics module about the first retention member toward the base until the retention feature engages with the second retention member.

30. 20. The system of any one of claims 1 to 9, 12, 14, 15, 18, and 19, wherein the sensor electronics module includes an opening, the base includes a raised portion configured to fit within the opening, and an outer periphery of the raised portion compliments an inner periphery of the opening.

31. 31. The system of claim 30, wherein the first plurality of contacts are disposed on the raised portion.

32. 32. The system of claim 30 or 31, wherein the opening is symmetrical about at least one axis parallel to the top surface of the sensor electronics module and asymmetrical about at least one other axis parallel to the top surface of the sensor electronics module.

33. The system of any of claims 30 to 32, wherein the battery is disposed within the raised portion of the base.

34. A system according to any of claims 30 to 33, wherein a top surface of the raised portion sits substantially flush with a top surface of the sensor electronics module.

35. the sensor electronics module: receiving the raised portion of the base within the opening of the sensor electronics module; The system of any one of claims 30 to 34, configured to be releasably coupled to the base by pressing the sensor electronics module against the base in a direction substantially perpendicular to a bottom surface of the base until the one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base.

36. 23. The system of any one of claims 1 to 9, 12, 14, 15 and 18 to 22, wherein the base includes a recess disposed on an upper surface of the base, and the sensor electronics module includes a protrusion configured to mate with the recess, thereby aligning the sensor electronics module with the base.

37. the base further includes a third plurality of contacts; the sensor electronics module further includes a fourth plurality of contacts, each configured to make electrical contact with a respective one of the third plurality of contacts; 20. The system of any of claims 1-6, 12, 14, 15, 18 and 19, wherein the system further comprises a second seal member configured to provide a continuous seal within the second cavity around the third and fourth pluralities of contacts.

38. 38. The system of claim 37, wherein the third plurality of contacts includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery.

39. 39. The system of claim 37 or 38, wherein the fourth plurality of contacts includes a first power contact configured to be in electrical contact with the first battery contact and a second power contact configured to be in electrical contact with the second battery contact.

40. 36. The system of any of claims 1-9, 12, 14, 15, 18, 19, 30, 34 and 35, wherein the second plurality of contacts comprises concentric circular contacts.

41. 41. The system of claim 40, wherein the concentric circular contacts are arranged around a center of the sensor electronics module.

42. 42. The system of claim 40 or 41, wherein each of the second plurality of contacts is configured to be in electrical contact with a respective one of the first plurality of contacts when the sensor electronics module is secured to the base in any of a plurality of radial orientations.

43. 20. The system of any one of claims 1 to 9, 12, 14, 15, 18 and 19, wherein the base includes an opening, the sensor electronics module includes a raised portion configured to fit within the opening, and an outer periphery of the raised portion complements an inner periphery of the opening.

44. 44. The system of claim 43, wherein the opening and the raised portion each have a substantially circular shape.

45. the sensor electronics module: placing the raised portion of the sensor electronics module within the opening in the base; 45. The system of claim 43 or 44, configured to be releasably coupled to the base by pressing the sensor electronics module against the base in a direction substantially perpendicular to a bottom surface of the base until the one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base.

46. 20. The system of any of claims 1-9, 12, 14, 15, 18 and 19, wherein the base includes a raised rail and the sensor electronics module includes a channel having a shape that compliments the shape of the raised rail.

47. 47. The system of claim 46, wherein the raised rail has a constant width along the length of the raised rail.

48. 47. The system of claim 46, wherein the width of the raised rail tapers along the length of the raised rail.

49. 49. The system of any one of claims 46 to 48, wherein the first plurality of contacts are disposed on a sidewall of the raised rail and the second plurality of contacts are disposed on a sidewall of the channel.

50. The system of any one of claims 37 to 39, wherein the first and third plurality of contacts are disposed on a sidewall of the base, and the second and fourth plurality of contacts are disposed on a sidewall of the sensor electronics module.

51. the sensor electronics module: aligning the channel of the sensor electronics module with the raised rail of the base; The system of any of claims 46 to 50, configured to be releasably coupled to the base by sliding the sensor electronics module along the raised rail in a direction parallel to the body of the host until the sensor electronics module is seated against the base and one or more retention features of the sensor electronics module engage with one or more corresponding retention members of the base.

52. 1. An analyte sensor system comprising: A base configured to adhere to the skin of a host, said base comprising: an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level in the host; Battery, and a base including a first plurality of contacts; a sensor electronics module configured to releasably couple to the base, the sensor electronics module comprising: a second plurality of contacts, each configured to make electrical contact with a respective one of the first plurality of contacts when the sensor electronics module is secured to the base in any of a plurality of radial orientations; and a sensor electronics module including a wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal.

