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

An analyte sensor system is provided. The 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 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 sealing member configured to provide a seal around the first and second plurality of contacts within a first cavity. Related analyte sensor systems, analyte sensor base assemblies and methods are also provided.

TECHNICAL FIELD

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 related to disposable analyte sensor bases having a battery disposed therein and reusable sensor electronics modules configure to releasably couple to the bases.

BACKGROUND

Diabetes is a metabolic condition relating to the production or use of insulin by the body. Insulin is a hormone that allows the body to use glucose for energy, or store glucose as fat.

When a person eats a meal that contains 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 in a range that provides sufficient energy to support bodily functions and avoids problems that can arise when glucose levels are too high, or too low. Regulation of blood glucose levels depends on the production and use of insulin, which regulates the movement of blood glucose into cells.

When the body does not produce enough insulin, or when the body is unable to effectively use insulin that is present, blood sugar levels can elevate beyond normal ranges. The state of having a higher than normal blood sugar level is called “hyperglycemia.” Chronic hyperglycemia can lead to a number of health problems, such as cardiovascular disease, cataract and other eye problems, nerve damage (neuropathy), and kidney damage. Hyperglycemia can also lead to acute problems, such as diabetic ketoacidosis—a state in which the body becomes excessively acidic due to the presence of blood glucose and ketones, which are produced when the body cannot use glucose. The state of having lower than normal blood glucose levels is called “hypoglycemia.” Severe hypoglycemia can lead to acute crises that can result in seizures or death.

A diabetes patient can receive insulin to manage blood glucose levels. Insulin can be received, for example, through a manual injection with a needle. Wearable insulin pumps are also available. Diet and exercise also affect blood glucose levels. A glucose sensor can provide an estimated glucose concentration level, which can be used as guidance by a patient or caregiver.

Diabetes conditions are sometimes referred to as “Type 1” and “Type 2”. A Type 1 diabetes patient is typically able to use insulin when it is present, but the body is unable to produce sufficient amounts of insulin, because of a problem with the insulin-producing beta cells of the pancreas. A Type 2 diabetes patient may produce some insulin, but the patient has become “insulin resistant” due to a reduced sensitivity to insulin. The result is that even though insulin is present in the body, the insulin is not sufficiently used by the patient's body to effectively regulate blood sugar levels.

Blood sugar concentration levels may be monitored with an analyte sensor, such as a continuous glucose monitor. A wearable continuous glucose monitor may be powered by a battery that powers the sensor and other components, such as wireless communication circuitry. It is important that battery power be consistently available to assure that analyte concentration levels can be sensed and communicated by the analyte sensor.

SUMMARY

According to some embodiments, an analyte sensor system is provided. The 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 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 sealing member configured to provide a seal around the first and second plurality of contacts within a first cavity.

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 to 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 make electrical contact with the first sensor contact and a second signal contact configured to make 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. In some embodiments, the second plurality of contacts further includes 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. In some embodiments, 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.

In some embodiments, the base further includes a first retaining member and a second retaining member, and the sensor electronics module further includes a securement 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. In some embodiments, the second retaining member is frangible and configured to be separable from the base.

In some embodiments, the base further includes a cover configured to secure to the base and configured 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 line configured to secure the cover to the base. In some embodiments, the first sealing member is configured as a portion 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 secure to a bottom of the base.

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, the first sealing member extends over the first plurality of conductive traces, thereby sealing the first plurality of conductive traces from moisture ingress. In some embodiments, the first sealing member extends over the battery, thereby sealing the battery from moisture ingress. In some embodiments, at least some of the second plurality of contacts are in direct electrical contact with the analyte sensor or the battery.

In some embodiments, the second plurality of contacts are disposed on the securement feature. In some embodiments, the second plurality of contacts include 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 include 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 retaining member includes a hood and the first plurality of contacts are disposed within the hood. In some embodiments, the first sealing member is disposed around a circumference of the securement feature such that the first cavity is disposed within the hood. In some embodiments, the first sealing 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 mating the securement feature with the first retaining member while the sensor electronics module is disposed at an elevated angle with respect to the base, and pivoting the sensor electronics module, about the first retaining member, toward the base until the retention feature mates with the second retaining member.

In some embodiments, the sensor electronics module includes an aperture and the base includes a raised portion configured to fit within the aperture, an outer perimeter of the raised portion complimenting an inner perimeter of the aperture. In some embodiments, the first plurality of contacts is disposed on the raised portion. In some embodiments, the aperture is symmetrical about at least one axis parallel to a 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, a top surface of the raised portion sits substantially flush with a 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 within the aperture of the sensor electronics module and 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 couple with one or more corresponding retaining members of the base. In some embodiments, the base includes a recess disposed in a 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.

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 make electrical contact with a respective one of the third plurality of contacts, and the system further includes a second sealing member configured to provide a continuous seal around the third and fourth plurality of contacts within a 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 make electrical contact with the first battery contact and a second power contact configured to make electrical contact with the second battery contact. In some embodiments, the second plurality of contacts include concentric, circular contacts. In some embodiments, the concentric, circular contacts are disposed around a center of the sensor electronics module. In some embodiments, each of the second plurality of contacts are configured to make electrical contact with the 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.

In some embodiments, the base includes an aperture and the sensor electronics module includes a raised portion configured to fit within the aperture, an outer perimeter of the raised portion complimenting an inner perimeter of the aperture. In some embodiments, the aperture and the raised portion each have a substantially circular shape. In some embodiments, the sensor electronics module is configured to releasably couple to the base by fitting the raised portion of the sensor electronics module within the aperture of the base and 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 couple with one or more corresponding retaining members of the base.

In some embodiments, the base includes a raised rail and the sensor electronics module includes a channel having a shape that compliments a shape of the raised rail. In some embodiments, the raised rail has a constant width along a length of the raised rail. In some embodiments, a width of the raised rail tapers along a length of the raised rail. In some embodiments, the first plurality of contacts is disposed on a sidewall of the raised rail and the second plurality of contacts is disposed on a sidewall of the channel. In some embodiments, 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. 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 host's body until the sensor electronics module is seated against the base, and one or more retention features of the sensor electronics module couple with one or more corresponding retaining members of the base.

According to some embodiments, an analyte sensor system is provided. The 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 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 wireless transceiver configured to transmit a wireless signal based at least in part on the sensor signal.

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

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 to the sensor electronics module. In some embodiments, the first plurality of contacts comprises 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 comprises a first signal contact configured to make electrical contact with the first sensor contact and a second signal contact configured to make electrical contact with the second sensor contact. In some embodiments, the first plurality of contacts further comprises a first battery contact and a second battery contact, each configured to be electrically coupled to a respective terminal of the battery.

According to some embodiments, an analyte sensor base assembly is provided. The assembly includes a base configured to attach to a 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 a sealing member configured to provide a seal around at least the at least one battery contact.

In some embodiments, the sealing member is further configured to provide the seal around at least the at least one sensor contact. In some embodiments, the assembly includes at least two sensor contacts and at least two battery contacts, wherein the sealing member is configured to provide the 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 to a sensor electronics module that is couplable to the base.

In some embodiments, the base further includes a first retaining member configured to mate with a securement feature of a couplable sensor electronics module, and a second retaining member configured to mate with a retention feature of the couplable sensor electronics module. In some embodiments, the second retaining member is frangible and configured to be separable from the base. In some embodiments, the base further includes a cover configured to secure to the base and configured 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, the sealing member is disposed within the hood.

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 of the host. The reusable portion may be configured to couple to the base may include a wireless transceiver, wherein 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 may be configured to mechanically couple with the base or the reusable portion and electrically couple with the base or the reusable portion, wherein the batteries deliver power to the analyte sensor and the wireless transceiver.

According to some embodiments, an analyte monitoring kit is provided. The kit may include a sensor electronics package including a processor and a communication circuit, 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 of a host, wherein the sensor electronics package is configured to electrically and mechanically couple with each of the plurality of sensor devices and draw power from the sensor device battery to power the processor and the communication circuit, wherein the sensor electronics package is reusable with the plurality of sensor devices.

According to some embodiments, a biosensor device is provided. The device may include an analyte sensor configured to generate a signal a sensor signal representative of a concentration level of a substance in a fluid of a host, a processor configured to receive the sensor signal and determine a value based on the sensor signal, a communication circuit operatively 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 deliver power to the processor or the communication circuit, the supercapacitor reducing a load on the battery to reduce strain on the battery during a high-load period.

This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. The detailed description is included to provide further information about the present patent application. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense.

DETAILED DESCRIPTION

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

Definitions

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

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

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

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

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

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

The terms “glucose sensor” and “member for determining the amount of glucose in a biological sample” as used herein are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and furthermore refer without limitation to any mechanism (e.g., enzymatic or non-enzymatic) by which glucose can be quantified. For example, some embodiments utilize a membrane that contains glucose oxidase that catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate, as illustrated by the following chemical reaction:
Glucose+O2→Gluconate+H2O2

Because for each glucose molecule metabolized, there is a proportional change in the co-reactant O2and the product H2O2, one can use an electrode to monitor the current change in either the co-reactant or the product to determine glucose concentration.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Overview

Energy in an analyte sensor system may be managed by controlling energy output, such as the consumption of energy by communication circuits or other circuits, and by controlling energy inputs, such as replacing or recharging batteries. Wearable analyte sensor systems may include a battery, capacitor, or other power storage component, that powers a sensor, processor, communication circuit, or other electrical components. Management of energy consumption (e.g. power management, i.e. management of energy expended per unit of time) can be important to extend the life of sensor components (e.g., a battery) and to assure that the analyte sensor continues to perform its intended function(s). For example, where a component (e.g., a sensor electronics module, which may include relatively costly wireless sensor electronics package components) has a battery that is not rechargeable or replaceable, the life of the component may be extended by managing the use of energy stored in the battery.

Sensor systems may apply algorithms that take into account one or more of a variety of real-time, systemic, trend, model, or other factors such as wireless performance, analyte management (e.g., glucose management), battery state, power management trends or characteristic, patient or environmental risk factors, risk tolerance, location, or a combination thereof. For example, a system may take an action responsive to a condition. A system response may include changing system behavior to decrease power consumption or increase power consumption based on the determined condition. For example, an analyte management condition (e.g., estimated glucose level in range or below or above a specified value or exhibiting a specified trend) may be used as an input to determine system behavior and energy consumption. In various examples, a condition may be predetermined and programmed or hard-wired into a device, or specified by a user, or determined by a processor (e.g., based upon information learned from data.)

In some examples, a sensor system may receive an operational parameter that relates to a peripheral device, which may be a therapy device such as an insulin pump or pen. The sensor system may receive the operational parameter from the peripheral device, or from a remote resource based on an identification of the peripheral device (e.g., pump model number or serial number), or from a memory (e.g., retrieved from a lookup table.) The sensor system may manage its operations based at least in part on the operational parameter. For example, based on the operational parameter, a system may communicate according to a schedule, or with a specified device or group of devices, or manage power consumption to extend a battery.

System hardware may be configured to enable replacement of batteries, and system components (e.g., sensor base and sensor electronics) may be configured to provide a water-tight seal after replacement of batteries. Battery-supporting technologies such as supercapacitors may also be used to facilitate energy management.

Example System

FIG.1is an illustration of an example system100. The system100may include an analyte sensor system102that may be coupled to a host101. The host101may be a human patient. The patient may, for example, be subject to a temporary or permanent diabetes condition or other health condition for which analyte monitoring may be useful.

The analyte sensor system102may include an analyte sensor104, which may for example be a glucose sensor. The glucose sensor may be any device capable of measuring the concentration of glucose. For example, the analyte sensor104may be fully implantable, or 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., with a sensor residing under or in the skin of a host). It should be understood that the devices and methods described herein can be applied to any device capable of detecting a concentration of glucose and providing an output signal that represents the concentration of glucose (e.g., as a form of analyte data).

The analyte sensor system102may also include sensor electronics106. In some examples, the analyte sensor104and sensor electronics106may be provided as an integrated package. In other examples, the analyte sensor104and sensor electronics106may be provided as separate components or modules. For example, the analyte sensor system102may include a disposable (e.g., single-use) base that may include the analyte sensor104, 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, which may include some or all of the sensor electronics106shown inFIG.2. The sensor electronics package may be reusable.

An analyte sensor may use any known method, including invasive, minimally-invasive, or non-invasive sensing techniques (e.g., optically excited fluorescence, microneedle, transdermal monitoring of glucose), to provide a data stream indicative of the concentration of the analyte in a host. The data stream may be a raw data signal, which may be converted into a calibrated and/or filtered data stream that is used to provide a useful value of the analyte (e.g., estimated blood glucose concentration level) to a user, such as a patient or a caretaker (e.g., a parent, a relative, a guardian, a teacher, a doctor, a nurse, or any other individual that has an interest in the wellbeing of the host).

Analyte sensor104may, for example, be a continuous glucose sensor, which may, for example, include a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device. In some embodiments, such a sensor or device may recurrently (e.g., periodically or intermittently) analyze sensor data. The glucose sensor may use any method of glucose-measurement, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, iontophoretic, radiometric, immunochemical, and the like. In various examples, the analyte sensor system102may be or include a continuous glucose monitor sensor available from DexCom™ (e.g., the DexCom G5™ sensor or Dexcom G6™ sensor or any variation thereof.)

In some examples, analyte sensor104may be an implantable glucose sensor, such as described with reference to U.S. Pat. No. 6,001,067 and U.S. Patent Publication No. US-2005-0027463-A1. In some examples, analyte sensor104may be a transcutaneous glucose sensor, such as described with reference to U.S. Patent Publication No. US-2006-0020187-A1. In some examples, analyte sensor104may be configured to be implanted in a host vessel or extracorporeally, such as is described in U.S. Patent Publication No. US-2007-0027385-A1, co-pending U.S. Patent Publication No. US-2008-0119703-A1 filed Oct. 4, 2006, U.S. Patent Publication No. US-2008-0108942-A1 filed on Mar. 26, 2007, and U.S. Patent Application No. US-2007-0197890-A1 filed on Feb. 14, 2007. In some examples, the continuous glucose sensor may include a transcutaneous sensor such as described in U.S. Pat. No. 6,565,509 to Say et al., for example. In some examples, analyte sensor104may be a continuous glucose sensor that includes a subcutaneous sensor such as 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., for example. In some examples, the continuous glucose sensor may include a refillable subcutaneous sensor such as described with reference to U.S. Pat. No. 6,512,939 to Colvin et al., for example. The continuous glucose sensor may include an intravascular sensor such as described with reference to U.S. Pat. No. 6,477,395 to Schulman et al., for example. The continuous glucose sensor may include an intravascular sensor such as described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al., for example.

The system100may also include a second medical device108, which may, for example, be a drug delivery device (e.g., insulin pump or insulin pen). In some examples, the medical device108may be or include a sensor, such as another analyte sensor, a heart rate sensor, a respiration sensor, a motion sensor (e.g. accelerometer), posture sensor (e.g. 3-axis accelerometer), acoustic sensor (e.g. to capture ambient sound or sounds inside the body). In some examples, medical device108may be wearable, e.g. on a watch, glasses, contact lens, patch, wristband, ankle band, or other wearable item, or may be incorporated into a handheld device (e.g., a smartphone). In some examples, the medical device108may include a multi-sensor patch that may, for example, detect 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 levels (e.g. using impedance or pressure).

The analyte sensor system102may communicate with the second medical device108via a wired connection, or via a wireless communication signal110. For example, the analyte sensor system may be configured to communicate using via radio frequency (e.g. Bluetooth, Medical Implant Communication System (MICS), WiFi, NFC, RFID, Zigbee, Z-Wave or other communication protocols), optically (e.g. infrared), sonically (e.g. ultrasonic), or a cellular protocol (e.g., CDMA (Code Division Multiple Access) or GSM (Global System for Mobiles), or wired connection (e.g. serial, parallel, etc.). In some examples, an array or network of sensors may be associated with the patient. For example, the analyte sensor system102, medical device108, and an additional sensor130may communicate with one another via wired or wireless (e.g., Bluetooth, MICS, or any of the other options discussed above,) communication. The additional sensor130may be any of the examples discussed above with respect to medical device108. The analyte sensor system102, medical device108, and additional sensor130on the host101are provided for the purpose of illustration and discussion and are not necessarily drawn to scale.

The system may also include one or more peripheral devices, such as a hand-held smart device (e.g., smartphone)112, tablet114, smart pen116(e.g., insulin delivery pen with processing and communication capability), computer118, watch120, or peripheral medical device122, any of which may communicate with the analyte sensor system102via a wireless communication signal, and may also communicate over a network124with a server system (e.g., remote data center)126or with a remote terminal128to facilitate communication with a remote user (not shown) such as a technical support staff member or a clinician.

The system100may also include a wireless access point (WAP)132that may be used to communicatively couple one or more of analyte sensor system102, network124, server system126, medical device108or any of the peripheral devices described above. For example, WAP132may provide Wi-Fi and/or cellular connectivity within system100. Other communication protocols (e.g., Near Field Communication (NFC) or Bluetooth) may also be used among devices of the system100. In some examples, the server system126may be used to collect analyte data from analyte sensor system102and/or the plurality of other devices, and to perform analytics on collected data, generate or apply universal or individualized models for glucose levels, and communicate such analytics, models, or information based thereon back to one or more of the devices in the system100.

FIG.2is a schematic illustration of various example electronic components that may be part of a medical device system200. In an example, the system may include a sensor electronics106and a base290. While a specific example of division of components between the base and sensor electronics is shown, it is understood that some examples may include additional components in the base290or in the sensor electronics106, and the some of the components (e.g., supercapacitor284) that are shown in the sensor electronics106may be alternative or additionally (e.g., redundantly) provided in the base. In an example, the base290may include the analyte sensor104and a battery292. In some examples, the base may be replaceable, and the sensor electronics106may include a debouncing circuit (e.g., gate with hysteresis or delay) to avoid, for example, recurrent execution of a power-up or power down process when a battery is repeatedly connected and disconnected or avoid processing of noise signal associated with removal or replacement of a battery.

The sensor electronics106may include electronics components that are configured to process sensor information, such as sensor data, and generate transformed sensor data and displayable sensor information. The sensor electronics106may, for example, include electronic circuitry associated with measuring, processing, storing, or communicating continuous analyte sensor data, including prospective algorithms associated with processing and calibration of the sensor data. The sensor electronics module106may include hardware, firmware, and/or software that enables measurement of levels of the analyte via a glucose sensor. Electronic components may be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronic components may take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, and/or a processor.

As shown inFIG.2, the sensor electronics106may include a potentiostat202, which may be coupled to the analyte sensor104and configured to recurrently obtain analyte sensor readings using the analyte sensor, for example by continuously or recurrently placing a voltage bias across sensor electrodes and measuring a current flow indicative of analyte concentration. The sensor electronics may also include a processor204, which may retrieve instructions206from memory208and execute the instructions to determine control application of bias potentials to the analyte sensor104via the potentiostat, interpret signals from the sensor, or compensate for environmental factors. The processor may also save information in data storage memory210or retrieve information from data storage memory210. In various examples, data storage memory210may be integrated with memory208, 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 U.S. Pat. Nos. 7,310,544 and 6,931,327.

