A small, wearable device for measuring samples

Abstract

Implementations generally relate to devices for measuring an analyte in a host. Implementations can provide for miniaturization of the size of a wearable device that includes a transcutaneous analyte sensor for measuring the analyte.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 295,819, filed December 31, 2021, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION SUMMARY OF THE DISCLOSURE Systems, methods and devices for measuring an analyte in an individual are provided. More particularly, an on-skin medical device is provided that is wearable by a recipient and has an analyte sensor. [Background technology]

[0003] Description of Related Art Diabetes mellitus is a disorder in which the pancreas cannot make enough insulin (Type I or insulin-dependent) and / or insulin is not effective (Type 2 or non-insulin-dependent). In the diabetic state, the victim suffers from hyperglycemia, which can cause many physiological disorders associated with deterioration of small blood vessels, such as kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (hypoglycemia) can be precipitated by inadvertent overdosing of insulin or after normal administration of insulin or glucose-lowering agents 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 lack of comfort and convenience, people with diabetes typically measure their glucose levels only two to four times per day. Unfortunately, such time intervals are spread out so far apart that the person with diabetes may not know about a hyperglycemic or hypoglycemic condition until it is too late, sometimes resulting in dangerous side effects. Glucose levels may alternatively be continuously monitored by a measurement system that includes an on-skin sensor assembly. The sensor assembly may have a wireless transmitter that transmits measurement data to a receiver, which can process and display information based on the measurements.

[0005] Minimizing the size of the on-skin sensor assembly can be important in achieving a comfortable, minimally invasive, and user-friendly measurement system. Such a reduction in size can, among other benefits, increase the comfort experienced by the recipient.

[0006] This Background is provided to introduce a brief background to the Summary and Detailed Description that follow. This Background is not intended to aid in determining the scope of the claimed subject matter, nor should it be deemed to limit the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. Summary of the Invention [Problem to be solved by the invention]

[0007] This Summary is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the Detailed Description. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all of the disadvantages noted in any part of this disclosure. [Means for solving the problem]

[0008] In a first aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising a body configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor, at least a portion of the body comprising a liquid crystal polymer.

[0009] Implementations of the embodiments may include one or more of the following: The body may comprise a housing. The body may be configured to hold one or more electrical components. The body may include a base and an enclosure configured to be coupled to the base, with a seal formed between the base and the enclosure, at least a portion of the enclosure comprising a liquid crystal polymer. The base may be configured to hold one or more electrical components within a periphery of the base, with the enclosure configured to extend over the one or more electrical components. The enclosure may include an outer shell comprising a liquid crystal polymer. The outer shell may be disposed on an inner shell of the enclosure comprising one or more of a nylon plastic, a polyolefin, or a thermoplastic elastomer. A filler may be disposed between the base and the enclosure. The filler may comprise a thermoplastic. The enclosure may be coupled to the base with an adhesive comprising a polyolefin, a polyurethane, a silicone, an epoxy, or an acrylate. The seal between the base and the enclosure may be moisture resistant. The seal between the base and the enclosure may be ultrasonically welded, laser welded, vibration welded, or electromagnetically welded. The patch may be configured to couple the body to the skin. The transdermal analyte sensor may be configured to extend from the body and be positioned within the skin. The body may be configured to carry one or more electrical components for receiving a signal from the transdermal analyte sensor.

[0010] In a second aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a transcutaneous analyte sensor configured to generate a signal indicative of an analyte concentration in the recipient; and a body configured to be positioned adjacent to the recipient's skin, the body including one or more bending portions configured to enable the body to bend to conform to the contours of the skin.

[0011] Implementations of the embodiments may include one or more of the following: The body may comprise a housing. The housing may have an exterior and an interior, and the one or more bending portions include one or more living hinges extending along the exterior of the housing. The exterior may include a top surface and a bottom surface, and the one or more living hinges extend along the top surface. The housing may be configured to bend along the one or more living hinges in a direction away from the bottom surface. The exterior may include a top surface and a bottom surface, and the one or more living hinges extend along the bottom surface. The housing may be configured to bend along the one or more living hinges in a direction away from the top surface. The one or more living hinges may comprise a channel extending along the exterior of the housing. The one or more living hinges may extend across the exterior along a central axis of the housing. The body may have an S-shape, and the one or more bending portions each include a recess forming an S-shape. The S-shape of the body may conform to an oval periphery. The body may comprise a housing including a plurality of compartments, the plurality of compartments being separated by one or more flex portions comprising horizontal and vertical living hinges. The flexible cover may be configured to extend over the housing and bend with the housing. The one or more flex portions may comprise a fabric extending between rigid portions of the body. A flexible circuit board may be disposable within the body and may be coupled to one or more electrical components and configured to flex with the body.

[0012] In a third aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a transcutaneous analyte sensor configured to generate a signal indicative of an analyte concentration in the recipient; and a body configured to be positioned adjacent to the recipient's skin, the body including one or more electrical conduits formed from an anisotropic conductive adhesive (ACA).

[0013] Implementations of the embodiments may include one or more of the following: The one or more electrical conduits may be configured to transmit electrical energy to or from the transdermal analyte sensor. The electrical energy may include an electrical signal to or from the transdermal analyte sensor. The electrical energy may include power to or from the transdermal analyte sensor. The device may further comprise a battery, and the one or more electrical conduits transmit power from the battery to one or more electrical components disposed within the body. The one or more electrical components may comprise a wireless transmitter. The one or more electrical components may comprise one or more electrical terminals for the transdermal analyte sensor. The one or more electrical conduits may electrically connect the one or more electrical components to a printed circuit board (PCB). The ACA may include particles collimated by applying an electric or magnetic field to the particles. The ACA may be cured by heat or ultraviolet light.

[0014] In a fourth aspect, a method for forming one or more electrical conduits of an on-skin wearable medical device, the method comprising: placing an anisotropic conductive adhesive (ACA) on an electrical substrate of the on-skin wearable medical device, collimating particles of the ACA, and curing the ACA to form one or more electrical conduits.

[0015] Implementations of the embodiments may include one or more of the following: The electrical conductivity of the one or more electrical conduits may be in a direction perpendicular to the plane of the electrical substrate. Collimating the particles of the ACA may include applying an electric or magnetic field to the ACA. Curing the ACA may include applying heat or ultraviolet light to the ACA. The method may include forming one or more electrical conduits between the electrical substrate and one or more electrical components of the on-skin wearable medical device. Curing the ACA physically and electrically couples the one or more electrical components to the electrical substrate. The one or more electrical conduits may be configured to transmit electrical energy to or from the transdermal analyte sensor. The electrical energy may include an electrical signal to or from the transdermal analyte sensor. The electrical energy may include power to or from the transdermal analyte sensor. The one or more electrical conduits may be configured to transmit power from a battery to one or more electrical components disposed within a body of the on-skin wearable medical device.

[0016] In a fifth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a transcutaneous analyte sensor configured to generate a signal indicative of an analyte concentration in the recipient; a body configured to be positioned adjacent to the skin of the recipient; and a loop antenna coupled to the body and configured to receive or transmit a signal from the body.

[0017] Implementations of the embodiments may include one or more of the following: The body may include a socket configured to couple to a plug coupled to the transcutaneous analyte sensor, the loop antenna surrounding the socket. The loop antenna may form at least a partial loop around the socket. The socket may include a gasket configured to form a seal with the plug. One or more electrical contacts may be disposed within the socket for contacting one or more electrical contacts coupled to the plug. The one or more electrical contacts disposed within the socket may include a conductive elastomeric material. The loop antenna may surround the one or more electrical contacts disposed within the socket. A channel may surround the socket, the loop antenna being disposed within the channel. The loop antenna may have a rectangular cross-section. The loop antenna may have an oblong shape.

[0018] In a sixth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising a body including a sensor receiving portion having one or more slots, and a transcutaneous analyte sensor configured to generate a signal indicative of an analyte concentration in the recipient, the transcutaneous analyte sensor comprising: a transcutaneous analyte sensor disposed within the sensor receiving portion; and one or more conductor bodies, each conductor body having a branched portion configured to couple to a portion of the transcutaneous analyte sensor, each of the one or more conductor bodies configured to be pressed into a respective one of the one or more slots to couple to a respective portion of the transcutaneous analyte sensor.

[0019] Implementations of the embodiments may include one or more of the following: Each of the one or more conductor bodies may include a lower surface and an upper surface, the lower surface including a bifurcated portion and the upper surface including a releasable portion configured to release from an applicator for the one or more conductor bodies. The releasable portion may comprise a breakable portion of the one or more conductor bodies. The releasable portion may be configured to release from the applicator by shear force. The sensor receiving portion may include a channel extending across the one or more slots, the transcutaneous analyte sensor extending along the channel. Each of the one or more slots may include a lower surface, the channel being elevated above the respective lower surface. Each of the one or more slots may include a cavity extending from the channel to the respective lower surface, the one or more conductor bodies each including one or more arms configured to be disposed within a respective one of the cavities. Each of the one or more conductor bodies may be configured to be forced into a respective one of the one or more slots to apply pressure to the transcutaneous analyte sensor and hold the transcutaneous analyte sensor in place. The bifurcated portion may have a wedge shape, and the one or more conductor bodies apply pressure to the transcutaneous analyte sensor from perpendicular and lateral directions relative to the transcutaneous analyte sensor. The one or more conductor bodies may electrically couple the transcutaneous analyte sensor to one or more electrical components disposed within the body. Each of the one or more slots may include a lower surface, and the bifurcated portion is configured to face opposite the lower surface when the one or more conductor bodies are pressed into a respective one of the one or more slots. Each of the one or more conductor bodies may have an apex portion coupled to the bifurcated portion, and each of the one or more slots includes a lower surface, and the apex portion is configured to face toward the lower surface when the one or more conductor bodies are pressed into a respective one of the one or more slots. The apex portion may comprise a living hinge. The bifurcated portion may include at least two arms having inner surfaces configured to face toward each other and extend parallel to each other when the one or more conductor bodies are pressed into a respective one of the one or more slots.The inner surfaces may be configured to move toward one another when one or more conductor bodies are forced into respective ones of the one or more slots.

[0020] In a seventh aspect, a medical system comprising an on-skin wearable medical device configured to be peeled onto a recipient's skin to at least partially deploy the on-skin wearable medical device on the recipient's skin.

[0021] Implementations of embodiments may include one or more of the following: The applicator may be configured to at least partially deploy the on-skin wearable medical device on the skin of the recipient. The applicator may include a reel configured to hold the on-skin wearable medical device. The elongated retainer body may be configured to hold the on-skin wearable medical device and wrap around the reel. The on-skin wearable medical device may be configured to be released from the elongated retainer body and at least partially deployed on the skin of the recipient. The elongated retainer body may comprise a ribbon. The elongated retainer body may be configured to be unwound from the reel. The elongated retainer body may be configured to hold a plurality of on-skin wearable medical devices. The elongated retainer body may be configured to be peeled along the skin of the recipient and to be pulled from the applicator while being peeled along the skin of the recipient. The on-skin wearable medical device may include a transcutaneous analyte sensor, and the applicator includes a needle configured to insert the transcutaneous analyte sensor into the skin of the recipient. The applicator may be configured to retract the needle from the recipient's skin. The system may include a trigger assembly for inserting the needle into the recipient's skin. The trigger assembly may be actuated based on movement of the applicator relative to the recipient's skin. The applicator may include a first portion and a second portion, the first portion configured to hold a used needle after insertion into the recipient's skin, the second portion holding a reel configured to hold the on-skin wearable medical device, and the first portion being separable from the second portion. The applicator may include an insertion assembly configured to be positioned over the on-skin wearable medical device to insert a transcutaneous analyte sensor of the on-skin wearable medical device into the recipient's skin. At least a portion of the on-skin wearable medical device may be flexible. A flexible housing of the on-skin wearable medical device may be configured to be peeled off onto the recipient's skin.The on-skin wearable medical device may be configured to be peeled onto the skin of a recipient for inserting a transcutaneous analyte sensor of the on-skin wearable medical device into the skin of the recipient. The on-skin wearable medical device may be configured to hold one or more electrical components for the on-skin wearable medical device. The one or more electrical components may include one or more of a battery, a transmitter, or contacts for the transcutaneous analyte sensor.

[0022] In an eighth aspect, a medical device applicator system comprising a reel configured to hold a plurality of flexible on-skin wearable medical devices on the reel, the on-skin wearable medical devices being configured to be deployed from the reel onto the skin of a recipient.

[0023] Implementations of embodiments may include one or more of the following: At least one of the plurality of flexible on-skin wearable medical devices is configured to be peeled onto the skin of a recipient to at least partially deploy the on-skin wearable medical device on the skin of the recipient. The system may include an elongated retainer body configured to hold the on-skin wearable medical device and wrap around a reel. The elongated retainer body may be configured to be unwound from the reel. The system may include an insertion assembly for inserting a needle into the skin of the recipient to insert a transcutaneous analyte sensor of one of the on-skin wearable medical devices into the skin of the recipient. The system may include a retraction assembly for retracting the needle from the skin of the recipient after inserting the transcutaneous analyte sensor of one of the on-skin wearable medical devices into the skin of the recipient with the needle. The system may include an applicator housing configured to hold the reel and be grasped by a user. The applicator housing may include an opening configured for the elongated retainer body configured to hold the on-skin wearable medical device to be unwound therefrom. The system may include a plurality of flexible on-skin wearable medical devices, each of which may include a transcutaneous analyte sensor configured to be inserted into the skin of a recipient.

[0024] In a ninth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a body including a sensor receiving portion; a transcutaneous analyte sensor disposed within the sensor receiving portion; an electrical connector body including a first end, a second end and a central portion between the first end and the second end, wherein the first end is conductive and configured to form an electrical connection with the first portion of the transcutaneous analyte sensor, and the second end is conductive and configured to form an electrical connection with the second portion of the transcutaneous analyte sensor, the central portion including an insulator electrically insulating the first end from the second end; and an upper member configured to be disposed over the transcutaneous analyte sensor and the electrical connector body.

[0025] Implementations of the embodiments may include one or more of the following: The first end may include a conductive elastomeric material. The second end may include a conductive elastomeric material. The central portion may include an elastomeric material. The electrical connector body may comprise a continuum extending from the first end to the second end. The first end may be electrically connected to the electrical board and the second end is electrically connected to the electrical board. The device may include at least one conductive tab configured to electrically connect the first end to the electrical board and at least one conductive tab configured to electrically connect the second end to the electrical board. The sensor receiving portion may include a cavity configured to receive the transcutaneous analyte sensor, and the top member seals the cavity. The device may include an adhesive material configured to create a seal between the top member and the body. The first end and the second end may each be configured to electrically connect the transcutaneous analyte sensor to one or more electrical components of the body.

[0026] In a tenth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising a housing configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor, the housing including a wall comprising a film layer.

[0027] Implementations of the embodiments may include one or more of the following: The housing may include a bottom configured to be placed adjacent to the skin and a top configured to be raised above the bottom, at least a portion of the top comprising the film layer. The housing may include an outer top surface configured to face away from the skin, at least a portion of the outer top surface comprising the film layer. The housing may include a bottom configured to be placed adjacent to the skin, at least a portion of the bottom comprising the film layer. The housing may include a bottom surface configured to face toward the skin, at least a portion of the bottom comprising the film layer. The housing may include a bottom configured to be placed adjacent to the skin and a top configured to be raised above the bottom, the bottom comprising the film layer and the top comprising the film layer, the bottom film layer being coupled to the top film layer. The bottom film layer may be coupled to the top film layer to form a seal of the interior cavity of the housing. The bottom film layer may be coupled to the top film layer around an edge of the housing. The bottom film layer may be coupled to a socket for receiving a plug coupled to the transdermal analyte sensor, and the top film layer may be coupled to a socket for receiving a plug coupled to the transdermal analyte sensor. The device may include a patch coupled to the housing and configured to couple the housing to the skin. The housing may be flexible. The housing may have a length, a width, and a height, the length and the width each being greater than the height. The device may include a socket for receiving a plug coupled to the transdermal analyte sensor. The socket may include an opening at a top of the housing. The length may be greater than the width, and the socket has an oblong shape with a major dimension extending along the width of the housing. The housing may have a rectangular shape. The device may include a cover layer forming an exterior surface of the housing and disposed over the film layer. The device may include one or more electrical components disposed within an interior cavity of the housing. The one or more electrical components may include one or more of a transmitter, a battery, or contacts for the transdermal analyte sensor. A filler material may be disposed within the interior cavity of the housing.

[0028] In an eleventh aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a body configured to be worn on the skin; and a socket coupled to the body and configured to couple to a plug coupled to a transcutaneous analyte sensor, the socket including a raised portion and a channel surrounding the raised portion, the raised portion including one or more electrical contacts for electrical connection with the transcutaneous analyte sensor, and the channel including a fluid disposed therein to form a seal with at least a portion of the plug.

[0029] Implementations of the embodiments may include one or more of the following: The fluid may include a gel. The gel may include petrolatum. The channel may include a reservoir for receiving and storing any excess fluid after coupling the plug to the socket. A raised outer wall may surround the channel. The raised outer wall may contour to the shape of the plug. The raised portion may include a coupler for coupling with the plug. The raised portion may be configured to enter a cavity in the plug. The raised portion may include a top surface on which the one or more electrical contacts are disposed, the top surface being configured to face the plug, the socket including a bottom surface facing opposite the top surface, and the one or more electrical contacts passing from the top surface to the bottom surface. The one or more electrical contacts may include a conductive elastomeric material.

