Pre-connected analyte sensor

Abstract

To provide various analyte sensing devices and associated housings.SOLUTION: Some devices comprise one or more caps. Some devices comprise a two part adhesive patch. Some devices include one or more sensor flexures configured to position and / or hold a sensor in place during installation. Some devices utilize one or more dams and / or wells to hold the epoxy to secure the sensor. Some devices utilize a pocket and one or more adjacent regions and various transitions to prevent epoxy from wicking into undesired regions of the device. Some devices include a heat sealable thermoplastic elastomer for welding the cap to the device. Related methods for manufacturing such devices and / or housings are also provided.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] INCORPORATION-BY-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 62 / 837,091, filed April 22, 2019, which is incorporated herein by reference in its entirety for all purposes.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to sensors, and more particularly to analyte sensors, such as continuous analyte sensors. [Background technology]

[0003] Diabetes is a disease in which the pancreas cannot produce enough insulin (type 1, or insulin-dependent), and / or insulin is ineffective (type 2, or non-insulin-dependent). In the diabetic state, the victim suffers from hyperglycemia, which can lead to many physiological disorders associated with deterioration of small blood vessels, such as kidney failure, skin ulcers, or bleeding into the vitreous of the eye. Hypoglycemic reactions (low blood sugar) can be precipitated by inadvertent overdosing of insulin or after normal administration of insulin or glucose-lowering drugs accompanied by abnormal exercise or inadequate food intake.

[0004] Traditionally, people with diabetes carry self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger-prick method. Due to the lack of comfort and convenience, people with diabetes typically measure their glucose levels only two to four times per day. Unfortunately, these time intervals are spread so far apart that people with diabetes may not know about their hyperglycemic or hypoglycemic condition until it is too late, sometimes resulting in dangerous side effects. Glucose levels can alternatively be continuously monitored by a sensor system including an on-skin sensor assembly. The sensor system may have a wireless transmitter that transmits measurement data to a receiver, which can process and display information based on the measurements.

[0005] This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. It is not intended as an aid in determining the scope of the claimed subject matter, nor is it to be construed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems discussed above. Summary of the Invention

[0006] According to some embodiments, an analyte sensing device is provided. The device includes a housing having a cavity therein, the cavity having a first portion and a second portion. The device includes a first conductive contact and a second conductive contact disposed within the first portion of the cavity. The device includes an analyte sensor including an elongated body, a first electrode in electrical communication with the first conductive contact, and a second electrode in electrical communication with the second conductive contact. The device includes a cap configured to fit over or within the cavity. The cap includes a first portion configured to be disposed over the first portion of the cavity, a second portion, a dam portion disposed on a side of the cap configured to face the cavity, the dam portion dividing the first portion of the cavity from the second portion of the cavity, a shelf disposed adjacent to the dam portion, and a mating component configured to seal the first portion of the cavity from the second portion of the cavity.

[0007] In some embodiments, the device includes an electronics assembly substrate disposed within the housing, with first and second conductive contacts extending from the electronics assembly substrate into the first portion of the cavity. In some embodiments, the mating component is disposed on the ledge and configured to press against a portion of the analyte sensor and against a surface of the housing within the cavity, thereby sealing the first portion of the cavity from the second portion of the cavity. In some embodiments, the first portion of the cap includes a first hole configured to receive a sealing sealant into the first portion of the cavity that seals at least a portion of the analyte sensor from moisture ingress. In some embodiments, the first portion of the cap includes a second hole configured to allow excess sealing sealant to flow out of the first portion of the cavity. In some embodiments, the mating component prevents the sealing sealant from flowing into the second portion of the cavity. In some embodiments, the second portion of the cap is configured to be disposed over the second portion of the cavity. In some embodiments, the second portion of the cap includes a slot configured to allow at least a portion of the analyte sensor to pass through the cap. In some embodiments, the outward-facing surface of the cap is configured to fit flush with the outward-facing surface of the housing. In some embodiments, the outward-facing surface of the cap is configured to fit in a recessed position relative to the outward-facing surface of the housing. In some embodiments, the cap is disposed on the outward-facing surface of the housing. In some embodiments, the cap is secured to the cavity utilizing at least one of a toe feature, a snap feature, a friction-fit feature, and a pressure-sensitive adhesive. In some embodiments, the first portion of the cap and the second portion of the cap are coplanar and formed from a single piece. In some embodiments, the hermetic sealant is a curable sealant configured to harden upon exposure to ultraviolet radiation, and the cap comprises a material that is substantially transparent to ultraviolet radiation. In some embodiments, the dam portion is configured to contact a portion of the housing within the cavity. In some embodiments, the conforming material comprises a foam or rubber material.

[0008] In some embodiments, the device includes an adhesive patch including a first adhesive portion configured to secure and simultaneously adhere the cap to the housing, and a second adhesive portion configured to adhere the first adhesive portion and the wearable assembly to the skin of the host. In some embodiments, the cap is secured to the first adhesive portion of the adhesive patch before being fitted onto or into the cavity of the housing. In some embodiments, the first adhesive portion includes at least one hole configured to substantially align with at least one hole in the cap when the cap is secured to the first adhesive portion of the adhesive patch. In some embodiments, the second adhesive portion of the adhesive patch is initially disposed on a separate liner from the first adhesive portion of the adhesive patch. In some embodiments, the second adhesive portion includes at least one hole configured to substantially align with at least one hole in the cap when the cap is secured to the second adhesive portion of the adhesive patch.

[0009] In some embodiments, the second portion of the cap is configured to be disposed adjacent to the second portion of the cavity. In some embodiments, the first portion of the cap extends along a first plane, the second portion of the cap extends along a second plane different from the first plane, the dam portion extends between the first plane and the second plane and includes at least a portion of the cap connecting the first portion of the cap with the second portion of the cap, and at least some of the second portion of the cap includes a ledge.

[0010] In some embodiments, the device includes at least one passivation layer deposited over at least a portion of the first portion of the cavity and over at least a portion of the sensor, wherein the at least one passivation layer prevents ingress of moisture into the portion of the sensor. In some embodiments, the device includes one or more conductive traces deposited on the at least one passivation layer and electrically coupled to one of the first conductive contact and the second conductive contact.

[0011] According to some embodiments, an analyte sensing device includes a housing, an electronics assembly board disposed within the housing, and an analyte sensor including an elongated body having at least a first bend.

[0012] In some embodiments, the first bend is oriented such that the portion of the elongate body distal to the first bend extends substantially parallel to the plane of the electronics assembly substrate and the portion of the elongate body proximal to the first bend is substantially perpendicular to the plane of the electronics assembly substrate and extends at least partially into the electronics assembly substrate. In some embodiments, the housing includes a recess, and at least some of the portion of the elongate body proximal to the first bend extends through the electronics assembly substrate and into the recess. In some embodiments, the portion of the elongate body proximal to the first bend exerts a bias force against the portion of the electronics assembly substrate, thereby securing the analyte sensor in a desired orientation with respect to the electronics assembly substrate.

[0013] In some embodiments, the first bend is oriented such that the portion of the elongate body distal to the first bend extends substantially parallel to the plane of the electronics assembly substrate, and the portion of the elongate body proximal to the first bend extends substantially perpendicular to the plane of the electronics assembly substrate and away from the electronics assembly substrate. In some embodiments, the housing further includes a recess in a sidewall of the housing, with at least some of the portions of the elongate body proximal to the first bend extending into the recess, thereby constraining the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the portion of the elongate body proximal to the first bend exerts a bias force against a portion of the housing, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the elongate body of the analyte sensor includes at least one additional bend proximal to the first bend. The at least one additional bend causes at least a first portion of the portion of the elongate body proximal to the first bend and distal to the at least one additional bend to extend in a first direction within the recess and exert a first bias force at a first location along the recess, and at least a second portion of the portion of the elongate body proximal to the first bend and proximal to the at least one additional bend to extend in a second direction within the recess and exert a second bias force at a second location along the recess, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly substrate.

[0014] In some embodiments, the first bend is oriented such that a portion of the elongate body distal to the first bend extends in a first direction substantially parallel to the plane of the electronics assembly substrate, and a portion of the elongate body proximal to the first bend extends in a second direction different from the first direction but also substantially parallel to the plane of the electronics assembly substrate. In some embodiments, the elongate body of the analyte sensor includes at least one additional bend proximal to the first bend. The at least one additional bend causes at least a first portion of the elongate body portion proximate the first bend and distal to the at least one additional bend to extend in a second direction and exert a first bias force at a first location along one of the housing and the electronics assembly board, and at least a second portion of the elongate body portion proximate the first bend and proximate the at least one additional bend to extend in a third direction substantially parallel to the plane of the electronics assembly board and exert a second bias force at a second location along one of the housing and the electronics assembly board, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly board. In some embodiments, the electronics assembly substrate includes a support post, and the first bend is oriented such that a portion of the elongate body distal to the first bend extends in a first direction substantially parallel to the plane of the electronics assembly substrate and a portion of the elongate body proximal to the first bend extends substantially along the circumference of the support post, thereby securing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the portion of the elongate body distal to the first bend exerts a first bias force at a first location along one of the housing and the electronics assembly substrate, thereby securing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the first bend exerts a second bias force at a second location along one of the housing and the electronics assembly substrate, thereby further securing the analyte sensor in a desired orientation.In some embodiments, the portion of the elongate body proximal to the first bend exerts a third bias force at a third location along one of the housing and the electronics assembly substrate, thereby further securing the analyte sensor in a desired orientation. In some embodiments, the second bias force is exerted in a direction substantially opposite to the third bias force. In some embodiments, the first bias force is exerted in a direction substantially perpendicular to each of the second bias force and the third bias force. In some embodiments, the first bend provides a first torque about the first bend that presses the portion of the elongate body distal to the first bend against the first location. In some embodiments, the first bend provides a second torque about the first bend that presses the portion of the elongate body proximal to the first bend against a third location.

[0015] According to some embodiments, an analyte sensing device includes a housing having a cavity having a first portion and a second portion, a first conductive contact disposed in the first portion of the cavity, a second conductive contact disposed in the first portion of the cavity, and a first well portion surrounding the first conductive contact. The first well portion is defined by a first dam portion disposed adjacent a first side of the first conductive contact and a second dam portion disposed adjacent a second side of the first conductive contact opposite the first side. The device includes an analyte sensor having an elongated body, a first electrode in electrical communication with the first conductive contact, and a second electrode in electrical communication with the second conductive contact, the analyte sensor being disposed on the first dam and the second dam.

[0016] In some embodiments, the device includes an electronics assembly substrate disposed within the housing, with a first conductive contact and a second conductive contact extending from the electronics assembly substrate into a first portion of the cavity. In some embodiments, the first dam portion and the second dam portion each include a sloped cross-section, and an analyte sensor is disposed on the lowest point of the sloped cross-section of the first dam portion and on the lowest point of the sloped cross-section of the second dam portion. In some embodiments, the sloped cross-sections of the first and second dam portions are one of a triangularly concave, a parabolically concave, a semicircularly concave, or a hyperbolic concave cross-section. In some embodiments, the device further includes a conductive epoxy disposed on at least a portion of the first conductive contact within the first well portion. In some embodiments, the conductive epoxy is disposed at least at the height of the lowest point of the sloped cross-section of the first dam portion or the lowest point of the sloped cross-section of the second dam portion such that the first electrode of the analyte sensor is in direct physical and electrical contact with the conductive epoxy.

[0017] According to some embodiments, the housing of the analyte sensing device includes a first pocket having a first pocket base, a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base, and a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base, wherein the first and second adjacent regions are contiguous with the first pocket.

[0018] In some embodiments, the housing includes an electronics assembly substrate disposed within the housing. In some embodiments, the first pocket has a substantially rectangular shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded rectangular shape such that portions of the sidewalls of the first pocket are substantially planar while other portions of the sidewalls connecting the substantially planar portions are curved. In some embodiments, the first pocket has a substantially diamond shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded diamond shape such that portions of the sidewalls of the first pocket are substantially planar while other portions of the sidewalls connecting the substantially planar portions are curved. In some embodiments, the first pocket has a substantially polygonal shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded polygonal shape such that portions of the sidewall of the first pocket are substantially planar while other portions of the sidewall connecting the substantially planar portions are curved. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at an elevated height relative to the first pocket base. In some embodiments, at least one of the first transition and the second transition is stepped up from the first pocket base. In some embodiments, the elevated height is approximately 0.5 millimeters. In some embodiments, the housing includes epoxy disposed on the pocket base, the epoxy forming an upwardly deflecting meniscus at at least one of the first and second transitions, the elevated height exceeding the height of the upwardly deflecting meniscus. In some embodiments, the elevated height is a function of the first predetermined amount and at least one of the viscosity, surface energy, and surface tension properties of the epoxy.In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at the same height as the first pocket base. In some embodiments, at least one of the first transition and the second transition is flush with the first pocket base. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at a lower height compared to the first pocket base. In some embodiments, at least one of the first transition and the second transition is stepped down from the first pocket base. In some embodiments, the lower height is approximately 0.5 millimeters. In some embodiments, the housing includes epoxy disposed on the pocket base, the epoxy forming a meniscus that bends downward at at least one of the first and second transitions. In some embodiments, the epoxy adheres to at least one of the first and second transitions and inhibits the epoxy from creeping into at least one of the first and second transitions. In some embodiments, one of the first adjacent region base and the second adjacent region base is positioned at a lower height than the first pocket base, and the other of the first adjacent region base and the second adjacent region base is positioned at a higher height than the first pocket base. In some embodiments, both of the first adjacent region base and the second adjacent region base are positioned at a lower height than the first pocket base. In some embodiments, the first adjacent region has any of a substantially rectangular shape, a substantially rounded rectangular shape, a substantially diamond shape, a substantially rounded diamond shape, a substantially polygonal shape, a substantially rounded polygonal shape, and a substantially irregular shape. In some embodiments, the second adjacent region has any of a substantially rectangular shape, a substantially rounded rectangular shape, a substantially diamond shape, a substantially rounded diamond shape, a substantially polygonal shape, a substantially rounded polygonal shape, and a substantially irregular shape. In some embodiments, the sidewall of the first pocket is disposed substantially perpendicular to the first pocket base.In some embodiments, the sidewall of the first pocket is disposed at an angle from substantially perpendicular to the first pocket base. In some embodiments, the sidewall of at least one of the first and second adjacent regions is disposed substantially perpendicular to the respective first and second adjacent region bases. In some embodiments, the sidewall of at least one of the first and second adjacent regions is disposed at an angle from substantially perpendicular to the respective first and second adjacent region bases. In some embodiments, the sidewall of at least one of the first and second transitions is disposed substantially perpendicular to the first pocket base. In some embodiments, the sidewall of at least one of the first and second transitions is disposed at an angle from substantially perpendicular to the first pocket base. In some embodiments, the sidewall of at least one of the first and second transitions is rounded to avoid forming an angled corner at at least one of the first and second transitions. In some embodiments, the first width of the first transition and the second width of the second transition are substantially within the range of 0.5 mm to 2.0 mm. In some embodiments, the first width of the first transition is greater than the second width of the second transition. In some embodiments, the first width of the first transition is less than the second width of the second transition. In some embodiments, the housing includes a conductive contact disposed in the first adjacent region or in the second adjacent region. In some embodiments, the housing includes an analyte sensor having an elongated body, a first electrode, and a second electrode. One of the first electrode and the second electrode is in electrical communication with the conductive contact.

[0019] In some embodiments, the housing includes posts disposed in the first adjacent region or in the second adjacent region and epoxy disposed on the posts. A portion of the analyte sensor is disposed in the epoxy disposed on the posts. In some embodiments, the epoxy disposed on the posts exerts a centering force on the portion of the analyte sensor disposed therein such that the analyte sensor is aligned substantially along a centerline of the post. In some embodiments, the post has a substantially symmetrical shape about the centerline of the post.

[0020] In some embodiments, the first pocket base has a first surface energy and the first adjacent region base has a second surface energy different from the first surface energy, hi some embodiments, the second adjacent region base has one of the second surface energy and a third surface energy different from the first and second surface energies.

[0021] In some embodiments, the housing includes a third adjacent region abutting the first pocket, the third adjacent region having a third adjacent region base positioned at a height lower than a top surface of the sidewall of the first pocket and a third transition between the top surface of the sidewall of the first pocket and the third adjacent region base. In some embodiments, epoxy disposed in the first pocket adheres to the third transition and inhibits the epoxy from creeping into the third adjacent region. In some embodiments, the third adjacent region is configured to receive at least an excess portion of the epoxy disposed in the first pocket, thereby inhibiting the epoxy from creeping into at least one of the first and second adjacent regions.

[0022] According to some embodiments, an analyte sensing device includes a housing. The housing includes: a first pocket having a first pocket base; a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base; a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base; and conductive contacts disposed in the first adjacent region or the second adjacent region. The device includes an electronics assembly substrate disposed within the housing and electrically coupled to the conductive contacts. The device includes an analyte sensor including at least one electrode in electrical communication with the conductive contacts; and epoxy disposed on the first pocket base, the epoxy securing at least a portion of the analyte sensor to the first pocket base.

[0023] In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at a height greater than that of the first pocket base. In some embodiments, the epoxy forms an upwardly bending meniscus at at least one of the first and second transitions, the height being greater than the height of the upwardly bending meniscus. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at the same height as the first pocket base. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at a lower height than that of the first pocket base. In some embodiments, the epoxy forms a downwardly bending meniscus at at least one of the first and second transitions. In some embodiments, the epoxy adheres to at least one of the first and second transitions and inhibits the epoxy from creeping into at least one of the first and second transitions.

[0024] According to some embodiments, an analyte sensing device includes a housing including an opening defining a cavity therein, the cavity having a first portion and a second portion. The device includes a first heat-sealable thermoplastic elastomer disposed along the periphery of the first portion of the cavity. The device includes an analyte sensor having at least a portion disposed within the first portion of the cavity. The device includes a cap configured to fit over or within the opening and over the first portion of the cavity. The cap includes a second heat-sealable thermoplastic elastomer along at least a portion of the cap disposed over the boundary between the first and second portions of the cavity. The first and second heat-sealable thermoplastic elastomers are configured to seal the first portion of the cavity from moisture intrusion when melted. In some embodiments, the boundary between the first and second portions of the cavity includes a portion of the first heat-sealable thermoplastic elastomer.

[0025] According to some embodiments, an analyte sensing device includes a housing including a cavity within the housing, a first conductive contact, a second conductive contact, and a cap configured to fit over or within the opening. The analyte sensor includes an elongated body, a first electrode in physical contact with the first conductive contact, and a second electrode in physical contact with the second conductive contact. The cap includes a base, and a sealing material configured to at least partially fill the cavity. The sealing member includes a first cavity configured to align over the first electrode and the first conductive contact, and a second cavity configured to align over the second electrode and the second conductive contact.

[0026] In some embodiments, the first cavity contains a first conductive elastomer puck, and the second cavity contains a second conductive elastomer puck. In some embodiments, the first conductive elastomer puck is configured to press against the first electrode and the first conductive contact, and the second conductive elastomer puck is configured to press against the second electrode and the second conductive contact. In some embodiments, the first conductive elastomer puck secures the first electrode to the first conductive contact, and the second conductive elastomer puck secures the second electrode to the second conductive contact. In some embodiments, the first conductive elastomer puck is configured to press against the first electrode and the cap, and the second conductive elastomer puck is configured to press against the second electrode and the second conductive contact. In some embodiments, the first and second conductive elastomer pucks have a substantially cylindrical shape. In some embodiments, the first conductive contact has a gap formed therein. In some embodiments, the first conductive elastomer puck is disposed within the gap of the first conductive contact. In some embodiments, the first conductive elastomer puck is disposed within the gap of the first conductive contact by a force fit. In some embodiments, the first cavity is configured to hold a first injection of conductive epoxy configured to electrically couple the first electrode and the first conductive contact. In some embodiments, the second cavity is configured to hold a second injection of conductive epoxy configured to electrically couple the second electrode and the second conductive contact. In some embodiments, the first and second cavities have a substantially conical shape. In some embodiments, the base of the cap further includes at least a first hole laterally aligned with the first cavity and a second hole laterally aligned with the second cavity, and at least a portion of the sealing material physically isolates the first hole from the first cavity and physically isolates the second hole from the second cavity.

[0027] According to some embodiments, a method for manufacturing an analyte sensing device includes forming a housing including an opening defining a cavity having a first portion and a second portion therein. The method includes disposing a first conductive contact and a second conductive contact in the first portion of the cavity. The method includes electrically coupling a first electrode of an analyte sensor to the first conductive contact. The method includes electrically coupling a second electrode of the analyte sensor to the second conductive contact. The method includes forming a cap having a first portion and a second portion, a dam portion disposed on a side of the cap configured to face the opening, a ledge adjacent the dam portion, and a mating component disposed on the ledge. The method includes fitting the cap over or within the opening such that the first portion of the cap is disposed over the first portion of the cavity, the dam portion physically divides the first portion of the cavity from the second portion of the cavity, and the mating component presses against the portion of the analyte sensor and against a surface of the housing within the cavity, thereby sealing the first portion of the cavity from the second portion of the cavity.

[0028] In some embodiments, the method includes disposing an electronics assembly substrate in a housing, with first and second conductive contacts extending from the electronics assembly substrate into a first portion of a cavity. In some embodiments, the first portion of the cap includes a first hole, and the method further includes depositing a sealing sealant through the first hole into the first portion of the cavity, thereby sealing at least a portion of the analyte sensor from moisture ingress. In some embodiments, the first portion of the cap includes a second hole, and the method further includes allowing excess sealing sealant to flow out of the first portion of the cavity through the second hole. In some embodiments, the matching component prevents the sealing sealant from flowing into the second portion of the cavity. In some embodiments, the cap includes a second portion disposed over the second portion of the cavity. In some embodiments, the second portion of the cap includes a slot, and the method further includes passing at least a portion of the analyte sensor through the slot. In some embodiments, the outward-facing surface of the cap fits flush with the outward-facing surface of the housing. In some embodiments, the outward-facing surface of the cap fits in a recessed position relative to the outward-facing surface of the housing. In some embodiments, the cap is disposed on an outwardly facing surface of the housing. In some embodiments, the method includes securing the cap to the housing using at least one of a toe feature, a snap feature, a friction fit feature, and a pressure-sensitive adhesive. In some embodiments, the first portion of the cap and the second portion of the cap are coplanar and formed from a single piece. In some embodiments, the cap includes a material that is substantially transparent to ultraviolet radiation, and the method further includes curing the sealing sealant by exposing the sealing sealant to ultraviolet radiation through the cap. In some embodiments, the dam portion contacts a portion of the housing within the cavity. In some embodiments, the conforming material includes a foam or rubber material.

[0029] In some embodiments, the method includes securing the cap to the housing using a first adhesive portion of an adhesive patch, the adhesive patch further including a second adhesive portion configured to adhere the first adhesive portion and the wearable assembly to the skin of the host. In some embodiments, the method includes securing the first adhesive portion of the adhesive patch to the cap before the cap is fitted over or into the opening of the housing. In some embodiments, the first adhesive portion includes at least one hole configured to substantially align with at least one hole in the cap when the cap is secured to the first adhesive portion of the adhesive patch. In some embodiments, the second adhesive portion includes at least one hole configured to substantially align with at least one hole in the cap when the cap is secured to the second adhesive portion of the adhesive patch.

[0030] In some embodiments, the second portion of the cap is disposed adjacent to the second portion of the cavity. In some embodiments, the first portion of the cap extends along a first plane, the second portion of the cap extends along a second plane different from the first plane, the dam portion extends between the first plane and the second plane and includes at least a portion of the cap connecting the first portion of the cap with the second portion of the cap, and at least some of the second portion of the cap includes a shelf.

[0031] In some embodiments, the method includes depositing at least one passivation layer over at least a portion of the first portion of the cavity and over at least a portion of the analyte sensor, thereby preventing ingress of moisture into portions of the sensor. In some embodiments, the method includes depositing one or more conductive traces on the at least one passivation layer and electrically coupling the one or more conductive traces to one or more of the first conductive contact and the second conductive contact.

[0032] According to some embodiments, a method of manufacturing an analyte sensing device includes manufacturing a housing, disposing an electronics assembly substrate within the housing, and coupling an analyte sensor including an elongated body having at least a first bend to at least one of the housing and the electronics assembly substrate.

[0033] In some embodiments, the method includes forming a first bend in the analyte sensor such that a portion of the elongate body distal to the first bend extends substantially parallel to the plane of the electronics assembly substrate and a portion of the elongate body proximal to the first bend extends substantially perpendicular to the plane of the electronics assembly substrate and at least partially into the electronics assembly substrate. In some embodiments, the housing includes a recess, and the method further includes extending at least some of the portion of the elongate body proximal to the first bend through the electronics assembly substrate and into the recess. In some embodiments, the portion of the elongate body proximal to the first bend exerts a bias force against the portion of the electronics assembly substrate, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly substrate.

[0034] In some embodiments, the method includes forming a first bend in the analyte sensor such that a portion of the elongate body distal to the first bend extends substantially parallel to the plane of the electronics assembly substrate and a portion of the elongate body proximal to the first bend extends substantially perpendicular to the plane of the electronics assembly substrate and away from the electronics assembly substrate. In some embodiments, the housing further includes a recess in a sidewall of the housing, and the method further includes extending at least some of the portion of the elongate body proximal to the first bend within the recess, thereby constraining the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the portion of the elongate body proximal to the first bend exerts a bias force against a portion of the housing, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the method includes forming at least one additional bend in the analyte sensor proximate the first bend such that the at least one additional bend causes at least a first portion of the elongate body proximate the first bend and distal to the at least one additional bend to extend in a first direction within the recess and exert a first bias force at a first location along the recess, and at least a second portion of the portion of the elongate body proximate the first bend and proximate the at least one additional bend to extend in a second direction within the recess and exert a second bias force at a second location along the recess, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly substrate.

[0035] In some embodiments, the method includes forming a first bend in the analyte sensor such that a portion of the elongate body distal to the first bend extends in a first direction substantially parallel to the plane of the electronics assembly substrate, and a portion of the elongate body proximal to the first bend extends in a second direction different from the first direction but also substantially parallel to the plane of the electronics assembly substrate. In some embodiments, the method further includes forming at least one additional bend in the analyte sensor proximate the first bend such that the at least one additional bend causes at least a first portion of the elongate body proximate the first bend and distal to the at least one additional bend to extend in a second direction and exert a first bias force at a first location along one of the housing and the electronics assembly board, and at least a second portion of the elongate body proximate the first bend and proximate the at least one additional bend to extend in a third direction substantially parallel to the plane of the electronics assembly board and exert a second bias force at a second location along one of the housing and the electronics assembly board, thereby fixing the analyte sensor in a desired orientation with respect to the electronics assembly board.

[0036] In some embodiments, the electronics assembly substrate includes a support post, and the method further includes forming a first bend in the analyte sensor such that a portion of the elongate body distal to the first bend extends in a first direction substantially parallel to a plane of the electronics assembly substrate and a portion of the elongate body proximal to the first bend extends substantially along a circumference of the support post, thereby securing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the portion of the elongate body distal to the first bend exerts a first bias force at a first location along one of the housing and the electronics assembly substrate, thereby securing the analyte sensor in a desired orientation with respect to the electronics assembly substrate. In some embodiments, the first bend exerts a second bias force at a second location along one of the housing and the electronics assembly substrate, thereby further securing the analyte sensor in the desired orientation. In some embodiments, the portion of the elongate body proximal to the first bend exerts a third bias force at a third location along one of the housing and the electronics assembly substrate, thereby further securing the analyte sensor in a desired orientation. In some embodiments, the second bias force is exerted in a direction substantially opposite to the third bias force. In some embodiments, the first bias force is exerted in a direction substantially perpendicular to each of the second bias force and the third bias force. In some embodiments, the first bend provides a first torque about the first bend that presses the portion of the elongate body distal to the first bend against the first location. In some embodiments, the first bend provides a second torque about the first bend that presses the portion of the elongate body proximal to the first bend against a third location.

[0037] According to some embodiments, a method of manufacturing an analyte sensing device is provided. The method includes forming a housing including a cavity having a first portion and a second portion. The method includes forming a first dam portion in the first portion of the cavity adjacent to a first side of a first conductive contact. The method includes forming a second dam portion in the first portion of the cavity adjacent to a second side of the first conductive contact opposite the first side, the first dam portion and the second dam portion defining a first well portion that contains the first conductive contact. The method includes disposing an analyte sensor in the first dam portion and the second dam portion. The method includes coupling a first electrode of the analyte sensor to the first conductive contact. The method includes coupling a second electrode of the analyte sensor to the second conductive contact.