The sensor electronics106may also include a sensor212, which may be coupled to the processor. The sensor212may, for example, be a temperature sensor or an accelerometer. The sensor electronics106may also include a power source such as a capacitor or battery214, which may be integrated into the sensor electronics, or may be removable, or part of a separate electronics package. The battery214(or other power storage component, e.g., capacitor) may optionally be rechargeable via a wired or wireless (e.g., inductive or ultrasound) recharging system216. The recharging system may harvest energy or may receive energy from an external source or on-board source. In various examples, the recharge circuit may include a triboelectric charging circuit, a piezoelectric charging circuit, an RF charging circuit, a light charging circuit, an ultrasonic charging circuit, a heat charging circuit, a heat harvesting circuit, or a circuit that harvests energy from the communication circuit. In some examples, the recharging circuit may recharge the rechargeable battery using power supplied from a replaceable battery (e.g., a battery supplied with a base component.)

The sensor electronics may also include one or more supercapacitors284in the sensor electronics package (as shown), or in the base. For example, the supercapacitor284may allow energy to be drawn from the battery in a highly consistent manner to extend a life of the battery. The battery may recharge the supercapacitor after the supercapacitor delivers energy to the communication circuit or to the processor, so that the supercapacitor is prepared for delivery of energy during a subsequent high-load period. In some examples, the supercapacitor may be configured in parallel with the battery. A device may be configured to preferentially draw energy from the supercapacitor, as opposed to the battery. In some examples, a supercapacitor may be configured to receive energy from the rechargeable battery for short-term storage and transfer energy to the rechargeable battery for long-term storage.

The supercapacitor may extend an operational life of the battery by reducing the strain on the battery during the high-load period. In some examples, a supercapacitor removes at least 10% of the strain off the battery during high-load events. In some examples, a supercapacitor removes at least 20% of the strain off the battery during high-load events. In some examples, supercapacitor removes at least 30% of the strain off the battery during high-load events. In some examples, a supercapacitor removes at least 50% of the strain off the battery during high-load events.

The sensor electronics106may also include a wireless communication circuit218, which may for example include a wireless transceiver operatively coupled to an antenna. The wireless communication circuit218may be operatively 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.

Peripheral device250may include, a user interface252, a memory circuit254, a processor256, a wireless communication circuit258, a sensor260, or any combination thereof. The user interface252may, for example, include a touch-screen interface, a microphone (e.g., to receive voice commands), or a speaker, a vibration circuit, or any combination thereof, which may receive information from a user (e.g., glucose values) or deliver information to the user such as glucose values, glucose trends (e.g., an arrow, graph, or chart), or glucose alerts. The processor256may be configured to present information to a user, or receive input from a user, via the user interface252. The processor256may also be configured to store and retrieve information, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information in the memory circuit254. The wireless circuit communication circuit258may include a transceiver and antenna configured communicate via a wireless protocol, such as Bluetooth, MICS, or any of the other options discussed above. The sensor260may, for example, include an accelerometer, a temperature sensor, a location sensor, biometric sensor, or blood glucose sensor, blood pressure sensor, heart rate sensor, respiration sensor, or other physiologic sensor. The peripheral device250may, for example, be devices such as a hand-held smart device (e.g., smartphone or other device such as a proprietary handheld device available from Dexcom)112, tablet114, smart pen116, watch120or other wearable device, or computer118shown inFIG.1.

The peripheral device250may be configured to receive and display sensor information that may be transmitted by sensor electronics module106(e.g., in a customized data package that is transmitted to the display devices based on their respective preferences). Sensor information (e.g., blood glucose concentration level) or an alert or notification (e.g., “high glucose level”, “low glucose level” or “fall rate alert” may be communicated via the user interface252(e.g., via visual display, sound, or vibration). In some examples, the peripheral device250may be configured to display or otherwise communicate the sensor information as it is communicated from the sensor electronics module (e.g., in a data package that is transmitted to respective display devices). For example, the peripheral device250may transmit data that has been processed (e.g., an estimated analyte concentration level that may be determined by processing raw sensor data), so that a device that receives the data may not be required to further process the data to determine usable information (such as the estimated analyte concentration level.) In other examples, the peripheral device250may process or interpret the received information (e.g., to declare an alert based on glucose values or a glucose trend. In various examples, the peripheral device250may receive information directly from sensor electronics106, or over a network (e.g., via a cellular or Wi-Fi network that receives information from the sensor electronics or from a device that is communicatively coupled to the sensor electronics106.)

Referring again toFIG.2, the medical device270may include a user interface272, a memory circuit274, a processor276, a wireless communication circuit278, a sensor280, a therapy circuit282, or any combination thereof. The user interface272may, for example, include a touch-screen interface, a microphone, or a speaker, a vibration circuit, or any combination thereof, which may receive information from a user (e.g., glucose values, alert preferences, calibration coding) or deliver information to the user, such as e.g., glucose values, glucose trends (e.g., an arrow, graph, or chart), or glucose alerts. The processor276may be configured to present information to a user, or receive input from a user, via the user interface272. The processor276may also be configured to store and retrieve information, such as communication information (e.g., pairing information or data center access information), user information, sensor data or trends, or other information in the memory circuit274. The wireless circuit communication circuit278may include a transceiver and antenna configured 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 Mobiles). The sensor280may, for example, include an accelerometer, a temperature sensor, a location sensor, biometric sensor, or blood glucose sensor, blood pressure sensor, heart rate sensor, respiration sensor, or other physiologic sensor. The medical device270may include two or more sensors (or memories or other components), even though only one is shown in the example inFIG.2. In various examples, the medical device270may be a smart handheld glucose sensor (e.g., blood glucose meter), drug pump (e.g., insulin pump), or other physiologic sensor device, therapy device, or combination thereof. The medical device270may be the device122shown inFIG.1.

In examples where the medical device122or medical device270is an insulin pump, the pump and analyte sensor system may be in two-way communication (e.g., so the pump can request a change to an analyte transmission protocol, e.g., request a data point or request data on a more frequency 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, for example, not in response to a request. In one-way communication, a glucose value may be incorporated in an advertisement message, which may be encrypted with a previously-shared key. In a two-way communication, a pump may request a value, which the analyte system may share, or obtain and share, in response to the request from the pump, and any or all of these communications may be encrypted using one or more previously-shared keys. An insulin pump to may receive and track analyte (e.g., glucose) values transmitted from analyte sensor system102using one-way communication to the pump for one or more of a variety of reasons. For example, an insulin pump may suspend or activate insulin administration based on a glucose value being below or above a threshold value.

In some examples, the system100shown inFIG.1may include two or more peripheral devices that each receive information directly or indirectly from the analyte sensor system102. Because different display devices provide may different user interfaces, the content of the data packages (e.g., amount, format, and/or type of data to be displayed, alarms, and the like) may be customized (e.g., programmed differently by the manufacture and/or by an end user) for each particular device. For example, in the embodiment ofFIG.1, a plurality of different peripheral devices may be in direct wireless communication with a sensor electronics module (e.g., such as an on-skin sensor electronics module106that is physically connected to the continuous analyte sensor104) during a sensor session to enable a plurality of different types and/or levels of display and/or functionality associated with the displayable sensor information, or, to save battery power in the sensor system102, one or more specified devices may communicate with the analyte sensor system and relay (i.e., share) information to other devices directly or through a server system (e.g., network-connected data center)126.

Example Methods

FIG.3is a flowchart illustration of an example method300of managing power consumption in an analyte monitoring system. The method may, for example, include modulating power output from a first communication circuit to increase range or bandwidth by increasing power output and to conserve energy by decreasing power output from the first communication circuit. The method may, for example, be implemented in a system as shown inFIG.1or a device as shown inFIG.2. The method may be repeated continuously or recurrently (e.g. periodically) or responsive to one or more events to manage power on an ongoing basis.

At302, a signal representative of an analyte (e.g., glucose) concentration level may be received. The signal may be received, for example, from an analyte sensor, which may, for example, be a portion of a continuous glucose monitoring system as described above.

At304, a determination is made as to whether a first condition is satisfied. In some examples, a processor operatively coupled to an analyte sensor (e.g., CGM processor) may determine whether the first condition is satisfied. In some examples, a processor in a peripheral device (e.g., smart phone or other display device) may determine whether the first condition is satisfied. Responsive to the condition not being satisfied, the method may return to step302and continue to receive analyte concentration levels.

In some examples, the first condition may be a connectivity condition, and step304may include determining whether the connectivity condition has been satisfied. The connectivity condition may, for example, include the existence of a connection (e.g. Bluetooth connection), a reliability of a connection (e.g., based upon the occurrence of successful connection attempts, or based on connection failures), or a 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 satisfied may include applying a connectivity parameter to a model. The model may include a plurality of communication states. The communication states may, for example, be based upon reliability of communication, elapsed time with consecutive successful communication sessions, elapsed time since an unsuccessful attempt (or series of attempts) to establish communication, or other measures of communication effectiveness or reliability.

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

In some examples, determining whether a first condition is satisfied may, for example, include applying an analyte parameter to a model (e.g., a state model). In some examples, the condition may correspond to recognition of a state of disease management that is clinically relevant to the user of a peripheral device. A condition may, for example, be based upon by an analyte level (e.g. low estimated glucose level or high estimated glucose level), a trend (e.g., analyte concentration level rate of change or a predictive data), a deviation from a trend (e.g., reversal of a trend), or a probability of a clinically relevant condition occurring in the future (e.g., urgent low glucose soon).

In some examples, a condition may correspond to or be based upon one or more requirements of a peripheral device, such as an insulin pump. For example, a connectivity state may go from a low power usage model to a high-power usage model based upon a basal or bolus insulin deliver conditions (e.g., a high-power usage model or more reliable or frequency communication may be used when insulin is being delivered to avoid loss of a connection.)

In some examples, a state model may include a plurality of analyte concentration level states. An analyte concentration level state may be defined or determined by an analyte concentration range or trend (e.g., glucose below target range, glucose in target range, or glucose above target range.)

In some examples, a state model may additionally or alternatively include a plurality of communication states (e.g., low power state, high power state or high-reliability state, partnered state to coordinate with a peripheral device such as a pump, battery life extension state to assure that predicted battery life meets a battery life criterion.)

Responsive to the condition being satisfied, the method300may include, at306, shifting from a first wireless communication mode to a second wireless communication mode responsive to satisfaction of a condition. In some examples, shifting from the first wireless communication mode to the second wireless communication mode includes reducing power output from a communication circuit to save energy. In some examples, the first wireless communication mode may consume more power than the second wireless communication mode. This shift to the second wireless communication mode may allow an analyte monitoring system to save power when the first condition is satisfied by shifting to the second wireless communication mode. In some examples, a system may balance need for communication and power consumption. For example, satisfaction of the first condition may be associated with a less urgent need for communication (e.g., a determination that analyte concentration levels and/or trends are in a “managed” range or state), in which case less frequent (e.g. on 15-minute intervals instead of 5-minute intervals), less power-demanding (e.g. lower transmit power or lower power protocol), or less automatic or on-demand communication (e.g. NFC instead of Bluetooth) communication may be acceptable. In some examples, a processor may monitor power consumption continuously or recurrently intermittently or may increase or decrease power consumption responsive to a protocol or satisfaction of a condition.

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 as 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 required to maintain an active state (e.g. based on a minimum connection interval) than the continuous connection mode. 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., in a Bluetooth protocol.) The one-way communication protocol may require less time actively transmitting and receiving, and therefore uses less power.

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 techniques tend to have a relatively short range (e.g., 4 cm up to about 30 cm), but require less power, no power, and in some examples can harvest power.

In some examples, an authentication process may be performed in the first communication mode (e.g., in a two-way communication scheme to allow for exchange of keys), and the system may shift to the second communication mode after authentication. In some examples, the system may transmit encrypted broadcast data via the second wireless communication mode. The encrypted broadcast data may, for example, include analyte concentration level information, trend information, or state information. In some examples, the encrypted broadcast data may be used to determine whether to shift from the second wireless communication mode to the first wireless communication mode (e.g., to determine whether the second condition is satisfied.) In some examples, the encrypted broadcast data may include an indication to shift back from the second wireless communication mode to the first wireless communication mode. For example, an analyte system processor (e.g., CGM processor) may apply an algorithm to determine whether to shift 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., smart phone or other handheld display device) may apply an algorithm to determine whether to shift from the first mode to the second mode (e.g., to save power.)

After shifting to the second wireless communication mode, the method may include at308transmitting using the second wireless communication mode for a period of time, or until the satisfaction of a second condition (e.g., as determined at step310.)

At310, the method may include determining whether a second condition is satisfied. The second condition may be a different condition or may be an inverse of the first condition (e.g., an analyte level or trend moving out of range or otherwise satisfying or failing to satisfy a glucose management condition, or failure to satisfy a communication condition.) When the second condition is not satisfied, the method may return to transmitting the wireless signal using the second (e.g., low-power) wireless communication mode at308.

Responsive 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, at312, shifting from a second wireless communication mode to the first wireless communication mode. In some examples, the method300may include shifting from the second communication mode back to the first communication mode includes increasing power output to increase communication range or bandwidth, and, at314, communicating using the first wireless communication mode. Alternatively, the method may at310include shifting to a third wireless communication mode (e.g., to an intermediate power-consuming mode (e.g., intermittent two-way communication), or to 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 at314.

In some examples, the method300may include shifting from a one-way communication mode (e.g., broadcast) to a two-way communication mode when a sensor calibration is needed or to acknowledge that an alert or alarm has been received.

FIG.4is a flowchart illustration of an example method400of managing power output based upon monitored sensor values or performance metrics. The method may be implemented, for example, in a system as shown inFIG.1or a device as shown inFIG.2.

The method400may include, at402, monitoring one or more physiologic sensor values (e.g., analyte concentration level, temperature, activity level, heart rate.). The physiologic sensor values may, for example, be received from a wearable sensor device that includes an analyte sensor (e.g., analyte sensor) and a communication circuit. The wearable sensor device may, for example, includes an analyte monitor, and the one or more physiologic sensor values include an estimated analyte concentration level.

The method may also include, at404, monitoring one or more communication performance metrics pertaining to communication to or from the wearable sensor device. The communication performance metrics may, for example, include packet capture rates or received signal strength indicator values.

The method may further include, at406, determining whether a condition is satisfied. The determination may, for example, be based at least in part upon the monitored physiologic sensor values (e.g., satisfaction of an analyte management condition) or the communication performance metrics (e.g., satisfaction of a communication reliability condition), or both or a combination thereof. For example, the method may include determining whether an analyte management condition is satisfied based at least in part on the estimated analyte concentration level. The analyte risk management condition may, for example, include a range, a trend, a projected analyte level, or other analyte management information. As described in detail above, the condition may correspond to recognition of a state of disease management that is clinically relevant to a user of a peripheral device

The method may additionally or alternatively include determining whether a communication reliability condition is satisfied based at least in part on the communication performance metrics, and responsive to determining that the communication reliability condition is satisfied, conserving power by shifting to a more energy efficient communication scheme, or maintaining a current communication scheme (e.g., refraining from increasing power output). The communication reliability condition may, for example, be based on signal strength or packet rate falling below a threshold, or a combination thereof.

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

Responsive to the satisfaction of a condition, the method may further include, at408, increasing or decreasing power output of the communication circuit. In some examples, the method may include shifting to a lower-power protocol. For example, the method may include shifting from a long-range communication protocol to a short-range communication protocol (e.g., MICS or Bluetooth to NFC), or from a continuously connected mode to a recurrently (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., shifting the communication mode). In some examples, the method may include periodically communicating the estimated analyte concentration level to another device and increasing or decreasing power output may include decreasing a frequency of communication of the estimated analyte concentration level.

In some example, increasing or decreasing power output may include shifting a frequency, shifting a mode, shifting a power level, or shifting a time period between communications, to increase communication range or reliability, or to conserve energy. For example, a system may shift between communicating one or more of once a minute, once every five minutes, once every ten minutes, or once every 30 minutes.

In some examples, increasing or decreasing power output may include restricting communication to a specified peripheral device of a plurality of available peripheral devices (e.g., increasing power to a pump but not to a smart watch). In some examples, the method may further include determining a specified 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 a communication scheme is modified based at least in part on the monitored physiologic sensor values, the communication performance metrics, and the battery status.

FIG.5is a flowchart illustration of an example method500of selecting a communication protocol based upon satisfaction of an analyte management condition. The method500may, for example, be applied to an analyte monitoring system including 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 as shown inFIG.1or a device as shown inFIG.2.

The method may include, at502, receiving an analyte management condition from a partner device, such as an insulin pump or an insulin pen. The analyte management condition may include, for example, a range of analyte concentration levels (e.g., glucose concentration levels), a rate or change, or other parameter based on one or more analyte concentration levels. In various examples, the analyte management condition may be determined by the partner device or may be input by a user of the partner device.

At504, the method500may further include receiving, e.g., from an analyte sensor, an analyte signal representative of an analyte concentration level (e.g., glucose concentration level.) The method500may also include, at506, determining an analyte parameter based at least in part upon the analyte signal. For example, an estimated analyte concentration level (e.g., estimated glucose concentration level) may be determined. The method500may further include, at508, determining a whether the analyte management condition is satisfied. The determination may be based at least in part on the analyte parameter. For example, the method may include determining whether an estimated analyte concentration level falls below a threshold, or exceeds a threshold, or a rate of change exceeds a rate of change threshold, or a predicted analyte concentration level meets a condition (e.g., above or below a threshold.) In some examples, determining whether the analyte management condition is satisfied may include applying the analyte parameter to a model (e.g., state model). The model may be predefined or may be learned from data, and may reside in the system (e.g., in the sensor electronics) or locally (e.g., on a smart device on or near the patient (host), or may reside on a remote system (e.g., on a networked resource.) One or more parameters (e.g., an analyte parameter) may be applied to the model (e.g., provided as input) and a state may be determined by applying the one or more parameters to the model. The state may, for example, relate to the host, such as a glucose state (e.g., in range, out of range, or trend) or may relate to communications (e.g., reliable or unreliable), or a combination thereof.

The method500may further include determining a communication protocol for communicating with the partner device based at least in part on whether the analyte management condition is satisfied. For example, the method may include, at510communicating via a first communication mode (e.g., power level, frequency, protocol) when the condition is satisfied, and, at512, communicating via second communication mode when the condition is not satisfied. In an example, when an estimated analyte level (e.g., estimated glucose level) falls within a safe zone (e.g., 80 to 140 mg/DL), which may be specified by a partner device (e.g., insulin pump) or based upon a requirement or characteristic of the partner device, an analyte monitor (e.g., CGM) may communicate (e.g., advertise in a Bluetooth protocol) less frequently (e.g., every 15 or 30 minutes instead of continuously or every 1 or 5 minutes) to conserve power, or may shift to a one-way communication scheme, or may otherwise control operation of the system conserve power as described herein.

FIG.6is a flowchart illustration of an example method600of managing power using an operational parameter received from a peripheral device. The method600may be implemented in an analyte monitoring system (e.g., CGM) including a communication 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, for example, be implemented in a system as shown inFIG.1or a device as shown inFIG.2.

The method600may include, at602, receiving via the communication circuit an operational parameter relating to a peripheral device. The peripheral device may, for example, include a drug pump, a smart pen, a handheld device (e.g., smart phone) or another type of display device that is configured to communicate with the analyte monitoring system. The operational parameter may be received from the peripheral device, or the operational parameter may be received from a remote resource (e.g., a server) or local device (e.g., smartphone app). In some examples, the operational parameter may be retrieved from a memory circuit based upon an identity or characteristic of the peripheral device (e.g., retrieved from a lookup table.) In an example, a system may communicate with a peripheral device and receive (or exchange) device identification information, and the system may then provide the device identification information (e.g., via a device such as a smart phone) and receive the operational parameter, which may be received from or determined by a remote resource (e.g., network server) or by a smart device.