53. 53. The system of claim 52, wherein the second plurality of contacts are concentric and annularly spaced apart from one another.

54. 54. The system of claim 52 or 53, wherein each one of the second plurality of contacts is configured to make electrical contact with the each one of the first plurality of contacts at any point along the each one of the second plurality of contacts.

55. The system of any of claims 52 to 54, wherein the second plurality of contacts are formed by laser direct structuring.

56. 56. The system of any of claims 52-55, further comprising a first seal member configured to provide a seal within the first cavity around the first and second pluralities of contacts.

57. The system of any of claims 52 to 56, wherein the base is disposable.

58. The system of any of claims 52 to 57, wherein the sensor electronics module is reusable.

59. The system of any of claims 52-58, wherein the battery is configured to provide power to the analyte sensor and the sensor electronics module.

60. 60. The system of any of claims 52-59, wherein the first plurality of contacts includes a first sensor contact and a second sensor contact, each configured to be electrically coupled to a respective terminal of the analyte sensor.

61. 61. The system of claim 60, wherein the second plurality of contacts includes a first signal contact configured to be in electrical contact with the first sensor contact and a second signal contact configured to be in electrical contact with the second sensor contact.

62. 61. The system of claim 60, wherein the first plurality of contacts further includes a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery.

63. 1. An analyte sensor base assembly comprising: a base configured to adhere to the skin of the host; an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level in the host; at least one battery; at least one sensor contact; at least one battery contact; a seal member configured to provide a seal around the at least one battery contact.

64. 64. The assembly of claim 63, wherein the seal member is further configured to provide the seal at least around the periphery of the at least one sensor contact.

65. 65. The assembly of claim 63 or 64, including at least two sensor contacts and at least two battery contacts, the seal member configured to provide the seal around the at least two sensor contacts and the at least two battery contacts.

66. 66. The assembly of any of claims 63-65, wherein the base further comprises a plurality of conductive traces configured to electrically connect the battery to the at least one battery contact.

67. 67. The assembly of any of claims 63-66, wherein the base further comprises a plurality of conductive traces configured to electrically connect the analyte sensor to the at least one sensor contact.

68. 68. The assembly of any one of claims 63 to 67, wherein the assembly is disposable.

69. 69. The assembly of any of claims 63 to 68, wherein the battery is configured to provide power to the analyte sensor and a sensor electronics module coupleable to the base.

70. The base is a first retention member configured to mate with a fastening feature of a matable sensor electronics module; The assembly of any of claims 63 to 69, further comprising: a second retention member configured to mate with a retention feature of the matable sensor electronics module.

71. 71. The assembly of claim 70, wherein the second retention member is frangible and configured to be separable from the base.

72. 72. The assembly of claim 70 or 71, wherein the base further includes a cover configured to securely attach to the base and to secure the battery within the base.

73. 73. The assembly of any of claims 70-72, wherein the first retaining member includes a hood, and the at least one sensor contact and the at least one battery contact are disposed within the hood.

74. 74. The assembly of claim 73, wherein the seal member is disposed within the hood.

75. 74. The assembly of claim 73, wherein the sealing member is an overmolded elastomer.

76. 1. An analyte monitoring system comprising: a base configured to connect to a host, the base including an analyte sensor configured to detect a sensor signal indicative of an analyte concentration level in the host; and a reusable portion configured to couple to the base, the reusable portion including a wireless transceiver, the reusable portion receiving signals from the base and transmitting wireless signals based at least in part on the sensor signal; a battery assembly including a battery housing and one or more batteries, the battery assembly configured to mechanically couple with the base or the reusable portion and to electrically couple with the base or the reusable portion, the battery providing power to the analyte sensor and the wireless transceiver.

77. 77. The system of claim 76, wherein the battery assembly is slidably coupled to the base or the reusable portion.

78. 77. The system of claim 76, wherein the reusable portion includes a housing, and the battery housing forms a lid configured to couple to the housing.

79. 77. The system of claim 76, wherein the battery assembly includes a portion defining a cavity, and the base or the reusable portion includes a protrusion sized and shaped to fit inside the cavity.

80. 80. The system of claim 79, further comprising a radial seal or face seal between the battery assembly or the protrusion.

81. 81. The system of claim 80, wherein the radial seal or face seal is overmolded within the battery assembly.

82. 81. The system of claim 80, wherein the radial seal or face seal is overmolded within the protrusion.

83. 1. An analyte monitoring system comprising: a base configured to connect to a host, the base including an analyte sensor configured to generate a sensor signal indicative of an analyte concentration level in the host; a reusable part configured to couple to the base, the reusable part including a wireless transceiver, the reusable part receiving the sensor signal from the base and transmitting a wireless signal based at least in part on the sensor signal; a battery coupled to the base, the battery powering the analyte sensor and the wireless transceiver.