[0038] In some embodiments, the method includes disposing an electronics assembly substrate in a housing, with first and second conductive contacts extending from the electronics assembly substrate into a first portion of the cavity. In some embodiments, the first dam portion and the second dam portion each include a sloped cross-section, and an analyte sensor is disposed on a lowest point of the sloped cross-section of the first dam portion and on a lowest point of the sloped cross-section of the second dam portion. In some embodiments, the sloped cross-sections of the first and second dam portions are one of a triangularly concave, a parabolically concave, a semicircularly concave, or a hyperbolic concave cross-section. In some embodiments, the method includes disposing conductive epoxy on at least a portion of the first conductive contact within the first well portion. In some embodiments, the conductive epoxy is disposed at least at the height of the lowest point of the sloped cross-section of the first dam portion or the lowest point of the sloped cross-section of the second dam portion such that the first electrode of the analyte sensor is in direct physical and electrical contact with the conductive epoxy when disposed in the first dam portion and the second dam portion.

[0039] According to some embodiments, a method of manufacturing a housing for an analyte sensing device is provided. The method includes forming a first pocket within the housing, the first pocket having a first pocket base. The method includes forming a first adjacent region within the housing abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base. The method includes forming a second adjacent region within the housing abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base.

[0040] In some embodiments, the method includes disposing an electronics assembly substrate in a housing. In some embodiments, the first pocket has a substantially rectangular shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded rectangular shape such that portions of the sidewalls of the first pocket are substantially planar while other portions of the sidewalls connecting the substantially planar portions are curved. In some embodiments, the first pocket has a substantially diamond shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded diamond shape such that portions of the sidewalls of the first pocket are substantially planar while other portions of the sidewalls connecting the substantially planar portions are curved. In some embodiments, the first pocket has a substantially polygonal shape such that sidewalls of the first pocket are substantially planar and meet to form angled corners. In some embodiments, the first pocket has a substantially rounded polygonal shape such that portions of the sidewall of the first pocket are substantially planar while other portions of the sidewall connecting the substantially planar portions are curved. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at an elevated height relative to the first pocket base such that at least one of the first transition and the second transition is stepped up from the first pocket base. In some embodiments, the elevated height is approximately 0.5 millimeters. In some embodiments, the method includes disposing epoxy on the pocket base, the epoxy forming an upwardly deflecting meniscus at at least one of the first and second transitions, the elevated height exceeding the height of the upwardly deflecting meniscus. In some embodiments, the elevated height is a function of a first predetermined amount and at least one of the viscosity, surface energy, and surface tension properties of the epoxy. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at the same height as the first pocket base.In some embodiments, at least one of the first transition and the second transition is flush with the first pocket base. In some embodiments, the method includes depositing epoxy on the pocket base, wherein at least one of the first adjacent region base and the second adjacent region base is disposed at a lower height compared to the first pocket base. In some embodiments, the higher height is a function of the first predetermined amount and at least one of the viscosity, surface energy, and surface tension properties of the epoxy. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at the same height as the first pocket base. In some embodiments, at least one of the first transition and the second transition is flush with the first pocket base. In some embodiments, the method includes depositing epoxy on the pocket base, wherein at least one of the first adjacent region base and the second adjacent region base is disposed at a lower height compared to the first pocket base. In some embodiments, at least one of the first transition and the second transition steps down from the first pocket base. In some embodiments, the lower height is approximately 0.5 millimeters. In some embodiments, the epoxy forms a meniscus that bends downward at at least one of the first and second transitions. In some embodiments, the epoxy adheres to at least one of the first and second transitions, inhibiting the epoxy from creeping into at least one of the first and second transitions. In some embodiments, one of the first adjacent region base and the second adjacent region base is positioned at a lower height compared to the first pocket base, and the other of the first adjacent region base and the second adjacent region base is positioned at a higher height compared to the first pocket base. In some embodiments, both of the first adjacent region base and the second adjacent region base are positioned at a lower height compared to the first pocket base.In some embodiments, the first adjacent region has any of a substantially rectangular shape, a substantially rounded rectangular shape, a substantially diamond-shaped shape, a substantially rounded diamond-shaped shape, a substantially polygonal shape, a substantially rounded polygonal shape, and a substantially irregular shape. In some embodiments, the second adjacent region has any of a substantially rectangular shape, a substantially rounded rectangular shape, a substantially diamond-shaped shape, a substantially rounded diamond-shaped shape, a substantially polygonal shape, a substantially rounded polygonal shape, and a substantially irregular shape. In some embodiments, the sidewalls of the first pocket are disposed substantially perpendicular to the first pocket base. In some embodiments, the sidewalls of the first pocket are disposed at an angle from substantially perpendicular to the first pocket base. In some embodiments, the sidewalls of at least one of the first and second adjacent regions are disposed substantially perpendicular to the respective first and second adjacent region bases. In some embodiments, the sidewall of at least one of the first and second adjacent regions is disposed at an angle from substantially perpendicular to the respective first and second adjacent region bases. In some embodiments, the sidewall of at least one of the first and second transitions is disposed substantially perpendicular to the first pocket base. In some embodiments, the sidewall of at least one of the first and second transitions is disposed at an angle from substantially perpendicular to the first pocket base. In some embodiments, the sidewall of at least one of the first and second transitions is rounded to avoid forming an angled corner at at least one of the first and second transitions. In some embodiments, the first width of the first transition and the second width of the second transition are substantially within the range of 0.5 mm to 2.0 mm. In some embodiments, the first width of the first transition is greater than the second width of the second transition. In some embodiments, the first width of the first transition is less than the second width of the second transition. In some embodiments, the method includes disposing a conductive contact in the first adjacent region or in the second adjacent region.In some embodiments, the method includes disposing an analyte sensor having a first electrode and a second electrode on a housing, and electrically connecting one of the first electrode and the second electrode with a conductive contact.

[0041] In some embodiments, the method includes disposing a post in a first adjacent region or in a second adjacent region, disposing an epoxy on the post, and disposing a portion of the analyte sensor in the epoxy disposed on the post. In some embodiments, the epoxy exerts a centering force on the portion of the analyte sensor disposed therein such that the analyte sensor is aligned substantially along a centerline of the post. In some embodiments, the post has a substantially symmetrical shape about the centerline of the post.

[0042] In some embodiments, the method includes forming a pocket base with a first surface energy and forming a first adjacent region base with a second surface energy different from the first surface energy. In some embodiments, the method includes forming a second adjacent region base having one of the second surface energy and a third surface energy different from the first and second surface energies.

[0043] In some embodiments, the method includes forming a third adjacent region abutting the first pocket, the third adjacent region having a third adjacent region base positioned at a height lower than a top surface of a sidewall of the first pocket and a third transition between the top surface of the sidewall of the first pocket and the third adjacent region base. In some embodiments, epoxy disposed in the first pocket adheres to the third transition and inhibits the epoxy from creeping into the third adjacent region. In some embodiments, the third adjacent region is configured to receive at least an excess portion of the epoxy disposed in the first pocket, thereby inhibiting the epoxy from creeping into at least one of the first and second adjacent regions.

[0044] According to some embodiments, a method for manufacturing an analyte sensing device is provided. The method includes forming a housing. The housing includes: a first pocket having a first pocket base; a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base; a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base; and conductive contacts disposed in the first adjacent region or the second adjacent region. The method includes disposing an electronics assembly substrate in the housing and electrically coupling the electronics assembly substrate to the conductive contacts. The method includes disposing an analyte sensor including at least one electrode in electrical communication with the conductive contacts. The method includes disposing epoxy on the first pocket base, the epoxy securing at least a portion of the analyte sensor to the first pocket base.

[0045] In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at a height greater than that of the first pocket base. In some embodiments, the epoxy forms an upwardly bending meniscus at at least one of the first and second transitions, the height being greater than the height of the upwardly bending meniscus. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at the same height as the first pocket base. In some embodiments, at least one of the first adjacent region base and the second adjacent region base is disposed at a lower height than that of the first pocket base. In some embodiments, the epoxy forms a downwardly bending meniscus at at least one of the first and second transitions. In some embodiments, the epoxy adheres to at least one of the first and second transitions and inhibits the epoxy from creeping into at least one of the first and second transitions.

[0046] According to some embodiments, a method of manufacturing an analyte sensing device is provided. The method includes forming a housing, the housing including an opening defining a cavity having a first portion and a second portion within the housing. The method includes disposing a first heat-sealable thermoplastic elastomer along a periphery of the first portion of the cavity. The method includes disposing at least a portion of an analyte sensor within the first portion of the cavity. The method includes fitting a cap over or within the opening and over the first portion of the cavity, the cap including a second heat-sealable thermoplastic elastomer along at least a portion of the cap disposed over a boundary between the first and second portions of the cavity. The method includes melting the first and second heat-sealable thermoplastic elastomers, thereby sealing the first portion of the cavity from moisture ingress.

[0047] In some embodiments, the boundary between the first and second portions of the cavity comprises a first heat-sealable thermoplastic elastomer portion.

[0048] According to some embodiments, a method of manufacturing an analyte sensing device is provided. The method includes forming a housing including an opening defining a housing cavity within the housing. The method includes disposing a first conductive contact and a second conductive contact within the housing cavity. The method includes disposing a first electrode of an analyte sensor on the first conductive contact. The method includes disposing a second electrode of the analyte sensor on the second conductive contact. The method includes providing a cap. The cap includes a base and a sealing material including a first cavity and a second cavity. The method includes fitting the cap onto or within the opening such that the sealing material at least partially fills the void within the housing cavity and presses against the housing, the first cavity aligns over the first electrode and the first conductive contact, and the second cavity aligns over the second electrode and the second conductive contact.

[0049] In some embodiments, the method includes disposing a first conductive elastomer puck in the first cavity and a second conductive elastomer puck in the second cavity before fitting the cap over or into the opening. The first conductive elastomer puck is configured to press against the first electrode and the first conductive contacts when the cap is fitted over or into the opening, thereby securing the first electrode to the first conductive contacts. The second conductive elastomer puck is configured to press against the second electrode and the second conductive contacts when the cap is fitted over or into the opening, thereby securing the second electrode to the second conductive contacts.

[0050] In some embodiments, the first and second conductive elastomer pucks have a substantially cylindrical shape. In some embodiments, the base of the cap further includes at least a first hole laterally aligned with the first cavity and a second hole laterally aligned with the second cavity, and at least a portion of the encapsulation material physically isolates the first hole from the first cavity and physically isolates the second hole from the second cavity. In some embodiments, the method includes injecting a conductive epoxy through the first hole and through a portion of the encapsulation material into the first cavity, thereby electrically connecting the first electrode to the first conductive contact, and injecting a conductive adhesive through the second hole and through a portion of the encapsulation material into the second cavity, thereby electrically connecting the second electrode to the second conductive contact. In some embodiments, the first and second cavities have a substantially conical shape.

[0051] It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art from this disclosure, and that various configurations of the subject technology have been shown and described by way of example. As will be understood, the subject technology is capable of other different configurations, and its several details can be modified in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive. [Brief explanation of the drawings]

[0052] The present embodiments will now be described in detail, with an emphasis on highlighting advantageous features. These embodiments are for illustrative purposes only and are not to scale, instead emphasizing the principles of the present disclosure. These drawings include the following figures, in which like numerals refer to like parts:

[0053] [Figure 1] FIG. 1 is a schematic diagram of an analyte sensor system attached to a host and in communication with multiple exemplary devices, according to some embodiments. [Figure 2] FIG. 2 is a block diagram illustrating electronics associated with the sensor system of FIG. 1, according to some embodiments. [Figure 3A] 1 illustrates a wearable device having an analyte sensor, according to some embodiments. [Figure 3B] 1 illustrates a wearable device having an analyte sensor, according to some embodiments. [Figure 3C] 1 illustrates a wearable device having an analyte sensor, according to some embodiments. [Figure 3D] 1 illustrates an example implementation of an elongated sensor connected to a potentiostat. [Figure 4A] 1 illustrates a schematic diagram of a pre-connected analyte sensor system according to some embodiments. [Figure 4B] FIG. 1 illustrates another schematic diagram of a pre-connected analyte sensor system according to some embodiments. [Figure 4C] 1 illustrates a hierarchical diagram of a pre-connected analyte sensor system, according to some embodiments. [Figure 4D] 1 illustrates a schematic diagram of an array of pre-connected analyte sensor systems according to some embodiments. [Figure 5A] FIG. 1 illustrates a perspective view of a wearable sensor assembly, according to some embodiments. [Figure 5B] FIG. 1 illustrates a perspective view of a wearable sensor assembly, according to some embodiments. [Figure 5C] FIG. 1 illustrates an exploded view of components of a wearable sensor assembly, according to some embodiments. [Figure 6A] FIG. 1 illustrates a perspective view of an embodiment of a wearable assembly having a sensor directly connected to an electronics assembly board where the sensor electronics are located, according to some embodiments. [Figure 6B] 6B shows a plan view of the bottom of the wearable assembly of FIG. 6A according to some embodiments. [Figure 6C] 6B shows a side cross-sectional view of the wearable assembly of FIG. 6A according to some embodiments. [Figure 7A] 1 illustrates a perspective view of a cap for sealing an opening in a housing of a wearable assembly, according to some embodiments. [Figure 7B] 7B illustrates another perspective view of the cap of FIG. 7A, according to some embodiments. [Figure 7C] 7A and 7B positioned over an opening in a housing of a wearable assembly, according to some embodiments. [Figure 7D] 7A-7C are perspective views of the cap of FIGS. 7A-7C positioned flush or slightly recessed within the opening of the housing, according to some embodiments. [Figure 8A] 1 illustrates a plan view of a two-part patch for securing a wearable assembly to the skin of a host, according to some embodiments. [Figure 8B]10A-10C illustrate a top view of a cap, such as the cap described in connection with FIGS. 7A-7D, 9 and / or 10, coupled to a patch for securing a wearable assembly to the skin of a host, according to some embodiments. [Figure 8C] 1 illustrates a plan view of a patch configured to function as a cap for securing a wearable assembly to the skin of a host, similar to the caps described in connection with FIGS. 7A-7D, 9 and / or 10, in accordance with some embodiments. [Figure 8D] 8A illustrates a cap, such as the caps described in connection with FIGS. 7A-7D, 9 and / or 10, and a plan view of a portion of the patch of FIG. 8A configured to adhere the wearable assembly to the skin of a host, according to some embodiments. [Figure 9] 1 illustrates a side cross-sectional view of a cap for sealing an opening in a housing of a wearable assembly, according to some embodiments. [Figure 10] FIG. 1 illustrates a perspective view of a cap including a pre-connected sensor and configured to seal an opening in a housing of a wearable assembly, according to some embodiments. [Figure 11A] 1A-1C illustrate side and top views of a first type of sensor flexure, according to some embodiments. [Figure 11B] 10A-10C illustrate side and top views of a second type of sensor flexure, according to some embodiments. [Figure 11C] 10A-10C illustrate side and top views of a third type of sensor flexure, according to some embodiments. [Figure 12] 11B illustrates a side cross-sectional view of an example of the first type of sensor flexure of FIG. 11A, according to some embodiments. [Figure 13] 11B illustrates a side cross-sectional view of another example of the first type of sensor flexure of FIG. 11A, according to some embodiments. [Figure 14A] 11C illustrates a plan view of an example of the second type of sensor flexure of FIG. 11B, according to some embodiments. [Figure 14B]14B illustrates a side cross-sectional view of the example of FIG. 14A. [Figure 15] 11C illustrates a side cross-sectional view of another example of the second type of sensor flexure of FIG. 11B, according to some embodiments. [Figure 16A] 11C illustrates a first cross-sectional side view of yet another example of the second type of sensor flexure of FIG. 11B, according to some embodiments. [Figure 16B] 16B illustrates a second cross-sectional side view of FIG. 16A taken along section line BB', according to some embodiments. [Figure 17] 11D illustrates a plan view of an example of the third type of sensor flexure of FIG. 11C, according to some embodiments. [Figure 18] 11D illustrates a plan view of another example of the third type of sensor flexure of FIG. 11C, according to some embodiments. [Figure 19] 11D illustrates a plan view of yet another example of the third type of sensor flexure of FIG. 11C, according to some embodiments. [Figure 20] 11D illustrates a plan view of yet another example of the third type of sensor flexure of FIG. 11C, according to some embodiments. [Figure 21A] FIG. 1 illustrates a top view of a portion of a wearable assembly comprising multiple dams forming multiple wells to contain and prevent unwanted bleeding or migration of epoxy, according to some embodiments. [Figure 21B] 21B illustrates a side cross-sectional view of a portion of the wearable assembly of FIG. 21A taken along section line AA', according to some embodiments. [Figure 21C] 21B illustrates another cross-sectional side view of the portion of the wearable assembly of FIG. 21A taken along section line BB', according to some embodiments. [Figure 21D] 21B illustrates another side cross-sectional view of the portion of the wearable assembly of FIG. 21A taken along section line CC', according to some embodiments. [Figure 22]10A-10C illustrate perspective views of multiple pockets having various shapes for securing sensors utilizing epoxy in combination with step-up, step-down, or flush transitions of various widths to prevent the epoxy from bleeding into adjacent areas, according to some embodiments. [Figure 23] 23A-23C illustrate plan views of various exemplary shapes for the pocket of FIG. 22, according to some embodiments. [Figure 24] 22A-22C illustrate side views of a set of exemplary step-up transitions as seen along section line A-A' in FIG. 22, an exemplary flush transition as seen along section line B-B' in FIG. 22, and an exemplary step-down transition as seen along section line C-C' in FIG. 22, in accordance with some embodiments. [Figure 25] 25A-25C illustrate side views of another set of transitions of FIG. 24 as seen along section lines AA', BB', and CC' of FIG. 24, according to some embodiments. [Figure 26] 1 illustrates photographs of top views of exemplary first and second arrays of epoxidation pockets combined with step-up and step-down transitions to adjacent regions, according to some embodiments. [Figure 27] 22-26 illustrate plan and side cross-sectional views of an arrangement that utilizes pockets and adjacent areas similar to those described in connection with FIGS. 22-26 to secure sensors directly to an electronics substrate assembly, and further utilizes posts to center the sensors, according to some embodiments. [Figure 28A] FIG. 1 illustrates a perspective view of a wearable assembly having sensors directly connected to an electronics assembly board, according to some embodiments. [Figure 28B] 28B illustrates an exploded perspective view of the wearable assembly of FIG. 28A further including a passivation layer deposited on at least a portion of the electronics assembly substrate and the sensor. [Figure 28C] 28C illustrates an exploded perspective view of the wearable assembly of FIG. 28B further including a hermetic sealant disposed on the passivation layer. [Figure 29]1 illustrates a side cross-sectional view of a wearable assembly comprising an electronics assembly substrate having multiple passivation layers and conductive trace layers deposited in series thereon, according to some embodiments. [Figure 30A] 1 illustrates a top view of a wearable assembly having a heat-sealable thermoplastic elastomer and a mating cap having a heat-sealable thermoplastic elastomer, according to some embodiments. [Figure 30B] 30B illustrates a side cross-sectional view of the wearable assembly of FIG. 30A along section line A-A' with a mating cap positioned for securing to the wearable assembly, according to some embodiments. [Figure 31] 1 illustrates a side cross-sectional view of a wearable assembly and an overmolded cap, according to some embodiments. [Figure 32] 1 illustrates a side cross-sectional view of a wearable assembly and another overmolded cap, according to some embodiments. [Figure 33] 1 illustrates a flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 34] 10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 35] 10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 36] 10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 37] 10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 38]10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 39] 10 illustrates another flowchart of example operations that may be performed to manufacture and use an analyte sensor directly connected to a transmitter circuit board, according to some embodiments. [Figure 40A] 1 illustrates a perspective view of a pocket and a step-down transition to an adjacent region having a different surface energy than the pocket to prevent epoxy from bleeding into the adjacent region, according to some embodiments. [Figure 40B] 1 illustrates a perspective view of a pocket and a flush transition to an adjacent area having a different surface energy than the pocket to prevent epoxy from bleeding into the adjacent area, according to some embodiments. [Figure 41] 1 illustrates a side cross-sectional view of a pocket having a step-down transition to an adjacent region and further including an additional step-down transition to an additional adjacent region to prevent epoxy from bleeding into the adjacent region, according to some embodiments.

[0054] Like numbers refer to like elements throughout. Elements are not to scale unless otherwise noted. DETAILED DESCRIPTION OF THE INVENTION

[0055] The following description and examples illustrate in detail some exemplary implementations, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that there are many variations and modifications of the invention that are encompassed by its scope. Therefore, the description of a particular exemplary embodiment should not be considered as limiting the scope of the invention.

[0056] definition To facilitate understanding of the various embodiments described herein, several terms are defined below.

[0057] The term "analyte," as used herein, is a broad term and is to be given its ordinary and customary meaning to those skilled in the art (not limited to any special or customized meaning), and further refers to, but is not limited to, a substance or chemical constituent in a bodily fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine) that may be analyzed. Analytes may include naturally occurring substances, man-made substances, metabolites, or reaction products. In some embodiments, the analyte for measurement by the sensor head, devices, and methods is an analyte. However, other analytes are considered as well, including acarboxyprothrombin, acylcarnitines, adenine phosphoribosyltransferase, adenosine deaminase, albumin, α-fetoprotein, amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), andrenostenedione, antipyrine, arabinitol enantiomers, arginase, benzoylecgonine (cocaine), biotinidase, biopterin, c-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β-hydroxycholic acid, cortisol, creatine kinase, creatine kinase MM isoenzyme, cyclosporin A, and D-penicillin. Lamin, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylation polymorphism), alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus , HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sex differentiation, 21-deoxycortisol), desbutylhalofantrine, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte protoporphyrin, esterase D, fatty acids / acylglycines, free β-human chorionic gonadotropin, free erythrocyte porphyrin,Free thyroxine (FT4), free tri-iodothyronine (FT3), fumarylacetoacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, analyte-6-phosphate dehydrogenase, glutathione, glutathione peroxidase, glycocholate, glycosylated hemoglobin, halofantrine, hemoglobin variants, hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-α-hydroxyprogesterone, hypoxanthine phosphoribosyltransferase, immunoreactive trypsin, lactate, Lead, lipoproteins ((a), B / A-1, β), lysozyme, mefloquine, netilmicin, phenobarbitone, phenytoin, phytanic acid / pristanic acid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase, quinine, inverted tri-iodothyronine (rT3), selenium, serum pancreatic lipase, sisomicin, somatomedin C, specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, guinea worm, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia lamblia duodenalisa), Helicobacter pylori, Hepatitis B virus, Herpes virus, HIV-1, IgE (atopic disease), Influenza virus, Leishmania donovani, Leptospirosis, Measles / Mumps / Rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerciasis volvulus, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma cruzi / Langer, Vesicular stomatitis virus virus), Wuchereria bancrofti, Yellow fever virus), specific antigens (Hepatitis B virus, HIV-1), acetoacetate, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, leukocytes, and zinc protoporphyrin.The present invention is not limited to the above. Salts, sugars, proteins, fats, vitamins, and hormones naturally occurring in blood or interstitial fluid may also constitute analytes in certain embodiments. Analytes, such as metabolites, hormones, antigens, antibodies, etc., may naturally occur in bodily fluids. Alternatively, analytes, such as contrast agents for diagnostic imaging, radioisotopes, chemical agents, fluorocarbon-based artificial blood, or drugs or pharmaceutical compositions may be introduced into the body, including insulin, glucagon, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons), cocaine (crack cocaine), stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine), depressants (barbiturates, methaqualone, tranquilizers, Examples include, but are not limited to, Valium, Librium, Miltown, Serax, Equanil, Tranxene), hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil), designer drugs (fentanyl, meperidine, amphetamine, methamphetamine, and phencyclidine analogs, e.g., Ecstasy), anabolic steroids, and nicotine. Metabolites of drugs and pharmaceutical compositions are also contemplated as analytes. For example, analytes such as neurochemicals and other chemicals produced in the body, such as ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA), may be analyzed.

[0058] As used herein, the term "microprocessor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a computer system, state machine, or the like that performs arithmetic and logical operations using logic circuitry that responds to and processes the basic instructions that drive the computer.

[0059] As used herein, the term "calibration" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers, without limitation, to a process of determining a relationship between sensor data and corresponding reference data that can be used to convert the sensor data into a meaningful value substantially equivalent to the reference data, with or without utilizing the reference data in real time. In some embodiments, i.e., analyte sensors, the calibration can be updated or recalibrated over time (at the factory, in real time and / or retrospectively) as changes in the relationship between the sensor data and the reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, etc.

[0060] As used herein, the terms "calibrated data" and "calibrated data stream" are broad terms that have their ordinary and customary meaning given to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, data that has been transformed from its raw state to another state using a function, e.g., a transformation function, including through the use of sensitivities, to provide a meaningful value to a user.

[0061] As used herein, the term "algorithm" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a computational process (e.g., a program) involved in transforming information from one state to another, for example, using computer processing.

[0062] As used herein, the term "sensor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a component or region of a device that quantifies an analyte. A "lot" of sensors generally refers to a group of sensors manufactured on or about the same day and using the same processes and tools / materials. Additionally, sensors that measure temperature, pressure, etc. may be referred to as "sensors."

[0063] As used herein, the terms "glucose sensor" and "component for determining the amount of glucose in a biological sample" are broad terms that are given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings) and refer to, but are not limited to, any mechanism for quantifying glucose (e.g., enzymatic or non-enzymatic). For example, some embodiments utilize a membrane containing glucose oxidase, which catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate, as illustrated by the following chemical reaction: Glucose + O2 → Gluconic acid + H2O2

[0064] For each glucose molecule metabolized, there is a proportional change in the co-reactant O2 and product H2O2, so electrodes can be used to monitor the current change in the co-reactant or product to determine the glucose concentration.

[0065] As used herein, the terms "operably connected" and "operably coupled" are broad terms given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings), and refer, without limitation, to one or more components being coupled to another component in a manner that allows for the transmission of a signal between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal, e.g., an electrical or electromagnetic signal, which can then be transmitted to an electronic circuit. In this case, the electrodes are "operably coupled" to the electronic circuit. These terms are broad enough to include wireless connections.

[0066] The term "determining" encompasses a variety of actions. For example, "determining" may include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, database, or other data structure), checking, etc. "Determining" may also include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc. "Determining" may also include resolving, selecting, choosing, calculating, deriving, establishing, etc. Determining may also include verifying that a parameter matches a predetermined criterion, including meeting, passing, exceeding, etc. a threshold.

[0067] As used herein, the term "substantially" is a broad term having its ordinary and customary meaning given to those of ordinary skill in the art (and is not limited to any special or customized meaning), including, but not limited to, most but not entirely of what is specified.

[0068] As used herein, the term "host" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, mammals, particularly humans.

[0069] As used herein, the term "continuous analyte (or glucose) sensor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a device that continuously or uninterruptedly measures the concentration of an analyte, for example, over a time interval ranging from a fraction of a second to, for example, 1, 2, or 5 minutes or more. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor such as that described in U.S. Patent No. 6,001,067, which is incorporated herein by reference in its entirety.

[0070] As used herein, the term "sensing membrane" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers, without limitation, to a permeable or impermeable membrane that may be composed of two or more domains, typically several microns or more thick, and constructed of materials that are permeable to oxygen and permeable or impermeable to glucose. In one example, the sensing membrane contains immobilized glucose oxidase enzyme, which can cause an electrochemical reaction to occur to measure glucose concentration.

[0071] As used herein, the term “sensor data” is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to any data associated with a sensor, such as a continuous analyte sensor, without limitation. Sensor data includes a raw data stream, or simply a data stream, of an analog or digital signal directly related to the analyte being measured from an analyte sensor (or other signal received from another sensor), as well as calibrated and / or filtered raw data. In one example, sensor data includes digital data of “counts” converted from an analog signal (e.g., voltage or amperes) by an A / D converter and includes one or more data points representing glucose concentrations. Thus, the terms “sensor data point” and “data point” generally refer to a digital representation of sensor data at a particular time. The terms broadly encompass multiple time-interval data points from a sensor, such as a substantially continuous glucose sensor, including individual measurements taken at time intervals ranging from a fraction of a second to, for example, one, two, or five minutes or more. In another example, sensor data includes an integrated digital value representing one or more data points averaged over a period of time. The sensor data may include calibration data, smoothed data, filtered data, conversion data, and / or other data related to the sensor.

[0072] As used herein, the term "sensor electronics" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the components (e.g., hardware and / or software) of a device configured to process data. As described in more detail below (see, e.g., FIG. 2), "sensor electronics" may be arranged and configured to measure, convert, store, transmit, communicate, and / or retrieve sensor data associated with an analyte sensor.