[0030] In a twelfth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: an elongated housing configured to be worn on the skin and having a long dimension; and an elongated socket coupled to the elongated housing and configured to connect to a plug coupled to a transcutaneous analyte sensor, the elongated socket having a long dimension extending along the long dimension of the elongated housing.

[0031] Implementations of the embodiments may include one or more of the following: The elongated socket may comprise an upper level disposed above a lower level of the elongated housing. The lower level may include one or more electrical components, including one or more of a transmitter or a battery. The elongated socket may be disposed above the transmitter. The elongated housing may include a co-molded material. The co-molded material may include a first material having a greater rigidity than a second material. The first material may comprise a frame to which the second material is coupled, the second material forming at least a portion of an exterior surface of the elongated housing. The elongated housing may be flexible. The elongated housing may include a base configured to be placed adjacent to the skin and a top configured to be elevated above the base, the base including a film layer. A patch may be coupled to the base, the patch configured to couple the elongated housing to the skin.

[0032] In a thirteenth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a body configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor; one or more electrical components disposed within the body; at least one power source disposed within the body and configured to provide power to the one or more electrical components; and a conductive tape configured to electrically couple the at least one power source to the one or more electrical components.

[0033] Implementations of the embodiments may include one or more of the following: The at least one power source may comprise at least one battery. The conductive tape may be configured to couple to a positive or negative terminal of the at least one battery. The conductive tape may be flexible. The conductive tape may be wrapped around at least a portion of the at least one power source.

[0034] In a fourteenth aspect, a system includes a first conductive film, a second conductive film configured to be disposed adjacent to the first conductive film, a non-conductive film configured to be laterally sandwiched by the first conductive film and the second conductive film, a transdermal analyte sensor disposed above the first conductive film, the second conductive film, and the non-conductive film, the transdermal analyte sensor being in electrical contact with the first conductive film and the second conductive film, and a barrier film configured to be disposed over the transdermal analyte sensor to create a seal over the transdermal analyte sensor, the first conductive film, the second conductive film, and the non-conductive film, the barrier film configured to be disposed over the transdermal analyte sensor to create a seal over the transdermal analyte sensor, the first conductive film, the second conductive film, and the non-conductive film, the first conductive film, the second conductive film, and the non-conductive film, the barrier film further configured to couple to an electrical substrate to form an electrical connection between the transdermal analyte sensor and the electrical substrate.

[0035] Implementations of the embodiments may include one or more of the following: The solidified backing layer may be configured to be disposed over the barrier film. The transdermal analyte sensor may be further configured to bend in an area away from the first conductive film, the second conductive film, and the non-conductive film. The barrier film may be non-conductive. The transdermal analyte sensor may have a tip configured to be disposed over the first conductive film, the first conductive film being the working electrode and the second conductive film being the reference electrode.

[0036] In a fifteenth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a body configured to be worn on the skin and configured to connect to a transcutaneous analyte sensor; an electrical substrate disposed within the body; at least one battery having a periphery and electrical terminals, the electrical terminals being disposed on the electrical substrate, the at least one battery configured to power one or more electrical components of the on-skin wearable medical device; and a sealing portion disposed around the at least one battery and configured to reduce moisture ingress to the electrical terminals.

[0037] Implementations of the embodiments may include one or more of the following: The electrical substrate may include electrical contacts, the electrical terminal contacting the electrical contacts, and the seal configured to reduce moisture ingress to the contact between the electrical terminal and the electrical contact. The seal may be disposed on the electrical substrate. The seal may extend around an entire perimeter of the at least one battery. The battery may include a coin cell battery. The electrical terminal of the coin cell battery may be a negative terminal. The perimeter may be circular. The body may include a housing having an internal cavity, and the seal includes a hardenable material filling the internal cavity. The at least one battery may have a bottom surface and a top surface, the bottom surface of the at least one battery facing the electrical substrate, and the seal covers the top surface of the at least one battery. The seal may include one or more of a hardenable material or a foam.

[0038] In a sixteenth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising: a housing configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor, the housing including one or more walls defining a cavity for receiving a hardenable material, the cavity having an end with an opening; a substrate disposed inside the housing and at the opening of the cavity; a hardenable material disposed within the cavity; and an adhesive layer disposed between the substrate and the opening of the cavity, the adhesive layer configured to prevent the hardenable material from exiting the cavity through the opening.

[0039] Implementations of the embodiments may include one or more of the following: The adhesive layer may be disposed on a substrate. The substrate may include an electrical substrate configured to electrically couple with the transdermal analyte sensor. The one or more walls may each have an edge defining an opening of the cavity, and the adhesive layer is in contact with the edge of the one or more walls and the substrate. The adhesive layer may include a first surface and a second surface opposite the first surface, the first surface and the second surface each including an adhesive portion. The first surface may be in contact with the substrate. The cavity may be configured to receive the transdermal analyte sensor. The adhesive layer may be configured to electrically couple with the transdermal analyte sensor. The adhesive layer may be configured to prevent the curable material from flowing through the opening onto a portion of the substrate disposed outside the opening.

[0040] In a seventeenth aspect, an on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising a body configured to be worn on the skin and configured to connect to a transcutaneous analyte sensor, at least a portion of the body comprising a hot melt material.

[0041] Implementations of the embodiments may include one or more of the following: The body may comprise a housing. The body may be configured to hold one or more electrical components. The body may include a base, an enclosure, and a filler material disposed between the base and the enclosure. The filler material may include a hot melt material. The base and the enclosure may be comprised of a first material, the hot melt material configured to be molded at a lower pressure or temperature than the first material. The hot melt material may be configured such that at least a portion of the base and the enclosure harden more quickly than a material from which the base and the enclosure are constructed after molding. The enclosure may be made of a material having a higher hardness or lower moisture permeability than the hot melt material. The base may be comprised of a material having a higher hardness, cohesiveness, or wear resistance than the hot melt material. The base may be comprised of a material having a lower moisture permeability than the hot melt material. The enclosure and base may be molded from one or more of poly(methyl methacrylate) (PMMA), acrylonitrile butadiene styrene (ABS), nylon (polyamide, PA), polycarbonate (PC), polyethylene (PE), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), thermoplastic elastomer (TPE), or thermoplastic polyurethane (TPU). The base may be composed of a different material than the enclosure. The base and the enclosure may be composed of the same material. The filler may be composed of a different material than the base and the enclosure. The base may be composed of a first polymer and the enclosure is composed of a second polymer different from the first polymer. The electrical board may be disposed between the base and the enclosure. The filler may be configured to surround the electrical board. The filler may occupy a void between the base and the enclosure. The enclosure may be configured to couple to the base, thereby forming a seal between the base and the enclosure. The hot melt material may be configured to be molded by low pressure molding. The hot melt material may be configured to harden more quickly than a thermosetting polymer after molding.The body may include a first housing, a second housing, and a filler material between the first housing and the second housing. The patch may be configured to couple the body to skin. The transdermal analyte sensor may be configured to extend from the body and be disposed within the skin. The body may be configured to hold one or more electrical components for receiving a signal from the transdermal analyte sensor.

[0042] In further aspects and embodiments, the features of the methods and various aspects described above are formulated with respect to a system, as in the various aspects, having an applicator configured to perform the features of the methods. Any of the features of the embodiments of any of the aspects, including but not limited to any of the embodiments of any of the first to seventeenth aspects mentioned above, are applicable to all other aspects and embodiments identified herein, including but not limited to any of the embodiments of any of the first to seventeenth aspects mentioned above. Furthermore, any of the features of the embodiments of the various aspects, including but not limited to any of the embodiments of any of the first to seventeenth aspects mentioned above, may be independently combined in any manner, partially or wholly, with other embodiments described herein, e.g., one, two or more embodiments may be combined in whole or in part. Furthermore, any of the features of the embodiments of the various aspects, including but not limited to any of the embodiments of any of the first to seventeenth aspects mentioned above, may be optional with respect to other aspects or embodiments. Any aspect or embodiment of the method may be performed by a system or apparatus of another aspect or embodiment, and any aspect or embodiment of the system or apparatus may be configured to perform the method of another aspect or embodiment, including but not limited to any embodiment of any of the first to seventeenth aspects referred to above.

[0043] This Summary is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the Detailed Description. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all of the disadvantages noted in any part of this disclosure.

[0044] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the disclosure, in which like reference characters indicate corresponding features consistently throughout like embodiments. [Brief description of the drawings]

[0045] [Figure 1] FIG. 1 is a schematic diagram of an analyte sensor system attached to a recipient and in communication with a number of exemplary devices. [Diagram 2] FIG. 2 is a block diagram showing the electronics associated with the analyte sensor system of FIG. 1. [Figure 3A] FIG. 1 is a diagram of an on-skin wearable medical device having a transcutaneous analyte sensor. [Figure 3B] FIG. 1 is a diagram of an on-skin wearable medical device having a transcutaneous analyte sensor. [Figure 3C] FIG. 1 is a diagram of an on-skin wearable medical device having a transcutaneous analyte sensor. [Figure 4A] FIG. 1 is a perspective view of an on-skin wearable medical device. [Figure 4B] FIG. 4B is a top view of the on-skin wearable medical device shown in FIG. 4A. [Figure 4C] FIG. 4B is an exploded view of the on-skin wearable medical device of FIG. 4A. [Figure 4D]FIG. 4B is a cross-sectional view of a section of the on-skin wearable medical device of FIG. 4A. [Figure 4E] FIG. 4B is a three-dimensional cross-sectional exploded view of a section of the on-skin wearable medical device of FIG. 4A. [Figure 4F] FIG. 4F is a cross-sectional view of a section of the on-skin wearable medical device shown in FIG. 4E. [Figure 5A] FIG. 13 is a top perspective view of the socket and plug of an on-skin wearable medical device with the plug removed from the socket. [Figure 5B] FIG. 5B is a bottom perspective view of the socket and plug of the on-skin wearable medical device shown in FIG. 5A with the plug removed from the socket. [Figure 5C] FIG. 5B is an isolated bottom perspective view of the plug of FIG. 5A. [Figure 5D] 5B is an enlarged cross-sectional view of the plug of FIG. 5A installed in the socket of FIG. 5A. [Figure 6A] FIG. 1 is a top perspective view of an on-skin wearable medical device. [Figure 6B] FIG. 6B is a side perspective view of the on-skin wearable medical device of FIG. 6A. [Figure 6C] FIG. 6B is a top perspective view of the on-skin wearable medical device of FIG. 6A with the plug removed. [Figure 6D] FIG. 6D is a bottom perspective view of the plug of FIG. 6C. [Figure 6E] FIG. 6B is a top exploded perspective view of the on-skin wearable medical device of FIG. 6A. [Figure 6F] FIG. 6B is a bottom exploded perspective view of the on-skin wearable medical device of FIG. 6A. [Figure 6G] FIG. 2 is an isolated perspective view of a first portion of the housing of an on-skin wearable medical device. [Figure 6H] FIG. 6C is a bottom perspective view of a first portion of the housing of the on-skin wearable medical device of FIG. 6G. [Figure 6I] FIG. 6B is an exploded perspective view of the housing of the on-skin wearable medical device of FIG. 6A. [Figure 7] FIG. 1 is a perspective view of a housing of an on-skin wearable medical device. [Figure 8A] FIG. 13 is a top perspective view of a socket for an on-skin wearable medical device. [Figure 8B] FIG. 8B is a bottom perspective view of the socket of FIG. 8A. [Figure 8C] FIG. 8B is an exploded view of the on-skin wearable medical device of FIG. 8A. [Figure 8D] FIG. 8B is a top view of the socket of FIG. 8A. [Figure 8E] 8B is a cross-sectional view of the socket of FIG. 8A taken along line AA shown in FIG. 8A. [Figure 8F] FIG. 8B is an exploded perspective view of the loop antenna of FIG. 8A. [Figure 9A] FIG. 1 is a perspective view of the components of the sensor connection of an on-skin wearable medical device in a pre-assembled state. [Figure 9B] FIG. 9B is a perspective view of the sensor connection part of FIG. 9A, with the sensor disposed within the channel. [Figure 9C] FIG. 9B is a perspective view of the sensor connection part of FIG. 9A having multiple conductors coupled to a sensor. [Figure 9D] FIG. 9B is a perspective view of the components of the sensor connection of FIG. 9A in an assembled state. [Figure 10A] FIG. 2 is an exploded view of the components of the sensor connection. [Figure 10B] FIG. 10B is a cross-sectional perspective view of the sensor connection portion of FIG. 10A. [Figure 10C] FIG. 10B is a top view of the sensor connection portion of FIG. 10A. [Figure 11A] FIG. 13 is a perspective view of the components of the sensor connection; [Figure 11B] FIG. 11B is an exploded cross-sectional view of the components of the sensor connection shown in FIG. [Figure 11C] FIG. 13 is a perspective cross-sectional view of the components of the sensor connection. [Figure 11D] FIG. 11B is a top view of the sensor connection portion of FIG. 11A. [Figure 12A] FIG. 1 is a cross-sectional view of an anisotropic conductive adhesive (ACA) within the body of an on-skin wearable medical device. [Figure 12B]FIG. 12B is a cross-sectional view of the ACA of FIG. 12A formed within an electrical conduit. [Figure 12C] FIG. 12B is a cross-sectional view of the cured ACA of FIG. 12A. [Figure 12D] 1 is a flow chart of a method. [Figure 13A] FIG. 1 is a perspective view of an on-skin wearable medical device. [Figure 13B] FIG. 1 is an exploded view of an on-skin wearable medical device. [Figure 14] FIG. 1 is an exploded view of an on-skin wearable medical device. [Figure 15] FIG. 1 is an exploded view of an on-skin wearable medical device. [Figure 16A] FIG. 1 is a top perspective view of a system configured to deploy an on-skin wearable medical device, with parts shown as transparent. [Figure 16B] FIG. 1 is a bottom perspective view of a system configured to deploy an on-skin wearable medical device, with parts shown as transparent. [Figure 16C] FIG. 16B is a side perspective view of the system shown in FIG. 16A being applied to the skin. [Figure 16D] FIG. 16B is a side schematic view of the system shown in FIG. 16A being peeled off onto the skin of a recipient. [Figure 16E] FIG. 16B is a side schematic view of the system shown in FIG. 16A with the needle inserted into the skin of a recipient. [Figure 16F] FIG. 16B is a side schematic diagram of the system shown in FIG. 16A, with the transcutaneous analyte sensor inserted into the skin of a recipient. [Figure 16G] 16B is a side schematic view of the system shown in FIG. 16A removed from the skin of a recipient, with the first portion of the applicator separated from the second portion of the applicator. FIG. [Figure 17A] FIG. 1 is a top perspective view of an on-skin wearable medical device. [Figure 17B] FIG. 17B is a top perspective view of the on-skin wearable medical device of FIG. 17A in a bent state. [Figure 17C]FIG. 17B is a bottom perspective view of the on-skin wearable medical device of FIG. 17A. [Figure 17D] FIG. 17B is a side view of the on-skin wearable medical device of FIG. 17A. [Figure 17E] FIG. 17B is a top view of the on-skin wearable medical device of FIG. 17A, with parts shown as transparent. [Figure 18A] FIG. 1 is a top perspective view of an on-skin wearable medical device. [Figure 18B] FIG. 18B is a top perspective view of the on-skin wearable medical device of FIG. 18A in a bent state. [Figure 18C] FIG. 18B is a bottom perspective view of the on-skin wearable medical device of FIG. 18A. [Figure 18D] FIG. 18B is a side view of the on-skin wearable medical device of FIG. 18A. [Figure 18E] FIG. 18B is a top view of the on-skin wearable medical device of FIG. 18A, with parts shown as transparent. [Figure 19A] FIG. 1 is a top perspective view of an on-skin wearable medical device. [Figure 19B] FIG. 19B is a top perspective view of the on-skin wearable medical device of FIG. 19A in a bent state. [Figure 19C] FIG. 19B is a bottom perspective view of the on-skin wearable medical device of FIG. 19A. [Figure 19D] FIG. 19B is a side view of the on-skin wearable medical device of FIG. 19A. [Figure 19E] FIG. 19B is a top view of the on-skin wearable medical device of FIG. 19A, with parts shown as transparent. [Figure 20A] FIG. 1 is a top view of an on-skin wearable medical device. [Figure 20B] FIG. 20B is a perspective view of the on-skin wearable medical device of FIG. 20A. [Figure 21A] FIG. 1 is a perspective view of an on-skin wearable medical device. [Figure 21B] FIG. 21B is an exploded view of the on-skin wearable medical device of FIG. 21A. [Figure 22A] FIG. 1 is a perspective view of an on-skin wearable medical device. [Figure 22B] FIG. 22B is a cross-sectional view of the on-skin wearable medical device of FIG. 22A. [Figure 23A] FIG. 1 is a top view of an on-skin wearable medical device. [Figure 23B] FIG. 23B is a perspective view of the on-skin wearable medical device of FIG. 23A. [Figure 24] FIG. 1 is a perspective view of an on-skin wearable medical device. [Figure 25A] FIG. 1 is a top view of an on-skin wearable medical device. [Figure 25B] FIG. 25B is a perspective view of the on-skin wearable medical device of FIG. 25A. [Figure 26] FIG. 13 is a perspective view of the components of the sensor connection; [Figure 27] FIG. 2 is a perspective view of the sensor connection portion assembled. [Figure 28] FIG. [Figure 29] FIG. 4 is a detailed view of the sensor connection portion. [Figure 30A] FIG. 2 shows the sensor assembly inserted into the housing. [Figure 30B] FIG. 2 is a diagram of the sensor assembly inserted into the housing. [Diagram 31] FIG. 2 is a cross-sectional view of a conductor body and an analyte sensor. [Figure 32A] FIG. 1 is a perspective view of an analyte sensor inserted into the sensor receiving portion. [Figure 32B] FIG. 1 is a perspective view of an analyte sensor inserted into the sensor receiving portion. [Diagram 33] FIG. 2 is a cross-sectional view of a conductor body inserted into a sensor receiving portion. [Diagram 34] FIG. 2 is a cross-sectional view of a battery on a substrate. [Diagram 35] FIG. 35 is a top view of the battery of FIG. 34 on a substrate. [Diagram 36] FIG. 2 is a cross-sectional view of a battery on a substrate. [Figure 37] FIG. 2 is a cross-sectional view of the hardenable material exiting the cavity. [Figure 38] FIG. 2 is a cross-sectional view of a hardenable material held within a cavity. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] The following description and examples illustrate some exemplary implementations of the present disclosure in detail. Those skilled in the art will recognize that there are many variations and modifications of the present disclosure that are encompassed by the scope of the present disclosure. Therefore, the description of a specific exemplary implementation should not be considered as limiting the scope of the present disclosure.