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

The method may further include, at604, operating a system (e.g., analyte monitoring system such as a CGM) based at least in part upon the operational parameter. In various examples, a determination may be made based on the operational parameter, the system may be operated based at least in part on the determination. For example, the system may determine whether the operational parameter is within acceptable bounds. In some examples, the system may, for example, determine whether an analyte concentration is a defined analyte concentration range or satisfies a trend criterion, such as an average rate of change being below a threshold value.

In some examples, the operational parameter may include an operational requirement of the peripheral device. The method600may include controlling operation of the system to satisfy the operational requirement.

In an example, the operational requirement may include a sensor accuracy requirement and the system may be controlled to satisfy the sensor accuracy requirement (e.g., calibrate or replace a sensor that does not satisfy the sensor accuracy requirement). In an example, the operational requirement may include a calibration schedule, and the system may be operated to satisfy the calibration schedule (e.g., a system may prompt a user for calibrations to satisfy the schedule received from a partner device).

In an example, the operational requirement may include a battery life requirement, and the system may be operated to satisfy the battery life requirement (e.g., the system may suggest replacement of a battery, or a transceiver or other component that contains a battery, to assure that the battery life requirement is satisfied.) In some examples, the operational parameter may include a specified period of time (e.g., a pump session time), and operation of a system (e.g., continuous analyte sensor) may be controlled to manage energy consumption from the battery (e.g., analyte sensor battery) so that energy stored in the battery is not depleted before the specified period of time expires, e.g., the processor may control operation of the communication circuit in a manner calculated to assure that energy stored in the battery is not depleted before the specified period of time expires. For example, the processor may modify a communication scheme to conserve battery energy during the specified period of time. For example, the processor may shift to a communication mode that consumes less energy (e.g., shift from MICS or Bluetooth to NFC, shift from an always connected mode to a recurrent (e.g., periodic) communication mode, or shift from a two-way communication mode to a one-way (e.g., broadcast) communication mode.

In some examples, a system (e.g., 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 by the communication circuit so that the system communicates only with the peripheral device during the 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 the specified period of time. In another example, the system (e.g., analyte monitoring system) may receive an operational parameter that indicates that the system may only communicate with the peripheral device during a specified period of time (e.g., the parameter may prescribe a communication schedule to reduce a need to broadcast). In another example, the system (e.g., analyte monitoring system) may receive an operational parameter that indicates that the system may communicate only with the peripheral device (e.g., with no other devices) during a specified period of time (e.g., to assure that a communication to a pump is successful). In another example, the system may receive an operational parameter to blacklist a communication device, such as a device that was previously connected with the system (e.g., a previous pump that was replaced may be blacklisted.)

In some examples, the operational parameter may include a specified number of additional peripheral devices, and the method may include communicating only with the peripheral device 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.

In some examples, the operational parameter may include an identification of one or more additional peripheral devices, and the method may include communicating only with the identified one or more 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. For example, an analyte monitoring system may communicate with a default or user-specified primary device. In some examples, the identification may specify a specific device, e.g., using a device ID. In some examples, the identification may specify a type of device (e.g. a watch). Types of peripheral devices may include, for example, a handheld device (e.g., smartphone), a watch, a tablet, a pen, a pump, or a desktop computer.

In some examples, a system (e.g., analyte monitoring system) may receive information about connections between peripheral devices. For example, an analyte system may receive information that a smart phone is in communication with a watch. Responsive to receiving information that a first peripheral device is in communication with a second peripheral device, the system may restrict communication to a specified device or group of devices (e.g., an analyte monitoring system may communicate with a smart phone, or smartphone and pump) and rely on the specified device to communicate with a third device (e.g., the smartphone may pass information to a smartwatch to reduce battery consumption by an analyte sensor system.)

In some examples, an operational parameter may be a schedule for providing information such as an analyte level or trend (or both), and a system may communicate according to the schedule. For example, an analyte signal representative of an analyte concentration level may be received from an analyte sensor, processed to determine an estimated analyte concentration level, and transmitted via a wireless signal (e.g., using a communication circuit) according to a schedule specified by the operational parameter.

In some examples, a system (e.g., analyte monitoring system) may receive an identification (e.g., list) of one or more authorized peripheral devices. The system may accept operational parameters or communication requests from one or more peripheral devices based upon the identification of authorized devices.

FIG.7Ais a flowchart illustration of an example method700of managing power based upon user input. In some examples, the method800may be implemented in a system that may include an analyte sensor configured to generation 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, 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 to receive user input via a detected communication signal. The system may be configured to control a mode of communication for the communication circuit based at least in part on the user input. The system may, for example, be the system200shown inFIG.2.

At702, user input is received. The user input may be received directly, e.g., via a user interface (e.g., a graphical user interface GUI) or may be received from another device (e.g., a smart phone or other smart device) that may receive the 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 the user may provide inputs via selecting the options from the menu and pressing the buttons. In some examples, the user input may be received over a network. For example, a host (e.g., child) to which an analyte sensor (e.g., glucose sensor) is attached may be in a first location, and the user (e.g., a caregiver) may provide the user input at a second location (e.g., via a smart phone) and the input may be relayed over a network (e.g., cellular network or the internet) to a smart device that is near the host.

The user input may, for example, include a request to initiate an energy-saving mode. The user input may also relate to energy management, e.g., the user input may include a request to align an estimated battery life with a parameter of a partner device (e.g., a pump session.) In some examples, the user input may include a specified condition. In some examples, responsive to satisfaction of 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 over-ride the low-power consumption mode responsive to satisfaction of the specified condition (e.g., estimated glucose level moving out of a safe range, or initiation of delivery of basal or bolus insulin by a pump.)

At704, a sensor signal may be received from an analyte sensor. The sensor signal may, for example, be indicative of an analyte concentration level in a host (e.g., indicative of a glucose concentration.) The sensor signal may be received, for example, by a processor204as shown inFIG.2from an analyte sensor104.

At706, an estimated analyte concentration level (e.g., estimated glucose concentration level) is determined based on the sensor signal.

At708, an operational mode of the communication circuit may be determined based at least in part on the user input. The determined operational mode may, for example, be an energy-saving mode, in which power consumption by the communication circuit or by the system may be reduced. The system may invoke any of the methods described herein to conserve or manage energy expenditure (e.g., the system may communicate less frequently than in a normal mode of operation or limit the number of devices with which the system communicates or communicate using a low-power technique (e.g., NFC) for non-critical communications or for all communications or for all communications.)

At710, the estimated analyte concentration level, or information based on the estimated analyte concentration level, may be transmitted via the communication circuit using the determined operational mode. Transmitting using the energy-saving mode include, for example, transmitting information less often than in a normal operating mode, or transmitting using a less power-intensive mode of communication (e.g., NFC as opposed to Bluetooth), or communicating with fewer devices (e.g., communicating with a pump but not a watch), or communication via a peripheral device (e.g., communicating with a watch through a smartphone.

In some examples, a communication circuit may be controlled based at least in part on the analyte concentration level.

In some examples, a system (e.g., CGM system) may determine whether a condition is satisfied based at least in part on the analyte concentration level and control operation of the communication circuit to decreasing power consumption by the communication circuit based upon the determination of whether the condition is satisfied. For example, the condition may include range of analyte concentration levels, and determining whether the condition is satisfied may include determining whether the determined analyte concentration level falls within the range of analyte concentration levels. In an example, when an analyte concentration level is well controlled (e.g., estimated glucose level between 80 and 150 mg/dL and steady (e.g., no rapid rate of change)), a system may communicate less frequently that when an analyte concentration level is not well controlled (e.g., estimated glucose level beyond a specified threshold, e.g., below 70 mg/DL or over 150 mg/dL or 200 mg/DL or 250 mg/DL, or rising or falling quickly or a combination thereof.)

In some examples, the condition may include a trend condition, and determining whether the condition is satisfied may include determining whether the trend condition is satisfied using a plurality of analyte concentration levels. For example, a trend condition may include an analyte concentration level rate of change being below a specified threshold (e.g., estimated glucose rate of change not more than 2 mg/dL/minute or not more than 3 mg/dL/minute). The trend condition may also include an analyte concentration level (e.g., estimated glucose concentration level rate of change not more than 2 mg/dL per minute when the estimated glucose concentration level is less than 120 mg/dL.

In some examples, transmitting using the determined operational mode may include decreasing power consumption by refraining from automatic transmission of analyte concentration information, or transmitting analyte concentration information less often. In some examples, transmitting using the determined operational mode may include transmitting only in response to a request (e.g., shift to a “pull” mode instead of “push” mode), or transmitting less often unless a request is received (e.g., a request from a partner device or a user.)

In some examples, a determined operational mode may be overridden to communicate responsive to an analyte concentration level falling below a threshold or outside a range.

In some examples, the user input may include a specification of a condition, and the operation of the communication circuit may be modified responsive to satisfaction of the condition. The condition may, for example, includes a range of analyte concentration levels or an analyte trend condition, or any other condition discussed herein.

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

In some examples, the user input may include a request to operate the system in a manner to assure that an estimated battery life matches or exceeds an operation parameter relating to a partner device. For example, the operational parameter may be a period of time (e.g., a pump session time), and the system may operate the in a manner to extend the life of a battery in the system so that the battery does not expire (e.g., be depleted to a charge level that is insufficient to perform a function) before the period of time expires.)

In some examples, the system may monitor for an alert condition based at least in part upon the estimated analyte concentration level and the system may override the energy savings mode to communicate an alert.

In some examples, a determined operational mode of communication may include a hibernation mode (e.g., low-power consumption mode). In the hibernation mode, a system may stop communication, or may communicate only very infrequently, or may only list but not transmit, or transmit very unfrequently, or one or more non-communication operations (e.g., sensing) may be suspended, or any combination thereof. In some examples, a system may enter a hibernation mode responsive to a user input that includes a request to stop a sensor session, or responsive to a request to start a sensor session (e.g., because after starting a session a sensor may not be used during a warm-up period in which the host/sensor adapts to the insertion of a sensor into the host). In some examples, the system may shift out of the hibernation mode after a specified period of time (e.g., after expiration of a warm-up period.)

FIG.7Bis a flowchart illustration of an example method700of managing power based upon a sleep command (e.g., an instruction to enter a hibernation mode or other low-power consumption state.) The method may be applied, for example, to an analyte monitoring system including 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 as shown inFIG.1or a device as shown inFIG.2.

The method770may include, at772, receiving via the communication circuit a sleep command from a peripheral device. It may be desirable, for example, to cause an 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.) The method770may include, at774, shifting the system into a low-power state responsive to receipt of the sleep command. In some examples, the system may stop communicating in a sleep state. For example, a communication circuits may stop sending and receiving completely for a period of time, or the communication circuit may enter a listening-only mode, which may optionally involve a lower-power listening mode than normal operation (e.g., longer duty cycles or wake up and listen on a schedule.) In some examples, other portions of a system may also stop consuming energy or enter a low-power mode. For example, analyte sensor may stop applying a sensing voltage to an electrode or a processor may stop collecting or processing data. In another example, when the system is in the low power mode, the analyte sensor may still continue to apply voltage for analyte measurement purposes, however, the transmission/communication circuit may remain in the sleep or low power mode. Yet, in another example, when sensor electronics are removed from a host (e.g., when a transmitter is disconnected from a sensor), the sensor electronics may stop processing or communicating (e.g., because the sensor electronics are not receiving sensor data anyway.)

The method may include, at776, waking the system from the low power state. In some examples, the system may include a clock that triggers a wake-up event when a period of time (e.g., warm-up period) expires, e.g., 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, e.g., in response to a command from a peripheral device such as a pump or a smart device (e.g., smart phone or proprietary hand-held device)

FIG.8is a flowchart illustration of an example method800of determining an operating protocol to assure battery life satisfies a specified time parameter. The method 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 as shown inFIG.1or a device as shown inFIG.2.

The method800may include, at802, receiving a specified time parameter from a peripheral device. The specified time parameter may, for example, be a specified time, such as a specific date (e.g., date, week, or month), or an amount of time, such as a number of days, weeks, or months. The method800may further include, at804determining an amount of energy remaining in a battery, e.g. based upon a voltage measurement, a current measurement, a coulomb counter, or any combination thereof. The method800may further include, at806, determining a system operating protocol calculated to assure that projected energy consumption by providing an estimated battery life that satisfies the specified time parameter. For example, a projected energy consumption rate may be determined based on one or more communication parameters (e.g., strength of transmissions, how often the system communicates, or how many devices with which the system will communicate), one or more data processing parameters (e.g., how much data processing will occur, and how often it will occur), one or more sensing parameters (e.g., how often a sensor reading will be obtained), or any combination thereof. In an example, the lifetime or expiration of an analyte sensor system (e.g., CGM) may be aligned with or extended to exceed the lifetime or expiration of a pump, e.g., a CGM may be operated to assure that the battery life of the CGM outlast the battery life of the pump or changing of a pump insertion site. In some examples, the system may assure that enough battery remains at the end of the 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 a user to change or check an analyte sensor system battery to coordinate battery replacement with pump replacement or insertion site change.

FIG.9is a flowchart illustration of an example method900of using information from a non-volatile memory after a power reset. The method may be implemented, for example, in a system as shown inFIG.1or a device as shown inFIG.2.

The method900may include, at902, receiving a sensor signal representative of an analyte concentration level from a wearable analyte monitor. The method900may further include, at904, recurrently storing information in a nonvolatile memory in preparation for an unplanned power reset, such as when a removeable battery is removed from a device. The stored information may include, for example, an estimated analyte concentration level determined from the sensor signal, and an associated time stamp. In some examples, the method900may also include storing time data, session data, pairing information, reset counts, or battery effects of resets in the nonvolatile memory. A reset count and effect of resets may be accounted for in an estimation of battery life remaining.

In some examples, periodically storing information may include storing critical information. Critical information may be used to reestablish a session after a power reset and continue the session according to operating parameters that were in use prior to the power reset. For example, a mode (e.g., communication mode, operating mode of a device, or mode of interaction with a peripheral device such as a pump) or status (e.g., analyte trend or patient status) may be resumed after a power reset.

The method900may further include, at906, retrieving the stored information from the nonvolatile memory after a power reset. In some examples, the method may further include initiating a power-up mode after a power reset and using the stored information to assess device status or an analyte status in the power-up mode. In some examples, a debouncing circuit (e.g., gate with hysteresis) may be used to avoid recurrent execution of a power-up or power down process when a battery is repeatedly connected and disconnected or avoid processing of noise signal associated with removal or replacement of a battery. In some examples, a system may execute instructions to remove noise associated with removal or insertion of a battery. For example, a system or device may detect connection or disconnection of a battery, and the system may delay a power up or power-down process or delay processing of a signal for a specified period of time after a connection or disconnection from the battery is detected. In some examples, a system or device may delay a 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 successive execution of power-up and power-down processes when a battery is connected and disconnected multiple times in a short time window.

The method may further include, at908, resuming operating using the retrieved information. In some examples, the method may further include determining an operating mode based at least in part on the stored information. In some examples, the determined operating mode may include one or more of a power consumption mode or a communication mode. For example, the system may determine using stored information whether to operate in a low power operating mode, normal operating mode (e.g., default), or high-power operating mode (e.g., high frequency communication or high power to assure range or high probably of communication success, which may be useful for example when the patient is in an unmanaged condition, e.g., in or trending toward a high glucose state or low glucose state.)

In some examples, a low-power mode may be initiated based on a battery condition (e.g., based on current, voltage, or remaining energy) or the amount of battery life remaining (e.g., time until expiration or estimated time until satisfaction of an end-of-life condition). In various examples, the low-power mode may conserve power by communicating less often, or shifting to from a first communication mode or protocol to a second mode or protocol that uses less power (e.g., shift from Bluetooth to NFC), or communicating with fewer devices, or relying on a peripheral device to communicate with another device (e.g., engaging a smartphone to communicate to a watch, pump, or smart pen), or performing a non-communication operation (e.g., sensing) less often, or offloading processing to a peripheral device (e.g., rely on a smartphone for complex processing). In some example, the determination of whether to operate in the low-power mode after a power reset may be based upon battery power after reset (e.g., to detect whether a battery with sufficient power (e.g., new battery) has been inserted, or whether a low-power battery (e.g., the same battery as was removed, or another low-power battery) has been inserted. In some example, a power level assessment (e.g., decision whether to operate in a low-power mode) may be triggered after a power reset based upon information stored before the reset (e.g., based on one or more of the mode of operation before reset, or an analyte management condition (e.g., glucose level or trend), or communication condition (e.g., reliable or not) or communication mode (e.g. 2-way or 1-way.))

In some examples, the method may include determining an analyte trend a based at least in part on an estimated analyte concentration level retrieved from the nonvolatile memory.

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 critical for resuming a session after a power reset may be saved more frequently than other types of information.

Example Battery and Device Structures

FIG.10Ais a cross sectional view of an example sensor assembly1000. The sensor assembly1000may include a base1002that may include a mounting unit1004that is configured to couple with a sensor electronics module1006, which may be or include the sensor electronics module106ofFIGS.1and2. The sensor assembly1000may also include one or more batteries1018, which may be removable or replaceable. Battery1018may be electrically coupled to an electrical contact1028, which may be sized and shaped to electrically couple with an electrical contact1030on the sensor electronics module1006, as further explained below.

The base1002may include contacts1008, which may be part of a contact subassembly1010. The contacts1008may be configured to electrically and mechanically contact respective contacts (not shown) on the sensor electronics module, e.g., to enable signal transfer or power transfer. The contact subassembly1010may include a hinge1012that is configured to allow the contact subassembly1010to pivot between a first position (for insertion) and a second position (for use) relative to the mounting unit1004. The term “hinge” as used herein is a broad term and is used in its ordinary sense, including, without limitation, to refer to any of a variety of pivoting, articulating, and/or hinging mechanisms, such as an adhesive hinge, a sliding joint, and the like; the term hinge does not necessarily imply a fulcrum or fixed point about which the articulation occurs. In some examples, the contacts1008may be formed from a conductive elastomeric material, such as a carbon filled elastomer, in electrical connection with the sensor1016.

In some examples, the mounting unit1004may be provided with an adhesive pad1014, disposed on the mounting unit's back surface. The adhesive pad may include a releasable backing layer. The mounting unit1004may be adhered to the skin of a host by pressing the base1002of the mounting unit and the adhesive pad1014onto the skin. Appropriate adhesive pads can be chosen and designed to stretch, elongate, conform to, and/or aerate the region (e.g., host's skin). Various configurations and arrangements can provide water resistant, waterproof, and/or hermetically 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.

FIG.10Bis an enlarged view of a portion of the sensor assembly ofFIG.10A. The base1002may be configured to receive one or more batteries1018, which may for example be coin cell batteries (e.g. silver oxide, lithium, alkaline, zinc air, etc.). A sealed region1020may extend over the batteries to isolate and secure the batteries1018in the base1002. In various embodiments, the sealed region may be coupled to the base using mechanical connections (e.g. snap fit), adhesives, welded joints, or any combination thereof.

The base1002may include one or more protrusions1024(e.g., seal member or seal feature) that extend upward to the sensor electronics module1006. Electrical connector1026may extend through the protrusion1024and electrically connect via electrical contact1028with a second electrical contact1030on the sensor electronics module1006. In some examples, an end surface1034of the protrusion1024(e.g., sealing member) may seal against an opposing surface on the sensor electronics module to form a seal (e.g., face seal.) In some examples, an outer side surface1036of the protrusion1024may seal against a corresponding surface (e.g., an inner surface on a cavity on sensor electronics module1006) to form a radial seal (e.g., an O-ring or lip seal against the sensor electronical module.)