[0073] As used herein, the terms "sensitivity" or "sensor sensitivity" are broad terms given their ordinary and customary meaning to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, the amount of signal produced by a given concentration of the analyte or sample being measured (e.g., HO) associated with the analyte being measured (e.g., glucose). For example, in one embodiment, the sensor has a sensitivity of about 1 to about 300 picoamps of current per 1 mg / dL of glucose analyte.

[0074] As used herein, the term "sample" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to a sample of a host body, e.g., a bodily fluid, including, but not limited to, blood, serum, plasma, interstitial fluid, cerebrospinal fluid, lymphatic fluid, ocular fluid, saliva, oral fluid, urine, excretions, or exudates.

[0075] As used herein, the term "distal to" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that one element is relatively farther from the reference point than another element.

[0076] As used herein, the term "proximal to" is a broad term that is given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that an element is relatively closer to the reference point than another element.

[0077] As used herein, the terms "electrical connection" and "electrical contact" are broad terms that are given their ordinary and customary meaning to those skilled in the art (and are not limited to any special or customized meaning), and refer to, but are not limited to, any connection between two electrical conductors known to those skilled in the art. In one embodiment, an electrode is in electrical connection (e.g., electrically connected) with the electronic circuitry of a device. In another embodiment, two materials, such as, but not limited to, two metals, can be in electrical contact with each other such that current can flow from one of the two materials to the other and / or such that an electrical potential can be applied.

[0078] As used herein, the term "elongated conductor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, an elongated body formed at least in part on a conductive material and including any number of coatings that may be formed thereon. By way of example, "elongated conductive body" may refer to a bare elongated conductive core (e.g., a metal wire), an elongated conductive core coated with one, two, three, four, five, or more layers of material (each of which may or may not be conductive), a trace, and / or an electrode coated thereon with one, two, three, four, five, or more layers of material (each of which may or may not be conductive).

[0079] As used herein, the term "ex vivo portion" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted to reside and / or exist outside the host organism.

[0080] As used herein, the term "in vivo portion" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted for insertion into and / or reside within the body of a host.

[0081] As used herein, the term "potentiostat" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, an electrical device that controls the potential between a working electrode and a reference electrode at one or more preset values.

[0082] As used herein, the term "processor module" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, computer systems, state machines, processors, components thereof, and the like, designed to perform arithmetic or logical operations using logic circuitry that responds to and processes the basic instructions that drive a computer.

[0083] As used herein, the term "sensor session" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, the period from implantation of a sensor (e.g., by a host) until removal of the sensor (e.g., removal of the sensor from the host's body and / or removal of (e.g., disconnection from) the system electronics).

[0084] As used herein, the terms "substantial" and "substantially" are broad terms that are to be given their ordinary and customary meaning to those skilled in the art (and are not to be limited to any special or customized meaning), and refer to, but are not limited to, a sufficient amount to provide a desired function.

[0085] "Coaxial two-conductor based sensor": A round wire sensor consisting of a conductive central core, an insulating middle layer, and a conductive outer layer with an exposed conductive layer at one end for electrical contact.

[0086] "Pre-connected sensor": A sensor that has a "sensor interconnect / interposer / sensor carrier" connected to it. This "pre-connected sensor" therefore comprises two parts that are joined together: the sensor itself and the interconnect / interposer / sensor carrier. The term "pre-connected sensor" unit refers to the unit formed by the permanent joining of these two different parts.

[0087] Other definitions are provided within the description that follows and, in some cases, from the context of the use of a term.

[0088] As used herein, the following abbreviations apply: Eq and Eq (equivalent), mEq (milliequivalent), M (mole), mM (millimole), μM (micromole), N (normal), mol (mole), mmol (millimole), μmol (micromole), nmol (nanomole), g (gram), mg (milligram), μg (microgram), Kg (kilogram), (liter), mL (milliliter), dL (deciliter), μL (microliter), cm (centimeter), mm (millimeter), μm (micrometer), nm (nanometer), h and hr (hour), min. (minute), s and sec (second), °C (Celsius) °F (Fahrenheit), Pa (pascal), kPa (kilopascal), MPa (megapascal), GPa (gigapascal), Psi (pounds per square inch), kPsi (pounds per square inch).

[0089] System Overview / Overview In vivo analyte sensing techniques may rely on in vivo sensors, which may include an elongated conductive body having one or more electrodes, such as a working electrode and a reference electrode.

[0090] For example, a tantalum wire coated with platinum metal may be used as a bare core sensing element with one or more reference or counter electrodes for an analyte sensor. This sensing element is then coated with a membrane to obtain the final sensor.

[0091] According to some embodiments, described herein are pre-connected sensors that include an analyte sensor (also referred to herein as a "sensor interposer") mounted on a sensor carrier. The analyte sensor may include a working electrode and a reference electrode at a distal end of an elongated conductive body. The sensor carrier may include circuitry such as a substrate, one or more electrical contacts coupled to one or more electrical contacts of the sensor, and one or more additional or external electrical contacts for coupling the one or more electrical contacts coupled to the sensor contacts to external equipment such as a membrane dip coating station, a testing station, a calibration station, or sensor electronics of a wearable device. In some embodiments, the substrate may be referred to as an inter-body.

[0092] Further described herein, according to some other embodiments, is a sensor that includes a working electrode and a reference electrode at the distal end of an elongate conductor and that is mounted directly to a transmitter circuit board or substrate without the use of such a sensor carrier as described above. Utilizing a sensor that is mounted and / or electrically connected directly to a transmitter circuit board or substrate without the use of such a sensor carrier can allow for a more streamlined manufacturing process that may include fewer steps and / or reduce manufacturing costs compared to embodiments that utilize a sensor pre-connected to a sensor carrier.

[0093] The following description and examples describe the present embodiments with reference to the drawings, in which reference numbers label elements of the present embodiments, and these reference numbers are reproduced below in connection with a discussion of the features of the corresponding drawings.

[0094] Sensor System 1 illustrates an exemplary system 100 according to some exemplary implementations. The system 100 includes an analyte sensor system 101 including sensor electronics 112 and an analyte sensor 138. The system 100 may include other devices and / or sensors, such as a medication pump 102 and a glucose meter 104. The analyte sensor 138 may be physically connected to the sensor electronics 112 and may be integral with (e.g., permanently attached to) or removably attached to the sensor electronics. For example, in some embodiments, the continuous analyte sensor 138 may be connected to the sensor electronics 112 through a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics. In some other embodiments, the continuous analyte sensor 138 may be directly connected to the sensor electronics 112 without utilizing a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics. The sensor electronics 112 , medication pump 102 , and / or glucose meter 104 may be coupled to one or more devices, such as display devices 114 , 116 , 118 , and / or 120 .

[0095] In some example implementations, system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and / or other patient-related data) provided over network 409 (e.g., via wired, wireless, or a combination thereof) from sensor system 101 and other devices, such as display devices 114, 116, 118, and / or 120, associated with a host (also referred to as a patient), and generate reports providing high-level information, such as statistics, regarding analytes measured over a particular time frame. A detailed description of the use of cloud-based analyte processing systems may be found in U.S. Patent Application No. 13 / 788,375, entitled "Cloud-Based Processing of Analyte Data," filed March 7, 2013, published as U.S. Patent Application Publication No. 2013 / 0325352, which is incorporated herein by reference in its entirety. In some implementations, one or more steps of the factory calibration algorithm may be executed in the cloud.

[0096] In some example implementations, the sensor electronics 112 may include electronic circuitry associated with measuring and processing data generated by the analyte sensor 138. This generated analyte sensor data may include algorithms that can be used to process and calibrate the analyte sensor data, although these algorithms may be provided in other ways. The sensor electronics 112 may include hardware, firmware, software, or a combination thereof that provides a measurement of the level of an analyte via an analyte sensor, such as a glucose sensor. Example implementations of the sensor electronics 112 are further described below with respect to FIG. 2. In one implementation, the factory calibration algorithms described herein may be executed by the sensor electronics.

[0097] As mentioned above, sensor electronics 112 may be coupled (e.g., wirelessly, etc.) with one or more devices, such as display devices 114, 116, 118, and / or 120. Display devices 114, 116, 118, and / or 120 may be configured to present (and / or alert) information, such as sensor information, transmitted by sensor electronics 112 for display on display devices 114, 116, 118, and / or 120. In one implementation, the factory calibration algorithms described herein may be performed, at least in part, by the display devices.

[0098] In some example implementations, the relatively small key fob-like display device 114 may comprise a watch, a belt, a necklace, a pendant, jewelry, an adhesive patch, a pager, a key fob, a plastic card (e.g., a credit card), an identification (ID) card, and / or the like. This small display device 114 may include a relatively small display (e.g., smaller than the large display device 116) and may be configured to display a particular type of displayable sensor information, such as a numeric value, an arrow, or a color code.

[0099] In some example implementations, the relatively large handheld display device 116 may include a handheld receiver device, a palmtop computer, etc. This large display device may include a relatively large display (e.g., larger than the small display device 114) and may be configured to display information such as a graphical representation of sensor data, including current and historical sensor data, output by the sensor system 100.

[0100] In some example implementations, the analyte sensor 138 may comprise a glucose sensor configured to measure glucose in blood or interstitial fluid using one or more measurement techniques, such as enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, colorimetric, iontophoretic, radiometric, immunochemical, etc. In implementations in which the analyte sensor 138 includes a glucose sensor, the glucose sensor may comprise any device capable of measuring the concentration of glucose and may measure glucose using a variety of techniques, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring), to provide data, such as a data stream indicative of the glucose concentration in the host. The data stream may be sensor data (raw and / or filtered) that can be converted into a calibrated data stream used to provide glucose values ​​to a host, such as a user, patient, or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual interested in the health of the host). Additionally, the analyte sensor 138 may be implanted as at least one of the following types of analyte sensors: an implantable glucose sensor, a transcutaneous glucose sensor implanted within a host's blood vessel or externally, a subcutaneous sensor, a refillable subcutaneous sensor, and an intravascular sensor.

[0101] While the disclosure herein refers to some implementations that include an analyte sensor 138 comprising a glucose sensor, the analyte sensor 138 may include other types of analyte sensors as well. Also, while some implementations refer to the glucose sensor as an implantable glucose sensor, other types of devices capable of detecting the concentration of glucose and providing an output signal representative of the glucose concentration may also be used. Furthermore, while the description herein refers to glucose as the analyte to be measured, processed, etc., other analytes may also be used, including, for example, ketone bodies (e.g., acetone, acetoacetate, and beta-hydroxybutyrate, lactate, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, citric acid cycle intermediates, choline, insulin, cortisol, testosterone, etc.

[0102] In some manufacturing systems, sensors 138 are manually sorted, placed, and held in fixtures. These fixtures are then manually moved from station to station during manufacturing for various process steps, including interfacing with electrical measurement equipment for test and calibration operations. However, manual manipulation of sensors can be inefficient, can cause delays due to non-ideal mechanical and electrical connections, risks damage to the sensors and / or test and calibration equipment, and can introduce sensor variability that contributes to inaccurate validation data collected during manufacturing. Additionally, the process of packaging sensors 138 with sensor electronics 112 into a wearable device involves additional manual manipulation of the sensors, which can damage the sensors 138.

[0103] Identification and other data associated with each sensor, if utilized, may be stored in a sensor carrier for logging and tracking of each sensor during manufacturing, testing, calibration, and in vivo operation. After testing and calibration operations, the sensor carrier may be used to connect the sensor to the sensor electronics of a wearable device, such as an on-skin sensor assembly, in a sealed, electrically robust arrangement. In embodiments not incorporating such a sensor carrier, the sensor may be connected directly to the sensor electronics of the wearable device (e.g., to the sensor electronics printed circuit board).

[0104] 2 shows example electronics 112 that may be used in sensor electronics 112 or implemented in a manufacturing station, such as a test station, calibration station, smart carrier, or other equipment used during the manufacture of device 101, according to some example implementations. Sensor electronics 112 may include electronic components configured to process sensor information, such as sensor data, and generate converted sensor data and displayable sensor information, for example, via a processor module. For example, the processor module may convert the sensor data into one or more of the following: filtered sensor data (e.g., one or more filtered analyte concentration values), raw sensor data, calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, acceleration / deceleration information, sensor diagnostic information, position information, alarm / alert information, calibration information as may be determined by a factory calibration algorithm, smoothing and / or filtering algorithms disclosed herein, and / or the like.

[0105] In some embodiments, processor module 214 is configured to accomplish a significant portion, if not all, of the data processing, including data processing related to factory calibration. Processor module 214 may be integral with sensor electronics 112 and / or may be located remotely, such as in one or more of devices 114, 116, 118, and / or 120 and / or in cloud 490. For example, in some embodiments, processor module 214 may be located at least partially within cloud-based analyte processor 490 or elsewhere in network 409.

[0106] In some example implementations, processor module 214 may be configured to calibrate the sensor data, and data storage memory 220 may store the calibrated sensor data points as transformed sensor data. In some example implementations, processor module 214 may also be configured to wirelessly receive calibration information from display devices, such as devices 114, 116, 118, and / or 120, to enable calibration of sensor data from sensor 138. Furthermore, processor module 214 may be configured to perform additional algorithmic processing on the sensor data (e.g., calibrated and / or filtered data and / or other sensor information), and data storage memory 220 may be configured to store the transformed sensor data and / or sensor diagnostic information associated with the algorithms. Processor module 214 may further be configured to store and use calibration information determined from factory calibration, as described below.

[0107] In some example implementations, sensor electronics 112 may include an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222. ASIC 205 may further include potentiostat 210, a telemetry module 232 for transmitting data from sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and / or 120, and / or other components for signal processing and data storage (e.g., processor module 214 and data storage memory 220). While FIG. 2 illustrates ASIC 205, other types of circuitry may be used as well, including a field-programmable gate array (FPGA), one or more microprocessors configured to provide some (if not all) of the processing performed by sensor electronics 12, analog circuitry, digital circuitry, or a combination thereof.

[0108] 2 , through a first input port 211 for sensor data, the potentiostat 210 is coupled to an analyte sensor 138, such as a glucose sensor, to generate sensor data from the analyte. The potentiostat 210 may be coupled to a working electrode 211 and a reference electrode 212 that form part of the sensor 138. The potentiostat may provide a voltage to one of the electrodes 211, 212 of the analyte sensor 138 to bias the sensor for measurement of a value (e.g., current) of an analyte concentration (also referred to as the analog portion) in the host. The potentiostat 210 may have one or more connections to the sensor 138, depending on the number of electrodes (such as a counter electrode as a third electrode) incorporated in the analyte sensor 138.

[0109] In some exemplary implementations, the potentiostat 210 may include a resistor that converts current values ​​from the sensor 138 into voltage values, and in some exemplary implementations, a current-to-frequency converter (not shown) may be configured to continuously integrate measured current values ​​from the sensor 138 using, for example, a charge counting device. In some exemplary implementations, an analog-to-digital converter (not shown) may digitize the analog signal from the sensor 138 into so-called "counts" for processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.

[0110] The telemetry module 232 may be operatively connected to the processor module 214 and may provide hardware, firmware, and / or software that enables wireless communication between the sensor electronics 112 and one or more other devices, such as a display device, a processor, a network access device, etc. Various wireless technologies that may be implemented in the telemetry module 232 include Bluetooth, Bluetooth Low-Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access technology, radio frequency (RF), infrared (IR), paging network communication, magnetic induction, satellite data communication, spread spectrum communication, frequency hopping communication, near field communication, and / or the like. In some example implementations, the telemetry module 232 includes a Bluetooth chip, although Bluetooth technology may also be implemented in a combination of the telemetry module 232 and the processor module 214.

[0111] The processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data (e.g., counts) from the sensors, filter the data, calibrate the data, perform fail-safe checks, and / or the like.

[0112] The potentiostat 210 may measure the analyte (eg, glucose, etc.) at discrete time intervals or continuously using, for example, a current-to-voltage or current-to-frequency converter.

[0113] The processor module 214 may further include a data generator (not shown) configured to generate data packages for transmission to devices such as display devices 114, 116, 118, and / or 120. Additionally, the processor module 214 may generate data packets for transmission to these external sources via the telemetry module 232. In some example implementations, the data packages may include identifier codes for the sensors and / or sensor electronics 112, raw data, filtered data, calibrated data, rate of change information, trend information, error detection or correction, and / or the like.

[0114] The processor module 214 may also include a program memory 216 and other memory 218. The processor module 214 may be coupled to a communication interface, such as a communication port 238, and a power source, such as a battery 234. Additionally, the battery 234 may be further coupled to a battery charger and / or regulator 236 to provide power to the sensor electronics 112 and / or charge the battery 234.

[0115] The program memory 216 may be implemented as a semi-static memory for storing data such as identifiers (e.g., sensor identifiers (IDs)) of the coupled sensors 138, and for storing code (also referred to as program code) for configuring the ASIC 205 to perform one or more operations / functions described herein. For example, the program code may configure the processor module 214 to process and filter data streams or counts, perform calibration methods described below, perform fail-safe checks, etc.

[0116] The memory 218 may also be used to store information. For example, the processor module 214, including the memory 218, may be used as a system cache memory, where temporary storage is provided for recent sensor data received from the sensors. In some example implementations, the memory may comprise memory storage components such as read-only memory (ROM), random access memory (RAM), dynamic RAM, static RAM, non-static RAM, electrically erasable programmable read-only memory (EEPROM), rewritable ROM, flash memory, etc.

[0117] The data storage memory 220 may be coupled to the processor module 214 and may be configured to store various sensor information. In some example implementations, the data storage memory 220 stores one or more days' worth of analyte sensor data. The stored sensor information may include one or more of the following: timestamps, raw sensor data (one or more raw analyte concentration values), calibrated data, filtered data, converted sensor data, and / or other displayable sensor information, calibration information (e.g., reference BG values ​​and / or previous calibration information, such as from a factory calibration), sensor diagnostic information, etc.

[0118] The user interface 222 may include one or more buttons 224, a liquid crystal display (LCD) 226, a vibrator 228, an audio transducer (e.g., a speaker) 230, a backlight (not shown), and / or the like. The components that make up the user interface 222 may provide controls for interacting with a user (e.g., a host).

[0119] A battery 234 may be operably connected to the processor module 214 (and possibly other components of the sensor electronics 112) and provide the necessary power for the sensor electronics 112. In other implementations, the receiver may be powered transcutaneously, for example, via inductive coupling.

[0120] The battery charger and / or regulator 236 may be configured to receive energy from an internal and / or external charger. In some example implementations, the battery 234 (or batteries) is configured to be charged via an inductive and / or wireless charging pad, although other charging and / or power mechanisms may also be used.

[0121] One or more communication ports 238, also referred to as external connectors, may be provided to enable communication with other devices. For example, a PC communication (com) port may be provided to enable communication with systems separate from or integrated with the sensor electronics 112. The communication port may comprise, for example, a serial (e.g., Universal Serial Bus or "USB") communication port to enable communication with another computer system (e.g., a PC, a personal digital assistant or "PDA," a server, etc.). In some example implementations, factory information may be sent from sensors or cloud data sources to the algorithm.

[0122] The one or more communication ports 238 may further include an input port 237 that can receive calibration data and an output port 239 that can be used to transmit calibration data or calibration data to a receiver or mobile device. Figure 2 illustrates these aspects schematically. It will be appreciated that the ports may be physically separated, although in alternative implementations, a single communication port may provide the functionality of both a second input port and an output port.

[0123] In some analyte sensor systems, the on-skin portion of the sensor electronics may be simplified to minimize the complexity and size of the on-skin electronics, for example, to provide raw, calibrated, and / or filtered data to a display device configured to perform calibration and other algorithms necessary for displaying the sensor data. However, the sensor electronics 112 (e.g., via the processor module 214) may also be implemented to execute predictive algorithms used to generate transformed sensor data and / or displayable sensor information. The predictive algorithms may, for example, evaluate baseline clinical acceptability and / or sensor data, evaluate calibration data for optimal calibration based on inclusion criteria, evaluate the quality of the calibration, compare estimated analyte values ​​corresponding to measured analyte values ​​over time, analyze variability in estimated analyte values, assess the stability of the sensor and / or sensor data, detect signal artifacts (noise), replace signal artifacts, determine rate of change and / or trends in sensor data, perform dynamic and intelligent analyte value estimation, perform diagnostics on the sensor and / or sensor data, set operating modes, evaluate the data for anomalies, and / or the like.

[0124] 3A, 3B, and 3C illustrate an exemplary implementation of the analyte sensor system 101 implemented as a wearable device, such as on-skin sensor assemblies 500, 600. As shown in FIG. 3, the on-skin sensor assembly includes a housing 128. An adhesive patch 126 can couple the housing 128 to the skin of a host. The adhesive 126 can be a pressure-sensitive adhesive (e.g., acrylic, rubber, or other suitable type) bonded to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for attachment to the skin. The housing 128 can include a through-hole 180 that cooperates with a sensor insertion device (e.g., a sensor insertion needle, not shown) used to implant the sensor 138 under the skin of a subject.

[0125] The wearable sensor assembly 500, 600 can include sensor electronics 112 (e.g., as at least part of the electronics module 135) operable to measure and / or analyze a glucose indicator sensed by a glucose sensor 138. The sensor electronics 112 in the electronic unit 500, 600 can transmit information (e.g., measurements, analyte data, and glucose data) to a remotely located device (e.g., 114, 116, 118, 120 shown in FIG. 1). As shown in FIG. 3C, in this implementation, the sensor 138 extends from its distal end into a through-hole 180 and is routed to the electronics module 135 in the housing 128. The working electrode 211 and the reference electrode 212 are connected to circuitry in the electronics module 135, including a potentiostat.

[0126] 3D shows an exemplary embodiment of an analyte sensor 138 including an elongated body portion. The elongated body portion may be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than about 0.1 inches, less than about 0.075 inches, less than about 0.05 inches, less than about 0.025 inches, less than about 0.01 inches, less than about 0.004 inches, or less than about 0.002 inches. While the elongated conductive body is shown here as having a circular cross-section, in other embodiments, the cross-section of the elongated conductive body may be oval, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, etc.

[0127] In the implementation of FIG. 3D , the analyte sensor 138 comprises a wire core 139. At a distal in vivo portion of the sensor 138, the wire core 139 forms an electrode 211 a. At a proximal ex vivo portion of the sensor 138, the wire core 139 forms a contact 211 b. The electrode 211 a and the contact 211 b are in electrical communication along the length of the wire core 139 as the wire core 139 extends along the elongated body portion of the sensor 138. The wire core can be made from a single material, such as platinum or tantalum, or may be formed as multiple layers, such as a conductive or non-conductive material with an outer coating of a different conductive material.

[0128] Layer 104 surrounds at least a portion of wire core 139. Layer 104 may be formed of an insulating material such as polyimide, polyurethane, parylene, or other known insulating materials. For example, in one embodiment, layer 104 is disposed over wire core 139 and configured such that electrode 211 a is exposed through window 106.

[0129] In some embodiments, the sensor 138 further comprises a layer 141 surrounding the insulating layer 104, such as a sleeve composed of a conductive material. At the distal in vivo portion of the sensor 138, the sleeve layer 141 forms an electrode 212a. At the proximal ex vivo portion of the sensor 138, the sleeve layer 141 forms a contact 212b. The electrode 212a and the contact 212b are in electrical communication along the length of the sleeve layer 141 as the sleeve layer 141 extends along the elongated body portion of the sensor 138. This sleeve layer 141 may be formed from a silver-containing material applied onto the insulating layer 104. The silver-containing material may include any of a variety of materials and may be in a variety of forms, such as, for example, an Ag / AgCl-polymer paste, paint, a polymer-based conductive mixture, and / or a commercially available ink. This layer 141 may be processed using a pasting / dipping / coating step, for example, using a die-metered dip coating process. In one exemplary embodiment, the Ag / AgCl polymer paste is applied to an elongated body by dip-coating the body (e.g., using a meniscus coating technique), then pulling the body through a die to meter the coating to a precise thickness. In some embodiments, multiple coating steps are used to build the coating to a predetermined thickness.

[0130] The sensor 138 shown in FIG. 3D also includes a membrane 108 covering at least a portion of the distal in vivo portion of the sensor 138. This membrane is typically formed of multiple layers, which may include one or more of an interference domain, an enzyme domain, a diffusion resistance domain, and a bioprotective domain. This membrane is important for supporting the electrochemical process that enables analyte detection and is typically meticulously fabricated by dip coating, spraying, or other manufacturing steps. The distal in vivo portion of the sensor 138 preferably receives as little handling as practical from the time the membrane 108 is formed until the time the distal in vivo portion of the sensor 138 is implanted in a subject. In some embodiments, electrode 211a forms the working electrode of an electrochemical measurement system, and electrode 212a forms the reference electrode of the system. During use, both electrodes may be implanted within a host for analyte monitoring.

[0131] While the above description is particularly applicable to coaxial wire-type structures, the embodiments herein are also applicable to other physical electrode configurations. For example, two electrodes 211a and 212a can be fixed to a distal in vivo portion of an elongated flexible strip of a planar substrate, such as a thin, flat polymer flex circuit. Two contacts 211b and 212b can be fixed to a proximal ex vivo portion of the flexible planar substrate. Electrodes 211a and 212a can be electrically connected to their respective contacts 211b and 212b through circuit traces on the planar substrate. In this case, electrodes 211a and 212a and contacts 211b and 212b can be adjacent to each other on a flat surface rather than being coaxial, as shown in FIG. 3D.

[0132] In some other embodiments, the two contacts 211b and 212b may be directly bonded to one or more contacts and / or traces of the sensor electronics 112 (see Figures 1 and 2) without utilizing such a flexible strip of the planar substrate, as described in more detail below.

[0133] Also shown in Figure 3D is a diagrammatic representation of contacts 211b and 212b electrically coupled to a simple current-to-voltage converter type potentiostat 210. The potentiostat includes a battery 320 having an output coupled to the input of an operational amplifier 322. The output of operational amplifier 322 is coupled to contact 324, which is electrically coupled to working electrode contact 211b through resistor 328. Amplifier 322 couples contact 324 to a battery voltage V b and the current i required to maintain that bias m This current flows from the working electrode 211a through the interstitial fluid surrounding the sensor 138 to the reference electrode 212a. The reference electrode contact 212b is electrically coupled to another contact 334 that is connected to the other side of the battery 320. In this circuit, the current i m is (V b -V m ) / R, where V m is the voltage measured at the output of amplifier 322. The magnitude of this current for a given bias on the working electrode 211a is a measure of the analyte concentration near window 106.

[0134] Contacts 324 and 334 are typically conductive pads / traces on a circuit board. During testing, the surface of this board always has a certain level of parasitic leakage current i pIf possible, this leakage current should not form part of the measurement of the current due to the analyte. To reduce the effect of this leakage current on the measured current, an optional additional pad / trace 336 may be provided between the bias contact 324 and the return contact 334, which is connected directly to the battery output. This optional additional pad / trace is sometimes referred to as a "guard trace." Because they are held at the same potential, leakage current from the bias contact 324 and the guard trace 336 is not particularly significant. Furthermore, leakage current from the guard trace 336 to the return contact 334 does not pass through the amplifier output resistor 328 and is therefore not included in the measurement. Additional aspects and implementations of guard traces may be found in paragraphs

[0128] and

[0129] of U.S. Patent Publication No. 2017 / 0281092, which is incorporated herein by reference.

[0135] During manufacturing, various coating, testing, calibration, and assembly operations are performed on sensor 138. However, transporting individual sensors and electrically interfacing the sensors to and from multiple test and calibration equipment installations can be challenging. These processes can also subject the sensors to handling damage. To help address these issues, sensor 138 may be provided as part of a pre-connected sensor that includes a sensor carrier, described in more detail below in connection with at least FIGS. 4A-4D and 5A-5C.

[0136] However, such pre-connected sensor embodiments may require additional manufacturing steps that may undesirably increase manufacturing costs. Accordingly, in some other embodiments, at least a portion of sensor 138, e.g., contacts 211b and 212b, may be coupled directly to one or more contacts and / or traces of sensor electronics 112 (e.g., at least a portion of electronics module 135, see FIGS. 1 and 2), without utilizing a sensor carrier, as described in more detail below in connection with at least FIGS. 6A-6C, thereby reducing the number of manufacturing steps and reducing manufacturing complexity and / or cost.

