Pre-connected analyte sensors

Abstract

A pre-connected analyte sensor is provided. A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured to mechanically couple the sensor to a test, calibration, or wearable device. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the test, calibration, or wearable device.

Description

[0001] Incorporation by Reference of Related Applications

[0002] Any and all claims identified in the Application Data Sheet, or any corrections thereto, are hereby incorporated by reference herein pursuant to 37 CFR 1.57. This application claims the benefit of U.S. Provisional Application No. 62 / 576,560, filed October 24, 2017. The foregoing application is incorporated herein by reference in its entirety and is hereby expressly made a part of this specification. Technical Field

[0003] The present disclosure relates generally to sensors and, more particularly, to analyte sensors such as continuous analyte sensors. Background Art

[0004] Diabetes is a condition in which the pancreas fails to produce enough insulin (Type 1 or insulin-dependent) and / or insulin is ineffective (Type 2 or non-insulin-dependent). In the diabetic state, patients suffer from high blood sugar levels, which can cause a series of physiological disturbances related to the deterioration of small blood vessels, such as kidney failure, skin ulcers, or hemorrhages in the vitreous humor of the eye. Hypoglycemic reactions (low blood sugar) can occur due to inadvertent overdose of insulin, or when taking normal doses of insulin or glucose-lowering agents accompanied by heavy exercise or insufficient food intake.

[0005] Conventionally, diabetics wear self-monitoring blood glucose (SMBG) monitors, which typically require an uncomfortable finger-pricking procedure. Due to the lack of comfort and convenience, diabetics typically measure their glucose levels only two to four times a day. Unfortunately, these intervals are so long that diabetics may not notice hyperglycemia or hypoglycemia until it is too late, sometimes leading to dangerous side effects. Alternatively, glucose levels can be continuously monitored by a sensor system comprising an on-skin sensor assembly. The sensor system can have a wireless transmitter that sends the measurement data to a receiver that can process and display information based on the measurements.

[0006] This background information is provided to provide a brief context for the following summary and detailed description. This background information is not intended to help determine the scope of the claimed subject matter, nor is it to be considered to limit the claimed subject matter to implementations that solve any or all of the above-mentioned disadvantages or problems. Summary of the Invention

[0007] The manufacturing process of an analyte sensor, such as a continuous analyte sensor, 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. Accurately placing and aligning 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," "intermediaries," or "sensor carriers" can be attached to the elongated body of the sensor to assist in handling and temporary and permanent electrical and mechanical connections. The sensor carrier (also referred to as a "sensor intermediary") 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 the embodiments of the present invention as expressed by the appended claims, its more significant features will now be briefly discussed. After considering this discussion, and specifically after reading the section entitled "Detailed Description of the Invention," it will be understood how the features of the embodiments of the present invention provide the advantages described herein.

[0008] According to a first aspect, a method of manufacturing a sensor is provided. The method comprises 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 a longitudinal axis of the sensor. The method comprises attaching a sensor carrier to the analyte sensor, the sensor carrier comprising a central body, a first conductive portion disposed on the central body, the first conductive portion being in electrical communication with the first electrode, and a second conductive portion disposed on the central body, the second conductive portion being in electrical communication with the second electrode. The first conductive portion and the second conductive portion form a connecting portion configured to establish an electrical connection between the sensor and a separate device.

[0009] In a generally applicable embodiment of the first aspect (i.e., independently combinable with any aspect or embodiment described herein), the method further comprises coupling an outer layer to the intermediate body. The outer layer comprises an identifier. The outer layer, the sensor, and the intermediate body may form a laminated configuration. The identifier may be a QR code. The identifier may comprise any one of an optical identifier, a radio frequency identifier, or a memory-encoded identifier. The identifier may identify the analyte sensor, calibration data for the analyte sensor, or a history of the analyte sensor.

[0010] In a generally applicable embodiment of the first aspect (ie, independently combinable with any aspect or embodiment described herein), the method further comprises coating the sensor with a film after attaching the sensor to the sensor carrier.

[0011] In a generally applicable embodiment of the first aspect (i.e., independently combinable 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.

[0012] In a generally applicable embodiment of the first aspect (ie independently combinable with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are welding points. The welding points can attach the sensor to the sensor carrier.

[0013] In a generally applicable embodiment of the first aspect (ie independently combinable with any aspect or embodiment described herein), the first conductive portion and the second conductive portion are conductive tapes that can attach the sensor to the sensor carrier.

[0014] In a generally applicable embodiment of the first aspect (ie independently combinable with any aspect or embodiment described herein), the connecting portion is configured to mechanically cooperate with the separate device.

[0015] In a generally applicable embodiment of the first aspect (ie independently combinable with any aspect or embodiment described herein), the separate device is an electronics unit configured to measure analyte data.

[0016] In a generally applicable embodiment of the first aspect (i.e., independently combinable with any aspect or embodiment described herein), the separate device is a component of a manufacturing station. The method may further comprise 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 comprise releasing the electrical connection between the sensor and the calibration station. The method may further comprise establishing an electrical connection between the sensor and at least one testing station via the connection portion of the sensor carrier.

[0017] In a generally applicable embodiment of the first aspect (i.e., independently combinable with any aspect or embodiment described herein), the intermediate body further comprises a reference structure that controls the position and spatial orientation of the analyte sensor relative to the substrate of the intermediate body. The reference structure may comprise a flexible portion of the substrate that is folded over at least a portion of the analyte sensor.

[0018] In generally applicable embodiments of the first aspect (ie, independently combinable with any aspect or embodiment described herein), the first conductive portion and / or the second conductive portion comprises at least one of a coil spring, a leaf spring, or a conductive elastomer.

[0019] According to a second aspect, a device is provided, comprising an analyte sensor having an elongated body, a first electrode in electrical communication with a first conductive contact, and a second electrode in electrical communication with a second conductive contact. The sensor carrier can be attached to the analyte sensor. The sensor carrier can comprise a central body, a first conductive portion disposed on the central body, the first conductive portion in electrical communication with the first conductive contact, and a second conductive portion disposed on the central body, the second conductive portion in electrical communication with the second conductive contact. The first conductive portion and the second conductive portion can form a connecting portion configured to establish electrical communication between the first conductive contact and the second conductive contact and a separate device.

[0020] In a generally applicable embodiment of the second aspect (i.e., independently combinable with any aspect or embodiment described herein), the device further comprises an identifier coupled to the intermediate body. The identifier, the sensor, and the intermediate body may form a laminated configuration. The identifier may be a QR code. The identifier may be any one of an optical identifier, a radio frequency identifier, or a memory-encoded identifier. The identifier may be configured to identify any one of the analyte sensor, the calibration data of the analyte sensor, and the history of the analyte sensor.

[0021] In a generally applicable embodiment of the second aspect (i.e., independently combinable 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 connecting portion. The first conductive portion and the second conductive portion may be at least partially embedded in the intermediate body.

[0022] In a generally applicable embodiment of the second aspect (i.e., independently combinable with any aspect or embodiment described herein), the first conductive portion and the second conductive portion comprise at least one of a solder joint, a conductive tape, a coil spring, a leaf spring, or a conductive elastomer.