In the example shown inFIGS.10A and10B, the protrusion1024and electrical connector1026are laterally offset from the one or more batteries (i.e., to the right of the battery inFIG.10B), in which case the electrical connector1026may be electrically coupled with the battery via electrical connector1032. In some alternative examples, such as the embodiment shown inFIG.13A, the protrusions may extend upward from batteries, as shown, for example, inFIG.11A.

The protrusions1024may form a seal with the sensor electronics module1006when the sensor electronics module is assembled with the base1002. For example, the protrusions may form a radial seal or face seal with the sensor electronics module1006. The protrusions may be overmolded to a base or over or around the electrical contact1028. Alternatively, a seal component may be coupled to the protrusion (e.g., the protrusion itself may be integral with the base and a seal component may be overmolded to the base or otherwise coupled to or placed around the protrusion.) The protrusions or seal may be formed of a material to form a water-tight seal, such as an elastomeric or conformable material (e.g., Silicone, TPE, Polypropylene, etc.)).

Each of the example bases shown inFIGS.10A through39Cmay include one or more electrical contacts1028,1029that may be configured to deliver battery power to a sensor electronics module (e.g., sensor electronics module106or sensor electronics module1006, not shown inFIGS.11A-39C). While some of the examples are shown with two batteries, other examples may include a single battery, or more than two batteries (e.g., three, four, or more batteries.) In various examples, the batteries may all be the same, or the batteries may be sized differently, or may have difference 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 preferably in series, so that one contact1028is positive and the other contact1029is negative (or vice-versa) to thereby form a closed circuit when coupled with the sensor electronics module. The base may also include electrical contacts1008,1010, which may be configured to interface with the sensor electronics module to operatively couple one or more sensor system components (e.g., potentiostat202shown inFIG.2) to supply power to generate a sensor signal (e.g., to apply a bias to via sensor1016to generate a signal indicative of an analyte concentration level). In some examples, a cover, film, flex circuit substrate, potting material (e.g., epoxy), or other component may be provided and configured to extend over the batteries and seal with the base. A sealed interface may be created using one or more of a sealing member (e.g. O-ring or elastomer), ultrasonic welding, laser, radiofrequency (RF), or heat welding. A sensor electronics sealing member may also be provided between the sensor electronics module1006and the base. In any of the examples shown inFIGS.10A-39C, the batteries may be coupled to a 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 materials and/or structures, which may in various configurations be affixed to the base, or to a sensor electronics module. Any of the structural elements shown inFIGS.10A-39Cmay be combined with an example shown in another of theFIGS.10A-39C, and many of the examples may have similar or identical components, as shown in the drawings.

A battery seal may be provided between the sensor electronics module and the batteries or battery contacts, for example to avoid contact between the batteries and the outside environment (e.g., water during swimming or bathing), which may corrode, deplete, or damage the batteries or electronic components. The battery seal may, for example, be a face seal, radial seal (e.g., O-ring), or an irregular seal. The seal may, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature that may be coupled to or assembled with the base or sensor electronics module, or other overmolded or assembled seal components or features. The seal or seals may create one continuous seal around the perimeter of both batteries (e.g., seeFIGS.12A and15A,16A,18A, and19A), or may create a seal around each battery individually (e.g., seeFIGS.11A,13A,14A, and23A-39C). In various configurations, the batteries1018may be assembled into the base through the bottom of the base (e.g., seeFIGS.11A and11B,13A-16B,20A-25B,28A-34and38A-39C), or through the top of the base (e.g., seeFIGS.12A-12B,17A-19B,26A-37B and35A-37D).

Any of the examples shown inFIGS.11A through39Cmay be coupled to an adhesive component such as adhesive pad1014shown inFIGS.10A,23A-23C,28A-28C,30A-30B,32,34,36and/or38A-38B, or alternatively or additionally may include adhesive on the bottom surface1052of the base, to couple the base to a host.

FIG.11Ais a perspective top view of an example sensor base1102that has two protruding seal members1124,1125, which may be offset from batteries1018.FIG.11Ashows electrical contacts1128,1129as conductive elastomeric puck style contacts that may press against corresponding contacts (not shown) on the sensor electronics modules when the sensor electronics module is assembled with the base1102. Battery power may be supplied to the sensor electronics module via electrical contacts1128,1129. The seal members1124,1125may be configured to seal against a sensor electronics module (not shown) so that electrical contacts1128,1129may be sealed from exposure to potential environmental elements, such as water. The seal members1124,1125, may, for example be overmolded elastomeric seal (e.g., overmolded onto the base.) The seal members1124may form a face seal when pressed against sensor electronics module. In an example, the outer side surfaces1130,1131of the sensor electronics module may seal against one or more inner surfaces of corresponding cavities in the sensor electronics module. Alternatively, or additionally, end surfaces1132,1133may form a seal against opposing surfaces on the sensor electronics module.

FIG.11Bis a perspective bottom view of the base1102. The batteries1018may be sealed in the base. In some examples, the analyte sensor1016(not shown inFIG.11B) may be delivered through the bottom surface1104of the base1102and into a host, e.g., through a hole (not shown inFIG.11B) in the sealed region1020(e.g., cover.) The analyte sensor2016may, for example, be delivered via a mechanical or electrical delivery system (e.g., applicator, not shown), which may, for example, be configured to insert a needle/sensor assembly into a host and withdraw the needle to leave the sensor in the host for sensing an analyte (e.g., glucose) concentration. Example sensor delivery systems are shown and described in U.S. Pat. No. 7,949,381, U.S. patent application Ser. No. 15/387,088 (published as US20170188910A1), and U.S. patent application Ser. No. 15/298,721 (published as US20170112534A1) which are incorporated by reference. Any of the examples shown inFIGS.11A-39Cmay be similarly configured to receive a sensor1016and sensor delivery system.

The base1102and the bases shown inFIGS.12A-39Cmay include a mounting unit1004, electrical contacts1008,1010, and a sealed region1020, as described in reference to at leastFIGS.10A and10B.

FIGS.12A and12Billustrate an example base1202in which batteries may be loaded from a top side as opposed to a bottom side as shown inFIG.11B. A seal member1224may extend around both batteries1218,1219and optionally also around battery contacts1228,1229. Battery contacts1228,1229may be separate parts, or may be a portion of a battery. The seal member1224may be overmolded to the base or assembled with the base and placed around battery contacts1228,1229, or around the battery contacts1228,1229and the batteries1018. An outer surface1230of the seal member1224may be configured to seal against an opposing internal surface (e.g., inner surface of a cavity) on the sensor electronics module (e.g., sealed against inner surface1952on sensor electronics module1904inFIG.19B). Additionally, or alternatively, an inner surface1231of the seal member1224may be configured to seal against an opposing surface on the sensor electronics module. As shown inFIG.12B, the batteries1218,1219may be electrically coupled via connector1232. A sensor (e.g., sensor104or sensor1016) may be delivered via a passageway in the base such as the hole1240shown inFIG.12B.

FIGS.13A and13Billustrate an example base1302that includes seal members1324,1325having side surface1330,1331that may form a face seal with corresponding surfaces on the sensor electronics module (e.g. seal against inner surfaces of a cavity on sensor electronics module) to seal battery electrical contacts13281329against exposure to water or moisture. Additionally. or alternatively, the end surfaces1332,1333may form a seal against the sensor electronics module.

FIG.13Bshows a film1310(or alternatively flex circuit substrate) that may be laser or heat bonded (e.g., glued or welded) to the mounting unit1304to seal the batteries in the mounting unit1304. For example, a sealed path1312may be laser bonded or heat bonded around the batteries to create an isolated region around the batteries. A sensor (e.g., sensor104or sensor1016) may be delivered via a passageway in the base such as the hole1340shown inFIG.13B.

FIGS.14A and14Billustrate an example base1402and sensor electronics module1450. The sensor electronics module may include one or more protrusions1452(e.g., second protrusion is behind base and thus not shown) that include one or more electrical contacts1454that is configured to electrically couple with electrical contacts1428,1429on the base1402. Protrusion1452may be configured to fit into corresponding recesses1434,1435in seal members1424,1425so that one or more outer surfaces1456on the protrusion form a radial seal with seal members.

The seal members1424,1425may also optionally have end surfaces1432,1433that may be sized and shaped to form seal against an opposing surface1458on the sensor electronics module to further seal battery electrical contacts14281429against exposure to water or moisture.

FIG.14Bshows a film1410(or alternatively flex circuit substrate) that may be laser or heat bonded to the mounting unit1404to seal the batteries in the mounting unit1404. For example, a sealed weld path1412may be laser bonded or heat bonded around the batteries to create an isolated region around the batteries.

FIGS.15A and15Billustrate an example base1502having a seal member1524that may extend around one or more battery contacts1528,1529. An outer surface1530, inner surface1531, or both, may be configured to seal against corresponding opposing surfaces on a sensor electronics module (not shown inFIG.15A,15B) to form a seal around both battery contacts. The seal member1524may, for example, be an overmolded elastomeric gasket.

FIGS.16A and16Billustrate an example base1602having a seal member1624that may extend around one or more battery contacts1628,1629. An outer surface1630of the seal member may include one or more ribs1631that may form a radial seal (e.g., similar to an O-ring) with an inner surface1652of a cavity1654formed by the sensor electronics module1650. The seal member1624may, for example, be a molded elastomeric seal placed over the battery contacts1628,1629. In another example, the seal member1624may be overmolded onto the base.

FIGS.17A and17Billustrate an example base1702that includes a radial seal (e.g., O-ring seal) that extends around a bottom component1704of the base. The radial seal1724and a top component1706(which may be a portion of a sensor electronics module) may be configured to form a fluid-tight seal to avoid exposure to water or moisture.

FIGS.18A and18Billustrate an example base1802that includes a radial seal that extends around a bottom component1804of the base. The radial seal1824and a portion1806of a sensor electronics module may be configured to form a fluid-tight seal to avoid exposure to water or moisture. The radial seal1824may, for example, be or include an overmolded elastomeric feature (e.g., overmolded onto the base so that it extends around inserted batteries or battery contacts).

FIGS.19A and19Billustrate an example base1902that includes a seal member1924that extends around both batteries1918,1919. The seal member1924may be overmolded to the base, and sized and shaped to extend around batteries1918,1919(or around the battery contacts (not shown) and the batteries). An outer surface1930of the seal member1924may include a ring feature1931that may be configured to seal against an opposing internal surface1954in a cavity on sensor electronics module1950.

FIGS.20A and20Billustrate another example base2002that includes a single seal member2024that may include a cavity2126that may be configured to receive a protrusion2052extending from a bottom side2054of a sensor electronics module2050. The seal member2024may be configured to seal against an outer surface2058of a protrusion. In some examples, the seal member2024may form a face seal with the protrusion2052, or may form a radial seal (e.g., via an internal rib (not shown) in the cavity2026on the seal member). The protrusion2052may include one or more electrical contacts2056(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 contacts2056may electrically couple with corresponding contacts (not shown) on an inside surface of the seal member2024(e.g., on the walls inside the cavity2026on the seal member2024that receives the protrusion.)

FIGS.21A and21Billustrate another example base2102that includes a single seal member2124that may include a cavity2126that may be configured to receive a protrusion2152extending from a bottom side2154of a sensor electronics module2150. The seal member2124may be configured to seal against an outer surface2158of a protrusion. In various examples, the seal member2124may form a face seal with the protrusion2152, or may form a radial seal (e.g., via an internal rib (not shown) in the cavity2126on the seal member). The protrusion2152may include one or more electrical contacts2156,2160. The electrical contacts2156,2160may electrically couple with corresponding contacts (not shown) on an inside surface of the seal member2124(e.g., on the walls inside the cavity2126on the seal member2124that receives the protrusion.)

FIGS.22A and22Billustrate another example base2202that is similar to the example1102shown inFIG.11A, but in which seal members2224,2225are situated in a front portion2204of the base2202.

Several embodiments utilizing a protrusion or “toe” on a sensor electronics module to secure the sensor electronics module to a base are described in connection withFIGS.23A-29Cbelow.

While not shown inFIGS.23A-29C, bases2302-2902can comprise an analyte sensor (e.g., analyte sensor104ofFIG.1, analyte sensor212ofFIG.2, analyte sensor1016ofFIG.10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration of a host, while sensor electronics modules2350-2950can include sensor electronics (e.g., sensor electronics106ofFIGS.1and/or2) as described herein 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.

In some embodiments, an analyte sensor base assembly may include base2302-2902configured to attach to a skin of a host and one or more of the analyte sensor as described above and configured to generate a sensor signal indicative of an analyte concentration level of the host, at least one battery at least as will be described below, at least one sensor contact2308-2908and/or2310-2910, at least one battery contact2328-2938and/or2329-2929, a sealing member2324-2924configured to provide a seal around at least the at least one battery contact2328-2938and/or2329-2929, and/or any other features associated with and/or configured to couple with base2302-2902at least as described below.

FIG.23Ais a perspective view of an example base2302and a sensor electronics module2350configured to be secured to base2302, according to some embodiments.FIG.23Bis a perspective view of sensor electronics module2350secured to base2350ofFIG.23A.FIG.23Cis a plan view of sensor electronics module2350secured to base2302ofFIG.23A. Discussion follows with respect toFIGS.23A-23C.

As shown in the figures, analyte sensor system2300comprises base2302and sensor electronics module2350. Base2302can be configured to attach to the skin of the host, for example, utilizing an adhesive pad2314, which can be disposed on a back surface of base2302. In some embodiments, adhesive pad2314can include a releasable backing layer. Base2302can be adhered to the skin of the host by pressing base2302and adhesive pad2314onto the skin. Appropriate adhesive pads can be chosen and designed to stretch, elongate, conform to, and/or aerate the host's skin. Various configurations and arrangements can provide water resistant, waterproof, and/or hermetically sealed properties associated with the base/sensor electronics module embodiments described herein.

In some embodiments, base2302can be configured to physically and/or mechanically couple with sensor electronics module2350utilizing one or more retaining features. For example, base2302can have a raised perimeter2304configured to at least partially surround sensor electronics module2350as sensor electronics module2350is physically and/or mechanically coupled to base2302, thereby guiding sensor electronics module2350into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2302can further include a first retaining member2342and a second retaining member2344, while sensor electronics module2350can further include a securement feature2352configured to mate with first retaining member2342and a retention feature2356configured to mate with second retaining member2344.

First retaining member2342of base2302can comprise a recess, a ledge, a hook, a slit, or any other type of suitable retaining member. First retaining member2342can be disposed, for example, at a first end of base2302. Second retaining member2344of base2302can comprise a snap, a hook, a button or any other suitable retaining member. Second retaining member2344can be disposed, for example, at a second end of base2302opposite the first end.

Securement feature2352of sensor electronics module2350can comprise a protrusion, a toe or any other type of suitable retention feature configured to mate with and be substantially immobilized by first retaining member2342of base2302. Retention feature2356of sensor electronics module2350can comprise a recess, a ledge, a hook, a slit, or any other type of suitable retention feature configured to mate with, snap into and/or otherwise be substantially immobilized by second retaining member2344of base2302.

For example, to secure sensor electronics module2350to base2302, securement feature2352of sensor electronics module2350can be inserted into first retaining member2342of base2302such that sensor electronics module2350is disposed at an elevated angle with respect to base2302, as shown inFIG.23A. Sensor electronics module2350can then be pivoted toward base2302, substantially about mated first retaining member2342and first retention feature2352, until retention feature2356and second retaining member2344mate with one another (e.g., snap together into a retaining orientation), thereby securing sensor electronics module2350to base2302, as shown inFIGS.23B-23C.

In some embodiments, second retaining member2344is an integral part of base2302and is not configured to be separable from base2302. In such embodiments, second retaining member2344can be configured to release retention feature2356by, for example, applying enough force to second retaining member2344to sufficiently deflect and thereby decouple it from second retention feature2356. However, in other embodiments, similar to that described in more detail below in connection with at leastFIGS.24A-24D, second retaining member2344can be disposed on a frangible tab2362of base2302that is configured to separate from base2302, thereby decoupling second retaining member2344from retention feature2356and decoupling sensor electronics module2350from base2302.

While not shown inFIGS.23A-23C, base2302can comprise at least a battery (e.g., battery292ofFIG.2) configured to power the analyte sensor and/or sensor electronics module2350, a first sensor contact (e.g., similar to contact2408ofFIG.24A) and a second sensor contact (e.g., similar to contact2410ofFIG.24A), each electrically coupled to a respective terminal of the analyte sensor, and a first battery contact (e.g., similar to contact2428ofFIG.24A) and a second battery contact (e.g., similar to contact2429ofFIG.24A), each electrically coupled to a respective terminal of the battery.

While not shown inFIGS.23A-23C, sensor electronics module2350can comprise a plurality of contacts (e.g., similar to contacts2554ofFIG.25A), which can 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, a second power contact configured to make electrical contact with the second battery contact (e.g., seeFIGS.24A-29C). Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor.

While not shown inFIGS.23A-23C, analyte sensor assembly2300can further include a first sealing member (e.g., seeFIGS.24A-29C) configured to surround and seal each of 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 a first cavity.

FIGS.24A-27Billustrate several variations and/or embodiments of analyte sensor systems similar to that ofFIGS.23A-23Cand are described in more detail below. Where appropriate, sensor electronics module2350and base2302ofFIGS.23A-23Ccan be considered to include some or all of the features as described in connection with any of at leastFIGS.24A-27B.

FIG.24Ais a perspective view of a base2402including a cover2460having a frangible tab2462, on which a retaining member2444is disposed, according to some embodiments.FIG.24Bis a perspective magnified view of frangible tab2462and retaining member2444ofFIG.24Ashown retaining a sensor electronics module2450to base2402.FIG.24Cis a perspective view of cover2460ofFIG.24A. AndFIG.24Dis a perspective bottom view of base2402. Discussion follows with respect toFIGS.24A-24D.

An analyte sensor system2400can comprise base2402and sensor electronics module2450. As illustrated in the figures, base2402includes a cover2460configured to be attached to and/or disposed on a bottom side of base2402. Cover2460can comprise a plurality of conductive traces2466, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of cover2460or overmolding of a conductive elastomer. Conductive traces2466may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module2450and/or power from a battery2418to sensor electronics module2450and to the analyte sensor. Cover2460may further include a recess2468configured to receive battery2418. It is contemplated that fabricating traces2466onto cover2460instead of onto base2402may benefit manufacturability due to the small size of base2402and the manufacturing process of LDS traces.

Cover2460is further illustrated as having a frangible tab2462coupled to a main body of cover2460by a break line2464. Frangible tab2462is configured to separate from cover2460along break line2464when frangible tab2462is sufficiently bent, flexed or otherwise deflected from its resting position shown inFIG.24C. Cover2460can be secured to the bottom surface of base2402utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line2412. As shown inFIG.24D, once secured to base2402, cover2460may secure battery2418within a cavity in the bottom surface of base2402.

As shown inFIG.24A, base2402includes a sealing member2424. A first sensor contact2408and a second sensor contact2410are disposed in sealing member2424and each is electrically coupled to a respective terminal of the analyte sensor (not shown inFIGS.24A-24D) in base2402via at least some of conductive traces2466aon cover2460, as shown inFIG.24C. For example, when cover2460is properly secured to a bottom side of base2402, a first portion of conductive traces2466acan be configured to contact first and second sensor contacts2408,2410, and a second portion of conductive traces2466a(e.g., at the portions comprising raised post-like features illustrated inFIG.24C) can be further configured to contact respective terminals or electrodes of the analyte sensor.

