Pre-joined analyte sensor

Abstract

A method of manufacturing an on-skin wearable device includes assembling electronic circuitry into an interior volume of a housing, the electronic circuitry configured to detect a signal generated by an electrochemical reaction under a subject's skin at a working electrode of an analyte sensor, wirelessly transmitting data derived from the detected signal to the outside of the housing for processing and / or display by a separate device; after the electronic circuitry is assembled into the interior volume of the housing, the proximal portion of the analyte sensor is attached to an external electrical interface coupled to the electronic circuitry such that the electronic circuitry is connected to the analyte sensor to receive a signal from the analyte sensor without opening the housing, the external electrical interface is formed in a recess in an external bottom surface of the housing, the external bottom surface being configured to directly contact a patch for coupling the housing to a subject's skin; a curable liquid is dispensed into the recess to seal the attachment of the proximal end portion of the analyte sensor to the external electrical interface.

Description

[0001] This application is a divisional application of Chinese patent application No. 201880068924.1, entitled "Pre-connected Analyte Sensor". It was filed on October 23, 2018. Technical Field

[0002] This disclosure relates generally to sensors, and more specifically to analyte sensors such as continuous analyte sensors. Background Technology

[0003] Diabetes is a condition in which the pancreas cannot produce enough insulin (type 1 or insulin-dependent) and / or insulin is ineffective (type 2 or non-insulin-dependent). In diabetes, patients suffer from high blood sugar, which can cause a range of physiological disturbances associated with the deterioration of small blood vessels, such as kidney failure, skin ulcers, or vitreous hemorrhage. Hypoglycemia (low blood sugar) can be induced by unintentional overuse of insulin, or by excessive exercise or insufficient food intake while using normal doses of insulin or hypoglycemic agents.

[0004] Conventionally, people with diabetes wear self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger prick method. Due to this lack of comfort and convenience, people with diabetes usually only measure their glucose levels two to four times a day. Disadvantageously, these intervals are so long that it may be too late for people with diabetes to detect symptoms of high or low blood sugar, sometimes leading to dangerous side effects. Alternatively, glucose levels can be continuously monitored using a sensor system that includes a sensor assembly on the skin. The sensor system can have a wireless transmitter that sends measurement data to a receiver, which can process and display the information based on the measurement.

[0005] This background information is provided to provide a brief overview of the invention and specific embodiments described below. This background information is not intended to help define the scope of the claimed subject matter, nor is it intended to limit the claimed subject matter to embodiments that address any or all of the aforementioned drawbacks or problems. Summary of the Invention

[0006] The manufacturing process of analytical sensors, such as continuous analytical sensors, involves various steps, for which temporary mechanical and electrical connections are used between the sensor and manufacturing equipment, such as testing and / or calibration equipment. Accurate placement and alignment of the sensor to the mechanical and electrical interfaces of the testing and / or calibration equipment facilitates these connections. As described below, devices such as “interconnects,” “mediators,” or “sensor carriers” can be attached to the elongated body of the sensor to aid in handling and to provide temporary and permanent electrical and mechanical connections. The sensor carrier (also referred to as a “sensor mediator”) may also include features for tracking, data storage, and sealing the sensor electrodes to each other and to the environment. Without limiting the scope of embodiments of the invention as expressed by the appended claims, its more prominent features will now be briefly discussed. After considering this discussion, and explicitly after reading the section entitled “Detailed Description,” it will be understood how the features of the embodiments of the invention provide the advantages described herein.

[0007] According to a first aspect, a method of manufacturing a sensor is provided. The method includes providing an analyte sensor having: an elongated body; a first electrode; a second electrode coaxially positioned within the first electrode; and at least two electrical contacts longitudinally aligned and spaced apart along the longitudinal axis of the sensor. The method includes attaching a sensor carrier to the analyte sensor, the sensor carrier comprising: an intermediate body; a first conductive portion disposed on the intermediate body and electrically connected to the first electrode; and a second conductive portion disposed on the intermediate body and electrically connected to the second electrode. The first conductive portion and the second conductive portion form a connection portion configured to establish an electrical connection between the sensor and a separate device.

[0008] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the method further includes coupling an outer layer to the intermediate. The outer layer includes an identifier. The outer layer, the sensor, and the intermediate can form a laminated configuration. The identifier can be a QR code table. The identifier can include any of an optical identifier, a radio frequency identifier, or a memory-encoded identifier. The identifier can identify the analyte sensor, calibration data of the analyte sensor, or the history of the analyte sensor.

[0009] In a generally applicable embodiment of the first aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the method further includes coating the sensor with a film after attaching the sensor to the sensor carrier.

[0010] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are traces. The traces may extend from a distal location of the sensor carrier and terminate at a proximal end of the sensor carrier. The traces may form exposed contact surfaces in the connecting portion. The first conductive portion and the second conductive portion may be embedded in the intermediate body.

[0011] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are solder joints. The solder joints allow the sensor to be attached to the sensor carrier.

[0012] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are conductive tape. The conductive tape can attach the sensor to the sensor carrier.

[0013] In a generally applicable embodiment of the first aspect (i.e., which can be combined independently with any aspect or embodiment described herein), the connecting portion is configured to mechanically engage with the individual device.

[0014] In a generally applicable embodiment of the first aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the separate device is an electronic device unit configured to measure analyte data.

[0015] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the separate device is a component of a manufacturing station. The method may further include performing at least one of a potentiostat measurement, an impregnation process, a curing process, a calibration process, or a sensitivity measurement while establishing the electrical connection between the sensor and the manufacturing station. The method may further include terminating the electrical connection between the sensor and the calibration station. The method may further include establishing an electrical connection between the sensor and at least one test station via the connection portion of the sensor carrier.

[0016] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the intermediate further includes a reference structure that controls the position and spatial orientation of the analyte sensor relative to a substrate of the intermediate. The reference structure may include a flexible portion of the substrate folded over at least a portion of the analyte sensor.

[0017] In a generally applicable embodiment of the first aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the first conductive portion and / or the second conductive portion comprises at least one of a helical spring, a leaf spring, or a conductive elastomer.

[0018] According to a second aspect, an apparatus is provided comprising an analyte sensor having: an elongated body, a first electrode electrically connected to a first conductive contact, and a second electrode electrically connected to a second conductive contact. A sensor carrier can be attached to the analyte sensor. The sensor carrier may comprise: an intermediate body; a first conductive portion disposed on the intermediate body and electrically connected to the first conductive contact; and a second conductive portion disposed on the intermediate body and electrically connected to the second conductive contact. The first conductive portion and the second conductive portion may form a connection portion configured to establish electrical communication between the first conductive contact and the second conductive contact and a separate device.

[0019] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the device further includes an identifier coupled to the intermediate. The identifier, the sensor, and the intermediate can form a laminated configuration. The identifier can be a QR code table. The identifier can be any of an optical identifier, a radio frequency identifier, or a memory-encoded identifier. The identifier can be configured to identify any of the analyte sensor, calibration data of the analyte sensor, and the history of the analyte sensor.

[0020] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are traces. The traces may form exposed contact surfaces in the connection portion. The first conductive portion and the second conductive portion may be at least partially embedded in the intermediate body.

[0021] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the first conductive portion and the second conductive portion comprise at least one of a solder joint, conductive tape, helical spring, leaf spring, or conductive elastomer.

[0022] In a generally applicable embodiment of the second aspect (i.e., which can be combined independently with any aspect or embodiment described herein), the connecting portion is configured to mechanically engage with the separate device.

[0023] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the separate device is an electronic device unit configured to measure analyte data.

[0024] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the individual device is a component of the manufacturing station. At least one of a potentiostat measurement, an impregnation process, a curing process, a calibration process, or a sensitivity measurement may be configured to be performed when the electrical connection is established between the sensor and the manufacturing station. The manufacturing station may include a calibration station configured to disconnect the electrical connection between the sensor and the calibration station and establish an electrical connection between the sensor and at least one test station via the connection portion of the sensor carrier.

[0025] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the intermediate further includes a reference structure configured to control the position and spatial orientation of the analyte sensor relative to a substrate of the intermediate.

[0026] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the first electrode may be coaxially positioned within the second electrode, and the first and second electrical contacts may be longitudinally aligned and spaced apart along the longitudinal axis of the sensor.

[0027] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first electrode and the second electrode may be attached to a flexible planar substrate. Additionally, the first electrical contact and the second electrical contact may be attached to the flexible planar substrate.

[0028] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the first conductive contact and the second conductive contact are attached to the intermediate by a conductive adhesive.

[0029] In a generally applicable embodiment of the second aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the first conductive contact and the second conductive contact are attached to the intermediate via an anisotropic conductive film.

[0030] According to a third aspect, a pre-connected analyte sensor array is provided. The array includes: a substrate; a first plurality of electrical contacts disposed on the substrate; a second plurality of electrical contacts disposed on the substrate; and a plurality of analyte sensors disposed on the substrate. Each of the plurality of analyte sensors includes a first sensor contact coupled to a corresponding first contact of the first plurality of electrical contacts on the substrate and a second sensor contact coupled to a corresponding second contact of the second plurality of electrical contacts on the substrate. The array may include one or more strips.

[0031] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first plurality of electrical contacts are aligned along the substrate. The first plurality of electrical contacts may be formed from exposed contact surfaces.

[0032] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the second plurality of electrical contacts are aligned along the substrate. The second plurality of electrical contacts may be formed from exposed contact surfaces.

[0033] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the first plurality of electrical contacts and the second plurality of electrical contacts are configured to be connected to a separate device. The separate device may be a component of a manufacturing station.

[0034] In a generally applicable embodiment of the third aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the substrate includes at least one slit feature configured to facilitate slitting the substrate into a plurality of sensor carriers, wherein each of the plurality of sensor carriers is attached to a corresponding analyte sensor in the analyte sensor.

[0035] In a generally applicable embodiment of the third aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the strip further includes a plurality of identifiers disposed on the substrate.

[0036] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the substrate includes an elongated dimension, wherein the plurality of analyte sensors extend beyond the edge of the substrate in a direction orthogonal to the elongated dimension. The strip may further include a feed guide strip that travels along opposite edges of the substrate along the elongated dimension. The substrate may further include a flexible substrate configured to be wound onto a reel. The feed guide strip is removable from the substrate.

[0037] In a generally applicable embodiment of the third aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the substrate comprises a molded thermoplastic having a plurality of reference features that control the position and orientation of the plurality of analyte sensors, and wherein the first plurality of electrical contacts and the second plurality of electrical contacts each comprise embedded conductive traces in the molded thermoplastic.

[0038] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the strip further includes a first reference structure coupled to the strip, the first reference structure being configured to position the plurality of analyte sensors. The first reference structure includes at least one slit feature configured to facilitate slicing the first reference structure into a plurality of second reference structures, wherein each of the plurality of second reference structures is coupled to a corresponding sensor carrier among a plurality of sensor carriers formed through the substrate.

[0039] In a generally applicable embodiment of the third aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the strip further includes a carrier having a processing circuitry configured to perform at least potentiostat measurements on the plurality of analyte sensors. The strip may further include a communication circuitry operable by the processing circuitry to transmit and receive data associated with each of the analyte sensors and an identifier of that analyte sensor.

[0040] According to a fourth aspect, a method is provided. The method includes providing a pre-connected analyte sensor, the pre-connected analyte sensor comprising: an intermediate; an analyte sensor permanently attached to the intermediate; and an identifier coupled to the intermediate. The method includes communicatively coupling the analyte sensor to a processing circuitry system of the manufacturing station by coupling the intermediate to a corresponding feature of the manufacturing station. The method includes operating the processing circuitry system of the manufacturing station to communicate with the pre-connected analyte sensor.

[0041] In a generally applicable embodiment of the fourth aspect (i.e., which may be combined independently with any aspect or embodiment described herein), operating the processing circuitry system includes obtaining a signal from the analyte sensor via a connection portion. Operating the processing circuitry system may include operating an optical, infrared, or radio frequency reader at the manufacturing station to obtain the identifier.

[0042] In a generally applicable embodiment of the fourth aspect (i.e., which can be independently combined with any aspect or embodiment described herein), the method further includes storing sensor data corresponding to the signal using the processing circuitry system of the manufacturing station and in conjunction with the identifier. The identifier may identify any one of the analyte sensor, calibration data of the analyte sensor, and the history of the analyte sensor.

[0043] In a generally applicable embodiment of the fourth aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the signal comprises a glucose sensitivity signal.

[0044] In a generally applicable embodiment of the fourth aspect (i.e., which may be independently combined with any aspect or embodiment described herein), the method further includes removing the pre-connected analyte sensor from the manufacturing station and communicatively coupling the analyte sensor to the processing circuitry of the wearable device by mechanically coupling the anchoring feature of the intermediate to a corresponding feature of the wearable device. The method may further include obtaining in vivo measurement data from the analyte sensor via the processing circuitry of the wearable device.

[0045] In a generally applicable embodiment of the fourth aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the analyte sensor is permanently attached to the intermediate by a conductive adhesive.

[0046] In a generally applicable embodiment of the fourth aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the analyte sensor is permanently attached to the intermediate via an anisotropic conductive film.

[0047] According to a fifth aspect, a wearable device is provided. The wearable device includes a housing and an electronic circuitry configured to process signals from an analyte sensor. The electronic circuitry is enclosed within the housing. The analyte sensor has a distal portion located outside the housing. An intermediate body has electrical connections to both the proximal portion of the analyte sensor and the electronic device, wherein the electrical connection between the intermediate body and the proximal portion of the analyte sensor is located outside the housing.

[0048] In a generally applicable embodiment of the fifth aspect (i.e., which can be combined independently with any aspect or embodiment described herein), the intermediate may be positioned adjacent to the outer surface of the housing. The device may include electrical contacts coupled to both the electronic device and the intermediate. The intermediate may be electrically connected to the electrical contacts via a conductive epoxy resin. The intermediate may be electrically connected to the electrical contacts via an anisotropic conductive film. The intermediate may be sealed. The electrical contacts may extend through the housing. The intermediate may be positioned in a recess on the outer surface of the housing. The electrical contacts may extend through the housing within the recess to electrically couple the intermediate to the electronic circuitry enclosed within the housing. The intermediate may be covered by a polymer within the recess.

[0049] In a generally applicable embodiment of the fifth aspect (i.e., which may be independently combined with any aspect or embodiment described herein), the analyte sensor is formed as an elongated body having a distal portion and a proximal portion, the distal portion being configured for percutaneous implantation in a subject, and the proximal portion being configured for electrical connection to the intermediate body. The distal portion of the analyte sensor may extend away from an opening through the housing. The electronic circuitry may include a potentiostat and / or a wireless transmitter.

[0050] According to a sixth aspect, a method for manufacturing a pre-connected analyte sensor is provided. The method includes mechanically and electrically connecting a proximal portion of an elongated conductor to a conductive portion of an intermediate, and after the connection, coating a distal portion of the elongated conductor with a polymer film to form an analyte sensor having a working electrode region configured to support an electrochemical reaction for the detection of an analyte in the distal portion of the elongated conductor.

[0051] In a generally applicable embodiment of the sixth aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the method further includes testing the analyte sensor, wherein the testing includes electrically coupling the intermediate to a test station. The method may further include calibrating the analyte sensor, wherein the calibration includes electrically coupling the intermediate to a test station. The coating may include dip coating.

[0052] In a generally applicable embodiment of the sixth aspect (i.e., which can be combined independently with any aspect or embodiment described herein), the intermediate may be part of an array formed of a plurality of coupled intermediates, wherein the method further includes mechanically and electrically connecting the proximal portion of each of a plurality of elongated electrodes to a conductive portion of each intermediate in the array. The coating may be performed in parallel on each distal portion of each of the plurality of elongated electrodes connected to the intermediate in the array. The method may include slicing one or more intermediates in the array after the coating.

[0053] In a generally applicable embodiment of the sixth aspect (i.e., which can be combined independently with any aspect or embodiment described herein), the mechanical and electrical connection includes applying a conductive paste to the conductive portion of the elongated conductor and the intermediate. In some embodiments, the mechanical and electrical connection includes compressing an anisotropic conductive film between the proximal portion of the elongated conductor and the conductive portion of the intermediate. The connection may be performed at a location remote from the coating. In some embodiments, the coating, the testing, and the calibration are all performed at a location remote from the connection.

[0054] According to a seventh aspect, a method of manufacturing a wearable transdermal analyte sensor for the skin includes: assembling an electronic circuit system into an internal volume of a housing, wherein the electronic circuit system is configured to (1) detect a signal generated by an electrochemical reaction under the skin of an object at a working electrode of the analyte sensor; and (2) wirelessly transmit data derived from the detected signal to an exterior of the housing for processing and / or display by a separate device. After assembling the electronic circuit system into the internal volume of the housing, a proximal portion of the analyte sensor is attached to an external electrical interface coupled to the electronic circuit system, such that the electronic circuit system becomes connected to the analyte sensor to receive signals from the analyte sensor without opening the housing.

[0055] In a generally applicable embodiment of the seventh aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the method includes sealing the interface after attaching the proximal portion of the analyte sensor. The method may include testing the functionality of the electronic circuitry system prior to attachment. The method may include testing the functionality of the analyte sensor prior to attachment. The assembly may be performed at a location remote from the attachment.

[0056] In a generally applicable embodiment of the seventh aspect (i.e., which may be combined independently with any aspect or embodiment described herein), the method may include coupling an intermediate to the proximal portion of the analyte sensor, and the attachment may include attaching the intermediate to the external electrical interface. The method may then include performing at least one manufacturing or testing procedure on the working electrode using the intermediate prior to the attachment. The execution may include coating the working electrode of the analyte sensor. The coupling may be performed at a first location, the assembly may be performed at a second location, and the execution may be performed at a third location, wherein the first, second, and third locations are remote from each other. The attachment and / or coupling may be performed via an anisotropic conductive film. The method may further include attaching an inserter to the housing to implant the working electrode into the object.

[0057] It should be understood that those skilled in the art will readily recognize various configurations of the invention based on this disclosure, wherein the various configurations of the invention are illustrated and described by way of illustration. As will be appreciated, the invention can have other different configurations, and certain details thereof can be modified in various other ways, all without departing from the scope of the invention. Therefore, the summary, drawings, and detailed description are to be considered illustrative rather than restrictive in nature. Attached Figure Description

[0058] Embodiments of the invention will now be described in detail, with particular emphasis on advantageous features. These embodiments are for illustrative purposes only and are not drawn to scale, but rather to highlight the principles of this disclosure. The accompanying drawings include the following figures, wherein similar reference numerals denote similar parts: Figure 1 This is a schematic diagram of an analytical sensor system attached to a host and communicating with a plurality of example devices, according to some embodiments.

[0059] Figure 2 This demonstrates, based on some embodiments, and Figure 1 A block diagram of the electronic devices associated with the sensor system.

[0060] Figures 3A-3C A wearable device with an analyte sensor is shown according to some embodiments.

[0061] Figure 3D An implementation of a slender sensor connected to a potentiostat is shown.

[0062] Figure 4A A schematic diagram of a pre-connected analyte sensor according to some embodiments is shown.

[0063] Figure 4BAnother schematic diagram of a pre-connected analyte sensor according to some embodiments is shown.

[0064] Figure 4C A layered view of a pre-connected analyte sensor according to some embodiments is shown.

[0065] Figure 4D A schematic diagram of a pre-connected analyte sensor array according to some embodiments is shown.

[0066] Figures 5A-5E A block diagram of a system having a manufacturing system for an analyte sensor and a wearable device, according to some embodiments, is shown.

[0067] Figure 6 A cross-sectional schematic diagram of a wearable device with a pre-connected analyte sensor is shown according to some embodiments.

[0068] Figure 7 A cross-sectional schematic diagram of a wearable device with a pre-connected analyte sensor is shown according to some embodiments.

[0069] Figure 8 A cross-sectional schematic diagram of a wearable device with a pre-connected analyte sensor is shown according to some embodiments.

[0070] Figure 9 A perspective view of a sensor assembly on the skin according to some embodiments is shown.

[0071] Figure 10 and 11 A perspective view of a sensor carrier with a spring according to some embodiments is shown.

[0072] Figure 12 A cross-sectional perspective view of a portion of a sensor carrier according to some embodiments is shown.

[0073] Figures 13A-13B A perspective view of a wearable sensor assembly according to some embodiments is shown.

[0074] Figure 13C An exploded view of the components of a wearable sensor assembly according to some embodiments is shown.

[0075] Figures 14A-14B A perspective view of another wearable sensor assembly according to some embodiments is shown.

[0076] Figure 14C An exploded view of components of another wearable sensor assembly including an external electrical interface, according to some embodiments, is shown.

[0077] Figure 14DDemonstrates the installation of pre-connected sensor assemblies Figure 14C Top view of the external electrical interface.

[0078] Figure 14E It is along Figure 14D The cross-section of line EE in the diagram.

[0079] Figure 15A Another embodiment of a printed circuit board substrate for a sensor carrier is shown.

[0080] Figure 15B and 15C Alternative embodiments of electrical interfaces for coupling sensors and sensor carriers to wearable sensor assemblies are shown.

[0081] Figure 16 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor by a conductive adhesive.

[0082] Figure 17 An end view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor by a conductive adhesive.

[0083] Figure 18 An end view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor via a conductive adhesive in a recess in a sensor carrier substrate.

[0084] Figure 19 An end view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to the analyte sensor via conductive adhesive in a corner of a sensor carrier substrate.

[0085] Figure 20 An end view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor via a conductive adhesive in a circular recess in a sensor carrier substrate.

[0086] Figure 21A and 21B The images show a perspective view and an end view of the analyte sensor attached to the sensor carrier within the guide structure.