[0023] In a generally applicable embodiment of the second aspect (ie independently combinable with any aspect or embodiment described herein), the connecting portion is configured to mechanically cooperate with the separate device.

[0024] In a generally applicable embodiment of the second aspect (ie independently combinable with any aspect or embodiment described herein), the separate device is an electronics unit configured to measure analyte data.

[0025] In a generally applicable embodiment of the second aspect (i.e., independently combinable with any aspect or embodiment described herein), the separate device is a component of a manufacturing station. At least one of a potentiostat measurement, an impregnation process, a curing process, a calibration process, or a sensitivity measurement can be configured to be performed while the electrical connection between the sensor and the manufacturing station is established. The manufacturing station can include a calibration station configured to release 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.

[0026] In a generally applicable embodiment of the second aspect (i.e., independently combinable with any aspect or embodiment described herein), the intermediate body further comprises a reference structure configured to control the position and spatial orientation of the analyte sensor relative to the substrate of the intermediate body.

[0027] In a generally applicable embodiment of the second aspect (i.e., independently combinable with any aspect or embodiment described herein), the first electrode can be coaxially positioned within the second electrode, and the first electrical contact and the second electrical contact can be longitudinally aligned and spaced apart along the longitudinal axis of the sensor.

[0028] In a generally applicable embodiment of the second aspect (i.e., independently combinable 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.

[0029] In a generally applicable embodiment of the second aspect (ie independently combinable with any aspect or embodiment described herein), the first and second electrically conductive contacts are attached to the intermediate body by an electrically conductive adhesive.

[0030] In a generally applicable embodiment of the second aspect (ie independently combinable with any aspect or embodiment described herein), the first and second electrically conductive contacts are attached to the intermediate body by an anisotropic conductive film.

[0031] According to a third aspect, a pre-connected analyte sensor array is provided. The array comprises: 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 analyte sensor in the plurality of analyte sensors comprises a first sensor electrical contact coupled to a corresponding first electrical contact of the first plurality of electrical contacts on the substrate and a second sensor electrical contact coupled to a corresponding second electrical contact of the second plurality of electrical contacts on the substrate. The array may comprise one or more strips.

[0032] In a generally applicable embodiment of the third aspect (ie independently combinable 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 by exposed contact surfaces.

[0033] In a generally applicable embodiment of the third aspect (ie independently combinable 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 by exposed contact surfaces.

[0034] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), the first and second plurality of electrical contacts are configured to connect to a separate device, which may be a component of a manufacturing station.

[0035] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), 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 corresponding one of the analyte sensors.

[0036] In a generally applicable embodiment of the third aspect (ie, independently combinable with any aspect or embodiment described herein), the strip further comprises a plurality of identifiers disposed on the substrate.

[0037] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), the substrate comprises an elongated dimension, wherein the plurality of analyte sensors extend beyond an edge of the substrate in a direction orthogonal to the elongated dimension. The strip may further comprise a feed guide strip that runs along opposite edges of the substrate in the elongated dimension. The substrate may further comprise a flexible substrate configured to be wound onto a reel. The feed guide strip is removable from the substrate.

[0038] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), the substrate comprises a molded thermoplastic having a plurality of fiducial 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.

[0039] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), the strip further comprises a first fiducial structure coupled to the strip, the first fiducial structure configured to position the plurality of analyte sensors, the first fiducial structure comprising 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 from the substrate.

[0040] In a generally applicable embodiment of the third aspect (i.e., independently combinable with any aspect or embodiment described herein), the strip further comprises a carrier having processing circuitry configured to perform at least potentiostat measurements on the plurality of analyte sensors. The strip may further comprise communication circuitry operable by the processing circuitry to send and receive data associated with each of the analyte sensors and an identifier of the analyte sensor.

[0041] 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 body; an analyte sensor permanently attached to the intermediate body; and an identifier coupled to the intermediate body. The method includes communicatively coupling the analyte sensor to processing circuitry at a manufacturing station by coupling the intermediate body to a corresponding feature of the manufacturing station. The method includes operating the processing circuitry at the manufacturing station to communicate with the pre-connected analyte sensor.

[0042] In a generally applicable embodiment of the fourth aspect (i.e., independently combinable with any aspect or embodiment described herein), operating the processing circuitry comprises obtaining a signal from the analyte sensor via a connection. Operating the processing circuitry may comprise operating an optical, infrared, or radio frequency reader of the manufacturing station to obtain the identifier.

[0043] In a generally applicable embodiment of the fourth aspect (i.e., independently combinable with any aspect or embodiment described herein), the method further comprises storing, with the processing circuitry of the manufacturing station, sensor data corresponding to the signal in conjunction with the identifier. The identifier may identify any of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor.

[0044] In a generally applicable embodiment of the fourth aspect (ie, independently combinable with any aspect or embodiment described herein), the signal comprises a glucose sensitivity signal.

[0045] In a generally applicable embodiment of the fourth aspect (i.e., independently combinable with any aspect or embodiment described herein), the method further comprises removing the pre-connected analyte sensor from the manufacturing station and communicatively coupling the analyte sensor to a processing circuit system of the wearable device by mechanically coupling an anchoring feature of the intermediate to a corresponding feature of the wearable device. The method may further comprise obtaining in vivo measurement data from the analyte sensor by the processing circuit system of the wearable device.

[0046] In a generally applicable embodiment of the fourth aspect (ie, independently combinable with any aspect or embodiment described herein), the analyte sensor is permanently attached to the intermediate body by a conductive adhesive.

[0047] In a generally applicable embodiment of the fourth aspect (ie, independently combinable with any aspect or embodiment described herein), the analyte sensor is permanently attached to the intermediate body via an anisotropic conductive film.

[0048] According to a fifth aspect, a wearable device is provided. The wearable device includes a housing and electronic circuitry configured to process an analyte sensor signal. The electronic circuitry is enclosed within the housing. The analyte sensor has a distal portion positioned outside the housing. An intermediate body has electrical connections to both a proximal portion of the analyte sensor and the electronics, wherein the electrical connection between the intermediate body and the proximal portion of the analyte sensor is located outside the housing.

[0049] In a generally applicable embodiment of the fifth aspect (i.e., independently combinable with any aspect or embodiment described herein), the intermediate body 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 body. The intermediate body may be electrically connected to the electrical contacts via a conductive epoxy. The intermediate body may be electrically connected to the electrical contacts via an anisotropic conductive film. The intermediate body may be sealed. The electrical contacts may extend through the housing. The intermediate body may be positioned in a recess on the outer surface of the housing. The electrical contacts may extend through the housing in the recess to electrically couple the intermediate body to the electronic circuit system enclosed within the housing. The intermediate body may be covered by a polymer in the recess.

[0050] In a generally applicable embodiment of the fifth aspect (i.e., independently combinable with any aspect or embodiment described herein), the analyte sensor is formed as an elongated body having a distal portion configured for percutaneous implantation in a subject and a proximal portion 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.

[0051] According to a sixth aspect, a method of manufacturing a pre-connected analyte sensor is provided. The method comprises mechanically and electrically connecting a proximal portion of an elongated conductor to a conductive portion of an intermediate body, 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 analyte detection in the distal portion of the elongated conductor.