84. 84. The system of claim 83, further comprising a seal between the battery and the base or the reusable portion, wherein at least one battery terminal is isolated from moisture when the system is submerged in water.

85. 85. The system of claim 84, wherein the seal comprises a face seal surrounding one or more terminals.

86. 85. The system of claim 84, wherein the seal comprises a radial seal surrounding one or more terminals.

87. 85. The system of claim 84, wherein the seal is overmolded into the base.

88. 84. The system of claim 83, wherein the base includes an exterior surface and a cavity formed in the exterior surface, the battery being within the cavity.

89. 90. The system of claim 88, further comprising a film extending over the exterior surface and the cavity.

90. 90. The system of claim 89, wherein the film comprises a flex circuit.

91. 84. The system of claim 83, wherein a seal is overmolded onto the base, the system further comprising a cover that extends over the battery and seals against the base.

92. 1. An analyte monitoring kit comprising: a sensor electronics package including a processor and communication circuitry; a plurality of sensor devices, each sensor device including a sensor device battery and a sensor configured to generate a signal indicative of an analyte concentration level in a host; the sensor electronics package electrically and mechanically couples to each of the plurality of sensor devices and draws power from the sensor device battery to power the processor and the communication circuitry, the sensor electronics package being reusable with the plurality of sensor devices.

93. 93. The analyte monitoring kit of claim 92, wherein the sensor electronics package is configured to activate in response to coupling of the sensor electronics package to a first sensor device of the plurality of sensor devices.

94. 94. The analyte monitoring kit of claim 93, wherein the sensor electronics package further includes a non-volatile memory, and wherein the sensor electronics package is configured to retrieve information from the non-volatile memory after coupling of the sensor electronics package to one of the plurality of sensor devices.

95. 95. The analyte monitoring kit of claim 94, wherein the sensor electronics package retrieves calibration information, pairing information, and session status information from the non-volatile memory to enable continuation of a sensing session after a power interruption.

96. 95. The analyte monitoring kit of claim 94, wherein the sensor electronics package is configured to pair with a display device in response to coupling of the sensor electronics package to a first sensor device of the plurality of sensor devices and store pairing data in the non-volatile memory, and wherein the sensor electronics package is configured to retrieve the pairing data from the non-volatile memory and reconnect with the paired display device in response to coupling of the sensor electronics package to a second sensor device of the plurality of sensor devices.

97. 95. The analyte monitoring kit of claim 94, wherein the processor is configured to recognize electrical recoupling of the sensor electronics package to the first sensor device of the plurality of sensor devices and to resume a monitoring session in response to recognizing the recoupling to the first sensor device of the plurality of sensor devices.

98. 95. The analyte monitoring kit of claim 94, wherein the processor is configured to periodically save critical information to the non-volatile memory in preparation for an unplanned power outage, and to retrieve the critical information from the non-volatile memory in response to coupling the sensor electronics package to a new sensor device among the plurality of sensor devices.

99. 1. A biosensor device comprising: an analyte sensor configured to generate a signal, a sensor signal, representative of a concentration level of a substance in a fluid of the host; a processor configured to receive the sensor signal and determine a value based on the sensor signal; a communication circuit operably coupled to the processor and configured to transmit the value based on the sensor signal; A battery, a supercapacitor electrically coupled to the battery; A biosensor device, wherein the battery and the supercapacitor are configured to power the processor or the communication circuitry, and the supercapacitor reduces the load on the battery during periods of high load, thereby reducing strain on the battery.

100. 100. The biosensor device of claim 99, wherein the supercapacitor extends the operating life of the battery by reducing the strain on the battery during periods of high load.

101. 100. The biosensor device of claim 99, wherein the battery recharges the supercapacitor after the supercapacitor supplies energy to the communication circuit or the processor, and the supercapacitor is ready to supply energy during a subsequent period of high load.

102. 100. The biosensor device of claim 99, wherein the supercapacitor is configured in parallel with the battery.

103. 103. The biosensor device of claim 102, wherein the device is configured to draw energy preferentially from the supercapacitor rather than the battery.

104. 100. The biosensor device of claim 99, wherein the supercapacitor removes at least 10% of the load from the battery during a high load event.

105. 100. The biosensor device of claim 99, wherein the supercapacitor removes at least 20% of the load from the battery during a high load event.

106. 100. The biosensor device of claim 99, wherein the supercapacitor removes at least 30% of the load from the battery during a high load event.

107. 100. The biosensor device of claim 99, wherein the supercapacitor removes at least 50% of the load from the battery during a high load event.

108. 100. The biosensor device of claim 99, wherein the supercapacitor allows energy to be drawn from the battery in a highly consistent manner, extending the life of the battery.

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