[0087] Figure 22 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor by conductive tape.

[0088] Figure 23 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having a substrate attached to and wrapped around an analyte sensor.

[0089] Figure 24 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor by welded conductive plastic.

[0090] Figure 25 and 26 Manufacturing apparatus for attaching a sensor carrier to an analyte sensor using conductive plastic, according to some embodiments, is shown.

[0091] Figure 27 This is a perspective schematic diagram showing the proximal portion of an analyte sensor having a flat electrical connector portion according to some embodiments.

[0092] Figure 28 This illustrates attachment to a sensor carrier according to some embodiments. Figure 24 Side view of the analyte sensor.

[0093] Figure 29 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having a flexible substrate configured to be wound around an analyte sensor.

[0094] Figure 30 A perspective view of a sensor carrier according to some embodiments is shown, the sensor carrier having a substrate having a flexible portion configured to be wound around an analyte sensor.

[0095] Figure 31A and 31B Another embodiment of a sensor carrier attached to an analyte sensor is shown.

[0096] Figure 32 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having movable fasteners for attaching an analyte sensor.

[0097] Figure 33 Demonstrates some embodiments Figure 29 A perspective view of the movable fastener.

[0098] Figure 34 A perspective view of a sensor carrier implemented as a barrel-shaped fastener according to some embodiments is shown.

[0099] Figure 35A A front view of a sensor carrier according to some embodiments is shown, the sensor carrier having a flexible substrate wrapped around an analyte sensor.

[0100] Figure 35BA perspective view of a sensor carrier according to some embodiments is shown, the sensor carrier having a flexible substrate wrapped around a plurality of analyte sensors.

[0101] Figure 36 An end view of a sensor carrier with a crimp connector according to some embodiments is shown.

[0102] Figure 37 An end view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor via a crimp connector.

[0103] Figure 38 A side view of a sensor carrier having several crimp connectors according to some embodiments is shown.

[0104] Figure 39 A perspective view of a sensor carrier according to some embodiments is shown.

[0105] Figure 40 A perspective view of a sensor carrier according to some embodiments is shown, the sensor carrier being formed from molded interconnects.

[0106] Figure 41 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier being formed from molded interconnects.

[0107] Figure 42 A side view of a sensor carrier according to some embodiments is shown, the sensor carrier being attached to an analyte sensor via a conductive coupler.

[0108] Figure 43 A side view of a sensor carrier according to some embodiments is shown, the sensor carrier having an elongated dimension for attachment to a plurality of analyte sensors.

[0109] Figure 44 A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having a flexible substrate for wrapping around an analyte sensor.

[0110] Figure 45 A top view of another sensor carrier according to some embodiments is shown, the other sensor carrier having a flexible substrate for wrapping around an analyte sensor.

[0111] Figure 46 A top view of another sensor carrier according to some embodiments is shown, the other sensor carrier having a flexible substrate for wrapping around an analyte sensor.

[0112] Figure 47AA side view of a sensor carrier according to some embodiments is shown, the sensor carrier having feed guide strips in an elongated dimension for attaching to a plurality of analyte sensors.

[0113] Figure 47B Demonstrates winding on a reel according to some embodiments Figure 47A A perspective view of the sensor carrier.

[0114] Figure 48 Demonstrates some embodiments Figure 47A A top view of the sensor carrier, wherein the sensor carrier is cut from the sensor carrier alone.

[0115] Figure 49 A perspective view of a sensor carrier according to some embodiments is shown, the sensor carrier having spring-loaded sockets for attaching a plurality of analyte sensors.

[0116] Figure 50 A perspective view of a sensor carrier according to some embodiments is shown, the sensor carrier having magnetic reference features for positioning and orientation of multiple analyte sensors.

[0117] Figure 51A A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having a rigid, curved panel for attaching to a plurality of analyte sensors.

[0118] Figure 51B A top view of a sensor carrier according to some embodiments is shown, the sensor carrier having a rigid-flexible panel for attaching to a plurality of analyte sensors, the plurality of analyte sensors having edge card connector pads for electrical connection.

[0119] Figure 52A A top view of a sensor carrier according to some embodiments is shown, the sensor carrier from... Figure 48 The sensor carrier is cut into individual pieces and attached to the analyte sensor to form a pre-connected sensor.

[0120] Figure 52B A sensor carrier according to some embodiments is shown, the sensor carrier having a design for attachment without the need for a V-shaped notch portion. Figure 51B Rigid and flexible panels for multiple analyte sensors.

[0121] Figure 53A A pre-connected sensor, according to some embodiments, is shown, which will be installed in a wearable device.

[0122] Figure 53B A pre-connected sensor in a folded position, according to some embodiments, is shown, which will be installed in a wearable device.

[0123] Figure 54 A sensor carrier according to some embodiments is shown, the sensor carrier being implemented as a sub-board for connection to an analyte sensor.

[0124] Figure 55 A sensor carrier implemented by a clamping clamp according to some embodiments is shown.

[0125] Figure 56 A sensor carrier according to some embodiments is shown, the sensor carrier having a clip for connection to an analyte sensor.

[0126] Figure 57 This is a flowchart illustrating operations that can be performed for manufacturing and using pre-connected sensors according to some embodiments.

[0127] Figure 58 A perspective view of a sensor holding device with a grooved flexible tube according to some embodiments is shown.

[0128] Figure 59 Demonstrates some embodiments Figure 58 An exploded perspective view of the equipment.

[0129] Figure 60 Demonstrates, according to some embodiments, the inclusion of, installed on Figure 55 The device of sensors in the equipment.

[0130] Figure 61 A simplified diagram of a carrier for pre-connecting sensors, according to some embodiments, is shown.

[0131] Throughout, similar reference numerals refer to similar elements. Unless otherwise noted, elements are not drawn to scale. Detailed Implementation

[0132] The following description and examples illustrate some exemplary embodiments, examples, and arrangements of the disclosed invention. Those skilled in the art will recognize that the scope of this invention encompasses many variations and modifications. Therefore, the description of certain example embodiments should not be construed as limiting the scope of the invention.

[0133] definition To facilitate understanding of the various embodiments described herein, several terms are defined below.

[0134] As used herein, the term "analyte" is a broad term and has its common and conventional meaning (and is not limited to a particular or customary meaning) to those skilled in the art, and further refers to, but not limited to, analyzable substances or chemical components in biological fluids (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine). An analyte may comprise naturally occurring substances, artificial substances, metabolites, and / or reaction products. In some embodiments, an analyte is measured by a sensor head, device, and method. However, other analytes are also anticipated, including but not limited to uncarboxylated prothrombin; acylcarnitine; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (Krebs cycle), histidine / uric acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinose enantiomers; arginase; benzoyl stigmine (cocaine); biotinylate; biopterin; C-reactive protein; carnitine; carnosine; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β-hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporine A; D-penicillamine; deethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylation gene polymorphism, alcohol dehydrogenase, α1- Antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte -6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, β-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); debutylhalopantriline; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycine; free β- Human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3); fumarate acetylacetase; galactose / gal-1-phosphate; galactose-1-phosphate uridine transferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione peroxidase; glycocholic acid; glycosylated hemoglobin; halopantriline; hemoglobin variants; aminohexosidase A; human erythrocyte carbonic anhydrase I; 17-α-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B / A-1, β); lysozyme; mefloquine;Netilmicin; Phenobarbital; Phenytoin; Phytanic acid / norphytanic acid; Progesterone; Prolactin; Proline dipeptidase; Purine nucleoside phosphorylase; Quinine; Reverse triiodothyronine (rT3); Selenium; Serum pancreatic lipase; Sisomycin; Somatostatin C; Specific antibodies (Adenovirus, Antinuclear antibody, Anti-ζ antibody, Arbovirus, Oyeki virus, Dengue virus, Draconis mesenae, Echinococcus granulosus, Entamoeba histolytica, Enterovirus, Giardia lamblia, Helicobacter pylori, Hepatitis B virus, Herpes simplex virus, HIV-1, IgE (atopic disease), Influenza virus, Leishmania donovani, Leptospira, Measles / Mumps / Rubella, Mycobacterium leprae, Mycoplasma pneumoniae, myoglobin, Onchocerca filariasis, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma japonicum, varicella-zoster virus, Wucet's nematode, yellow fever virus; specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyroid-stimulating hormone (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I Synthetic enzymes; vitamin A; leukocytes; and zinc protoporphyrin. In some embodiments, naturally occurring salts, sugars, proteins, fats, vitamins, and hormones in blood or interstitial fluid may also constitute the analyte. The analyte may be naturally present in biological fluids, such as metabolites, hormones, antigens, antibodies, etc. Alternatively, the analyte may be introduced into the body, for example, as a contrast agent for imaging, a radioactive isotope, a chemical agent, synthetic blood based on fluorescent carbon, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabinoids (marijuana, tetrahydrocannabinol, hashsh); inhalants (nitrous oxide). Amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (Quickcocaine); stimulants (amphetamine, methamphetamine, methylphenidate, methylphenidate, chlorpheniramine, preludin, didrex, preState, voranil, sandrex, plegine); sedatives (barbiturates, methylquinone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclohexylpiperidine, lysergic acid, mescaline, peyote, psilocybin));Anesthetics (heroin, codeine, morphine, opium, pethidine, percocet, compound oxycodone (Percodan), Tussionex, fentanyl, Darvon, Talwin, Lomotil); synthetic drugs (analytes of fentanyl, pethidine, amphetamine, methamphetamine, and phencyclidine, such as ecstasy); anabolic steroids; and nicotine. Metabolites of drugs and drug compositions are also expected analytes. Analytes of neurochemicals and other chemicals produced in the body, such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), serotonin (5HT), and 5-hydroxyindoleacetic acid (FHIAA) may also be analyzed.

[0135] As used herein, the terms “microprocessor” and “processor” are broad terms and have their common and conventional meanings (and are not limited to special or custom meanings) to those skilled in the art, and further refer to, but are not limited to, computer systems, state machines, etc., which use logic circuits to perform arithmetic and logical operations in response to and in response to basic instructions that drive the computer.

[0136] As used herein, the term "calibration" is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or custom meaning), and further refers to, but is not limited to, the process of determining a relationship between sensor data and corresponding reference data, which can transform the sensor data into meaningful values ​​substantially equivalent to the reference data, with or without the reference data. In some embodiments, i.e., in analyte sensors, calibration can be updated or recalibrated over time (in real time and / or retrospectively in the factory) as the relationship between the sensor data and the reference data changes (e.g., due to changes in sensitivity, baseline, transport, metabolism, etc.).

[0137] As used herein, the terms “calibrated data” and “calibrated data stream” are broad terms and have their common and conventional meanings to those skilled in the art (and are not limited to specific or custom meanings), and further refer to, but not limited to, data that is transformed from an original state to another state using a function (e.g., a transformation function, which includes the use of sensitivity) to provide a meaningful value to a user.

[0138] As used herein, the term "algorithm" is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or customary meaning), and further refers to, but is not limited to, the computational process (e.g., a program) involved in transforming information from one state to another, for example, through computer processing.

[0139] As used herein, the term "sensor" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and further refers to, but is not limited to, a component or area of ​​a device by which an analyte can be quantified. A "batch" of sensors typically refers to a group of sensors manufactured on or around the same day using the same processes and tools / materials. Furthermore, sensors that measure temperature, pressure, etc., can be called "sensors."

[0140] As used herein, the terms "glucose sensor" and "component for determining the amount of glucose in a biological sample" are broad terms and have their common and conventional meaning to those skilled in the art (and are not limited to their particular or custom meanings), and further indicate, but are not limited to, any mechanism by which glucose can be quantified (e.g., enzymatic or non-enzymatic). For example, some embodiments utilize membranes containing glucose oxidase, which catalyzes the conversion of oxygen and glucose into hydrogen peroxide and gluconate, as shown in the following chemical reaction: Glucose + O2 → Gluconate + H2O2 Because the co-reactant O2 and product H2O2 change proportionally for the metabolism of each glucose molecule, electrodes can be used to monitor the current changes in the co-reactants or products to determine the glucose concentration.

[0141] As used herein, the terms “operably connected” and “operably linked” are broad terms and have their common and conventional meaning to those skilled in the art (and are not limited to specific or custom meanings), and further indicate, but are not limited to, linking one or more components to another in a manner that allows signals to be transmitted between components. For example, one or more electrodes may be used to detect the amount of glucose in a sample and convert this information into a signal, such as an electrical or electromagnetic signal; said signal may then be transmitted to an electronic circuit system. In this case, the electrodes are “operably linked” to the electronic circuit system. These terms are broad enough to include wireless connectivity.

[0142] The term "determine" encompasses a wide variety of actions. For example, "determine" can include calculation, operation, processing, deriving, investigation, searching (e.g., looking in a table, database, or other data structure), confirmation, etc. Furthermore, "determine" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. And "determine" can include parsing, selecting, picking, calculating, deriving, establishing, etc. Determining can also include confirming that parameters match predetermined criteria, including satisfied, passed, exceeding a threshold, etc.

[0143] As used herein, the term “substantially” is a broad term and has its common and customary meaning to those skilled in the art (and is not limited to a particular or customary meaning), and further indicates, but is not limited to, to a large extent, but not necessarily all of what is specified.

[0144] As used herein, the term “host” is a broad term and has its common and conventional meaning (and not limited to a particular or customary meaning) to those skilled in the art, and further means, but not limited to, mammals, specifically humans.

[0145] As used herein, the term "continuous analyte (or glucose) sensor" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and further indicates, but is not limited to, an apparatus that continuously or constantly measures the concentration of an analyte at time intervals ranging from fractions of a second to, for example, one minute, two minutes, or five minutes or longer. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor as described in U.S. Patent No. 6,001,067, which is incorporated herein by reference in its entirety.

[0146] As used herein, the term "sensing membrane" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and further refers to, but is not limited to, a permeable or semi-permeable membrane that may consist of two or more domains and is typically made of a material with a thickness of several micrometers or greater, which may be permeable to oxygen and permeable or impermeable to glucose. In one example, the sensing membrane comprises immobilized glucose oxidase capable of undergoing an electrochemical reaction to measure glucose concentration.

[0147] As used herein, the term "sensor data" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and further refers to, but is not limited to, any data associated with a sensor (such as a continuous analyte sensor). Sensor data comprises a raw data stream (or simply a data stream) of analog or digital signals (or other signals received from another sensor) directly related to the analyte being measured from an analyte sensor, as well as calibrated and / or filtered raw data. In one instance, sensor data includes digital data in the form of "counts" converted from analog signals (e.g., voltage or current) by an A / D converter, and contains one or more data points representing glucose concentration. Thus, the terms "sensor data point" and "data point" generally refer to a digital representation of sensor data at a specific time. These terms broadly cover data points from multiple time intervals from a sensor (such as a substantially continuous glucose sensor), including individual measurements, for example, at time intervals from fractions of a second to, for example, one minute, two minutes, or five minutes or longer. In another example, sensor data includes integral numerical values ​​representing one or more data points averaged over a time period. Sensor data may contain calibrated data, smoothed data, filtered data, transformed data, and / or any other data associated with the sensor.

[0148] As used herein, the term "sensor electronics" is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or custom meaning), and refers to, but is not limited to, components (e.g., hardware and / or software) configured to process data. As described in further detail below (see, for example, Figure 2), "sensor electronics" can be arranged and configured to measure, convert, store, transmit, communicate, and / or retrieve sensor data associated with an analyte sensor.

[0149] As used herein, the term "sensitivity" or "sensor sensitivity" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and refers to the amount of signal generated by a given concentration of the measured analyte or a substance (e.g., H₂O₂) associated with the measured analyte (e.g., glucose). For example, in one embodiment, the sensor has a current sensitivity of about 1 picoampere to about 300 picoamperes per 1 mg / dL of glucose analyte.

[0150] As used herein, the term “sample” is a broad term and has its common and customary meaning (and is not limited to a particular or customary meaning) to those skilled in the art, and refers to, but is not limited to, a sample of the host body, such as bodily fluids, including blood, serum, plasma, interstitial fluid, cerebrospinal fluid, lymph, eye discharge, saliva, oral fluid, urine, excretions or secretions, etc.

[0151] As used herein, the term "far end" is a broad term and has its common and conventional meaning (and is not limited to a particular or customary meaning) to those skilled in the art, and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that one element is located relatively far from the reference point compared to another element.

[0152] As used herein, the term "proximal" is a broad term and has its common and conventional meaning (and is not limited to a particular or customary meaning) to those skilled in the art, and indicates, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that one element is located relatively close to a reference point compared to another element.

[0153] As used herein, the terms “electrical connection” and “electrical contact” are broad terms and have their common and conventional meanings to those skilled in the art (and are not limited to specific or custom meanings), and refer to any connection between two electrical conductors known to those skilled in the art. In one embodiment, an electrode is electrically connected to the electronic circuitry of a device (e.g., electrically connected to the electronic circuitry of the device). In another embodiment, two materials (such as, but not limited to, two metals) may be in electrical contact with each other, such that current can be transferred from one of the two materials to the other and / or a potential can be applied.

[0154] As used herein, the term "elongated conductive body" is a broad term and has its common and conventional meaning (and is not limited to a particular or custom meaning) to those skilled in the art, and refers to, but is not limited to, an elongated body at least partially formed of conductive material, and including any number of coatings that may be formed thereon. For example, "elongated conductive body" can refer to a bare, elongated conductive core (e.g., a metal wire); an elongated conductive core coated with one, two, three, four, five, or more layers of material, each layer of material being conductive or non-conductive; or an elongated non-conductive core with a conductive coating, trace, or electrode and coated with one, two, three, four, five, or more layers of material, each layer of material being conductive or non-conductive.

[0155] As used herein, the term “extracorporeal portion” is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or customary meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) suitable for retention and / or presence outside the living host.

[0156] As used herein, the term "in vivo portion" is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or custom meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) suitable for insertion into and / or present within the living body of a host.

[0157] As used herein, the term “potentialostat” is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or custom meaning), and refers to, but is not limited to, an electronic instrument that controls the potential between a working electrode and a reference electrode to one or more preset values.

[0158] As used herein, the term "processor module" is a broad term and has its common and conventional meaning (and not limited to a special or custom meaning) to those skilled in the art, and refers to, but not limited to, computer systems, state machines, processors and their components designed to perform arithmetic and logical operations using logic circuitry that responds to and processes the basic instructions that drive a computer.

[0159] As used herein, the term “sensor session” is a broad term and has its common and conventional meaning to those skilled in the art (and is not limited to a particular or custom meaning), and refers to, but not limited to, the period of time during which a sensor is in use, such as, but not limited to, the period from when the sensor is implanted (e.g., by the host) to when the sensor is removed (e.g., removed from the host’s body and / or removed from the system electronics (e.g., disconnected)).

[0160] As used herein, the terms “substantially” and “substantially” are broad terms and have their common and customary meanings (and are not limited to special or custom meanings) to those skilled in the art, and indicate, but are not limited to, a quantity sufficient to provide the required functionality.

[0161] "Sensor based on coaxial dual wires": A circular wire sensor consisting of a conductive core, an insulating intermediate layer, and a conductive outer layer, with the conductive layer exposed at one end for electrical contact.

[0162] "Pre-connected sensor": A sensor with an attached "sensor interconnect / mediator / sensor carrier". Therefore, this "pre-connected sensor" consists of two joined parts: the sensor itself and the interconnect / mediator / sensor carrier. The term "pre-connected sensor" unit refers to a unit formed by the permanent union of these two distinct parts.

[0163] Other definitions will be provided in the description below, and in some cases, depending on the usage of the terms.

[0164] As used herein, the following abbreviations are used: Eq and Eqs (equivalent); mEq (milliequivalent); M (molar); mM (millimole); μM (micromolar); N (normal); mol (molar); mmol (millimole); μmol (micromolar); nmol (nanomolar); g (gram); mg (milligram); μg (microgram); kg (kilogram); L (liter); mL (milliliters); dL (deciliters); μL (microliters); cm (centimeter); mm (millimeter); μm (micrometer); nm (nanometer); h and hr (hour); min. (minute); s and sec. (second); ℃ (degree Celsius); (Fahrenheit), Pa (Pascal), kPa (kilopascal), MPa (megapascal), GPa (gigapascal), Psi (pounds per square inch), kPsi (kilopounds per square inch).

[0165] System Overview / General Description In vivo analyte sensing technology can rely on in vivo sensors. In vivo sensors can comprise an elongated conductive body having one or more electrodes, such as a working electrode and a reference electrode.

[0166] For example, platinum-clad tantalum wire is sometimes used as a core-exposed sensing element with one or more reference or counter electrodes for an analyte sensor. This sensing element is coated in the form of a film to produce the final sensor.

[0167] This document describes a pre-connected sensor comprising an analyte sensor attached to a sensor carrier (also referred to herein as a "sensor intermediate"). The analyte sensor may include a working electrode and a reference electrode at the distal end of an elongated conductive body. The sensor carrier may include: a substrate; one or more electrical contacts coupled to one or more electrical contacts of the sensor; and circuitry, such as one or more additional or external electrical contacts, for coupling the one or more electrical contacts coupled to the one or more sensor contacts to an external device, such as a membrane coating station, a testing station, a calibration station, or sensor electronics for a wearable device. In some embodiments, the substrate may be referred to as an intermediate.

[0168] The following description and examples illustrate embodiments of the invention with reference to the accompanying drawings. In the drawings, reference numerals denote elements of this embodiment of the invention. These reference numerals are reproduced below in conjunction with the discussion of the corresponding features of the drawings.