[0052] In a generally applicable embodiment of the sixth aspect (i.e., independently combinable with any aspect or embodiment described herein), the method further comprises testing the analyte sensor, wherein the testing comprises electrically coupling the intermediate to a testing station. The method may further comprise calibrating the analyte sensor, wherein the calibrating comprises electrically coupling the intermediate to a testing station. The coating may comprise dip coating.

[0053] In a generally applicable embodiment of the sixth aspect (i.e., independently combinable with any aspect or embodiment described herein), the intermediate body can be part of an array formed of a plurality of coupled intermediate bodies, wherein the method further comprises mechanically and electrically connecting a proximal portion of each of a plurality of elongated electrodes to a conductive portion of each intermediate body of the array. The coating can be performed in parallel on each distal portion of each of the plurality of elongated electrodes connected to the intermediate body of the array. The method can comprise singulating one or more of the intermediate bodies of the array after the coating.

[0054] In a generally applicable embodiment of the sixth aspect (i.e., independently combinable with any aspect or embodiment described herein), mechanically and electrically connecting comprises applying a conductive paste to the elongated conductor and the conductive portion of the intermediate body. In some embodiments, mechanically and electrically connecting comprises compressing an anisotropic conductive film between the proximal portion of the elongated conductor and the conductive portion of the intermediate body. The connecting 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 connecting.

[0055] According to a seventh aspect, a method of manufacturing a wearable transcutaneous analyte sensor on the skin includes: assembling an electronic circuit system into an interior 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 a subject at a working electrode of an 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 interior volume of the housing, attaching a proximal portion of the analyte sensor 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 a signal from the analyte sensor without opening the housing.

[0056] In a generally applicable embodiment of the seventh aspect (i.e., independently combinable with any aspect or embodiment described herein), the method comprises sealing the interface after attaching the proximal portion of the analyte sensor. The method may comprise testing functionality of the electronic circuitry prior to the attachment. The method may comprise testing functionality of the analyte sensor prior to the attachment. The assembly may be performed at a location remote from the attachment.

[0057] In a generally applicable embodiment of the seventh aspect (i.e., independently combinable with any aspect or embodiment described herein), the method may include coupling an intermediate to the proximal portion of the analyte sensor, and the attaching 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 performing may include coating the working electrode of the analyte sensor. The coupling may be performed at a first position, the assembling may be performed at a second position, and the performing may be performed at a third position, wherein the first position, the second position, and the third position are remote from each other. The attachment and / or coupling may be performed by an anisotropic conductive film. The method may further include attaching an inserter to the housing to implant the working electrode into the object.

[0058] It should be understood that those skilled in the art will readily understand various configurations of the present invention technology based on this disclosure, wherein various configurations of the present invention technology are shown and described by way of illustration. As will be appreciated, the present invention technology can have other different configurations, and its several details can be modified in various other aspects, all of which do not depart from the scope of the present invention technology. Therefore, the present invention summary, drawings and detailed description should be considered to be illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Embodiments of the present invention will now be discussed in detail, with emphasis placed on advantageous features. These embodiments are for illustrative purposes only and are not drawn to scale, but rather to emphasize the principles of the present disclosure. The drawings include the following figures, in which like reference numerals represent like parts:

[0060] Figure 1 is a schematic diagram of an analyte sensor system attached to a host and in communication with a plurality of example devices, according to some embodiments.

[0061] Figure 2 is a diagram showing the Figure 1 Block diagram of the electronics associated with the sensor system.

[0062] Figures 3A-3C A wearable device with an analyte sensor is presented according to some embodiments.

[0063] Figure 3D An embodiment of an elongated sensor connected to a potentiostat is shown.

[0064] Figure 4A A schematic diagram of a pre-connected analyte sensor is shown, according to some embodiments.

[0065] Figure 4B Another schematic diagram of a pre-connected analyte sensor is shown, according to some embodiments.

[0066] Figure 4C Shown is a layered view of a pre-connected analyte sensor according to some embodiments.

[0067] Figure 4D A schematic diagram of a pre-connected analyte sensor array is shown, according to some embodiments.

[0068] Figures 5A-5E A block diagram of a system having a manufacturing system for an analyte sensor and a wearable device is shown, according to some embodiments.

[0069] Figure 6 A schematic cross-sectional view of a wearable device with a pre-connected analyte sensor is shown, according to some embodiments.

[0070] Figure 7 A schematic cross-sectional view of a wearable device with a pre-connected analyte sensor is shown, according to some embodiments.

[0071] Figure 8 A schematic cross-sectional view of a wearable device with a pre-connected analyte sensor is shown, according to some embodiments.

[0072] Figure 9 A perspective view of an on-skin sensor assembly is shown, according to some embodiments.

[0073] Figure 10 and 11 A perspective view of a sensor carrier with a spring is shown, according to some embodiments.

[0074] Figure 12 A cross-sectional perspective view of a portion of a sensor carrier is shown, according to some embodiments.

[0075] Figures 13A-13B A perspective view of a wearable sensor assembly is shown, according to some embodiments.

[0076] Figure 13C An exploded view of components of a wearable sensor assembly is shown, according to some embodiments.

[0077] Figures 14A-14B Shown is a perspective view of another wearable sensor assembly, according to some embodiments.

[0078] Figure 14C An exploded view of components of another wearable sensor assembly including external electrical interface embodiments is shown, according to some embodiments.

[0079] Figure 14DShown with pre-connected sensor assembly installed Figure 14C A top plan view of the external electrical interface.

[0080] Figure 14E It is along Figure 14D The cross section of line EE in .

[0081] Figure 15A Another embodiment of a printed circuit board substrate for a sensor carrier is presented.

[0082] Figure 15B and 15C Alternative embodiments of electrical interfaces for coupling sensors and sensor carriers to a wearable sensor assembly are presented.

[0083] Figure 16 Shown is a top view of a sensor carrier attached to an analyte sensor via a conductive adhesive, according to some embodiments.

[0084] Figure 17 An end view of a sensor carrier attached to an analyte sensor via a conductive adhesive is shown, according to some embodiments.

[0085] Figure 18 An end view of a sensor carrier attached to an analyte sensor via a conductive adhesive in a recess of a sensor carrier substrate is shown, according to some embodiments.

[0086] Figure 19 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 the corners of the sensor carrier substrate.

[0087] 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 of a sensor carrier substrate.

[0088] Figure 21A and 21B A perspective view and an end view, respectively, of an analyte sensor attached to a sensor carrier in a guiding configuration are shown.

[0089] Figure 22 A top view of a sensor carrier attached to an analyte sensor via conductive tape is shown, according to some embodiments.

[0090] Figure 23 A top view of a sensor carrier having a substrate attached to and wrapped around an analyte sensor is shown, according to some embodiments.

[0091] Figure 24 Shown is a top view of a sensor carrier attached to an analyte sensor via welded conductive plastic, according to some embodiments.

[0092] Figure 25 and 26 A manufacturing apparatus for attaching a sensor carrier to an analyte sensor via conductive plastic is presented in accordance with some embodiments.

[0093] Figure 27 is a perspective schematic diagram illustrating a proximal portion of an analyte sensor having a flat electrical connector portion according to some embodiments.