[0047] In vivo analyte sensing techniques may rely on in vivo sensors. The in vivo sensors may include an elongated conductive body having one or more electrodes, such as a working electrode and a reference electrode.

[0048] For example, platinum metal-coated tantalum wire is sometimes used as a core bare sensing element with one or more reference or counter electrodes for an analyte sensor. This sensing element is coated with a membrane to obtain the final sensor. Other forms of sensors that can be utilized are disclosed in U.S. Patent Application No. 16 / 854,647, entitled "Preconnected Analyte Sensors," U.S. Patent Application Publication No. 2020 / 0330010, filed April 21, 202, published October 22, 2020, and incorporated herein by reference in its entirety.

[0049] FIG. 1 illustrates an example system 100 according to some example implementations. The system 100 can include an analyte sensor system 101 including a sensor electronics 112 and an analyte sensor 138. The system 100 can include other medical devices and / or sensors, such as a medication delivery pump 102 and a glucose meter 104. The analyte sensor 138 can be physically connected to the sensor electronics 112, can be integral to the sensor electronics (e.g., non-releasably attached thereto), or can be releasably attachable to the sensor electronics. For example, in some implementations, the continuous analyte sensor 138 can be connected to the sensor electronics via a sensor carrier or sensor connection that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics 112. In some other implementations, the continuous analyte sensor 138 can be directly connected to the sensor electronics without utilizing a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics 112. The sensor electronics 112 , medication delivery 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 .

[0050] In some example implementations, the system 100 may include a cloud-based specimen processor 490 configured to analyze specimen data (and / or other patient-related data) provided over the network 409 (e.g., via wired, wireless, or combinations thereof) from the sensor system 101 and other devices, such as display devices 114, 116, 118, and / or 120 associated with a recipient (also referred to as a patient), to generate reports that provide high level information, such as statistics, regarding specimens measured over a particular time frame. A complete discussion of the use of cloud-based specimen processing systems may be found in U.S. Patent Application Serial No. 13 / 788,375, filed March 7, 2013, entitled "Cloud-Based Processing of Analyte Data," published as Patent Application Publication No. 2013 / 0325352, which is incorporated herein by reference in its entirety. In some implementations, one or more steps of a factory calibration algorithm may be performed in the cloud.

[0051] In some exemplary implementations, electrical components in the form of 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 also include algorithms that may be used to process and calibrate the analyte sensor data, although these algorithms may be provided in other manners as well. The sensor electronics 112 may include hardware, firmware, software, or a combination thereof to effectuate the measurement of an analyte level via an analyte sensor, such as a glucose sensor. Exemplary 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 performed by the sensor electronics.

[0052] The sensor electronics 112 can be coupled (e.g., wirelessly, etc.) with one or more devices, such as display devices 114, 116, 118, and / or 120, as described above. The display devices 114, 116, 118, and / or 120 may be configured to present (and / or alert) information, such as sensor information transmitted by the sensor electronics 112, for display on the 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.

[0053] In some example implementations, the relatively small key fob-like display device 114 may include 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 portion (e.g., smaller than the large display device 116) and may be configured to display certain types of displayable sensor information, such as numbers and arrows, or color codes.

[0054] In some example implementations, the relatively large portable display device 116 may include a portable receiver device, a palmtop computer, and / or the like. This large display device may include a relatively larger display portion (e.g., larger than the small display device 114) and may be configured to display information such as graphical representations of sensor data, including current and historical sensor data, output by the sensor system 100.

[0055] In some example implementations, the analyte sensor 138 may comprise a transcutaneous analyte sensor. The transcutaneous analyte sensor may be configured to generate a signal indicative of an analyte concentration in the recipient. 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, calorimetric, iontophoretic, radiometric, immunochemical, etc. In implementations in which the analyte sensor 138 includes a glucose sensor, the glucose sensor may include any device capable of measuring a concentration of glucose and may provide data, such as a data stream indicative of a concentration of glucose in the recipient, using a variety of techniques for measuring glucose, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring). The data stream may be sensor data (raw data and / or filtered data) or may be converted to a calibrated data stream used to provide glucose values ​​to a recipient, such as a user, patient, or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual interested in the recipient's health). Additionally, the analyte sensor 138 may be implanted as at least one of the following types of sensors: an implantable glucose sensor, a transcutaneous glucose sensor that is implanted within a recipient's blood vessel or outside the body, a subcutaneous sensor, a replaceable subcutaneous sensor, and an intravascular sensor.

[0056] The disclosure herein refers to some implementations that include an analyte sensor 138 that comprises a glucose sensor, although the analyte sensor 138 may include other types of analyte sensors as well. Additionally, while some implementations may refer to the glucose sensor as an implantable glucose sensor, other types of devices capable of detecting glucose concentrations and providing an output signal representative of the glucose concentration may be used as well. Additionally, while the description herein refers to glucose as the analyte that is measured, processed, etc., other analytes may be used as well, including, for example, ketone bodies (e.g., acetone, acetoacetate and beta-hydroxybutyrate, lactate esters, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, intermediates in the citric acid cycle, choline, insulin, cortisol, testosterone, etc.

[0057] In some manufacturing systems, the sensors 138 are manually sorted and placed and held in fixtures. These fixtures are manually moved from station to station during manufacturing for various process steps, including interfacing electrical measurement equipment for test and calibration operations. However, manual handling of sensors can be inefficient, can cause delays due to non-ideal mechanical and electrical connections, can risk damaging the sensors and / or test and calibration equipment, and can induce sensor variability that can lead to inaccurate validation data collected in manufacturing. Additionally, the process of packaging the sensors 138 with the sensor electronics 112 into a wearable device requires additional manual manipulation of the sensors, which can damage the sensors 138.

[0058] Identification and other data associated with each sensor, if utilized, may be stored on the sensor carrier for logging and tracking of each sensor during manufacturing, testing, calibration, and in vivo operation. Following testing and calibration operations, the sensor carrier can be used to connect the sensor to the sensor electronics of a wearable device, such as an on-skin sensor assembly, in a sealed and electrically robust configuration. In implementations 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).

[0059] 2 illustrates an example of electronics 112 that may be used in the sensor electronics 112 or implemented in a manufacturing station, such as a testing station, calibration station, smart carrier, or other equipment used during manufacturing of the device 101, according to some example implementations. The sensor electronics 112 may include electronics components configured to process sensor information, such as sensor data, via, for example, a processor module, to generate transformed sensor data and displayable sensor information. For example, the processor module may transform 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 concentrations), rate of change information, trend information, acceleration / deceleration information, sensor diagnostic information, location information, alarm / alert information, calibration information as may be determined by a factory calibration algorithm disclosed herein, sensor data smoothing and / or filtering algorithms, and the like.

[0060] In some implementations, the processor module 214 may be configured to accomplish a significant portion, if not all, of the data processing, including data processing for factory calibration. The processor module 214 may be integrated with the sensor electronics 112 and / or may be located remotely, such as in one or more of the devices 114, 116, 118, and / or 120, and / or in the cloud 490. For example, in some implementations, the processor module 214 may be located at least in part in the cloud-based analyte processor 490 or may be located elsewhere in the network 409.

[0061] In some example implementations, the processor module 214 may be configured to calibrate the sensor data, and the data storage memory 220 may store the calibrated sensor data points as transformed sensor data. Additionally, the processor module 214 may be configured in some example implementations to wirelessly receive calibration information from a display device, such as devices 114, 116, 118, and / or 120, to enable calibration of the sensor data from the sensor 138. Additionally, the 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 the data storage memory 220 may be configured to store transformed sensor data and / or sensor diagnostic information associated with the algorithm. The processor module 214 may further be configured to store and use calibration information determined from a factory calibration, as described below.

[0062] In some example implementations, the sensor electronics 112 may include an application specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the 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., a processor module 214 and a data storage memory 220). Although FIG. 2 illustrates an ASIC 205, other types of circuits may also be used, including a field programmable gate array (FPGA), one or more microprocessors configured to provide some, if not all, of the processing performed by the sensor electronics 112, analog circuits, digital circuits, or combinations thereof.

[0063] In the example illustrated in FIG. 2, the potentiostat 210 is coupled to an analyte sensor 138, such as a glucose sensor, via a first input port for sensor data 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 power the sensor (also referred to as the analog portion of the sensor) that measures a value (e.g., a current) indicative of the analyte concentration in the recipient. The potentiostat 210 may have one or more connections to the sensor 138 depending on the number of electrodes (e.g., a counter electrode as a third electrode) incorporated in the analyte sensor 138.

[0064] 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 also 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" to enable processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may in turn be directly related to an analyte level, such as a glucose level, in the recipient.

[0065] The telemetry module 232 can be operatively connected to the processor module 214 and can 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 radio techniques that can be implemented in the telemetry module 232 include Bluetooth, Bluetooth Low-Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access techniques, radio frequency (RF), infrared (IR), paging network communications, magnetic induction, satellite data communications, spread spectrum communications, frequency hopping communications, near field communications, and / or the like. In some example implementations, the telemetry module 232 includes a Bluetooth chip, although Bluetooth technology can also be implemented in combination with the telemetry module 232 and the processor module 214. The telemetry module 232, in implementations, can include a transmitter.

[0066] The processor module 214 can 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 sensor, filter the data, calibrate the data, perform fail-safe checks, and / or the like.

[0067] The potentiostat 210 can measure an analyte (eg, glucose and / or the like) at discrete time intervals or continuously using, for example, a current-to-voltage or current-to-frequency converter.

[0068] The processor module 214 may further include a data generator (not shown) configured to generate data packages for transmission to devices such as the 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.

[0069] The processor module 214 may also include program memory 216 and other memory 218. The processor module 214 may be coupled to a communications interface, such as a communications port 238, and a power source, such as a battery 234. In addition, the battery 234 may be further coupled to a battery charger and / or regulator 236 to power the sensor electronics 112 and / or charge the battery 234.

[0070] The program memory 216 may be implemented as a semi-static memory for storing data such as an identifier (e.g., a sensor identifier (ID)) of the coupled sensor 138, and for storing code (also referred to as program code) for configuring the ASIC 205 to perform one or more of the 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.

[0071] 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 cache memory for the system, with temporary storage 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), rewriteable ROM, flash memory, and the like.

[0072] 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: timestamp, raw sensor data (one or more raw analyte concentration values), calibrated data, filtered data, converted sensor data and / or any 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.

[0073] The user interface 222 may include a variety of interfaces, such as 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 comprise the user interface 222 may provide controls for interacting with a user (e.g., a recipient).

[0074] A power source or battery 234 can be operatively connected to the processor module 214 (and possibly other components of the sensor electronics 112) to provide the necessary power to the sensor electronics 112. In other implementations, the receiver can be powered transcutaneously, for example, via an inductive coupling.

[0075] The battery charger and / or regulator 236 may be configured to receive energy from an internal charger and / or an 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 any other charging and / or power mechanism may also be used.

[0076] 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 and can 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 to the algorithm from the sensor or from a cloud data source.

[0077] The one or more communication ports 238 may further include an input port 237 through which calibration data may be received, and an output port 239 that may be used to transmit calibrated or data to be calibrated to a receiver or mobile device. Figure 2 illustrates these aspects diagrammatically. It will be appreciated that while the ports may be physically separated, in alternative implementations a single communication port may provide the functionality of both a second input port and an output port.

[0078] In some analyte sensor systems, the on-skin portion of the sensor electronics may be simplified to minimize the complexity and / or size of the on-skin electronics, for example, providing only raw, calibrated, and / or filtered data to a display device configured to execute calibration and other algorithms required to display 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, including, for example, algorithms to evaluate the clinical acceptability of the reference and / or sensor data, evaluate the calibration data for a best calibration based on selection criteria, evaluate the quality of the calibration, compare the estimated analyte values ​​to time-corresponding measured analyte values, analyze the variability of the estimated analyte values, evaluate the stability of the sensors and / or sensor data, detect signal artifacts (noise), replace signal artifacts, determine the rate of change and / or trend of the sensor data, perform dynamic and intelligent analyte value estimation, perform diagnostics on the sensors and / or sensor data, set the operating mode, evaluate the data for anomalies, and / or the like. The sensor electronics 112 may include a transmitter in some implementations.

[0079] 3A, 3B, and 3C illustrate an exemplary implementation of the analyte sensor system 101 implemented as a wearable device, such as an on-skin wearable medical device or sensor assembly 500. As shown in FIG. 3A, the on-skin sensor assembly comprises a body in the form of a housing 128. The patch 126 can couple the housing 128 to the skin of a recipient. The adhesive of the patch 126 can be a pressure sensitive adhesive (e.g., acrylic, rubber-based, 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 may include a through hole 180 that cooperates with an applicator, such as a sensor inserter device (e.g., a sensor insertion needle, not shown), used to implant the sensor 138 under the skin of the recipient.

[0080] The wearable sensor assembly 500 can include electrical components in the form of sensor electronics 112 (e.g., as at least part of the electronics module 135) operable to measure and / or analyze glucose indicators sensed by the glucose sensor 138. The sensor electronics 112 in the sensor assembly 500 can transmit information (e.g., measurements, analyte data, and glucose data) to remotely located devices (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 for transfer to electrical components in the form of an electronics module 135 in an enclosure or housing 128. The working electrode 211 and the reference electrode 212 are connected to a circuit in the electronics module 135 that includes a potentiostat.

[0081] Variations in the configuration of the housing for an on-skin wearable medical device or sensor assembly may be provided. Figures 4A-4F, for example, show an implant including a body in the form of a housing 600 configured to be worn on the skin and configured to couple to an analyte sensor or a transcutaneous analyte sensor, the housing 600 including a wall including a film layer. The body may be configured to be placed adjacent to the skin of a recipient.

[0082] 4A illustrates a perspective view of housing 600, showing a top portion 602 (shown in FIG. 4D) raised above a bottom portion 604. Bottom portion 604 may be configured to be proximate to the recipient's skin, and the top portion may be raised from bottom portion 604 in a direction away from the recipient's skin.

[0083] The housing 600 can have dimensions including a width 606, and a length 608 (marked in FIG. 4B) and a height 610 (marked in FIG. 4D). The length 608 can be longer than the width 606. The housing 600 can have a rectangular shape as shown in FIG. 4B, or can have another shape (e.g., circular, triangular, hexagonal, or other) as desired. In an implementation, the width 606 and the length 608 can each be longer than the height 610. The housing 600 can have the appearance of a thin plate with a height that is shorter than the width 606 and the length 608. In an implementation, the width 606 or the length 608 can each be shorter than the height 610.

[0084] In implementations, the housing 600 can have a structure that includes multiple parts or layers of parts that form the housing 600 and the on-skin wearable medical device or sensor assembly. The housing 600 or the on-skin wearable medical device or sensor assembly can comprise an assembly of parts. Figure 4C illustrates an exploded perspective view showing the parts that can comprise the housing 600 and the on-skin wearable medical device or sensor assembly, for example. In implementations, features disclosed with respect to Figure 4C can be omitted or substituted, if desired.

[0085] The bottom of the housing 600 may include a patch 612 coupled to the housing 600 and configured to couple the housing 600 to the skin of a recipient. The patch 612 may include, for example, a flexible material and may be configured to be moisture permeable. The patch 612 may be moisture permeable to enhance the breathability of the patch 612. Such breathability may reduce adverse effects (e.g., the ability to pass sweat or other moisture) on the recipient's skin at the deployment site of the housing 600.

[0086] In implementations, the patch 612 may have the same perimeter size as the housing 600. Thus, the patch 612 may not protrude beyond the outer edge of the housing 600. FIG. 4D, for example, illustrates the patch 612 extending to the outer edge of the housing 600. In implementations, the patch 612 may protrude beyond the outer edge of the housing 600.

[0087] 4C, a first adhesive layer 614 may be provided that may couple the patch 612 to the housing 600. The first adhesive layer 614 may include, for example, a double-sided adhesive with adhesive portions on a top surface 616 of the first adhesive layer 614 and on a bottom surface 618 of the first adhesive layer 614. Other configurations of the adhesive layer 614 may be utilized if desired.