[0137] Sensors pre-connected to a sensor carrier FIG. 4A shows a schematic diagram of a pre-connected sensor 400. As shown in FIG. 4A, the pre-connected sensor 400 includes a sensor carrier 402 permanently attached to the sensor 138. In the example of FIG. 4A, the sensor carrier 402 includes an intermediate body, such as a substrate 404, and also includes one or more contacts, such as a first internal contact 406 and a second internal contact 408. The first internal contact 406 is electrically coupled to a first contact at the proximal end of the sensor 138, and the contact internal contact 408 is electrically coupled to a second contact at the proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. The contacts 406 and 408 may correspond to, for example, contacts 324 and 334 of FIG. 3D in some implementations.

[0138] 4A, the first internal contact 406 may be electrically coupled to the first external contact 410, and the second internal contact 408 may be electrically coupled to the second external contact 412. As described in further detail below, the external contacts 410 and 412 may be configured to electrically interface with the sensor electronics 112 within the wearable device 500 (see FIGS. 5A-5C). Additionally, the external contacts 410 and 412 may be configured to electrically interface with processing circuitry of manufacturing equipment, such as one or more test stations and / or one or more calibration stations. While various examples are described herein in which two external contacts 410 and 412 on the sensor carrier are coupled to two corresponding contacts on the sensor 138, this is for illustrative purposes only. In other implementations, the sensor carrier 402 and the sensor 138 may each be provided with a single contact, or may be provided with three or more contacts, e.g., any number N of external contacts on the sensor carrier (e.g., three or more external contacts 410 and 412) and any number M of contacts on the matable sensors 138 (e.g., three or more contacts 406 and 408). In some implementations, the sensor carrier 402 and the sensor 138 may have the same number of contacts (i.e., N=M). In some implementations, the sensor carrier 402 and the sensor 138 may have different numbers of contacts (i.e., N≠M). For example, in some implementations, the sensor carrier 402 may have additional contacts for coupling to or between various components of a manufacturing station.

[0139] As described in more detail below, the substrate 404 may be configured to couple with the sensor electronics 112 of the wearable device 500. In some embodiments, the substrate 404 may be sized and shaped to mechanically interface with the housing 128 and electrically interface with the sensor electronics 112 within the housing 128. Additionally, the substrate 404 may be sized and shaped to mechanically interface with manufacturing equipment, assembly equipment, a test station, and / or one or more calibration stations. As described in more detail below, the sensor carrier 402 may be attached to and / or electrically coupled to the sensor 138. The sensor 138 may be permanently bonded to a component of the sensor carrier 402 (e.g., the substrate 404) by using, for example, an adhesive (e.g., UV-cured, moisture-cured, multi-part activated, heat-cured, hot melt, etc.) including a conductive adhesive (e.g., carbon-filled, carbon nanotube-filled, silver-filled, conductive additives, etc.), conductive ink, spring contacts, clips, wrapped flexible circuits, conductive polymers (e.g., conductive elastomers, conductive plastics, carbon-filled PLA, conductive graphene PLA), conductive foams, conductive fabrics, barrel connectors, molded interconnect device structures, sewing, wire wrapping, wire bonding, wire threading, spot welding, swaging, crimping, stapling, clipping, soldering or brazing, plastic welding, or overmolding. In some embodiments, the sensor 138 may be permanently coupled to the substrate 404 by rivets, magnets, anisotropic conductive film, metal foil, or other suitable structures or materials for mechanically and electrically attaching the sensor carrier 402 to the sensor 138 before or during assembly, manufacturing, testing, and / or calibration operations. While the above-described attachment techniques for the sensor 138 are described in connection with the use of the sensor carrier 402, the present disclosure also contemplates the use of any of the above-described techniques for directly attaching the sensor 138 to an electronics assembly board, such as electronics assembly board 630, as described in more detail in connection with FIGS. 6A-6C below.

[0140] In some embodiments, the sensor carrier 402 may be 3D printed around the sensor 138 to form a pre-connected sensor 400. Additionally, the sensor carrier 402 may include a datum feature 430 (sometimes referred to as a datum structure), such as a recess, opening, surface, or protrusion, for aligning, positioning, and orienting the sensor 138 relative to the sensor carrier 402. The sensor carrier 402 may also include or form one or more fastening features for securing and aligning the analyte sensor during manufacturing (e.g., relative to a manufacturing station). Additionally, the sensor carrier 402 may include an identifier 450 configured to identify the sensor. In some embodiments, the identifier 450 is formed on the substrate 404. The identifier 450 is described further below.

[0141] FIG. 4B shows another schematic diagram of a preconnected analyte sensor 400. The preconnected analyte sensor 400 shown in FIG. 4B may include similar components to the preconnected analyte sensor 400 shown in FIG. 4A. FIG. 4B is shown without the optional cover 460 for clarity. FIG. 4C shows an exploded view of the preconnected analyte sensor 400 shown in FIG. 4B.

[0142] In the example of FIG. 4B , the sensor carrier 402 includes an intermediate body, such as a substrate 404, and also includes one or more traces, such as a first trace 414 and a second trace 416. The first trace 414 may include a first internal contact 406 and a first external contact 410. The second trace 416 may include a second internal contact 408 and a second external contact 412. In some embodiments, the first internal contact 406 is electrically coupled to a first contact at the proximal end of the sensor 138, and the second internal contact 408 is electrically coupled to a second contact at the proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. The electrical coupling may include a clip, a conductive adhesive, a conductive polymer, a conductive ink, a metal foil, a conductive foam, a conductive cloth, wire wrapping, wire threading, or any other suitable method. In some embodiments, a non-conductive adhesive 426 (e.g., epoxy, cyanoacrylate, acrylic, rubber, urethane, hot melt, etc.) can be used to attach the sensor 138 to the substrate 404. The non-conductive adhesive 426 can be configured to secure, seal, insulate, or provide strain relief for the sensor 138. The sensor 138 can be attached to the substrate 404 by other methods, such as those described in FIG. 4A above.

[0143] As shown in FIG. 4C , the pressure-sensitive adhesive 428 can be configured to isolate the exposed ends of the traces 414 and 416. For example, the pressure-sensitive adhesive 428 may laminate the sensor 138 between the substrate 404 and the cover 460. In such a case, the sensor 138, the substrate 404, the pressure-sensitive adhesive 428, and the cover 460 may form a laminated configuration. In the laminated configuration, the sensor 138 and its connections to one or more contacts (e.g., the first internal contact 406 and the second internal contact 408) are isolated from one or more exposed contacts (e.g., the first external contact 410 and the second external contact 412). Furthermore, the laminated configuration may create a moisture seal region surrounding the sensor 138. The moisture seal may be created as embodied by a combination of the pressure-sensitive adhesive 428 and the non-conductive adhesive 426. In other embodiments, the laminated structure can be made by one or a combination of the following materials and methods: non-conductive adhesive, pressure-sensitive adhesive tape, elastomer, thermal bonding, hot plate welding, laser welding, ultrasonic welding, RF welding, or any suitable type of lamination method. The cover 460 may be comprised of a polymer sheet, structure, or film that at least partially covers the substrate 404. The cover 460 may optionally contain an identifier 450 capable of identifying the sensor 138. In some embodiments, the identifier 450 may incorporate various identification protocols or technologies such as, but not limited to, NFC, RFID, QR code, barcode, Wi-Fi, trimming resistor, capacitance value, impedance value, ROM, memory, IC, flash memory, etc.

[0144] The optional component, guide fixture 420, is an exemplary embodiment of an interface with a work station, such as a test station, calibration station, assembly station, coating station, or manufacturing station, or as part of a wearable assembly. The guide fixture 420 includes a datum feature (or datum structure) 430, such as a recess, opening, surface, or protrusion, for aligning, positioning, and orienting the sensor 138 relative to the sensor carrier 402. The datum feature 430 may be used in manufacturing and for assembly into the wearable electronic component. In some embodiments, the datum feature 430 is a raised protrusion configured to align with a corresponding datum feature 432 on the substrate 404. The corresponding datum feature 432 on the substrate 404 may feature a notch, slot, hole, or recess. The corresponding datum feature 432 in the sensor carrier may be a positioning feature that can interface with the datum feature 430 in a work station, such as a test station, calibration station, assembly station, coating station, or other manufacturing station. Guide fixture 420 may be configured to ensure proper placement of sensor carrier 402 to align exposed external contacts 410 and 412 for connection to a work station, such as a testing station, calibration station, assembly station, coating station, or other manufacturing station. In other embodiments, datum feature 430 may comprise a female feature that mates with a corresponding male datum feature 432.

[0145] FIG. 4D shows a schematic diagram of an array 480 of preconnected analyte sensors 400 having a plurality of preconnected sensors 400 with optional identifiers 450. While FIG. 4D shows an array formed as a one-dimensional strip of preconnected analyte sensors 400, a two-dimensional array can also be embedded. In some embodiments, the array 480 of preconnected analyte sensors can be disposed in a cartridge. Each of the plurality of preconnected sensors 400 can be singulated. In some embodiments, scoring 4020 can be provided to facilitate singulation into individual preconnected sensors 400. In some embodiments, the array 480 can be used individually, serially, or randomly to facilitate manufacturing, testing, and / or calibration of a plurality of sensors 138. In some embodiments, the array 480 can be used simultaneously to facilitate manufacturing, testing, and / or calibration of a plurality of sensors 138.

[0146] 5A and 5B show perspective views of an embodiment of a wearable assembly 500 including a pre-connected sensor 400. The wearable assembly 500 may include sensor electronics and an adhesive patch (not shown). The pre-connected sensor 400 may include a sensor carrier, such as the sensor carrier 402 described in FIGS. 4A-4D. The sensor carrier 402 may be disposed in or on the housing 128. The housing 128 may be composed of two housing components: an upper housing 520 and a lower housing 522. The upper housing 520 and the lower housing 522 can be assembled together to form the housing 128. The upper housing 520 and the lower housing 522 can be sealed to prevent moisture from entering the interior cavity of the housing 128. The sealed housing may include a sealing material (e.g., epoxy, silicone, urethane, or other suitable material). In other embodiments, the housing 128 is formed as a single-component sealing material (e.g., epoxy) configured to contain the sensor carrier 402 and the sensor electronics. 5A illustrates an opening 524 in the upper housing 520 configured to allow an insertion component (e.g., a hypodermic needle, a C-needle, a V-needle, an open-sided needle, etc.) to pass through the wearable assembly 500 for insertion and / or retraction. The opening 524 may be aligned with a corresponding opening in the lower housing 522. In other embodiments, the opening 524 may extend through an off-center position of the housing 128. In other embodiments, the opening 524 may extend through an edge of the housing 128 to form a C-shaped channel. In some embodiments, the opening 524 includes a sealing material, such as a gel, adhesive, elastomer, or other suitable material, disposed within the opening 524.

[0147] FIG. 5B shows a perspective view of the bottom of the wearable assembly 500. As shown, the pre-connected sensor 400 may be disposed within the housing 128. The pre-connected sensor 400 may be placed within an opening 526 (sometimes referred to as an opening, cavity, void, space, or pocket) in the bottom housing 522. As shown, the sensor 138 may extend outward from the opening 526. The opening 526 may be sized and shaped to hold the pre-connected sensor 400. Furthermore, the opening 526 may be sized and shaped to hold the pre-connected sensor 400 such that the sensor 138 extends substantially parallel to the skin surface and forms a 90-degree bend for insertion into the skin. It should be understood that the bottom surface of the lower housing 522 may contain an attachment member (e.g., an adhesive patch) for adhering the wearable assembly to the user's skin surface.

[0148] FIG. 5C shows an exploded view of the wearable assembly 500. Various electronic components, such as the potentiostat 210 and other components shown in FIG. 2, may be mounted on or to an electronics assembly board 530, typically some form of printed circuit board. The sensor carrier 402 is considered to be electrically coupled to the electronics assembly board 530. Various methods may be used to establish an electrical connection (e.g., pins, solder, conductive elastomer, conductive adhesive, etc.) between one or more contacts of the pre-connected sensor 400, such as the external contacts 410 and 412, and the electronics assembly board 530. The sensor carrier 402 may be configured to interface with the electronics assembly board 530 through the lower housing 522. In other implementations, the sensor carrier 402 may be configured to interface with the electronics assembly board 530 through the upper housing 520. In some other implementations, the sensor carrier 402 is configured to interface with the electronics assembly board 530 through a side of the wearable assembly 500. Also, as shown, an optional sealing member 528 may be configured to insulate at least a portion of the sensor carrier 402 from potential moisture intrusion. In some examples, the sealing member 528 may be a dispensed liquid (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 528 may be welded (e.g., laser or ultrasonic, hot plate) or permanently attached (e.g., anisotropic adhesive film, pressure-sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to an assembly to create a sealed region. The sealing member 528 may be used to physically couple and / or provide a sealed region of the sensor carrier 402 to the wearable assembly 500.

[0149] One advantage of the analyte sensor connection techniques described above is that the fabrication of the pre-connected sensor 400 can be separated from the fabrication of the electronics (e.g., electronics assembly board 530) encapsulated within the housing. As described above with reference to the pre-connected sensor structure and subsequent coating, testing, and calibration processes, the housing with the electronics contained therein can be manufactured in a facility separate from the facility where the pre-connected sensor 400 is attached to the sensor electrical interface. This is made possible by providing an analyte sensor electronic interface that is accessible from the exterior of the housing. There is no need to open the housing to attach the sensor.

[0150] In some advantageous methods, pre-connected sensor electrodes are fabricated and attached to a substrate at a first location and shipped to a second location for coating testing and calibration. The housing with integrated electronics is fabricated at a third location. The housing with electronics is then shipped from the third location to a second location where the completed analyte sensor is attached to an external electrical interface. All three locations are remote from one another. This minimizes handling of the sensitive membrane-coated sensor, while allowing other components of the complete device to be manufactured separately.

[0151] Sensors directly connected to the electronics assembly board of the wearable assembly FIG. 6A shows a perspective view of an embodiment of a wearable assembly 600 having a sensor 138 directly connected to an electronics assembly substrate 630 via first conductive contacts 324 and second conductive contacts 334 (see FIGS. 6B and 6C ), on which electronics 112 can be disposed, according to some embodiments. Although not shown in FIG. 6A , the wearable assembly 600 may include an adhesive patch 126. The housing 128 may comprise two housing components: an upper housing 620 and a lower housing 622. The upper housing 620 and the lower housing 622 can be assembled together to form the housing 128. The upper housing 620 and the lower housing 622 can be sealed to prevent moisture ingress into at least one internal cavity of the housing 128. The sealed housing may include a sealing material 628 (e.g., epoxy, silicone, urethane, or other suitable material). In other embodiments, the housing 128 is formed as a single-component encapsulant (e.g., epoxy) configured to contain the sensor 138 and at least a proximal portion of the sensor electronics 112. FIG. 6A illustrates an opening 624 in the upper housing 620 configured to allow an insertion component (e.g., a hypodermic needle, a C-needle, a V-needle, an open-sided needle, etc.) to pass through the wearable assembly 600 for insertion and / or retraction. The opening 624 may be aligned with a corresponding opening (not shown) in the lower housing 622. In other embodiments, the opening 624 may extend through an off-center location in the housing 128. In other embodiments, the opening 624 may extend through an edge of the housing 128, forming a C-shaped channel. In some embodiments, the opening 624 includes a sealing material, such as a gel, adhesive, elastomer, or other suitable material, disposed within the opening 624.

[0152] FIG. 6B shows a plan view of the bottom of the wearable assembly 600, according to some embodiments. As shown, the sensor 138 may be directly connected to the electronics assembly board 630 in the housing 128 via conductive contacts 324, 334, which may extend from the electronics assembly board 630, through a portion of the lower housing 622, and into a cavity in the housing 622 where the electrodes of the sensor 138 are located. The sensor 138 may be located within an opening 626 in the lower housing 622. As shown in FIGS. 6A and 6C , the sensor 138 may extend outward from the opening 626. The opening 626 may be sized and shaped to retain at least a proximal portion of the sensor 138. The sensor 138 may extend approximately parallel to the skin surface and form a 90-degree bend for insertion into the skin. It should be understood that the bottom surface of the lower housing 622 may contain an attachment member (e.g., an adhesive patch 126, not shown) for adhering the wearable assembly to a user's skin surface.

[0153] FIG. 6C shows a side cross-sectional view of the wearable assembly 600 along section line 6C-6C in FIG. 6B , according to some embodiments. Various electronic components, such as the potentiostat 210 and other components illustrated in FIG. 2 , may be mounted on or to an electronics assembly board 630, typically some form of printed circuit board. It is contemplated that the sensor 138 has a direct electrical coupling with the electronics assembly board 630. Various methods may be used to establish an electrical connection (e.g., pins, solder, conductive elastomers, conductive adhesives, etc.) between one or more contacts or electrodes of the sensor 138, such as contacts 211 b and 212 b, and one or more conductive contacts, such as contacts 324, 334, electrically and / or physically coupled to the electronics assembly board 630. The sensor 138 may be configured to interface with the electronics assembly board 630 through the lower housing 622. In other implementations, the sensor 138 may be configured to interface with the electronics assembly board 630 through the upper housing 620. In some other implementations, the sensor carrier 138 is configured to interface with the electronics assembly substrate 630 through a side of the wearable assembly 600. Also, as shown, an optional sealing member 628 may be configured to insulate at least a portion of the sensor 138 from potential moisture intrusion. In some examples, the sealing member 628 may be a dispensed liquid (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 628 may be welded (e.g., laser or ultrasonic, hot plate) or permanently attached (e.g., anisotropic adhesive film, pressure-sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to an assembly part to create a sealed region or cavity. In some embodiments, the sealing member 628 may be used to physically secure or couple at least a portion of the sensor 138 to the wearable assembly 600 and / or to provide a sealed region for at least a proximal portion of the sensor 138.

[0154] One advantage of the above-described analyte sensor connection techniques is that fabrication and / or manufacturing of wearable assembly 600 may require fewer steps compared to embodiments utilizing pre-connected sensor 400 of FIGS. 4A-5C, thereby reducing manufacturing complexity and cost.

[0155] Cap for simultaneous sealing against moisture intrusion and sensor fixation In some embodiments, it may be desirable to seal the sensor 138 and / or sensor electronics 112 (see FIG. 1 and, e.g., electronics module 135 in FIG. 3C ) from the external environment to prevent moisture from seeping into or condensing on such components, as such moisture could cause short circuits, oxidation, or other damage. One such solution may be to fill at least a portion of the cavity in which at least a portion of the sensor 138 is disposed with a sealing sealant. However, care must be taken to ensure that such sealing sealant does not inappropriately flow into other certain portions of the cavity, or such sealing sealant may undesirably block other features of the wearable assembly 600, such as the through-hole 180 for a needle or other sensor insertion member passed through during deployment of the wearable assembly 600. Additionally, the sensor 138 may need to be held in place while such sealing sealant is deployed and / or cured to avoid permanent mispositioning of the sensor 138. For example, applying pressure to a pressure-sensitive adhesive in contact with the sensor 138 may tend to cause the sensor 138 to move, resulting in misalignment. As another example, when using a curing epoxy to set the sensor 138 in place, additional fixtures may be required to datum the sensor 138 in place while the epoxy cures to avoid misalignment.

[0156] Some exemplary solutions for simultaneously holding the sensor 138 in place while ensuring that the sealing sealant does not inappropriately flow into undesired portions of the cavity of the housing 128 are described in more detail in connection with some of the following figures.

[0157] 7A and 7B illustrate perspective views of a cap 700 for sealing the opening 624 in the housing 128, according to some embodiments. Figure 7C illustrates a perspective view of the cap 700 positioned over the opening 626 in the housing 128, according to some embodiments.

[0158] As illustrated in FIG. 7C , the opening 626 in the lower housing 622 forms, provides, or defines a cavity 750 in which the sensor electronics 112 are disposed (e.g., on the electronics assembly board 630). A first portion 752 of the cavity 750 may hold at least a portion of the sensor 138. A second portion 754 of the cavity 750 may include at least the through-hole 180. When properly positioned, the sensor 138 may be in direct electrical contact with the sensor electronics 112 on the electronics assembly board 630, e.g., via the conductive contacts 324, 334, and may have portions disposed within the first portion 752 and the second portion 754 of the cavity 750. As further shown in FIG. 7C , at least a portion of the sensor 138 may be adhered to the housing 622 utilizing any suitable adhesive 724, e.g., a UV-curable adhesive, epoxy, or the like, as described in more detail in connection with the various figures below.

[0159] 7A , cap 700 is configured to cover, fit, or fit over opening 626 of lower housing 622, thereby providing a controlled fill volume within first portion 752 of cavity 750 and simultaneously pressing sensor 138 against the interior surface of cavity 750 and / or lower housing 622, thereby also serving as a datum feature for sensor 138. In some embodiments, cap 700 may comprise a molded part, a die-cut sheet of material, or any other suitable form. In some embodiments, cap 700 may have an adhesive, e.g., a pressure-sensitive adhesive, on one side (not shown) to secure cap 700 in or over opening 626.

[0160] The cap 700 comprises a first portion 710 configured to be disposed over a first portion 752 of the cavity 750 and a second portion 720 configured to be disposed over a second portion 754 of the cavity 750. In some embodiments, the first and second portions 710, 720 of the cap 700 may be coplanar and formed from a single piece. The first portion 710 of the cap 700 may further include a first hole 702 configured as an inlet port for receiving a sealing sealant (e.g., a curable epoxy) into the first portion 752 of the cavity 750 to seal at least a portion of the sensor 138 from moisture. The first portion 710 of the cap 700 may further include a second hole 704 configured as an outlet port for excess sealing sealant injected into the first portion 752 of the cavity 750 through the first hole 702. In some embodiments, the first hole 702 and the second hole 704 may be located near opposite ends of the first portion 710 of the cap 700, thereby providing complete or near-complete filling of the first portion 752 of the cavity 750 with the sealing sealant.

[0161] Cap 700 may further include a sealing dam portion 730 disposed on a side of cap 700 configured to face opening 626. In some embodiments, sealing dam portion 730 may have a height sufficient to allow sealing dam portion 730 to contact the surface of lower housing 622 within cavity 750 when cap 700 is properly positioned in or over opening 626. In some other embodiments, sealing dam portion 730 may have a slightly less height than just described to allow sealing dam portion 730 to nearly contact the surface of lower housing 622 within cavity 750 when cap 700 is properly positioned in or over opening 626.

[0162] Cap 700 may further include an optional ledge 732 disposed adjacent dam portion 730 and configured to receive a conforming component 740 (e.g., a soft, foam, or rubber material; see FIG. 7B ). In some embodiments, ledge 732 may have a height such that a surface of conforming component 740 configured to face opening 626 extends slightly farther from cap 700 than a similarly facing surface of dam portion 730. When cap 700 is properly positioned in or over opening 626, conforming component 740 is configured to press against at least a portion of sensor 138 and against the surface of lower housing 622 within cavity 750. Thus, conforming component 740 datums sensor 138 to the surface of lower housing 622 within cavity 750 in a conforming manner, sealing first portion 752 of cavity 750 from second portion 754 of cavity 750. In some embodiments, dam portion 730 can further assist in sealing first portion 752 of cavity 750 from second portion 754 of cavity 750. Thus, when a sealing sealant is injected into first portion 752 of cavity 750 to seal at least some of sensors 138 from moisture ingress, dam portion 730 and / or mating component 740 prevent the sealing sealant from flowing into second portion 754 of cavity 750, thereby preventing undesired blockage of through-hole 180 while providing assembly tolerances between cap 700, opening 626, and / or lower housing 622.

[0163] The second portion 720 of the cap 700 may further include a slot 722 configured to allow at least a distal portion of the sensor 138 to pass through the cap 700. Utilizing the slot 722 in the cap 700 instead of a circular hole may allow for a smaller through-hole 180 in the wearable assembly 600.

[0164] In some embodiments, the outward-facing surface of cap 700 may be configured to, when properly positioned, fit nominally flush with the outward-facing surface of lower housing 622. Alternatively, the outward-facing surface of cap 700 may be configured to, when properly positioned, fit slightly recessed relative to the outward-facing surface of lower housing 622. In such nominally flush or slightly recessed embodiments, the outer periphery of cap 700 may substantially correspond to the inner periphery of opening 626.

[0165] 7D illustrates a perspective view of cap 700 positioned flush or slightly recessed within opening 626 of housing 128, according to some embodiments. Cap 700 may be held in place while sealing the sealant deposit using a toe feature, a snap feature, a friction fit feature, a pressure-sensitive adhesive, or any other suitable fastening method. In some embodiments, cap 700 may comprise a material that is transparent or sufficiently translucent to ultraviolet radiation to allow for curing of a UV-curable epoxy sealing sealant disposed in first portion 752 of cavity 750.

[0166] In yet another alternative, cap 700 may be configured to cover opening 626 while positioned flush on the outward-facing surface of lower housing 622. In such other alternatives, the outer periphery of cap 700 may be larger than the inner periphery of opening 626 and may have any size and shape up to the outer periphery of lower housing 622 (not shown). In such embodiments, cap 700 may be adhered to the outward-facing surface of lower housing 622 in a portion of lower housing 622 outside the inner periphery of opening 626, which may ultimately help adhere wearable assembly 600 to the flat surface of skin.

[0167] Although the cap 700 is described above as being utilized in connection with a wearable assembly 600 that does not include a pre-connected sensor 400 or sensor carrier 402, the present disclosure is not so limited and the cap 700 may also be utilized with a wearable assembly 500 that includes a pre-connected sensor 400.

[0168] In some embodiments, rather than utilizing a separate adhesive to adhere cap 700 to lower housing 622, the adhesive portion normally utilized to adhere patch 126 to lower housing 622 of wearable assembly 600 may be reused to additionally adhere or otherwise secure cap 700 to lower housing 622 once properly positioned in, on, or above lower housing 622. For example, as shown in FIG. 8A , patch 126 may comprise two portions: a first adhesive portion 802 configured to secure cap 700 to lower housing 622 and simultaneously adhere lower housing 622 of wearable assembly 600 to patch 126, and a second adhesive portion 804 configured to adhere first adhesive portion 802, and thus wearable assembly 600, to the user's skin.

[0169] 8B illustrates the outward-facing surface of cap 700 secured to first adhesive portion 802. First adhesive portion 802 may include an opening or hole configured to align with first and second holes 702, 704 of cap 700 and through-hole 180 of wearable assembly 600 when cap 700 is properly positioned, flush, or recessed over opening 626 of lower housing 622.

[0170] 8C , the cap 700 may be omitted, and the first adhesive portion 802 may include the first and second holes 702, 704, as well as an opening or hole configured to align with the through-hole 180 of the wearable assembly 600 when the first adhesive portion 802 is properly positioned on the lower housing 622. In such an alternative embodiment, the first adhesive portion 802 may further include a mating component 740 having substantially the same functionality as described above in connection with FIGS. 7A-7D . Thus, properly positioning and applying the first adhesive portion 802 on the lower housing 622 causes the mating component 740 to press against at least a portion of the sensor 138 and against the surface of the lower housing 622 within the cavity 750. Thus, the mating component 740 datums the sensor 138 to the surface of the lower housing 622 within the cavity 750 in a mating manner and also seals the first portion 752 of the cavity 750 from the second portion 754 of the cavity 750. Thus, when a sealing sealant is injected into the first portion 752 of the cavity 750 to seal at least a portion of the sensor electronics 112 and the sensor 138 from the ingress of moisture, the mating component 740 prevents the sealing sealant from flowing into the second portion 754 of the cavity 750, thereby preventing undesired blockage of the through-hole 180.

[0171] 8B or 8C is used, the second adhesive portion 804 may first be placed on the liner 806, the liner 806 may be removed, and the second adhesive portion 804 may be separately placed on the outward-facing surface of the first adhesive portion 802 of the patch 126 for later securing the wearable assembly 600 to the user's skin. As shown in FIG. 8D, the second adhesive portion 804 may further include an opening or hole 880b configured to align with the through-hole 180 of the wearable assembly 600 when the second adhesive portion 804 is properly placed on the outward-facing surface of the first adhesive portion 802 of the patch 126.

[0172] FIG. 9 illustrates a cross-sectional side view of an alternative cap 900 from cap 700, according to some embodiments. Like numbers between cap 900 and cap 700 correspond to like features. Cap 900 comprises a first portion 910 configured to be positioned over first portion 752 of cavity 750 in lower housing 622, and a second portion 920. In some embodiments, second portion 920 is configured to be positioned over second portion 754 of cavity 750, which may include through-hole 180 in lower housing 622. In other embodiments, second portion 920 is configured to be positioned adjacent to second portion 754 of cavity 750. First portion 910 includes a first hole 902 configured as an inlet port for receiving a hermetic sealant (e.g., epoxy) into first portion 752 of cavity 750 to seal at least a portion of sensor 138 from moisture ingress. The first portion 910 of the cap 900 may further include a second hole 904 configured as an exit port for excess sealing sealant that is injected into the first portion 752 of the cavity 750 through the first hole 902. In some embodiments, the first hole 902 and the second hole 904 may be located near opposite ends of the first portion 910 of the cap 900, thereby providing complete or near-complete filling of the first portion 752 of the cavity 750 with the sealing sealant.