[0094] Figure 28 Attached to a sensor carrier according to some embodiments is shown Figure 24 Side view of the analyte sensor.

[0095] Figure 29 A top view of a sensor carrier having a flexible substrate configured to wrap around an analyte sensor is shown, according to some embodiments.

[0096] Figure 30 A perspective view of a sensor carrier having a substrate with a flexible portion configured to wrap around an analyte sensor is shown, according to some embodiments.

[0097] Figure 31A and 31B Another embodiment of a sensor carrier attached to an analyte sensor is shown.

[0098] Figure 32 A top view of a sensor carrier having a removable fastener for attaching an analyte sensor is shown according to some embodiments.

[0099] Figure 33 Demonstrates some embodiments of the Figure 29 A perspective view of a removable fastener.

[0100] Figure 34 A perspective view of a sensor carrier implemented as a barrel-shaped fastener is shown, according to some embodiments.

[0101] Figure 35A Shown is a front view of a sensor carrier having a flexible substrate wrapped around an analyte sensor, according to some embodiments.

[0102] Figure 35BA perspective view of a sensor carrier having a flexible substrate wrapped around a plurality of analyte sensors is shown, according to some embodiments.

[0103] Figure 36 An end view of a sensor carrier with a crimp connector is shown in accordance with some embodiments.

[0104] Figure 37 An end view of a sensor carrier attached to an analyte sensor via a crimp connector is shown, according to some embodiments.

[0105] Figure 38 A side view of a sensor carrier with several crimp connectors is shown, according to some embodiments.

[0106] Figure 39 A perspective view of a sensor carrier is shown according to some embodiments.

[0107] Figure 40 A perspective view of a sensor carrier formed from a molded interconnect device is shown according to some embodiments.

[0108] Figure 41 A top view of a sensor carrier formed from a molded interconnect arrangement is shown according to some embodiments.

[0109] Figure 42 A side view of a sensor carrier attached to an analyte sensor via a conductive coupling is shown, according to some embodiments.

[0110] Figure 43 A side view of a sensor carrier having an elongated dimension for attachment to a plurality of analyte sensors is shown according to some embodiments.

[0111] Figure 44 A top view of a sensor carrier having a flexible substrate for wrapping around an analyte sensor is shown, according to some embodiments.

[0112] Figure 45 A top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor is shown, according to some embodiments.

[0113] Figure 46 A top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor is shown, according to some embodiments.

[0114] Figure 47AShown is a side view of a sensor carrier having a feed guide strip in an elongated dimension for attachment to a plurality of analyte sensors, according to some embodiments.

[0115] Figure 47B Shown is a sheet wound on a reel according to some embodiments. Figure 47A A perspective view of a sensor carrier.

[0116] Figure 48 Demonstrates some embodiments of the Figure 47A A top view of a sensor carrier, wherein the sensor carrier is singulated from the sensor carrier.

[0117] Figure 49 A perspective view of a sensor carrier having spring-loaded receptacles for attaching a plurality of analyte sensors is shown, according to some embodiments.

[0118] Figure 50 A perspective view of a sensor carrier having magnetic reference features for positioning and orienting a plurality of analyte sensors is shown, according to some embodiments.

[0119] Figure 51A A top view of a sensor carrier having a rigid curved panel for attachment to a plurality of analyte sensors is shown, according to some embodiments.

[0120] Figure 51B Shown is a top view of a sensor carrier having a rigid-flex panel for attachment to a plurality of analyte sensors having edge card connector pads for electrical connection, according to some embodiments.

[0121] Figure 52A A top view of a sensor carrier according to some embodiments is shown. Figure 48 The sensor carrier is singulated and attached to the analyte sensor to form a pre-connected sensor.

[0122] Figure 52B A sensor carrier according to some embodiments is shown having a structure for attaching to a sensor carrier without requiring a V-shaped notched portion. Figure 48 B. Rigid-flexible panel of multiple analyte sensors.

[0123] Figure 53A A pre-connected sensor is shown according to some embodiments, which is to be installed in a wearable device.

[0124] Figure 53B A pre-connected sensor is shown in a folded position according to some embodiments, wherein the pre-connected sensor is installed in a wearable device.

[0125] Figure 54 A sensor carrier according to some embodiments is presented, implemented as a daughterboard for connection to an analyte sensor.

[0126] Figure 55 A sensor carrier implemented by a compression clip is shown according to some embodiments.

[0127] Figure 56 A sensor carrier is shown having a clip for connecting to an analyte sensor according to some embodiments.

[0128] Figure 57 is a flow diagram of illustrative operations that may be performed for manufacturing and using a pre-connected sensor, according to some embodiments.

[0129] Figure 58 A perspective view of a sensor holding device having a grooved flexible tube is shown, according to some embodiments.

[0130] Figure 59 Demonstrates some embodiments of the Figure 58 Exploded perspective view of the device.

[0131] Figure 60 Shown according to some embodiments includes an apparatus installed in Figure 55 The device of the sensor in the device.

[0132] Figure 61 A simplified diagram of a carrier for pre-connecting sensors is shown, according to some embodiments.

[0133] Like reference numerals refer to like elements throughout. Unless otherwise noted, elements are not drawn to scale. DETAILED DESCRIPTION

[0134] The following description and examples describe in detail some exemplary embodiments, embodiments and arrangements of the disclosed invention. Those skilled in the art will recognize that the scope of the present invention encompasses many variations and modifications of the present invention. Therefore, the description of some exemplary embodiments should not be considered as limiting the scope of the present invention.

[0135] definition

[0136] To facilitate understanding of the various embodiments described herein, a number of terms are defined below.

[0137] As used herein, the term "analyte" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and further refers to, but is not limited to, an analyte or chemical constituent in a biological fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymph, or urine). An analyte may comprise a naturally occurring substance, an artificial substance, a metabolite, and / or a reaction product. In some embodiments, the analyte measured by the sensor head, device, and method is an analyte. However, other analytes are also contemplated, including, but not limited to, uncarboxylated prothrombin; acylcarnitines; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (Krebs cycle ( cycle), histidine / uric acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; C-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-beta-hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; D-penicillamine; desethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylating gene polymorphisms, alcohol dehydrogenase, α1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy) dystrophy), analytes—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); debutylhalofantrine; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine acid (FT3); fumaryl acetoacetase; galactose / gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione peroxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoprotein ((a), B / A-1, beta); lysozyme; mefloquine; netilmicin; phenobarbital; phenytoin; phytanic acid / pristanic acid; progesterone; prolactin; proline dipeptidase; purine nucleoside phosphorylase; quinine; trans-triiodothyronine (rT3); selenium;Serum pancreatic lipase; cytomegalovirus; somatomedin C; specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, Oye-Yeke disease virus, dengue virus, Guinea worm, 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 volvulus, parainfluenza virus, Plasmodium falciparum, poliomyelitis toxins, Pseudomonas aeruginosa, respiratory syncytial virus, Rickettsia (tsutsugamushi disease), Schistosoma mansoni, Toxoplasma gondii, Treponema pallidum, Trypanosoma cruzi / Janzia, Varicella zoster virus, Wuchereria bancrofti, 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 synthase; vitamin A; white blood cells; and zinc protoporphyrin. In certain embodiments, blood Salts, sugars, proteins, fats, vitamins, and hormones naturally present in the body fluids or interstitial fluids may also constitute analytes. Analytes may be naturally present in biological fluids, for example, metabolites, hormones, antigens, antibodies, etc. Alternatively, analytes may be introduced into the body, for example, as contrast agents for imaging, radioisotopes, chemicals, synthetic blood based on fluorescent carbon, or drugs or pharmaceutical compositions including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chloroquine); Hydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Seroxat, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); sedatives (barbiturates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid); acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, pethidine, Percocet, Percodan, Tussionex, fentanyl, Darvon, Talwin, Lomotil);Man-made drugs (fentanyl, pethidine, amphetamine, methamphetamine, and phencyclidine analogs, such as ecstasy); anabolic steroids; and nicotine. Metabolites of drugs and pharmaceutical compositions are also expected analytes. Analytes such as 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), can also be analyzed.