[0088] The first adhesive layer 614 can couple the patch 612 to a bottom film layer 620 of the housing 600. The bottom film layer 620 can comprise, for example, a wall of the housing 600 that can seal an interior cavity 622 (depicted in FIG. 4D ) of the housing 600. The bottom film layer 620 can include a top surface 621 and a bottom surface 623. In implementations, the bottom film layer 620 can be configured to prevent moisture from passing therethrough to reduce the likelihood of moisture entering the interior cavity 622 of the housing. The bottom surface 623 can face toward the skin, and at least a portion of the bottom surface 623 can include a film layer.

[0089] A second adhesive layer 624 may be disposed on the top surface 621 of the bottom film layer 620. The second adhesive layer 624, similar to the first adhesive layer 614, may include a double-sided adhesive having an adhesive portion on the top surface 626 of the second adhesive layer 624 and an adhesive portion on the bottom surface 628 of the second adhesive layer 624.

[0090] In implementations, the bottom film layer 620 can include an adhesive surface on one or more of the top surface 621 or bottom surface 623 of the bottom film layer 620 for coupling the bottom film layer 620 to the patch 612 or the electrical substrate 630. Thus, if desired, one or more of the first adhesive layer 614 or the second adhesive layer 624 may be omitted.

[0091] The housing 600 may include one or more electrical components disposed therein. The electrical components may be disposed within an internal cavity of the housing. For example, an electrical board 630 may be provided that may be configured to electrically couple to one or more other electrical components. In implementations, the electrical board 630 may be configured to be flexible to allow flexibility of the housing 600. In implementations, the electrical board 630 may include one or more flex portions that may be configured to allow the housing 600 to flex at the flex portions. The housing 600 may include one or more flex portions that may be disclosed herein. The housing 600 may be flexible.

[0092] The electrical board 630 may support electrical components thereon, including a power source such as a battery 632, a socket 634 for receiving a plug coupled to an analyte sensor or transcutaneous analyte sensor, and / or sensor electronics 636 for processing signals received from the analyte sensor or transcutaneous analyte sensor. The sensor electronics 636 may include, for example, a processor for processing signals from the sensor and may include a transmitter for transmitting the signals to a receiver. The socket 634 may include one or more electrical contacts or terminals for the sensor.

[0093] A power source, such as a battery 632, may be configured to power the electrical components within the interior cavity 622 (depicted in FIG. 4D). In implementations, a conductive tape 638 may be configured to electrically couple the power source to the electrical components. As shown in FIG. 4C, the conductive tape 638 may be positioned to contact the negative terminal of the battery. In implementations, the conductive tape 640 may be positioned to contact the positive terminal of the battery. The conductive tape 640 may couple to the electrical board 630 and be wrapped around at least a portion of the battery 632 to provide power to the electrical board and the electrical components coupled to the electrical board.

[0094] The conductive tape 640 may be flexible to increase the flexibility of the housing 600 and reduce the overall size and stiffness of the housing 600. In implementations, the conductive tape 640 may be omnidirectional and configured to allow current to flow therefrom in various directions. Other forms of conductive tape may be utilized with the housing 600.

[0095] A conductive tape 642 may be utilized to electrically couple the socket 634 to the electrical board 630. The conductive tape 642 may be unidirectional in embodiments to allow electrical signals and power from the socket 634 to flow in a desired direction between the electrical board 630 and the socket 634. In implementations, the conductive tape 642 may include two sections, a first section allowing unidirectional flow from the electrical board 630 to the socket 634 and a second section allowing unidirectional flow from the socket 634 to the electrical board 630. The first and second sections may be spaced apart from each other on a single piece of unidirectional conductive tape to avoid potential electrical interference. In implementations, the conductive tape 642 may include a cut or gap that physically separates the first and second sections to avoid electrical interference.

[0096] In implementations, other forms of electrical contact between the socket 634 and the electrical board 630 may be utilized. For example, electrical contacts or terminals such as elastomer pucks or other forms of contacts or terminals may be utilized to connect the socket 634 and the electrical board 630. Thus, the conductive tape 642 may be omitted in embodiments or may be utilized in combination with other forms of electrical contact. Any electrical contacts or terminals disclosed in the implementations herein may be utilized.

[0097] Referring to FIG. 4C, a third adhesive layer 644 may be provided that may couple the socket 634 to the electrical substrate 630 .

[0098] The filler 646 may be disposed within the internal cavity 622 (depicted in FIG. 4D ) of the housing 600. The filler 646 may include a filler layer configured to fit between the bottom film layer 620 and the top film layer 648, and may be shaped to fill a void that may surround an electrical component within the housing 600. For example, the filler 646 may be shaped to fit the contours of a power source in the form of a battery 632, may fit the contours of the socket 634, or may fit the contours of the sensor electronics 636. The filler 646 may include cutouts to fit the contours of such components, with the void or remaining portions of the internal cavity 622 being filled by the filler 646. The filler 646 may have a height that does not exceed the height of the electrical component. For example, the height of the filler 646 may be equal to or less than the height of the socket 634.

[0099] In implementations, the filler 646 can include a relatively lightweight material and can be configured to not allow air to pass through the material of the filler 646. For example, the filler 646 can include closed-cell foam or other material that does not allow air to pass through. Such a feature can be advantageous when the housing 600 is subject to changes in air pressure. A material such as closed-cell foam can reduce the likelihood of air within the housing 600 expanding in response to a drop in air pressure outside the housing 600. Thus, the likelihood of bursting or other damage to the housing 600 can be reduced.

[0100] In implementations, the filler 646 can include a compliant material that can provide impact protection to the housing 600 .

[0101] A fourth adhesive layer 650 may be provided that may couple the filler 646 to the top film layer 648. The fourth adhesive layer 650, like the first and second adhesive layers, may comprise a double-sided adhesive having an adhesive portion on a top surface 652 of the fourth adhesive layer 650 and an adhesive portion on a bottom surface 654 of the fourth adhesive layer 650. In implementations, the top film layer 648 may include a top or bottom adhesive surface, and thus the fourth adhesive layer 650 may be eliminated, if desired.

[0102] The top film layer 648 may comprise the top of the housing 600 and may have a similar structure to the bottom film layer 620. The top film layer 648 may have a contoured shape with a raised ridge portion 656 that is raised against a flange 658 that extends around the outer edge of the top film layer 648. The flange 658 may connect to the bottom film layer 620 to seal the interior cavity 622, which is marked in FIG. 4D.

[0103] 4D , the flange 658 may be connected to an outer portion 660 of the bottom film layer 620. The connection of the top film layer 648 to the bottom film layer 620 may extend around the entire interior cavity 622 and around the entire edge of the housing 600. The connection may be made in a variety of ways, including heat welding, ultrasonic welding, or other forms of welding or connection. The seal of the interior cavity 622 may be moisture impermeable to reduce the possibility of moisture entering the interior cavity 622.

[0104] 4E and 4F , in an implementation, the top film layer 648 and the bottom film layer 620 may each be coupled to a socket 634. For example, the socket 634 may include a peripheral portion 662 that may extend around a central cavity of the socket 634. The peripheral portion 662 may include flat portions against which the top film layer 648 and the bottom film layer 620, respectively, abut to seal the socket 634. Thus, moisture impermeability may be achieved around the socket 634.

[0105] Referring back to FIG. 4C, a cover layer 664 may be provided and may constitute an outer top surface of the housing 600. The cover layer 664 may be disposed on the top film layer 648. The outer top surface may be configured to face away from the skin. At least a portion of the outer top surface may include a film layer. In implementations, the cover layer 664 may comprise the film layer of the housing 600. In implementations, the cover layer 664 may have other configurations. The cover layer 664 may include a raised ridge portion 666 on a flange 668 that extends around an edge of the cover layer 664, similar to the top film layer 648. The flange 668 may be configured to couple to an outer portion 670 of the patch 612, for example, as shown in FIG. 4D.

[0106] In implementations, the cover layer 664 may comprise a smooth layer that provides a smooth, low friction exterior surface for the housing 600. The cover layer 664 can further provide an aesthetic improvement to the housing 600.

[0107] As discussed, at least a portion of the top 602 of the housing 600 may include a film layer, or at least a portion of the bottom 604 (depicted in FIG. 4D ) of the housing 600 may include a film layer. In implementations, both the top 602 and bottom 604 may include a film layer, and the film layers may be coupled to one another to form a seal for the interior cavity 622.

[0108] In implementations, each film layer may be flexible, and thus, in implementations, housing 600 may be flexible. The flexibility of housing 600 may allow for improved contouring to the recipient's skin and flexibility as the skin moves. Housing 600 may have a relatively thin profile, allowing for flexibility both toward and away from the skin.

[0109] 4A and 4B, in an implementation, the socket 634 may comprise an opening in the top 602 of the housing 600. The socket 634 may be exposed and comprise an opening in a top exterior surface of the housing 600. The socket 634 may be configured to receive a plug coupled to an analyte sensor or a transcutaneous analyte sensor. The plug may be configured to be inserted into the socket 634 in a downward direction from the top of the housing 600 toward the socket 634. In an implementation, the socket 634 may have an oblong shape with a major dimension 672 of the socket 634 extending along the width 606 of the housing 600. Such an orientation may achieve various advantages.

[0110] For example, the major dimension 672 of the socket 634 extending along the width 606 of the housing 600 allows the electronic components (shown in FIG. 4C ) to be located in areas spaced apart from one another with the flexible electrical board 630 located between them. The electronic components may be spaced apart along the length 608 of the housing 600. For example, the sensor electronics 636 may be spaced apart from the socket 634, which may be spaced apart from the battery 632. Thus, the orientation of the socket 634 along the width 606 of the housing 600 may allow the housing 600 to bend about bend portions 674, 676 (as noted in FIGS. 4B and 4C ) located between these respective electronic components. The axis about which the housing 600 may bend may extend parallel to the major dimension 672 of the socket 634 and along the width 606 of the housing 600.

[0111] In configurations, the use of film layers can enable high speed reel-to-reel manufacturing processes. For example, each film layer can comprise a flattened film sheet that can be thermoformed or otherwise formed into a desired shape. The film layers can be rolled together and welded together to form the housing 600 (e.g., top film layer 648 and bottom film layer 620 are pulled off a reel and brought into contact with each other in a high speed process and welded together). Other layers or components can be die cut and inserted into the layers during assembly. Such configurations can enable mass production of the housing 600 and the components placed therein. Other manufacturing processes can be utilized if desired.

[0112] Figures 5A-5D illustrate an embodiment of a socket 700 and plug 702 that may be utilized alone or in combination with the implementations herein. Socket 700 may be utilized in an implementation having a socket, such as, for example, the implementations of Figures 4A-4F or the implementations of Figures 6A-8F.

[0113] 5A, the socket 700 may be configured to couple to a body that may be worn on the skin, such as an implementation of a housing or another form of body disclosed herein. The socket 700 may be configured to couple to a plug 702, which may be coupled to an analyte sensor 704 or a transcutaneous analyte sensor, for example, as depicted in FIG. 5B.

[0114] The socket 700 may include a raised portion 706 and a channel 708 surrounding the raised portion 706. The raised portion 706 may include one or more electrical contacts 710 for electrical connection with the analyte sensor 704, and the channel 708 may include a fluid 709 disposed therein to form a seal with at least a portion of the plug 702.

[0115] The raised portion 706 may be raised above the channel 708 and may include an upper surface 712 that may have a flat shape. The flat shape of the upper surface 712 may allow, for example, electrical contacts 710 to protrude from the upper surface 712 for connection with the analyte sensor 704. The electrical contacts 710 may be disposed on the upper surface 712 that is configured to face a plug.

[0116] The raised portion 706 may include a first coupler 714 in the form of an opening for receiving a corresponding second coupler 716 (depicted in FIG. 5B) of the plug 702. The first coupler 714 may receive the corresponding second coupler 716 to mechanically couple the plug 702 to the socket 700. The plug 702 may include an additional third coupler 718 (depicted in FIG. 5B) in the form of an opening for receiving the third coupler 718 that may be coupled to a fourth coupler 720. The second coupler 716 and the third coupler 718 may include protrusions for engaging gaps in the first and fourth couplers 714, 720, although other configurations may be utilized in embodiments. For example, one or more of the second coupler 716 and the third coupler 718 may include a gap and one or more of the first and fourth couplers 714, 720 may include a protrusion, although other configurations of couplers may be utilized as desired.

[0117] 5A , the channel 708 may comprise a recessed portion of the socket 700 and may be joined by a raised outer wall 722 that surrounds the channel 708. The raised outer wall 722 may be configured to retain a fluid 709 within the channel 708. The raised outer wall 722, in implementations, may have a height greater than the raised portion 706, which may enable alignment between the raised outer wall 722 and the plug 702. For example, the raised outer wall 722 may contour to the shape of a peripheral surface 724 of the plug 702 to enable alignment and sealing between the plug 702 and the socket 700.

[0118] The socket 700 may further include an opening 726 through which the analyte sensor 704 passes and through which an insertion needle 728 passes.

[0119] Fluid 709, in implementations, may include a fluid for sealing the connection between socket 700 and plug 702 to reduce the possibility of moisture interfering with the electrical connection between electrical contacts 710 and analyte sensor 704. The fluid may be configured to be moisture impermeable and therefore may include a gel. The gel may include petrolatum or other forms of gels or fluids, if desired. The fluid may be disposed within channel 708 and configured to move when plug 702 enters socket 700.

[0120] The electrical contacts 710 may protrude from the top surface 712 and, in implementations, may extend through the socket 700 to a bottom surface 729 (as depicted in FIG. 5B) that faces opposite the top surface 712. The electrical contacts 710 may include a portion 730 that protrudes from the bottom surface 729 and may be configured to electrically couple to an electrical component, such as an electrical board or other electrical component. The electrical component may include, for example, sensor electronics for receiving a signal from the analyte sensor 704 or a power source. Other forms of electrical components may be utilized.

[0121] In implementations, the electrical contacts 710 may include a conductive elastomeric material. Such a material may allow for compression of the electrical contacts 710 upon contact and compression by the analyte sensor 704. Other forms of electrical contacts may be utilized in implementations.

[0122] 5C, the plug 702 may include a recess 732 into which a conductive portion of the analyte sensor 704 is disposed and for the electrical contacts 710 to enter. The recess 732 may be shaped, for example, to receive the electrical contacts 710 and allow for an electrical connection between the contacts 710 and the analyte sensor 704. The portions of the analyte sensor 704 that may be contacted may include the respective working and reference electrodes, although other portions may be contacted as desired.

[0123] The plug 702 may include a cavity 734 for the raised portion 706 of the socket 700 to enter. The plug 702 may include an outer wall 735 for entering the channel 708 and surrounding the raised portion 706.

[0124] In operation, the plug 702 can be inserted into the socket 700 to electrically connect the electrical contacts 710 to the analyte sensor 704. Upon insertion, fluid 709 can move due to the presence of the outer wall 735. For example, FIG. 5D illustrates the outer wall 735 disposed within the channel 708.

[0125] In implementations, the socket 700 may include a reservoir 738 for receiving and storing any excess amount of fluid 709 after the plug 702 is coupled to the socket 700. The reservoir 738 may reduce the chance of the fluid 709 spilling out when the plug 702 is inserted into the socket 700.

[0126] The plug 702 and / or socket 700 configuration may be utilized with any of the implementations disclosed herein.

[0127] 6A-6I illustrate the implantation of an on-skin wearable medical device or on-skin sensor assembly including an elongated housing 800 having a long dimension 801 and an elongated socket 802 having a long dimension 804 extending along the long dimension 801 of the elongated housing 800.

[0128] 6A, elongated housing 800 may be configured similarly to housing 600 shown in FIG 4A unless otherwise noted. For example, electrical components within elongated housing 800 may include electrical components similar to electrical components within housing 600.

[0129] The elongated housing 800 may have an oblong shape and may be configured to be worn on the skin. For example, a patch 806 may be utilized to couple the elongated housing 800 to the skin. The patch 806 may be coupled to a bottom of the elongated housing 800 and may be configured to couple the elongated housing 800 to the skin. The patch 806 may protrude outward from an outer edge of the elongated housing 800 to form a skirt portion 808 that extends radially outward from the elongated housing 800.

[0130] The elongated housing 800 may be constructed of one or more materials that may be rigid or flexible. In implementations, the elongated housing 800 may be constructed of a co-molded material that includes a first material having greater rigidity than a second material. For example, referring to FIG. 6G, a first portion of the elongated housing 800 may comprise a frame 810 constructed of a first material. Thus, the frame 810 may comprise a relatively rigid body including a circumferential loop 812 and a central portion 814 for supporting the socket 802. FIG. 6H illustrates a bottom perspective view of the frame 810.

[0131] The second material 816 (depicted in FIG. 6I ) may be co-molded onto the frame 810 and may include a flexible material. The second material 816 may be coupled to the frame 810. The second material 816 may form at least a portion of the exterior surface of the elongated housing 800. The second material 816 may improve the compliance of the elongated housing 800 and may allow the elongated housing 800 to be flexible and conform to the shape of the recipient's skin and / or movements of the recipient's skin. The proportion of the elongated housing 800 that includes a rigid first material and a compliant second material may be varied as desired to create a desired flexibility for the elongated housing 800.