[0173] Cap 900 may further include a sealing dam portion 930. Unlike cap 700, however, the first and second portions 910, 920 of cap 900 are not coplanar; instead, sealing dam portion 930 may comprise at least a portion of cap 900 extending between and connecting the planes of first and second portions 910, 920. Thus, at least a portion of second portion 920 positioned adjacent dam portion 930 may also function as a ledge 932 configured to receive a conforming component 940 (e.g., a soft, foam, or rubber material). When cap 900 is properly positioned in or over opening 626, conforming component 940 is configured to press against at least a portion of sensor 138 and against a surface of lower housing 622 within cavity 750. Thus, mating component 940 datums sensor 138 to the surface of lower housing 622 within cavity 750 in a mating manner and also seals first portion 752 of cavity 750 from second portion 754 of cavity 750, with or without the aid of dam portion 930. Thus, when a sealing sealant is injected into first portion 752 of cavity 750 to seal at least a portion of sensor 138 from moisture ingress, dam portion 930 and / or mating component 940 prevent the sealing sealant from flowing into second portion 754 of cavity 750, thereby preventing undesired blockage of through-hole 180 while providing assembly tolerances between cap 900, opening 626, and / or lower housing 622.

[0174] 9, second portion 920 of cap 900 may further include a slot, similar to slot 722 of cap 700, configured to allow at least a distal portion of sensor 138 to pass through cap 900 when cap 900 is properly positioned. Alternatively, in some embodiments in which second portion 920 of cap 900 does not extend transversely to through-hole 180, such a slot may be omitted.

[0175] Although the cap 900 is described above as being utilized in connection with a wearable assembly 600 that does not include a pre-connected sensor 400, the present disclosure is not so limited and the cap 900 may also be utilized with a wearable assembly 500 that includes a pre-connected sensor 400 and a sensor carrier 402.

[0176] In some embodiments, it may be advantageous to attach or couple the sensor 138 to the cap prior to assembly of the wearable assembly 600, and to provide one or more pairs of mating contacts on the cap and the wearable assembly 600 for connecting the sensor to the electronics of the wearable assembly 600 (e.g., sensor electronics 112) when the cap is properly placed in the lower housing 622 of the wearable assembly 600.

[0177] FIG. 10 illustrates a perspective view of a cap 1000 with a pre-attached sensor 138, according to some embodiments. Similar to the description above in connection with FIG. 8B, FIG. 10 illustrates the cap 1000 with an outward-facing side adhered to the patch 126. The cap 1000 includes a through-hole 1080 configured to align with the through-hole 180 of the wearable assembly 600 when the cap 1000 is properly placed in the lower housing 622. The sensor 138 may be glued or otherwise secured to the top surface of the cap 1000 such that a distal portion of the sensor 138 passes through the through-hole 1080 and away from the cap 1000. The cap 1000 further includes a first trace 1022 and a second trace 1032. The first trace 1022 is configured to electrically connect the contact 211b of the sensor 138 to a first contact 1024 on the cap 1000. The second trace 1032 is configured to electrically connect the contact 212b of the sensor 138 to a second contact 1034 on the cap 1000. As shown in the figure, the lower housing 622 is illustrated as having a plurality of contacts, e.g., contacts 324 and 334, disposed on its outwardly facing surface. The first and second contacts 1022 and 1024 are configured to make direct electrical and physical contact with the respective contacts 324 and 334 when the cap 1000 is properly placed on the lower housing 622, thereby electrically coupling the sensor 138 to the sensor electronics 112. The cap 1000 may be glued, adhered, or otherwise attached to the lower housing 622 utilizing any suitable means.

[0178] Use of sensor flexures to position and hold sensors on PCBs Due to the small size of the sensor 138 and constraints on acceptable handling positions along its length, establishing proper alignment of the sensor 138 on the wearable assembly 600 can be challenging, especially without a carrier or handle attached to the sensor 138 prior to integration with the electronics assembly board 630, especially when the sensor 138 has a substantially cylindrical or otherwise at least partially rounded shape. Additionally, the natural curvature of the sensor 138, which can be difficult to straighten, can cause the sensor 138 to undergo undesired movement when handled. The utilization of a single pre-bend in the distal region of the sensor 138 is of limited utility in preventing such undesired movement when placing the sensor 138 within the wearable assembly 600 due to the proximity of the single pre-bend to the needle penetration hole 180 and the membrane 108. Accordingly, several solutions utilizing the sensor bent shape to assist in the lateral and rotational positioning of the sensor 138 relative to the electronics assembly board 630 (e.g., transmitter PCB) are described below in connection with at least FIGS. 11A-20 .

[0179] The utilization of such bends, kinks, loops, and / or curves in the sensor 138, established by one or more pre-forming steps, provides retention functionality for the sensor 138 at points sufficiently distant to provide support, restraint, bias force, and / or positioning of the sensor 138 relative to features on the wearable assembly 600 and / or electronics assembly substrate 630. These shapes may also be desirably utilized to increase leakage current paths between electrodes on the sensor 138 by utilizing longer insulating areas and / or by bending the sensor 138 such that the resulting distance between electrode pads is increased compared to a straight, unbent, or single-bent sensor 138. Additionally, intentionally bending the sensor 138 at multiple points along its length can create a more manageable shape that can mimic a flat surface against which the sensor 138 can rest. Additionally, as described in more detail below, the elastic properties of the sensor 138 can be leveraged to create a biasing or holding force against one or more features of the electronics assembly substrate 630 and / or housing 622, thereby holding the sensor 138 in place prior to the application of subsequent mechanical features and / or adhesives.

[0180] 11A-11C separately illustrate three primary types of flexing in sensor 138, according to some embodiments. While embodiments are described for sensor 138 in relation to electronics assembly board 630, the present disclosure also contemplates similar embodiments for sensor 138 in relation to lower housing 622. For example, at least a portion of lower housing 622 may physically separate electronics assembly board 630 from the portion of lower housing 622 through which at least a portion of sensor 138 extends, where sensor 138 is described as contacting, extending in a particular direction, or applying a force or torque to a surface of electronics assembly board 630 (see, e.g., at least FIGS. 6A-7D and 9 ), and the present disclosure additionally and / or alternatively contemplates such contact, direction of extension, and / or application of a force or torque to a surface of lower housing 622.

[0181] 11A illustrates a side view and a top view of a first type of sensor flexure 1102a in which the sensor 138 is bent such that the portion of the sensor 138 proximal to the electronics assembly board 630 extends in a direction toward the wearable assembly 600, e.g., so that the proximal portion of the sensor 138 extends through the electronics assembly board 630. FIG. 11B illustrates a side view and a top view of a second type of sensor flexure 1102b in which the sensor 138 is bent such that the portion of the sensor 138 proximal to the electronics assembly board 630 extends in a direction away from the wearable assembly 600, e.g., so that the proximal portion of the sensor 138 extends away from the electronics assembly board 630. FIG. 11C illustrates side and top views of a third type of sensor flexure 1102c in which the sensor 138 is bent such that the portion of the sensor 138 proximal to the electronics assembly board 630 does not extend toward or away from the wearable assembly 600, but is substantially stretched parallel to the plane of the electronics assembly board 630 to which it is attached and / or electrically connected.

[0182] Several examples of each type of sensor flexure are described below, although the present disclosure contemplates any and all combinations of such examples, with or without additional flexure and / or sensor 138 features. Additionally, while embodiments are generally described as relating to a wearable assembly 600 that does not include a pre-connected sensor 400, the present disclosure is not so limited, and such embodiments may be utilized with a wearable assembly 500 that includes a pre-connected sensor 400 and sensor carrier 402. Several exemplary embodiments of a first type of sensor flexure, such as that illustrated in FIG. 11A, will now be described in connection with FIGS. 12 and 13 below.

[0183] 12 shows a side cross-sectional view of an exemplary configuration including a sensor flexure 1202 that extends a proximal portion of a sensor 138 through an electronics assembly board 630, according to some embodiments. FIG. 12 illustrates a lower housing 622 of a wearable assembly 600, an electronics assembly board 630 disposed on the lower housing 622, and a sensor 138 including multiple flexures 1202, 1204 disposed on and mechanically and electrically coupled to the electronics assembly board 630.

[0184] While electronics assembly substrate 630 is illustrated as including a PCB material such as FR4, the present disclosure is not so limited and any suitable PCB material is contemplated. Electronics assembly substrate 630 further includes a plurality of electrical contacts, e.g., contacts 324, 334, as described above in connection with at least FIG. 3D. While contact 324 is illustrated in FIG. 12 as a conductive plated through-hole, the present disclosure is not so limited and any other suitable contact is contemplated.

[0185] The sensor 138 is illustrated as having a first bend 1202 at a proximal portion of the sensor 138 and a second bend 1204 at an inner or distal portion of the sensor 138 such that the portion of the elongated body of the sensor 138 distal to the first bend 1202 extends substantially parallel to the plane of the electronics assembly board 630 and the portion of the elongated body proximal to the first bend 1202 extends substantially perpendicular to and through the plane of the electronics assembly board 630. In some embodiments, the first bend 1202 may be approximately a 90° bend. However, the present disclosure is not so limited and the first bend 1202 may have any suitable bend angle. In some embodiments, the first bend 1202 occurs along the working electrode contact 211b such that at least a portion of the contact 211b passes through the through-hole contact 324, thereby establishing mechanical positioning of the sensor 138 before a conductive connection (e.g., epoxy, solder, or the like) is applied, for example, to electrically connect contacts 211b and 324 and to electrically connect contacts 212b and 334.

[0186] Additionally, in some embodiments, the lower housing 622 may further comprise a molded shape including one or more features configured to support the electronics assembly board 630 and / or the sensor 138 at or near the second bend 1204. For example, the electronics assembly board 630 can be configured to rest on a portion of the lower housing 622. The lower housing 622 may further comprise one or more ridges, recesses, or surfaces 1212, 1214 configured to abut one or more respective edges (e.g., lateral edges) of the electronics assembly board 630. Among other benefits, the one or more ridges, recesses, or surfaces 1212, 1214 provide more precise positioning of the electronics assembly board 630 with respect to the lower housing 622.

[0187] Additionally and / or alternatively, the lower housing 622 may include a recess 1216 directly below the plated-through-hole contact 324 that allows a proximal portion of the sensor 138 to extend through the electronics assembly board 630, and in some cases, at least partially into the recess 1216. Among other advantages, the recess 1216 provides additional assembly tolerance for positioning the sensor 138 on the electronics assembly board 630.

[0188] Additionally and / or alternatively, the lower housing 622 can include a notch 1218 configured to align an inner and / or distal portion of the sensor 138 at, near, or adjacent to the second bend 1204. Among other benefits, the notch 1218 provides additional alignment and limits undesired movement of the sensor 138 before and / or after securing the sensor 138 to the electronics assembly board 630 and / or the lower housing 622.

[0189] In some embodiments, a first type of flexure (e.g., substantially parallel to substantially perpendicular to the plane of the electronics assembly substrate 630 and through the plane of the electronics assembly substrate 630) may be utilized to intentionally utilize the elastic properties of the sensor 138 to generate a bias or holding force against one or more features of the electronics assembly substrate 630 and / or the wearable assembly 600.

[0190] 13, for example, shows a side cross-sectional view of an exemplary arrangement including a first sensor flexure 1302 extending a proximal portion of the sensor 138 through the electronics assembly board 630 while simultaneously presenting a bias force against the electronics assembly board 630, according to some embodiments. The electronics assembly board 630 is shown with contacts 324, which may be conductive plated through-holes, as described above in connection with FIG. 12, or alternatively, may be planar plated contacts at least partially surrounding the illustrated through-holes in the electronics assembly board 630, or conductive pins or posts configured to extend through the lower housing 622 to reach connection portions of the sensor 138, as described above in connection with at least FIGS. 6A-9. The contacts 334 may similarly comprise such conductive pins or posts.

[0191] The sensor 138 is illustrated as having a first bend 1302 at a proximal portion of the sensor 138 and a second bend 1204 at an inner or distal portion of the sensor 138, as described above in connection with FIG. 12. The first bend 1302 may transition the direction of extension of the proximal portion of the sensor 138 from substantially in-plane with respect to the electronics assembly substrate 630 to a substantially angled through-plane with respect to the electronics assembly substrate 630 at a desired angle (e.g., 1-179°) such that at least some of the proximal portion of the sensor 138 contacts and exerts a biasing force against a portion of the electronics assembly substrate 630 (e.g., a sidewall of a through-hole). This causes the sidewalls of the through-hole to exert an equal but opposite bias force on the proximal portion of sensor 138, thereby securing sensor 138 in a desired orientation and position before conductive connections (e.g., epoxy, solder, or the like) are applied between the proximal portion of sensor 138 and contacts 324, and between or to appropriate portions of sensor 138 and contacts 334.

[0192] Some exemplary embodiments of the second type of sensor flexure, as illustrated in FIG. 11B, will now be described in connection with FIGS. 14A-16 below. FIG. 14A shows a top view of an exemplary configuration including a sensor flexure 1402 that extends a proximal portion of the sensor 138 away from (e.g., out of plane with) the electronics assembly board 630, according to some embodiments. FIG. 14B illustrates a side cross-sectional view of the arrangement of FIG. 14A. The following description refers to both figures. The figures illustrate a lower housing 622 of a wearable assembly 600, an electronics assembly board 630 disposed on or alternatively within the lower housing 622, and a sensor 138 including multiple flexures 1402, 1204 disposed on and electrically coupled to the electronics assembly board 630.

[0193] The electronics assembly substrate 630 may include a PCB material such as FR4, although the present disclosure is not so limited and any suitable PCB material is contemplated. The electronics assembly substrate 630 further includes a plurality of electrical contacts, e.g., contacts 324, 334, as described above in connection with at least FIG.

[0194] The sensor 138 is illustrated as having a first bend 1402 at a proximal portion of the sensor 138 and a second bend 1204 at an inner or distal portion of the sensor 138, as described above in connection with FIG. 12. The portion of the elongate body of the sensor 138 distal to the first bend 1302 extends substantially parallel to the plane of the electronics assembly board 630, and the portion of the elongate body proximal to the first bend 1302 extends substantially perpendicular to the plane of the electronics assembly board 630 and extends away from the electronics assembly board 630. In some embodiments, the first bend 1402 occurs along the working electrode contact 211b.

[0195] The lower housing 622 may further comprise a molded shape including one or more features configured to support the electronics assembly board 630 and / or the sensor 138 at or near each of the first bend 1402 and the second bend 1204. For example, the electronics assembly board 630 can be configured to rest on a portion of the lower housing 622. The lower housing 622 may further comprise one or more ridges, recesses, or surfaces 1412, 1414 configured to abut one or more respective edges (e.g., lateral edges) of the electronics assembly board 630. Among other benefits, the one or more ridges, recesses, or surfaces 1412, 1414 provide more precise positioning of the electronics assembly board 630 with respect to the lower housing 622.

[0196] Additionally and / or alternatively, lower housing 622 may include a recess 1416 in a sidewall of lower housing 622 directly adjacent contact 324 that allows a proximal portion of sensor 138 to extend substantially perpendicularly, at least partially within recess 1416, away from and relative to electronics assembly board 630. Among other advantages, recess 1416 establishes mechanical positioning of sensor 138 before, for example, conductive connections (e.g., epoxy, solder, or the like) are applied to electrically connect contacts 211b and 324 and electrically connect contacts 212b and 334.

[0197] Additionally and / or alternatively, the lower housing 622 can include a notch 1418 configured to align an inner and / or distal portion of the sensor 138 at, near, or adjacent to the second bend 1204. Among other benefits, the notch 1418 provides additional alignment and limits undesired movement of the sensor 138 before and after securing the sensor 138 to the electronics assembly board 630 and / or the lower housing 622.

[0198] In some embodiments, a second type of flexure (e.g., substantially parallel to substantially perpendicular to the plane of the electronics assembly board 630 and away from the electronics assembly board 630) may be utilized to intentionally utilize the elastic properties of the sensor 138 to generate a bias or holding force against one or more features of the electronics assembly board 630 and / or lower housing 622. Examples are described below in connection with FIGS. 15 and 16.

[0199] 15 shows a side cross-sectional view of an exemplary arrangement including a sensor flexure 1502 that extends a proximal portion of the sensor 138 away from the electronics assembly board 630 while simultaneously presenting a bias force against the lower housing 622, according to some embodiments. For ease of illustration and explanation, contacts on the sensor 138 and on the electronics assembly board 630 are not shown.

[0200] Sensor 138 is illustrated as having a first bend 1502 at a proximal portion of sensor 138 and a second bend 1204 at an inner or distal portion of sensor 138, as described above in connection with FIG. 12. First bend 1502 may transition the direction of extension of the proximal portion of sensor 138 from substantially in-plane with respect to electronics assembly board 630 to a plane that is substantially at no angle with respect to electronics assembly board 630 at a desired angle (e.g., 90-180 degrees) such that at least some of the proximal portion of sensor 138 contacts and exerts a biasing force against a sidewall of lower housing 622, for example, against a sidewall within recess 1416, as described above in connection with FIG. 14. This causes the sidewalls of the lower housing 622 to exert an equal but opposite bias force on the proximal portion of the sensor 138, thereby securing the sensor 138 in a desired orientation and position before conductive connections (e.g., epoxy, solder, or the like) are applied between the proximal portion of the sensor 138 and the contacts 324, and between or to appropriate portions of the sensor 138 and the contacts 334.

[0201] Figure 16A shows a first side view of an exemplary configuration including multiple sensor flexures 1602, 1604, 1606, 1608, 1610, at least some of which induce a bias force against portions of lower housing 622, according to some embodiments. Figure 16B shows a second side view of the exemplary arrangement of Figure 16A taken along section line B-B' of Figure 16A.

[0202] The sensor 138 is illustrated as having a first bend 1602 at a proximal portion of the sensor 138, one or more additional bends 1606, 1608, 1610 proximal to the first bend 1602, and a bend 1204 at an inner or distal portion of the sensor 138 distal to the bends 1602, 1606, 1608, 1610, as described above in connection with FIG. 12 . The first bend 1602 may transition the direction of extension of the proximal portion of the sensor 138 from substantially parallel to the plane of the electronics assembly board 630 to substantially perpendicular to and away from the plane of the electronics assembly board 630 at a desired angle (e.g., approximately 90°). In some embodiments, at least some portion of the sensor 138 proximal to the first bend 1602 may be disposed within a recess in the sidewall of the lower housing 622, for example, the recess 1406 as described above in connection with FIG. 14 .

[0203] 16B , one or more additional bends 1606, 1608, 1610 cause a portion of sensor 138 proximal to first bend 1602 to extend at an angle relative to opposing sidewalls 1622, 1624 of recess 1406. Thus, sensor 138 contacts and exerts a biasing force on sidewalls 1622, 1624 of recess 1406 at least at bends 1606, 1608, 1610. The exertion of such a biasing force by sensor 138 causes sidewalls 1622, 1624 to exert an equal but opposite biasing force on the proximal portion of sensor 138. The result of these bias forces can secure sensor 138 in a desired orientation and position before conductive connections (e.g., epoxy, solder, or the like) are applied between or to appropriate portions of sensor 138 and contacts 324, and between or to other portions of sensor 138 and contacts 334 (not shown in FIGS. 16A-16B). As shown, a bias force F applied perpendicular to the contact points between sensor 138 and sidewalls 1622, 1624 bias is a friction force F in a direction parallel to the side wall 1622 at the contact point between the sensor 138 and the side wall 1622, 1624. friction , resisting movement of the sensor 138 relative to the lower housing 622 and the electronics assembly board 630. Among other benefits, the one or more additional flexures 1606, 1608, 1610 provide additional alignment, limiting unwanted movement or rotation of the sensor 138 before or after securing the sensor 138 to the electronics assembly board 630 and / or lower housing 622, and centerline constraints.

[0204] Some exemplary embodiments of a third type of sensor flexure, as illustrated in Figure 11C, will now be described in connection with Figures 17-20 below. Figure 17 shows a top view of an exemplary configuration including a sensor flexure 1702 that causes a proximal portion of a sensor 138 to remain extending substantially in-plane relative to an electronics assembly substrate 630, according to some embodiments. Figure 17 illustrates an electronics assembly substrate 630 and a sensor 138 including at least a flexure 1702 disposed on and electrically coupled to the electronics assembly substrate 630.

[0205] The electronics assembly substrate 630 may include a PCB material such as FR4, although the disclosure is not so limited and any suitable PCB material is contemplated. The electronics assembly substrate 630 further includes a plurality of electrical contacts, e.g., contacts 324, 334, 336, as described above in connection with at least FIG. 3D. As described above, the contact 336 may include a guard trace.

[0206] The sensor 138 is illustrated as having at least a first bend 1702 at a proximal portion of the sensor 138. The first bend 1702 may transition the direction of extension of the proximal portion of the sensor 138 from substantially in-plane with the electronics assembly substrate 630 by any desired in-plane angle (shown in FIG. 17 as approximately 90°) such that at least a portion of the sensor 138 proximal to the first bend 1702 remains substantially in-plane with the electronics assembly substrate 630. In some embodiments, the first bend 1702 occurs along the insulating layer 104, which in some embodiments may comprise polyurethane or any other suitable electrical insulator. Although not shown in FIG. 17 , the sensor 138 may include any number of additional bends, such as the second bend 1204, at an inner or distal portion of the sensor 138, as described above in connection with FIG. 12 .

[0207] Contact 212b of sensor 138 can be in mechanical and electrical contact with contact 334. Insulation layer 104 can be in mechanical and electrical contact with contact 336. Contact 211b of sensor 138 can be in mechanical and electrical contact with contact 324. Among other advantages, by redirecting at least a first portion of sensor 138 between contacts 211b and 212b to extend in a different in-plane direction, the curvature direction of first bend 1702 compared to a second portion of sensor 138 between contacts 211b and 212b allows contacts 211b, 212b to be separated by a greater linear distance along sensor 138 and, therefore, a greater linear length of insulation layer 104. This may be, at least in part, a function of the limited dimensions of electronics assembly substrate 630 in any one direction. By extending portions of sensor 138 in at least two different in-plane directions relative to electronics assembly substrate 630, contacts 211b, 212b can be separated by a greater linear distance along sensor 138. Additionally, first bend 1702, by extending portions of sensor 138 in at least two different in-plane directions relative to electronics assembly substrate 630, creates a more manageable shape and provides at least three in-plane contacts (e.g., contacts 324, 334, 336) that can mimic a flat surface upon which sensor 138 can rest.

[0208] In some embodiments, a third type of flexure (e.g., one that changes the direction of extension of at least a portion of sensor 138 while remaining substantially in-plane with electronics assembly substrate 630) may be utilized to intentionally utilize the elastic properties of sensor 138 to generate a biasing or holding force against one or more features of electronics assembly substrate 630 and / or wearable assembly 600. Examples are described below in connection with FIGS. 18-20.

[0209] FIG. 18 shows a top view of an exemplary configuration including multiple sensor flexures 1802, 1804, 1806, at least some of which induce a bias force against portions 1822, 1824 of the lower housing 622 or electronics assembly board 630, according to some embodiments.

[0210] The sensor 138 is illustrated as having a first bend 1802 at a proximal portion of the sensor 138 and one or more additional bends 1804, 1806 proximal to the first bend 1802. Although not shown in FIG. 18 , the sensor 138 may further include a bend 1204 at an inner or distal portion of the sensor 138 distal to the bends 1802, 1804, 1806, as described above in connection with FIG. 12 .

[0211] One or more additional flexures 1804, 1806 may be configured to allow the sensor 138 to contact the sidewalls 1822, 1824 at least at the flexures 1804, 1806 to generate a bias force F bias , causing the portion of sensor 138 proximal to first bend 1802 to extend at an angle relative to the opposing sidewalls 1822, 1824 of lower housing 622 and / or electronics assembly board 630 such that sidewalls 1822, 1824 exert an equal but opposite bias force on the proximal portion of sensor 138, thereby securing sensor 138 in a desired orientation and position before conductive connections (e.g., epoxy, solder, or the like) are applied between or at contacts 211 b and 324 or between contacts 211 b and 334 and between or at contacts 212 b and 334.

[0212] Similar to that described above in connection with FIG. 16, a bias force F applied perpendicular to the contact point between the sensor 138 and the side walls 1822, 1824 bias is a friction force F in a direction parallel to the side walls 1822, 1824 at the contact point between the sensor 138 and the side walls 1822, 1824. frictionflexures 1804, 1806, which resist movement of sensor 138 relative to lower housing 622 and electronics assembly board 630. Among other benefits, one or more additional flexures 1804, 1806 provide additional alignment, limiting unwanted movement or rotation and centerline constraints of sensor 138 before and after securing sensor 138 to electronics assembly board 630 and / or lower housing 622.

[0213] FIG. 19 shows a top view of an exemplary configuration including at least one sensor flexure 1902 that substantially immobilizes or anchors the sensor 138 to a portion of the housing 128, such as a pin or post 1912 of the lower housing 622 or the electronics assembly board 630, or to a fabricated portion thereof, in accordance with some embodiments.

[0214] The sensor 138 is illustrated as having a first bend 1902 at a proximal portion of the sensor 138. In some embodiments, the first bend 1902 is an at least partially circumferential bend configured to at least partially wrap the proximal portion of the sensor around a pin or post 1912, which may include a portion of a contact 324, which may be part of the electronics assembly board 630. The first bend 1902 may change the direction of extension of at least a portion of the sensor 138 while remaining substantially in-plane with the electronics assembly board 630.

[0215] Among other advantages, the first bend 1902, which extends at least partially around the circumference or periphery of the pin or post 1912, secures the sensor 138 in a desired orientation and position before a conductive connection (e.g., epoxy, solder, or the like) is applied between or to the contacts 211 b and 324, or between or to the contacts 212 b and 334. Thus, the arrangement of FIG. 19 also provides alignment and limits undesired movement or rotation and centerline constraints of the sensor 138 before and after securing the sensor 138 to the electronics assembly board 630 and / or lower housing 622.

[0216] Although not shown in FIG. 19, the sensor 138 may further include a bend 1204 at an inner or distal portion of the sensor 138 distal to the bends 1902, 1904, 1906, as described above in connection with FIG.

[0217] FIG. 20 shows a top view of an exemplary arrangement including at least one sensor flexure 2002 that induces at least one bias force F1, F2, F3 against one or more portions 2012, 2014, 2016 of the lower housing 622 or electronics assembly board 630, according to some embodiments.

[0218] The sensor 138 is illustrated as having a first bend 2002 at a proximal portion of the sensor 138. The first bend 2002 causes the portion of the sensor 138 proximal to the first bend 2002 to change the direction of extension of at least a portion of the sensor 138 while remaining substantially parallel to the plane of the electronics assembly substrate 630. For example, the first bend 2002 is illustrated as occurring along a portion of the sensor 138 where the insulating layer 104 is present and exposed. However, the present disclosure is not so limited, and the first bend 2002 can occur along any suitable portion of the sensor 138. The first bend 2002 is illustrated as having an angle of less than 90°. However, the present disclosure is not so limited, and any suitable bend angle may be utilized depending on the particular circumstances of the situation and the layout of the particular features of the wearable assembly 600.

[0219] A first portion of the sensor 138 may be configured to contact a first sidewall or other feature 2012 of the lower housing 622 or electronics assembly board 630. In FIG. 20 , this first portion of the sensor 138 is illustrated as part of the reference electrode or contact 212b. However, the disclosure is not so limited, and other portions of the sensor 138 are also contemplated.

[0220] The sensor 138 may be configured to contact a second sidewall or other feature 2014 of the lower housing 622 or electronics assembly board 630 at the location of the first bend 2002 .

[0221] A second portion of the sensor 138 may be configured to contact a third sidewall or other feature 2016 of the lower housing 622 or electronics assembly board 630. In FIG. 20 , this third portion of the sensor 138 is illustrated as part of the working electrode or contact 211b proximal to the first bend 2002. However, the disclosure is not so limited and other portions of the sensor 138 are also contemplated.

[0222] 20 , the contact surface of the first sidewall 2012 and the bias force F1 are illustrated as being substantially perpendicular to the direction of extension of the first portion (e.g., reference electrode) of the sensor 138 and substantially perpendicular to the respective contact surface of each of the second and third sidewalls 2014, 2016. However, the present disclosure is not so limited, and the contact surface of the first sidewall 2012 can have any suitable orientation with respect to either the first portion of the sensor 138 and / or the respective contact surface of each of the second and third sidewalls 2014, 2016.