[0138] As used herein, the terms "microprocessor" and "processor" are broad terms and have their ordinary and customary meaning to those skilled in the art (and are not limited to special or customized meanings), and further refer to, but are not limited to, computer systems, state machines, etc. that perform arithmetic and logical operations using logic circuits that respond to and process the basic instructions that drive the computer.

[0139] As used herein, the term "calibration" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and further refers to, but is not limited to, the process of determining a relationship between sensor data and corresponding reference data that can convert the sensor data into a meaningful value that is substantially equivalent to the reference data, with or without the use of the reference data in real time. In some embodiments, i.e., in analyte sensors, as the relationship between the sensor data and the reference data changes (e.g., due to changes in sensitivity, baseline, transport, metabolism, etc.), the calibration can be updated or recalibrated over time (at the factory, in real time, and / or retrospectively).

[0140] As used herein, the terms "calibrated data" and "calibrated data stream" are broad terms and have their ordinary and customary meaning to one of ordinary skill in the art (and are not limited to special or customized meanings), and further refer to, but are not limited to, data that is transformed from an original state to another state using a function, such as a transfer function (including through the use of sensitivities) to provide a meaningful value to a user.

[0141] As used herein, the term "algorithm" is a broad term and has its ordinary and customary meaning to those skilled in the art (and is not limited to a special or customized meaning), and further refers to, but is not limited to, the computational process (e.g., procedure) involved in transforming information from one state to another, such as by using computer processing.

[0142] As used herein, the term "sensor" is a broad term and has its ordinary and customary meaning to those of ordinary skill in the art (and is not limited to a special or customized meaning), 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 generally refers to a group of sensors manufactured on or around the same day and using the same process and tools / materials. In addition, sensors that measure temperature, pressure, etc. may be referred to as "sensors."

[0143] As used herein, the terms "glucose sensor" and "means for determining the amount of glucose in a biological sample" are broad terms and have their ordinary and customary meanings to those of ordinary skill in the art (and are not limited to special or customary meanings), and further refer to, but are not limited to, any mechanism (e.g., enzymatic or non-enzymatic) by which glucose can be quantified. For example, some embodiments utilize a membrane containing glucose oxidase, which catalyzes the conversion of oxygen and glucose into hydrogen peroxide and gluconate, as shown in the following chemical reaction:

[0144] Glucose + O2 → Gluconate + H2O2

[0145] Because the co-reactant O2 and the product H2O2 change proportionally for each glucose molecule metabolized, electrodes can be used to monitor the current change in the co-reactant or product to determine the glucose concentration.

[0146] As used herein, the terms "operably connected" and "operably linked" are broad terms and have their ordinary and customary meaning to one of ordinary skill in the art (and are not limited to a special or customized meaning), and further mean, but are not limited to, linking one or more components to another component or components in a manner that allows signals to be transmitted between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert this information into a signal, such as an electrical signal or an electromagnetic signal; the signal can 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.

[0147] The term "determine" encompasses a wide variety of actions. For example, "determine" may include calculating, computing, processing, deriving, investigating, searching (e.g., searching in a table, database, or another data structure), confirming, and the like. Furthermore, "determine" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Furthermore, "determine" may include resolving, selecting, choosing, calculating, deriving, establishing, and the like. Determining may also include confirming that a parameter matches a predetermined criterion, including being met, passing, exceeding a threshold, and the like.

[0148] As used herein, the term "substantially" is a broad term and has its ordinary and customary meaning to persons of ordinary skill in the art (and is not limited to a special or customary meaning), and further means, but is not limited to, to a large extent but not necessarily all that is specified.

[0149] As used herein, the term "host" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning), and further means, but is not limited to, mammals, particularly, humans.

[0150] As used herein, the term "continuous analyte (or glucose) sensor" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning), and further refers to, but is not limited to, a device that continuously or constantly measures analyte concentration, for example, at time intervals ranging from a fraction of a second to, for example, 1 minute, 2 minutes, or 5 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.

[0151] As used herein, the term "sensing membrane" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and further refers to, but is not limited to, a permeable or semi-permeable membrane that can be composed of two or more domains and is typically composed of a material having a thickness of several microns or more, the material being permeable to oxygen and permeable or impermeable to glucose. In one example, the sensing membrane includes immobilized glucose oxidase that is capable of undergoing an electrochemical reaction to measure glucose concentration.

[0152] As used herein, the term "sensor data" is a broad term and has its ordinary and customary meaning (and is not limited to a special or customized meaning) for those of ordinary skill in the art, and further represents but is not limited to any data associated with a sensor (such as a continuous analyte sensor). Sensor data includes a raw data stream (or simply referred to as a data stream) of an analog or digital signal (or other signal received from another sensor) directly related to the measured analyte from the analyte sensor, as well as calibrated and / or filtered raw data. In one example, the sensor data includes digital data in the form of "counts" converted from an analog signal (such as a voltage or current) by an A / D converter, and includes one or more data points representing glucose concentration. Therefore, the terms "sensor data point" and "data point" generally represent a digital representation of sensor data at a specific time. These terms broadly encompass data points at multiple time intervals from a sensor (such as a substantially continuous glucose sensor), the sensor including, for example, individual measurements taken at time intervals from a fraction of a second to, for example, 1 minute, 2 minutes, or 5 minutes or longer. In another example, the sensor data includes an integral digital value representing one or more data points averaged over a period of time. The sensor data may include calibrated data, smoothed data, filtered data, transformed data, and / or any other data associated with a sensor.

[0153] As used herein, the term "sensor electronics" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning) and refers to, but is not limited to, components (e.g., hardware and / or software) of a device configured to process data. As described in further detail below (see, e.g., Figure 2 ), “sensor electronics” may be arranged and configured to measure, convert, store, transmit, communicate and / or retrieve sensor data associated with an analyte sensor.

[0154] As used herein, the term "sensitivity" or "sensor sensitivity" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning) and refers to the amount of signal generated by a certain concentration of a measured analyte or a measured substance (e.g., H2O2) associated with a measured analyte (e.g., glucose). For example, in one embodiment, the sensor has a sensitivity of about 1 picoampere to about 300 picoamperes of current for every 1 mg / dL of glucose analyte.