[0132] For example, FIG. 7 illustrates an embodiment in which the outer housing 900 is constructed entirely from a rigid material to form a rigid outer housing 900.

[0133] 6B and 6C, socket 802 may be configured to receive plug 815, similar to other socket and plug couplings disclosed herein. With reference to Figure 6D, plug 815 may be configured similar to plug 702, but may include protruding electrical contacts 817 for coupling with flat electrical contacts 818 of socket 802 shown in Figure 6C.

[0134] The elongated housing 800 may include a multi-level structure that may reduce the overall width and length of the elongated housing 800 from the configuration as shown in Figures 4A-4F. However, the multi-level structure may increase the height of the elongated housing 800 from the configuration as shown in Figures 4A-4F.

[0135] FIG. 6E, for example, illustrates a top exploded perspective view of elongated housing 800. Elongated housing 800 can include patch 806 and adhesive layer 820 for coupling patch 806 to bottom film layer 822. The bottom of the elongated housing can include a film layer. Bottom film layer 822 can be configured similarly to bottom film layer 620 of FIGS. 4A-4F. Bottom film layer 822 can couple to outer edge 824 (marked in FIG. 6F) of elongated housing 800 to seal an interior cavity of elongated housing 800.

[0136] The elongated housing 800 may include a filler 826 that may be configured similarly to the filler 646 of FIGS. 4A-4F. A multi-level structure of the elongated housing 800 is shown with respect to the electrical components. The sensor electronics 828, including the transmitter, may be located, for example, directly below the socket 802 and plug 815. The socket 802 may be located above the transmitter. The sensor electronics 828 may comprise a lower level of the elongated housing 800, and the elongated socket 802 comprises an upper level of the elongated housing 800 located above the lower level. Thus, the elongated socket 802 is located above the sensor electronics 828 and the transmitter in a multi-level configuration. Additionally, a power source, such as a battery 830, may be located at the lower level along with the sensor electronics 828.

[0137] FIG. 6F illustrates an inverted view of the elongated housing 800 from the configuration shown in FIG. 6E.

[0138] A multi-level structure may reduce the overall footprint or length and width of the elongated housing, for example, relative to configurations such as those shown in Figures 4A-4F, but may increase the height.

[0139] 6A, extending the long dimension 804 of the elongated socket 802 along the long dimension 801 of the elongated housing 800 can further reduce the overall footprint, or length and width, of the elongated housing. This is in contrast to implementations such as those shown in FIGS. 4A-4F, where the long dimension 672 of the socket 634 extends perpendicular to the long dimension of the housing 600, thus resulting in a reduced footprint of the elongated housing 800.

[0140] The elongated housing 800 or elongated socket 802 configuration may be utilized with any of the implementations disclosed herein.

[0141] In implementations, the transcutaneous analyte sensor may be in a fixed configuration relative to the housing. Figure 7, for example, illustrates an analyte sensor 902 that is fixed relative to the housing 900. The housing 900 may further carry a sensor connection area 904 on a top or top exterior surface of the housing 900. Various modifications of implementations may be made.

[0142] 8A-8F illustrate an implementation of socket 1000 that includes a loop antenna 1002 that encircles socket 1000. Socket 1000 may be configured similarly to other implementations of sockets disclosed herein unless otherwise noted.

[0143] The socket 1000 may include electrical contacts 1004, which may be configured similarly to other embodiments of electrical contacts disclosed herein. For example, the electrical contacts 1004 may be configured to electrically connect with an analyte sensor or may otherwise be configured to connect with one or more electrical contacts coupled to a plug. The electrical contacts 1004 may include a conductive elastomeric material, such as an elastomeric puck or another form of electrical contact. The electrical contacts 1004 may extend through the body of the socket 1000 to form a portion 1006 on a bottom surface of the socket 1000, as shown, for example, in FIG. 8B.

[0144] The electrical contacts 1004 may be disposed within a cavity 1008 of the socket 1000 .

[0145] The gasket 1010 may be disposed within the cavity 1008 of the socket 1000 and may be configured to form a seal with a plug that may be inserted into the socket 1000. The plug may be configured, for example, similar to the implementations of the plugs disclosed herein. The gasket 1010 may, for example, surround an outer surface of the plug to form a seal. The gasket 1010 may include an elastomeric material and, in implementations, may include a continuum having at least one of the electrical contacts 1004 (as shown in cross section in FIG. 8E).

[0146] The socket 1000 may include a channel 1012 that surrounds the socket 1000. The channel 1012 may surround the cavity 1008 and electrical contacts 1004 of the socket 1000. Figure 8C illustrates a side view of the socket 1000 and Figure 8D illustrates a top view of the socket 1000.

[0147] The loop antenna 1002 may surround the socket 1000 and may be disposed within the channel 1012. An isolated view of the loop antenna 1002 is shown in FIG. 8F. The loop antenna 1002 may form a full loop around the socket 1000, or in implementations may form only a partial loop around the socket 1000 (or at least a partial loop around the socket 1000). With reference to FIG. 8A, the loop antenna 1002 may surround an electrical contact 1004 in the socket 1000. The loop antenna 1002 may be coupled to the body and configured to receive or transmit signals from the body.

[0148] 8B, the loop antenna 1002 may include electrical contacts 1003 that may be disposed on a bottom surface of the socket 1000. The electrical contacts 1003 may contact an electrical component, such as an electrical board or a power source, or may be in electrical communication with the sensor electronics. The electrical contacts 1003 may be configured to receive electrical signals from the loop antenna 1002 or to transmit electrical signals from the loop antenna 1002.

[0149] The loop antenna 1002 can have an oblong or elongated shape that can conform to the shape of the socket 1000 and the channel 1012. Other shapes of loop antennas may be utilized as desired. Figure 8E illustrates a cross-sectional view of the loop antenna 1002 disposed within the channel 1012. The loop antenna 1002 may have a rectangular cross-section or another cross-sectional shape as desired.

[0150] The use of loop antenna 1002 may advantageously result in a greater overall length of material utilized as an antenna. The location of the spread around the socket 1000 may take advantage of the oblong shape of the socket 1000 and the space around the cavity 1008 for receiving the plug. Furthermore, in implementations where the socket 1000 is located on the top of the housing or includes a top opening on the top exterior surface of the housing, the antenna may be advantageously positioned away from the recipient's skin, which may improve the operation of the antenna. For example, in implementations such as those shown in FIG. 6E, the socket may be positioned at an upper level, which may increase the distance from the recipient's skin.

[0151] In implementations, the loop antenna may be utilized elsewhere within the body, such as a housing configured to be worn on the skin and configured to couple to a transdermal analyte sensor. The loop antenna may be configured to couple to the body to receive signals from the body or to transmit signals. The loop antenna may be provided at various locations within the body or housing. In implementations, the loop antenna may be located on the top or upper level of the housing. Other locations may be utilized.

[0152] Any of the implementations disclosed herein may utilize a loop antenna.

[0153] Implementations disclosed herein may include electrical and mechanical connections between the analyte sensor or transcutaneous analyte sensor and the body. The electrical and mechanical connections may be utilized to transmit power and / or sensor signals to or from the analyte sensor. The electrical and / or mechanical connections may include sensor connections. The electrical and / or mechanical connections may include a sensor carrier or a sensor interposer.

[0154] 9A-9D, for example, illustrate implementations that include one or more conductor bodies 1100, each having a branched portion 1102 configured to couple to a portion of an analyte sensor 1104, each of which is configured to be pressed into a respective slot 1106 to couple to a respective portion of the analyte sensor 1104.

[0155] The conductor body 1100 may include a lower surface 1108 and an upper surface 1110. The lower surface 1108 may include a bifurcated portion 1102. The bifurcated portion 1102 may be formed by arms 1112 of the conductor body 1100 that are separated from one another by a gap 1114 (depicted in FIG. 9B). The arms 1112 may be at an angle to one another to form a wedge shape that receives the analyte sensor 1104.

[0156] The top surface 1110 may include a releasable portion 1116 configured to release one or more conductor bodies 1100 from an applicator 1118 for application to a sensor receiving portion 1121 of the body. The releasable portion 1116 may include a breakable portion in implementations. For example, the applicator 1118 may be configured to twist relative to the releasable portion 1116 such that a shear force (e.g., as depicted in FIG. 9D ) breaks the portion 1116, releasing the conductor body 1100 from the applicator 1118.

[0157] The one or more conductor bodies 1100 may be configured to be inserted into a sensor-receiving portion 1121 of a body. The sensor-receiving portion 1121 may comprise a portion of a housing or a plug, or other form of body that receives the analyte sensor 1104. For example, a plug or housing implementation may utilize the sensor-receiving portion 1121 disclosed herein. The sensor-receiving portion 1121 may be located on the top or a top surface of the housing, or on the bottom or a bottom surface of the housing, as desired.

[0158] The sensor receiving portion 1121 may include one or more slots 1106 and may include a channel 1120 extending across the one or more slots 1106. The channel 1120 may be configured to receive an analyte sensor 1104, which extends along the length of the channel 1120.

[0159] Each of the one or more slots 1106 may include a lower surface 1122 (depicted in FIG. 9B ), and the channel 1120 may be elevated above the lower surface 1122. Each of the one or more slots 1106 may include a cavity 1124 extending downwardly from the channel 1120 to the respective lower surface 1122.

[0160] 9B, in the assembly, the analyte sensor 1104 may be inserted into the channel 1120. The applicator 1118 may be coupled to the conductor body 1100 and can move the conductor body 1100 towards the analyte sensor 1104.

[0161] The applicator 1118 can press the arms 1112 of the conductor body 1100 into the cavity 1124, causing the conductor body 1100 to apply pressure to the analyte sensor 1104 to hold the analyte sensor 1104 in place. For example, Figure 9C illustrates the applicator 1118 pressing the conductor body 1100 into place. The conductor body 1100 can apply pressure to the analyte sensor 1104 from both perpendicular and lateral directions relative to the analyte sensor 1104.

[0162] The releasable portion 1116 may then be released, such as by a shear force provided by an applicator 1118. Figure 9D illustrates the conductor body 1100 in place.

[0163] The conductor body 1100 may be utilized to electrically couple the analyte sensor 1104 to one or more electrical components. The electrical components may comprise any of the components disclosed herein and may be disposed within the body of the on-skin wearable medical device or on-skin sensor assembly. The electrical components may comprise an electrical board, or sensor electronics, or a power source (e.g., a battery), among other forms of electrical components. The electrical components may be disposed within the body.

[0164] The configuration of conductor body 1100 and sensor receiving portion 1121 may be utilized with any of the configurations disclosed herein.

[0165] The configuration of the conductor body may vary in implementation. For example, with reference to Figures 31-33, one or more conductor bodies 2700 may include a bifurcated portion 2702 configured to face a lower surface 2704 of a sensor receiving portion 2705 when the conductor body 2700 is pressed into a respective slot 2708.

[0166] 31 , a cross-sectional view of a conductor body 2700 is shown relative to the analyte sensor 1104. The conductor body 2700 is shown in a configuration prior to insertion into respective slots 2708 of the sensor receiving portion 2705. The bifurcated portion 2702 is formed by a plurality or pair of arms 2710 extending from an apex portion 2712 of the conductor body 2700. The apex portion 2712 may be coupled to the bifurcated portion 2702.

[0167] Each of the arms 2710 may include an inner surface 2714. The inner surfaces 2714 may be configured to face toward one another and may receive an analyte sensor 1104 between the inner surfaces 2714. Each of the arms 2710 may include an outer surface 2716 opposite the respective inner surfaces 2714. The inner surfaces 2714 may extend away from the apex portion 2712 to an opening 2718 of the channel 2720 for receiving the analyte sensor 1104.

[0168] 31, the arms 2710 splay outward from one another to form a wedge shape of the bifurcated portion 2702. The conductor body 2700 may be configured to receive the analyte sensor 1104 in such a configuration.

[0169] The conductor body 2700 may be extruded or otherwise formed in the configuration shown in FIG.

[0170] In implementations, the apex portion 2712 may comprise a living hinge. The apex portion 2712 may be configured to deflect, for example, such that the arms 2710 move toward one another to close or reduce the size of the channel 2720. The analyte sensor 1104 may be compressed by the inner surface 2714 and held in place by compression against the analyte sensor 1104. Mechanical and electrical contact may be made with the analyte sensor 1104.

[0171] 32A, for example, the analyte sensor 1104 may be disposed within one or more conductor bodies 2700 and pressed toward the lower surface 2704. The branched portion 2702 as shown in FIG 32A may be in an outwardly flared state due to the diameter of the analyte sensor 1104. The conductor bodies 2700 and the analyte sensor 1104 may be pressed downward.

[0172] 32(b) illustrates the conductor body 2700 pressed into the slot 2708. The outer wall 2722 of each slot 2708 that bounds the slot 2708 (and extends upwardly from the lower surface 2704) may compress the exterior surface 2716 of the arm 2710 inwardly. The analyte sensor 1104 may be compressed laterally within the channel 2720. The apex portion 2712 of each conductor body 2700 faces toward the lower surface 2704 when the conductor body 2700 is pressed into the respective slot 2708.

[0173] FIG. 33 illustrates a cross-sectional view of the resulting configuration of the conductor body 2700. The inner surfaces 2714 can face toward each other and extend parallel to each other when the conductor body 2700 is forced into the slot 2708. The inner surfaces 2714 move toward each other when the conductor body 2700 is forced into the slot 2708. The apex portion 2712 can form a bottom or lower portion of the conductor body 2700 that can support the analyte sensor 1104. The conductor body 2700 can otherwise have a structure similar to the conductor body 1100 discussed with respect to FIGS. 9A and 9B and can include an elastomeric body or other form of body. The features of FIGS. 31-33 can be utilized with any of the implementations disclosed herein.

[0174] 10A-10C illustrate an implementation of a sensor connection portion or sensor carrier or interposer including an electrical connector body 1200 including a first end 1202, a second end 1204, and a central portion 1206 disposed between the first end 1202 and the second end 1204.

[0175] The first end 1202 may be electrically conductive and configured to form an electrical connection with a first portion 1208 of an analyte sensor 1210 or transcutaneous analyte sensor disclosed herein. Although only a portion of the analyte sensor 1210 is shown in Figures 10A-11D, the entire analyte sensor 1210 may be configured similarly to other embodiments disclosed herein.

[0176] The second end 1204 may be electrically conductive and configured to form an electrical connection with the second portion 1212 of the analyte sensor 1210. The first portion 1208 or the second portion 1212 of the analyte sensor 1210 may include a working electrode or a reference electrode, as desired, among other portions of the analyte sensor 1210. The first end 1208 and the second end 1204 may each be configured to electrically connect the sensor 1210 with one or more electrical components of the body.

[0177] The central portion 1206 may comprise an insulator that electrically insulates the first end 1202 from the second end 1204 .

[0178] The electrical connector body 1200 may comprise an elastomeric material, and the first end 1202 and the second end 1204 may each comprise a conductive elastomeric material. The central portion 1206 may comprise an elastomeric material including an insulator, and the conductive material of the first end 1202 and the second end 1204 may be disposed on the insulator material. The electrical connector body 1200 may comprise a continuous body or continuous elastomeric body extending from the first end 1202 to the second end 1204.

[0179] The electrical connector body 1200 may be disposed within a cavity 1214 that includes a sensor receiving portion. The cavity 1214 may include an electrical substrate 1215 and electrical contacts 1216 for contacting the respective first and second ends 1202, 1204.

[0180] A retainer 1218 in the form of a hardenable material may be disposed adjacent the cavity 1214 and configured to retain a portion of the analyte sensor 1210 .

[0181] A top member 1220 may be provided that may be disposed over the analyte sensor 1210 and the electrical connector body 1200. The top member 1220 may include a curable material that may be dispensed onto the electrical connector body 1200 and cured in place to seal the cavity 1214 and the analyte sensor 1210 and electrical connector body 1200. In implementations, additional adhesive material may create a seal between the top member 1220 and the cavity 1214 or other body.

[0182] During assembly, the electrical connector body 1200 may be placed onto the electrical contacts 1216 and electrically connected to the electrical board 1215. The analyte sensor 1210 may then be placed onto the electrical connector body 1200 with the portions 1208, 1212 of the analyte sensor 1210 aligned with the respective ends 1202, 1204 of the electrical connector body 1200. The top member 1220 may then be placed over the analyte sensor 1210 and the electrical connector body 1200 to press the analyte sensor 1210 against the electrical connector body 1200.

[0183] Figure 10B illustrates a perspective cross-sectional view of the resulting configuration, and Figure 10C illustrates a top view of the resulting configuration.

[0184] In implementations, the analyte sensor 1210 may be disposed between the electrical connector body 1200 and the electrical board 1215.

[0185] Any of the implementations disclosed herein may utilize such sensor connections for the analyte sensors.

[0186] 11A-11D illustrate a variation of the implementation of FIGS. 10A-10C in which a conductive tab 1300 and conductive pad 1303 are utilized. With reference to FIG. 11A, the conductor body 1200 of FIGS. 10A-C may be provided with conductive tabs 1300 each electrically connecting the respective ends 1202, 1204 to an electrical board 1302 (depicted in FIG. 11B). The conductive tabs 1300 may extend over the ends 1202, 1204 and may secure the ends in place. An analyte sensor 1210 (shown in FIG. 11B) may be disposed between the conductor body 1200 and the electrical board 1302. In an implementation, the analyte sensor 1210 may be disposed between the conductor body 1200 and the top member 1304.