[0169] Sensor system Figure 1 illustrates an example system 100 according to some example embodiments. System 100 includes an analyte sensor system 101, which includes sensor electronics 112 and an analyte sensor 138. System 100 may include other devices and / or sensors, such as a drug delivery pump 102 and a blood glucose meter 104. The analyte sensor 138 may be physically connected to the sensor electronics 112 and may be integrated with (e.g., non-releasably attached) or releasably attached to the sensor electronics. For example, the continuous analyte sensor 138 may be attached to the sensor electronics 112 via a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics. The sensor electronics 112, the drug delivery pump 102, and / or the blood glucose meter 104 may be coupled to one or more devices, such as display devices 114, 116, 118, and / or 120.

[0170] In some example embodiments, system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and / or other patient-related data) provided via network 409 (e.g., via a wired network, wireless network, or a combination thereof) from sensor system 101 and other devices associated with the host (also referred to as the patient), such as display devices 114, 116, 118, and / or 120, etc., and generate reports providing advanced information (such as statistics) about the measured analytes over a time period. A full discussion of the use of cloud-based analyte processing systems can be found in U.S. Patent Application Publication No. 2013 / 0325352 entitled “Cloud-based Processing of Analyte Data”, filed March 7, 2013, which is incorporated herein by reference in its entirety. In some embodiments, one or more steps of a factory calibration algorithm may be performed in the cloud.

[0171] In some example embodiments, sensor electronics 112 may include electronic circuitry associated with measuring and processing data generated by analyte sensor 138. The generated analyte sensor data may also include algorithms that can be used to process and calibrate the analyte sensor data, but these algorithms may also be provided in other ways. Sensor electronics 112 may include hardware, firmware, software, or a combination thereof to provide a measurement of analyte levels via an analyte sensor (such as a glucose sensor). Example embodiments of sensor electronics 112 are further described below with reference to FIG2.

[0172] In one implementation, the factory calibration algorithm described herein can be performed by sensor electronics.

[0173] As described above, sensor electronics 112 can be coupled (e.g., wirelessly, etc.) to one or more devices (such as display devices 114, 116, 118, and / or 120). Display devices 114, 116, 118, and / or 120 can be configured to present information (and / or alarms), such as sensor information emitted by sensor electronics 112, for display at display devices 114, 116, 118, and / or 120.

[0174] In one implementation, the factory calibration algorithm described herein may be performed at least in part by the display device.

[0175] In some example implementations, the relatively small key card display device 114 may include a wristwatch, belt, necklace, pendant, jewelry, adhesive patch, pager, key card, plastic card (e.g., credit card), identification (ID) card, etc. This small display device 114 may include a relatively small display (e.g., smaller than the large display device 116) and may be configured to display certain types of displayable sensor information, such as numerical values, arrows, or color codes.

[0176] In some example implementations, the relatively large handheld display device 116 may include a handheld receiver device, a PDA, etc. This large display device may include a relatively large display (e.g., larger than the small display device 114) and may be configured to display information such as a graphical representation of sensor data (including current and historical sensor data output by the sensor system 100).

[0177] In some example embodiments, the analyte sensor 138 may include 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, iontophoresis, radiometric, immunochemical, etc. In embodiments where the analyte sensor 138 includes a glucose sensor, the glucose sensor may include any device capable of measuring glucose concentration, and various techniques for measuring glucose (including invasive, minimally invasive, and non-invasive sensing techniques, such as fluorescence monitoring) may be used to provide data indicating glucose concentration in the host body, such as a data stream. The data stream may be sensor data (raw and / or filtered data) that can be converted into a calibrated data stream for providing glucose values ​​to a host (e.g., a user, patient) or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual concerned with the host's health). In addition, the analyte sensor 138 can be implanted as at least one of the following types of analyte sensors: implantable glucose sensor, percutaneous glucose sensor (implanted in or outside the host blood vessel), subcutaneous sensor, refillable subcutaneous sensor, and intravascular sensor.

[0178] While this disclosure describes some embodiments including an analyte sensor 138 comprising a glucose sensor, the analyte sensor 138 may also include other types of analyte sensors. Furthermore, although some embodiments refer to the glucose sensor as an implantable glucose sensor, other types of devices capable of detecting glucose concentration and providing an output signal representing the glucose concentration may also be used. Additionally, while this specification refers to glucose as an analyte for positive measurement, processing, etc., other analytes may also be used, such as those containing ketone bodies (e.g., acetone, acetoacetic acid, β-hydroxybutyrate, lactate, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, intermediates in the citric acid cycle, choline, insulin, cortisol, testosterone, etc.

[0179] In some manufacturing systems, sensors 138 are manually sorted, placed, and held in fixtures. These fixtures are manually moved between stations during the production process for various processing steps, including those involving electrical measuring devices for testing and calibration operations. However, manual handling of sensors can be inefficient, can cause delays due to suboptimal mechanical and electrical connections, and can damage the sensors and / or testing and calibration equipment. It can also lead to sensor variability, resulting in inaccurate verification data collected during manufacturing. Furthermore, the process of encapsulating sensor 138 along with sensor electronics 112 into a wearable device involves further manual manipulation of the sensor, which can damage sensor 138.

[0180] The various systems, apparatuses, and methods described herein help reduce or eliminate manual interaction with sensors. For example, pre-connected sensors may be provided, comprising sensor interconnects or sensor carriers electrically coupled to sensor electrodes and having mechanical and electrical characteristics configured for precise interface with wearable electronics, automated equipment, and / or robust connection to measuring devices.

[0181] Identification and other data associated with each sensor can be stored on the sensor carrier for logging and tracking of each sensor during manufacturing, testing, calibration, and in vivo operation. After testing and calibration, the sensor carrier can be used to connect the sensors to the sensor electronics of a wearable device, such as a sensor assembly on the skin, in a sealed and electrically robust configuration.

[0182] Figure 2 illustrates an example of an electronic device 112 according to some exemplary embodiments, which may be used in sensor electronics 112 or implemented in a manufacturing station (such as a test station, calibration station, smart carrier, or other equipment used during the manufacture of device 101). Sensor electronics 112 may include electronic components configured to process sensor information (such as sensor data) and, for example, generate transformed sensor data and displayable sensor information via a processor module. For example, the processor module may transform sensor data into one or more of the following: filtered sensor data (e.g., one or more filtered analyte concentration values), raw sensor data, calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, acceleration / deceleration rate information, sensor diagnostic information, location information, alarm / warning information, calibration information such as that determined by factory calibration algorithms as disclosed herein, smoothing and / or filtering algorithms for sensor data, etc.

[0183] In some embodiments, processor module 214 is configured to perform a significant portion (if not all) of data processing, including data processing related to factory calibration. Processor module 214 may be integral with sensor electronics 112 and / or may be remotely located, for example, within one or more of devices 114, 116, 118 and / or 120 and / or cloud 490. For example, in some embodiments, processor module 214 may be at least partially located within a cloud-based analytics processor 490 in network 409 or elsewhere.

[0184] In some example embodiments, processor module 214 may be configured to calibrate sensor data, and data storage memory 220 may store calibrated sensor data points as transformed sensor data. Furthermore, in some example embodiments, processor module 214 may be configured to wirelessly receive calibration information from a display device (such as devices 114, 116, 118, and / or 120) to calibrate sensor data from sensor 138. Additionally, processor module 214 may be configured to perform additional algorithmic processing on sensor data (e.g., calibrated and / or filtered data and / or other sensor information), and data storage memory 220 may be configured to store transformed sensor data and / or sensor diagnostic information associated with the algorithm. Processor module 214 may be further configured to store and use calibration information determined from factory calibration, as described below.

[0185] In some example implementations, sensor electronics 112 may include an application-specific integrated circuit (ASIC) 205 coupled to user interface 222. ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from sensor electronics 112 to one or more devices (such as devices 114, 116, 118, and / or 120), and / or other components for signal processing and data storage (e.g., processor module 214 and data storage memory 220). While ASIC 205 is depicted in Figure 2, other types of circuitry may also be used, including field-programmable gate arrays (FPGAs), one or more microprocessors configured to provide some (if not all) of the processing performed by sensor electronics 12, analog circuitry, digital circuitry, or combinations thereof.

[0186] In the example depicted in Figure 2, a potentiostat 210 is coupled to an analyte sensor 138 (such as a glucose sensor) via a first input port 211 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 supply a voltage to one of the electrodes 211, 212 of the analyte sensor 138 to bias a sensor (also referred to as the analog portion of the sensor) used to measure a value (e.g., current) indicating the concentration of the analyte in the host body. The potentiostat 210 may have one or more connections to the sensor 138 depending on the number of electrodes (such as a counter electrode as a third electrode) incorporated into the analyte sensor 138.

[0187] In some example embodiments, potentiostat 210 may include a resistor that converts the current value from sensor 138 into a voltage value, while in some example embodiments, a current / frequency converter (not shown) may also be configured to continuously integrate the measured current value from sensor 138 using, for example, a charge counting device. In some example embodiments, an analog-to-digital converter (not shown) may digitize the analog signal from sensor 138 into a so-called "count" to allow processing by processor module 214. The resulting count may be directly correlated with the current measured by potentiostat 210, which may be directly correlated with the level of an analyte (such as glucose) within the host body.

[0188] Telemetry module 232 can be operatively connected to processor module 214 and can provide hardware, firmware, and / or software to enable wireless communication between sensor electronics 112 and one or more other devices (such as display devices, processors, network access devices, etc.). Various radio technologies that can be implemented in telemetry module 232 include Bluetooth, Bluetooth Low Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access technology, radio frequency (RF), infrared (IR), paging network communication, magnetic induction, satellite data communication, spread spectrum communication, frequency hopping communication, near-field communication, etc. In some example implementations, telemetry module 232 includes a Bluetooth chip; however, Bluetooth technology can also be implemented in a combination of telemetry module 232 and processor module 214.

[0189] Processor module 214 can control the processing performed by sensor electronics 112. For example, processor module 214 can be configured to process data from the sensor (e.g., counting), filter data, calibrate data, perform fault-safe checks, etc.

[0190] The potentiostat 210 can measure analytes (e.g., glucose, etc.) at discrete time intervals or continuously, for example, using a current / voltage or current / frequency converter.

[0191] Processor module 214 may further include a data generator (not shown) configured to generate data packets for transmission to devices such as display devices 114, 116, 118, and / or 120. Additionally, processor module 214 may generate data packets for transmission to these external sources via telemetry module 232. In some example embodiments, the data packets may include identification codes of the sensor and / or sensor electronics 112, raw data, filtered data, calibrated data, change rate information, trend information, error detection or correction, etc.

[0192] Processor module 214 may also include program memory 216 and other memory 218. Processor module 214 may be coupled to a communication interface (such as communication port 238) and a power source (such as battery 234). In addition, battery 234 may be further coupled to battery charger and / or regulator 236 to power sensor electronics 112 and / or charge battery 234.

[0193] Program memory 216 may be implemented as a semi-static memory for storing data (such as identifiers of the coupled sensor 138, e.g., sensor identifier (ID)) and for storing code (also referred to as program code) that configures ASIC 205 to perform one or more of the operations / functions described herein. For example, program code may configure processor module 214 to process data streams or counts, filter, perform calibration methods described below, perform fail-safe checks, etc.

[0194] Memory 218 can also be used to store information. For example, processor module 214, which includes memory 218, can be used as a cache memory for the system, providing temporary storage for sensor data recently received from the sensor. In some example embodiments, the memory may include memory storage components such as read-only memory (ROM), random access memory (RAM), dynamic RAM, static RAM, non-static RAM, electrically erasable programmable read-only memory (EEPROM), rewritable ROM, flash memory, etc.

[0195] Data storage memory 220 may be coupled to processor module 214 and may be configured to store various sensor information. In some example embodiments, data storage memory 220 stores one or more days of analyte sensor data. The stored sensor information may include one or more of the following: timestamps, raw sensor data (one or more raw analyte concentration values), calibrated data, filtered data, transformed sensor data and / or any other displayable sensor information, calibration information (e.g., reference BG values ​​from factory calibration and / or previous calibration information), sensor diagnostic information, etc.

[0196] User interface 222 may include various 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), etc. Components including user interface 222 can provide controls for interaction with a user (e.g., a host).

[0197] Battery 234 can be operatively connected to processor module 214 (and possibly other components of sensor electronics 112) and provide the necessary power to sensor electronics 112. In other embodiments, the receiver can be powered percutaneously, for example, via inductive coupling.

[0198] The battery charger and / or regulator 236 can be configured to receive energy from an internal and / or external charger. In some example implementations, the battery 234 (or battery pack) is configured to be charged via an inductive and / or wireless charging pad, but any other charging and / or power mechanism may also be used.

[0199] One or more communication ports 238 (also referred to as one or more external connectors) can be configured to enable communication with other devices. For example, a PC communication (com) port can be configured to enable communication with systems that are separate from or integrated with the sensor electronics 112. For instance, the communication port may include a serial (e.g., Universal Serial Bus or "USB") communication port and allow communication with another computer system (e.g., a PC, a personal digital assistant or "PDA"), a server, etc. In some example implementations, factory information can be sent from sensor or cloud data sources to the algorithm.

[0200] One or more communication ports 238 may further include: an input port 237 for receiving calibration data; and an output port 239 for transmitting or sending calibration data to a receiver or mobile device. Figure 2 schematically illustrates these aspects. It should be understood that the ports may be physically separate, but in alternative embodiments, a single communication port may provide the functionality of both a second input port and an output port.

[0201] In some analyte sensor systems, the skin portion of the sensor electronics can be simplified to minimize the complexity and / or size of the on-skin electronics, for example, by providing only raw, calibrated, and / or screened data to a display device configured to run other algorithms required for calibration and displaying sensor data. However, the sensor electronics 112 (e.g., via processor module 214) can be implemented to execute intended algorithms for generating transformed sensor data and / or displayable sensor information, such as algorithms that perform: assessing the clinical acceptability of reference and / or sensor data; evaluating calibration data for optimal calibration based on inclusion criteria; assessing the quality of calibration; comparing estimated analyte values ​​with time-corresponding measured analyte values; analyzing changes in estimated analyte values; assessing the stability of the sensor and / or sensor data; detecting signal artifacts (noise); replacing signal artifacts; determining the rate of change and / or trend of sensor data; performing dynamic and intelligent analyte value estimation; performing diagnostics on the sensor and / or sensor data; setting operating modes; assessing data anomalies, etc.

[0202] Figures 3A, 3B, and 3C illustrate exemplary embodiments of an analyte sensor system 101 implemented as a wearable device, such as an on-skin sensor assembly 600. As shown in Figure 3, the on-skin sensor assembly includes a housing 128. An adhesive tab 126 couples the housing 128 to the host's skin. The adhesive 126 may be a pressure-sensitive adhesive (e.g., acrylic, rubber-based, or other suitable type) that bonds to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for skin attachment. The housing 128 may include a through-hole 180 that cooperates with a sensor insertion device (not shown) for implanting a sensor 138 under the skin of an object.

[0203] The wearable sensor assembly 600 may include sensor electronics 112 operable to measure and / or analyze glucose indicators sensed by glucose sensor 138. Sensor electronics 112 within the sensor assembly 600 can transmit information (e.g., measurement data, analysis data, and glucose data) to remote devices (e.g., 114, 116, 118, 120 shown in FIG. 1). As shown in FIG. 3C, in this embodiment, sensor 138 extends from its distal end into a through-hole 180 and is guided to an electronics module 135 within housing 128. Working electrode 211 and reference electrode 212 are connected to circuitry within the electronics module 135, which includes a potentiostat.

[0204] Figure 3D illustrates an exemplary embodiment of the analyte sensor 138, which includes an elongated body portion. The elongated body portion can be long and thin, yet flexible and robust. For example, in some embodiments, the minimum size of the elongated conductive body is less than about 0.1 inch, 0.075 inch, 0.05 inch, 0.025 inch, 0.01 inch, 0.004 inch, or 0.002 inch. While the elongated conductive body is described herein as having a circular cross-section, in other embodiments, the cross-section of the elongated conductive body can be oval, rectangular, triangular or polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregularly shaped, etc.

[0205] In the embodiment of Figure 3D, the analyte sensor 138 includes a lead wire core 139. At the distal body portion of the sensor 138, the lead wire core 139 forms an electrode 211a. At the proximal body portion of the sensor 138, the lead wire core 139 forms a contact 211b. As the lead wire core 139 extends along the elongated body portion of the sensor 138, the electrode 211a and the contact 211b are electrically connected along the length of the lead wire core. The lead wire core may be made of a single material (such as platinum or tantalum) or may be formed as a multilayer material, such as a conductive material or a non-conductive material with an outer coating of a different conductive material.

[0206] Layer 104 surrounds at least a portion of the conductor core 139. Layer 104 may be formed of an insulating material, such as polyimide, polyurethane, parylene, or any other known insulating material. For example, in one embodiment, layer 104 is disposed on the conductor core 139 and configured such that electrode 211a is exposed through window 106.

[0207] In some embodiments, sensor 138 further includes a layer 141 surrounding insulating layer 104, such as a sleeve comprising a conductive material. At the distal body portion of sensor 138, sleeve layer 141 forms an electrode 212a. At the proximal body portion of sensor 138, sleeve layer 141 forms a contact 212b. As sleeve layer 141 extends along an elongated body portion of sensor 138, electrode 212a and contact 212b are electrically connected along the length of sleeve layer. This sleeve layer 141 may be formed of a silver-containing material coated onto insulating layer 104. The silver-containing material may comprise any of a variety of materials and take various forms, such as Ag / AgCl polymer pastes, coatings, polymer-based conductive mixtures, and / or commercially available inks. This layer 141 may be treated using an adhesive / dipping / coating step (e.g., a dip-coating process using a mold metering method). In one exemplary embodiment, the Ag / AgCl polymer paste is applied to an elongated body by dip coating the body (e.g., using a meniscus coating technique) and then pulling the body through a mold to meter the coating to a precise thickness. In some embodiments, multiple coating steps are used to accumulate the coating to a predetermined thickness.

[0208] The sensor 138 shown in Figure 3D also includes a membrane 108 covering at least a portion of the distal in vivo portion of the sensor 138. This membrane is typically formed of multiple layers, which may include one or more of interference domains, enzyme domains, diffusion resistance domains, and bioprotection domains. This membrane is important for supporting the electrochemical process enabling analyte detection and is typically carefully fabricated through dip coating, spraying, or other manufacturing steps. Preferably, the distal in vivo portion of the sensor 138 undergoes as little treatment as possible from the formation of membrane 108 until the distal in vivo portion of the sensor 138 is implanted into the subject. In some embodiments, electrode 211a forms the working electrode of the electrochemical measurement system, and electrode 212a forms the reference electrode of this system. In use, both electrodes can be implanted into the host for analyte monitoring.

[0209] While the above description is particularly applicable to coaxial conductor-type structures, the embodiments described herein are also applicable to other physical configurations of the electrodes. For example, two electrodes 211a and 212a can be attached to the distal body portion of an elongated flexible strip of a planar substrate (such as a thin, flat polymer flexible circuit). Two contacts 211b and 212b can be attached to the proximal body portion of this flexible planar substrate. Electrodes 211a and 212a can be electrically connected to their corresponding contacts 211b and 212b (circuit traces) on the planar substrate. In this case, electrodes 211a and 212a and contacts 211b and 212b can be adjacent to each other on a flat surface, rather than being coaxial as shown in Figure 3D.

[0210] Figure 3D also shows contacts 211b and 212b electrically coupled to a simple current / voltage converter-based potentiostat 210. The potentiostat includes a battery 320, the output of which is coupled to the input of an operational amplifier 322. The output of the operational amplifier 322 is coupled to a contact 324, which is electrically coupled to the working electrode contact 211b via a resistor 328. The amplifier 322 biases the contact 324 to the battery voltage Vb and drives the current im required to maintain this bias. This current flows from the working electrode 211a through the interstitial fluid surrounding the sensor 138 and to the reference electrode 212a. The reference electrode contact 212b is electrically coupled to another contact 334 connected to the other side of the battery 320. For this circuit, the current im is equal to (Vb - Vm) / R, where Vm is the voltage measured at the output of the amplifier 322. The magnitude of this current, given a bias voltage on the working electrode 211a, is a measure of the analyte concentration near window 106.

[0211] Contacts 324 and 334 are typically conductive pads / traces on a circuit board. During testing, there is always a parasitic leakage current ip at a certain level on the surface of this board. If possible, this leakage current should not be part of the current measurement due to the analyte. To reduce the effect of this leakage current on the measured current, an optional additional pad / trace 336 may be provided between the bias contact 324 and the return contact 334, which is directly connected to the battery output. This optional additional conductive pad / trace may be referred to as a “protection trace”. Because they are held at the same potential, there will be virtually no leakage current between the bias contact 324 and the protection trace 336. Furthermore, the leakage current from the protection trace 336 to the return contact 334 will not pass through the amplifier output resistor 328 and will therefore not be included in the measurement. Other aspects and embodiments of the protection trace can be found in paragraphs

[0128] and

[0129] of U.S. Patent Publication 2017 / 0281092, which are incorporated herein by reference.

[0212] During the manufacturing process, various coating, testing, calibration, and assembly operations are performed on sensor 138. However, it can be difficult to transport individual sensors and electrically interface them with multiple testing and calibration facilities. These processes can also damage the sensors during handling. To help address these issues, sensor 138 can be provided as part of a pre-connected sensor that includes a sensor carrier described in more detail below.