[0155] As used herein, the term "sample" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, a sample of the host body, such as body fluids, including blood, serum, plasma, interstitial fluid, cerebrospinal fluid, lymph fluid, ocular fluid, saliva, oral fluid, urine, excretions or secretions, etc.

[0156] As used herein, the term "distal" is a broad term and has its ordinary and customary meaning to those of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements compared to a particular reference point. Generally, the term indicates that one element is located relatively far away from a reference point compared to another element.

[0157] As used herein, the term "proximal" is a broad term and has its ordinary and customary meaning to those of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. Generally, the term indicates that one element is located relatively close to a reference point compared to another element.

[0158] As used herein, the terms "electrically connected" and "electrically in contact" are broad terms and have their ordinary and customary meanings to those of ordinary skill in the art (and are not limited to special or customary 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 (e.g., electrically coupled to) the electronic circuitry of a device. In another embodiment, two materials (such as, but not limited to, two metals) can be in electrical contact with each other such that current can be transferred from one of the two materials to the other and / or an electrical potential can be applied.

[0159] As used herein, the term "elongated conductive body" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customary meaning), and refers to, but is not limited to, an elongated body formed at least in part of a conductive material, and includes any number of coatings that may be formed thereon. For example, an "elongated conductive body" may refer to a bare elongated conductive core (e.g., a metal wire); an elongated conductive core coated with one, two, three, four, five, or more layers of a material, each of which may be conductive or non-conductive; or an elongated non-conductive core with a conductive coating, trace, or electrode thereon and coated with one, two, three, four, five, or more layers of a material, each of which may be conductive or non-conductive.

[0160] As used herein, the term "extracorporeal portion" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted to remain and / or exist outside the living body of a host.

[0161] As used herein, the term "in vivo portion" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, a part of a device (e.g., a sensor) that is suitable for insertion into and / or presence within the living body of a host.

[0162] As used herein, the term "potentiostat" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, an electronic instrument that controls the potential between a working electrode and a reference electrode at one or more preset values.

[0163] As used herein, the term "processor module" is a broad term and has its ordinary and customary meaning to those skilled in the art (and is not limited to a special or customized meaning), and refers to, but is not limited to, a computer system, state machine, processor, and components thereof, etc. that is designed to perform arithmetic and logical operations using logic circuits that respond to and process basic instructions that drive the computer.

[0164] As used herein, the term "sensor session" is a broad term and has its ordinary and customary meaning to one of ordinary skill in the art (and is not limited to a special or customized meaning) and refers to, but is not limited to, a 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., the sensor is removed from the host's body and / or the system electronics are removed (e.g., disconnected)).

[0165] As used herein, the terms "substantially" and "substantially" are broad terms and have their ordinary and customary meaning to those of ordinary skill in the art (and are not limited to a special or custom meaning) and mean, but are not limited to, an amount sufficient to provide the desired function.

[0166] “Coaxial twin-wire based sensor”: A circular wire sensor consisting of a conductive central core, an insulating intermediate layer, and a conductive outer layer, with the conductive layer exposed at one end for electrical contact.

[0167] "Pre-connected sensor": A sensor with a sensor interconnect / intermediary / sensor carrier attached. Thus, this "pre-connected sensor" consists of two joined parts: the sensor itself and the interconnect / intermediary / sensor carrier. The term "pre-connected sensor" unit refers to the permanent union of these two distinct parts.

[0168] Additional definitions are provided in the description that follows and, in some cases, depending on where the term is used.

[0169] As used herein, the following abbreviations are used: Eq and Eqs (equivalent); mEq (milliequivalent); M (mole); mM (millimole); μM (micromole); N (normal); mol (mole); mmol (millimole); μmol (micromole); nmol (nanomole); g (gram); mg (milligram); μg (microgram); kg (kilogram); L (liter); mL (milliliter); dL (deciliter); μL (microliter); cm (centimeter); mm (millimeter); μm (micrometer); nm (nanometer); h and hr (hour); min. (minute); s and sec. (second); °C (degrees Celsius); °F (degrees Fahrenheit), Pa (Pascal), kPa (kilopascal), MPa (megaPascal), GPa (gigaPascal), Psi (pounds per square inch), kPsi (kilopounds per square inch).

[0170] Overview / general description of the system

[0171] In vivo analyte sensing techniques may rely on in vivo sensors.In vivo sensors may include an elongated conductive body having one or more electrodes, such as a working electrode and a reference electrode.

[0172] For example, platinum metal-clad tantalum wire is sometimes used as a core bare sensing element with one or more reference or counter electrodes for the analyte sensor.This sensing element is coated in the form of a film to produce the final sensor.

[0173] Described herein are pre-connected sensors comprising an analyte sensor attached to a sensor carrier (also referred to herein as a "sensor intermediary"). The analyte sensor may comprise a working electrode and a reference electrode at the distal end of an elongated conductive body. The sensor carrier may comprise: 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 dip 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 intermediary.

[0174] The following description and examples describe embodiments of the present invention with reference to the accompanying drawings. In the accompanying drawings, reference numerals are used to label the elements of the present embodiment of the present invention. In the following, these reference numerals are reproduced in conjunction with the discussion of the corresponding drawing features.

[0175] Sensor system

[0176] Figure 1 Described is an example system 100 according to some example embodiments. System 100 includes an analyte sensor system 101, which includes a sensor electronic device 112 and an analyte sensor 138. System 100 can include other devices and / or sensors, such as a drug delivery pump 102 and a blood glucose meter 104. The analyte sensor 138 can be physically connected to the sensor electronic device 112 and can be integrated with the sensor electronic device (e.g., non-releasably attached) or releasably attached to the sensor electronic device. For example, a continuous analyte sensor 138 can be attached to the sensor electronic device 112 by a sensor carrier, which mechanically and electrically interfaces the analyte sensor 138 with the sensor electronic device. The sensor electronic device 112, the drug delivery pump 102, and / or the blood glucose meter 104 can be coupled to one or more devices (e.g., display devices 114, 116, 118, and / or 120).

[0177] In some example embodiments, the system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and / or other patient-related data) provided from the sensor system 101 and other devices associated with the host (also referred to as the patient) (e.g., display devices 114, 116, 118, and / or 120, etc.) via a network 409 (e.g., via a wired network, a wireless network, or a combination thereof) and generate a report that provides high-level information (e.g., statistics) about the measured analytes over a certain timeframe. A full discussion of using a cloud-based analyte processing system can be found in U.S. Patent Application Publication No. 2013 / 0325352, entitled "Cloud-Based Processing of Analyte Data," filed on March 7, 2013, which is incorporated herein by reference in its entirety. In some embodiments, one or more steps of the factory calibration algorithm may be performed in the cloud.

[0178] In some example embodiments, the sensor electronics 112 may include electronic circuitry associated with measuring and processing data generated by the analyte sensor 138. This generated analyte sensor data may also include algorithms that can be used to process and calibrate the analyte sensor data, although these algorithms may also be provided in other ways. The sensor electronics 112 may include hardware, firmware, software, or a combination thereof to provide measurements of analyte levels via an analyte sensor (e.g., a glucose sensor). Figure 2 An example implementation of sensor electronics 112 will be further described.

[0179] In one embodiment, the factory calibration algorithm described herein may be executed by the sensor electronics.