[0223] 20, the contact surfaces of the second and third side walls 2014, 2016, respectively, and the bias forces F2 and F3 are shown facing in opposite directions. However, the present disclosure is not so limited, and the contact surfaces of the second and third side walls 2014, 2016, respectively, and the bias forces F2 and F3 can have any suitable orientation relative to one another and / or with respect to other features of the wearable assembly 600.

[0224] The sensor 138 may be initially bent at the first bend 2002 to an angle less than that shown in FIG. 20 or that desired in actual implementation, and then placed in the illustrated or desired orientation, thereby causing the angle of the first bend 2002 to be slightly greater than the initial bend angle. As illustrated in FIG. 20 , due to the elastic and / or resilient properties of the sensor 138, the sensor 138 tends to decrease the angle of the first bend 2002 from the angle shown toward the initial bend angle. This tendency causes the sensor 138 to generate at least one bias or holding force F1, F2, F3 in a direction substantially perpendicular to and opposite the point of contact with the electronics assembly board 630 and / or one or more respective sidewalls 2012, 2014, 2016 of the lower housing 622.

[0225] For example, as shown, a tendency of sensor 138 to decrease the flex angle of first flexure 2002 induces a torque at first flexure 2002, forcing a second portion of sensor 138 against the contact surface of third sidewall 2016 with force F3, creating an equal but opposite bias force on the second portion of sensor 138. This opposite bias force presses sensor 138 against the contact surface of second sidewall 2014 at first flexure 2002 with force F2, creating an equal but opposite bias force on sensor 138 at first flexure 2002.

[0226] The torque at the first flexure 2002 caused by the sensor 138 tending to reduce the flexure angle of the first flexure 2002 also presses the first portion of the sensor 138 against the contact surface of the first sidewall 2012 with a force F1, creating an equal but opposite bias on the first portion of the sensor 138.

[0227] The biasing or holding forces F1, F2, F3 also induce orthogonal frictional forces (not shown) at the contact points in respective directions parallel to sidewalls 2012, 2014, 2016, which further resist movement of sensor 138 relative to lower housing 622 and electronics assembly board 630. Alone or in combination, these biasing, holding, and / or frictional forces act to secure sensor 138 in a desired orientation and position before a conductive connection (e.g., epoxy, solder, or the like) is applied between or to contacts 212b and 324, or between or to contacts 211b and 334.

[0228] Among other benefits, the first flexure 2002 provides additional alignment, limits undesired movement or rotation of the sensor 138 before and after securing the sensor 138 to the electronics assembly board 630 and / or lower housing 622, and limits centerline constraints.

[0229] Use of board dams to form wells for direct board sensor connections For some sensor wire direct-to-board designs, conductive or other adhesive epoxies used in different locations to bond the sensor 138 to the PCB (e.g., electronics assembly board 630) can bleed or run together, causing undesirable electrical shorts or otherwise undesirably bleed or run along the sensor into adjacent areas. Some solutions are described below in connection with at least Figures 21A-27.

[0230] FIG. 21A shows a top view of a portion of a wearable assembly 600 including multiple dam portions 2112, 2114, 2116 forming multiple well portions 2102, 2104 for containing and preventing unwanted oozing or migration of epoxy 2122, 2124, according to some embodiments. Each of FIGS. 21B, 21C, and 21D shows a side cross-sectional view of the portion of the wearable assembly 600 shown in FIG. 21A taken along section lines A-A', B-B', and C-C', respectively. The portion of the wearable assembly 600 shown in FIGS. 21A-21D can be manufactured by any suitable process, such as low-pressure overmolding of the electronics assembly substrate 630 and / or lower housing 622. Further discussion follows with reference to each of FIGS. 21A-21D.

[0231] 21B illustrates an electronics assembly substrate 630 including contacts 324, 334, as described above in connection with at least FIG. 3D. An overmolded structure 2150 may be formed on, above, around, or as an integral part of the electronics assembly substrate 630, for example, utilizing a low-pressure overmolding process. Such a low-pressure overmolding process may allow for a complete perimeter seal around the electronics assembly substrate 630, thereby sealing a portion of the electronics assembly substrate 630 from moisture intrusion and leaving less of the electronics assembly substrate 630 exposed for a subsequent potting process.

[0232] The overmold structure 2150 includes a plurality of dam portions 2112, 2114, 2116 spaced apart adjacent to the contacts 324, 334. The contacts 324 and 334 may each be a contact pad or plate disposed on the electronics assembly substrate 630. In some embodiments, the contacts 324 and 334 may be formed by gold plating. As shown, the contacts 324 and 334 are rectangular in shape. In other embodiments, the contacts 324 and 334 may be circular, oval, diamond, rounded rectangular, rounded diamond, polygonal, or rounded polygonal. As shown, a first dam portion 2112 is disposed adjacent to a first side of the contact 334. The second dam portion 2114 is disposed adjacent a second side of the contact 334 opposite the first side, between the contacts 324, 334, and adjacent the first side of the contact 324. The third dam portion 2116 is disposed adjacent a second side of the contact 324 opposite the first side. Thus, the first and second dam portions 2112, 2114 define the first well portion 2102 in which the contact 334 is disposed, and the second and third dam portions 2114, 2116 define the second well portion 2104 in which the contact 324 is disposed. As shown in FIG. 21D , side walls 2132 and 2134, disposed on opposite sides of the contact 324, form the remaining walls of the second well portion 2104. Although not explicitly shown in FIGS. 21A-21D, a similar pair of side walls are disposed on opposite sides of contact 334, thereby forming the remaining walls of first well portion 2102.

[0233] Once the wells 2102, 2104 are formed, conductive epoxy 2122, 2124 can be deposited over the contacts 324, 334 in the wells 2102, 2104 in preparation for placement of the sensor 138.

[0234] 21C and 21D, at least one of the dam portions 2112, 2114, 2116 can have a sloped cross-section as viewed perpendicular to section line B-B' or C-C'. For example, the dam portions 2112, 2114, 2116 can have a triangular, parabolic, semicircular, hyperbolic, or other concave cross-section that has its lowest point substantially equidistant from the corresponding sidewall of the respective well portion (e.g., sidewalls 2132, 2134 of the second well portion 2104) along the cross-section, or at any other desired location along the cross-section. Respective portions of the sensor 138 are configured, by virtue of their sloped or notched features, to be positioned substantially at this lowest point of the respective recess or cross-section of the dam portions 2112, 2114, 2116. Thus, the dam portions 2112, 2114, 2116 not only define the well portions 2102, 2104, but also guide the respective portions of the sensor 138 into the desired positions before they are fixed in place.

[0235] In some embodiments, one or more dam portions (e.g., third dam portion 2116 as shown in FIGS. 21A-21B) may have a substantially flat cross-section rather than the sloped cross-section described above. For example, if first and second dam portions 2112, 2114 have the sloped cross-sections described above and adequately constrain at least the lateral positioning of sensor 138, third dam portion 2116 need not have a sloped cross-section; the flat cross-section simply serves as a platform upon which the proximal end of sensor 138 rests.

[0236] 21B and 21D, the epoxy 2122, 2124 can be deposited on each of the wells 2102, 2104 to at least a minimum height. In some embodiments, such minimum height is large enough that a respective portion of the sensor 138 is in physical and electrical contact with at least the top surface of the epoxy 2122, 2124 when the sensor 138 is positioned laterally across the dams 2112, 2114, 2116, as shown in FIG. 21A. For example, the contact 212b (of the reference electrode) can contact the conductive epoxy 2122 disposed on the contact 334 of the first well 2102, while the contact 211b (of the working electrode) can contact the conductive epoxy 2124 disposed on the contact 324 of the second well 2104. A portion of the sensor 138 distal to the portion of the contact 212b in contact with the conductive epoxy 2122 can be placed on the first dam portion 2112, the insulating layer 104 of the sensor 138 can be placed on the second dam portion 2114, and a portion of the sensor 138 proximal to the portion of the contact 211b in contact with the conductive epoxy 2124 can be placed on the third dam portion 2116.

[0237] As shown in FIG. 21B , conductive epoxy 2122 may fill the void in the first well 2102 between contact 334 of the electronics assembly substrate 630 and contact 212b of the sensor 138 (e.g., reference electrode). Thus, conductive epoxy 2122 may physically separate contact 334 and contact 212b. One benefit of this separation may be a reduction in signal noise or signal shift of the sensor 138 that may occur when contact 334 and contact 212b are in physical contact. In some cases, the material of contact 212b of the reference electrode could react electrically with the material of contact 334 of the electronics assembly substrate 630. For example, contact 212b may include silver and silver chloride, and contact 334 may include gold, nickel, and copper. It is believed that electrical interaction between gold and silver / silver chloride or copper and silver / silver chloride could result in corrosion of contact 334. Thus, filling the space between contact 334 and contact 212b with conductive epoxy 2122 may reduce corrosion of contact 334. In some embodiments, contact 334 may have a channel (not shown) extending through the center of the contact to allow for deposition of the conductive epoxy. In other embodiments, contact 334 may have an intermediate layer (not shown) disposed on contact 334 that separates contact 334 from contact 212b. In such embodiments, the intermediate layer may comprise plastic, epoxy, or a composite material such as FR4. In embodiments in which contact 334 is in physical contact with contact 212b (e.g., FIG. 15), it is also contemplated that a carbon conductive ink could be disposed on the underlying copper layer of contact 334. The carbon conductive ink would replace the more common gold layer, as the carbon in the carbon conductive ink has a lower galvanic potential, which is believed to enhance corrosion resistance. In some embodiments, a corrosion prevention layer may be formed on contact 334 to enhance resistance to corrosion. It is also contemplated that any of the above features and techniques could be applied to contact 324 as well.

[0238] In some embodiments in which the sensor 138 is attached directly to the electronics assembly board 630 without utilizing a separate sensor carrier, the sensor 138 may be handed off from a placement gripper to the wearable assembly 600 during manufacturing. Such a “hand-off” method should maintain the position of the sensor 138 placed by such a placement gripper, and epoxy, for example, a UV-cured epoxy, may be used to seal or bond the sensor 138 to the electronics assembly board 630. However, this epoxy must be prevented from flowing into adjacent areas along the sensor 138, for example, areas where the through-holes 180 of the sensor assemblies 500, 600 on the skin are located. Additionally, strain relief may be desirable outside the encapsulant to reduce strain on the wires and maintain the position of the sensor 138 relative to the mounting surface.

[0239] Additional or alternative solutions for holding the sensor 138 placed by such a placement gripper while the epoxy cures, as well as preventing the epoxy from wicking up along the sensor 138 and simultaneously providing strain relief for the sensor 138, are described below in connection with FIGS. 22-27 and 40A-41. Various shapes of pockets configured to hold a predetermined amount of epoxy to secure the sensor 138 are described as being utilized in combination with a step-up, step-down, or flush transition from the pocket to an adjacent region to prevent epoxy deposited in the pocket from oozing, wicking, or otherwise flowing beyond the pocket boundary onto an adjacent region or sensor. In some embodiments, the pockets, transitions, and adjacent regions may be formed using a low-pressure molding process or any other suitable process. In some embodiments, the pockets and their adjacent regions are continuous with one another; for example, adjacent regions are disposed directly adjacent to their respective pockets without any features other than the transition between them. In some embodiments, the epoxy is comprised of a non-conductive material. In some embodiments, the epoxy is comprised of a conductive material.

[0240] FIG. 22 shows a perspective view of multiple pockets having various shapes combined with step-up, step-down, or flush transitions of various widths to adjacent regions, according to some embodiments. FIG. 23 illustrates plan views of several exemplary shapes for the pockets of FIG. 22. FIG. 24 illustrates side views of a set of exemplary step-up transitions as seen along section line A-A' of FIG. 22, exemplary flush transitions as seen along section line B-B' of FIG. 22, and exemplary step-down transitions as seen along section line C-C' of FIG. 22. FIG. 25 shows a set of side views taken along section lines A-A', B-B', and C-C' of FIG. 24, further illustrating exemplary widths "w" of the transitions and exemplary orientations of the sidewalls of the pockets and / or adjacent regions. The pockets, transitions, and adjacent regions are now described in conjunction with FIGS. 22-25.

[0241] FIG. 22 illustrates multiple pockets 2200a-2200p, each with a corresponding adjacent region on either side. Each of pockets 2200a-2200p is illustrated as having a different combination of pocket shape, type of transition between the pocket and the adjacent region, and transition width "w." Callouts "E," "F," and "P" in FIG. 22 illustrate several embodiments of these different combinations, which are described in more detail in connection with FIGS. 23-25. It should be understood that any of the pockets, adjacent regions, and / or transitions therebetween described in connection with at least FIGS. 22-25 can be implemented in the housing of any of wearable assemblies 500, 600, as described above in connection with at least FIGS. 5A-6C.

[0242] As shown in callout "E," a first adjacent region 2210e is disposed on a first side of the pocket 2200e, and a second adjacent region 2220e is disposed on a second side of the pocket 2200e opposite the first side. Callout "E" further illustrates a first transition 2204e between the pocket 2200e and the first adjacent region 2210e, and a second transition 2206e between the pocket 2200e and the second adjacent region 2220e. The first and second transitions 2204e, 2206e may include structures and / or shapes that separate the bases 2215e, 2225e of the first and second adjacent regions 2210e, 2220e, respectively, from the base 2205e of the pocket 2200e. In callout "E," first and second transitions 2204e, 2206e are depicted as so-called "step-down" transitions because the respective bases 2215e, 2225e of each adjacent region 2210e, 2220e are positioned at a height that is less than the base 2205e of pocket 2200e by an amount "h." An exemplary value of "h" is 0.5 mm, although the present disclosure is not so limited and any suitable value for "h" is contemplated. Each of transitions 2204e, 2206e is also depicted as having a width "w." In some embodiments, width "w" may be defined as the separation distance between the sidewalls 2208e of a particular transition 2204e, 2206e. An example range of values ​​for "w" is 0.5 to 2.0 mm, although the present disclosure is not so limited and any suitable value or range for "w" is contemplated. The first adjacent region 2210e has a sidewall 2212e. The second adjacent region 2220e has a sidewall 2222e, the pocket has a sidewall 2202e, and the sidewalls of the first and second transitions 2204e, 2206e are shown as 2208e. Callout "E" further illustrates section line A-A' to which the "step-down" view shown in FIG. 24 may correspond.

[0243] Callout "P" illustrates a pocket 2200p having a first transition 2204p to a first adjacent region 2210p and a second transition 2206p to a second adjacent region 2220p. The layout of callout "P" is substantially similar to that of callout "E," except that the first and second transitions 2204p, 2206p are illustrated as "flush" transitions, so to speak, because the respective bases 2215p, 2225p of each of the adjacent regions 2210p, 2220p are positioned at the same height as the base 2205p of the pocket 2200p. Callout "P" further illustrates a section line B-B' to which the "flush" view illustrated in FIG. 24 can correspond.

[0244] Callout "F" illustrates a pocket 2200f having a first transition 2204f to a first adjacent region 2210f and a second transition 2206f to a second adjacent region 2220f. The arrangement of callout "F" is substantially similar to that of callout "E," except that the first and second transitions 2204f, 2206f are illustrated as "step-up" transitions, so to speak, because the respective bases 2215f, 2225f of each of the adjacent regions 2210f, 2220f are positioned at a height that is higher by an amount "h" compared to the base 2205f of the pocket 2200f. An exemplary value of "h" is 0.5 mm, although the present disclosure is not so limited and any suitable value of "h" is contemplated. Callout "F" further illustrates a section line C-C' to which the "step-up" view illustrated in FIG. 24 may correspond.

[0245] As illustrated in Figure 23, such pockets may have any one of several shapes. In some embodiments, a substantially rectangular pocket 2300a may be utilized. The sidewalls of the rectangular pocket 2300a are shown as substantially planar such that they meet to form sharp angled corners.

[0246] In some other embodiments, a substantially rounded rectangular pocket 2300b may be utilized. Portions of the sidewalls of the rounded rectangular pocket 2300b are shown as substantially planar, while other portions of the sidewalls connecting the substantially planar portions are curved to avoid sharp angled corners. Pockets 2200a, 2200b, 2200e, 2200f, 2200j, 2200k, and 2200p in FIG. 22 are illustrated as having such a rounded rectangular shape.

[0247] In yet other embodiments, substantially triangular or diamond-shaped pockets 2300c may be utilized. The sidewalls of triangular or diamond-shaped pockets 2300b are shown as substantially planar so that they meet to form sharp angled corners. Pockets 2200c, 2200d, 2200g, and 2200h in FIG. 22 are illustrated as having such triangular or diamond shapes.

[0248] In yet other embodiments, a substantially rounded triangular or diamond-shaped pocket (not shown) may be utilized. Similar to the rounded rectangular pocket 2300b, portions of the sidewalls of the rounded triangular or diamond-shaped pocket may be substantially planar, with other portions of the sidewalls connecting the substantially planar portions being curved to avoid forming sharp angled corners.

[0249] In yet another embodiment, a substantially polygonal pocket 2300d may be utilized. The sidewalls of polygonal pocket 2300d are shown as substantially planar so that they meet and form sharp corners. Pockets 2200m and 2200n in FIG. 22 are shown as having such a polygonal shape.

[0250] In yet other embodiments, a substantially rounded polygonal pocket (not shown) may be utilized. Similar to the rounded rectangular pocket 2300b, portions of the sidewalls of the rounded polygonal pocket may be substantially planar, with other portions of the sidewalls connecting the substantially planar portions being curved to avoid forming sharp angled corners.

[0251] Additionally, while the above shapes have been described in connection with the pocket itself, the present disclosure also contemplates that such shapes may be applied to any of the adjacent regions. For example, while the adjacent region illustrated in FIG. 22 is shown as having a rounded square or rectangular shape, other suitable shapes, as described above or elsewhere in this disclosure, may also be applied to the adjacent region, including any suitable variable shape, as may be necessary or desired in a particular situation.

[0252] As illustrated in FIG. 24 , the pockets can also have any one of several types of transitions to adjacent regions, e.g., fluid stops. For example, a “step-down” embodiment shows a sidewall 2412a of a first adjacent region 2410a, a sidewall 2402a of a pocket 2400a, a sidewall 2422a of a second adjacent region 2420a, and a sidewall 2408a of first and second transition regions 2404a, 2406a. The bases 2415a, 2425a of the first and second adjacent regions 2410a, 2420a, respectively, are shown positioned at a height that is lower than the base 2405a of the pocket 2400a by an amount “h.” An exemplary value for “h” is 0.5 mm, although the present disclosure is not so limited and any suitable value for “h” is contemplated. As shown, when epoxy 2430a is placed on base 2405a of pocket 2400a, first and second step-down transitions 2404a and 2406a, the surface tension and surface energy of epoxy 2430a can inhibit or prevent epoxy 2430a from impinging on first and second adjacent regions 2410a, 2420a, thereby forming downwardly deflecting menisci 2432a at first and second transitions 2404a, 2406a that attach to the edges of first and second transitions 2404a, 2406a. In some embodiments, the step-down height "h," and possibly the width "w" of the transitions 2404a, 2406a, and / or the area or volume of the pocket 2400a, depend not only on a predetermined amount of applied epoxy 2430a, but also on the particular viscosity, surface energy, and / or surface tension characteristics between the epoxy 2430a, the surrounding environment, and the surface of the pocket, sensor, dispensing tip, or other contact surface or fluid. Other factors include the surrounding shape of the pocket and the surrounding environment (e.g., material, temperature, humidity). This adhesive effect of such a "step-down" transition, and the inhibition or prevention of the epoxy 2430a from flowing, may be performed contrary to conventional wisdom, which would expect such a "step-down" transition to not adequately inhibit or prevent the epoxy 2430a from flowing into the first and second adjacent regions 2410a, 2420a.Both Figure 6B and Figure 30A illustrate an example of a step-down transition.

[0253] The "flush" embodiment of Figure 24 shows the sidewall 2412b of the first adjacent region 2410ab, the sidewall 2402b of the pocket 2400b, the sidewall 2422b of the second adjacent region 2420b, and the sidewall 2408b of the first and second transition regions 2404a, 2406b. The bases 2415b, 2425b of the first and second adjacent regions 2410b, 2420b, respectively, are shown as being disposed flush with the base 2405b of the pocket 2400b. As shown, when epoxy 2430b is disposed on base 2405b of pocket 2400b, first and second flush transitions 2404b and 2406b can prevent epoxy 2430b from flowing into first and second adjacent regions 2410b, 2420b and forming meniscus 2432b at first and second transitions 2404a, 2406b, due in part to the surface tension and surface energy of epoxy 2430b. Additionally, the interaction between epoxy 2430b and transition sidewall 2408b and the width "w" of the transition (as described in more detail in connection with the orthogonal side view of FIG. 25) can also affect the tendency of epoxy 2430b to be retained within pocket 2400b by transitions 2404b, 2406b, with a relatively narrow width "w" potentially providing better retention of epoxy 2430b within pocket 2400b. This adhesive effect of such a "flush" transition, and the inhibition or prevention of epoxy 2430b from running, may be performed contrary to conventional wisdom, which would predict that such a "flush" transition would not adequately inhibit or prevent epoxy 2430b from running into the first and second adjacent regions 2410b, 2420b.

[0254] The "step-up" embodiment of Figure 24 shows sidewall 2412c of first adjacent region 2410c, sidewall 2402c of pocket 2400c, sidewall 2422c of second adjacent region 2420c, and sidewall 2408c of first and second transition regions 2404a, 2406c. Bases 2415b, 2425b of first and second adjacent regions 2410c, 2420c, respectively, are shown as being positioned at a height "h" that is greater by an amount "h" than base 2405c of pocket 2400c. An exemplary value of "h" is 0.5 mm, although the present disclosure is not so limited and any suitable value of "h" is contemplated. As shown, when epoxy 2430c is placed on base 2405c of pocket 2400c, first and second step-up transitions 2404c and 2406c can prevent epoxy 2430c from flowing into first and second adjacent regions 2410c, 2420c. However, the surface tension and surface energy of epoxy 2430c can cause an upwardly deflecting meniscus 2432c to form at first and second transitions 2404a, 2406c and the step-ups. Retention of the epoxy 2430c within the pocket 2400c may be most effective if the step-up height "h" exceeds the height of the upwardly deflecting meniscus 2432c because the surface tension and surface energy of the epoxy 2430c can cause the epoxy 2430c to creep along the top of the meniscus 2432c and into the adjacent regions 2410c, 2420c when the upwardly deflecting meniscus 2432c reaches the level of the base 2415c, 2425c of either of the adjacent regions 2410c, 2420c. Thus, the step-up height "h", and, as the case may be, the width "w" of the transitions 2404c, 2406c, the area or volume of the pocket 2400c, depend not only on a predetermined amount of epoxy 2430c applied, but also on the particular viscosity, surface energy, and / or surface tension characteristics between the epoxy 2430c, the surrounding environment, and the surface of the pocket, sensor, dispensing tip, or other contact surface or fluid. Other factors include the surrounding shape of the pocket and the surrounding environment (eg, material, temperature, humidity).The effect of this creeping of epoxy 2430b when used in such a "step-up" transition where the height "h" is insufficient, which would be expected to adequately inhibit or prevent epoxy 2430c from flowing into the first and second adjacent regions 2410c, 2420c, and its limited ability to inhibit or prevent epoxy 2430c from hitting adjacent regions, may be contrary to conventional wisdom, even if the height of the upwardly deflecting meniscus 2432c reaches the transition height "h".

[0255] 22 and 25, the transitions between pockets 2400a-c and adjacent regions 2410a-c, 2420a-c may also have varying widths "w" between the sidewalls of the transition. Example values ​​for "w" range from 0.5 to 2.0 mm, although the present disclosure is not so limited and any suitable value for "w" is contemplated. For example, the first row of pockets 2200a, 2200b, 2200c, and 2200d in FIG. 22 is shown as having a relatively narrow transition width “w” of approximately 0.5 mm; the second row of pockets 2200e, 2200f, 2200g, 2200h, and 2200p in FIG. 22 is shown as having a relatively medium transition width “w” of approximately 1.0 mm, which is larger than the relatively narrow transition width; and the third row of pockets 2200j, 2200k, 2200m, and 2200n in FIG. 22 is shown as having a relatively wide transition width “w” of approximately 2.0 mm, which is larger than either the relatively narrow or relatively medium transition widths. FIG. 25 illustrates the transition width “w” as a value that can correspond to any desired and / or appropriate width capable of retaining epoxy in the pocket. Additionally, the transitions on either side of the pocket can have different widths. For example, a first width of a first transition between a pocket and a first adjacent region may be greater than or less than a second width of a second transition between a pocket and a second adjacent region.

[0256] 25, in some embodiments, the adjacent region sidewalls 2422a-c, pocket sidewalls (not shown in FIG. 25), and / or transition sidewalls 2408a-c can be substantially perpendicular to their respective bases 2415a-c, 2425a-c, 2405a-c, as illustrated by solid perpendicular lines at the sidewalls. In still other embodiments, the adjacent region sidewalls 2422a-c, pocket sidewalls (not shown in FIG. 25), and / or transition sidewalls 2408a-c can be slightly sloped or angled from such a substantially perpendicular orientation to their respective bases 2415a-c, 2425a-c, 2405a-c, as illustrated by dashed lines at the sidewalls.

[0257] 22-25 show the same type of transition on either side of a particular pocket, the present disclosure is not so limited, and any combination of step-up, step-down, and flush transitions may be used with any pocket. For example, a first transition on a first side may be either a step-up, flush, or step-down transition, while a second transition on another side of the pocket may be either a step-up, flush, or step-down transition.

[0258] Additionally, any number of pockets and / or adjacent regions may be utilized within the same wearable assembly 600, on the same housing 622 for such wearable assembly 600, on the same electronics assembly board 630, or even to secure different portions of the same sensor 138. For example, in some embodiments, two or more pockets may be formed adjacent to one another, each having its own respective adjacent region, or alternatively, adjacent pockets may share an intervening adjacent region from different sides. Some embodiments are further contemplated having more or fewer than the described two adjacent regions per pocket.

[0259] 26 illustrates a photograph of a first configuration including a pocket 2600a, a first step-down transition 2604a to a first adjacent region 2610a, and a second step-down transition 2606a to a second adjacent region 2620a. As shown in the photograph, the epoxy 2630a attached to the sensor 138 was substantially contained within the pocket 2600a. As discussed above in connection with FIG. 24, the surface tension and surface energy of the epoxy 2630a can inhibit or prevent the epoxy 2630a from impinging on the first and second adjacent regions 2610a, 2620a, resulting in the formation of a downwardly deflecting meniscus at the first and second transitions 2604a, 2606a that attaches to the edges of the first and second transitions 2604a, 2606a. 26 further illustrates a second arrangement below the first, including a pocket 2600b, a first step-up transition 2604b to a first adjacent region 2610b, and a second step-up transition 2606b to a second adjacent region 2620b. As shown in the photograph, epoxy 2630b adhering to the sensor 138 has crept over the transitions 2604b, 2606b and into the adjacent regions 2610b, 2620b.

[0260] It is believed that the failure of the second arrangement to retain the epoxy 2630b within the pocket 2600b may have been due to insufficient height of the transitions 2604b, 2606b such that the upwardly deflecting meniscus of the epoxy 2630b at the step-up transitions 2604b, 2606b reached the base of the first and second adjacent regions 2610b, 2610b, causing the epoxy 2630b to creep along the top of the meniscus and overflow into the adjacent regions 2610b, 2620b. Once the epoxy 2630b began to actuate, the sensor 138 may have provided an additional surface over which the epoxy 2630b could overflow.

[0261] 22-26, a flush or step-up transition having an insufficient height "h" can be intentionally implemented between one or more pockets and one or more adjacent regions, for example, to intentionally overflow epoxy onto a particular portion of the sensor 138 (e.g., the reference electrode 212). In some of those embodiments, a step-down transition can be utilized between one or more pockets and other adjacent regions, for example, to intentionally inhibit or prevent overflow of epoxy onto other portions of the sensor 138 (e.g., the working electrode 211).