[0213] Figure 4A illustrates a schematic diagram of a pre-connected sensor 400. As shown in Figure 4A, the pre-connected sensor 400 includes a sensor carrier 402 permanently attached to a sensor 138. In the example of Figure 4A, the sensor carrier 402 includes an intermediate body, such as a substrate 404, and also includes one or more contacts, such as a first internal contact 406 and a second internal contact 408. The first internal contact 406 is electrically coupled to a first contact on the proximal end of the sensor 138, and the internal contact 408 is electrically coupled to a second contact on the proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. In some embodiments, for example, contacts 406 and 408 may correspond to... Figure 3D Contacts 324 and 334.

[0214] As shown in Figure 4A, a first internal contact 406 can be electrically coupled to a first external contact 410, and a second internal contact 408 can be electrically coupled to a second external contact 412. As described in further detail below, external contacts 410 and 412 can be configured to electrically interface with sensor electronics 112 in the wearable device 600. Furthermore, external contacts 410 and 412 can be configured to electrically interface with the processing circuitry of a manufacturing facility (such as one or more test stations and / or one or more calibration stations). While various examples of two external contacts 410 and 412 on the sensor carrier coupled to two corresponding contacts on the sensor 138 are described herein, this is merely illustrative. In other embodiments, sensor carrier 402 and sensor 138 may each have a single contact, or each may have two or more contacts. For example, any N external contacts of the sensor carrier (e.g., two or more external contacts 410 and 412) and any M contacts of the sensor 138 (e.g., two or more contacts 406 and 408) may be coupled. In some embodiments, sensor carrier 402 and sensor 138 may have the same number of contacts (i.e., N = M). In some embodiments, sensor carrier 402 and sensor 138 may have different numbers of contacts (i.e., N ≠ M). For example, in some embodiments, sensor carrier 402 may have additional contacts for coupling to or between various components of the manufacturing station.

[0215] As described in further detail below, substrate 404 may be configured to couple with sensor electronics 112 in wearable device 600. In some embodiments, substrate 404 may be sized and shaped to mechanically interface with housing 128 and electrically interface with sensor electronics 112 within housing 128. Furthermore, substrate 404 may be sized and shaped to mechanically interface with manufacturing equipment, assembly equipment, test stations, and / or one or more calibration stations. As described in further detail below, sensor carrier 402 may be attached and / or electrically coupled to sensor 138. Sensor 138 can be permanently coupled to components of sensor carrier 402 (e.g., substrate 404) by means of, for example, adhesives (e.g., UV-curable, moisture-curable, multipart activated, thermosetting, hot melt adhesives, etc.), conductive adhesives (e.g., carbon-filled, carbon nanotube-filled, silver-filled, conductive additives, etc.), conductive inks, spring contacts, clips, wound flexible circuits, conductive polymers (e.g., conductive elastomers, conductive plastics, carbon-filled PLA, conductive graphene PLA), conductive foams, conductive fabrics, barrel connectors, molded interconnect structures, sewing, winding, wire bonding, wire threading, spot welding, forging, crimping, binding, cutting, soldering or brazing, plastic welding or overmolding. In some embodiments, before or during assembly, manufacturing, testing and / or calibration operations, sensor 138 can be permanently coupled to substrate 404 by rivets, magnets, anisotropic conductive films, metal foils or other suitable structures or materials to mechanically and electrically attach sensor carrier 402 to sensor 138. In some embodiments, sensor carrier 402 may be 3D printed around sensor 138 to form pre-attached sensor 400. Furthermore, sensor carrier 402 may include reference features 430 (sometimes referred to as reference structures), such as recesses, openings, surfaces, or protrusions, for aligning, positioning, and orienting sensor 138 relative to sensor carrier 402. Sensor carrier 402 may also include, or may form itself, one or more anchoring features for securing and aligning the analyte sensor during manufacturing (e.g., relative to a manufacturing station). Additionally, sensor carrier 402 may include an identifier 450 configured to identify the sensor. In some embodiments, identifier 450 is formed on substrate 404. Identifier 450 will be further explained below.

[0216] Figure 4B shows another schematic diagram of the pre-connected analyte sensor 400. The pre-connected analyte sensor 400 shown in Figure 4B may include similar components to the pre-connected analyte sensor 400 shown in Figure 4A. For clarity, Figure 4B is shown without the optional cover 460. Figure 4C shows an exploded view of the pre-connected analyte sensor 400 shown in Figure 4B.

[0217] In the example of Figure 4B, the sensor carrier 402 includes an intermediate, such as a substrate 404, and also includes one or more traces, such as a first trace 414 and a second trace 416. The first trace 414 may include a first internal contact 406 and a first external contact 410. The second trace 416 may include a second internal contact 408 and a second external contact 412. In some embodiments, the first internal contact 406 is electrically coupled to a first contact on the proximal end of the sensor 138, and the second internal contact 408 is electrically coupled to a second contact on the proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. Electrical couplers are described in conjunction with various embodiments herein, such as clips, conductive adhesives, conductive polymers, conductive inks, metal foils, conductive foams, conductive fabrics, wire wrapping, wire threading, or any other suitable method. In some embodiments, a non-conductive adhesive 426 (e.g., epoxy resin, cyanoacrylate, acrylic materials, rubber, urethane, hot melt adhesive, etc.) may be used to attach the sensor 138 to the substrate 404. The non-conductive adhesive 426 may be configured to attach, seal, insulate, or provide strain relief to the sensor 138. The sensor 138 may also be attached to the substrate 404 by other methods (such as those described in FIG. 4A above).

[0218] As shown in Figure 4C, the pressure-sensitive adhesive 428 can be configured to isolate the exposed ends of traces 414 and 416. For example, the pressure-sensitive adhesive 428 can laminate the sensor 138 between the substrate 404 and the cap 460. In this case, the sensor 138, substrate 404, pressure-sensitive adhesive 428, and cap 460 can form a laminated configuration. In the laminated configuration, the sensor 138 and its connection to one or more contacts (e.g., first internal contact 406 and second internal contact 408) are isolated from one or more exposed contacts (e.g., first external contact 410 and second external contact 412). Furthermore, the laminated configuration can create a moisture-sealed area around the sensor 138. The moisture seal can be achieved as embodied by a combination of pressure-sensitive adhesive 428 and non-conductive adhesive 426. In other embodiments, the laminated structure can be produced by one or a combination of the following materials and methods: non-conductive adhesives, pressure-sensitive adhesive tapes, elastomers, thermal bonding, hot plate welding, laser welding, ultrasonic welding, RF welding, or any suitable type of lamination method. The cover 460 may consist of a polymer sheet, structure, or film that at least partially covers the substrate 404. The cover 460 may optionally contain an identifier 450 that can identify the sensor 138. In some embodiments, the identifier 450 may include various identification protocols or technologies, such as, but not limited to, NFC, RFID, QR codes, barcodes, Wi-Fi, adjustable resistors, capacitance values, impedance values, ROM, memory, ICs, flash memory, etc.

[0219] The guide and fixation device 420, as an optional component, is an exemplary embodiment of an interface with a workstation (such as a test station, calibration station, assembly station, coating station, or manufacturing station) or as part of a wearable assembly. The guide and fixation device 420 includes a reference feature (or reference structure) 430, such as a recess, opening, surface, or protrusion, for aligning, positioning, and orienting the sensor 138 relative to the sensor carrier 402. The reference feature 430 can be used during manufacturing and for assembly into wearable electronic components. In some embodiments, the reference feature 430 is a raised protrusion configured to align with a corresponding reference feature 432 on the substrate 404. The corresponding reference feature 432 on the substrate 404 may be a cutout, slot, hole, or recess. The corresponding reference feature 432 in the sensor carrier may be a placement feature that interfaces with the reference feature 430 in a workstation (such as a test station, calibration station, assembly station, coating station, or other manufacturing station). The guide and fixing device 420 can be configured to ensure proper placement of the sensor carrier 402 to align the exposed external contacts 410 and 412 for connection to a workstation (such as a test station, calibration station, assembly station, coating station, or other manufacturing station). In other embodiments, the reference feature 430 may consist of a female feature to engage with a corresponding male reference feature 432.

[0220] Figure 4D shows a schematic diagram of an array 480 of pre-connected analyte sensors 400 having a plurality of pre-connected sensors 400 with optional identifiers 450. Figure 4D shows an array formed as one-dimensional strips of the pre-connected analyte sensors 400, but a two-dimensional array could also be incorporated. In some embodiments, the pre-connected analyte sensor array 480 may be housed in a housing. Each of the plurality of pre-connected sensors 400 may be individually cut. In some embodiments, notches 4020 may be provided to facilitate individual cutting into individual pre-connected sensors 400. In some embodiments, the array 480 may be used to facilitate the individual fabrication, testing, and / or calibration of a plurality of sensors 138 in a sequential or random manner. In some embodiments, the array 480 may be used to facilitate the simultaneous fabrication, testing, and / or calibration of a plurality of sensors 138.

[0221] Figures 5A-5E illustrate block diagrams of various machines and assemblies that can be associated with the pre-connected analyte sensor 400 during its pre-implantation lifespan. Such machines and assemblies may include manufacturing equipment, such as one or more manufacturing stations 5091, one or more testing stations 5002 and / or one or more calibration stations 5004, and a wearable assembly 600 on the skin. At least some of these are configured to house the sensor carrier 402 and, through the sensor carrier 402, communicatively couple the machines and assemblies to the sensor 138.

[0222] In some embodiments, prior to the membrane 108 described in the figures, sensor 138 is coupled to sensor carrier 402. With sensor 138 attached to the sensor carrier, and possibly multiple carriers mounting sensors, such as... Figure 4D When attached together as shown, subsequent device manufacturing steps (such as membrane coating, testing, calibration, and assembly into wearable units) can be performed with easier installation and removal from manufacturing and testing equipment, less sensor handling, and a lower chance of membrane damage, resulting in a significant overall increase in production efficiency.

[0223] Another benefit of pre-connected sensor construction is the easier separation of different types of manufacturing and testing equipment across different facilities, which are better equipped to handle such equipment. For example, manufacturing electrodes may require various types of metal forming / extrusion machines, while film coating, testing, and calibration require humid chemical laboratories and sensitive electronic testing equipment. Therefore, sensor electrodes can be formed and mounted on a carrier in one location and then transported to different remote facilities configured for film coating, testing, and calibration. In this context, "remote" does not mean located in the same production facility within the same building. It may even be advantageous for different business entities to perform different tasks specialized in appropriate manufacturing and testing technologies.

[0224] Manufacturing station 5091 may include a testing station as described herein, a calibration station as described herein, or another manufacturing station. Manufacturing station 5091 may include a processing circuitry system 5092 and / or mechanical components 5094 operable to perform testing operations, calibration operations, and / or other manufacturing operations, such as sensor alignment operations, film coating operations, curing operations, calibration inspection operations, glucose sensitivity operations (e.g., sensitivity slope, baseline, and / or noise calibration operations), and / or visual inspection operations.

[0225] The pre-connected analyte sensor 400 can be connected to one or more test stations 5002, which have a processing circuitry 5012 configured to perform test operations via sensor 138 to verify the operational integrity of sensor 138. Test operations may include verifying the electrical performance of sensor 138, verifying communication between the working electrode and contact 408, verifying communication between a reference electrode or additional electrode and contact 406, and / or other electronic verification operations of sensor 138. The processing circuitry 5012 can perform test operations by communicatively coupling to sensor 138 by inserting substrate 404 into socket 5006 (e.g., a recess in the housing of test station 5002) until contact 410 is coupled to contact 5010 of test station 5002 and contact 412 is coupled to contact 5008 of test station 5002.

[0226] System 5000 may include one or more calibration stations 5004 having a processing circuitry 5020 configured to perform calibration operations via sensor 138 to obtain calibration data for in vivo operation of sensor 138. The calibration data obtained by calibration device 5004 may be provided to sensor assembly 600 on the skin for use during in vivo operation of sensor 138. Processing circuitry 5020 may perform calibration operations communicatively coupled to sensor 138 by inserting substrate 404 into socket 5014 (e.g., a recess in the housing of calibration station 5004) until contact 410 is coupled to contact 5018 of test station 5002 and contact 412 is coupled to contact 5016 of test station 5002.

[0227] In the examples of Figures 5A-5E, test station 5002 and calibration station 5004 include sockets 5006 and 5014. However, this is merely illustrative, and sensor carrier 402 can be mounted to test station 5002, calibration station 5004, and / or manufacturing station 5091 using other mounting features (such as gripping, cutting, or clamping features). For example, manufacturing station 5091 includes gripping structures 5093 and 5095, wherein at least one gripping structure is movable to grip sensor carrier 402 (or a carrier having multiple sensor carriers and sensors). Structure 5093 can be a fixed structure having one or more electrical contacts (such as contact 5008). Structure 5095 can be a movable feature that moves (e.g., slides in direction 5097) to grip and secure sensor carrier 402 in an electrically coupled position in manufacturing station 5091. In other implementations, features 5093 and 5095 are both movable.

[0228] The sensor carrier 402 may also include an identifier 450 (see, for example, Figures 4A-4D). The identifier 450 may be formed on or embedded in the substrate 404. The identifier 450 may be implemented as a visual or optical identifier (e.g., a barcode or QR code pre-printed or printed in real-time on or etched into the substrate 404), a radio frequency (RF) identifier, or an electrical identifier (e.g., a laser-tunable resistor, capacitor identifier, inductor identifier, or micro-storage circuitry (e.g., an integrated circuit or other circuitry where the identifier is encoded in the identifier's memory) that can be programmed with the identifier and / or other data before, during, or after testing and calibration). The identifier 450 may be used to track the sensor throughout the manufacturing process of each sensor (e.g., by storing a history of test and / or calibration data for each sensor). In other words, the identifier 450 identifies any of the analyte sensor, the calibration data of the analyte sensor, and the history of the analyte sensor. For example, the identifier 450 may be used for binning test and calibration performance data. The identifier 450 can be a discrete raw value, or it can encode information in addition to an identification number. The identifier 450 can be used to digitally store data in non-volatile memory on the substrate 404 or stored as a reference number for storing data outside the sensor carrier 402.

[0229] Test station 5002 may include reader 5011 (e.g., optical sensor, RF sensor, or electrical interface, such as an integrated circuit interface) that reads identifier 450 to obtain a unique identifier for sensor 138. Test data obtained by test station 5002 may be stored and / or transmitted along with the identifier of sensor 138.

[0230] Calibration station 5004 may include a reader 5011 (e.g., an optical sensor, RF sensor, or electrical interface) that reads identifier 450 to obtain a unique identifier for sensor 138. Calibration data obtained by calibration station 5004 may be stored and / or transmitted along with the identifier for sensor 138. In some embodiments, calibration data obtained by calibration station 5004 may be added to identifier 450 by calibration station 5004 (e.g., by programming calibration data into the identifier). In some embodiments, calibration data obtained by calibration station 5004 may be transmitted by the calibration station along with identifier 450 to a remote system or device.

[0231] As shown in Figures 5A-5E and as described in further detail below, the skin sensor assembly 600 may include one or more contacts, such as contact 5022, configured to couple an internal electronic circuitry system to contacts 410 and 412 of the sensor carrier 402 and thus to the sensor 138. The sensor carrier 402 may be sized and shaped to be fixed within or on a cavity 5024 in the housing 128, such that the sensor 138 is coupled via the sensor carrier 402 to electronics within the housing 128, and the sensor 138 may be positioned to extend from the housing 128 for insertion for in vivo manipulation.

[0232] Although Figures 5A-5E show one calibration station and one test station, it should be understood that more than one test station and / or more than one calibration station may be used in the manufacturing and testing phases of production. Although calibration station 5004 and test station 5002 are shown as different stations in Figures 5A-5E, it should be understood that in some embodiments, the calibration station and test station may be combined into one or more calibration / test stations (e.g., a station where the processing circuitry system for performing test and calibration operations is housed within a common housing and coupled to a single interface 5006).

[0233] The wearable assembly 600 may also include a reader (e.g., an optical sensor, RF sensor, or electrical interface) that reads the identifier 450 to obtain a unique identifier for the sensor 138, the reader being positioned near the contact 5022. The sensor electronics can obtain calibration data for in-vivo operation of the sensor 138 based on the read identifier 450. The calibration data may be stored in and obtained from the identifier 450 itself, or the identifier 450 may be used to obtain calibration data for the installed sensor 138 from a remote system (such as a cloud-based system).

[0234] Figures 6-8 are schematic diagrams of various embodiments of securing a pre-connected sensor 400 within a wearable assembly 600. In the example of Figure 6, the sensor carrier 402 is in direct contact with the base wall 605 and the housing 128, and contact 5022 includes a plurality of contacts on the housing 128 for contacting both contacts 410 and 412 of the sensor carrier 402 (e.g., both located on the top surface of the sensor carrier 402). In the example of Figure 7, a mechanical receptacle 700 is disposed on the base wall 605 for mechanically securing the sensor carrier 402. In the example of Figure 8, a mechanical receptacle 800 is disposed on the base wall 605 for cooperating with the receiver 702 to mechanically secure the sensor carrier 402. Figure 8 In one example, receiver 702 includes additional contacts 704 for contacting contacts 410 on the rear surface of sensor carrier 402.

[0235] Figure 9 illustrates a detailed example of a sensor module 300, which includes a pre-connected sensor 400 and a sealing structure 192. As shown, the sealing structure 192 may be disposed on a substrate 404, wherein the sealing structure 192 may be configured to prevent moisture from entering towards contacts 410 and 412. Furthermore, contacts 410 and 412 may be implemented as leaf spring contacts for coupling to sensor electronics. In some embodiments, the pre-connected sensor 400 includes at least one contact. In some embodiments, the pre-connected sensor 400 includes at least two contacts. In some embodiments, the pre-connected sensor 400 includes at least three contacts. In some embodiments, the pre-connected sensor 400 includes at least four contacts. An adhesive 126 may couple a housing 128 to the host skin 130. The adhesive 126 may be a pressure-sensitive adhesive (e.g., acrylic type, rubber-based type, or other suitable type) that bonds to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for skin attachment. As shown in Figure 9, substrate 404 may include at least one arm 202 or other mechanical feature for interfacing with corresponding mating features (e.g., mechanical interlocking, such as snap-fit, clamping, and / or interference features) on base 128 to mechanically secure substrate 404 to housing 128. Coupling features (such as arm 902 and / or other features of substrate 404) may be sized and shaped to releasably mechanically attach substrate 404 to connectors associated with manufacturing equipment (e.g.,...). Figures 5A-5E (one or more of connectors 5006, 5014 and / or 5093 / 5095) for use in testing and / or calibration operations during manufacturing and prior to attachment to feature 900 of housing 128.

[0236] Figure 10 shows a perspective view of the sensor module 400 in an embodiment where contacts 406 and 408 are implemented using a helical spring 306. In the example of Figure 10, a protrusion 308 on the substrate 404 can align the sensor 138 and secure the spring 306 to the substrate 404. (Not all protrusions 308 are labeled for clarity in Figure 10.) The protrusions 308 can protrude distally.

[0237] At least three, at least four, and / or fewer than ten protrusions 308 may be configured to contact the periphery of the spring 306. The protrusions 308 may be separated by gaps. As the spring 306 is inserted between the protrusions 308, the gaps allow the protrusions 308 to flex outward. A downward force for coupling the electronic device unit 500 to the base 128 may push the spring 306 against the sensor 138, thereby electrically coupling the spring 306 to the sensor 138. The sensor 138 may travel between at least two of the protrusions 308. Test station 5002 and / or calibration station 5004 may also have mating connector structures that compress the spring 306 when the substrate 404 is inserted into the recess 5006 or 5014, thereby electrically coupling the spring 306 between the sensor 138 and the processing circuitry 5012 or 5020.

[0238] Sensor 138 may include a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to sensor carrier 402, having electrical interconnections (e.g., spring 306) mechanically coupled to substrate 404 and electrically coupled to proximal portion 138b. Spring 306 may be a conical spring, a helical spring, or any other type of spring described herein or suitable for electrical connection.

[0239] Substrate 404 may have a base portion 312 comprising at least two proximal protrusions 308 located around spring 306. The proximal protrusions 308 are configured to assist in orienting spring 306. A segment of glucose sensor 138 is located between the proximal protrusions 308 (at the distal end of spring 306).

[0240] The base portion 312 can be configured to be mechanically coupled to the housing 128, manufacturing equipment 5091, testing equipment 5002, and / or calibration equipment 5004. For example, the base portion 312 includes anchoring features such as arm 202. The anchoring features may include arm 202 and / or features that may include one or more notches, recesses, protrusions, or other features such as base 312, arm 202, and / or substrate 404, which mechanically interface with corresponding features of a clamping connector formed by clamping connector features (features 5093 and 5095 of Figures 5A-5E) to secure and align the sensor 138. In a suitable example, a slidable (or otherwise operable or rotatable) feature (feature 5095 of Figures 5A-5E) may be arranged to slide together over, around, or otherwise engage with one or more of the arm 202, base 312, and / or sensor carrier 402 to secure the sensor carrier 402 to a manufacturing device. For example, in other embodiments of the sensor carrier 402 where the arm 202 is not provided, a receptacle connector (one of the receptacles 5006 of 5014 of Figures 5A-5E) or a clamping connector formed by clamping connector features (features 5093 and 5095 of Figures 5A-5E) may include a flip-up assembly, a sliding assembly, or other movable components that support or cover the sensor carrier 402 to latch the sensor carrier 402 to a manufacturing, testing, and / or calibration device.

[0241] Referring now to Figures 11 and 12, another embodiment of the sensor module 400 is shown, the sensor module comprising: a base portion 312d; a glucose sensor 138 having a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to the base portion 312d; and an electrical interconnect (e.g., a leaf spring 306d) mechanically coupled to a substrate 404 and electrically coupled to the proximal portion 138b. The leaf spring 306d may be configured to bend in response to pressure from test station contacts, calibration station contacts, and / or the electronic device units 500 coupled to the base 128 when the pre-connected sensor 400 is placed between electronic device units 500 coupled to the base 128.