[0187] Conductive pads 1303 may be disposed on the sides of the conductor body 1200 and may be configured to electrically couple to respective ones of the conductive tabs 1300.

[0188] 11B illustrates an assembled view of the connection. The top member 1304 can be placed on the electrical conductor body 1200 in a manner similar to the top member 1220 shown in FIGS.

[0189] Figure 11C illustrates a cross-sectional side view of the assembled interface with the analyte sensor 1210. Figure 11D illustrates a top view of the assembled interface.

[0190] The conductive tab 1300 and sensor receiving portion configuration may be utilized with the implementations disclosed herein.

[0191] Any of the implementations disclosed herein may utilize such sensor connections for the analyte sensors.

[0192] 12A-12D illustrate systems and methods for forming electrical conduits utilizing anisotropic conductive adhesives (ACAs). ACAs include materials that can be aligned and positioned at desired locations in response to electric or magnetic fields, or both. The ACAs may be collimated and then cured to form the electrical conduits. The ACAs may include ferrite or iron particles and may be suspended in a carrier material, such as a material that can be used for electrical encapsulation or potting.

[0193] 12A, the electrical board 1400 may be disposed within a body, such as an enclosure as disclosed herein. Other forms of bodies may be utilized. The body may be configured to hold materials, such as the ACA and / or carrier material.

[0194] The ACA 1402 may be disposed, for example, on an electrical substrate 1400 as shown in Figure 12A. Ferrite or iron particles may be suspended within a carrier material in Figure 12A. For example, step 1403 in Figure 12D may illustrate such a step. The ACA 1402 may be delivered by aerosol dispensing, pad / screen printing, or direct volumetric dispensing, among other forms of dispensing.

[0195] Other electrical components may be provided for connecting electrical conduits. The electrical components may include one or more of a battery 1404, sensor electronics 1406, or a socket 1408 for coupling to a sensor, among other forms of electrical components. For example, step 1405 of FIG. 12D may illustrate such a step.

[0196] The particles of the ACA may be collimated into columns 1410. With reference to FIG. 12B, such a process may include application of a magnetic field 1411 (shown in FIG. 12B) or an electric field, or another process, to the ACA 1402 to collimate the ACA 1402. The pattern of the field (e.g., magnetic or electric field) may be controlled to generate a desired pattern of electrical conduits. For example, step 1407 of FIG. 12D may illustrate such a process.

[0197] With reference to FIG. 12C, the ACA can be cured to produce the electrical conduit 1412. For example, heat or thermal curing, ultraviolet (UV) curing, or other forms of curing can be utilized. For example, step 1409 of FIG. 12D can illustrate such a step. Curing can physically and / or electrically couple or secure the electrical component to the electrical substrate 1400. In implementations, curing can include utilizing a self-catalyzing material.

[0198] The resulting electrical conduit 1412 can be conductive in a direction perpendicular to the plane of the electrical substrate 1400 .

[0199] The process can include filling the housing or body with the ACA and then providing the desired pattern of electrical conduits. The carrier material remaining within the housing or body can be cured to form a seal within the housing or body.

[0200] The form of electrical conduit that may be formed may include an electrical conduit for transmitting electrical energy to or from the analyte sensor. The electrical energy may include an electrical signal to or from the analyte sensor. The electrical energy may include power to or from the analyte sensor. The electrical component may include a battery 1404. The electrical conduit may transmit power from the battery to one or more electrical conduits disposed within the body or housing. The electrical component may include a wireless transmitter. The electrical component may include one or more electrical terminals for the analyte sensor. The electrical component may include sensor electronics. The electrical conduit may electrically connect the electrical component to an electrical board in the form of a printed circuit board (PCB).

[0201] The ACA may be applied and cured in one go to improve manufacturing efficiency. All electrical conduits within the housing or body may be formed using the ACA according to implementations herein.

[0202] Any of the implementations disclosed herein may utilize ACA or a method that utilizes ACA.

[0203] 13A illustrates a perspective view of an on-skin wearable medical device 1500 according to an implementation herein. The device 1500 may comprise a body 1501 configured to be worn on the skin and coupled to a transcutaneous analyte sensor in a manner as may be disclosed herein. The body 1501 may be configured as a housing. The body 1501 may be configured to hold one or more electrical components therein. The body 1501 may be configured to be placed adjacent to the skin of a recipient.

[0204] The body 1501 has a base 1502 and an enclosure 1504 coupled to the base 1502. The coupling may be easily achieved via adhesive in implementations, among other forms of coupling. In implementations, the coupling may form a seal between the base 1502 and the enclosure 1504. The seal may be airtight and / or moisture-proof.

[0205] In some implementations, the adhesive may be a hot melt adhesive or film that includes a thermoplastic (e.g., polyolefin). In some embodiments, the adhesive may be a reactive polyurethane. The reactive polyurethane may be dispensed and moisture cured. In some embodiments, the adhesive may be a silicone or epoxy. The silicone or epoxy may be cured using ultraviolet (UV) light to create a seal between the base 1502 and the enclosure 1504. The epoxy may alternatively be cured in an oven, which may be for about 30 minutes, at a temperature of approximately 80 degrees Celsius. Other forms of adhesive may be utilized. Similar to epoxy, acrylates may be used as adhesives and cured under the same or similar conditions as epoxies using an oven. In some embodiments, the seal between the base 1502 and the enclosure 1504 may be achieved using welding. Welding techniques may include ultrasonic welding, laser welding, vibration welding, or electromagnetic welding.

[0206] At least a portion of the body 1501 may be made of liquid crystal polymer (LCP). In implementations, for example, the enclosure 1504 may be made entirely or in part of liquid crystal polymer (LCP). In other implementations, the enclosure 1504 may be made entirely or in part of one or more of the following: polyproplene (PP), polyethylene terephthalate glycol (PETG), polycarbonate (PC), copolyester (CP), and cyclic olefin copolymer (COC). The enclosure 1504 may have low oxygen absorption and low moisture absorption. For example, the moisture absorption rate may be 0.01% to 0.06%. Preferably, the moisture absorption rate may be 0.03%. Other absorption amounts may be utilized. The enclosure 1504 may be biocompatible. The enclosure 1504 may be sterilizable. The enclosure 1504 may entirely cover the base 1502 such that the base 1502 is secured within the enclosure 1504 .

[0207] The base 1502 may be made in whole or in part of PP, PETF, PC, CP, COC, or LCP. The base 1502 may have a bottom surface 1506. The bottom surface 1506 may face away from the enclosure 1504. The enclosure 1504 may not extend above the bottom surface 1506. The bottom surface 1506 may be curved (e.g., concave) or flat. The bottom surface 1506 may be connected in whole or in part to a patch (not shown). The patch may connect the body 1501 to the skin.

[0208] The base 1502 may hold one or more electrical components (e.g., shown as electrical component 1511 in FIG. 13B) within a perimeter 1508 of the base 1502. The enclosure 1504 may extend over the electrical components. The one or more electrical components may include an electronic board (e.g., a printed circuit board, a flexible circuit board) and may include a power source, a transmitter, and / or a sensor electronically coupled to the electronic board. The electronic components may include sensor electronics. A power source (e.g., a battery, among other forms of power) may provide power to the remainder of the one or more electronic components.

[0209] The sensor may comprise an analyte sensor as disclosed herein and may transcutaneously measure an analyte (e.g., glucose) in the user's blood. The sensor may be configured to generate a signal indicative of an analyte concentration in the recipient. The sensor measurement may be communicated to a transmitter, which may then communicate the measurement to an output device. The body 1501 may hold one or more of the electrical components for receiving the signal from the analyte sensor. The output device may be, by way of example, a display, a computing device, or a portable electronic device. The user may view the measurement on a user interface of the output device and act based on the measurement (e.g., perform a medical treatment, seek medical attention, ingest food). The sensor may be configured to extend from the body 1501 to be disposed within the skin. The aforementioned features of the device 1500 discussed in this paragraph may be included in other on-skin wearable medical devices discussed throughout this disclosure.

[0210] Figure 13B illustrates an exploded view of an on-skin wearable medical device 1509. The device can have the same dimensions as the device of Figure 13A, except that the entire enclosure 1510 is made of LCP.

[0211] FIG. 14 illustrates an exploded view of an on-skin wearable medical device. The device may include one or more aspects of the device 1500 and may further include a filler 1520. In some implementations, the filler 1520 may be sandwiched between an electrical board 1522 and a base 1524. The electrical board 1522 in the example may include one or more electrical components such as a processor, a battery, and / or memory storage. The filler 1520 may be sandwiched between an enclosure 1526 and the electrical board 1522. In some implementations, the filler may be disposed between a first housing and a second housing. The filler 1520 may be disposed, for example, between the base 1524 and the enclosure 1526 or other form of housing. The filler 1520 may occupy an empty space or void between the enclosure 1526 and the base 1524. The filler 1520 may partially or completely surround the electrical board 1522. The filler material 1520 may include thermoplastic and / or thermoset polymers, among other forms of materials.

[0212] In some embodiments, the filler material 1520 may be made of or may include a hot melt material, such as a thermoplastic polyamide or polyolefin. In such embodiments, the hot melt material is specifically configured to be molded at low pressure, also known as low pressure molding (LPM), which helps protect sensitive electronics and also cools or hardens quickly to improve manufacturing throughput. The hot melt material can cool or harden more quickly after molding than a thermosetting polymer. The hot melt material can cool or harden more quickly than the material from which at least a portion of the base and enclosure are constructed after molding.

[0213] The enclosure 1526 and base 1524 may also be molded parts, but may be made using different processes and using different materials or polymers. For example, the enclosure 1526 and base 1524 may be molded from a thermosetting polymer using conventional injection molding techniques performed at higher pressures and temperatures than the LPM process. In this manner, the polymer used to form the enclosure 1526 and base 1524 may have different chemical and physical properties, such as improved hardness, improved cohesion, improved abrasion resistance, and / or reduced moisture permeability, as compared to the hot melt material of the LPM process. The base 1524 and enclosure 1526 may be composed of a first material, and the hot melt material may be configured to be molded at a lower pressure or temperature than the first material. The hot melt material may include a filler composed of a different material than the base and / or enclosure. In some embodiments, the enclosure 1526 and the base 1524 can be molded from poly(methyl methacrylate) (PMMA), acrylonitrile butadiene styrene (ABS), nylon (polyamide, PA), polycarbonate (PC), polyethylene (PE), polyoxymethylene (POM), polypropylene (PP), polystyrene (PS), thermoplastic elastomers (TPE), thermoplastic polyurethanes (TPU), and / or combinations thereof. The enclosure 1526 and the base 1524 may be made of different materials or polymers from one another. In an example, the enclosure 1526 and the base 1524 may be made of the same material.

[0214] In some embodiments, the filler material 1520 may be made of or include a curable material. For example, the curable material may be platinum cure silicone, polyurethane, polysulfide, polyurea, epoxy, and combinations thereof. The curable material cures through addition reactions, the use of a catalyst, and / or a chemical reaction that does not require moisture.

[0215] In some embodiments, the on-skin wearable medical device 1500 may be assembled or at least partially assembled according to the following method: In a first step, the electrical board 1522 may be first placed on either the enclosure 1526 or the base 1524. The enclosure 1526 and / or the base 1524 may include alignment and / or fastening features configured to align and / or fasten the electrical board 1522. In a second step, the other of the enclosure 1526 or the base 1524 is assembled to the integrated electrical board 1522 and the enclosure 1526 or the base 1524. In a third step, the assembled enclosure 1526, base 1524 and electrical board 1522 are placed in a mold. In a fourth step, filler material 1520 (e.g., a hot melt material) is injected (e.g., via an LPM process) into cavities within the assembled enclosure 1526 and base 1524. In a fifth step, filler material 1520 is cooled and allowed to harden.

[0216] FIG. 15 illustrates an exploded view of an on-skin wearable medical device. The device may have an outer shell 1530, which may comprise a solidified outer shell 1530. The outer shell 1530 may include an outer shell 1530 of an enclosure and may extend over an inner shell 1532 of the enclosure. The outer shell 1530 may be made of LCP. Electronic components may be disposed within the housing (e.g., disposed on an electrical board 1522). The inner shell 1532 may be made of one or more of nylon plastic, polyolefin, or thermoplastic elastomer, among other materials. The outer shell 1530 may be flush on the inner shell 1532. In implementations, the outer shell 1530 may be made of another material, such as COC, for example, or another material.

[0217] Any of the implementations disclosed herein may include the features of Figures 13A-15. Any of the implementations disclosed herein may utilize liquid crystal polymers (LCPs) in the body, housing, or other components, if desired.

[0218] 16A-16G illustrate implementations of a system 1600 that may be utilized herein. An embodiment of the system 1600 may comprise an on-skin wearable medical device or on-skin sensor assembly configured to be peeled onto a recipient's skin to at least partially deploy the on-skin wearable medical device or on-skin sensor assembly onto the recipient's skin. An embodiment of the system 1600 may include a reel 1602 configured to hold a plurality of flexible on-skin wearable medical devices or on-skin sensor assemblies on the reel 1602, the on-skin wearable medical devices or on-skin sensor assemblies configured to be deployed from the reel 1602 onto the recipient's skin. Other embodiments of the system are disclosed herein.

[0219] The system 1600 may include one or more on-skin wearable medical devices or on-skin sensor assemblies. All or a portion of the on-skin wearable medical devices or on-skin sensor assemblies may be represented by a housing 1604 shown in Figures 16A-16G. The housing 1604 may include a flexible housing configured to flex and may be capable of being wound around a reel 1602 or another device for holding the housing 1604. At least a portion of the on-skin wearable medical device may be flexible.

[0220] In an implementation, the housing 1604 may include the sensor electronics, power source, sensor socket, or transcutaneous analyte sensor coupled thereto, although in an implementation, any or all of those components may be added to the housing 1604 during deployment or after deployment on the recipient's skin. For example, as shown in FIG. 16A, the housing 1604 may be deployed on the recipient's skin and then the electronics or analyte sensor may be coupled thereto, or in an implementation, the housing 1604 may include all components for operation. The on-skin wearable medical device may be configured to hold one or more electrical components for the on-skin wearable medical device. One or more of a battery, transmitter, or contacts for the transcutaneous analyte sensor may be provided. The housing 1604 may include certain components, but not all components for operation. For example, the analyte sensor in an implementation may be coupled to the housing 1604 during deployment.

[0221] The housing 1604 can be configured to adhere to the skin of a recipient. For example, the housing 1604 can include a patch 1606 (as depicted in FIG. 16B) or adhesive side configured to couple to the skin of a recipient. In implementations, a liner can be placed over the patch 1606 or adhesive side and removed prior to deployment.

[0222] Once the patch or adhesive side is exposed, the housing 1604 may be peeled onto the recipient's skin to at least partially deploy the on-skin wearable medical device or on-skin sensor assembly on the recipient's skin. Such peeling may include a wiping or swabbing action, or a lateral movement of the housing 1604 that may be parallel to the plane of the recipient's skin. The movement may be along the plane of the recipient's skin or may include movement along the recipient's skin along a parallel plane. Other forms of peeling may be utilized. In implementations, only the patch may be peeled off and not the housing, or the entire on-skin wearable medical device or on-skin sensor assembly may be peeled off for deployment. The on-skin wearable medical device may be peeled onto the recipient's skin to insert a transcutaneous analyte sensor of the on-skin wearable medical device into the recipient's skin.

[0223] 16A-16G illustrate implementations of an applicator 1608 that may be utilized to peel an on-skin wearable medical device or on-skin sensor assembly against a recipient's skin and at least partially deploy the on-skin wearable medical device or on-skin sensor assembly against the recipient's skin.

[0224] The applicator 1608 may include an applicator housing 1610 that may be configured to be grasped by a user. The applicator 1608 may hold a reel 1602 that may be configured to hold an on-skin wearable medical device or an on-skin sensor assembly.

[0225] In implementations, an elongated retainer body 1612 may be provided that holds an on-skin wearable medical device or on-skin sensor assembly and may be configured to wrap around the reel 1602. The elongated retainer body 1612 may comprise, for example, a ribbon that wraps around the reel 1602. The on-skin wearable medical device or on-skin sensor assembly, or a housing 1604 of such device or assembly, may be configured to be releasably coupled to the elongated retainer body 1612 and released or peeled away from the retainer body 1612 at a desired time. The elongated retainer body 1612 may comprise, for example, perforations or other releasable couplings between the on-skin wearable medical device or on-skin sensor assembly or housing 1604 and the elongated retainer body 1612. In implementations, the elongated fastener body 1612 can include tracks or alignment guides 1614 that can be utilized to position the elongated fastener body 1612 and to determine how far the elongated fastener body 1612 has been pulled off the reel 1602.

[0226] The elongated retainer body 1612 may include one or more of the on-skin wearable medical devices or on-skin sensor assemblies, or the housing 1604. The elongated retainer body 1612 may be configured to hold multiple on-skin wearable medical devices.

[0227] The applicator housing 1610 may include an elongated retainer body 1612 and a dispenser opening 1616 (as depicted in FIG. 16B ) through which the on-skin wearable medical device or on-skin sensor assembly or housing 1604 is dispensed. The dispenser opening 1616 may be located at the bottom or another portion of the applicator housing 1610, as desired. The dispenser opening 1616 may be configured to allow the elongated retainer body 1612 to be withdrawn.