[0180] As described above, sensor electronics 112 may 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 may be configured to present information (and / or alerts), such as sensor information transmitted by sensor electronics 112, for display at display devices 114, 116, 118, and / or 120.

[0181] In one embodiment, the factory calibration algorithm described herein may be performed at least in part by a display device.

[0182] In some example embodiments, the relatively small key fob-type display device 114 may include a wristwatch, a belt, a necklace, a pendant, jewelry, an adhesive patch, a pager, a key fob, a plastic card (e.g., a credit card), an identification (ID) card, 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.

[0183] In some example embodiments, the relatively large handheld display device 116 may include a handheld receiver device, a palmtop computer, etc. This large display device may include a relatively large display (e.g., larger than the small display device 114) and may be configured to display information, such as graphical representations of sensor data (including current and historical sensor data output by the sensor system 100).

[0184] 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 (e.g., enzymatic, chemical, physical, electrochemical, spectrophotometric, polarization, calorimetric, iontophoretic, radiometric, immunochemical, etc.). In embodiments where the analyte sensor 138 comprises a glucose sensor, the glucose sensor may include any device capable of measuring glucose concentration and may use a variety of glucose measurement techniques, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring), to provide data, e.g., a data stream, indicative of glucose concentration in the host. The data stream may be sensor data (raw and / or filtered data) that may be converted into a calibrated data stream for providing a glucose value to a host (e.g., a user, patient) or a caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual concerned with the host's health). Furthermore, the analyte sensor 138 may be implanted as at least one of the following types of analyte sensors: an implantable glucose sensor, a transcutaneous glucose sensor (implanted in a host vessel or externally), a subcutaneous sensor, a refillable subcutaneous sensor, an intravascular sensor.

[0185] Although the present disclosure herein represents some embodiments comprising an analyte sensor 138 comprising a glucose sensor, the analyte sensor 138 may also comprise other types of analyte sensors. In addition, although some embodiments refer to a glucose sensor as an implantable glucose sensor, other types of devices that can detect glucose concentration and provide an output signal representative of the glucose concentration may also be used. In addition, although this specification refers to glucose as the analyte being measured, processed, etc., other analytes may also be used, such as ketone bodies (e.g., acetone, acetoacetic acid and β-hydroxybutyric acid, lactic acid, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, intermediates in the citric acid cycle, choline, insulin, cortisol, testosterone, etc.

[0186] 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 interfacing with electrical measurement equipment for test and calibration operations. However, manual handling of sensors can be inefficient, can cause delays due to imperfect mechanical and electrical connections, can cause damage to the sensors and / or test and calibration equipment, and can result in sensor variability that leads to inaccurate verification data being collected during the manufacturing process. Furthermore, the process of packaging the sensors 138 along with the sensor electronics 112 into the wearable device involves further manual manipulation of the sensors, which can damage the sensors 138.

[0187] Various systems, devices, and methods described herein help reduce or eliminate manual interaction with sensors. For example, pre-connected sensors can be provided that include a sensor interconnect or sensor carrier electrically coupled to sensor electrodes and having mechanical and electrical features configured to precisely interface with wearable electronic devices, automated equipment, and / or robustly connect to measurement equipment.

[0188] Identification and other data associated with each sensor can be stored on the sensor carrier for recording and tracking each sensor during manufacturing, testing, calibration, and in vivo operation. After testing and calibration operations, the sensor carrier can be used to connect the sensors to the sensor electronics of a wearable device, such as an on-skin sensor assembly, in a sealed and electrically robust arrangement.

[0189] Figure 2 An example of an electronic device 112 according to some example embodiments is depicted, which can be used in a sensor electronics device 112 or can be implemented in a manufacturing station (such as a test station, calibration station, smart carrier, or other equipment used during the manufacture of the device 101). The sensor electronics device 112 can include electronic components that are configured to process sensor information (such as sensor data) and generate transformed sensor data and displayable sensor information, such as by a processor module. For example, the processor module can transform the sensor data into one or more of the following: filtered sensor data (e.g., one or more filtered analyte concentration values), raw sensor data, calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, acceleration / deceleration rate information, sensor diagnostic information, position information, alarm / warning information, calibration information such as can be determined by a factory calibration algorithm as disclosed herein, a smoothing and / or filtering algorithm for sensor data, and the like.

[0190] In some embodiments, the processor module 214 is configured to perform a substantial portion, if not all, of the data processing, including data processing associated with factory calibration. The processor module 214 can be integral to the sensor electronics 112 and / or can be remotely located, for example, within one or more of the devices 114, 116, 118, and / or 120 and / or the cloud 490. For example, in some embodiments, the processor module 214 can be located at least partially within the cloud-based analyte processor 490 or elsewhere in the network 409.

[0191] In some example embodiments, the processor module 214 can be configured to calibrate the sensor data, and the data storage memory 220 can store the calibrated sensor data points as transformed sensor data. In addition, in some example embodiments, the processor module 214 can be configured to wirelessly receive calibration information from a display device (such as device 114, 116, 118 and / or 120) to implement calibration of the sensor data from the sensor 138. In addition, the processor module 214 can be configured to perform additional algorithmic processing on the sensor data (e.g., calibrated and / or filtered data and / or other sensor information), and the data storage memory 220 can be configured to store the transformed sensor data and / or sensor diagnostic information associated with the algorithm. The processor module 214 can be further configured to store and use calibration information determined from factory calibration, as described below.

[0192] In some example embodiments, the sensor electronics 112 may include an application specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices (e.g., devices 114, 116, 118, and / or 120), and / or other components for signal processing and data storage (e.g., a processor module 214 and a data storage memory 220). Figure 2 An ASIC 205 is depicted, but other types of circuitry may be used, including a field programmable gate array (FPGA), one or more microprocessors configured to provide some, if not all, of the processing performed by the sensor electronics 12, analog circuitry, digital circuitry, or a combination thereof.

[0193] exist Figure 2 In the depicted example, the potentiostat 210 is coupled to an analyte sensor 138 (e.g., a glucose sensor) via a first input port 211 for sensor data to generate sensor data from the analyte. The potentiostat 210 can be coupled to a working electrode 211 and a reference electrode 212 that form part of the sensor 138. The potentiostat can provide a voltage to one of the electrodes 211, 212 of the analyte sensor 138 to bias the sensor (also referred to as the analog portion of the sensor) for measuring a value (e.g., current) indicative of the analyte concentration in the host. The potentiostat 210 can have one or more connections to the sensor 138 depending on the number of electrodes incorporated into the analyte sensor 138 (e.g., a counter electrode as a third electrode).

[0194] In some exemplary embodiments, the potentiostat 210 may include a resistor that converts the current value from the sensor 138 into a voltage value, and in some exemplary embodiments, a current / frequency converter (not shown) may also be configured to continuously integrate the measured current value from the sensor 138 using, for example, a charge counting device. In some exemplary embodiments, an analog-to-digital converter (not shown) may digitize the analog signal from the sensor 138 into so-called "counts" to allow processing by the processor module 214. The resulting counts can be directly correlated to the current measured by the potentiostat 210, which can be directly correlated to the analyte level (e.g., glucose level) in the host.