[0242] As used herein, a cantilever spring is a type of leaf spring. As used herein, a leaf spring can be made of a plurality of bent metal strips held together in a stacked manner. As used herein, in many embodiments, a leaf spring comprises only one bent metal strip (e.g., one layer) (rather than multiple layers of bent metal). For example, the leaf spring 306d in Figure 11 can be made of one layer or multiple layers of metal. In some embodiments, the leaf spring includes a single layer of flat metal fixed at one end (making the leaf spring a cantilever spring).

[0243] As shown in Figures 11 and 12, the base portion 312d includes a proximal protrusion 320d having a channel 322d therein where at least a portion of the proximal portion 138b is located. The channel 322d positions a first region of the proximal portion 138b such that the region is electrically coupled to the leaf spring 306d.

[0244] As shown in the cross-sectional perspective view of Figure 12, the leaf spring 306d bends away from the first region and protrudes proximally for electrical coupling with the test station 5002, calibration station 5004, and / or wearable assembly 600. At least a portion of the leaf spring 306d forms a "W" shape. At least a portion of the leaf spring 306d forms a "C" shape. The leaf spring 306d bends around the proximally protruding portion 320d. The leaf spring 306d protrudes proximally for electrical coupling with the test station 5002, calibration station 5004, and / or electronic device unit 500. A seal 192 is configured to prevent fluid intrusion into the leaf spring 306d.

[0245] The leaf spring 306d is oriented such that the sensor carrier 402, coupled to the test station 5002, calibration station 5004, and / or electronic unit 500, presses against the leaf spring 306d and rests against the first electrical contact of the test station 5002, calibration station 5004, and / or electronic unit 500, and the second electrical contact of the glucose sensor 138, thereby electrically coupling the glucose sensor 138 to the test station 5002, calibration station 5004, and / or electronic unit 500. The proximal height of the seal 192 may be greater than the proximal height of the leaf spring 306d, such that the test station 5002, calibration station 5004, and / or electronic unit 500 contact the seal 192 before contacting the leaf spring 306d. As shown, spring 306 and / or leaf spring 306d may cooperate with a base feature (e.g., feature 308) and / or channel 322d on substrate 404 to form a reference feature that fixes and aligns sensor 138 relative to sensor carrier 402 (e.g., for manufacturing, calibration, testing and / or in vivo operation).

[0246] Figures 13A and 13B show perspective views of an embodiment of a wearable assembly 600 including a pre-connected sensor 400. The wearable assembly 600 may include sensor electronics and an adhesive tab (not shown). The pre-connected sensor 400 may include a sensor carrier, such as sensor carrier 402 shown in Figures 4A-4D. Sensor carrier 402 may be placed in or on a housing 128. Housing 128 may consist of two housing assemblies, namely a top housing 520 and a bottom housing 522. Top housing 520 and bottom housing 522 may be assembled together to form housing 128. Top housing 520 and bottom housing 522 may be sealed to prevent moisture intrusion into the internal cavities of housing 128. The sealed housing may contain a sealing material (e.g., epoxy, silicone, urethane, or other suitable material). In other embodiments, housing 128 is formed as a single component encapsulation material (e.g., epoxy) configured to accommodate sensor carrier 402 and sensor electronics. Figure 13A illustrates a aperture 524 within the top housing 520, configured to allow insertion components (e.g., hypodermic needles, C-needles, V-needles, side-opening needles, etc.) to pass through the wearable assembly 600 for insertion and / or retraction. Aperture 524 may be aligned with a corresponding aperture in the bottom housing 522. In other embodiments, aperture 524 may extend through an off-center location of housing 128. In other embodiments, aperture 524 may extend through an edge of housing 128, thereby forming a C-shaped channel. In some embodiments, aperture 524 comprises a sealing material, such as a gel, adhesive, elastomer, or other suitable material located within aperture 524.

[0247] Figure 13B shows a perspective view of the bottom of the wearable assembly 600. As shown, a pre-connected sensor 400 can be housed within the housing 128. The pre-connected sensor 400 can be mounted within an aperture 526 in the bottom housing 522. As shown, a sensor 138 can extend from the aperture 526. The aperture 526 can be sized and shaped to hold the pre-connected sensor 400. Furthermore, the aperture 526 can be sized and shaped to hold the pre-connected sensor 400, wherein the sensor 138 extends generally parallel to the skin surface and forms a 90-degree bend for insertion into the skin. It should be understood that the bottom surface of the bottom housing 522 may contain attachment members (e.g., adhesive pads) for bonding the wearable assembly to the user's skin surface.

[0248] Figure 13C shows an exploded view of the wearable assembly 600. Various electronic components (such as the potentiostat 210 shown in Figure 2 and other components) can be mounted on or attached to the electronics assembly substrate 530 (typically some form of printed circuit board). The sensor carrier 402 is intended to have electrical coupling with the electronics assembly substrate 530. Various methods can be used to establish an electrical connection between one or more contacts of the pre-connected sensor 400 (such as external contacts 410 and 412) and the electronics assembly substrate 530 (e.g., pins, solder, conductive elastomers, conductive adhesives, etc.). The sensor carrier 402 can be configured to interface with the electronics assembly substrate 530 via a bottom housing 522. In other embodiments, the sensor carrier 402 can be configured to interface with the electronics assembly substrate 530 via a top housing 520. In some other embodiments, the sensor carrier 402 is configured to interface with the electronic assembly substrate 530 via the side of the wearable assembly 600. As shown, an optional sealing member 528 may be configured to insulate at least a portion of the sensor carrier 402 from potential moisture intrusion. In some cases, the sealing member 528 may be a dispensed liquid (e.g., adhesive, gel) or solid material (e.g., elastomer, polymer). The sealing member 528 may be an assembled component that is welded (e.g., laser or ultrasonic, hot plate) or otherwise permanently attached (e.g., anisotropic film, pressure-sensitive adhesive, cyanoacrylate, epoxy resin or other suitable adhesive) to create a sealed area. The sealing member 528 may be used to physically couple the sensor carrier 402 to the wearable assembly 600 and / or provide a sealed area between the sensor carrier and the wearable assembly.

[0249] Figures 14A-14E illustrate another embodiment of the wearable assembly 600. The embodiments of Figures 14A-14E are similar to those shown in Figures 13A-13C. As shown in Figure 14A, the wearable assembly 600 includes a housing formed as a top housing 520 and a bottom housing 522. The wearable assembly also includes a through-hole 524 for use during the insertion of the sensor 138 gap into the body of an object. Referring particularly to Figures 14B, C, and D, the bottom housing 522 includes a recess 726 having a base plate 704. The base plate 704 may include locating pins 784 and 786 extending upward from the base plate 704, and two openings 722 and 724. The locating pins may be formed as an integral part of the base plate 704, for example, during the molding of the housing, or they may be separate portions coupled to the base plate using friction fit, adhesive, or any other means. In some embodiments, at least one locating pin is present. In some embodiments, at least two locating pins are present. In some embodiments, at least three locating pins are present. On the opposite side of the base plate 704 is a printed circuit board 530 (visible in FIG. 14E), on which some or all of the sensor electronic circuitry (e.g., potentiostat 210 or at least traces connected to the potentiostat) is mounted. Conductive pins 712 and 714 may also be mounted on the printed circuit board 530, extending through holes 722 and 724 in the base plate 704 to form an external electrical interface accessible without opening the housing. A pre-connected sensor 400 falls into this recess 726. Holes 794 and 796 fall on locating pins 784 and 786, and conductive pins 712 and 714 extend through holes 706 and 708 in the sensor carrier substrate 404. Similar to the different embodiments shown in Figures 4A to 4C, these holes 706 and 708 extend through electroplated metal (e.g., copper) contacts 406 and 408 on the substrate 404. Generally, the number of holes 706, 708 in the substrate 404 corresponds to the number of electrodes present in the sensor 138, and the number of electrodes, in turn, corresponds to the number of pins 712, 714. For example, a three-electrode system having a working electrode, a reference electrode, and a counter electrode can have three holes in the substrate corresponding to three pins extending upward through the base plate 704. Pins 712 and 714 can be electrically connected to contacts 408 and 406 in various ways (e.g., solder, forging, or conductive gel, paste, adhesive, or film). After this connection is made, an electronic circuitry system for detecting and / or processing signals from the analyte sensor placed within the housing becomes connected to the analyte sensor to receive signals from it.In Figures 14D and 14E, the connecting materials that bond the sensor 138 to the sensor carrier 402 are shown as 762 and 764. These connections can be established by any of the methods described above with reference to Figure 4A.

[0250] Once the substrate 404 is placed on the pins 712, 714, the proximal portion of the sensor 138 can be secured to the base plate 704 by pressure-sensitive adhesive 772 to hold the proximal portion of the sensor on or near the housing before extending downward at the inserter opening 524. This achieves accurate sensor insertion positioning and controls the bias force in the insert pin. Various methods and / or structural features can be used to perform this retention function, such as protrusions or shelves in the base plate 704, overmolded portions, snap-fit ​​additional plastic parts mounted above the sensor, or any type of gel or adhesive placed before or after the pre-connected sensor is placed in the recess 726. As shown in Figure 13C, optional sealing members 528a and 528b can be configured to seal and insulate at least a portion of the sensor carrier 402 from potential moisture intrusion. In some cases, sealing member 528 can be a dispensed liquid (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). Sealing member 528 can be an assembled component that is welded (e.g., laser or ultrasonic, hot plate) or otherwise permanently attached (e.g., pressure-sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealed area. Sealing member 528 can be used to physically couple sensor carrier 402 to wearable assembly 600, and / or provide a sealed area between the sensor carrier and the wearable assembly. Two sealing members 528a and 528b are partially separated by walls 766 and 768. These walls allow for two different sealing methods to be used in two different portions of the recess 726 separated by the walls. For example, 528b can be a solid polymer that is press-fitted into the recessed portion through an opening 524 on one side of the wall. The remaining portion of the recess 726 can be filled with a liquid UV-cured epoxy resin that hardens to form sealing member 528a. The depths of the two recessed portions on each side of the wall can be the same or different.

[0251] Figure 15A illustrates another alternative embodiment of the sensor carrier 402, which may also be in the form of a printed circuit board. In this embodiment, a protective trace 407, as described with reference to item 336 in FIG3D, is disposed on the substrate 404 of the sensor carrier 402. As explained above, this protective trace 407 is positioned between contacts 406 and 408 and is connected to a bias voltage by the sensor electronics. The protective trace 407 may be coupled to the sensor electronics via one or more conductive pins 713 (not shown in FIG14A to 14E) extending through the substrate 704, similar to pins 712 and 714. In FIG15A, the pins are shown as tower-shaped contacts connected to the side of the substrate 404. An insulating layer 780 (such as a solder mask) may be positioned above the protective trace 407 to eliminate the risk of short-circuiting the analyte sensor electrode to the protective trace.

[0252] Figures 15B and 15C illustrate other embodiments of connecting a sensor carrier 402, on which an analyte sensor 138 is mounted, to an electronic circuitry system within a wearable sensor. In Figure 15B, the sensor 138 is coupled to the sensor carrier 402 via conductive adhesives 762 and 764, as shown above with reference to Figures 14C and 14D. On the other side of the sensor carrier substrate are conductive contact pads 812 and 814. The circuit board 530 also has contact pads 826 and 828 bonded to the circuit board, which are accessible via the base plate 704 of the recess 726. An anisotropic film 820 is used to electrically and mechanically bond the sensor carrier contact 812 to the circuit board contact 826, and also electrically and mechanically bond the sensor carrier contact 814 to the circuit board contact 828. An anisotropic film 820 is compressed between the contacts by heat, which causes the conductive particles in the film 820 to vertically bridge the gap between contact pairs 812 / 826 and 814 / 828. The conductive particles in the film 820 are horizontally spaced, so no short circuit occurs between the contact pairs. Electrical and mechanical bonding technologies have been widely used in display applications of small electronic devices (such as smartphones) and enable simple and consistent connections in production environments.

[0253] In Figure 15C, the proximal region of sensor 138 is coupled to contacts 812 and 814 of sensor carrier 402 via an anisotropic membrane 820. Different regions of the same anisotropic membrane 820 can be used to connect sensor carrier contacts 812 and 814 to circuit board contacts 826 and 828, respectively. In this embodiment, the region of membrane 820 that connects sensor 138 to contacts 812 and 814 can be horizontally adjacent to or otherwise separated from the region of membrane 820 that connects circuit board contacts 826 and 828 to sensor carrier contacts 812 and 814.

[0254] In the example of Figures 10-15, the pre-connected sensor 400 can be mounted as a separate interface between sensor 138 and sensor electronics. However, it should be understood that in some embodiments described herein, the pre-connected sensor 400 may include a sensor carrier that connects to an additional interface between sensor 138 and sensor electronics within the wearable assembly 600. For example, channel 322d and leaf spring 306d may be formed on a separate substrate, which, after calibration and testing operations, is mechanically attached within seal 192 to base portion 312d for mounting into the wearable assembly 600.

[0255] One advantage of the aforementioned analyte sensor connection technology is that the manufacturing of the pre-connected sensor 400 can be separated from the manufacturing of the electronics enclosed within the housing. As described above with reference to the pre-connected sensor structure and subsequent coating, testing, and calibration processes, the housing containing the electronics can be manufactured in a separate facility from the facility that attaches the pre-connected sensor 400 to the sensor electrical interface. This is made possible by providing an analyte sensor electronic interface that can be accessed from the outside of the housing. It is not necessary to open the housing to attach the sensor.

[0256] In some advantageous methods, the electrodes of the pre-connected sensor are fabricated and mounted on a substrate at a first location, and then transported to a second location for coating testing and calibration. The housing with internal electronics is fabricated in a third location. The housing with electronics is then transported from the third location to the second location, where the complete analyte sensor is attached to an external electrical interface. These three locations can all be geographically separated. This minimizes the handling of the sensitive film-coated sensor while still allowing other components of the entire device to be fabricated separately.

[0257] Figure 16 shows a top view of an embodiment of the sensor carrier 402, wherein the substrate 404 is a substantially planar substrate, and the sensor 138 is attached to the substrate 404 by a conductive adhesive 1500. As shown in Figure 16, the conductive adhesive 1500 can be applied to the contacts 1000 and 1002 of the sensor 138 to mechanically attach the sensor 138 to the substrate 404. Once applied, the conductive adhesive 1500 on contacts 1000 and 1002 can self-form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronic device unit 500. Figure 17 A side view of the sensor carrier 402 of FIG. 16 is shown, in which conductive adhesive 1500 is visible covering a portion of the sensor 138 at its proximal end. In other embodiments, the sensor 138 may be attached to the substrate 404 by conductive adhesive 1500 or by any other suitable method using, for example, clips, conductive polymers, metal foils, conductive foams, conductive fabrics, windings, wire threading, or any other suitable method.

[0258] Figures 18, 19, and 20 illustrate examples of the substrate 404 of Figure 16, which has additional reference features for controlling the position and spatial orientation of the sensor 138 on the substrate 404. In the example of Figure 18, the substrate 404 includes a V-shaped recess 1700. The sensor 138 is partially disposed within the recess 1700 such that the sensor 138 is oriented in a direction along the recess, and a conductive adhesive 1500 substantially covers the sensor 138 and fills any unfilled portions of the recess 1700 to secure the sensor 138 within the recess. In the example of Figure 19, the substrate 404 includes a first planar portion 1800 and a second planar portion 1802 extending at a non-parallel (e.g., perpendicular) angle relative to the first planar portion, and the sensor 138 is attached to the interface between the first and second planar portions by the conductive adhesive 1500. In the example of FIG20, substrate 404 includes a circular recess 1900, wherein sensor 138 is attached by a conductive adhesive 1500 that substantially covers the portion of recess 1700 that is not filled by sensor 138 to secure sensor 138 within the recess.

[0259] Figures 21A and 21B illustrate an example sensor carrier 402, wherein at least one pair of guide structures 2106 and 2108 are formed on a substrate 404, such as on one or both contacts 406 and 408. These guide structures help position the sensor body 138 in place when a conductive adhesive is applied to bond the sensor body 138, etc., together. This eliminates the need for external guide fixing devices during manufacturing when assembling the sensor to the sensor carrier. Structures 2106 and 2108 can be made of solder or other conductive adhesives. Although not shown in Figures 21A and 21B, additional adhesive bonding material can be provided between the guide structures to secure the sensor to the guide structures during manufacturing.

[0260] Conductive adhesive 1500 may be, for example, a conductive liquid dispensing gel. The conductive liquid dispensing gel may be a one-component or two-component adhesive that cures (e.g., at room temperature or high curing temperatures). The conductive liquid dispensing gel may be a fast-curing adhesive. A two-component conductive liquid dispensing gel may comprise a base adhesive (e.g., epoxy resin, polyurethane, etc.) and a conductive filler (e.g., silver, carbon, nickel, etc.). Conductive adhesive 1500 may comprise, for example, an adhesive resin having one or more embedded conductive materials (such as silver, copper, or graphite). Conductive adhesive 1500 may be a thermosetting conductive adhesive.

[0261] Figure 22 shows a top view of an embodiment of the sensor carrier 402, wherein the substrate 404 is a substantially planar substrate, and the sensor 138 is attached to the substrate 404 via conductive tape 2000. As shown in Figure 22, conductive tape 2000 can be applied to one or more contacts of the sensor 138 (e.g., connection areas 1000 and 1002) to mechanically attach the sensor 138 to the substrate 404. Once applied, the conductive tape 2000 on contacts 1000 and 1002 can self-form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronic device unit 500. As shown in Figure 22, tape 200 can be applied over the sensor 138 or can be inserted between the substrate 404 and the sensor 138. In an embodiment where tape 2000 is disposed between substrate 404 and sensor 138, substrate 404 may be a flexible substrate that can be rolled or folded around sensor 138 as shown in the end view of FIG23. The rolled substrate of FIG23 includes an extension 2100 that can form one or more contacts (e.g., 406 or 408).

[0262] The conductive tape 2000 can be configured as a multi-zone tape having one or more conductive tape 2000 and non-conductive tape regions. The combination of conductive and non-conductive regions can be used for electrically isolated connection regions. Using a multi-zone tape simplifies the assembly of multiple connection regions in a single assembly step. The spacing of the conductive regions on the tape can be matched to the target connection regions of the sensor wire 138. In other embodiments, the spacing of the conductive regions of the tape is significantly smaller than the spacing of the target connection regions of the sensor wire 138. The shorter spacing allows for greater variability in tape placement while ensuring an isolated connection between the sensor 138 and the substrate 404. The conductive tape 2000 can be formed from a polymer substrate and a conductive adhesive (such as a carbon-impregnated adhesive, a metal-impregnated adhesive). As another example, the conductive tape 2000 can be a metal substrate with both conductive and non-conductive adhesives. Some examples of non-conductive substrates are polyimides, composites, polymers, etc. Some examples of conductive substrates are metals (e.g., foils, electroplating, cladding, etc.), conductive polymers, and conductive elastomers. Examples of non-conductive adhesives include epoxy resins, cyanoacrylates, acrylic materials, rubber, urethane, and hot melt adhesives. Examples of conductive adhesives include carbon-filled adhesives, nanoparticle-filled adhesives, metal-filled adhesives (e.g., silver), and conductive inks.

[0263] Figure 24 shows a top view of an embodiment of the sensor carrier 402, wherein the substrate 404 is a substantially planar substrate, and the sensor 138 is attached to the substrate 404 by soldering or bonding conductive plastic 2200 to the non-conductive (e.g., plastic) substrate 404. As shown in Figure 24, the conductive plastic 2200 can be coated onto the contacts 1000 and 1002 of the sensor 138 to mechanically attach the sensor 138 to the substrate 404. Once coated, the conductive plastic 2200 on contacts 1000 and 1002 can self-form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronic device unit 500.

[0264] Figures 25 and 26 illustrate an exemplary ultrasonic welding system for welding conductive plastic 2200 to a substrate 404. As shown in Figure 25, the substrate 404 may have a recess in which a protrusion on the conductive plastic member 2200 can be received. A sensor 138 may be disposed within the recess in the protrusion on the conductive plastic member 2200, and the conductive plastic member 2200 may be pressed in direction 2302 and vibrated by an ultrasonic welding head 2300 to form a molten region 2400. When the welding head 2300 is removed, the molten region solidifies to secure the sensor 138 between the substrate 404 and the conductive plastic 2200, forming a conductive contact to the sensor 138.

[0265] In some embodiments, to provide additional surface area for clamping or soldering contacts to substrate 404, the proximal end of sensor 138 may be curled or otherwise planarized, as shown in FIG27. As shown in FIG27, contacts 1000F and 1002F may be flat contacts converging into the cylindrical wire sensor 138. As shown in the side view of sensor carrier 402 in FIG28, flat contacts 1000F and 1002F may be attached to substrate 404 by conductive attachment members 2600 and 2602 (such as clips, solder, anisotropic conductive films, conductive tape, plastic members with embedded conductors, conductive springs, or elastic conductive members (by way of example)).

[0266] In one example, connectors such as contacts 1000F and 1002F (and / or other forms of contacts 1000 and 1002 as described herein) can be laser-soldered to corresponding contacts on substrate 404. In an embodiment where sensor 138 is laser-soldered to substrate 404, the trace surface of substrate 404 can be preheated by laser irradiation at the soldering location. Surface heat dissipation allows pre-deposited solder material to flow back to each side of sensor 139. Guides such as borosilicate glass “corners” can be placed over the sensor and pre-deposited solder to hold the solder, thereby driving molten solder toward the sensor. The resulting “carrier” engagement can then securely anchor the sensor to the trace on substrate 404, which can help increase or maximize the trace-solder-sensor contact wire bonding area. During the hot portion of the soldering process, the use of guides such as borosilicate glass corners can also protect printed circuit board assembly electronics that may be contained on and / or within the substrate from solder debris.