[0228] The dispenser opening 1616 may be positioned such that the elongated retainer body 1612 or the adhesive portion of the housing 1604 contacts the recipient's skin. The elongated retainer body 1612 may be pulled from the reel 1602 as the applicator housing 1604, with the adhesive from the housing 1610 or another adhesive that adheres to the skin, is moved laterally along the recipient's skin along the skin. The elongated retainer body 1612 may be peeled along the recipient's skin or may be pulled from the applicator while being peeled along the recipient's skin.

[0229] The applicator 1608 may include an insertion assembly 1618 configured to insert a needle into the recipient's skin to insert the analyte sensor into the recipient's skin. The insertion assembly 1618 may include an insertion driver, such as, for example, an insertion spring, configured to drive the needle with the analyte sensor into the recipient's skin. The insertion assembly 1618 may be configured to be positioned over an on-skin wearable medical device or on-skin sensor assembly to insert the analyte sensor into the recipient's skin.

[0230] The applicator 1608 may include a storage assembly 1620 in the form of a retraction driver, such as a retraction spring, configured to retract the needle from the recipient's skin after the analyte sensor is deployed on the skin. The analyte sensor may remain within the recipient's skin upon retraction of the needle. The storage assembly 1620 may be configured to automatically retract the needle after insertion of the needle. The storage assembly 1620 may retract the needle from the recipient's skin after the needle inserts a transcutaneous analyte sensor of one of the on-skin wearable medical devices into the recipient's skin.

[0231] The applicator 1608 may include a trigger assembly 1622 configured to actuate the insertion assembly 1618 at a desired time. The trigger assembly 1622 may trigger the insertion of a needle into the recipient's skin. The trigger assembly 1622 may include, for example, a cam 1624 and an anvil 1626 configured to be struck by the cam 1624 at a desired time to actuate the insertion assembly 1618. The cam 1624 may be configured to rotate based on one or more gears 1628 being rotated based on the elongated retainer body 1612 being unwound from the reel 1602. The track or alignment guide 1614 may be coupled to the gears 1628 in an implementation to rotate the gears 1628, or another method may be utilized. The trigger assembly 1622 may be actuated based on movement of the applicator 1608 relative to the recipient's skin. The trigger assembly 1622 may cause the needle to be inserted into the recipient's skin.

[0232] In implementations, the insertion assembly 1618 and storage assembly 1620, as well as the utilized needle (whether prior to insertion or a used needle resulting from insertion), may be held within a first portion 1630 of the applicator 1608, which may be separable from a second portion 1632 of the applicator 1608. The first portion 1630 may further include an analyte sensor in implementations. The second portion 1632 may hold the reel 1602 and the trigger assembly 1622. Thus, the needle and analyte sensor may be sterilized separately from the second portion 1632, if desired. The first portion 1630 may include one or more ports, for example, for receiving a sterilizing gas or other form of sterilant.

[0233] Additionally, if first portion 1630 holds a used needle, first portion 1630 may be discarded after use. The used needle may pose a biohazard upon disposal. Second portion 1632 may be reused as desired and may comprise a reusable applicator body. First portion 1630 may hold a used needle after insertion into the recipient's skin.

[0234] 16C-16G illustrate an exemplary deployment operation of the on-skin wearable medical device or on-skin sensor assembly. FIG. 16C illustrates that the applicator 1608 can be slid laterally along the recipient's skin 1640 with the adhesive portion of the on-skin wearable medical device or on-skin sensor assembly or the adhesive portion of the elongated retainer body 1612 in contact with the skin. Due to the adhesion, the elongated retainer body 1612 can be pulled out from the reel 1602 shown in FIG. 16A. The on-skin wearable medical device or on-skin sensor assembly can be peeled off the applicator on the recipient's skin.

[0235] 16D illustrates the elongated retainer body 1612 being unwound from the reel 1602, and the on-skin wearable medical device or on-skin sensor assembly, or housing 1604, may be positioned under the needle 1642. The trigger assembly 1622 shown in FIGS. 16A and B may be actuated to actuate the insertion assembly. In implementations, an analyte sensor may be positioned within the first portion 1630 for insertion into the skin of a recipient.

[0236] FIG 16E illustrates the insertion assembly 1618 being actuated with the needle 1642 and analyte sensor inserted into the recipient's skin 1640. FIG 16F illustrates the retraction assembly 1620 being actuated to retract the used needle 1642. The analyte sensor 1644 may remain within the recipient's skin 1640. The housing 1604 may then be separated from the elongated retainer body 1612 and may remain on the recipient's skin 1640. Electrical components may be added to the housing 1604, if desired.

[0237] 16G, the first portion 1630 may be separated from the second portion 1632 after use. The first portion 1630 may be disposed and the second portion 1632 may be reusable, especially if the second portion 1632 includes additional on-skin wearable medical devices or on-skin sensor assemblies, or the housing 1604.

[0238] Variations on the systems disclosed herein may be provided.

[0239] 17A-25B illustrate implementations of a body that includes one or more bending portions configured to allow the body to bend to conform to the contours of the skin.

[0240] 17A-17E illustrate implementations of a body 1700, for example in the form of a housing that includes an exterior 1701 and may include an interior (e.g., an interior cavity for receiving electrical components or other features of the body). Exterior 1701 may include a top surface 1702 and may include a bottom surface 1703 (depicted in FIG. 17C).

[0241] The top surface 1702 or bottom surface 1703 may include one or more flexing portions in the form of one or more living hinges 1704. The living hinges 1704 may comprise channels in the top surface 1702 or bottom surface 1703 of the body 1700 that are configured to allow the body 1700 to flex. The channels may extend along the exterior of the housing. Although two living hinges 1704 are shown in Figures 17A-17E, fewer or more may be provided, if desired.

[0242] The living hinge 1704 may comprise a channel that extends along the top surface 1702 or the bottom surface 1703. The living hinge 1704 may have other configurations in other implementations.

[0243] 17A-17E, the living hinge 1704 may be disposed on a bottom surface 1703 of the body 1700. The living hinge 1704 may extend along the minor dimension or axis of the body 1700 in implementations in which the body 1700 has an elongated or oblong configuration. The top surface 1702 of the body 1700 may comprise a smooth surface that may be devoid of a living hinge.

[0244] In implementations, the living hinge 1704 can divide the body 1700 into a rigid portion and a flexible portion. The rigid portion can include, for example, rigid portions 1705, 1707, 1709 (depicted in FIG. 17D ), and the flexible portion can include a flex portion or section that includes the living hinge 1704.

[0245] 17C, in an implementation, electrical components may be disposed in the rigid portions 1705, 1707, 1709. For example, a power source or battery 1708 may be disposed in the rigid portion 1705, a sensor coupler 1710 may be disposed in the rigid portion 1707, and sensor electronics 1712 may be disposed in the rigid portion 1709. Flexible electrical conduits or flexible electrical boards can join the electrical components through the bent portion. A flexible circuit board may be utilized. The flexible circuit board may be disposed inside the body and coupled to one or more electrical components and configured to bend with the body. The electrical components may remain unbent in the rigid portion while the bent portion is bent.

[0246] The bending portion can be capable of bending in a direction. In the implementations of Figures 17A-17E, the body 1700 can be configured to bend toward the recipient's skin or away from the top surface 1702 (e.g., as shown in Figure 17B). In implementations, bending can also occur in a direction away from the recipient's skin or toward the top surface 1702 (e.g., away from the bottom surface).

[0247] 18A-18E illustrate an implementation of a body 1800 in the form of a housing including a single bent portion. The bent portion can include a living hinge 1802, which can be disposed on a bottom surface 1803 of the body 1800. The living hinge 1802 can extend along a minor dimension or axis of the body 1800 in implementations in which the body 1800 has an elongated or oblong configuration. The living hinge 1802 can extend along a central minor axis of the body 1800 or housing.

[0248] 19A-19E illustrate an implementation of a body 1900 in the form of a housing that includes flexures in the form of living hinges 1901 on both a top surface 1902 and a bottom surface 1904 of the body 1900. Improved flexibility in the direction towards and away from the recipient's skin can be achieved.

[0249] 20A-20B illustrate an implementation of the body 2000 in the form of a housing having an "S" shape, with recesses 2002 forming bent portions to form the "S" shape. The recesses 2002 may form cutouts in the body 2000. The body 2000 may be configured to bend around the bent portions. The "S" shape may conform to the periphery of an oval, or may have another shape, if desired. The bent portions may each include a recess forming an "S" shape or an S-shape.

[0250] 21A-21B illustrate an implementation of a body 2100 in the form of a housing having multiple compartments 2102. The compartments 2102 may be separated by flexing portions 2104, 2106 configured to allow the body 2100 to flex. The flexing portion 2104 may include, for example, a horizontal living hinge and the flexing portion 2106 may include a vertical living hinge. The compartments 2102 may be separated by living hinges and are capable of bending about both the flexing portions 2104, 2106. In an implementation, electrical conduits or electrical boards may pass through flexible connections 2108 between the compartments 2102.

[0251] In implementations, the cover 2110 may extend over the compartment 2102. The cover 2110 may be configured to flex with the compartment 2102 and the remainder of the housing. The cover may be flexible and configured to flex with the housing.

[0252] Body 2100 may have an oval or elongated configuration in implementation, or another configuration as desired.

[0253] 22A-22B illustrate an implementation of body 2200 configured similarly to body 2100 shown in Figures 21A-21B, but having a circular profile. Body 2200 can include sections 2202 separated by bend portions configured to allow body 2200 to bend.

[0254] 23A-B illustrate an implementation of a body 2300 having bent portions in the form of flexible wings 2302. The wings 2302 may extend outwardly from a housing 2304, which may be rigid or flexible. The wings 2302 may comprise a fabric material or an elastomeric material or other form of flexible material.

[0255] 24 illustrates an implementation of a body 2400 that includes bending portions in the form of living hinges 2402 that are configured to allow wings 2404 to bend relative to a central portion 2406. The central portion 2406 and wings 2404 may be flexible or rigid, as desired.

[0256] 25A and 25B illustrate an implementation of a body 2500 that includes a living hinge 2502 in the form of a fabric extending between rigid portions or sections 2504. The rigid portions or sections 2504 may include a central section 2506 and a peripheral section 2508.

[0257] Any implementation of the body or housing disclosed herein may include one or more bent portions.

[0258] 26 illustrates an implementation of a sensor connection configuration. The sensor connection may comprise a sensor carrier or a sensor interposer as desired. The sensor connection may include an analyte sensor 2600, a first conductive film 2602, and a second conductive film 2604. A non-conductive film 2606 may be laterally sandwiched by the first conductive film 2602 and the second conductive film 2604. The second conductive film 2604 may be disposed adjacent to the first conductive film 2602.

[0259] The first conductive film 2602, the second conductive film 2604, and the non-conductive film 2606 may each include a film fed from a roll and thermoformed to form a laminar film disposed adjacent one another. The films 2602, 2604, 2606 may be drawn adjacent one another in a width direction 2609 shown in FIG. 26 and then cut or otherwise singulated to form edges 2611, 2613. The films 2602, 2604, 2606 may include a triblock configuration.

[0260] The first conductive film 2602 and the second conductive film 2604 may each include a conductive material. Such conductive materials may include a polymer that may be blended with a conductive material. Such polymers may include elastomeric polymers such as ethylene vinyl acetate (EVA) or another form of polymer. The polymer may be blended with a conductive material such as conductive carbon or silver or nickel or another form of conductive material. The film material may be unwound from a roll in a width direction 2609 shown in FIG. 26.

[0261] The non-conductive film 2606 may include an insulating polymeric material or another form of material. The non-conductive film 2606 may include a polymer such as ethylene vinyl acetate (EVA) or thermoplastic polyurethane (TPU), or another form of a non-conductive polymer. The non-conductive film 2606 may include a dielectric material disposed between the first conductive film 2602 and the second conductive film 2604.

[0262] The analyte sensor 2600 may be disposed on the substrate 2607 with the working electrode 2615 disposed on the second conductive film 2604 and the reference electrode 2617 disposed on the first conductive film 2602. The analyte sensor 2600 may be disposed on the first conductive film 2602, the second conductive film 2604 and in electrical contact with the first conductive film 2602 and the second conductive film 2604. The analyte sensor 2600 may further include a non-conductive or insulator portion 2619 that may be disposed between the working electrode 2615 and the reference electrode 2617. The non-conductive or insulator portion 2619 may be disposed on the non-conductive film 2606. In implementations, the configuration of the analyte sensor 2600 or the substrate 2607 may be varied. For example, the relative positions of the working electrode 2615 and the reference electrode 2617 may be alternated or the configuration of the non-conductive or insulator portions 2619 may be changed as desired.

[0263] The analyte sensor 2600 may be disposed on the substrate 2607 during the process of the films 2602, 2604, 2606 being unwound in the width direction 2609. The analyte sensor 2600 may be placed on the substrate 2607 or multiple analyte sensors may be placed on adjacent substrates as the substrate is being unwound from the roll.

[0264] The analyte sensor 2600 may be attached to the substrate 2607 using a tack adhesive or another form of coupling. The tack adhesive may include, for example, silver epoxy or another form of adhesive. In implementations, the analyte sensor 2600 may be disposed on the substrate 2607 without the use of an adhesive. The first conductive film 2602 and the second conductive film 2604 may be coupled to a tip of the analyte sensor 2600. The tip may be configured to be disposed on the first conductive film 2602. The first conductive film 2602 may comprise a working electrode and the second conductive film 2604 may comprise a reference electrode.

[0265] 26, in implementations, the barrier film 2608 may be disposed over the analyte sensor 2600 and may be disposed over the films 2602, 2604, 2606. The barrier film 2608 may be disposed over the analyte sensor 2600 and the films 2602, 2604, 2606 in a narrow sheet that is placed widthwise 2609 over the analyte sensor 2600 and the films 2602, 2604, 2606 as the films 2602, 2604, 2606 are unwound from the roll. Thus, the films 2602, 2604, 2606 and the barrier film 2608 may be unwound in a long sheet with the lengths of the films 2602, 2604, 2606 and the barrier film 2608 aligned.

[0266] The barrier film 2608 may comprise a non-conductive material and may comprise a polymer. The barrier film 2608 may comprise, for example, a non-conductive EVA or a thermoplastic such as a low melting point thermoplastic (TPU) or a polyolefin or polyethylene terephthalate (PET) or polybutylene terephthalate (PBT). Other forms of non-conductive materials may be utilized. The barrier film 2608 may be configured to be laminated onto the films 2602, 2604, 2606 and the analyte sensor 2600, which may be a vacuum assisted process.

[0267] The barrier film 2608 may be configured to have moisture barrier properties and may seal the electrical connection between the analyte sensor 2600 and the films 2602, 2604. The barrier film 2608 may have reflow properties and may have adhesive properties to adhere to a sensor receiving portion of a body or housing for receiving the analyte sensor 2600. The barrier film 2608 may be cured into the films 2602, 2604, 2606 and the analyte sensor 2600. The barrier film 2608 may be disposed on the analyte sensor 2600 to create a seal on the analyte sensor 2600, the first conductive film 2602, the second conductive film 2604 and the non-conductive film 2606.

[0268] FIG. 27 illustrates an assembly process in which, for example, layers of films 2602, 2604, 2606, 2608 may be rolled together to form an assembly 2610. In an implementation, a solidified backing layer 2612 may be disposed on the barrier film 2608. The solidified backing layer 2612 may be configured to cover and protect the films 2602, 2604, 2606, 2608. The backing layer 2612 may include a polymeric material such as PET or another form of material. FIG. 27 illustrates the assembly 2610 after it has been formed. The analyte sensor 2600 may extend from the films 2602, 2604, 2606 and may be configured to bend in areas away from the films 2602, 2604, 2606. FIG. 28 illustrates an assembled cross-sectional view of the assembled assembly 2610 after it has been formed, and FIG. 29 illustrates a detailed view of the assembled cross-sectional view of FIG. 28.

[0269] In implementations where the assembly 2610 is formed from a long continuous sheet of adjacent assemblies, the assembly 2160 may be singulated to form edges 2611, 2613. Singulation may include cutting the assembly 2610 from the long sheet, which may include laser cutting or die cutting, or another form of cutting. In implementations, the films 2602, 2604, 2606 may be singulated before the barrier film 2608 or solidified backing layer 2612 is placed thereon.

[0270] The assembly 2610 may comprise a sensor connection assembly or a sensor carrier or interposer and may be formed in a scaled-up sensor construction operation. A reel-to-reel process may be used to bring the individual films together to form the assembly 2610.

[0271] The assembly 2610 may be coupled to an electrical board. The electrical board may include a body or housing electrical board 2621. The electrical board 2621 may be connected to electrical components as may be disclosed herein. FIG. 30A illustrates a manufacturing process in which the assembly 2610 may be applied to a housing 2618 for the analyte sensor 2600, for example, using a heated press 2620. FIG. 30B illustrates the assembly 2610 coupled to the housing 2618. The assembly 2610 may be disposed within a sensor receiving portion in the form of a cavity of the housing 2618. An electrical connection may be formed between the assembly 2610 and the electrical board 2621. The first conductive film 2602, the second conductive film 2604, and the non-conductive film 2606 may be configured to couple to the electrical board 2621 to form an electrical connection between the analyte sensor 2600 and the electrical board.