A first battery contact2428and a second battery contact2429are also disposed in sealing member2424and each is electrically coupled to a respective terminal of battery2418via at least some of conductive traces2466bon cover2460, also as shown inFIG.24C. For example, when cover2460is properly secured to base2402, a first portion of conductive traces2466bcan be configured to contact first and second battery contacts2428,2429, and a second portion of conductive traces2466b(e.g., at the portions abutting and/or contacting cavity2468for receiving battery2418as illustrated inFIG.24C) can be further configured to contact respective terminals or electrodes of battery2418. In some embodiments, when cover2460is properly secured to base2402, a current-limiting diode2498(seeFIG.24C) can be disposed in series between and electrically connecting at least two portions of conductive traces2466band can be configured to limit an amount of current that can be drawn from battery2418, thereby increasing a useful life of battery2418. Such a current-limiting diode2498can be disposed within a pocket2499in base2402(seeFIG.24D).

In some embodiments, as shown in at leastFIG.24A, first and second sensor contacts2408,2410can be disposed a predetermined distance from first and second battery contacts2428,2429, which can substantially reduce signal interference compared to embodiments (see, e.g.,FIGS.25A-25B) where first and second sensor contacts2508,2510and first and second battery contacts2528,2529are disposed immediately adjacent to one another. 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 board material and/or the solder mask over 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. Contacts2408,2410,2428,2429can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

While not shown inFIGS.24A-24D, a facing (e.g., bottom) surface of sensor electronics module2450further comprises a plurality of contacts, which can include a first signal contact configured to make electrical contact with first sensor contact2408, a second signal contact configured to make electrical contact with second sensor contact2410, a first power contact configured to make electrical-contact with first battery contact2428, and a second power contact configured to make electrical contact with second battery contact2429. Accordingly, the first and second signal contacts on the bottom surface of sensor electronics module2450are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery2418when sensor electronics module2450is properly secured to base2402. Such contacts on sensor electronics module2450can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

When sensor electronics module2450is secured to base2402, sealing member2424is configured to press against the facing surface of sensor electronics module2450, thereby forming a first cavity2420between base2402and sensor electronics module2450. Accordingly, single sealing member2424is configured to surround and create one continuous seal around each of first and second sensor contacts2408,2410, first and second battery contacts2428,2429, the first and second signal contacts and the first and second power contacts of sensor electronics module2450within first cavity2420. Sealing member2424can, for example, be comprised of or include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to or assembled with base2402.

In some embodiments, base2402can be configured to physically and/or mechanically couple with sensor electronics module2450utilizing one or more retaining features. For example, base2402can have a raised perimeter2404configured to at least partially surround sensor electronics module2450as sensor electronics module2450is physically and/or mechanically coupled to base2402, thereby guiding sensor electronics module2450into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2402can further include a first retaining member2442and a second retaining member2444, while sensor electronics module2450can further include a first retention feature (not shown inFIGS.24A-24Dbut having similar structure, function and location as securement feature2352ofFIGS.23A-23C) configured to mate with first retaining member2442and a retention feature2456configured to mate with second retaining member2444. First and second retaining members2442,2444, the securement feature and retention feature2456can have similar or the same structure, function and locations as first and second retaining members2342,2344, securement feature2352and retention feature2356ofFIGS.23A-23C, respectively.

To secure sensor electronics module2450to base2402, the first retention feature (not shown inFIGS.24A-24D) of sensor electronics module2450can be inserted into first retaining member2442of base2402such that sensor electronics module2450is disposed at an elevated angle with respect to base2402, similar to that shown inFIG.23A. Sensor electronics module2450can then be pivoted toward base2402, substantially about mated first retaining member2442and the first retention feature, until retention feature2456and second retaining member2444mate with one another, thereby securing sensor electronics module2450to base2402in an orientation as shown inFIGS.23B-23C and24B.

As illustrated inFIGS.24A-24C, second retaining member2444of base2402can be disposed on frangible tab2462of cover2460. Frangible tab2462is configured to separate from base2402along break line2464. Accordingly, reusable sensor electronics module2450can be decoupled from disposable base2402by sufficiently bending, flexing or otherwise deflecting frangible tab2462from its resting position to decouple second retaining member2444from second retention feature2456. Reusable sensor electronics module2450, comprising relatively more expensive components than disposable base2302, can then be secured and/or installed into a new disposable base2402having a fresh analyte sensor and charged battery2418in preparation for a subsequent sensor session for the host. Such an arrangement, wherein sensor electronics (e.g., including a wireless transceiver) are disposed in a mechanically separable enclosure or module from the analyte sensor and/or battery, can advantageously allow for replacement of inexpensive components of analyte sensor system2400(e.g., base2402) and reuse of relatively more expensive components of analyte sensor system2400(e.g., sensor electronics module2450).

FIG.25Ais an exploded perspective view of an example base2502and a sensor electronics module2550configured to be secured within base2502, according to some embodiments.FIG.25Bis a plan view of base2502ofFIG.25A. Discussion follows with respect toFIGS.25A-25B.

An analyte sensor system2500can comprise base2502and sensor electronics module2550. As with base2402ofFIGS.24A-24D, base2502is configured to receive a battery2518within a cavity in a bottom surface of base2502. Base2502can also include a cover2560configured to be attached to and/or disposed on a bottom side of base2502. However, unlike cover2460ofFIGS.24A-24D, cover2560may not cover a substantial portion of the bottom surface of base2502but may instead be shaped and sized to secure battery2518within base2502. Cover2560can be secured to the bottom surface of base2502utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line2512.

As shown inFIG.25B, base2502can comprise a plurality of conductive traces2566, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base2502or overmolding of a conductive elastomer. Conductive traces2566may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module2550and/or power from battery2518to sensor electronics module2550and to the analyte sensor. It is contemplated that fabricating traces2566directly onto base2502may reduce part count and overall sensor electronics module size and/or volume.

Base2502further includes a first sensor contact2508and a second sensor contact2510, each electrically coupled to a respective terminal of the analyte sensor in base2502via at least some of conductive traces2566. Base2502further includes a first battery contact2528and a second battery contact2529, each electrically coupled to a respective terminal of battery2518via at least some other of conductive traces2566. As shown in the figures, contacts2508,2510,2528,2529can be disposed immediately adjacent to one another (e.g., disposed along a straight or curvilinear line) and may comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

Base2502further includes a sealing member2524, which can extend over, and thereby seal, conductive traces2566from moisture ingress and which also surrounds and creates a single continuous seal around contacts2508,2510,2528,2529on base2302. Sealing member2524can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to or assembled with base2502.

A facing (e.g., bottom) surface of sensor electronics module2550further comprises a plurality of contacts2544, which can include a first signal contact configured to make electrical contact with first sensor contact2508, a second signal contact configured to make electrical contact with second sensor contact2510, a first power contact configured to make electrical contact with first battery contact2528, and a second power contact configured to make electrical contact with second battery contact2529. Accordingly, the first and second signal contacts on the bottom surface of sensor electronics module2550are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery2518when sensor electronics module2550is properly secured to base2502. Such contacts2554on sensor electronics module2550can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

When sensor electronics module2550is secured to base2502, sealing member2524is configured to press against the facing surface of sensor electronics module2550, thereby forming a first cavity2520between base2502and sensor electronics module2550. Accordingly, when sensor electronics module2550is secured to base2502, sealing member2524is configured to surround and create a continuous seal around each of first and second sensor contacts2508,2510, first and second battery contacts2528,2529, the first and second signal contacts and the first and second power contacts of sensor electronics module2550.

In some embodiments, base2502can be configured to physically and/or mechanically couple with sensor electronics module2550utilizing one or more retaining features. For example, base2502can have a raised perimeter2504configured to at least partially surround sensor electronics module2550as sensor electronics module2550is physically and/or mechanically coupled to base2502, thereby guiding sensor electronics module2550into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2502can further include a first retaining member2542and a second retaining member (not shown inFIGS.25A-25Bbut having similar structure, function and location as second retaining member2344,2444ofFIGS.23A-24D), while sensor electronics module2550can further include a securement feature2552configured to mate with first retaining member2542and a retention feature2556configured to mate with the second retaining member. First and second retaining members2542, securement feature2552, and retention feature2556can have similar or the same structure, function and locations as first and second retaining members2342,2344, securement feature2352and retention feature2356ofFIGS.23A-23C, respectively, with the exception that securement feature2552may be wider than securement feature2352ofFIGS.23A-23C.

While not shown inFIGS.25A-25B, the second retaining member can be disposed on base2502, for example as described in connection withFIGS.23A-23C, rather than on a cover, for example as described in connection withFIGS.24A-24D. In some embodiments, the second retaining member is an integral part of base2502and is not configured to be separable from base2302. In some other embodiments, base2502may comprise a frangible tab similar to that previously described in connection with at leastFIGS.24A-24Dand the second retaining member can be disposed on the frangible tab. Sensor electronics module2550can be secured to and decoupled from base2502substantially as previously described in connection with at leastFIGS.23A-24D.

FIG.26Ais an exploded perspective view of an example base2602and a sensor electronics module2650configured to be secured within base2602, according to some embodiments.FIG.26Bis a plan view of base2602ofFIG.26A. Discussion follows with respect toFIGS.26A-26B.

An analyte sensor system2600can comprise base2602and sensor electronics module2650. Base2602is configured to receive a battery2618within a cavity in a top surface of base2602. As shown inFIG.26B, base2602can comprise a plurality of conductive traces2666, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base2602or overmolding of a conductive elastomer. Conductive traces2666may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module2650and/or power from battery2618to sensor electronics module2650and/or to the analyte sensor.

Base2602further includes a first sensor contact2608and a second sensor contact2610, each electrically coupled to a respective terminal of the analyte sensor in base2602via at least some of conductive traces2666. Base2602further includes a first battery contact2628and a second battery contact2629, each electrically coupled to a respective terminal of battery2618via at least some other of conductive traces2666. In some embodiments, at least one terminal of battery2618can be a radial conductive connection comprising a conductive material disposed on a sidewall of a portion of base2602configured to hold battery2618. Such a radial conductive terminal can be configured to both physically secure battery2618to base2602as well as provide electrical connection from one battery terminal to one of battery contacts2628,2629.

As shown in the figures and similar to embodiments illustrated byFIGS.25A-25B, contacts2608,2610,2628,2629can be disposed immediately adjacent to one another (e.g., disposed along a straight or curvilinear line) and may comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

Base2602further includes a cover2660comprising a sealing member2624, which can extend over and thereby seal conductive traces2666and battery2618and which also surrounds and creates a continuous seal around each of contacts2608,2610,2628,2629on base2302. Cover2660and/or sealing member2624can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to a surface of base2602utilizing any suitable method, for example adhesive, heat-staking, and/or laser, heat or ultra-sonic welding along weld line2612. Because cover2660can also extend over a through-hole2640of base2602, cover2660can also comprise a second seal2625surrounding through-hole2640. Due to cover2660extending over substantially all or a significant majority of a top surface of base2602, cover2660may act as an insulating cover for all or at least some of the components of base2602disposed thereunder.

A facing (e.g., bottom) surface of sensor electronics module2650further comprises a plurality of contacts2654, which can include a first signal contact configured to make electrical contact with first sensor contact2608, a second signal contact configured to make electrical contact with second sensor contact2610, a first power contact configured to make electrical contact with first battery contact2628, and a second power contact configured to make electrical contact with second battery contact2629. Accordingly, the first and second signal contacts on the bottom surface of sensor electronics module2650are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery2618when sensor electronics module2650is properly secured to base2602. Such contacts on sensor electronics module2650can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

When sensor electronics module2650is secured to base2602, portions of sealing member2624on cover2660and around contacts2608,2610,2628,2629are configured to press against the facing surface of sensor electronics module2650, thereby forming a first cavity2620between base2602and sensor electronics module2650. Accordingly, when sensor electronics module2650is secured to base2602, sealing member2624is configured to surround and create a continuous seal around first and second sensor contacts2608,2610, first and second battery contacts2628,2629, and the plurality of contacts2654(e.g., the first and second signal contacts and the first and second power contacts) of sensor electronics module2650.

In some embodiments, base2602can be configured to physically and/or mechanically couple with sensor electronics module2650utilizing one or more retaining features. For example, base2602can have a raised perimeter2604configured to at least partially surround sensor electronics module2650as sensor electronics module2650is physically and/or mechanically coupled to base2602, thereby guiding sensor electronics module2650into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2602can further include a first retaining member2642and a second retaining member (not shown inFIGS.26A-26Bbut having similar structure, function and location as second retaining member2344(FIG.23A),2444(FIG.24D), while sensor electronics module2650can further include a securement feature2652configured to mate with first retaining member2642and a retention feature2656configured to mate with the second retaining member. First and second retaining members2642, securement feature2652and retention feature2656can have similar or the same structure, function and locations as first and second retaining members2342,2344, securement feature2352, and retention feature2356ofFIGS.23A-23C, respectively, with the exception that securement feature2652may be wider than securement feature2352ofFIGS.23A-23C, similar to securement feature2552ofFIGS.25A-25B, but also having a substantially rounded front edge.

While not shown inFIGS.26A-26B, the second retaining member can be disposed on base2602, for example as described in connection withFIGS.23A-23C and25A-25B, rather than on a cover, for example as described in connection withFIGS.24A-24D. In some embodiments, the second retaining member is an integral part of base2602and is not configured to be separable from base2302. In some other embodiments, base2602may comprise a frangible tab similar to that previously described in connection with at leastFIGS.24A-24Dand the second retaining member can be disposed on the frangible tab. Sensor electronics module2650can be secured to and decoupled from base2602substantially as previously described in connection with at leastFIGS.23A-24D.

FIG.27Ais an exploded perspective view of an example base2702and a sensor electronics module2750configured to be secured within base2702, according to some embodiments.FIG.27Bis a plan view of base2702ofFIG.27A. Discussion follows with respect toFIGS.27A-27B.

An analyte sensor system2700can comprise base2702and sensor electronics module2750. While several features are not shown inFIGS.27A-27B, base2702and sensor electronics module2750can comprise substantially the same features as previously described for base2602and sensor electronics module2650in connection withFIGS.26A-26Bwith the following differences.

Securement feature2752of sensor electronics module2750, configured to mate with first retaining member2742of base2702, can comprise a protrusion or “toe” similar to that previously described for first retaining member2342ofFIGS.23A-23C. In addition, rather than first sealing member2724covering a substantial portion of a top surface of base2702, first sealing member2724may instead form a continuous circumferential seal that extends around a battery2718, disposed in a cavity in a top surface of base2702, and each of the contacts on base2302. A separate, second sealing member2725can surround a through-hole2740in base2702. Sealing members2724,2725can, for example, include overmolded components such as overmolded gaskets, overmolded elastomeric features, and/or ultra-violet curable silicone that may be coupled to a surface of base2702utilizing any suitable method. In addition, in some embodiments, power and signal contacts2754on an underside of sensor electronics module2750may directly contact respective terminals on battery2718and respective leads of the analyte sensor (not shown inFIGS.27A-27B), rather than being connected via a plurality of conductive traces at locations removed from such terminals and leads.

FIGS.28A-29Cillustrate several variations and/or embodiments of analyte sensor systems similar to that of at leastFIGS.23A-27B, however, providing electrical contacts on a first retention feature of a sensor electronics module, and are described in more detail below.

FIG.28Ais a perspective view of an example base2802and a sensor electronics module2850configured to be secured within base2802, according to some embodiments.FIG.28Bis a perspective view of sensor electronics module2850secured to base2802ofFIG.28A.FIG.28Cis a plan view of sensor electronics module2850secured to base2802ofFIG.28A.

As shown in the figures, analyte sensor system2800comprises base2802and sensor electronics module2850. Base2802can be configured to attach to the skin of the host, for example, utilizing an adhesive pad2814, which can be disposed on a back surface of base2802. Adhesive pad2814can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

Base2802can be configured to physically and/or mechanically couple with sensor electronics module2850utilizing one or more retaining features. For example, base2802can have a raised perimeter2804configured to at least partially surround sensor electronics module2850as sensor electronics module2850is physically and/or mechanically coupled to base2802, thereby guiding sensor electronics module2850into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2802can further include a first retaining member2842and a second retaining member2844, while sensor electronics module2850can further include a securement feature2852configured to mate with first retaining member2842and a retention feature2856configured to mate with second retaining member2844.

First retaining member2842of base2802can comprise a cap or hood and can be disposed, for example, at a first end of base2802. Second retaining member2844of base2802can comprise a snap, a hook, a button or any other suitable retaining member. Second retaining member2844can be disposed, for example, at a second end of base2802opposite the first end.

Securement feature2852of sensor electronics module2850can comprise a protrusion, a toe or any other type of suitable retention feature configured to mate with and be substantially immobilized by first retaining member2842of base2802. Retention feature2856of sensor electronics module2850can comprise a recess, a ledge, a hook, a slit, or any other type of suitable retention feature configured to mate with, snap into and/or otherwise be substantially immobilized by second retaining member2844of base2802.

Sensor electronics module2850can comprise a plurality of contacts2854, which can include first and second signal contacts and first and second power contacts, each disposed on first retention feature2852. Such first and second power contacts can be configured to receive power from a battery (not shown inFIGS.28A-28B) disposed within base2802, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. Accordingly, securement feature2852is configured to secure sensor electronics module2850to base2802and also provide electrical connections therebetween, utilizing the same structure for both, disparate functions.

Sensor electronics module2850can further include a first sealing member2824configured to surround and seal each of the first and second sensor contacts and the first and second battery contacts within a first cavity2820located within the cap or hood formed by first retaining member2842of base2802. For example, first sealing member2824can be a radial or slot seal disposed around a circumference of securement feature2852and configured to press against an inner surface of the cap or hood formed by first retaining member2842and/or of base2802when sensor electronics module2850is properly secured to base2802.

While not shown inFIGS.28A-28C, base2802further comprises a plurality of electrical contacts (e.g., see contacts2908,2910,2928,2929ofFIGS.29A-29C) disposed within the cap or hood formed by first retaining member2842of base2802, for example including first and second sensor contacts, each electrically coupled to a respective terminal of the analyte sensor, and first and second battery contacts, each electrically coupled to a respective terminal of the battery (e.g., see battery2918ofFIGS.29A-29C). The first and second signal contacts and the first and second power contacts (e.g., together contacts2954) of sensor electronics module2850are configured to electrically contact the first and second sensor contacts and the first and second battery contacts (e.g., see contacts2908,2910,2928,2929ofFIGS.29A-29C) of base2802, respectively, when sensor electronics module2850is properly secured to base2802.

To secure sensor electronics module2850to base2802, securement feature2852of sensor electronics module2850can be inserted into first retaining member2842of base2802such that sensor electronics module2850is disposed at an elevated angle with respect to base2802, as shown inFIG.28A. Sensor electronics module2850can then be pivoted toward base2802, substantially about mated first retaining member2842and securement feature2852, until retention feature2856and second retaining member2844mate with one another (e.g., snap together into a retaining orientation), thereby securing sensor electronics module2850to base2802, as shown inFIGS.28B-28C. In some embodiments, a force required to secure sensor electronics module2850to base2802and, thereby, seal contacts2908,2910,2928,2929within first cavity2820can be less than for some other toe-in concepts (see, e.g.,FIGS.23A-27B) at least because first sealing member2824is disposed around a circumference of securement feature2852, rather than on a portion of base2802or on a cover that is laterally spaced from securement feature2852.