[0267] In another example, connectors such as contacts 1000F and 1002F (and / or other forms of contacts 1000 and 1002 described herein) can be soldered to corresponding contacts on substrate 404 without a laser. In these examples, solder wire can be pre-fed to the tip of the soldering iron to form droplets of molten solder on the tip. The soldering iron can then be moved downwards so that the droplets contact the sensor and conductive traces on the substrate. For example, the Ag / AgCl coated sensor described herein can have a low thermal mass, allowing the sensor coating to heat up rapidly without freezing the solder. Once the coating is heated, the solder wets the coating. The traces will also have very low thermal mass, allowing them to heat up rapidly without freezing the solder. A soldering mask can be provided around the traces to prevent solder from flowing out from the edges of the traces.

[0268] In some embodiments, substrate 404 may be at least partially formed of a flexible circuit (e.g., a polyimide substrate with conductive traces or other suitable flexible circuitry) folded over and / or around at least a portion of sensor 138 to the conductive traces of the flexible circuitry. Figure 29 shows a top view of a flexible circuitry embodiment of substrate 404, wherein substrate 404 is a flexible circuitry having a central, non-conductive elongated portion 2702, along which sensor 138 is oriented, and has an upper extension 2700 and a lower extension 2704 extending from the central portion in a direction perpendicular to the elongated dimension of the central portion 2702. Extensions 2700 and 2704 respectively contain conductive contacts 2706 and 2708 forming contacts 408 and 406. Conductive contacts 2706 and 2708 can be coupled to external contacts forming contacts 412 and 410 via traces and / or conductive vias on or within substrate 404. In some cases, extensions 2700 and 2704 can allow testing, calibration, sensor electronics, or other devices to be connected to the sensor carrier / sensor assembly in areas not occupied by the sensor. This can allow for additional connection types and / or improved electrical coupling.

[0269] Figure 30 illustrates an embodiment of the sensor carrier 402, wherein the substrate 404 includes a wedge-shaped base portion 2800 and a foldable flexible portion 2802. Conductive contacts 2804 may extend from the base portion 2800 to the foldable portion 2802 such that contacts 410 and 412 are electrically coupled to the sensor 138 when the sensor 138 is placed on the base portion 2800 and optionally the foldable portion 2802 is folded over the sensor 138 (e.g., in direction 2820) to wrap around and around the sensor 138. The base portion 2800 may be rigid and may taper in a direction away from the sensor 138. The base portion 2800 may include conductive contacts 410 and 412 at its narrow end. The base portion 2800 can, for example, be removably inserted into the recesses 5006 and 5014 of the test station 5002 and calibration station 5004 for testing and calibration operations. In the examples of Figures 27 and 28, the flexible substrate can be folded over and secured, for example, to the sensor and / or itself, to secure the sensor by soldering, mechanical crimping, spring contact, rivets, adhesives such as epoxy resin, etc.

[0270] Figures 31A and 31B illustrate another embodiment of the sensor carrier 402. In this embodiment, the sensor carrier 402 comprises a block 404 made of a non-conductive material (e.g., polymer or ceramic). The block 404 includes a through-hole 1420 extending therethrough along the y-axis, through which a proximal external portion of the analyte sensor 138 extends. Slots or blind holes 1410 and 1412 intersect the through-hole 1420 on a z-axis orthogonal to the y-axis of the through-hole. Conductive contact materials 406 and 408 are electroplated on the top surface and extend into the slots 1410 and 1412. Additional holes 1430 and 1432 extending along the x-axis intersect both the through-hole 1420 and the slots 1410 and 1412. Each hole 1430 and 1432 extends across its corresponding slot and partially extends onto the blocky species on the other side of each slot, thereby forming blind holes or recesses 1442, 1444 on the other side. Plugs 1451 and 1453, which may be conductive or non-conductive, are inserted into holes 1430 and 1432 and push contacts 212b and 211b of the wire analyte sensor into recesses 1442, 1444, thereby causing contacts 212b and 211b to make electrical contact with sensor carrier contacts 406 and 408.

[0271] Figure 32 shows a top view of a sensor carrier having a substrate 404, a reference feature 2900, and a movable connector 2902 for each of contacts 406 and 408. A sensor 138 can be aligned with the reference feature 2900, and the movable connector 2902 can be moved to secure each of contacts 1000 and 1002 between the corresponding reference feature and the movable connector. The movable connector 2902 and / or the reference feature 2900 are electrically coupled to contacts 1000 and 1002. The movable connector 2902 and / or the reference feature 2900 can also be electrically coupled to other contacts (not shown) forming contacts 410 and 412 on the substrate 404. Figure 33 is a perspective view of a reference feature 2900 and one of its associated movable contacts 2902 that can move in direction 2904 toward the reference feature 2900 to fix the sensor 138. Contacts 1000 and 1002 may be flat to enhance contact with the reference feature 2900 and the contacts 2902. If desired, additional conductive material 2906 may be formed on the substrate 404 between the reference feature 2900 and the contacts 2902 to enhance electrical contact with the sensor 138. The additional conductive material may be an exposed surface of a portion of an embedded conductive layer (e.g., copper or other conductive metal layer) within the substrate 404, or it may be solder or conductive adhesive (as an example).

[0272] Figure 34 shows a perspective view of a pre-connected sensor formed by a sensor carrier implemented as a barrel-shaped connector substantially surrounding sensor 138. In the example of Figure 34, substrate 404 may be an insulating layer formed around sensor 138 by a conductive strip extending from internal contacts having contacts 1000 and 1002 to the outer surface forming contacts 410 and 412. As shown in Figure 34, annular contacts 410 and 412 can be removably housed by press-fit into conductive supports 3102 and 3104 of device 3100 (e.g., test station 5002, calibration station 5004, and / or electronic device unit 500). Conductive supports 3102 and 3104 can establish electrical communication between sensor 138 and device 3100 (e.g., test station 5002, calibration station 5004, and / or electronic device unit 500).

[0273] Figure 35A illustrates an embodiment of the sensor carrier 402, in which flexible circuitry is wound over the ends of sensors 138 such that a top portion 3200 and a bottom portion 3202 of the flexible substrate are formed on opposite sides of the sensors 138. As shown in Figure 35B, the top portion 3200 and the bottom portion 3202 can be wound over the ends of multiple sensors 138, such that a flexible circuit strip 3404 forms a common sensor carrier for multiple sensors. The flexible circuit strip 3204 may include pairs of internal contacts for coupling to contacts 1000 and 1002 of each sensor 138, and pairs of external contacts, each pair of external contacts being coupled to a corresponding pair of internal contacts and forming contacts for coupling to test station 5002 and / or calibration station 5004. In this manner, multiple sensors can be transported as a group and coupled to test and calibration equipment. The strip sensor carrier 3204 may include an identifier for each sensor 138, enabling test and / or calibration data for each sensor to be recorded and stored. Individual pre-connected sensors can be formed by slicing the strip sensor carrier 3204 into individual sensor carriers for each sensor that can be mounted in an electronic device unit (such as the wearable sensor unit in Figures 13 and 14). The strip 3204 may include slicing features 3220 (e.g., markings and / or notches facilitating slicing into individual pre-connected sensors).

[0274] While Figures 35A and 35B show a flexible circuit strip wrapped around the end of sensor 138, this is illustrative only. It should be understood that the flexible strip carrier of one or more other sensors 138 may be attached to one or more sensors in other ways. For example, the end or other portion of sensor 138 may extend into the substrate of flexible circuit strip 3204 to couple to internal conductive contacts in the strip, or the end or other portion of sensor 138 may be attached to the surface of flexible circuit strip 3204 (e.g., using anisotropic conductive film (ACF) or other conductive adhesives, laser solder or other solders, clips or other attachment mechanisms, and / or positioning and aligning reference features of the sensor).

[0275] Figure 36 illustrates an embodiment of the sensor carrier 302, wherein a crimp connector 3301 extends through a portion of the substrate 404. As shown in Figure 36, the crimp connector 3301 may have a base portion 3300 extending from a first side of the substrate 404 (e.g., to form one of contacts 410 and 412). The crimp connector 3301 also includes an arm 3302 extending from an opposing second side of the substrate 404. As shown in Figure 37, the arms 3302 may be pressed together or crimped to mechanically secure and electrically couple to the sensor 138, thereby forming, for example, a contact 406. Figure 38 shows a side view of the sensor carrier of Figures 36 and 37 and illustrates how two crimp connectors are provided, extending through the substrate 404 and forming contacts 406 and 408 on the first side and contacts 410 and 412 on the second side. Although contacts 410 and 412 are formed on the second side of substrate 404 in FIG. 38, it should be understood that contacts 410 and 412 may be formed on the first side, or on the sidewall or edge of substrate 404 (e.g., by including one or more elbows or other conductive couplings within substrate 404).

[0276] Figure 39 illustrates an embodiment of the pre-connected sensor, wherein the sensor carrier 402 includes a distally oriented channel 358 that distally guides the sensor 138 such that the sensor 138 includes an bend of at least 45 degrees and / or less than 135 degrees. A channel cap 362 secures the glucose sensor 138 within the distally oriented channel 358. In the example of Figure 39, one or more contacts (e.g., 408 and 406) are implemented using a conductive elastic member 1400. In other embodiments, the contacts can be of any suitable type (e.g., a coil spring 306, a leaf spring 306d). The contacts (e.g., the conductive elastic member 1400) form a conductive coupling between the sensor 138 and external devices (e.g., a test station 5002, a calibration station 5004, and / or a sensor assembly 600 on the skin). As shown, the contacts may cooperate with a base feature (e.g., protrusion 308) and / or channel 322d on substrate 404 to form a reference feature that secures and aligns the sensor 138 relative to sensor carrier 402 (e.g., for manufacturing, calibration, testing, and / or in-vivo operation). In some embodiments, the sensor 138 may be bent, glued, or joined to attach within sensor carrier 402.

[0277] Figure 40 illustrates an embodiment of the sensor carrier 402, wherein the substrate 404 is a molded interconnect device. In the example of Figure 40, the substrate 404 is formed of a molded thermoplastic or thermosetting plastic (e.g., acrylonitrile-butadiene-styrene, liquid crystal polymer, polyimide / polyphthalamide plastic, or other thermoplastic or thermosetting polymer material) containing conductive traces 3702. The conductive traces 3702 may be formed on the surface of the substrate 404 and / or may penetrate and / or pass through portions of the substrate 404 to form suitable connections. The conductive traces may be formed on the molded substrate using various techniques (e.g., selective electroplating by laser etching, combining electroplatable and non-electroplated substrate polymers, or other suitable methods). In other embodiments, conductive materials (e.g., conductive polymers, metal stampings, electroplated polymers, metal structures) may be molded with a non-conductive material overlaid.

[0278] To create the appropriate electrical connection as shown in FIG40, conductive trace 3702 is electrically coupled between contacts (e.g., contact areas 1000 and 1002 on sensor 138) and external contacts (e.g., contacts 410 and 412). Although the contacts (e.g., 410 and 412) are formed on the same surface of the substrate 404 to which sensor 138 is attached in the example of FIG37, this is merely illustrative. It should be understood that the contacts (e.g., contacts 410 and 412) may be formed on opposite surfaces, edges, or sidewalls of substrate 404 and coupled to contacts (e.g., contacts 408 and 406) via conductive materials (e.g., conductive layers, structures, adhesives, clips, solder, or interconnects, etc.) within or on substrate 404. For example, contacts (e.g., contacts 410 and 412) may form designated areas to interface electrical couplings on different surfaces or areas of the substrate 404 to which the sensor 138 is attached. The designated areas may form alignment features such as channels, trenches, recesses, slots, or similar features for orienting the sensor.

[0279] The molded thermoplastic substrate 404 may be an injection-molded substrate having features that facilitate various aspects of testing, calibration, and wearable device mounting of the sensor 138. For example, the molded thermoplastic substrate 404 may include reference features or other positional or positioning features, such as a recess 3700 whose shape is complementary to the shape of the proximal end of the sensor 138. For example, the recess 3700 may include three or more stepped regions corresponding to steps between different layers of the coaxial analyte sensor as shown in Figure 3D. In other configurations, the molded thermoplastic substrate 404 may include a flat-walled recess as in the example of Figure 18, a corner-forming wall as in the example of Figure 19, or a circular recess as in the example of Figure 20. In other configurations, the molded thermoplastic substrate 404 may include raised features or protrusions on its surface for positioning and aligning the sensor 138. For example, raised channels with shapes corresponding to the shape of the sensor 138 may be provided on the surface of the molded thermoplastic substrate 404. As another example, one or more pillars may extend from the surface of the molded thermoplastic substrate 404. For example, one or more protruding lines may be formed on the surface of the molded thermoplastic substrate 404, and the sensor 138 may be positioned and aligned against the protruding lines, and / or positioned and aligned between the protruding lines. In this way, various configurations can be provided for the molded thermoplastic substrate 404, including reference features that orient the sensor 138 in a preferred location and preferred orientation.

[0280] The molded thermoplastic substrate 404 may also include features of other shapes, such as finger holders 3720 on opposite sides of the substrate to facilitate gripping, holding, and transporting the sensor 138. The molded thermoplastic substrate 404 may also include features of other shapes, such as anchoring features corresponding to the shapes of connectors used in manufacturing equipment 5091, testing equipment 5004, and calibration equipment 5004, for example, gripping connector features 5093 / 5095 of manufacturing equipment 5091 and / or recessed connectors 5006 and 5014 of testing equipment 5002 and calibration equipment 5004. Anchoring features formed on and / or by the molded thermoplastic substrate 404 itself may include one or more protrusions, such as pillars, snap-fit ​​features, arms like arm 202 (see, for example, Figures 11-14), recesses, notches, hooks, and / or tapered portions similar to the tapered portion shown in Figure 28 (as examples). In some instances, the shape of a portion or the entire molded thermoplastic substrate 404 may correspond to the shape of a mounting socket on or within one or more of the manufacturing equipment 5091, testing equipment 5002, calibration equipment 5004, carrier, and / or wearable device.

[0281] Although substrate 404 is shown as substantially linear in FIG. 40, the molded thermoplastic substrate 404 may have feature 3720 and / or an integral shape such as a handle shape for inserting, pulling, or otherwise manipulating sensor 138 during manufacturing and assembly operations. For example, the molded thermoplastic substrate 404 may include a main portion and a grip portion extending from the main portion, the main portion being configured to mechanically and electrically interface with manufacturing equipment 5091, testing equipment 5002, calibration equipment 5004, and / or wearable device. The grip portion may extend from manufacturing equipment 5091, testing equipment 5002, or calibration equipment 5004 during manufacturing operations to facilitate removal of sensor carrier 402 and sensor 138 from the equipment after or between manufacturing operations. The grip portion may be integrally formed with the main portion or may be a separate component extending from or within the surface of the molded thermoplastic substrate 404. The gripping component can be a column, rod, shaft, or arched handle that is shaped for (e.g., by a technician) to hold with a gripping tool or by hand.

[0282] As shown in Figure 40, sensor 138 can be placed in recess 3700 and secured to substrate 404 using adhesive 3704 (e.g., a conductive adhesive as described herein). Adhesive 3704 can be applied to couple the contacts 1000 of sensor 138 to a first conductive trace 3702 on substrate 404 to form contact 408 between sensor 138 and sensor carrier 402. Adhesive 3704 can also be applied to couple the contacts 1002 of sensor 138 to a second conductive trace 3702 on substrate 404 to form contact 406 between sensor 138 and sensor carrier 402. In this way, molded thermoplastic substrate 404 can provide handles and / or strain relief components for moving and / or otherwise disposing of sensor 138.

[0283] Figure 41 shows a top view of the sensor carrier 402 of Figure 40. As shown in Figures 40 and 41, a first conductive trace 3702 may extend from a contact portion with a contact 1000 within a recess 3700 to form one or more exposed portions on the surface of a substrate 404, the exposed portions forming external contacts 412 for coupling to a test station 5002, a calibration station 5004, and / or an electronic device unit 500. A second conductive trace 3702 may extend from a contact portion with a contact 1002 within a recess 3700 to form one or more exposed portions on the surface of a substrate 404, the exposed portions forming external contacts 410 for coupling to a test station 5002, a calibration station 5004, and / or an electronic device unit 500.

[0284] Figure 42 illustrates a specific embodiment of the sensor carrier 402 shown in Figures 40 and 41. In this embodiment of the sensor carrier 402, the sensor 138 is attached to the substrate 404 via a conductive coupler 3900 (such as a clip, conductive adhesive, conductive polymer, metal foil, conductive foam, conductive fabric, wire winding, wire threading, or any suitable method). As shown in Figure 43, the substrate 4000 may have an elongated dimension along which parallel conductive strips 4001 and 4002 are formed. Multiple sensors 138 may be attached to the substrate 4000 and extend beyond the edge of the substrate in a direction perpendicular to the elongated dimension. Monolithic features such as notches 4020 may be provided, which facilitate the monolithic cutting of the substrate 4000 into individual sensor carrier substrates 404 for each sensor, and / or partial electrical isolation of the conductive strips 4001 and 4002 of each sensor. Each sensor can be attached to the substrate 4000 using, for example, a clip 3900 or any other method (including by using conductive adhesive, conductive polymer, metal foil, conductive foam, conductive fabric, winding, wire threading, or any other suitable method). An identifier 450 for each sensor can be provided on a corresponding portion of the substrate 4000.

[0285] Sensors 138 may each have a pair of sensor contacts (e.g., contacts 1000 and 1002) coupled to a corresponding pair of contacts formed by strips 4001 and 4002 on a substrate. Openings in the substrate 4000 and / or through-holes extending through the substrate 4000 may provide exposed portions of strips 4001 and 4002, forming multiple pairs of contacts for coupling each sensor 138 to a test station 5002, a calibration station 5004, and / or an electronics unit 500 (e.g., the electronics unit of a wearable device). Each of the multiple pairs of contacts is coupled through the substrate to an associated pair of portions of strips 4001 and 4002.

[0286] Figures 44-46 illustrate various contact configurations on a sensor carrier that can be slit from a sensor carrier strip of the type shown in Figure 43. In the example of Figure 44, a Z-shaped contact configuration on substrate 4000 has been slit to form a pre-connected sensor on a smaller portion of the substrate (referred to as substrate 404). In this case, the Z-shaped contact configuration can achieve a larger distance between connectors (e.g., larger pitch connections) on test, manufacturing, or calibration equipment, but a Z-shaped substrate is not required to generate a larger distance, and other substrate shapes can be used. In the example of Figure 45, a square portion of substrate 4000 has been slit to form a pre-connected sensor on substrate 404. In the example of Figure 46, a square portion of substrate 4000 has been slit to form a pre-connected sensor, and an opening 4300 (e.g., an air gap) provides improved electrical isolation between the slit contact strip portions 4001 and 4002 in the slit substrate 404.

[0287] As shown in Figure 47A, in some embodiments, the elongated substrate 4000 of the sensor carrier forming a plurality of sensors 138 may have a feed guide strip 4402 traveling along the elongated edge of the elongated substrate. The feed guide strip 4402 may include positioning features 4404 that can be approached and manipulated to move and align the strip of pre-connected sensors through one or more manufacturing stations.

[0288] In the embodiment of Figure 47A, sensor 138 can be attached in bulk to substrate 4000 and single-cut on substrate 404 after manufacturing or testing operations. As shown in Figure 47B, the strip of the pre-connected sensor shown in Figure 47A can be provided on reel 4410 for bulk storage and / or transport, and optionally automatically pulled from the reel using feed guide strip 4402 to move through one or more test stations and / or one or more calibration stations. Figure 48 shows a pre-connected sensor with a sensor carrier that has been single-cut from substrate 4000 and separated from the single-cut portion 4402 of feed guide strip 4402. Alternatively, feed guide strip 4402 can be separated as a strip before the single-cut of individual pre-connected sensors. In other embodiments, the feed guide is integrated into the final product configuration and is not removed from the sensor carrier during or after single-cutting.

[0289] Figure 49 illustrates an embodiment of the sensor carrier 402, wherein multiple sets of contacts 406 and 408 are formed by a socket 4600 having slots for receiving corresponding multiple sensors 138. In some embodiments, the socket 4600 may be an elongated member comprising an elastic or flexible material. The socket 4600 may have slots that optionally pierce an insulating layer or deform a portion of the outer layer to contact the sensors 138.

[0290] Figure 50 illustrates an embodiment of a sensor carrier for a plurality of sensors 138 having recesses 4700 forming reference features to maintain precise alignment and position of each sensor. Complementary magnetic features may be provided on the sensors 138 and the substrate 404 to maintain precise alignment and position of each sensor and facilitate accurate sensor processing.

[0291] Figure 51A illustrates an embodiment of an elongated substrate 4800 formed from a rigid, flexible, or combined rigid / flexible substrate using printed circuit board technology, from which multiple sensor carriers 402 can be individually cut. The flexible portion of the substrate can be made of materials such as polyimide, PEEK, polyester, or any suitable type. The rigid portion of the substrate can be made of materials such as FR4, FR5, FR6, metal insulating substrate (IMS), PTFE, or any suitable type. As shown in Figure 51A, each sensor carrier may include a sensor connection portion 4804 and an interface or processing portion 4802. In some embodiments, each sensor carrier may include a sensor connection portion 4804 extending from the rigid or flexible portion and an interface or processing portion 4802 extending from the rigid or flexible portion. In these embodiments, one or more contacts, such as contacts 406 and 408, may be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 may contain anchoring or reference features for the sensor carrier 402.