[0262] 27 shows a plan view (top) and a cross-sectional plan view (bottom) along section line A-A′ of an arrangement utilizing pockets 2700 a, 2700 b and adjacent regions 2710 a, 2710 b, 2720 similar to those described above in connection with FIGS. 22-26 to directly secure a sensor 138 to an electronics substrate assembly 630 and further utilize optional support posts 2712 for centering the sensor 138, according to some embodiments. In this view, a first pocket 2700 a and a second pocket 2700 b are each illustrated as having a step-down transition on either side to adjacent regions 2710 a, 2710 b, 2720. Adjacent region 2710a is shown as a first adjacent region of first pocket 2700a, adjacent region 2710b is shown as a first adjacent region of second pocket 2700b, and adjacent region 2720 is shown as a second adjacent region of each of first and second pockets 2700a, 2700b. Contacts 324 are shown in adjacent region 2710a, contacts 334 are shown in adjacent region 2720, and through-holes 180 are shown in adjacent region 2710b. Adjacent region 2710b is further shown having struts 2712 disposed therein. While particular orientations and arrangements of the pockets, adjacency regions, contacts, and struts are shown, they should be construed as examples and not limitations of the present disclosure, and any arrangement of all or a subset of the above features is contemplated, alone or in combination with other features described in this disclosure or elsewhere.

[0263] Conductive epoxy or other suitable conductive material is disposed on contacts 324, 334 to electrically couple the respective portions of sensor 138 thereto (e.g., contacts 211b and 212b, respectively, as described above in connection with at least FIG. 3D).

[0264] As further illustrated in FIG. 27 and described above in connection with FIGS. 22-26, epoxy is disposed within pockets 2700a, 2700b and is retained therein by a step-down transition, e.g., a fluid stop, between pockets 2700a, 2700b and adjacent regions 2710a, 2710b, 2720. Similarly, epoxy can be disposed on the top surfaces of posts 2712, with step-down features also at the transition from the circumferential edge and base of adjacent region 2710b where posts 2712 are disposed, retaining the epoxy on their top surfaces. Thus, when sensor 138 is placed on the arrangement of FIG. 27, each portion of sensor 138 can be contacted and secured not only by the conductive epoxy disposed on contacts 324, 334, but also by the UV-curable epoxy disposed within pockets 2700a, 2700b and on posts 2712. Additionally, due to the substantially symmetrical shape and relatively small top surface of the support posts 2712, the surface energy and surface tension of the epoxy disposed on the top surface of the support posts 2712 tends to exert a small centering force on the portion of the sensor 138 disposed thereon, maintaining or self-correcting the alignment of the sensor 138.

[0265] Although the support posts 2712 are shown as having a substantially circular shape, the present disclosure is not so limited and the support posts 2712 may have any suitable shape, and a symmetrical shape as viewed through a centerline defined by the direction of extension of the sensor 138 across the top surface of the support posts 2712 may best allow the surface energy and / or surface tension of the epoxy disposed thereon to provide symmetrical forces about the portion of the sensor 138 that is placed on the support posts 2712.

[0266] In addition to or as an alternative to the use of step-up, step-down, and / or flush transitions as described above in connection with Figures 22-27, the present disclosure also contemplates forming the base of adjacent regions to have different surface energies compared to the pocket, thereby preventing the epoxy from bleeding into the adjacent regions. Figure 40A shows a perspective view of a pocket 4000a with a base 4005a having a first surface energy, and adjacent regions 4010a, 4020a have respective bases 4015a, 4025a having surface energies that differ from the first surface energy of the pocket base 4005a. In some embodiments, the bases 4015a, 4025a can have the same second surface energy that is different from the first surface energy of the pocket base 4005a. In some other embodiments, the base 4015a can have a second surface energy, while the base 4025a can have a third surface energy that is different from the first and second surface energies. In some embodiments, the first, second, and / or third surface energies of the pocket base 4005a and adjacent region bases 4015a, 4025a can be determined, set, and / or modified by, for example, applying one or more of plasma etching, Teflon tape, relatively low surface energy tape, different surface textures, grooves, or any other suitable materials or features to one or more of the pocket base 4005a and adjacent region bases 4015a, 4025a. Figure 40A further illustrates step-down transitions 4004a and 4006a to the respective adjacent regions 4010a, 4020a.

[0267] 40B illustrates a pocket 4000b with a base 4005b having a first surface energy, and adjacent regions 4010a, 4020b have respective bases 4015a, 4025b having surface energies that are different from the first surface energy of the pocket base 4005b. In some embodiments, the bases 4015a, 4025b can have the same second surface energy that is different from the first surface energy of the pocket base 4005b. In some other embodiments, the base 4015b can have the second surface energy, while the base 4025b can have a third surface energy that is different from the first and second surface energies. In some embodiments, the first, second, and / or third surface energies of the pocket base 4005b and adjacent region bases 4015a, 4025b can be determined, set, and / or modified by, for example, applying one or more of plasma etching, Teflon tape, relatively low surface energy tape, different surface textures, grooves, or any other suitable materials or features to one or more of the pocket base 4005b and adjacent region bases 4015a, 4025b. In contrast to Figure 40A, Figure 40B further illustrates flush transitions 4004b and 4006b to the respective adjacent regions 4010a, 4020b.

[0268] The different surface energies at the transitions 4004a-b, 4006a-b can cause epoxy disposed within the pockets 4000a-b to form a downwardly deflecting meniscus at the transitions 4004a-b, 4006a-b, respectively, similar to that described above in connection with at least Figures 24 and 25, thereby preventing the epoxy from undesirably creeping from the pocket bases 4005a-b into adjacent regions 4010a-b, 4020a-b.

[0269] FIG. 41 illustrates a side cross-sectional view of a pocket 4100 having step-down transitions 4104, 4106 to respective adjacent regions 4110, 4120, and further including an additional step-down transition 4152 to an additional adjacent region 4150 to prevent epoxy from bleeding into the adjacent regions 4110, 4120, in accordance with some embodiments.

[0270] In some embodiments, in addition to or as an alternative to utilizing one or more adjacent regions, as described above in connection with at least Figures 22-27, one or more adjacent regions 4150 may be positioned directly adjacent to and / or abutting the sidewall 4108 of the pocket 4100 and configured to receive at least an excess portion of the epoxy 4130 positioned within the pocket 4100, thereby preventing the epoxy 4130 from creeping into at least one of the adjacent regions 4110, 4120.

[0271] For example, Figure 41 shows a pocket 4100 having a base 4105 and a sidewall 4108 having a top surface 4109, an adjacent region 4110 having a base 4115, a transition 4104 between the base 4115 and the base 4105, an adjacent region 4120 having a base 4125, and a transition 4106 between the base 4125 and the base 4105. The transitions 4104, 4106 are shown as "step-down" transitions, as previously described in connection with Figures 22-27. However, the present disclosure is not so limited, and one or both of the transitions 4104, 4106 can alternatively be "flush" or "step-up" transitions, as previously described.

[0272] While the transitions 4104, 4106 may be configured to prevent the epoxy 4130 disposed within the pocket 4100 on the base 4105 from wicking and / or creeping into adjacent regions 4110, 4120 if the pocket 4100 is sufficiently overfilled with epoxy 4130, one or both of the transitions 4104, 4106 relative to the epoxy 4130 may be insufficient alone to prevent the epoxy 4130 from wicking and / or creeping into adjacent regions 4110, 4120. Thus, by providing adjacent region 4150 with a base 4155 positioned at a lower height than the top surface 4109 of the sidewall 4108 of pocket 4100, and a transition 4152 between the top surface 4109 of the sidewall 4108 of pocket 4100 and the base 4155, adjacent region 4150 can be configured to receive at least an excess portion of epoxy 4130 disposed within pocket 4100, thereby preventing the epoxy 4130 from creeping into at least one of adjacent regions 4110, 4120. In such embodiments, step-down transition 4152 can be specifically configured to allow the excess portion of epoxy 4130 to flow, creep and / or wick into adjacent region 4150 rather than adjacent regions 4110, 4120. In some embodiments, the transition 4152 may alternatively be configured to cause the epoxy 4130 disposed within the pocket 4100 to adhere to the transition 4152, thereby inhibiting the epoxy 4130 from creeping into adjacent regions 4150.

[0273] In any of the above embodiments featuring a pocket and adjacent region, an additional conductive adhesive material, such as conductive epoxy, may be implemented to mechanically and electrically connect the sensor 138 to the contacts of the electronics assembly board 630. For example, the sensor 138 may be mounted in the pocket as described above and then mounted and electrically connected to the electronics assembly board 630 as depicted in FIGS. 21A-21D. In some embodiments, the sensor 138 is first mounted in the pocket and then mounted to the electronics assembly board. In other embodiments, the sensor 138 is first mounted to the electronics assembly board and then mounted to the pocket.

[0274] Utilizing a passivation layer on the connected sensor within the pocket of the wearable transmitter The aforementioned wearable analyte sensor transmitter assemblies 500, 600 may be vulnerable to leakage currents in the circuitry disposed therein as a result of unwanted moisture ingress. Such leakage currents may be detected during long-term thermal and humidity testing of the analog front end (AFE) of such transmitters. Therefore, it may be desirable to prevent moisture from interfering with the signal received by the AFE. An exemplary solution is described in connection with Figures 28A-28C below.

[0275] FIG. 28A shows a perspective view of a wearable assembly 600 including a lower housing 622 having an opening 626, and a sensor 138 disposed at least partially within the opening and directly connected to an electronics assembly board 630 (not shown in FIGS. 28A-28C) by one or more conductive contacts (e.g., conductive contacts 324, 334), as previously described in FIGS. 6A-6C. FIG. 28A further illustrates a dam portion 2806 formed by the opening 626, having at least a proximal portion of the sensor 138 disposed therein, separating a first portion of the cavity from a second portion of the cavity having an inner and / or distal portion of the through-hole 180 and the sensor 138. The dam portion 2806 is shown having a narrow gap 2808 configured to allow the sensor 138 to pass through.

[0276] As shown in FIG. 28B, the electrical and moisture passivation layer 2802 can be applied to at least a proximal portion of the sensor 138 and an upper surface of at least a portion of the housing 622 disposed within the first portion of the cavity using any suitable method, such as vacuum deposition, inkjet printing, 3D printing, sputtering, chemical vapor deposition, or any other suitable deposition technique.

[0277] Once the passivation layer 2802 is applied, a first portion of the cavity formed by the opening 626 and containing at least the proximal portion of the sensor 138 can be filled with epoxy or other suitable material for mechanical fixation and protection of at least the proximal portion of the sensor 138. Additionally or alternatively, to fill the first portion of the cavity with epoxy, a cap can be placed over the opening 626, for example, as described above in connection with FIGS. 7A-10 . Although FIGS. 28A-28C show the dam portion 2806 to be part of the lower housing 622, the present disclosure is not so limited, and such a dam portion can be part of a cap that is placed in, on, or over the opening 626, as described above in connection with at least FIGS. 7A-10 .

[0278] Another passivation technique that may be utilized to prevent or substantially reduce moisture ingress to the circuitry of the wearable 500, 600 is shown in FIG. 29. As shown in the figure, the lower housing 622 may have a molded shape configured to receive the electronics assembly board 630. Rather than directly connecting one or more electrical connections to the electronics assembly board 630, multiple contacts, conductive trace layers, and passivation layers may be deposited successively such that those electrical connections can be made at a level higher than the level of the electronics assembly board 630 while sealing and protecting the underlying electronics assembly board 630 and / or sensor 138 from moisture ingress.

[0279] For example, one or more electrical contacts, conductive pucks, or other conductive structures 2902a can be deposited in appropriate locations on the electronics assembly substrate 630. One or more conductive trace layers 2904 can be deposited on the contacts 2902a and portions of the lower housing 622. In some embodiments, the conductive trace layer 2904 extends laterally greater than either or both of the contacts 2902a and the electronics assembly substrate 630. Multiple passivation layers 2906, 2908 can then be deposited over at least the remaining exposed portions of the electronics assembly substrate 630 and portions of the conductive trace layer 2904, thereby sealing and passivating the electronics assembly substrate 630 and / or the sensor 138 from the ingress of moisture from the external environment. In some embodiments, the passivation layers 2906, 2908 can include different passivation materials, such as a conformal coating, a UV-curable adhesive, a sputtered metal (e.g., aluminum), a thin metal coating, a polymer (e.g., polyethylene), an elastomer, a ceramic, or any other suitable material. One or more electrical contacts, conductive pucks, or other conductive structures 2902b can be deposited at appropriate exposed locations on the conductive trace layer 2904, and one or more additional conductive trace layers 2912 can be deposited over the contacts 2902b and the passivation layers 2906, 2908. In some embodiments, the conductive trace layer 2912 extends laterally from the contacts 2902b, such that one or more electrical connections can be made on the conductive trace layer 2912 at locations laterally removed from the contacts 2902b. One or more additional passivation layers 2914, 2916 can then be deposited over the underlying layers to seal and protect not only the underlying passivation and conductive layers, but also the electronics assembly substrate 630 from mechanical and moisture-related damage.

[0280] Sealing the housing cavity without UV epoxy filling and sealing In some embodiments, it may be desirable to be able to seal the cavity of housing 622 and electronic circuitry disposed therein to prevent moisture intrusion without having to fill the cavity with a curable epoxy. Accordingly, some solutions are described below in connection with Figures 30A-33.

[0281] 30A illustrates a plan view of a wearable assembly 600 including a heat sealable thermoplastic elastomer 3002 and a mating cap 3004 including a heat sealable thermoplastic elastomer 3006, according to some embodiments. FIG. 30B illustrates a side cross-sectional view of the wearable assembly 600, taken along section line A-A' in FIG. 30A, and the mating cap 3004 positioned for securing to the wearable assembly 600.

[0282] The wearable assembly 600 comprises a lower housing 622 including an opening 626 forming a cavity within the lower housing 622. A first portion of the cavity is configured to accommodate at least a proximal portion of the sensor 138, while a second portion of the cavity comprises a through-hole 180 configured for a sensor applicator needle to pass through. A heat-sealable thermoplastic elastomer 3002 is partially or completely disposed around the first portion of the cavity formed by the opening 626. As shown in FIG. 30B , the heat-sealable thermoplastic elastomer 3002 surrounds at least a proximal portion of the sensor 138 disposed in the first portion of the cavity. The sensor 138 is electrically connected to the electronics assembly board 630 and is further shown passing through a slit (not shown) in the heat-sealable thermoplastic elastomer 3002, thereby extending into the second portion of the cavity with the through-hole 180. While FIG. 30B illustrates the electronic-sensor assembly 630 within the same cavity as the proximal portion of the sensor 138, the disclosure is not so limited. Alternatively, the electronic sensor assembly 630 can be disposed in a cavity within the housing 622 that is distinct from the proximal portion of the sensor 138 and can be separated from the sensor 138 by at least a portion of the housing 622, through which one or more conductive contacts (e.g., contacts 324, 334 in FIG. 3D) can provide a direct electrical connection between the sensor 138 and the electronics assembly board 630 (see, e.g., FIGS. 6A-6C).

[0283] 30B , the heat sealable thermoplastic elastomer 3006 disposed on the cap 3004 is configured to abut a portion of the heat sealable thermoplastic elastomer 3002 adjacent to or abutting a second portion of the cavity through which the sensor 138 is configured to pass when the cap 3004 is properly positioned. Upon proper positioning of the cap 3004 on the lower housing 622 of the wearable assembly 600, heat can be applied to the heat sealable thermoplastic elastomer 3002, 3006, for example by a laser, to melt the heat sealable thermoplastic elastomer 3002, 3006 to the respective portions of the cap 3004 and the lower housing 622, thereby welding and sealing at least a first portion of the cavity formed by the opening 626 that accommodates at least a proximal portion of the sensor 138 from the ingress of moisture. Among other advantages, the seal provided by melting the heat-sealable thermoplastic elastomer 3002, 3006 is moisture resistant, so that a curing epoxy seal within the cavity (as described above in connection with at least Figures 6A-10) is not necessary and is eliminated, reducing manufacturing complexity.

[0284] Another solution will now be described in connection with FIG. 31 below. FIG. 31 illustrates a side cross-sectional view of a portion of the lower housing 622 and an overmolded cap 3100 of a wearable assembly 600, according to some embodiments. As shown, an electronics assembly board 630 is configured to fit within the shape of the lower housing 622. Contacts 324, 334 are disposed on the electronics assembly board 630. The sensor 138 is disposed on the contacts 324, 334 such that respective portions of the sensor are in physical and electrical contact with the contacts 324, 334 (e.g., respective contacts 211 b and 212 b, as described above in connection with at least FIG. 3D ). While the electronics assembly board 630 is shown disposed within the same cavity as at least a proximal portion of the sensor 138, the present disclosure is not so limited, and at least a portion of the housing 622 can physically separate the electronics assembly board 630 from the cavity in which the proximal portion of the sensor 138 is disposed (e.g., see FIGS. 6A-6C ). In such an embodiment, the contacts 324 , 334 may extend through a portion of the housing 622 that physically separates the electronics assembly board 630 from making electrical contact with the sensor 138 .

[0285] FIG. 31 further illustrates a cap or overmolded cap 3100 comprising a base material 3102, such as polycarbonate, plastic, metal, or any other material with adequate strength to maintain a seal. The overmolded cap 3100 further includes an insulating and sealing material 3104 having a plurality of cavities within which the conductive elastomeric pucks 3106 and 3108 reside or fit. In some embodiments, the cavities and conductive elastomeric pucks 3106, 3108 may have a substantially cylindrical shape. However, the present disclosure is not so limited, and any shape is contemplated. In some embodiments, a portion of the insulating and sealing material 3104 is disposed directly between the opposing surfaces of the base material 3102 and the conductive elastomeric pucks 3106 and 3108. When the overmolded cap 3100 is placed over and / or within the cavity of the housing 622, the conductive elastomer pucks 3106 and 3108 press against portions of the sensor 138 and against the contacts 324, 334, thereby securing the portions of the sensor 138 to the respective contacts 324, 334. Although not shown, it is contemplated that in some embodiments the conductive elastomer pucks 3106 and 3108 may be positioned adjacent the contacts 324 and 334, respectively, and the sensor 138 may be positioned adjacent the conductive elastomer pucks 3106 and 3108 on the opposite side from the contacts 324 and 334. In such embodiments, the conductive elastomer puck 3106 may press against the first electrode of the sensor 138 on one side and against the cap 3100 on the other side. The conductive elastomer puck 3108 may press against the second electrode of the sensor 138 on one side and against the cap 3100 on the other side. Additionally, in other embodiments, the conductive elastomer pucks 3106 and 3108 may each be comprised of two halves, and a portion of the sensor 138 may reside between the two halves of the puck 3106 or 3108, or both pairs of halves of the pucks 3106 and 3108. It is further contemplated that in other embodiments, one or more of the contacts 324 and 334 may have a gap formed therein.In such embodiments, at least one of the conductive elastomer pucks 3106 and 3108 may reside within the gap of either the contacts 324 or 334 (eg, via a press fit or a friction fit).

[0286] 31, the insulating and sealing material 3104 is configured to fill, or at least partially fill, the contact portions of the cavity contacts 324, 334 and the sensor wire 138, sealing them from moisture ingress. Among other advantages, the embodiment according to FIG. 31 can eliminate the curable epoxy dispensing and curing steps, the conductive epoxy dispensing and curing steps, and potentially the extra strain relief steps associated with the sensor 138, thereby reducing manufacturing complexity.

[0287] Yet another solution is now described in connection with FIG. 32 below. FIG. 32 illustrates a side cross-sectional view of a portion of a lower housing 622 and an overmolded cap 3200 of a wearable assembly 600, according to some embodiments. As shown, an electronics assembly board 630 is configured to reside within the shape of the lower housing 622. Contacts 324, 334 are disposed on the electronics assembly board 630. The sensor 138 is disposed on the contacts 324, 334 such that respective portions of the sensor are in physical and electrical contact with the contacts 324, 334 (e.g., respective contacts 211 b and 212 b, as described above in connection with at least FIG. 3D ). While the electronics assembly board 630 is shown disposed within the same cavity as at least a proximal portion of the sensor 138, the present disclosure is not so limited, and at least a portion of the housing 622 can physically separate the electronics assembly board 630 from the cavity in which the proximal portion of the sensor 138 is disposed (e.g., see FIGS. 6A-6C ). In such an embodiment, the contacts 324 , 334 may extend through a portion of the housing 622 that physically separates the electronics assembly board 630 from making electrical contact with the sensor 138 .

[0288] 32 further illustrates an overmolded cap 3200 comprising a base material 3202, such as polycarbonate, plastic, metal, or any other material having suitable strength to maintain a seal. The base material 3202 is shown having a plurality of openings or holes 3216, 3218 at locations configured to be laterally aligned over the contacts 324, 334 when the overmolded cap 3200 is properly positioned. The overmolded cap 3200 further includes an insulating and sealing material 3204 having a plurality of cavities 3210, 3212 configured to be positioned directly over the contacts 324, 334 when the overmolded cap 3200 is properly positioned. The cavities 3210, 3212 are configured to receive respective injections of conductive epoxy 3206, 3208 through the holes 3216, 3218 via an injection needle and through the insulating and sealing material 3204 along the line of the needle penetration 3214 after the overmolded cap 3200 is properly positioned. Thus, the holes 3216, 3218 are also laterally aligned with the first and second cavities 3206, 3208. Additionally, as shown, at least a portion of the encapsulation material 3204 physically isolates the first hole 3216 from the first cavity 3210 and the second hole 3218 from the second cavity 3212. In some embodiments, the cavities 3210, 3212 and conductive epoxy injections 3206, 3208 may have a substantially conical shape. However, the present disclosure is not so limited and any shape is contemplated.

[0289] When the overmold cap 3200 is placed on the electronics assembly substrate 630, the cavities 3210, 3212 align directly over the contacts 324, 334. The insulating and sealing material 3204 presses against the portions of the sensor 138 and the contacts 324, 334, thereby holding the portions of the sensor 138 to their respective contacts 324, 334 and substantially sealing the cavities 3210, 3212. Thus, when the needle is pressed through the insulating and sealing material 3204 at the openings 3216, 3218 along the needle penetration line 3214 until the tip of the needle penetrates the cavity 3206, 3208, and the conductive epoxy 3206, 3208 is subsequently injected into the cavity 3206, 3208, the conductive epoxy 3206, 3208 is contained within the cavity 3206, 3208, eliminating the possibility of undesired shorting if the conductive epoxy 3206, 3208 were otherwise allowed to overflow laterally substantially beyond the contacts 324, 334. Additionally, in some embodiments, a conductive epoxy that does not require heating to cure can be utilized such that heat exposure and associated damage to the sensor 138 is reduced. The insulating and sealing material 3204 further seals the contacts 324, 334 and the contacting portions of the sensor 138 from moisture intrusion.

[0290] Among other advantages, the embodiment according to FIG. 32 can eliminate the curable epoxy dispensing and curing step, and potentially the extra strain relief step associated with the sensor 138, thereby reducing manufacturing complexity.

[0291] Manufacturing method for the above embodiment Some exemplary methods for fabricating an analyte sensing device and / or housing having an analyte sensor directly connected to a printed circuit board of a wearable transmitter assembly without utilizing a sensor carrier are provided below in connection with Figures 33-37.

[0292] The methods disclosed herein include one or more steps or actions for achieving the described method. The steps and / or actions of the methods may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0293] An exemplary method 3300 for fabricating an analyte sensing device and / or system will now be described below in connection with Figure 33. Method 3300 may correspond at least to what has been described above in connection with Figures 7A-10 and 28A-29.

[0294] Block 3302 includes forming a housing with an opening that defines a cavity within the housing having a first portion and a second portion. For example, as described above in connection with FIGS. 6A-10, lower housing 622 can be formed to include opening 626 that defines cavity 750 within lower housing 622 having first portion 752 and second portion 754.

[0295] Block 3304 includes disposing a first conductive contact and a second conductive contact in a first portion of the cavity. For example, first conductive contact 324 and second conductive contact 334 can be disposed in first portion 752 of cavity 752.

[0296] Block 3306 includes electrically coupling a first electrode of the analyte sensor to the first conductive contact. For example, first electrode 211b of analyte sensor 138 can be electrically coupled directly to first conductive contact 324.

[0297] Block 3308 includes electrically coupling a second electrode of the analyte sensor to the second conductive contact. For example, the second electrode 212b of the analyte sensor 138 can be electrically coupled directly to the second conductive contact 334.

[0298] Block 3310 includes forming a cap including a first portion and a second portion, a dam portion disposed on a side of the cap configured to face the opening, a ledge portion adjacent to the dam portion, and a matching component disposed on the ledge. For example, as described above in connection with Figures 7A-7C and 9, cap 700, 900 can be formed to include first portion 710, 910 and second portion 720, 920, dam portion 730, 930 disposed on a side of cap 700, 900 configured to face opening 626, a ledge portion 732 adjacent to dam portion 730, and a matching component 740, 940 disposed on ledge 732.

[0299] 7A-7C, the first portion 710 of the cap 700 and the second portion 720 of the cap 700 can be coplanar and formed from a single piece. As described above in connection with FIG. 9, the first portion 910 of the cap 900 can extend along a first plane, the second portion 920 of the cap 900 can extend along a second plane different from the first plane, a dam portion 930 can comprise at least some of the cap 900 extending between the first and second planes and connecting the first portion 910 of the cap 900 with the second portion 920 of the cap 900, and at least some of the second portion 920 of the cap 900 can comprise a ledge upon which the mating component 940 rests.

[0300] Block 3312 includes fitting the cap onto or into the opening such that the first portion of the cap is positioned over the first portion of the cavity, the dam portion physically divides the first portion of the cavity from the second portion of the cavity, and the mating component presses against the portion of the analyte sensor and against a surface of the housing within the cavity, thereby sealing the first portion of the cavity from the second portion of the cavity. For example, the cap 700, 900 can be fitted onto or within the opening 626 such that the first portion 710, 910 of the cap 700, 900 is positioned over the first portion 752 of the cavity 750, the dam portion 730, 930 physically divides the first portion 752 of the cavity 750 from the second portion 754 of the cavity 750, and the matching component 740, 940 presses against a portion of the analyte sensor 138 and against the surface of the lower housing 622 within the cavity 750, thereby sealing the first portion 752 of the cavity 750 from the second portion 754 of the cavity 750.

[0301] In some embodiments, the method 3300 may further include disposing the electronics assembly substrate 630 within the housing 622, with the first conductive contact 324 and the second conductive contact 334 extending from the electronics assembly substrate to the first portion 752 of the cavity 750.

[0302] In some embodiments, the first portion 710, 910 of the cap 700, 900 can include a first hole 702, 902, and the method 3300 can further include, for example, depositing a sealing sealant 628, 928 into the first portion 752 of the cavity 750 through the first hole 702, 902, thereby sealing at least a portion of the analyte sensor 138 from the ingress of moisture.

[0303] In some embodiments, the first portion 710, 910 of the cap 700, 900 can include a second hole 704, 904, and the method 3300 can further include, for example, causing excess sealing sealant 628, 928 to flow from the first portion 752 of the cavity 750 through the second hole 704, 904.

[0304] In some embodiments, the dam portion 730, 930 can contact a portion of the lower housing 622 within the cavity 750. In some embodiments, the conforming component 740, 940 can comprise a foam or rubber material. In some embodiments, the conforming component 740, 940 can prevent the sealing sealant 628, 928 from flowing into the second portion 754 of the cavity 750.

[0305] In some embodiments, the cap 700 can include a second portion 720, 920 disposed over the second portion 754 of the cavity 750. In some other embodiments, the cap 900 can include a second portion 920 disposed adjacent to the second portion 754 of the cavity 750. In some embodiments, the second portion 710 of the cap 700 can include a slot 722, and the method 3300 can further include, for example, passing at least a portion of the analyte sensor 138 through the slot 722.

[0306] In some embodiments, the outward facing surface of the cap 700, 900 can fit flush with the outward facing surface of the lower housing 622. In some other embodiments, the outward facing surface of the cap 700, 900 can fit in a recessed position relative to the outward facing surface of the lower housing 622. In still other embodiments, the cap 700, 900 can be disposed on the outward facing surface of the lower housing 622.

[0307] In some embodiments, the method 3300 may further include securing the cap 700, 900 to the lower housing 622, for example, utilizing at least one of a toe feature, a snap feature, a friction fit feature, and a pressure sensitive adhesive.

[0308] In some embodiments, the cap 700, 900 comprises a material that is substantially transparent to ultraviolet radiation, and the method 3300 can further include curing the sealing sealant 628, 928, for example, by exposing the sealing sealant 628, 928 to ultraviolet radiation through the cap 700, 900.

[0309] 8A-8C 。 Method 3300 may further include, for example, utilizing a first adhesive portion 902 of adhesive patch 126 to secure cap 700, 900 to lower housing 622, adhesive patch 126 further comprising a second adhesive portion 804 configured to adhere first adhesive portion 802 and wearable assembly 600 to the host's skin. Method 3300 may further include, for example, securing first adhesive portion 802 of adhesive patch 126 to cap 700, 900 before cap 700, 900 is fitted onto or into opening 626 of lower housing 622. The first adhesive portion 802 can include at least a hole 880a configured to substantially align with at least one hole in the cap 700, 900 when the cap 700, 900 is secured to the first adhesive portion 802 of the adhesive patch 126. The second adhesive portion 804 can include at least a hole 880b configured to substantially align with at least one hole in the cap 700, 900 when the cap 700, 900 is secured to the second adhesive portion 804 of the adhesive patch 126.