In some embodiments, second retaining member2844is an integral part of base2802and is not configured to be separable from base2802. In such embodiments, second retaining member2844can be configured to release retention feature2856by, for example, applying enough force to second retaining member2844to sufficiently deflect and thereby decouple it from second retention feature2856. However, in other embodiments, similar to those previously described in connection with at leastFIGS.23A-24D, second retaining member2844can be disposed on a frangible tab2862of base2802that is configured to separate from base2802, thereby decoupling second retaining member2844from retention feature2856and so decoupling sensor electronics module2850from base2802.

FIGS.29A-29Cillustrate a variation and/or embodiment of an analyte sensor system similar to that ofFIGS.28A-28C, which is described in more detail below.FIG.29Ais an exploded perspective view of an example base2902and a sensor electronics module2950configured to be secured within base2902, according to some embodiments.FIG.29Bis a perspective view of portions of base2902ofFIG.29A.FIG.29Cis a perspective view of a bottom of base2902ofFIG.29A. Discussion follows with respect toFIGS.29A-29C.

An analyte sensor system2900can comprise base2902and sensor electronics module2950. Base2902is configured to receive a battery2918within a cavity in a bottom surface of base2902. Base2902can also include a cover2960(shown as transparent for illustrative purposes) configured to be attached to and/or disposed on a bottom side of base2902and shaped and sized to secure battery2918within base2902. Cover2960can be secured to the bottom surface of base2902utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line2912.

As shown inFIG.29B, base2902can comprise a plurality of conductive traces2966, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base2902or overmolding of a conductive elastomer. Conductive traces2966may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module2950and/or power from battery2918to sensor electronics module2950and/or to the analyte sensor. As illustrated in at leastFIG.29B, according to some embodiments, those of conductive traces2966utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module2950can be disposed at least a predetermined distance away from those of conductive traces2966utilized to ultimately route power from battery2918to sensor electronics module2950and/or to the analyte sensor. At least one advantage of such a disposition of conductive traces2966is reduced signal interference between the electrical signal traces and the power traces. Base2902further includes a first plurality of conductive contacts2937, each in electrical contact with a respective one of conductive traces2966. Conductive contacts2937can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures. A sealing member2925(shown as transparent for illustrative purposes inFIG.29B) is disposed over conductive traces2966and around at least a portion of conductive contacts2937. Sealing member2925can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to or assembled with base2902.

Base2902further includes a first retaining member2942, which, similar to first retaining member2842ofFIGS.28A-28B, can comprise a cap or hood and can be disposed, for example, at a first end of base2902. Furthermore, in some instances, first retaining member2942can be a separate component apart from base2902, as shown inFIG.29A. As shown inFIG.29B, first retaining member2942further comprises a second plurality of conductive contacts2938, each configured to electrically contact a respective one of conductive contacts2937of base2902when first retaining member2942is secured to base2902, for example by adhesive, welding or any other suitable method. First retaining member2942further comprises a second plurality of conductive traces2967, which, like conductive traces2966of base2902, can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of first retaining member2942or overmolding of a conductive elastomer. First retaining member2942further comprises a sensor contact2908, a second sensor contact2910, a first battery contact2928and a second battery contact2929, each electrically coupled to a respective one of conductive contacts2938via a respective one of conductive traces2967. As shown in the figures, contacts2908,2910,2928,2929can be disposed immediately adjacent to one another (e.g., disposed along a straight or curvilinear line) and may comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

First retaining member2942further includes a sealing member2924(e.g., disposed on an inner surface of first retaining member2942), which can extend over and thereby seal conductive traces2967, around each of conductive contacts2937, and which also surrounds and creates one continuous seal around contacts2908,2910,2928,2929. Sealing member2924can, for example, be composed of or include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to or assembled with first retaining member2942.

Sensor electronics module2950includes a securement feature2952configured to mate with first retaining member2942. Securement feature2952comprises a plurality of contacts2954, which can include a first signal contact configured to make electrical contact with first sensor contact2908, a second signal contact configured to make electrical contact with second sensor contact2910, a first power contact configured to make electrical contact with first battery contact2928, and a second power contact configured to make electrical contact with second battery contact2929. Accordingly, the first and second signal contacts on securement feature2952of sensor electronics module2950are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery2918when sensor electronics module2950is properly secured to base2902. Such contacts2954on securement feature2952of sensor electronics module2950can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures. It is contemplated that including signal contacts2954into securement feature2952can increase space efficiency of sensor electronics module2950and minimize the overall height and/or area of sensor electronics module2950.

When sensor electronics module2950is secured to base2902, sealing member2924is configured to press against the facing surface of securement feature2952of sensor electronics module2950, thereby forming a first cavity2920between base2902(e.g., first retaining member2942) and sensor electronics module2950(e.g., first retention feature2952). Accordingly, when sensor electronics module2950is secured to base2902, sealing member2924is configured to surround and create a continuous seal around first and second sensor contacts2908,2910, first and second battery contacts2928,2929, the first and second signal contacts and the first and second power contacts of sensor electronics module2950(e.g., contacts2854).

Base2902can be configured to physically and/or mechanically couple with sensor electronics module2950utilizing one or more retaining features. For example, base2902can have a raised perimeter2904configured to at least partially surround sensor electronics module2950as sensor electronics module2950is physically and/or mechanically coupled to base2902, thereby guiding sensor electronics module2950into position during such physical and/or mechanical coupling.

To accomplish, affect and/or support such physical and/or mechanical coupling, base2902can further include a second retaining member (not shown inFIGS.29A-29Cbut having similar structure, function and location as second retaining member2344,2444ofFIGS.23A-24D), while sensor electronics module2950can further include a retention feature2956configured to mate with the second retaining member. Second retaining member2942and retention feature2956can have similar or the same structure, function and locations as second retaining member2344and retention feature2356ofFIGS.23A-23C, respectively.

While not shown inFIGS.29A-29B, the second retaining member can be disposed on base2902, for example as described in connection withFIGS.23A-23C, rather than on a cover, for example as described in connection withFIGS.24A-24D. In some embodiments, the second retaining member is an integral part of base2902and is not configured to be separable from base2902. In some other embodiments, base2902may comprise a frangible tab similar to that previously described in connection with at leastFIGS.23A-24Dand the second retaining member can be disposed on the frangible tab. Sensor electronics module2950can be secured to and decoupled from base2902substantially as previously described in connection with at leastFIGS.23A-24D. Example Over-the-Top Embodiments

Several “over the top” embodiments utilizing a sensor electronics module configured to be disposed over, surround and/or shroud an underlying base are described in connection withFIGS.30A-37Dbelow.

While not shown inFIGS.30A-37D, bases3002-3702can comprise an analyte sensor (e.g., analyte sensor104ofFIG.1, analyte sensor212ofFIG.2, analyte sensor1016ofFIG.10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration of a host, while sensor electronics modules3050-3750can include sensor electronics (e.g., sensor electronics106ofFIGS.1and/or2) as described herein 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.

In some embodiments, an analyte sensor base assembly may include base3002-3702configured to attach to a skin of a host and one or more of the analyte sensor as described above and configured to generate a sensor signal indicative of an analyte concentration level of the host, at least one battery at least as will be described below, at least one sensor contact3008-3708and/or3010-3710, at least one battery contact3028-3738and/or3029-3729, a sealing member3024-3724and/or3325,35253725configured to provide a seal around at least the at least one battery contact3028-3738and/or3029-3729, and/or any other features associated with and/or configured to couple with base3002-3702at least as described below.

FIG.30Ais an exploded perspective view of an example base3002and a sensor electronics module3050configured to be secured over or on base3002, according to some embodiments.FIG.30Bis a perspective assembled view of sensor electronics module3050secured to base3002ofFIG.30A. Discussion follows with respect toFIGS.30A-30Bbelow.

As shown in the figures, analyte sensor system3000comprises base3002and sensor electronics module3050. Base3002can be configured to attach to the skin of the host, for example, utilizing an adhesive pad3014, which can be disposed on a back surface of base3002. Adhesive pad3014can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

As shown in the figures, sensor electronics module3050can have a raised perimeter3004configured to at least partially surround base3002as sensor electronics module3050is physically and/or mechanically coupled to base3002, thereby guiding sensor electronics module3050into position during such physical and/or mechanical coupling.

Sensor electronics module3050can further include an aperture3070. In some embodiments, aperture3070can be shaped such that there are a limited number of orientations between sensor electronics module3050and base3002that allow securing of one to the other. For example, aperture3070may have a shape that is symmetrical about at least one axis parallel to a top surface of sensor electronics module3050but that is asymmetrical about at least one other axis parallel to the top surface of sensor electronics module3050. Such partially symmetrical shapes of aperture3070can make it easier for a host to secure sensor electronics module3050to base3002in the proper orientation.

Base3002can have an outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3004of sensor electronics module3050. Base3002can further have a raised portion3005having an outer perimeter or shape that compliments an inner perimeter or shape of aperture3070. Accordingly, when sensor electronics module3050is secured over a top of base3002, base3002is configured to fit securely within raised perimeter3004of sensor electronics module3050and raised portion3005is configured to fit securely within aperture3070. In some embodiments, a battery may be located in a cavity (not shown inFIGS.30A-30B) within raised portion3005of base3002. In some embodiments, when properly secured, a top surface of raised portion3005may sit substantially flush with a top surface of sensor electronics module3050, thereby providing tactile feedback that sensor electronics module3050is properly secured to base3002. However, the present disclosure is not so-limited and the top surface of raised portion3005may sit at an elevated or reduced position compared to the top surface of sensor electronics module3050. Accordingly, the use of aperture3070in sensor electronics module3050and raised portion3005of base3002allow analyte sensor system3000to have a significantly reduced thickness or depth compared to other analyte sensor systems.

Base3002can further comprise a first sensor contact3008and a second sensor contact3010, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact3028and a second battery contact3029, each electrically connected to a respective terminal of the battery.FIG.30Aillustrates contacts3008,3010,3028,3029disposed on a sloped surface3097of raised portion3005of base3002. Advantages of disposing contacts3008,3010,3028,3029disposed on sloped surface3097included but are not limited to space efficiency and a lower profile of sensor electronics module3050. However, the present disclosure is not so limited and contacts3008,3010,3028,3029can be disposed on any suitable surface of base3002. Base3002can further comprise a first sealing member3024configured to surround and seal each of contacts3008,3010,3028,3029within a first cavity3020formed between facing surfaces of base3002and sensor electronics module3050and first sealing member3024. Sealing member3024can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone.

Sensor electronics module3050can comprise a plurality of contacts3054, disposed on an inner surface facing base3002, which can include a first signal contact configured to make electrical contact with first sensor contact3008, a second signal contact configured to make electrical contact with second sensor contact3010, a first power contact configured to make electrical contact with first battery contact3028, and a second power contact configured to make electrical contact with second battery contact3029. Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. In some alternative embodiments, first sealing member3024can alternatively be disposed on the same surface of sensor electronics module3050as contacts3054, facing base3002, to form first cavity3020.

Sensor electronics module3050can be secured to base3002by pressing sensor electronics module3050against base3002in a direction substantially perpendicular to a bottom surface of base3002until one or more retention features (not shown in FIGS.30A-30B) of sensor electronics module3050couple with one or more corresponding retaining members (not shown inFIGS.30A-30B) of base3002. In some embodiments, the retaining members of base3002may be the same members or features utilized to secure base3002to an applicator (not shown) for initial deployment to the skin of the host. Sensor electronics module3050can be decoupled from base3002by pulling sensor electronics module3050perpendicularly away from base3002while pushing against raised portion3005of base3002with sufficient force to cause decoupling.

An embodiment similar to that described in connection withFIGS.30A-30Cis shown inFIGS.31A-31Cand described below.FIG.31Ais an exploded perspective view of an example base3102and a sensor electronics module3150configured to be secured over or on base3102, according to some embodiments.FIG.31Bis a perspective view of a battery3118disposed on a cover3160of base3102ofFIG.31A.FIG.31Cis a perspective bottom view of base3102and sensor electronics module3150ofFIG.31A. Discussion follows with respect toFIGS.31A-31Cbelow.

As shown in the figures, analyte sensor system3100comprises base3102and sensor electronics module3150. As shown in the figures, sensor electronics module3150can have a raised perimeter3104configured to at least partially surround base3102as sensor electronics module3150is physically and/or mechanically coupled to base3102, thereby guiding sensor electronics module3150into position during such physical and/or mechanical coupling.

Sensor electronics module3150further includes an aperture3170. Similar to aperture3070ofFIGS.30A-30C, aperture3170can be shaped such that there are a limited number of orientations between sensor electronics module3150and base3102that allow them to be secured to one another, making it easier for a host to secure sensor electronics module3150to base3102in the proper orientation.

Base3102can have an outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3104of sensor electronics module3150. Base3102can further have a raised portion3105having an outer perimeter or shape that compliments an inner perimeter or shape of aperture3170. Accordingly, when sensor electronics module3150is secured over a top of base3102, base3102is configured to fit securely within raised perimeter3104of sensor electronics module3150and raised portion3105is configured to fit securely within aperture3170.

As shown inFIG.31A, a battery3118may be located in a cavity within raised portion3105of base3102. As previously described in connection withFIGS.30A-30C, when properly secured, a top surface of raised portion3105may sit substantially flush with, at an elevated position compared to, or at a lowered position compared to a top surface of sensor electronics module3150, thereby providing tactile feedback that sensor electronics module3150is properly secured to base3102.

Base3102is shown having a cover3160configured to be attached to and/or disposed on a bottom side of base3102. Cover3160can comprise a plurality of conductive traces3166, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of cover3160or overmolding of a conductive elastomer. Conductive traces3166may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module3150and/or power from battery3118to sensor electronics module3150and to the analyte sensor. Cover3160may be further configured to receive battery3118. Cover3160can be secured to the bottom surface of base3102utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line3112. As shown inFIG.31D, once secured to base3102, cover3160may secure battery3118within a cavity in the bottom surface of base3102.

As shown inFIGS.31A-31B, a first sensor contact3108and a second sensor contact3110are each electrically coupled to a respective terminal of the analyte sensor in base3102via at least some of conductive traces3166on cover3160. A first battery contact3128and a second battery contact3129are also each electrically coupled to a respective terminal of battery3118via at least some other of conductive traces3166on cover3160. Contacts3108,3110,3128,3129can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

Base3102further comprises a first sealing member3124. When cover3160is secured to base3102, each of contacts3108,3110,3128,3129can protrude through first sealing member3124.

As shown inFIG.31C, a facing (e.g., bottom) surface of sensor electronics module3150further comprises a plurality of contacts3154, which can include a first signal contact configured to make electrical contact with first sensor contact3108, a second signal contact configured to make electrical contact with second sensor contact3110, a first power contact configured to make electrical contact with first battery contact3128, and a second power contact configured to make electrical contact with second battery contact3129. Accordingly, the first and second signal contacts on the bottom surface of sensor electronics module3150are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery3118when sensor electronics module3150is properly secured to base3102. Such contacts on sensor electronics module3150can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

When sensor electronics module3150is secured to base3102, sealing member3124is configured to press against the facing surface of sensor electronics module3150, thereby forming a first cavity3120between base3102and sensor electronics module3150. Accordingly, sealing member3124is configured to surround and create a continuous seal around first and second sensor contacts3108,3110, first and second battery contacts3128,3129, the first and second signal contacts and the first and second power contacts of sensor electronics module3150within first cavity3120. Sealing member3124can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to or assembled with base3102.

Sensor electronics module3150can be secured to and decoupled from base3102in similar fashions to that previously described in connection withFIGS.30A-30C.

FIG.32is a perspective view of an example base3202and a sensor electronics module3250configured to be secured over or on base3202, according to some embodiments. Analyte sensor system3200comprises base3202and sensor electronics module3250.

Base3202can be configured to attach to the skin of the host, for example, utilizing an adhesive pad3214, which can be disposed on a back surface of base3202. Adhesive pad3214can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

Sensor electronics module3250is illustrated as having a raised perimeter3204configured to at least partially surround base3202as sensor electronics module3250is physically and/or mechanically coupled to base3202, thereby guiding sensor electronics module3250into position during such physical and/or mechanical coupling.

Sensor electronics module3250can further include a protrusion3252extending away from an underside of sensor electronics module3250and configured to mate within a corresponding recess3242in a top surface of base3204when sensor electronics module3250is properly oriented and secured to base3202. Utilizing protrusion3252and recess3242can allow the host to properly orient and align sensor electronics module3250with respect to base3202without direct line of sight of the aligning/securing process.

When sensor electronics module3250is secured over a top of base3202, base3202is configured to fit securely within raised perimeter3204of sensor electronics module3250and protrusion3252is configured to fit securely within recess3242.

Further aspects of analyte sensor system3200are discussed in connection with a similar embodiment as shown inFIGS.33A-33Cbelow. Accordingly, analyte sensor system3200can be considered to have similar or the same features as those described for analyte sensor system3300ofFIGS.33A-33D.

FIG.33Ais an exploded perspective view of an example base3302and a sensor electronics module3350configured to be secured over or on base3302, according to some embodiments.FIG.33Bis a perspective view of a battery3318disposed on a cover3360of base3302ofFIG.33A.FIG.33Cis an exploded perspective bottom view of cover3360and base3302ofFIG.33A. AndFIG.33Dis a perspective bottom view of cover3360secured to base3302ofFIG.33A. Discussion follows with respect toFIGS.33A-33Dbelow.

As shown in the figures, analyte sensor system3300comprises base3302and sensor electronics module3350. Sensor electronics module3350can have a raised perimeter3304configured to at least partially surround base3302as sensor electronics module3350is physically and/or mechanically coupled to base3302, thereby guiding sensor electronics module3350into position during such physical and/or mechanical coupling.

Sensor electronics module3350further includes a protrusion3352and base3202further includes a recess3342, similar to and having substantially the same functionality as protrusion3252and recess3242ofFIG.32, respectively.

In some embodiments, base3302can have an outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3304of sensor electronics module3350. However, the present disclosure is not so-limited and base3302can have any outer perimeter or shape that will fit securely within raised perimeter3304of sensor electronics module3350.

Base3302is shown having a cover3360configured to be attached to and/or disposed on a bottom side of base3302. Cover3360can comprise a plurality of conductive traces3366, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of cover3360or overmolding of a conductive elastomer. Conductive traces3366may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module3350and/or power from battery3318to sensor electronics module3350and/or to the analyte sensor. Cover3360can be secured to the bottom surface of base3302utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line3312. Once secured to base3302, cover3360may secure battery3318within a cavity in the bottom surface of base3302.

As shown inFIGS.33A-33B, a first sensor contact3308and a second sensor contact3310are each electrically coupled to a respective terminal of the analyte sensor in base3302via at least some of conductive traces3366on cover3360. A first battery contact3328and a second battery contact3329are also each electrically coupled to a respective terminal of battery3318via at least some other of conductive traces3366on cover3360. Contacts3308,3310,3328,3329can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

Base3302further comprises a first sealing member3324and a second sealing member3325. When cover3360is secured to base3302, contacts3308and3310can protrude through first sealing member3324and contacts3328and3329can protrude through second sealing member3325.

As shown inFIG.33A, a facing (e.g., bottom) surface of sensor electronics module3350further comprises a plurality of contacts3354, which can include a first signal contact configured to make electrical contact with first sensor contact3308, a second signal contact configured to make electrical contact with second sensor contact3310, a first power contact configured to make electrical contact with first battery contact3328, and a second power contact configured to make electrical contact with second battery contact3329. Accordingly, the first and second signal contacts on the bottom surface of sensor electronics module3350are configured to receive the sensor signal from the analyte sensor, while the first and second power contacts are configured to receive power from battery3318when sensor electronics module3350is properly secured to base3302. Such contacts on sensor electronics module3350can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or contacts, or any other suitable conductive materials.