[0292] Figure 51B illustrates another embodiment of the elongated substrate 4800 shown in Figure 51A, the elongated substrate having an optional electrical connection interface 4850 for connection to a workstation (such as a test station, calibration station, assembly station, coating station, or other manufacturing station). The optional electrical connection interface 4850 can be coupled to one or more sensor carriers 402 via electrical traces configured on one or more layers of a circuit board. As shown in Figure 51B, a plurality of sensor carriers 402 are assembled in a panel, and each sensor carrier 402 may include a sensor connection portion 4804 extending from a rigid or flexible portion and an interface or processing portion 4802 extending from a rigid or flexible portion. In these embodiments, one or more contacts, such as contacts 406 and 408, may be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 may contain anchoring or reference features of the sensor carrier 402. In some embodiments, the elongated substrate 4800 shown in FIG. 51B can be configured to allow the sensor 138 to extend beyond the edge of the substrate. This can be achieved by removing a portion of the elongated substrate 4860 for further processing. In some embodiments, perforations (e.g., V-grooves, rat-tooth patterns, or other suitable types) are included in the elongated substrate 4800 to allow removal of the bottom portion of the panel 4860 for impregnation or calibration. In this embodiment, the elongated substrate 4800 can be configured for impregnation or calibration, as described in FIG. 52B.

[0293] Referring now to FIG52A, an embodiment of the sensor carrier 402 is shown having one or more sensor contacts (e.g., contacts 406 and 408) on a sensor connection portion 4804 and one or more interface contacts (e.g., contacts 410 and 412) on an interface or processing portion 4802. One or more interface contacts (e.g., 410 and 412) may be formed on the sensor carrier 402 for connection to a test station 5002, a calibration station 5004, and / or an electronics unit 500. In this configuration, testing and / or calibration operations can be performed by coupling portion 4802 to test and / or calibration equipment.

[0294] Figure 52B illustrates an example panel embodiment of multiple sensor carriers 402 having an electrical connection interface 4850 for interfacing with electronics at a workstation (e.g., a test station, calibration station, assembly station, coating station, or other manufacturing station). The illustration in Figure 52B shows the elongated substrate 4800 of Figure 51B after the bottom panel portion 4860 (from the illustration in Figure 51B) has been removed and the sensor 138 is attached via one or more sensor contacts (e.g., contacts 406 and 408). In some embodiments, the sensor may be permanently attached (e.g., by conductive adhesive, conductive polymer, conductive ink, solder, welding, brazing, or other suitable methods) to the sensor carrier 402, and the two components may be calibrated together or separately. In other embodiments, the sensor may be releasably attached (e.g., by clips, foil, conductive foam, conductive fabric, winding, wire threading, or any other suitable method).

[0295] Following testing and / or calibration, the flexible portion 4802 can be folded around, covered, wrapped around, covered, or manipulated to enclose portion 4804 for mounting onto the skin sensor assembly 600. In the example of FIG. 53A, portion 4802 may form a separate processing circuit for sensor 138 (e.g., an embodiment of sensor electronics 112). In other embodiments, portion 4802 may be directly coupled to signal processing circuitry for assembly 600, a system-in-package (SIP) embodiment of sensor electronics, or a main printed circuit board for sensor electronics. In the example of FIG. 53B, the flexible portion 4804 is folded to enclose portion 4802 for mounting into the skin sensor assembly 600 so that sensor 138 is positioned to extend (e.g., through opening 4808) for insertion for in vivo operation.

[0296] Figure 54 illustrates an embodiment in which the sensor carrier 402 is manufactured as a daughter board of the main printed circuit board 5100 for sensor electronics using printed circuit board technology. As shown in Figure 54, one or more contacts (e.g., contact 5104 (e.g., solder contact)) can be formed between the sensor carrier 402 and the main PCB 5100 to form a sensor electronics unit for sensor 138 in the skin sensor assembly 600. Conductive traces 5102 can couple contact 5104 to sensor 138 via conductive attachment mechanisms 5103 (e.g., solder, conductive adhesive, conductive tape, or other conductive attachments as discussed herein).

[0297] Figure 55 illustrates an embodiment of the sensor carrier 402, wherein a clamping clip 5200 is configured to close the arm 5204 of the crimp connector 5202 to secure the sensor 138 to the substrate 404. The connector 5204 may be formed of a conductive material forming one of the contacts 410 and 412. As shown in Figure 55, the clamping clip 5200 includes a clamping arm 5208 with a sloped surface that pushes the arm outward as the clamping clip 5200 moves toward the substrate 404 in direction 5206 and springs back to secure the clamping clip 5200 to the substrate 404. In other embodiments, the clamping clip 5200 may be configured without the clamping arm 5208, such that the clamping clip 5200 is removable after the arm 5204 has been clamped closed, thus preventing the clamping clip 5200 from forming part of the sensor carrier. As shown in FIG55, one or more electrode protrusions 5220 may be provided to form one or more contacts, such as contacts 410 and 412, on substrate 404. While the protrusions 5220 are formed on the surface of substrate 404 opposite to the surface to which sensor 138 is attached in the example of FIG55, this is merely illustrative. It should be understood that the protrusions of the contacts (such as contacts 410 and 412) may be formed on the opposing surface, on the same surface as sensor 138, or on the edge or sidewall of substrate 404, and coupled to contacts 408 and 406 via conductive vias or other conductive layers, structures, or interconnections within or on substrate 404. In some embodiments, a clamping clip 5200 may be used to apply a bias force to sensor 138 together with a crimp connector 5202, or a bias force may be applied directly to the substrate without the crimp connector 5202. The clamping clamp 5202 can apply force radially, axially, or in the appropriate direction to provide bias force on the sensor 138 and the conductive path.

[0298] Figure 56 illustrates an embodiment of the sensor carrier 402, wherein contacts 406 and 408 are formed by foldable conductive clips 5300. A sensor 138 can be inserted through an opening 5302 in each clip 5300 and is mechanically secured to the substrate 404 and electrically coupled to the clip 5300 by folding a portion 5304 of each clip 5300 over the sensor 138.

[0299] A portion 5304 of the clip 5300 may also form contacts 410 and 412 for coupling to external devices such as manufacturing stations (e.g., testing stations, calibration stations, assembly stations, coating stations, or other manufacturing stations). However, this is merely illustrative. In other embodiments, one or more electrode protrusions conductively coupled to the clip 5300 may be provided to form one or more of the contacts 410 and 412, for example, on the substrate 404. Such protrusions may be formed on the surface of the substrate 404 opposite to the surface to which the sensor 138 is attached, on the same surface as the sensor 138, or on the edge or sidewall of the substrate 404, and coupled to the clip 5300 via conductive vias or other conductive layers, structures, or interconnections within or on the substrate 404.

[0300] The clip 5300 also forms a reference feature for positioning and aligning the sensor 138 relative to the substrate 404. The substrate 404 may be sized and shaped (or may include structural features that form anchoring features of the substrate 404 relative to the manufacturing station and / or the housing of the wearable device. In this way, the sensor carrier 402 can be used to easily position and align the sensor 138 for manufacturing and assembly operations (e.g., using reference features to align the sensor relative to the substrate 404 and using anchoring features to align the substrate relative to the manufacturing or wearable device).

[0301] When mounted in the sensor assembly 600 on the skin, the conductive components of the sensor carrier 402 in the various embodiments described herein are electrically isolated from each other and from the environment. For example, contacts 406, 408, 410, and 412 can be electrically isolated from each other and from the environment by using non-conductive adhesives (e.g., one-component or two-component epoxy resins), polyurethane, low-pressure overmolding (e.g., moldable polyamides or moldable polyolefins), injection-molded thermoplastics or thermosetting plastics, non-elastomers (e.g., welded flip plastics, bonded flip plastics, single- or double-sided cavities filled with sealants (e.g., epoxy resins, urethane, silicone resins, etc.), or factory-pre-compressed elastomers (e.g., constrained double-sided cavities used to hold the elastomer in a compressed state). The double cavity can hold the elastomer in a compressed state by means of snap-fit, such as ultrasonic welding, laser welding, solvent bonding or thermal fusion bonding, or mechanical fasteners such as screws, rivets, clamps or other fasteners.

[0302] Figure 57 illustrates the illustrative operations that can be performed for the manufacture and use of pre-connected analyte sensors.

[0303] In block 5400, an analyte sensor, such as analyte sensor 138, may be provided. As described herein, the analyte sensor may have an elongated body (e.g., an elongated conductive body with an elongated conductive core) and a working electrode located on the elongated body (e.g., at the distal end of the elongated body). The analyte sensor may also include one or more electrical contacts along the proximal end of the elongated body or elsewhere, and coupled to the working electrode and / or a reference electrode, respectively.

[0304] In block 5402, a sensor carrier of one embodiment of sensor carrier 402 as described herein can be attached to, for example, the proximal end of an elongated body. Attaching the sensor carrier includes coupling one or more contacts of the sensor carrier (e.g., on a substrate) to one or more corresponding electrical contacts on the elongated body.

[0305] In block 5403, a workstation, such as a manufacturing station, is provided. As described herein, the manufacturing station can be configured to perform one or more dip-coating processes to form the aforementioned film 108 on the working electrode.

[0306] In block 5404, an analyte sensor can be coupled to at least one test station (e.g., test station 5002) by circuitry that couples the sensor carrier to at least one test station. The circuitry coupling the sensor carrier to the at least one test station may include a mating interface that mechanically couples one or more anchoring features (such as the substrate of the sensor carrier) to the test station, such that one or more external contacts on the substrate are coupled to one or more corresponding contacts at the test station. The sensor identifier on the sensor carrier can be read by the test station. Test data associated with the identifier obtained by the test station can be stored and / or transmitted by the test station.

[0307] In block 5406, an analyte sensor can be coupled to at least one calibration station (e.g., calibration station 5004) by circuitry that couples the sensor carrier to at least one calibration station. The circuitry coupling the sensor carrier to the at least one calibration station may include a mating interface that mechanically couples one or more anchoring features (such as the substrate of the sensor carrier) to the calibration station, such that one or more external contacts on the substrate are coupled to one or more corresponding contacts at the calibration station. An identifier for the sensor on the sensor carrier can be read by the calibration station. Calibration data associated with the identifier obtained by the calibration station can be stored and / or transmitted by the calibration station. The calibration data can be stored on the sensor carrier or transmitted for subsequent use by the on-skin sensor assembly 600 during in vivo use of the sensor 138.

[0308] The sensor carrier 402 can be coupled to one or more additional manufacturing stations as needed. These additional manufacturing stations may include a potentiostat measurement station, a sensor calibration station, a membrane impregnation station, a curing station, an analyte sensitivity measurement station, and / or a testing station.

[0309] In block 5408, a sensor carrier can be coupled to sensor electronics (e.g., sensor electronics 112 of electronics unit 500) of a wearable device (e.g., on-skin sensor assembly 600). Coupling the sensor carrier to the sensor electronics may include coupling one or more external contacts on the sensor carrier to corresponding contacts on the sensor electronics. In some embodiments, coupling the sensor carrier to the sensor electronics may include securing the sensor carrier between a base (e.g., base 128) and electronics unit 500 as described herein. A reader in on-skin sensor assembly 600 can obtain a sensor identifier from the sensor carrier. Sensor calibration data can be obtained based on the identifier.

[0310] In block 5410, the in vivo signal from the working electrode (e.g., and the reference electrode) can be acquired and processed by sensor electronics. The in vivo signal from the working electrode (e.g., and the reference electrode) can be received from the sensor by the sensor electronics through the circuitry of the sensor carrier.

[0311] The methods disclosed herein include one or more steps or actions for implementing the described methods. Method steps and / or actions may be interchanged without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims. For example, the operations described above in conjunction with boxes 5404 and 5406 may be reversed and / or performed in parallel.

[0312] In some cases, it may be necessary to couple sensor 138 to one or more contacts on a substrate in a preferred location and orientation. Figure 58 illustrates an exemplary device 5531 in which sensor 138 is oriented to substrate 5530 using an elastic tube. As shown in Figure 58, device 5531 may include substrate 5530 having one or more conductive contacts (such as contacts 5532 and 5534 (e.g., exposed copper pads on a printed circuit substrate)) and elastic tube 5500. Elastic tube 5500 may be formed of a non-conductive elastomer.

[0313] As shown in the figure, the elastic tube 5500 can be formed with a "D", "O", elliptical, pyramidal, or hemispherical cross-section, wherein the cross-section has an elongated slit 5503 in the bottom portion of the elastic tube 5500, in which the sensor 138 is disposed. In this way, the sidewalls of the elongated slit of the elastic tube 5500 can align the sensor 138 relative to the substrate 5530.

[0314] The bottom portion 5502 on each side of the cutout 5503 can be attached to the substrate 5530. The bottom portion 5502 can be attached to the substrate using an adhesive 5504 (such as a pressure-sensitive adhesive). The elongated opening 5501 and cutout 5503 in the flexible tube 5500 provide sufficient space for the tube 5500 to be placed above the sensor 138 for device assembly, with the sensor 138 properly positioned on the substrate 5530.

[0315] Figure 59 shows an exploded perspective view of the device of Figure 55, in which contacts 5532 and 5534 can be seen on substrate 5530. Sensor 138 may be positioned above one or more contacts (such as contacts 5532 and 5534).

[0316] During the initial placement of the tube above the sensor, the sensor 138 can be loosely held within the opening 5501 of the tube 5500, and then secured to the substrate 5530 by the tube when it is compressed (e.g., through the upper housing of the wearable device). In this way, the sensor 138 can be communicatively coupled and mechanically secured to the substrate without soldering or other bonding operations.

[0317] During manufacturing operations and / or during use within the sensor 138, the sensor 138 can be held in place on the substrate 404 by external compression of the tube 5500. Figure 60 illustrates an example of holding the sensor 138 in place by compressing the tube 5500 through a housing structure. For example, a housing 5700 (e.g., a housing for a wearable device or a cover or clip for a manufacturing station) can be included in an assembly configuration to compress the tube 5500 to secure the protruding member 5702 of the sensor 138.

[0318] As described above in conjunction with, for example, Figures 35B, 43, 47A, 47B, 50, and 51, multiple sensors 138 can be carried by a common sensor carrier during manufacturing operations. However, in some cases, a common carrier, such as a smart carrier, can be provided for manufacturing operations of multiple pre-connected sensors. Figure 61 shows an example of a carrier for multiple pre-connected sensors. As shown in Figure 58, the carrier 5800 may include a housing 5802 for interfaces 5804 for multiple pre-connected sensors. The housing 5802 may be a substantially solid substrate, or it may be a housing forming an inner cavity in which other components are mounted and / or connected.

[0319] Each interface 5804 can be configured to house a sensor carrier 402 in any of the embodiments described herein. For example, each interface 5804 may include one or more features that interface with one or more corresponding anchoring features of the sensor carrier as described herein according to various embodiments. The carrier 5800 may include circuitry 5806 (e.g., one or more processors and / or memories) configured to communicate with the sensor 138 and / or an external computing device. The circuitry 5806 may include communication circuitry systems, such as one or more antennas, for transmitting and / or receiving data from external devices. The housing 5802 may include one or more structures 5810 (e.g., clips, buckles, protrusions, recesses, notches, posts, etc.) for mechanically coupling the carrier 5800 to a manufacturing apparatus. One or more conductive contacts 5808 may be provided on the housing 5802 to communicatively couple the manufacturing apparatus to the sensor 138 via the carrier.

[0320] As shown in the figure, each interface 5804 can be associated with a specific identifier (for example, represented as I1, I2, ..., I in Figure 58). N-1 and I N Circuit 5806 can electronically identify a sensor mounted in interface 5804 of carrier 5800 by means of an identification number associated with the interface. However, this is merely illustrative. In other embodiments, sensor 138 can be uniquely identified by circuit 5806 using a reader in each interface of interface 5804, with the reader reading an identifier such as identifier 450 on the sensor carrier. Test and / or calibration data can be collected by processing circuitry system 5806 and stored and / or transmitted along with the identifier of each sensor.

[0321] During manufacturing, one or more pre-connected sensors can be mounted on carrier 5800. Carrier 5800 can secure the pre-connected sensors therein and perform potentiostat measurements for each sensor (e.g., using circuit 5806). Sensor 138 can be secured to interface 5804 by individual mounting features, or carrier 5800 can have a locking mechanism, such as a sliding lever 5812. The sliding lever 5812 can slide between an open position and a closed position as shown (e.g., via handle 5814), in which the sensor carrier can be inserted into and removed from interface 5804, and in the closed position, the lever 5812 prevents the sensor carrier from being removed from the interface.

[0322] In some cases, initial measurement tests can be performed by the carrier 5800 to test the potentiostat connection via the sensor interconnect electrodes and the sensor surface. Manufacturing operations that can be performed on the sensor 138 coupled to the carrier 5800 may include physical manipulation of the sensor, such as sensor calibration. By allowing multiple sensors to be calibrated in a single operation using an automated calibration device, the carrier 5800 can facilitate more efficient manufacturing.

[0323] The carrier 5800 can facilitate potentiostat measurements and / or other measurements at various stages of the manufacturing process of the sensor 138. Potentiostat measurements can be performed before, during, and / or after calibration operations, and information regarding sensor damage or any other possible mechanical stress that may be introduced through calibration can be stored and / or transmitted along with the associated sensor ID.

[0324] Manufacturing operations that can be performed on the sensor 138 coupled to the carrier 5800 may also include a membrane process, wherein an impregnation operation is performed to form a membrane, such as membrane 508 for each sensor. The calibrated sensor 138 mounted in the carrier 5800 may be impregnated simultaneously. Potentiostat measurements may be performed before, during, and / or after the membrane operation, and information associated with the electrochemical and impregnation processes of the sensor may be collected, processed, stored, and / or emitted by the carrier 5800.

[0325] Manufacturing operations that can be performed on the sensors 138 coupled to the carrier 5800 may also include a curing process. Performing curing on a group of sensors 138 mounted in the carrier 5800 allows the curing process to occupy less space, which can reduce the footprint of the manufacturing area used by the curing equipment. Potentiostat measurements can be performed before, during, and / or after the curing operation, and information associated with the electrochemical and impregnation processes of the sensors can be collected, processed, stored, and / or emitted by the carrier 5800.

[0326] Manufacturing operations that can be performed on the sensor 138 coupled to the carrier 5800 may also include calibration operations. Because the carrier 5800 can perform connectivity testing early in the manufacturing process, improved analyte / electrochemical calibrations can be performed by the carrier 5800 itself and / or in collaboration with external manufacturing equipment. Calibration data can be collected, processed, stored, and / or emitted by the carrier 5800.

[0327] Collecting calibration and / or test data via the Carrier 5800 saves time connecting and disconnecting additional external devices. Collecting calibration and / or test data via the Carrier 5800, especially when data is automatically collected and stored along with the sensor ID, also reduces calibration / test errors because the data is collected from the same device throughout the process.

[0328] Manufacturing operations that can be performed on the sensor 138 connected to the carrier 5800 may also include analyte concentration measurements. For example, the carrier 5800 may be moved by manufacturing equipment (e.g., a robotic arm) to expose the sensor 138 mounted in the carrier to various analyte baths (e.g., a glucose bath). The carrier 5800 may collect potential measurements during exposure to various baths. Information associated with potential measurements during exposure to various baths may be collected, processed, stored, and / or emitted by the carrier 5800.

[0329] Manufacturing operations that can be performed on the sensor 138 connected to the carrier 5800 may also include analyte sensitivity measurements. Sensitivity measurements that can be performed by the carrier 5800 may include baseline measurements, slope measurements, and / or noise measurements; baseline measurements indicate the signal from each sensor in the absence of analyte exposure, and slope measurements indicate the signal change for a given amount of analyte. These sensitivity measurements may be stored and / or transmitted by the carrier 5800.

[0330] Manufacturing operations that can be performed on the sensors 138 coupled to the carrier 5800 may also include visual inspection operations (e.g., by a technician). Providing a pre-connected set of sensors mounted in the carrier 5800 that have undergone all the aforementioned testing / calibration / manufacturing operations allows for more efficient and / or automated visual inspection and rejection (e.g., because the exact physical location of each sensor within the carrier 5800 is known). Sensors 138 that have exhibited abnormal electrochemical or mechanical stress during manufacturing operations may be marked by the carrier 5800 (e.g., using a display, visual indicator, or transmitting the marking information to an external device) for retesting or rejection.

[0331] The connections between components shown in some of the accompanying figures illustrate exemplary communication paths. Additional communication paths (direct or mediated) may be included to further facilitate information exchange between components. Communication paths can be bidirectional, allowing components to exchange information.

[0332] The various operations described above can be performed by any suitable device capable of performing the operations, such as various hardware and / or software components, circuits and / or modules. Generally, any operation shown in the accompanying drawings can be performed by a corresponding functional device capable of performing the operation.

[0333] The various illustrative logic blocks, modules, and circuits described in this disclosure (as shown in the boxes of Figure 2) can be implemented or performed as follows: a digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other programmable logic device (PLD), discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. The processor may be a microprocessor, but alternatively, it may be any commercially available processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration.