[0310] 28A-29, the method 3300 can further include, for example, depositing at least one passivation layer 2802, 2906, 2908 over at least a portion of the analyte sensor 138, thereby preventing moisture ingress to portions of the sensor 138. The method 3300 can further include depositing one or more conductive traces 2904, 2912 over the passivation layers 2906, 2908 and electrically coupling the conductive traces 2904, 2912 to one or more of a first conductive contact 324 and a second conductive contact 334, for example, potentially illustrated as contact 2902a in FIG.

[0311] An exemplary method 3400 for fabricating an analyte sensing device and / or system will now be described below with reference to Figure 34. The method 3400 may correspond at least to what has been described above with reference to Figures 11A-20.

[0312] Block 3402 includes fabricating a housing. For example, the lower housing 622 can be formed as described above in connection with FIGS.

[0313] Block 3404 includes disposing an electronics assembly board within the housing. For example, electronics assembly board 630 can be disposed within housing 622.

[0314] Block 3406 includes coupling an analyte sensor comprising an elongated body having at least a first bend to at least one of the housing and the electronics assembly board. For example, analyte sensor 138 may be coupled to at least one of the housing 622 and the electronics assembly board 630 and comprises an elongated body having at least a first bend 1102a-c, 1202, 1302, 1402, 1502, 1602, 1702, 1802, 1902, or 2002, as described above in connection with FIGS.

[0315] In some embodiments, method 3400 may further involve providing one or more flexures in sensor 138 to position and / or hold sensor 138 in a desired orientation relative to electronics assembly substrate 630, as described above in connection with Figures 11A-20.

[0316] The method 3400 may further include, for example, forming the first bends 1202, 1302 in the analyte sensor 138 such that the portion of the elongate body distal to the first bends 1202, 1302 extends substantially parallel to the plane of the electronics assembly board 630, and the portion of the elongate body proximal to the first bends 1202, 1302 extends substantially perpendicular to the plane of the electronics assembly board 630 and at least partially into the electronics assembly board 630. In some embodiments, the lower housing 622 may include a recess 1216, and the method 3400 may include further extending at least some of the portion of the elongate body proximate to the first bend 1202 through the electronics assembly board 630 and into the recess 1206. In some embodiments, the portion of the elongate body proximate to the first bend 1302 applies a bias force F bias , thereby fixing the analyte sensor 138 in a desired orientation with respect to the electronics assembly substrate 630.

[0317] In some embodiments, the method 3400 may further include, for example, forming the first bends 1402, 1502, 1602 in the analyte sensor 138 such that the portions of the elongate body distal to the first bends 1402, 1502, 1602 extend substantially parallel to the plane of the electronics assembly board 630, and the portions of the elongate body proximal to the first bends 1402, 1502, 1602 extend substantially perpendicular to and away from the plane of the electronics assembly board 630. The lower housing 622 may further include a recess 1416 in a sidewall of the lower housing 622, and the method 3400 may include further extending at least some of the portions of the elongate body proximal to the first bends 1402, 1502, 1602 within the recess 1416, thereby constraining the analyte sensor 138 in a desired orientation relative to the electronics assembly board 630. In some embodiments, the portion of the elongate body proximal to the first bend 1502 exerts a bias force against the portion of the lower housing 622, thereby fixing the analyte sensor 138 in a desired orientation relative to the electronics assembly board 630.

[0318] In some embodiments, the method 3400 includes providing a first bias force F at a first location along the recess 1416 such that at least a first portion of the elongate body proximal to the first bend 1602 and distal to the additional bends 1606, 1608, 1610 extends in a first direction within the recess 1416. bias and at least a second portion of the elongate body extends in a second direction within a recess 1416 proximal to the first bend 1602 and proximal to the additional bends 1606, 1608, 1610, and exerts a second bias force F at a second location along the recess 1416. bias The method may further include forming at least one additional bend 1606, 1608, 1610 in the analyte sensor 138 proximal to the first bend 1602 to exert a force, thereby fixing the analyte sensor 138 in a desired orientation relative to the electronics assembly substrate 630.

[0319] In some embodiments, the method 3400 may further include forming the first bend 1702, 1802, 1902, 2002 in the analyte sensor 138 such that the portion of the elongate body distal to the first bend 1702, 1802, 1902, 2002 extends in a first direction substantially parallel to the plane of the electronics assembly board 630, and the portion of the elongate body proximal to the first bend 1702, 1802, 1902, 2002 extends in a second direction different from the first direction but also substantially parallel to the plane of the electronics assembly board 630.

[0320] In some embodiments, the method 3400 includes providing a first bias force F at a first location along one of the lower housing 622 and the electronics assembly board 630, wherein the additional bends 1804, 1806 extend in a second direction such that at least a first portion of the elongate body is proximal to the first bend 1802 and distal to the additional bends 1804, 1806. bias and at least a second portion of the elongated body proximate the first bend 1802 and proximate the additional bends 1804, 1806 extends in a third direction substantially parallel to the plane of the electronics assembly board 630 and exerts a second bias force F at a second location along one of the lower housing 622 and the electronics assembly board 630. bias The method may further include forming at least one additional bend 1804 1806 in the analyte sensor 138 proximal to the first bend 1802 to exert a force, thereby fixing the analyte sensor 138 in a desired orientation relative to the electronics assembly substrate 630.

[0321] In some embodiments, the electronics assembly board 630 may include a support post 1912, and the method 3400 may further include forming the first bend 1902 in the analyte sensor such that the portion of the elongate body distal to the first bend 1902 extends in a first direction substantially parallel to the plane of the electronics assembly board 630, and the portion of the elongate body proximal to the first bend 1902 extends substantially along the circumference of the support post 1912, thereby fixing the analyte sensor 138 in a desired orientation relative to the electronics assembly board 630.

[0322] In some embodiments, the portion of the elongate body distal to the first flexure 2002 exerts a first bias force F1 at a first location along one of the lower housing 622 and the electronics assembly board 630, thereby securing the analyte sensor 138 in a desired orientation with respect to the electronics assembly board 630. The first flexure 2002 can exert a second bias force F2 at a second location along one of the lower housing 622 and the electronics assembly board 630, thereby further securing the analyte sensor 138 in a desired orientation. The portion of the elongate body proximal to the first flexure 2002 can exert a third bias force F3 at a third location along one of the lower housing 622 and the electronics assembly board 630, thereby further securing the analyte sensor 138 in a desired orientation. In some embodiments, the second bias force F2 is applied in a direction substantially opposite to the third bias force F3, the first bias force F1 is applied in a direction substantially perpendicular to each of the second bias force F2 and the third bias force F3, and the first bend 2002 provides a first torque on the first bend 2002 that pushes a portion of the elongate body distal to the first bend 2002 toward a first location, and / or the first bend 2002 provides a second torque on the first bend 2002 that pushes a portion of the elongate body proximal to the first bend 2002 toward a third location.

[0323] An exemplary method 3500 for fabricating an analyte sensing device and / or system will now be described below in connection with FIG.

[0324] Block 3502 includes forming a housing including a cavity having a first portion and a second portion. For example, as described above in connection with FIGS. 6A-10, lower housing 622 can be formed including cavity 750 having first portion 752 and second portion 754.

[0325] Block 3504 includes forming a first dam portion in a first portion of the cavity adjacent to a first side of the first conductive contact. For example, first dam portion 2112 can be formed in a first portion of the cavity adjacent to a first side of first conductive contact 334.

[0326] Block 3506 includes forming a second dam portion in a first portion of the cavity adjacent a second side of the first conductive contact opposite the first side, where the first dam portion and the second dam portion define a first well portion that contains the first conductive contact. For example, second dam portion 2114 can be formed in the first portion of the cavity adjacent a second side of first conductive contact 334 opposite the first side. First dam portion 2112 and second dam portion 2114 define first well portion 2102 that contains first conductive contact 334.

[0327] Block 3508 includes disposing an analyte sensor on the first dam portion and the second dam portion. For example, analyte sensor 138 can be disposed on first dam portion 2112 and second dam portion 2114.

[0328] Block 3510 includes coupling a first electrode of the analyte sensor to the first conductive contact. For example, first electrode 212b of analyte sensor 138 can be coupled to first conductive contact 334.

[0329] Block 3512 includes coupling a second electrode of the analyte sensor to the second conductive contact. For example, second electrode 211b of analyte sensor 138 can be coupled to second conductive contact 324.

[0330] In some embodiments, the method 3500 can further include disposing the electronics assembly substrate within a housing, with the first and second conductive contacts extending from the electronics assembly substrate into the first portion of the cavity. For example, the electronics assembly substrate 630 can be disposed within the housing 622, with the first and second conductive contacts 324, 334 extending from the electronics assembly substrate 630 into the first portion of the cavity (see, e.g., FIGS. 6A-6C and 21A-21D).

[0331] In some embodiments, the first dam portion 2112 and the second dam portion 2114 each include a sloped cross-section, and the analyte sensor 138 can be placed on the lowest point of the sloped cross-section of the first dam portion 2112 and on the lowest point of the sloped cross-section of the second dam portion 2114. The sloped cross-section can be one of a triangularly concave, a parabolicly concave, a semicircularly concave, or a hyperbolic concave cross-section.

[0332] In some embodiments, the method 3500 may further include disposing conductive epoxy 2122 on at least a portion of the first conductive contact 334 in the first well portion 2102. The conductive epoxy 2122 is disposed up to at least the height of the lowest point of the sloped cross section of the first dam portion 2112 or the lowest point of the sloped cross section of the second dam portion 2114 such that the first electrode 212b of the analyte sensor 138 is in direct physical and electrical contact with the conductive epoxy 2122 when disposed on the first dam portion 2112 and the second dam portion 2114.

[0333] An exemplary method 3600 for fabricating a housing of an analyte sensing device will now be described below with reference to Figure 36. Method 3600 may correspond at least to what has been described above with reference to Figures 22-27.

[0334] Block 3602 includes forming a first pocket in the housing having a first pocket base. For example, the lower housing 622 can be formed as described above with reference to at least Figures 6A-10, and first pockets 2400a-c, 2700a having first pocket bases 2405a-c can be formed in the housing 622 as described above with reference to Figures 22-27.

[0335] Block 3604 includes forming a first abutment region within the housing abutting a first side of the first pocket, the first abutment region having a first abutment region base and a first transition between the first pocket base and the first abutment region base. For example, a first abutment region 2410a-c, 2710a abutting a first side of the first pocket 2400a-c, 2700a can be formed within the housing 622. The first abutment region 2410a-c, 2710a can have a first abutment region base 2415a-c and a first transition 2404a-c between the first pocket base 2405a-c and the first abutment region base 2415a-c.

[0336] Block 3608 includes forming a second adjacent region within the housing abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base. For example, a second adjacent region 2420a-c, 2720 abutting a second side of the first pocket 2400a-c, 2700a-b can be formed within the housing 622. The second adjacent region 2420a-c, 2720 can have a second adjacent region base 2425a-c and a second transition 2406a-c between the first pocket base 2405a-c and the second adjacent region base 2420a-c.

[0337] In some embodiments, the method 3600 may further include disposing the electronics assembly board 630 within the housing 622 .

[0338] In some embodiments, the first pockets 2400a-c, 2700a can have a substantially rectangular shape (e.g., 2300a), diamond shape (e.g., 2300c), or polygonal shape (e.g., 2300c) such that the first pockets 2400a-c, 2700a are substantially planar and meet to form angled corners. Alternatively, the first pockets 2400a-c, 2700a can have a substantially rounded rectangular shape, rounded diamond shape, or rounded polygonal shape (e.g., 2300b) such that portions of the sidewalls of the first pockets 2400a-c, 2700a are substantially planar, but other portions of the sidewalls connecting the substantially planar portions are curved.

[0339] In some embodiments, as described in connection with at least callout “F” in FIG. 22 and the “step-up” views in FIGS. 24 and 25, at least one of the first adjacent region base and the second adjacent region base is positioned at an elevated height “h” relative to the first pocket base such that at least one of the first transitions 2204f, 2404c and the second transitions 2206f, 2406c is stepped up from the first pocket base. In some embodiments, the elevated height “h” is approximately 0.5 millimeters. In some embodiments, the first predetermined amount of epoxy 2430c forms an upwardly deflecting meniscus 2432c at the first and second transitions 2404c, 2406c, and the elevated height “h” exceeds the height of the upwardly deflecting meniscus 2432c. In some embodiments, the elevated height “h” is a function of the first predetermined amount and at least one of the viscosity, surface energy, and surface tension properties of the epoxy 2430c.

[0340] In some embodiments, as described in connection with at least callout "P" in FIG. 22 and the "flush" views in FIGS. 24 and 25, at least one of the first adjacent region base and the second adjacent region base is positioned at the same height as the first pocket base such that at least one of the first transitions 2204p, 2404b and the second transitions 2206p, 2406b is flush with the first pocket base.

[0341] In some embodiments, as described in connection with at least callout "E" in Figure 22, Figures 24 and 25, and the "step-down" view of Figure 27, at least one of the first adjacent region base and the second adjacent region base is positioned at a reduced height "h" compared to the first pocket base such that at least one of the first transition 2204e, 2404a and the second transition 2206e, 2406a is reduced from the first pocket base. In some embodiments, the reduced height "h" is approximately 0.5 millimeters. In some embodiments, the first predetermined amount of epoxy 2430a forms a meniscus 2432a that bends downward at the first and second transitions 2404a, 2406a, thereby adhering the epoxy 2430a to at least one of the first and second transitions 2404a, 2406a and preventing the epoxy 2430c from creeping into adjacent regions of the first 2210e, 2410a, 2710a and second 2220e, 2420a, 2720a.

[0342] In some embodiments, the first adjacent region 2410a-c, 2710a and the second adjacent region 2420a-c, 2720 can have any shape described above for a pocket. In some embodiments, one or more sidewalls 2402a-c of the first pocket 2400a-c are disposed substantially perpendicular to the first pocket base, or alternatively, at an angle from substantially perpendicular to the first pocket base. In some embodiments, one or more sidewalls 2412a-c, 2422a-c of the first and second adjacent regions 2410a-c, 2420a-c are disposed substantially perpendicular to the respective first and second adjacent region bases, or alternatively, at an angle from substantially perpendicular to the respective first and second adjacent region bases. In some embodiments, one or more sidewalls 2408c of the first and second transitions 2404a-c, 2406a-c are disposed substantially perpendicular to the first pocket base, or alternatively at an angle from substantially perpendicular to the first pocket base, hi some embodiments, the sidewall 2408c of at least one of the first and second transitions 2404a-c, 2406a-c is rounded to avoid forming angled corners at the first and second transitions 2404a-c, 2406a-c.

[0343] In some embodiments, the first widths of the first transitions 2404a-c and the second widths of the second transitions 2406a-c are substantially within the range of 0.5 mm and 2.0 mm. In some embodiments, the first widths of the first transitions 2404a-c are greater than the second widths of the second transitions 2406a-c. In other embodiments, the first widths of the first transitions 2404a-c are less than the second widths of the second transitions 2406a-c.

[0344] In some embodiments, the method 3600 may further include, for example, disposing the conductive contacts 324, 334 in the first adjacent region 2710a or the second adjacent region 2720 of the electronics assembly substrate 630. In some embodiments, the analyte sensor 138 comprises a first electrode 211b and a second electrode 212b, and the method 3600 may further include, for example, disposing the analyte sensor 138 on the housing 622 and electrically connecting at least one of the first electrode 211b and the second electrode 212b with the conductive contacts 324, 334.

[0345] 27, the method 3600 may further include, for example, disposing a post 2712 in the first adjacent region 2710b or the second adjacent region 2720, disposing a second predetermined amount of epoxy on the post 2712, and disposing a portion of the analyte sensor 138 in the second predetermined amount of epoxy on the post 2712. The second predetermined amount of epoxy exerts a centering force on the portion of the analyte sensor 138 disposed therein such that the analyte sensor 138 is aligned substantially along a centerline of the post 2712. The post 2712 may have a substantially symmetrical shape about the centerline of the post 2712.

[0346] In some embodiments, the method 3600 can further include providing the pocket base with a first surface energy and providing the first adjacent region base with a second surface energy that is different from the first surface energy. For example, as described above in connection with Figures 40A-40B, the pocket bases 4005a-b can have a first surface energy and the first adjacent region bases 4015a-b can have a second surface energy that is different from the first surface energy.

[0347] In some embodiments, the method 3600 can further include providing the second adjacent region base with one of a second surface energy different from the first and second surface energies and a third surface energy. For example, as described above in connection with Figures 40A-40B, the second adjacent region bases 4025a-b can have one of a second surface energy and a third surface energy different from the first and second surface energies.

[0348] An exemplary method 3700 for fabricating an analyte sensing device and / or system will now be described below with reference to Figure 37. Method 3700 may correspond at least to what has been described above with reference to Figures 22-27.

[0349] Block 3702 includes forming a housing including: a first pocket having a first pocket base; a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base; a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base; and conductive contacts disposed in the first adjacent region or the second adjacent region. For example, the lower housing 622 can be formed as described above with reference to at least FIGS. 6A-10, and first pockets 2400a-c, 2700a having first pocket bases 2405a-c can be formed in the housing 622 as described above with reference to FIGS. A first abutting region 2410a-c, 2710a abutting a first side of the first pocket 2400a-c, 2700a can be formed in the housing 622. The first abutting region 2410a-c, 2710a can have a first abutting region base 2415a-c and a first transition 2404a-c between the first pocket base 2405a-c and the first abutting region base 2415a-c. A second abutting region 2420a-c, 2720 abutting a second side of the first pocket 2400a-c, 2700a-b can be formed in the housing 622. The second adjacent region 2420a-c, 2720 can have a second adjacent region base 2425a-c and a second transition 2406a-c between the first pocket base 2405a-c and the second adjacent region base 2420a-c. The conductive contacts 324, 334 can be disposed in the first adjacent region 2410a-c or the second adjacent region 2420a-c.

[0350] Block 3704 includes disposing an electronics assembly substrate within the housing and electrically coupling the electronics assembly substrate to the conductive contacts. For example, the electronics assembly substrate 630 can be disposed within the housing 622, and the electronics assembly substrate 630 can be electrically coupled to the conductive contacts 324, 334.

[0351] Block 3706 includes disposing an analyte sensor comprising at least one electrode in electrical communication with the conductive contacts. For example, analyte sensor 138 comprises at least one electrode 211b, 212b, which can be disposed in electrical communication with conductive contacts 324, 344.

[0352] Block 3708 includes disposing epoxy disposed on the first pocket base, the epoxy securing at least a portion of the analyte sensor to the first pocket base. For example, epoxy can be disposed on the first pocket bases 2405a-c such that the epoxy secures at least a portion of the analyte sensor 138 to the first pocket bases 2405a-c.

[0353] In some embodiments, as described in connection with at least callout "F" in Figure 22 and the "step-up" views of Figures 24 and 25, at least one of the first adjacent region base and the second adjacent region base is positioned at an elevated height "h" relative to the first pocket base such that at least one of the first transitions 2204f, 2404c and second transitions 2206f, 2406c step up from the first pocket base. In some embodiments, the first predetermined amount of epoxy 2430c forms an upwardly deflecting meniscus 2432c at the first and second transitions 2404c, 2406c, and the elevated height "h" exceeds the height of the upwardly deflecting meniscus 2432c.

[0354] In some embodiments, as described in connection with at least callout "P" in FIG. 22 and the "flush" views in FIGS. 24 and 25, at least one of the first adjacent region base and the second adjacent region base is positioned at the same height as the first pocket base such that at least one of the first transitions 2204p, 2404b and the second transitions 2206p, 2406b is flush with the first pocket base.

[0355] In some embodiments, as described in connection with at least callout "E" in FIG. 22, FIGS. 24 and 25, and the "step-down" view in FIG. 27, at least one of the first adjacent region base and the second adjacent region base is positioned at a lower height "h" compared to the first pocket base, such that at least one of the first transition 2204e, 2404a and the second transition 2206e, 2406a steps down from the first pocket base. In some embodiments, the first predetermined amount of epoxy 2430a forms a meniscus 2432a that bends downward at the first and second transitions 2404a, 2406a, thereby adhering the epoxy 2430a to at least one of the first and second transitions 2404a, 2406a and preventing the epoxy 2430c from creeping into adjacent regions of the first 2210e, 2410a, 2710a and second 2220e, 2420a, 2720a.

[0356] An exemplary method 3800 for fabricating an analyte sensing device and / or system will now be described below with reference to Figure 38. Method 3800 may correspond to at least the embodiments described above with reference to Figures 30A-30B.

[0357] Block 3802 includes forming a housing with an opening that defines a cavity within the housing having a first portion and a second portion. For example, as described above in connection with FIGS. 6A-10, lower housing 622 can be formed to include opening 626 that defines cavity 750 within lower housing 622 having first portion 752 and second portion 754.

[0358] Block 3804 includes disposing a first heat-sealable thermoplastic elastomer along the periphery of a first portion of the cavity. For example, first heat-sealable thermoplastic elastomer 3002 can be disposed along the periphery of first portion 752 of cavity 750.

[0359] Block 3806 includes disposing at least a portion of the analyte sensor within the first portion of the cavity. For example, at least a proximal portion of the analyte sensor 138 can be disposed within the first portion 752 of the cavity 750.

[0360] Block 3810 includes fitting a cap over or within the opening and over the first portion of the cavity, the cap including a second heat-sealable thermoplastic elastomer along at least a portion of the cap disposed on the boundary between the first and second portions of the cavity. For example, cap 3004 may include a second heat-sealable thermoplastic elastomer 3006 along at least a portion of cap 3004 disposed on the boundary between the first 752 and second 754 portions of cavity 750. Cap 3004 may be fitted over or within opening 626 and over first portion 752 of cavity 750.

[0361] Block 3812 includes melting the first and second heat-sealable thermoplastic elastomers, thereby sealing the first portion of the cavity from moisture intrusion. For example, the first 3002 and second 3006 heat-sealable thermoplastic elastomers can be melted, for example, by exposure to a laser or similar heat source, thereby preventing the first portion 752 of the cavity 750 from moisture intrusion. In some embodiments, the boundary between the first 752 and second 754 portions of the cavity 750 includes a portion of the first heat-sealable thermoplastic elastomer 3002.

[0362] An exemplary method for fabricating an analyte sensing device and / or system will now be described below in connection with Figure 39. Method 3900 may correspond to at least the embodiments previously discussed in connection with Figures 31 and 32.

[0363] Block 3902 includes forming a housing including an opening that defines a housing cavity within the housing. For example, lower housing 622 can be formed to include opening 626 that defines cavity 750 within lower housing 622.

[0364] Block 3904 includes disposing the first and second conductive contacts within the housing cavity. For example, first and second conductive contacts 324 and 334 can be disposed within cavity 750.

[0365] Block 3906 includes disposing a first electrode of the analyte sensor on the first conductive contact. For example, first electrode 211b of analyte sensor 138 can be disposed on first conductive contact 324.

[0366] Block 3908 includes disposing a second electrode of the analyte sensor on the second conductive contact. For example, second electrode 212b of analyte sensor 138 can be disposed on second conductive contact 334.

[0367] Block 3910 includes providing a cap including a base and a sealing material, the base including a first cavity and a second cavity. For example, the caps 3100, 3200 can include a base 3102, 3202 and a sealing material 2104, 3204, the base including a first cavity and a second cavity.

[0368] Block 3912 includes fitting the cap over or into the opening such that the encapsulation material at least partially fills the housing cavity and presses against the housing, with the first cavity aligning over the first electrode and first conductive contact, and the second cavity aligning over the second electrode and second conductive contact. For example, the cap 3100, 3200 can be fitted over or into the opening 626 such that the encapsulation material 3104, 3204 fills or partially fills the cavity 750 on the electronics assembly substrate 630 and presses against the electronics assembly substrate 630, with the first cavity aligning over the first electrode 211b and the first conductive contact 324, and the second cavity aligning over the second electrode 212b and the second conductive contact 334.

[0369] In some embodiments, the method 3900 may further include disposing a first conductive elastomer puck 3106 in the first cavity and a second conductive elastomer puck 3108 in the second cavity before fitting the cap 3100 over or within the opening 626. The first conductive elastomer puck 3106 is configured to press against the first electrode 211 b and the first conductive contact 324 when the cap 3100 is fitted over or within the ...

Claims

1. 1. An analyte sensing device comprising: A housing, a first pocket having an opening opposite a first pocket base, the opening being disposed at a height above the first pocket base and defining a volume therebetween; a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base, the first adjacent region base being disposed at a lower height farther from the opening than the first pocket base; and a housing including a conductive contact disposed in the first adjacent region; an electronics assembly substrate disposed within the housing and electrically coupled to the conductive contacts; an analyte sensor comprising at least one electrode in electrical communication with the conductive contact; an adhesive disposed on the first pocket base, the adhesive securing at least a portion of the analyte sensor to the first pocket base; The apparatus wherein the first adjacent region is continuous with the first pocket, and the first transition inhibits the adhesive from creeping from the first pocket base into the first adjacent region base.

2. 2. The apparatus of claim 1, further comprising a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base.

3. the second adjacent region base is disposed at a higher height closer to the opening than the first pocket base; The apparatus of claim 2 , wherein the adhesive forms an upwardly bending meniscus at the second transition, and the elevated height exceeds the height of the upwardly bending meniscus.

4. The apparatus of claim 2 , wherein the second adjacent region base is disposed at the same height as the first pocket base.

5. The apparatus of claim 2 , wherein the second adjacent region base is disposed at a lower height, further from the opening, than the first pocket base.

6. The device of claim 2 , wherein the adhesive forms a downwardly bending meniscus at the first transition and / or the second transition.

7. The device of claim 2 , wherein the adhesive is an epoxy adhesive or a UV-curable adhesive.

8. 2. The device of claim 1, wherein a second adjacent region abuts a second side of the first pocket, the second adjacent region is continuous with the first pocket, and the second adjacent region has a through hole for passing a sensor insertion needle therethrough.

9. the first pocket has first sidewalls extending from the first pocket base to the opening, the first sidewalls being separated from one another by a first width; the first adjacent region has second sidewalls extending from the first adjacent region base, the second sidewalls being separated from one another by a second width; 2. The device of claim 1, wherein the first transition has third sidewalls extending toward each other and separated from each other by a third width that is less than the first width and less than the second width.

10. 1. An analyte sensing device housing comprising: a first pocket having an opening opposite a first pocket base, the opening being disposed at a height above the first pocket base and defining a volume therebetween; a first adjacent region abutting a first side of the first pocket, the first adjacent region having a first adjacent region base and a first transition between the first pocket base and the first adjacent region base, the first adjacent region base being disposed at a lower elevation farther from the opening than the first pocket base; and an adhesive disposed on the first pocket base; Equipped with A housing, wherein the first adjacent region is continuous with the first pocket, and the first transition inhibits the adhesive from creeping from the first pocket base into the first adjacent region base.

11. a second adjacent region abutting a second side of the first pocket, the second adjacent region having a second adjacent region base and a second transition between the first pocket base and the second adjacent region base; The housing of claim 10 further comprising: an electronics assembly board disposed within the housing.

12. The housing of claim 11 , wherein the second adjacent region base is disposed at a higher height closer to the opening compared to the first pocket base.

13. The housing of claim 12 , wherein the adhesive forms an upwardly bending meniscus at the second transition, and the elevated height exceeds the height of the upwardly bending meniscus.

14. The housing of claim 13 , wherein the elevated height is selected as a function of a predetermined amount, viscosity, surface energy and / or surface tension properties of the adhesive.

15. The housing of claim 13 , wherein the adhesive adheres to the second transition, the second transition inhibiting the adhesive from creeping beyond the second transition.

16. The housing of claim 13 , wherein the adhesive is an epoxy adhesive or a UV-curable adhesive.

17. The housing of claim 11 , wherein the second transition is flush with the first pocket base.

18. The housing of claim 11 , wherein the second adjacent region base is disposed at a lower elevation farther from the opening than the first pocket base.

19. The housing of claim 11 , wherein the first pocket base has a first surface energy and the first adjacent region base has a second surface energy different from the first surface energy.

20. 11. The housing of claim 10, wherein the first pocket has a substantially rounded rectangular shape such that portions of a side wall of the first pocket are substantially planar while other portions of the side wall connecting the substantially planar portions are curved.

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