When sensor electronics module3350is secured to base3302, first sealing member3324is configured to press against the facing surface of sensor electronics module3350, thereby forming a first cavity3320abetween base3302and sensor electronics module3350, while second sealing member3325is configured to press against the facing surface of sensor electronics module3350, thereby forming a second cavity3320bbetween base3302and sensor electronics module3350. Accordingly, first sealing member3324is configured to surround and create a continuous seal around first and second sensor contacts3308,3310and the first and second signal contacts of3354within first cavity3320aand the first and second power contacts of sensor electronics module3350within first cavity3320a, while second sealing member3325is configured to surround and create a continuous seal around first and second battery contacts3328,3329and the first and second power contacts of3354within second cavity3320b. First and second sealing members3324,3325can, for example, include overmolded components such as overmolded gaskets, overmolded elastomeric features, and/or ultra-violet curable silicone that may be coupled to or assembled with base3302.

Sensor electronics module3350can be secured to and decoupled from base3302in similar fashions to that previously described in connection withFIGS.30A-30C.

FIGS.34-37Dillustrate several embodiments of analyte sensor systems in which a sensor electronics module having a substantially circular profile is configured to be omni-directionally secured to a base also having a substantially circular profile.

FIG.34is an exploded perspective view of an example base3402and a sensor electronics module3450configured to be secured over or on base3402, according to some embodiments.

Analyte sensor system3400comprises base3402and sensor electronics module3450. As illustrated, base3402and sensor electronics module3450can each have a substantially circular profile, which allows for omni-directional alignment of one with respect to the other.

Base3402can be configured to attach to the skin of the host, for example, utilizing an adhesive pad3414, which can be disposed on a back surface of base3402. Adhesive pad3414can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

Base3402can have a raised perimeter3404configured to at least partially surround sensor electronics module3450as sensor electronics module3450is physically and/or mechanically coupled to base3402, thereby guiding sensor electronics module3450into position during such physical and/or mechanical coupling. In some embodiments, raised perimeter2404can have a substantially circular perimeter. Base3402can further include an aperture3470, which, in some embodiments, can have a substantially circular shape.

Sensor electronics module3450can have a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3404of base3450. Sensor electronics module3450can further have a raised portion3405having a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of aperture3470. Accordingly, when sensor electronics module3450is secured over a top of base3402, sensor electronics module3450is configured to fit securely within raised perimeter3404of base3402and raised portion3405is configured to fit securely within aperture3470. In some embodiments, when properly secured, a bottom surface of raised portion3405may sit substantially flush with a bottom surface of base3402. However, the present disclosure is not so-limited and the bottom surface of raised portion3405may sit at an elevated or reduced position compared to the bottom surface of base3402. Accordingly, at least some of the substantially circular shape and/or perimeters of sensor electronics module3450, raised portion3405, raised perimeter3404of base3402and/or of aperture3470allow for omni-directional mounting of sensor electronics module3450to base3402. It is contemplated that the omni-directional mounting can increase convenience to the user when installing the sensor electronics module3450without first having to align it.

Base3402can further comprise a first sensor contact3408and a second sensor contact (not shown inFIG.34but substantially similar to first sensor contact3408), each configured to be electrically connected to a respective terminal of the analyte sensor, and a first battery contact3428and a second battery contact3429, each configured to be electrically connected to a respective terminal of a battery (not shown inFIG.34) disposed within base3402. Base3402can further comprise a first sealing member (not shown inFIG.34but substantially similar to first sealing member3524ofFIGS.35A-35D) configured to surround and seal the first and second sensor contacts3408and the first and second battery contacts3428within a first cavity3420formed between facing surfaces of base3402and sensor electronics module3450and the first sealing member. The first sealing member can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone.

Sensor electronics module3450can comprise a plurality of concentrically-circular contacts3454disposed on an inner surface facing base3402. In some embodiments, contacts3454may each have a substantially ring-like form and may each be annularly spaced apart from one another. As shown, contacts3454may be centered about raised portion3405, which allows contacts3454to make electrical contact with respective ones of the first and second sensor contacts3408and the first and second battery contacts3428of base3402when sensor electronics module3450is mounted to base3402. Due to the annular form of each of contacts3454, it is contemplated that sensor electronics module3450can be mounted onto base3402in any orientation. Each contact3454can be configured to make contact with one of sensor contacts or battery contacts at any point along the respective contact3454. Contacts3454can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3502or overmolding of a conductive elastomer. Contacts3454can include a first signal contact configured to make electrical contact with first sensor contact3408, a second signal contact configured to make electrical contact with the second sensor contact (not shown inFIG.34), a first power contact configured to make electrical contact with first battery contact3428, and a second power contact configured to make electrical contact with the second battery contact (not shown inFIG.34). Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. In some alternative embodiments, the first sealing member (not shown inFIG.34) can alternatively be disposed on the same surface, or an adjacent surface, of sensor electronics module3450as contacts3454, facing base3402to form first cavity3420.

Sensor electronics module3450can be secured to base3402by pressing sensor electronics module3450against base3402in a direction substantially perpendicular to a bottom surface of base3402until one or more retention features of sensor electronics module3450snap into one or more corresponding retaining members of base3402. In some embodiments, the retaining members of base3402may be the same members or features utilized to secure base3402to an applicator (not shown) for initial deployment to the skin of the host. Sensor electronics module3450can be decoupled from base3402by pulling sensor electronics module3450perpendicularly away from base3402while anchoring base3402with sufficient force to cause decoupling.

An embodiment similar to that described in connection withFIG.34is shown inFIGS.35A-35Dand described below.FIG.35Ais an exploded perspective view of an example base3502and a sensor electronics module3550configured to be secured over or on base3502, according to some embodiments.FIG.35Bis an exploded perspective bottom view of base3502and sensor electronics module3550ofFIG.35A.FIG.35Cis a plan view of a bottom of base3502ofFIG.35A.FIG.35Dis a perspective cutaway view of sensor electronics module3550secured to base3502ofFIG.35A.

Analyte sensor system3500comprises base3502and sensor electronics module3550. As illustrated, base3502and sensor electronics module3550can each have a substantially circular profile, which allows for omni-directional alignment therebetween. Base3502includes a battery3518configured to power the analyte sensor and/or sensor electronics module3550. Battery3518can be disposed in a cavity through a top side of base3502. In some embodiments, battery3518may be secured in its cavity utilizing conductive epoxy or another suitable adhesive compound.

Base3502can have a raised perimeter3504configured to at least partially surround sensor electronics module3550as sensor electronics module3550is physically and/or mechanically coupled to base3502, thereby guiding sensor electronics module3550into position during such physical and/or mechanical coupling. In some embodiments, raised perimeter2404can have a substantially circular perimeter. In contrast to base3402ofFIG.34, in some embodiments, base3502may not include an aperture similar to aperture3470.

Sensor electronics module3550can have a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3504of base3550. In contrast to sensor electronics module3450ofFIG.34, in some embodiments, sensor electronics module3550may not have a raised portion similar to raised portion3405, since base3502may not include an aperture similar to aperture3470. However, when sensor electronics module3550is secured over a top of base3502, sensor electronics module3550is similarly configured to fit securely within raised perimeter3504of base3502. The substantially circular shape and/or perimeter of sensor electronics module3550and raised perimeter3504of base3502allow for omni-directional mounting of sensor electronics module3550to base3502.

Base3502can further comprise a first sensor contact3508and a second sensor contact3510, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact3528and a second battery contact3529, each electrically connected to a respective terminal of battery3518. Base3502can further comprise a first sealing member3524configured to surround and seal each of first and second sensor contacts3508,3510and first and second battery contacts3528,3529within a first cavity3520formed between facing surfaces of base3502and sensor electronics module3550and first sealing member3524. In some embodiments, first sealing member3524can be disposed on a surface of base3202facing sensor electronics module3550, on a sidewall of raised perimeter3504of base3202, or both. In some embodiments, base3502can further comprise a second sealing member3525disposed within a perimeter of first sealing member3524and around a through-hole3540of base3202. First and/or second sealing members3524,3525can, for example, include overmolded components such as overmolded gaskets, overmolded elastomeric features, and/or ultra-violet curable silicone.

Base3502is further illustrated as including a plurality of conductive contacts3566, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3502or overmolding of a conductive elastomer. Conductive traces3566may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module3550and/or power from battery3518to sensor electronics module3550and to the analyte sensor.

Sensor electronics module3550can comprise a plurality of concentrically-circular contacts3554disposed on an inner surface facing base3502. In some embodiments, contacts3554may each have a substantially ring-like form and may each be annularly spaced apart from one another, which allows contacts3554to make electrical contact with respective ones of first and second sensor contacts3508,3510and first and second battery contacts3528,3529of base3502when sensor electronics module3550is mounted to base3502. Due to the annular form of each of contacts3554, it is contemplated that sensor electronics module3550can be mounted onto base3502in any orientation. Each contact3554can be configured to make contact with one of sensor contacts or battery contacts at any point along the respective contact3554. Contacts3554can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3502or overmolding of a conductive elastomer. Contacts3554can include a first signal contact configured to make electrical contact with first sensor contact3508, a second signal contact configured to make electrical contact with second sensor contact3510, a first power contact configured to make electrical contact with first battery contact3528, and a second power contact configured to make electrical contact with second battery contact3529. Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. In some alternative embodiments, one or both of first and second sealing members3524,3525can alternatively be disposed on the same surface, or an adjacent surface, of sensor electronics module3550as contacts3554, facing base3502, to form first cavity3520.

Sensor electronics module3550can be secured to base3502by pressing sensor electronics module3550against base3502in a direction substantially perpendicular to a bottom surface of base3502until one or more retention features of sensor electronics module3550snap into one or more corresponding retaining members of base3502. In some embodiments, the retaining members of base3502may be the same members or features utilized to secure base3502to an applicator (not shown) for initial deployment to the skin of the host. Sensor electronics module3550can be decoupled from base3502by pulling sensor electronics module3550perpendicularly away from base3502while anchoring base3502with sufficient force to cause decoupling.

FIG.36is an exploded perspective view of an example base3602and a sensor electronics module3650configured to be secured over or on base3602, according to some embodiments.

Analyte sensor system3600comprises base3602and sensor electronics module3650. As illustrated, base3602and sensor electronics module3650can each have a substantially circular profile, which allows for omni-directional alignment therebetween.

Base3602can be configured to attach to the skin of the host, for example, utilizing an adhesive pad3614, which can be disposed on a back surface of base3602. Adhesive pad3614can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

Sensor electronics module3650can have a raised perimeter3604configured to at least partially surround base3602as sensor electronics module3650is physically and/or mechanically coupled to base3602, thereby guiding sensor electronics module3650into position during such physical and/or mechanical coupling. In some embodiments, raised perimeter3604can have a substantially circular perimeter. Sensor electronics module3650can further include an aperture3670, which, in some embodiments, can have a substantially circular shape.

Base3602can have a substantially circular outer perimeter or shape that compliments the inner perimeter or shape of raised perimeter3604of sensor electronics module3650. Base3602can further have a raised portion3605having a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of aperture3670. Accordingly, when sensor electronics module3650is secured over a top of base3602, base3602is configured to fit securely within raised perimeter3604of sensor electronics module3650and raised portion3605is configured to fit securely within aperture3670. In some embodiments, when properly secured, a top surface of raised portion3605may sit substantially flush with a top surface of sensor electronics module3650. However, the present disclosure is not so-limited and the top surface of raised portion3605may sit at an elevated or reduced position compared to the top surface of sensor electronics module3650. Accordingly, at least some of the substantially circular shapes and/or perimeters of sensor electronics module3650, raised portion3605of base3602, raised perimeter3604of sensor electronics module3650and/or of aperture3670allow for omni-directional mounting of sensor electronics module3650to base3602.

Base3602can further comprise a first sensor contact3608and a second sensor contact3610, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact3628and a second battery contact3629, each electrically connected to a respective terminal of a battery (not shown inFIG.36) disposed within base3602. Base3602can further comprise a first sealing member (not shown inFIG.36but substantially similar to first sealing member3724ofFIGS.37A-37D) configured to surround and seal each of first and second sensor contacts3608and first and second battery contacts3628within a first cavity3620formed between facing surfaces of base3602and sensor electronics module3650and the first sealing member. The first sealing member can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone.

Sensor electronics module3650can comprise a plurality of concentrically-circular contacts3654disposed on an inner surface facing base3602. In some embodiments, contacts3654may each have a substantially ring-like form and may each be annularly spaced apart from one another. As shown, contacts3654may be centered about aperture3670, which allows contacts3654to make electrical contact with respective ones of first and second sensor contacts3608,3610and first and second battery contacts3628,3729of base3602when sensor electronics module3650is mounted to base3602. Due to the annular form of each of contacts3654, it is contemplated that sensor electronics module3650can be mounted onto base3602in any orientation. Each contact3654can be configured to make contact with one of sensor contacts or battery contacts at any point along the respective contact3654. Contacts3654can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3502or overmolding of a conductive elastomer. Contacts3654can include a first signal contact configured to make electrical contact with first sensor contact3608, a second signal contact configured to make electrical contact with second sensor contact3610, a first power contact configured to make electrical contact with first battery contact3628, and a second power contact configured to make electrical contact with second battery contact3629. Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. In some alternative embodiments, the first sealing member (not shown inFIG.36) can alternatively be disposed on the same surface, or an adjacent surface, of sensor electronics module3650as contacts3654facing base3602to form first cavity3620.

Sensor electronics module3650can be secured to base3602by pressing sensor electronics module3650against base3602in a direction substantially perpendicular to a bottom surface of base3602until one or more retention features of sensor electronics module3650snap into one or more corresponding retaining members of base3602. In some embodiments, the retaining members of base3602may be the same members or features utilized to secure base3602to an applicator (not shown) for initial deployment to the skin of the host. Sensor electronics module3650can be decoupled from base3602by pulling sensor electronics module3650perpendicularly away from base3602while pressing down on raised portion3605of base3602with sufficient force to cause decoupling.

An embodiment similar to that described in connection withFIG.36is shown inFIGS.37A-37Dand described below.FIG.37Ais an exploded perspective view of an example base3702and a sensor electronics module3750configured to be secured over or on base3702, according to some embodiments.FIG.37Bis an exploded perspective bottom view of base3702and sensor electronics module3750ofFIG.37A.FIG.37Cis a plan view of a bottom of base3702ofFIG.37A.FIG.37Dis a side cutaway view of sensor electronics module3750secured to base3702ofFIG.37A.

Analyte sensor system3700comprises base3702and sensor electronics module3750. As illustrated, base3702and sensor electronics module3750can each have a substantially circular profile, which allows for omni-directional alignment therebetween. While not shown inFIGS.37A-35D, base3702can comprise an analyte sensor (e.g., analyte sensor104ofFIG.1, analyte sensor212ofFIG.2, analyte sensor1016ofFIG.10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration of a host. Base3702further comprises a battery3718configured to power the analyte sensor and/or sensor electronics module3750. Battery3718can be disposed in a cavity through a top side of base3702. In some embodiments, battery3718may be secured in its cavity utilizing conductive epoxy or another suitable adhesive compound.

While not shown inFIGS.37A-37D, sensor electronics module3750can include sensor electronics (e.g., sensor electronics106ofFIGS.1and/or2) as described herein 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.

Sensor electronics module3750can have a raised perimeter3704configured to at least partially surround base3702as sensor electronics module3750is physically and/or mechanically coupled to base3702, thereby guiding sensor electronics module3750into position during such physical and/or mechanical coupling. In some embodiments, raised perimeter2404can have a substantially circular perimeter. Sensor electronics module3750can further include an aperture3770, which, in some embodiments, can have a substantially circular shape.

Base3702can have a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of raised perimeter3704of sensor electronics module3750. Base3702can further have a raised portion3405having a substantially circular outer perimeter or shape that compliments an inner perimeter or shape of aperture3770. Accordingly, when sensor electronics module3750is secured over a top of base3702, sensor electronics module3750is configured to fit securely within raised perimeter3704of base3702, while raised portion3705of base3702is configured to fit securely within aperture3770. The substantially circular shape and/or perimeter of at least some of sensor electronics module3750, aperture3770, raised perimeter3704of sensor electronics module3750, and raised portion3705of base3702allow for omni-directional mounting of sensor electronics module3750to base3702.

Base3702can further comprise a first sensor contact3708and a second sensor contact3710, each electrically connected to a respective terminal of the analyte sensor, and a first battery contact3728and a second battery contact3729, each electrically connected to a respective terminal of battery3718. Base3702can further comprise a first sealing member3724configured to surround and seal each of first and second sensor contacts3708,3710and first and second battery contacts3728,3729within a first cavity3720formed between facing surfaces of base3702and sensor electronics module3750and first sealing member3724. In some embodiments, first sealing member3724can be disposed on a surface of base3202facing sensor electronics module3750, on a sidewall of base3202, or both. In some embodiments, base3703can further comprise a second sealing member3725disposed within a perimeter of first sealing member3724and around a sidewall of raised portion3705of base3702. In some embodiments, base3702can further comprise a third sealing member3727disposed within a perimeter of first sealing member3724and around a through-hole3740of base3202. First, second and/or third sealing members3724,3725,3727can, for example, include overmolded components such as overmolded gaskets, overmolded elastomeric features, and/or ultra-violet curable silicone.

Base3702is further illustrated as including a plurality of conductive contacts3766, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3702or overmolding of a conductive elastomer. Conductive traces3766may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module3750and/or power from battery3718to sensor electronics module3750and to the analyte sensor.

Sensor electronics module3750can comprise a plurality of concentrically-circular contacts3754disposed on an inner surface facing base3702. In some embodiments, contacts3754may each have a substantially ring-like form and may each be annularly spaced apart from one another, centered about aperture3770, which allows contacts3754to make electrical contact with respective ones of first and second sensor contacts3708,3710and first and second battery contacts3728,3729of base3702when sensor electronics module3750is mounted to base3702. Due to the annular form of each of contacts3754, it is contemplated that sensor electronics module3750can be mounted onto base3702in any orientation. Each contact3754can be configured to make contact with one of sensor contacts or battery contacts at any point along the respective contact3754. Contacts3754can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3702or overmolding of a conductive elastomer. Contacts3754can include a first signal contact configured to make electrical contact with first sensor contact3708, a second signal contact configured to make electrical contact with second sensor contact3710, a first power contact configured to make electrical contact with first battery contact3728, and a second power contact configured to make electrical contact with second battery contact3729. Such first and second power contacts can be configured to receive power from battery3718, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor. In some alternative embodiments, one or more of first, second and/or third sealing members3724,3725,3727can alternatively be disposed on the same surface, or an adjacent surface, of sensor electronics module3750as contacts3754facing base3702to form first cavity3720.

Sensor electronics module3750can be secured to base3702by pressing sensor electronics module3750against base3702in a direction substantially perpendicular to a bottom surface of base3702until one or more retention features of sensor electronics module3750snap into one or more corresponding retaining members of base3702. In some embodiments, the retaining members of base3702may be the same members or features utilized to secure base3702to an applicator (not shown) for initial deployment to the skin of the host. Sensor electronics module3750can be decoupled from base3702by pulling sensor electronics module3750perpendicularly away from base3702while pushing down on raised portion3705of base3702with sufficient force to cause decoupling.

Slider Embodiments

FIGS.38A-39Cillustrate several embodiments of analyte sensor systems in which a base includes a rail along which a sensor electronics module, having a channel configured to accommodate the rail, can be slid over and secured onto the base.