[0334] In one or more aspects, the various functions described can be implemented as hardware, software, firmware, or any combination thereof. If implemented as software, these functions can be stored or transmitted as one or more instructions or code on a computer-readable medium. A computer-readable medium includes both computer storage media and communication media, with communication media including any medium that facilitates the transfer of a computer program from one place to another. A storage medium can be any available medium accessible to a computer. By way of example and not limitation, such computer-readable media can include various types of RAM, ROM, CD-ROM or other optical disc storage, disk storage or other magnetic storage devices, or any other medium that can be used to carry or store desired program code in the form of computer-accessible instructions or data structures. Furthermore, any connection is appropriately referred to as a computer-readable medium. For example, if software is transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technology (such as infrared, radio, and microwave), the definition of medium includes coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technology (such as infrared, radio, WiFi, Bluetooth). (RFID, NFC, and microwave). As used herein, disks and optical discs include compressed optical discs (CDs), laser discs, optical discs, digital versatile optical discs (DVDs), floppy disks, and Blu-ray discs. Optical discs, where magnetic disks typically reproduce data magnetically, and optical discs reproduce data optically via lasers. Therefore, in some aspects, computer-readable media may include non-transitory computer-readable media (e.g., tangible media). Furthermore, in some aspects, computer-readable media may include transient computer-readable media (e.g., signals). Combinations of the foregoing should also be included within the scope of computer-readable media.

[0335] In some aspects, a computer program product may be included for performing the operations presented herein. For example, such a computer program product may include a computer-readable medium having stored (and / or encoded) instructions that can be executed by one or more processors to perform the operations described herein. In some aspects, the computer program product may include packaging material.

[0336] Software or instructions can also be transmitted over a transmission medium. For example, if software is transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technology (such as infrared, radio, and microwave), then the definition of the transmission medium includes coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technology (such as infrared, radio, and microwave).

[0337] Furthermore, it should be understood that modules and / or other suitable means for performing the methods and techniques described herein can be downloaded and / or otherwise obtained by the user terminal and / or base station where applicable. For example, such devices can be coupled to a server to facilitate the delivery of means for performing the methods described herein. Alternatively, the various methods described herein can be provided via storage devices (e.g., RAM, ROM, physical storage media such as CDs or floppy disks), allowing the user terminal and / or base station to obtain the various methods when the storage device is coupled to or provided to the device. Furthermore, any other suitable techniques for providing the methods and techniques described herein to the device can be utilized.

[0338] It should be understood that the claims are not limited to the precise configuration and components described above. Various modifications, alterations, and variations can be made to the arrangement, operation, and details of the above methods and apparatus without departing from the scope of the claims.

[0339] Unless otherwise defined, all terms (including technical and scientific terms) shall have the meanings common and customary to those skilled in the art, and are not limited to specific or customary meanings unless expressly defined herein. It should be noted that the use of particular terms in describing certain features or aspects of this disclosure should not be construed as implying that the term is redefined herein to limit itself to any specific characteristic of the feature or aspect of this disclosure associated with that term. Unless expressly stated otherwise, the terms and phrases used in this application, and especially the terms and phrases and variations thereof in the appended claims, shall be interpreted as open-ended rather than restrictive. As examples of the foregoing, the term “comprising” should be understood to mean “including but not limited to”, etc.; as used herein, the term “comprising” is synonymous with “comprising,” “containing,” or “characterized by” and is inclusive or open-ended and does not exclude additional unlisted elements or method steps; the term “having” should be interpreted as “having at least”; the term “comprising” should be interpreted as “including but not limited to”; the term “example” is used to provide exemplary examples of the items discussed, not an exhaustive or limiting list thereof; adjectives such as “known,” “common,” “standard,” and similar meanings should not be construed as limiting the described items to items available at a specified time period or at a specified time, but rather should be understood as covering known, common, or standard techniques that are available or known now or at any time in the future; and the use of terms such as “preferred,” “ideal,” “required,” or “required,” and words with similar meanings should not be construed as implying that certain features are critical, necessary, or even essential to the structure or function of the invention, but should actually be understood as merely intended to highlight alternative or additional features that may or may not be utilized in specific embodiments of the invention. Similarly, unless otherwise explicitly stated, a group of items connected by the conjunction "and" should not be construed as requiring each item in those items to be present in the group, but rather as "and / or". Likewise, unless otherwise explicitly stated, a group of items connected by the conjunction "or" should not be construed as requiring mutual exclusivity in the group, but rather as "and / or".

[0340] When a range of values ​​is provided, it should be understood that the upper and lower limits of the range, as well as each intermediate value between the upper and lower limits, are covered within the embodiment.

[0341] Regarding the use of virtually any plural and / or singular terms herein, those skilled in the art can convert plural to singular and / or singular to plural as appropriate to the context and / or application. For clarity, various singular / plural arrangements may be explicitly stated herein. The indefinite article “a / an” does not exclude multiple. A single processor or another unit may fulfill the functions of several items recounted in the claims. The mere fact that certain measures are recited in different subsidiary claims does not indicate that a combination of these measures cannot be used to obtain an advantage. Any reference signs in the claims should not be construed as limiting the scope.

[0342] Those skilled in the art will also understand that if a particular number of introduced claims are desired, this intention will be explicitly stated in the claims, and if such statements are not present, this intention does not exist. For example, as an aid to understanding, the appended claims may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claim statements. However, the use of such phrases should not be construed as implying that a claim statement introduced by the indefinite article “a” or “an” limits any particular claim containing such an introduced claim statement to an embodiment containing only one such statement, even when the same claim contains the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and / or “an” should generally be interpreted as meaning “at least one” or “one or more”); the same applies to the use of definite articles used to introduce claim statements. Furthermore, even when a specific number is explicitly stated in the claims, those skilled in the art will recognize that such a statement should typically be interpreted as meaning at least the stated number (e.g., the simple statement "two statements" without other modifiers typically means at least two statements, or two or more statements). Additionally, in cases where conventions such as "at least one of A, B, and C" are used, such syntactic structures are generally intended to be in the sense of convention that those skilled in the art would understand, for example, including any combination of the listed items, including a single member (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In cases where conventions such as “at least one of A, B, or C” are used, such syntactic structures are generally intended to be understood in the sense of convention as would be known to a person skilled in the art (e.g., “a system having at least one of A, B, or C” would include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). A person skilled in the art will further understand that virtually any transitional word and / or phrase representing two or more alternative terms, whether in the description, claims, or figures, should be understood to consider the possibility of including one of the terms, any one of the terms, or both of the terms. For example, the phrase “A or B” should be understood to include the possibility of including “A” or “B” or “A and B”.

[0343] All figures used in this specification to represent amounts of ingredients, reaction conditions, etc., should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters set forth herein are approximations that may vary depending on the desired properties. At least, and not in an attempt to limit the application of the doctrine of equivalents to the scope of any claim in any application claiming priority to this application, each numerical parameter should be interpreted according to the number of significant figures and common rounding methods.

[0344] All references cited herein are incorporated herein by reference in their entirety. Where any publication or patent or patent application incorporated herein by reference conflicts with any disclosure contained herein, this specification is intended to supersede and / or give precedence to any such conflicting material.

[0345] This document includes headings for reference and to help locate the various sections. These headings are not intended to limit the scope of the concepts described herein. Such concepts may apply throughout the specification.

[0346] Furthermore, while the foregoing has been described in considerable detail by means of illustration and examples for the purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications can be made. 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 encompass all modifications and alternatives that fall within the true scope and spirit of the invention.

[0347] The various systems and methods described can be fully implemented and / or controlled in any number of computing devices. Typically, instructions are arranged on a generally non-transitory computer-readable medium, and these instructions are sufficient to allow a processor in the computing device to implement the methods of the invention. The computer-readable medium can be a hard disk drive or solid-state memory with instructions loaded into random access memory at runtime. Input to the application, for example, from multiple users or from any one user, can be made by any number of suitable computer input devices. For example, a user can use a keyboard, mouse, touchscreen, joystick, touchpad, other pointing devices, or any other such computer input device to input calculation-related data. Data can also be input via inserted memory chips, hard disk drives, flash drives, flash memory, optical media, magnetic media, or any other type of file storage medium. Output can be delivered to the user via a video graphics card or an integrated graphics chipset coupled to a display that the user can see. Alternatively, a printer can be used for hard copies of the output. Given this teaching, any number of other tangible outputs will also be understood as contemplated by the invention. For example, output can be stored on memory chips, hard disk drives, flash drives, flash memory, optical media, magnetic media, or any other type of output. It should also be noted that the present invention can be implemented on many different types of computing devices, such as personal computers, laptop computers, notebook computers, netbook computers, handheld computers, personal digital assistants, mobile phones, smartphones, tablet computers, and also on devices specifically designed for these purposes. In one embodiment, a user of a smartphone or Wi-Fi connected device can download a copy of the application to their device from a server using a wireless Internet connection. Appropriate authentication procedures and secure transaction processes can stipulate payment to the seller. The application can be downloaded via mobile connection or WiFi or other wireless network connection. The application can then be run by the user. Such networked systems can provide a suitable computing environment for implementations where multiple users provide separate inputs to the system and method. In the following systems intended for factory calibration, multiple inputs can allow multiple users to simultaneously input relevant data.

Claims

1. A method of manufacturing a skin-wearable device, the method comprising: assembling electronic circuitry into an interior volume of a housing, wherein the electronic circuitry is configured for (1) detecting a signal generated by an electrochemical reaction at a working electrode of an analyte sensor under a subject's skin, and (2) wirelessly transmitting data derived from the detected signal to outside of the housing for processing and / or display by a separate device; after assembling the electronic circuitry into the interior volume of the housing, attaching a proximal end portion of the analyte sensor to an external electrical interface coupled with the electronic circuitry such that the electronic circuitry is connected to the analyte sensor to receive signals from the analyte sensor without opening the housing, wherein the external electrical interface is formed in a recess located in an external bottom surface of the housing that is configured to directly contact a patch used to couple the housing to the subject's skin; and dispensing a curable liquid into the recess to seal the attachment of the proximal end portion of the analyte sensor to the external electrical interface.

2. The method of claim 1, further comprising testing functionality of the electronic circuitry prior to the attaching.

3. The method of claim 1, further comprising testing functionality of the analyte sensor prior to the attaching.

4. The method of claim 1, wherein the assembling is performed at a location remote from the attaching.

5. The method of claim 1, further comprising coupling an intermediary to the proximal end portion of the analyte sensor, and wherein the attaching comprises attaching the intermediary to the external electrical interface.

6. The method of claim 5, further comprising using the intermediary to perform at least one manufacturing or testing procedure on the working electrode prior to the attaching.

7. The method of claim 6, wherein the performing comprises coating the working electrode of the analyte sensor.

8. The method of claim 6, wherein the coupling is performed at a first location, the assembling is performed at a second location, and the performing is performed at a third location, and wherein the first location, the second location, and the third location are remote from one another.

9. The method of claim 5, wherein the coupling is performed using an anisotropic conductive film.

10. The method of claim 1, wherein the attaching is performed using an anisotropic conductive film.

11. The method of claim 1, further comprising attaching an inserter to the housing to implant the working electrode into a subject.

12. The method of claim 1, further comprising directly coupling the patch to an external bottom surface of the housing.

13. The method of claim 1, wherein the curable liquid physically couples the proximal end portion of the analyte sensor to the external electrical interface.

14. The method of claim 1, wherein the curable liquid is dispensed to seal attachment of the proximal end portion of the analyte sensor with the external electrical interface to prevent moisture ingress.

15. The method of claim 1, further comprising curing the curable liquid.

16. The method of claim 1, wherein the patch comprises an adhesive bonded to a carrier substrate, the carrier substrate comprising a top surface for direct coupling to an external bottom surface of the housing.

17. The method of claim 16, further comprising directly coupling the top surface of the carrier substrate to the external bottom surface of the housing.

18. The method of claim 17, further comprising covering the recess with the top surface of the carrier substrate.

19. The method of claim 1, wherein the proximal end portion of the analyte sensor is configured to extend parallel to a skin surface of the subject to which the patch is coupled.

20. The method of claim 19, wherein the analyte sensor comprises a bend that angles the proximal end portion of the analyte sensor from the distal end portion of the analyte sensor for insertion into a subject’s skin.

21. An apparatus comprising: an analyte sensor, the analyte sensor comprising: an elongate body; a first electrode in electrical communication with a first conductive contact; and a second electrode in electrical communication with a second conductive contact; and a sensor carrier attached to the analyte sensor, the sensor carrier including: an intermediate body; a first conductive portion disposed on the intermediate body, the first conductive portion in electrical communication with the first conductive contact; a second conductive portion disposed on the intermediate body, the second conductive portion in electrical communication with the second conductive contact, wherein the first conductive portion and the second conductive portion form a connection portion configured to establish electrical communication between the first and second conductive contacts and a separate device.

22. The apparatus of claim 21, further comprising: an identifier coupled to the intermediate body.

23. The apparatus of claim 22, wherein the identifier, the sensor, and the intermediate body form a laminate configuration.

24. The apparatus of claim 22 or 23, wherein the identifier is a QR code table.

25. The apparatus of claim 22 or 23, wherein the identifier is any of an optical identifier, a radio frequency identifier, or a memory encoded identifier.

26. The apparatus of claim 22 or 23, wherein the identifier is configured to identify any of the analyte sensor, calibration data for the analyte sensor, and history of the analyte sensor.

27. The apparatus of any of claims 21-26, wherein the first and second conductive portions are traces.

28. The apparatus of claim 27, wherein the trace forms an exposed contact surface in the connection portion.

29. The apparatus of any one of claims 21-28, wherein the first and second electrically conductive portions are at least partially embedded in the intermediate body.

30. The apparatus of any one of claims 21-29, wherein the first and second electrically conductive portions comprise at least one of a solder joint, an electrically conductive tape, a coil spring, a leaf spring, or an electrically conductive elastomer.

31. The apparatus of any one of claims 21-30, wherein the connection portion is configured to mechanically mate with the separate device.

32. The apparatus of any one of claims 21-31, wherein the separate device is an electronics unit configured to measure analyte data.

33. The apparatus of any one of claims 21-32, wherein the separate device is a component of a manufacturing station.

34. The apparatus of claim 33, wherein the manufacturing station is configured to perform at least one of a potentiostat measurement, an immersion process, a curing process, a calibration process, or a sensitivity measurement.

35. The apparatus of claim 33, wherein the manufacturing station comprises a calibration station configured to disengage an electrical connection between the sensor and the calibration station and establish an electrical connection between the sensor and at least one test station through the connection portion of the sensor carrier.

36. The apparatus of any one of claims 21-35, wherein the intermediate body further comprises a reference structure configured to control a position and spatial orientation of the analyte sensor relative to a substrate of the intermediate body.

37. The apparatus of any one of claims 21-36, wherein the first electrode is positioned coaxially within the second electrode.

38. The apparatus of claim 37, wherein the first and second electrical contacts are longitudinally aligned and spaced apart along a longitudinal axis of the sensor.

39. The apparatus of any one of claims 21-36, wherein the first and second electrodes are attached to a flexible planar substrate.

40. The apparatus of claim 39, wherein the first and second electrically conductive contacts are attached to the flexible planar substrate.

41. The apparatus of any one of claims 21-40, wherein the first and second electrically conductive contacts are attached to the intermediate body by an electrically conductive adhesive.

42. The apparatus of any one of claims 21-41, wherein the first and second electrically conductive contacts are attached to the intermediate body by an anisotropic conductive film.

43. A pre-connected analyte sensor array, the array comprising: a substrate; a first plurality of electrical contacts disposed on the substrate; a second plurality of electrical contacts disposed on the substrate; and a plurality of analyte sensors disposed on the substrate, each of the plurality of analyte sensors comprising: a working electrode; a counter electrode; and a reference electrode. a plurality of analyte sensors disposed on the substrate, each analyte sensor of the plurality of analyte sensors comprising: a first sensor electrical contact coupled to a corresponding one of the first plurality of electrical contacts on the substrate, and a second sensor electrical contact coupled to a corresponding one of the second plurality of electrical contacts on the substrate.

44. The array of claim 43, wherein the first plurality of electrical contacts are aligned along the substrate.

45. The array of any one of claims 43 or 44, wherein the first plurality of electrical contacts are formed by exposed contact surfaces.

46. The array of any one of claims 43, 44, or 45, wherein the second plurality of electrical contacts are aligned along the substrate.

47. The array of any one of claims 43-46, wherein the second plurality of electrical contacts are formed by exposed contact surfaces.

48. The array of any one of claims 43-47, wherein the first plurality of electrical contacts and the second plurality of electrical contacts are configured to connect with separate devices.

49. The array of claim 48, wherein the separate devices are components of a manufacturing station.

50. The array of any one of claims 43-49, wherein the substrate comprises at least one singulation feature configured to facilitate singulation of the substrate into a plurality of sensor carriers, wherein each sensor carrier of the plurality of sensor carriers is attached to a separate one of the analyte sensors.

51. The array of any one of claims 43-50, further comprising a plurality of identifiers disposed on the substrate.

52. The array of any one of claims 43-51, wherein the substrate comprises an elongate dimension, wherein the plurality of analyte sensors extend beyond edges of the substrate in a direction orthogonal to the elongate dimension.

53. The array of claim 52, further comprising a feed guide strip that travels along opposite edges of the substrate in the elongate dimension.

54. The array of any one of claims 43-53, wherein the substrate comprises a flexible substrate configured to be rolled onto a spool.

55. The array of claim 53, wherein the feed guide strip is removable from the substrate.

56. The array of any one of claims 43-55, wherein the substrate comprises a molded thermoplastic having a plurality of fiducial features that control a position and orientation of the plurality of analyte sensors, and wherein the first plurality of electrical contacts and the second plurality of electrical contacts each comprise embedded conductive traces in the molded thermoplastic.

57. The array of any one of claims 43-56, further comprising a first fiducial structure coupled to the array, the first fiducial structure configured to locate at least one analyte sensor.

58. The array of claim 57, wherein the first fiducial structure includes at least one singulation feature configured to facilitate singulation of the first fiducial structure into a plurality of second fiducial structures, wherein each of the plurality of second fiducial structures is coupled to a corresponding one of a plurality of sensor carriers formed through the substrate.

59. The array of any one of claims 43-58, wherein the substrate includes processing circuitry configured to perform at least potentiostat measurements on the plurality of analyte sensors.

60. The array of claim 59, further comprising communication circuitry operable by the processing circuitry to transmit and receive data associated with each of the analyte sensors and an identifier of the analyte sensor.

61. The array of claim 43, wherein the array comprises one or more strips.

62. A method comprising: providing a pre-connected analyte sensor comprising: an intermediary; an analyte sensor permanently attached to the intermediary; and an identifier coupled to the intermediary; and communicatively coupling the analyte sensor to processing circuitry of a manufacturing station by coupling the intermediary to a corresponding feature of the manufacturing station; and operating the processing circuitry of the manufacturing station to communicate with the pre-connected analyte sensor.

63. The method of claim 62, wherein operating the processing circuitry includes obtaining a signal from the analyte sensor.

64. The method of any one of claims 62 or 63, wherein operating the processing circuitry includes operating an optical, infrared, or radio frequency reader of the manufacturing station to obtain the identifier.

65. The method of claim 63, further comprising storing sensor data corresponding to the signal with the processing circuitry of the manufacturing station and in conjunction with the identifier.

66. The method of any one of claims 62-65, wherein the identifier identifies any one or more of the analyte sensor, calibration data for the analyte sensor, and history of the analyte sensor.

67. The method of any one of claims 63-66, wherein the signal includes a glucose sensitivity signal.

68. The method of any one of claims 62-67, further comprising removing the intermediary from the manufacturing station and communicatively coupling the analyte sensor to processing circuitry of a wearable device by coupling the intermediary to a corresponding feature of the wearable device.

69. The method of any one of claims 62-68, wherein the analyte sensor is permanently attached to the intermediary by a conductive adhesive.

70. The method of any one of claims 62-68, wherein the analyte sensor is permanently attached to the intermediary by an anisotropic conductive film.

71. The method of claim 68, further comprising obtaining in-vivo measurement data from the analyte sensor by the processing circuitry of the wearable device.

72. A method of manufacturing a pre-connected analyte sensor, the method comprising: mechanically and electrically connecting a proximal end portion of an elongate conductor to a conductive portion of an intermediary; after the connecting, coating a distal end portion of the elongate conductor with a polymeric film to form an analyte sensor having a working electrode region configured to support an electrochemical reaction for analyte detection in the distal end portion of the elongate conductor.

73. The method of claim 72, further comprising testing the analyte sensor, wherein the testing comprises electrically coupling the intermediary to a test station.

74. The method of claim 73, further comprising calibrating the analyte sensor, wherein the calibrating comprises electrically coupling the intermediary to a test station.

75. The method of any one of claims 72-74, wherein the coating comprises dip coating.

76. The method of any one of claims 72-75, wherein the intermediary is part of an array formed from a plurality of coupled intermediaries, wherein the method further comprises mechanically and electrically connecting a proximal end portion of each elongate electrode of a plurality of elongate electrodes to a conductive portion of each intermediary of the array.

77. The method of claim 76, comprising performing the coating on each distal end portion of each elongate electrode of the plurality of elongate electrodes connected to the intermediaries of the array in parallel.

78. The method of claim 77, comprising singulating one or more of the intermediaries of the array after the coating.

79. The method of any one of claims 72-78, wherein mechanically and electrically connecting comprises applying a conductive paste to the conductive portion of the intermediary and the elongate conductor.

80. The method of any one of claims 72-79, wherein mechanically and electrically connecting comprises compressing an anisotropic conductive film between the proximal end portion of the elongate conductor and the conductive portion of the intermediary.

81. The method of any one of claims 72-80, wherein the connecting is performed at a location remote from the coating.

82. The method of claim 81, wherein the coating, the testing, and the calibrating are all performed at locations remote from the connecting.

Images