[0272] In implementations, the barrier film 2608 may be reflowed within the cavity of the housing 2618 to seal the assembly 2610 within the cavity and to seal the electrical connections between the assembly 2610 and the electrical substrate 2621. The barrier film 2608 may be heated or otherwise induced to reflow, for example, to fill the cavity and encapsulate and protect the electrical connections. Various other methods of joining or bonding may be utilized, such as pressing, curing, thermal bonding, tacking, roller heating, laser heating, or ultrasonics, among others. The backing layer 2612 may also cover the electrical connections. Referring to FIG. 26, a retainer 2622 may be provided that may further couple the sensor 2600 to a sensor receiving portion of the housing.

[0273] The assembly 2610 may be applied to the housing 2618 in other manners as desired.

[0274] Any of the implementations disclosed herein can utilize the sensor connections discussed with respect to Figures 26-30B.

[0275] 34-36 illustrate implementations in which a seal may be placed around the battery to reduce moisture ingress to the battery's electrical terminals. For example, referring to FIG. 34, a battery 2800 is illustrated disposed on an electrical board 2802. The battery 2800 and / or electrical board 2802 may be disposed within a body as disclosed herein. For example, the body may comprise a housing having an internal cavity. The body may be configured to be worn on the skin and may be configured to couple to a transcutaneous analyte sensor. Other forms of bodies may be utilized if desired.

[0276] The battery 2800 may have a periphery 2804 and may include electrical terminals 2806. The electrical terminals 2806 may be configured to provide a flow of electrical energy to another element in contact with the electrical terminals 2806. The electrical terminals 2806 may include a negative terminal or a positive terminal. The battery 2800 may include an additional electrical terminal 2808 (a complementary positive or negative terminal) to complete a circuit for the battery 2800 to supply electrical energy. The battery 2800 may be configured to supply power to one or more electrical components of an on-skin wearable medical device.

[0277] In implementations, the battery 2800 can include a coin cell, and the electrical terminal 2806 can be located on a bottom surface 2811 or face of the battery 2800. Another electrical terminal 2808 can include a sidewall or top surface 2810 or face of the battery 2800. The battery 2800 can have a circular perimeter 2804, or in implementations another shape (e.g., rectangular, triangular, etc.).

[0278] Electrical terminals 2806 may be disposed on electrical substrate 2802. Electrical substrate 2802 may include electrical contacts 2812 that can contact electrical terminals 2806, for example, to pass electrical energy therethrough. Electrical contacts 2812 may be disposed on a bottom surface 2811 or below the surface of battery 2800.

[0279] It may be advantageous to reduce moisture ingress to the electrical terminals 2806. The seal 2814 may be disposed about the periphery 2804 of the battery 2800 and may be configured to reduce moisture ingress to the electrical terminals 2806. The seal 2814 may reduce the likelihood of moisture ingress to the lower surface 2811 or below the surface of the battery 2800 involving contact between the electrical terminals 2806 and the electrical contacts 2812. Thus, the likelihood of wear, leakage, electrical damage, corrosion, hydrolysis reactions, or electrical shorts may be reduced.

[0280] 34, the seal 2814 can have a variety of forms. The seal 2814 may comprise a bead of material that may be disposed around the perimeter 2804 of the battery 2800. The seal 2814 may extend around the entire perimeter 2804 of the battery 2800, as shown in the top view of FIG. 35. The seal 2814 may be disposed on the electrical substrate 2802 and in contact with a surface of the electrical substrate 2802 and a surface of the battery 2800. The seal 2814, in implementations, can serve to adhere or bond the battery 2800 to the electrical substrate 2802.

[0281] The encapsulant 2814 may include a curable material or foam, or may have another configuration in implementation. The curable material may include an epoxy, resin, or adhesive, or other form of material configured to harden. The curable material may be dispensed in liquid or fluid form and cured to a solid state to seal the electrical terminals 2806. The foam may include a closed cell foam or other material configured to prevent moisture transmission. Other forms of materials may be utilized if desired.

[0282] High contrast or fluorescent sealing materials may further be utilized to verify contiguous sealing and adequate sealing of the battery-substrate gap upon visual inspection.

[0283] Other configurations of seals may be utilized. For example, referring to FIG. 36, the interior cavity 2816 of the housing may be filled with a curable material 2818 that forms a seal. The seal may cover the top surface 2810 of the battery 2800 and the sides or sidewalls of the battery 2800. This may reduce the possibility of moisture ingress throughout the battery 2800 and electrical connection with the electrical board 2802. The curable material may include an ultraviolet (UV) curable material or a two-part epoxy, among other forms.

[0284] Upon assembly, the battery 2800 may be placed in place on the substrate. The encapsulation may be dispensed around the battery 2800. For example, a bead or a quantity of material may be provided within the enclosure. A curing process may be applied. For example, a UV flood cure or other curing means may be performed. In implementations where materials such as foam are utilized, the curing step may be omitted.

[0285] The features of Figures 34-36 may be utilized with any implementation, if desired.

[0286] 38 illustrates an implementation in which an adhesive layer may be configured to prevent the curable material from flowing out of the cavity. For example, referring to FIG. 37, an implementation is shown excluding the use of such an adhesive layer. A housing 2900 is illustrated. The housing 2900 may be configured similar to any of the implementations of the housings disclosed herein or may have other forms. The housing 2900 may be configured to be attached to the skin of a recipient. The housing 2900 may be configured to couple to a transcutaneous analyte sensor.

[0287] The housing may include one or more walls 2902 that define a cavity 2904 for receiving a hardenable material 2906. The cavity 2904 may comprise a sensor receiving portion of the housing similar in structure to the sensor receiving portions illustrated in FIGS. 9A-9B or 32A-32B. The cavity 2904 may be configured to receive an analyte sensor 2908 (depicted in FIG. 38). The cavity 2904 may be utilized in other ways in implementations.

[0288] The cavity 2904 may have an end 2910 with an opening 2912. A substrate 2914 may be disposed within the housing 2900 and may be disposed at the opening 2912 of the cavity 2904. The substrate 2914 may have a variety of implementations. The substrate 2914 may include, for example, an electrical substrate that may be configured to electrically couple with the analyte sensor 2908. The substrate 2914 in an implementation may be configured to support the analyte sensor 2908.

[0289] A gap 2916 or discontinuity may be disposed between the substrate 2914 and the walls 2902. Such a gap 2916 or discontinuity may result from the substrate 2914 including a separate material as the walls 2902. The gap 2916 or discontinuity may be narrow or small in size, but may be of sufficient size to allow for the flow of the hardenable material 2906 out of the cavity 2904.

[0290] The hardenable material 2906 can have a variety of forms and can include an epoxy, a resin, an adhesive, or another form of hardenable material. The hardenable material 2906, in implementations, can be electrically conductive. The hardenable material 2906 can be utilized to stabilize or seal the analyte sensor 2908 within the cavity 2904.

[0291] The hardenable material 2906 may be dispensed into the cavity 2904 in fluid or liquid form, which may occur prior to hardening of the hardenable material 2906. Figure 37, for example, illustrates the hardenable material 2906 dispensed into the cavity 2904 prior to complete hardening or solidification of the hardenable material 2906.

[0292] 37, the hardenable material 2906 may flow out of the cavity 2904 and through gaps 2916, or may crack between the wall 2902 and the substrate 2914. For example, FIG. 37 illustrates a portion 2918 of the hardenable material 2906 that extends outwardly to other portions of the substrate 2914 outside of the opening 2912. Such an outcome may be undesirable as the hardenable material 2906 may not be disposed in the cavity 2904 to the desired extent (due to flow-out) and the hardenable material 2906 may be undesirable in other portions of the substrate 2914 or within the housing 2900. It may be difficult to maintain a desired or uniform thickness of the hardenable material 2906.

[0293] 38 illustrates an implementation in which an adhesive layer 2920 is disposed between the substrate 2914 and the opening 2912 of the cavity 2904. The adhesive layer 2920 can be configured to prevent the hardenable material 2906 from flowing out of the cavity 2904 through the opening 2912. The hardenable material 2906 can be prevented from flowing through the opening 2912 and onto a portion of the substrate 2914 that is disposed outside of the opening 2912.

[0294] The adhesive layer 2920 may, for example, contact an edge 2922 of the wall 2902 that defines the opening 2912 of the cavity 2904. The adhesive layer 2920 may contact the edge 2922 and the substrate 2914 to reduce flow of the curable material 2906 therethrough.

[0295] In implementations, the adhesive layer 2920 can include a bottom surface 2924 or first surface that can face and contact the substrate 2914. The adhesive layer 2920 can include a top surface 2926 or second surface that can face opposite the bottom surface 2924. Each surface 2924, 2926 can include an adhesive portion in implementations. Thus, adhesion to the substrate 2914 and the wall 2902 can occur.

[0296] Adhesive layer 2920 may include a pressure sensitive adhesive in examples. Adhesive layer 2920 may include a tape or may have another configuration in examples. The adhesive on adhesive layer 2920 may include a tacky material that allows for adhesion to substrate 2914 and / or wall 2902. Adhesive layer 2920 may include a thin conformal layer of a pressure sensitive film.

[0297] 38 , the analyte sensor 2908 may be disposed on and in contact with the adhesive layer 2920. The adhesive layer 2920 may be configured to electrically couple to the analyte sensor 2908. The adhesive layer 2920 may be configured to conduct electrical energy to the substrate 2914, which may be configured to electrically couple to the analyte sensor 2908.

[0298] In implementations, adhesive layer 2920 may be non-conductive and may be utilized to hold the curable material within cavity 2904 if desired.

[0299] The features of FIG. 38 may be utilized with any implementation as desired.

[0300] The foregoing description presents the best modes contemplated for carrying out the invention and for the manner and process of making and using it in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the invention. The invention is, however, susceptible to modifications and alternative constructions from those contemplated above that are fully equivalent. Consequently, the invention is not limited to the particular embodiments disclosed. On the contrary, the invention covers all modifications and alternative constructions that are within the spirit and scope of the invention as generally expressed by the following claims which particularly point out and separately claim the subject matter of the invention. While the present disclosure has been illustrated and described in detail in the drawings and the foregoing specification, such illustrations and descriptions are to be considered illustrative or exemplary and not restrictive.

[0301] All references cited herein are incorporated herein by reference in their entirety. To the extent that publications and patents or patent applications incorporated by reference conflict with the present disclosure contained herein, the present specification is intended to supersede and / or take precedence over any such conflicting material.

[0302] Unless otherwise defined, all terms (including technical and scientific terms) should be given their ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning unless expressly defined as such herein. It should be noted that the use of a particular term when describing a particular feature or aspect of the present disclosure should not be interpreted as implying that the term is redefined herein to be limited to include any specific characteristic of the feature or aspect of the present disclosure with which the term is associated. Terms and phrases used in this application, and variations thereof, should be interpreted as open ended, as opposed to limiting, unless expressly stated otherwise, particularly in the appended claims. As an example of the foregoing, the term "including" should be read to mean "including, without limitation," "including but not limited to," and the like. As used herein, the term "comprising" is synonymous with "including," "containing," or "characterized by" and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The term "having" should be interpreted as "having at least." The term "includes" should be interpreted as "includes but is not limited to."The term "example" is used to provide illustrative instances of the item under discussion, and not an exhaustive or limiting list thereof; adjectives such as "known," "normal," "standard," and words of similar import should not be construed as limiting the items described to a given period of time, or to items available at a given time, but rather should be read to embrace known, conventional, or standard technology that may be available or known at any time now or in the future; and words such as "preferably," "preferred," "desired," or "desirable," and similar imports should not be understood to imply that a particular feature is critical, essential, or even critical to the structure or function of the invention, but rather are merely intended to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Similarly, a group of items joined with the conjunction "and" should not be read as requiring any and all of those items to be present in the group, but rather, unless expressly stated otherwise, should be read as "and / or." Similarly, a group of items joined with the conjunction "or" should not be read as requiring mutual exclusivity among the group, but rather, should be read as "and / or" unless expressly stated otherwise.

[0303] When a range of values ​​is provided, it is understood that the upper and lower limits, and each intervening value between the upper and lower limits of that range, are included within an embodiment.

[0304] With respect to the use of substantially any plural and / or singular term in this specification, those skilled in the art can interpret from the plural to the singular and / or from the singular to the plural as appropriate to the context and / or application. For clarity, various singular / plural permutations may be explicitly set forth herein. The indefinite articles "a" or "an" do not exclude the plural. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain means are recited in mutually different dependent claims does not indicate that a combination of these means cannot be used to advantage. Reference signs in the claims shall not be construed as limiting the scope.

[0305] Those skilled in the art will further understand that where a particular number is intended in the recitation of a claim introduced, such intent will be expressly recited in the claim, and that in the absence of such recitation, no such intent exists. For example, to aid in understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce a recitation of a claim. However, the use of such phrases should not be construed as suggesting that introducing a claim recitation with the indefinite article "a" or "an" limits any particular claim that includes a claim recitation so introduced to an embodiment that includes only one such recitation, even when the introductory phrase "one or more" or "at least one" and the indefinite article, e.g., "a" or "an," are included in the same claim (e.g., "a" and / or "an" should generally be construed to mean "at least one" or "one or more"), and the same applies to the use of definite articles used to introduce a recitation of a claim. In addition, even if a particular number of enumerations in an introduced claim is explicitly recited, one of ordinary skill in the art will recognize that such enumeration should typically be interpreted to mean at least the number recited (e.g., the mere recitation of "two enumerations" without other modifiers typically means at least two enumerations, or more than two enumerations). Furthermore, when a conventional expression similar to "at least one of A, B, and C, etc." is used, such a structure is generally intended in the sense that one of ordinary skill in the art would understand the conventional expression (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, and C, etc.).When a conventional expression similar to "at least one of A, B, or C, etc." is used, such a structure is generally intended in the sense that one of ordinary skill in the art would understand the conventional expression (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, and C, etc.). One of ordinary skill in the art will further appreciate that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of those terms, either of those terms, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0306] All numerical values ​​expressing amounts of raw materials, reaction conditions, and the like used herein should be understood to be modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth herein are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to this application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

[0307] Moreover, although the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Therefore, the specification and examples should not be construed as limiting the scope of the invention to the specific embodiments and examples described herein, but rather should be construed to cover all modifications and alternatives which come within the true scope and spirit of the invention.

Claims

1. 1. An on-skin wearable medical device configured to be deployed on the skin of a recipient, the on-skin wearable medical device comprising:

1. An on-skin wearable medical device comprising: a housing configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor, the housing including a film layer.

2. 2. The on-skin wearable medical device of claim 1, wherein the housing includes a bottom configured to be placed adjacent to the skin and a top configured to be raised above the bottom, at least a portion of the top comprising the film layer.

3. The on-skin wearable medical device of claim 1 or 2, wherein the housing includes an outer upper surface configured to face away from the skin, and at least a portion of the outer upper surface comprises the film layer.

4. The on-skin wearable medical device of any one of claims 1 to 3, wherein the housing includes a bottom configured to be placed in proximity to the skin, and at least a portion of the bottom comprises the film layer.

5. The on-skin wearable medical device of any one of claims 1 to 4, wherein the housing includes a bottom surface configured to face toward the skin, and at least a portion of the bottom surface is provided with the film layer.

6. The on-skin wearable medical device of any one of claims 1 to 5, wherein the housing includes a bottom configured to be placed in proximity to the skin and a top configured to be raised above the bottom, the bottom including the film layer, the top including the film layer, and the film layer of the bottom connected to the film layer of the top.

7. The on-skin wearable medical device of claim 6 , wherein the film layer at the bottom connects to the film layer at the top to form a seal for the internal cavity of the housing.

8. The on-skin wearable medical device of claim 7 , wherein the bottom film layer is connected to the top film layer around an edge of the housing.

9. 9. The on-skin wearable medical device of claim 6, wherein the bottom film layer is connected to a socket for receiving a plug connected to the transcutaneous analyte sensor, and the top film layer is connected to the socket for receiving the plug connected to the transcutaneous analyte sensor.

10. The on-skin wearable medical device of any one of claims 6 to 9, further comprising a patch coupled to the housing and configured to couple the housing to the skin.

11. The on-skin wearable medical device according to any one of claims 6 to 10, wherein the housing is flexible.

12. The on-skin wearable medical device of any one of claims 6 to 11, wherein the housing has a length, a width, and a height, and the length and the width are each greater than the height.

13. 13. The on-skin wearable medical device of claim 12, further comprising a socket for receiving a plug coupled to the transcutaneous analyte sensor.

14. The on-skin wearable medical device of claim 13 , wherein the socket comprises an opening in the top of the housing.

15. 15. The on-skin wearable medical device of claim 13 or claim 14, wherein the length is greater than the width, and the socket has an oblong shape with a major dimension extending along the width of the housing.

16. The on-skin wearable medical device according to any one of claims 6 to 15, wherein the housing has a rectangular shape.

17. The on-skin wearable medical device of any one of claims 6 to 16, further comprising a cover layer forming an outer surface of the housing and disposed over the film layer.

18. The on-skin wearable medical device of any one of claims 6 to 17, further comprising one or more electrical components disposed within the interior cavity of the housing.

19. 20. The on-skin wearable medical device of claim 18, wherein the one or more electrical components include one or more of a battery, a transmitter, or contacts for the transcutaneous analyte sensor.

20. The on-skin wearable medical device of any one of claims 6 to 19, further comprising a filler material disposed within an internal cavity of the housing.

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