While not shown inFIGS.38A-39C, bases3802-3902can comprise an analyte sensor (e.g., analyte sensor104ofFIG.1, analyte sensor212ofFIG.2, analyte sensor1016ofFIG.10A) configured to generate a sensor signal indicative of an analyte (e.g., glucose) concentration of a host, while sensor electronics modules3850-3950can include sensor electronics (e.g., sensor electronics106ofFIGS.1and/or2) as described herein 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.

In some embodiments, an analyte sensor base assembly may include base3802-3902configured to attach to a skin of a host and one or more of the analyte sensor as described above and configured to generate a sensor signal indicative of an analyte concentration level of the host, at least one battery at least as will be described below, at least one sensor contact3808-3908and/or3810-3910, at least one battery contact3828-3938and/or3829-3929, a sealing member3824-3924and/or3925configured to provide a seal around at least the at least one battery contact3828-3938and/or3829-3929, and/or any other features associated with and/or configured to couple with base3802-3902at least as described below.

FIG.38Ais a perspective view of an example base3802and a sensor electronics module3850configured to be slid over and secured to base3802, according to some embodiments.FIG.38Bis a perspective view of sensor electronics module3850secured to base3802ofFIG.38A. Discussion follows with respect toFIGS.38A-38Bbelow.

As shown in the figures, analyte sensor system3800comprises base3802and sensor electronics module3850. Base3802can be configured to attach to the skin of the host, for example, utilizing an adhesive pad3814, which can be disposed on a back surface of base3802. Adhesive pad3814can have substantially similar features and function as previously described for adhesive pad2314ofFIGS.23A-23C.

In some embodiments, base3802can be configured to slide over and physically and/or mechanically couple with sensor electronics module3850utilizing one or more retaining features. For example, base3802can have a raised central rail3872configured to guide sensor electronics module3850into position during physical and/or mechanical coupling to base3802. In some embodiments, rail3872can have a substantially constant width along its length. However, the present disclosure is not so limited and rail3872can have a width that tapers along its length such that rail3872is substantially wedge-shaped, having a first width at a first end of rail3872and a second width smaller than the first width at a second end of rail3872opposite the first end. Such a tapered width of rail3872may facilitate easy mating of sensor electronics module3850with base3802and a good seal around one or more components and/or electrical contacts disposed thereon. Sensor electronics module3850can further comprise a channel3874having a shape that compliments an outer perimeter or shape of rail3872of base3802.

While not shown inFIGS.38A-38B, to accomplish, affect and/or support such physical and/or mechanical coupling, base3802can further include at least one of a first and a second retaining member (e.g., see at least retaining members3944ofFIG.39A-39C), while sensor electronics module3850can further include at least one of a first and a second retention feature (e.g., see at least retention features3956ofFIG.39A-39C) configured to mate with the first and second retaining members, respectively. Such at least one retaining member(s) and retention feature(s) can prevent sensor electronics module3850from undesirably backing out from the secured position with respect to base3802, as shown inFIG.38, and as further described in connection withFIGS.39A-39Cbelow.

FIG.38Aillustrates base3802as having a first sensor contact3808and a second sensor contact3810, each electrically coupled to a respective terminal of the analyte sensor, and a first battery contact3828and a second battery contact3829, each electrically coupled to a respective terminal of a battery (not shown inFIGS.38A-38Bbut see e.g., battery3918ofFIGS.39A-39C).

Sensor electronics module3850can comprise a plurality of contacts3854disposed on an inner surface of channel3874. In some embodiments, contacts3854can include a first signal contact configured to make electrical contact with first sensor contact3808, a second signal contact configured to make electrical contact with second sensor contact3810, a first power contact configured to make electrical contact with first battery contact3828and a second power contact configured to make electrical contact with second battery contact3829. Such first and second power contacts can be configured to receive power from the battery, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor.

Base3802can further include a first sealing member3824configured to surround and seal first and second sensor contacts3808,3810, first and second battery contacts3828,3829, the first and second signal contacts and the first and second power contacts within a first cavity3820. While first sealing member3824is illustrated as being disposed on a sidewall of rail3874, the present disclosure is not so limited and first sealing member3824could alternatively be disposed on an inner surface of channel3874of sensor electronics module3850, surrounding contacts3854, and similarly configured to form first cavity3820.

Sensor electronics module3850can be secured to base3802by aligning channel3874of sensor electronics module3850with rail3872of base3802and sliding sensor electronics module3850in a direction parallel to the host's body until sensor electronics module3850reaches the end of its travel along rail3872, is seated against at least a portion of base3802, and the at least one retaining member(s) and retention feature(s) (not shown inFIGS.38A-38B) are engaged with one another. In some embodiments, such aligning and securing of sensor electronics module3850to base3802can be accomplished by the host with a single hand, having at least one finger against base3802and at least one other finger against sensor electronics module3850and pressing the fingers closer to one another until sensor electronics module3850is properly secured to base3802.

An embodiment similar to that described in connection withFIGS.38A-38Bis shown inFIGS.39A-39Cand described below.FIG.39Ais a perspective view of an example base3902and a sensor electronics module3950configured to be slid over and secured to base3902, according to some embodiments.FIG.39Bis another perspective view of base3902ofFIG.39A.FIG.39Cis an exploded perspective bottom view of base3902and sensor electronics module3950ofFIG.39A. Discussion follows with respect toFIGS.39A-39Cbelow.

As shown in the figures, analyte sensor system3900comprises base3902and sensor electronics module3950. Base3902is configured to receive a battery3918within a cavity in a bottom surface of base3902. Base3902can also include a cover3960configured to be attached to and/or disposed on a bottom side of base3902. Cover3960may be shaped and sized to secure battery3918within base3902. Cover3960can be secured to the bottom surface of base3902utilizing any suitable method, for example, snaps, adhesive, friction fittings, heat-staking, and/or laser, heat or ultra-sonic welding along weld line3912.

As shown inFIG.39B, base3902can comprise a plurality of conductive traces3966, which can be formed utilizing any suitable process, for example, laser direct structuring (LDS) of base3902or overmolding of a conductive elastomer. Conductive traces3966may be utilized to ultimately route electrical signals from the analyte sensor to sensor electronics module3950and/or power from battery3918to sensor electronics module3950and to the analyte sensor.

Base3902further includes a first sensor contact3908and a second sensor contact3910, each electrically coupled to a respective terminal of the analyte sensor in base3902via at least some of conductive traces3966. Contacts3908,3910can be disposed immediately adjacent to one another. Base3902further includes a first battery contact3928and a second battery contact3929, each electrically coupled to a respective terminal of battery3918via at least some other of conductive traces3966on cover3960. Contacts3928,3929can be similarly disposed immediately adjacent to one another. Contacts3908,3910,3928,3929are illustrated as being disposed on a sidewall of base3902and configured to face a mating surface of sensor electronics module3950. However, the present disclosure is not so-limited and contacts3908,3910,3928,3929can be disposed on any suitable surface of base3902. Contacts3908,3910,3938,3929can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures.

Base3902further includes a sealing member3924, which can extend over and thereby seal conductive traces3966and which also surrounds and creates a single continuous seal around contacts3908,3910to form a first cavity3920a, and another single continuous seal around contacts3928,3929on base2302to form a second cavity3920b. Sealing member3924can, for example, include an overmolded component such as an overmolded gasket, an overmolded elastomeric feature, and/or an ultra-violet curable silicone that may be coupled to a surface of base3902utilizing any suitable method.

Sensor electronics module3950can comprise a plurality of contacts3954disposed on a surface (e.g., a sidewall) of sensor electronics module3950configured to face the mating surface of sensor electronics module3950on which contacts3908,3910,3928,3929are disposed. Contacts3954can comprise conductive elastomeric contacts (e.g. pucks), springs, tabs, posts, pogo pins, flat conductive pads or traces, or any other suitable conductive materials and/or structures. In some embodiments, contacts3954can include a first signal contact configured to make electrical contact with first sensor contact3908, a second signal contact configured to make electrical contact with second sensor contact3910, a first power contact configured to make electrical contact with first battery contact3928and a second power contact configured to make electrical contact with second battery contact3929. Such first and second power contacts can be configured to receive power from battery3918, while such first and second signal contacts can be configured to receive the sensor signal from the analyte sensor.

In some embodiments, base3902can be configured to slide over and physically and/or mechanically couple with sensor electronics module3950utilizing one or more retaining features. For example, base3902can have a raised central rail3972configured to guide sensor electronics module3950into position during physical and/or mechanical coupling to base3902. In some embodiments, rail3972can have a substantially constant width along its length. However, the present disclosure is not so limited and rail3972can have any suitable shape, width or widths along its length. To accomplish, affect and/or support such physical and/or mechanical coupling, base3902can further include at least one retaining member3944. Retaining member(s)3944can comprise snaps, hooks, deflectable tabs or any other suitable type of retaining member(s).

Sensor electronics module3950can further comprise a channel3974having a shape that compliments an outer perimeter or shape of rail3972of base3902, and at least one retention feature3956configured to mate with retaining member(s)3944. In some embodiments, retention feature(s)3956can comprise recesses configured to accept retaining member(s)3944. Such retaining member(s)3944and retention feature(s)3956can substantially immobilize sensor electronics module3950to base3902and prevent sensor electronics module3950from undesirably backing out from such a secured position.

In some embodiments, base3902can have a break line3964defining a first portion of base3902, on which retaining member(s)3944are disposed, from a second portion of base3902disposed on an opposite side of break line3964from the first portion. Accordingly, the first portion of base3902can comprise a frangible tab configured to separate from the second portion of base3902along break line3964when the first portion of base3902is sufficiently bent, flexed or otherwise deflected from its resting position shown inFIG.39A, and similar to that previously described in connection withFIGS.24A-24D.

Sensor electronics module3950can be secured to base3902by aligning channel3974of sensor electronics module3950with rail3972of base3902and sliding sensor electronics module3950in a direction parallel to the host's body until sensor electronics module3950reaches the end of its travel along rail3972, is seated against at least a portion of base3902, and retaining member(s)3944and retention feature(s)3956are engaged with one another. In some embodiments, such aligning and securing of sensor electronics module3950to base3902can be accomplished by the host with a single hand, having at least one finger against base3902and at least one other finger against sensor electronics module3950and pressing the fingers closer to one another until sensor electronics module3950is properly secured to base3902.

Methods of Manufacture Related to the Above-Described Embodiments

Several example methods of fabricating disposable analyte sensor bases having one or more batteries disposed therein and reusable sensor electronics modules configure to releasably couple to the bases are provided below in connection withFIG.40.

An example method4000for fabricating an analyte sensing apparatus and/or system will now be described in connection withFIG.40below. Method4000may correspond at least to the previous description in connection withFIGS.1-39C.

Block4002includes forming a base configured to attach to a skin of a host. For example, a base can be formed according to the description related to at least any of bases1002-3902as previously described in connection with any ofFIGS.10A-39C.

Block4004includes disposing a first plurality of contacts on the base. For example, any of bases2302-3902can have disposed thereon at least a first plurality of contacts including first sensor contact2308-3908and second sensor contact2310-3910, as previously described in connection withFIGS.23A-39C. In some embodiments, the first plurality of contacts can further include first battery contact2328-3228,3428-3828and second battery contact2329-3229,3429-3829, as previously described in connection withFIGS.23A-32and34-38B.

Block4006includes 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, analyte sensor104can be attached to any of at least bases2302-3902. As previously described, analyte sensor104is configured to generate a sensor signal indicative of an analyte concentration level of the host.

Block4008includes attaching a battery to the base. For example, a battery, such as any battery described in connection with at leastFIGS.10A-39C, can be attached to the respective base1002-3902, as previously described in connection with at leastFIGS.10A-39C.

Block4010includes 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, a sensor electronics module can be formed according to the description related to at least any of sensor electronics modules2350-3950as previously described in connection with any ofFIGS.23A-39C.

Block4012includes disposing a second plurality of contacts at respective locations on the sensor electronics module such that 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 sensor electronics modules2350-3950can have disposed thereon at least a second plurality of contacts2354-3954, including a first signal contact configured to make electrical contact with first sensor contact2308-3908and a second signal contact configured to make electrical contact with the second sensor contact2310-3910when sensor electronics module2350-3950is secured to base2302-3902, as previously described in connection withFIGS.23A-39C. In some embodiments, the second plurality of contacts2354-3954can further include a first power contact configured to make electrical contact with first battery contact2328-3228,3428-3828and a second power contact configured to make electrical contact with second battery contact2329-3229,3429-3829when sensor electronics module2350-3950is secured to base2302-3902, as previously described in connection withFIGS.23A-32and34-38B.

Block4014includes disposing a first sealing member on one of the base and the sensor electronics module, the first sealing 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 module is secured to the base. For example, first sealing member2324-3924can be disposed on at least one of base2302-3902and sensor electronics module2350-3950, as previously described in connection with at leastFIGS.23A-39C, such that first sealing member2324-3924is configured to form a first cavity2320-3920and provide a continuous seal around the first and second plurality of contacts within first cavity2320-3920when sensor electronics module2350-3950is secured to base2302-3902.

In some embodiments, base2302-3902is configured to be disposable. In some embodiments, sensor electronics module2350-3950is configured to be reusable. In some embodiments, the battery is configured to provide power to analyte sensor104and to sensor electronics module2350-3950. In some embodiments, the first and second signal contacts are configured to receive the sensor signal via first2308-3908and second2310-3910sensor contacts and the first and second power contacts are configured to receive power from the battery when sensor electronics module2350-3950is secured to base2302-3902. In some embodiments, each of second plurality of contacts2654are in direct electrical contact with one of analyte sensor104and the battery.

In some embodiments, method4000may further comprise electrically coupling first2308-3908and second2310-3910sensor contacts to respective terminals of analyte sensor104. In some embodiments, method400may further comprise electrically coupling first battery contact2328-3228,3428-3828and second battery contact2329-3229,3429-3829to respective terminals of the battery.

In some embodiments, method4000may further comprise forming a first retaining member2342-3942and a second retaining member2344-3944on base2302-3902, and forming, on sensor electronics module2350-3950, a first retention feature2352-3952configured to mate with first retaining member2342-3942and a second retention feature3956configured to mate with the second retaining member2344-3944when sensor electronics module2350-3950is secured to base2302-3902, thereby releasably coupling sensor electronics module2350-3950to base2302-3902. In some embodiments, second retaining member2344-3944is frangible and configured to be separable from base2302-3902. In some embodiments, second plurality of contacts2854-2954are disposed on first retention feature2852,2952. In some embodiments, first retaining member2842,2942comprises a hood and the first plurality of contacts2908,2910,2928,2929are disposed within the hood. In some embodiments, first sealing member2824is disposed around a circumference of securement feature2852such that first cavity2820is disposed within the hood. In some embodiments, first sealing member2924is disposed on an inner surface of the hood.

In some embodiments, method4000may further comprise securing cover2460,2560,2960,3160,3360,3960to a bottom of base2402,2502,2902,3160,3360,3902. Such a cover can be configured to secure the battery within the respective base. In some embodiments, method4000may further comprise disposing a first plurality of conductive traces2466,3166,3366, on cover2460,3160,3360such that at least some of first plurality of contacts are coupled to one of analyte sensor104and the battery via first plurality of conductive traces2466,3166,3366when cover2460,3160,3360is secured to the bottom of base2402,3102,3302.

In some embodiments, method4000may further comprise disposing a first plurality of conductive traces2366,2566-2666,2866-3066,3466-3966on base2302,2502-2026,2802-3002,3402-3902such that at least some of the first plurality of contacts are electrically coupled to one of analyte sensor104and the battery via first plurality of conductive traces2366,2566-2666,2866-3066,3466-3966. In some embodiments, first sealing member2524-2624,2924,3824-3924extends over first plurality of conductive traces2566-2666,2966,3866-3966, thereby sealing first plurality of conductive traces2566-2666,2966,3866-3966from moisture ingress. In some embodiments, first sealing member2666extends over battery2618, thereby sealing battery2618from moisture ingress.

In some embodiments, method4000may further comprise forming an aperture3070-3170,3670-3770in sensor electronics module3050-3150,3650-3750, and forming a raised portion3005-3105,3605-3705on base3002-3102,3602-3702configured to fit within aperture3070-3170,3670-3770, wherein an outer perimeter of the raised portion compliments an inner perimeter of the aperture. In some embodiments, first plurality of contacts3008,3010,3028,3029are disposed on raised portion3005. In some embodiments, aperture3070-3170is symmetrical about at least one axis parallel to a top surface of sensor electronics module3050-3150and asymmetrical about at least one other axis parallel to the top surface of sensor electronics module3050-3150. In some embodiments, the battery is disposed within raised portion3005-3105,3605of base3002-3102,3602. In some embodiments, a top surface of raised portion3005-3105,3605-3705sits substantially flush with a top surface of sensor electronics module3050-3150,3650-3750when the sensor electronics module is secured to base3002-3102,3602-3702.

In some embodiments, method4000may include forming a recess3242-3342in a top surface of base3202-3302and forming a protrusion3252-3352configured to mate with recess3242-3342such that mating of protrusion3252-3352with recess3242-3342aligns sensor electronics module3250-3350for securing with base3202-3302.

In some embodiments, method4000may further comprise forming a third plurality of contacts on base3302,3902, forming a fourth plurality of contacts at locations on sensor electronics module3350,3950such that each of the fourth plurality of contacts is configured to make electrical contact with a respective one of the third plurality of contacts when sensor electronics module3350,3950is secured to base3302,3902, and disposing a second sealing member3325,3925on one of base3302,3902and sensor electronics module3350,3950. Second sealing member3325,3925is configured to form a second cavity3320b,3920band provide a continuous seal around the third and fourth plurality of contacts within the second cavity when sensor electronics module3350,3950is secured to base3302,3902. In some embodiments, the third plurality of contacts comprises first battery contact3328,3928and second battery contact3329,3929. In some embodiments, method4000further comprises electrically coupling first3328,3928and second3329,3929battery contacts to respective terminals of the battery. In some embodiments, fourth plurality of contacts3354,3954comprises a first power contact configured to make electrical contact with first battery contact3328,3928and a second power contact configured to make electrical contact with second battery contact3329,3929when sensor electronics module3350,3950is secured to base3302,3902.

In some embodiments, second plurality of contacts3454-3754comprise concentric, circular contacts. In some embodiments, concentric, circular contacts3454-3754are disposed around a center of sensor electronics module3450-3750. In some embodiments, each of second plurality of contacts3454-3754are configured to make electrical contact with the respective one of the first plurality of contacts when sensor electronics module3450-3750is secured to base3402-3702in any of a plurality of radial orientations.

In some embodiments, method4000may further comprise forming an aperture3470in base3402and forming a raised portion3405on sensor electronics module3450configured to fit within aperture3470, wherein an outer perimeter of raised portion3405compliments an inner perimeter of aperture3470. In some embodiments, aperture3470and raised portion3405each have a substantially circular shape.

In some embodiments, method4000may further comprise forming raised rail3872-3972on base3802-3902and forming channel3874-3974having a shape that compliments a shape of raised rail3872-3972on sensor electronics module3850-3950. In some embodiments, raised rail3872-3972can have a constant width along its length. In some embodiments, a width of raised rail3872-3972tapers along its length. In some embodiments, first plurality of contacts3808,3810,3828,3829are disposed on a sidewall of raised rail3872and second plurality of contacts3854is disposed on a sidewall of channel3874. In some embodiments, first3908,3910and third3928,3929plurality of contacts are disposed on a sidewall of base3902and the second and fourth plurality of contacts3954are disposed on a sidewall of sensor electronics module3950.