[0195] The telemetry module 232 can be operably connected to the processor module 214 and can provide the hardware, firmware, and / or software that enables wireless communication between the sensor electronics 112 and one or more other devices (e.g., a display device, a processor, a network access device, etc.). Various radio technologies that can be implemented in the telemetry module 232 include Bluetooth, Bluetooth Low Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access 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 embodiments, the telemetry module 232 includes a Bluetooth chip, but Bluetooth technology can also be implemented in a combination of the telemetry module 232 and the processor module 214.

[0196] The processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data from the sensor (eg, counts), filter the data, calibrate the data, perform fail-safe checks, and the like.

[0197] The potentiostat 210 can measure an analyte (eg, glucose, etc.) at discrete time intervals or continuously, for example, using a current / voltage or current / frequency converter.

[0198] The processor module 214 may further include a data generator (not shown) configured to generate data packets for transmission to devices such as the display devices 114, 116, 118, and / or 120. In addition, the processor module 214 may generate data packets for transmission to these external sources via the telemetry module 232. In some example embodiments, the data packets may include identification codes of the sensors and / or sensor electronics 112, raw data, filtered data, calibrated data, rate of change information, trend information, error detection or correction, etc.

[0199] The processor module 214 may also include a program memory 216 and other memory 218. The processor module 214 may be coupled to a communication interface (e.g., a communication port 238) and a power source (e.g., a battery 234). In addition, the battery 234 may be further coupled to a battery charger and / or regulator 236 to power the sensor electronics 112 and / or charge the battery 234.

[0200] The program memory 216 may be implemented as a semi-static memory for storing data such as an identifier of the coupled sensor 138 (e.g., a sensor identifier (ID)) and for storing code (also referred to as program code) that configures the ASIC 205 to perform one or more operations / functions described herein. For example, the program code may configure the processor module 214 to process data streams or counts, filter, perform calibration methods described below, perform fail-safe checks, and the like.

[0201] The memory 218 may also be used to store information. For example, the processor module 214 including the memory 218 may be used as a cache memory for the system, where temporary storage is provided for sensor data recently received from sensors. 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.

[0202] The data storage memory 220 can be coupled to the processor module 214 and can be configured to store various sensor information. In some example embodiments, the data storage memory 220 stores one or more days of analyte sensor data. The stored sensor information can include one or more of the following: timestamp, 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.

[0203] The 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. The components comprising the user interface 222 may provide controls for interacting with a user (e.g., a host).

[0204] The battery 234 may be operatively connected to the processor module 214 (and possibly other components of the sensor electronics 12) and provide the necessary power for the sensor electronics 112. In other embodiments, the receiver may be powered transcutaneously, such as by inductive coupling.

[0205] The battery charger and / or regulator 236 can be configured to receive energy from an internal and / or external charger. In some example embodiments, the battery 234 (or battery pack) is configured to be charged by an inductive and / or wireless charging pad, but any other charging and / or power mechanism can also be used.

[0206] One or more communication ports 238 (also referred to as one or more external connectors) may be provided to enable communication with other devices, for example, a PC communication (com) port may be provided to enable communication with a system separate from or integral to the sensor electronics 112. For example, 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 certain example embodiments, plant information may be sent to the algorithm from a sensor or cloud data source.

[0207] The one or more communication ports 238 may further include an input port 237 where calibration data may be received and an output port 239 that may be used to transmit calibrated data or calibration data to a receiver or mobile device. Figure 2 It will be appreciated 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.

[0208] In some analyte sensor systems, the on-skin portion of the sensor electronics can be simplified to minimize the complexity and / or size of the on-skin electronics, e.g., providing only raw, calibrated, and / or filtered data to a display device configured to run other algorithms required for calibration and display of sensor data. However, the sensor electronics 112 (e.g., via the processor module 214) can be implemented to execute desired algorithms for generating transformed sensor data and / or displayable sensor information, e.g., including algorithms for evaluating the clinical acceptability of reference and / or sensor data, evaluating calibration data for optimal calibration based on inclusion criteria, evaluating the quality of the calibration, comparing estimated analyte values ​​to measured analyte values ​​over time, analyzing changes in estimated analyte values, evaluating 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, evaluating data for anomalies, etc.

[0209] Figure 3A 、 3B3C show an exemplary embodiment of an analyte sensor system 101 implemented as a wearable device, such as a skin sensor assembly 600. As shown in FIG3 , the skin sensor assembly includes a housing 128. An adhesive sheet 126 can couple the housing 128 to the skin of the host. The adhesive 126 can be a pressure-sensitive adhesive (e.g., an acrylic type, a rubber-based type, or other suitable type) that is bonded to a carrier substrate (e.g., a spunlace polyester, a polyurethane film, or other suitable type) for skin attachment. The housing 128 can include a through-hole 180 that cooperates with a sensor insertion device (not shown) for implanting the sensor 138 under the skin of the subject.

[0210] The wearable sensor assembly 600 may include sensor electronics 112 operable to measure and / or analyze the glucose indicator sensed by the glucose sensor 138. The sensor electronics 112 within the sensor assembly 600 may transmit information (e.g., measurement data, analysis data, and glucose data) to a remote device (e.g., Figure 1 114, 116, 118, 120 as shown). Figure 3C As shown, in this embodiment, the sensor 138 extends from its distal end to the through-hole 180 and is directed to the electronics module 135 within the housing 128. The working electrode 211 and the reference electrode 212 are connected to circuitry in the electronics module 135 that includes a potentiostat.

[0211] Figure 3D An exemplary embodiment of an analyte sensor 138 is shown, comprising an elongated body portion. The elongated body portion can be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than approximately 0.1 inch, 0.075 inch, 0.05 inch, 0.025 inch, 0.01 inch, 0.004 inch, or 0.002 inch. Although 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, irregular, or the like.

[0212] exist Figure 3D In an embodiment, the analyte sensor 138 includes a wire core 139. At the distal intracorporeal portion of the sensor 138, the wire core 139 forms an electrode 211a. At the proximal extracorporeal portion of the sensor 138, the wire core 139 forms a contact 211b. As the wire core 139 extends along the elongated body portion of the sensor 138, the electrode 211a and the contact 211b are electrically connected over the length of the wire core. The wire core can be made of a single material (such as platinum or tantalum), or can be formed into multiple layers, such as a conductive material or a non-conductive material with an outer coating of a different conductive material.

[0213] Layer 104 surrounds at least a portion of conductive core 139. Layer 104 can 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 conductive core 139 and is configured such that electrode 211 a is exposed through window 106.

[0214] In some embodiments, sensor 138 further includes a layer 141, such as a sleeve comprising a conductive material, surrounding insulating layer 104. At the distal, internal portion of sensor 138, sleeve layer 141 forms electrode 212a. At the proximal, external portion of sensor 138, sleeve layer 141 forms contact 212b. As sleeve layer 141 extends along the elongated body portion of sensor 138, electrode 212a and contact 212b are electrically connected along the length of the sleeve layer. Sleeve layer 141 can be formed from a silver-containing material applied to insulating layer 104. The silver-containing material can comprise any of a variety of materials and take various forms, such as Ag / AgCl polymer pastes, paints, polymer-based conductive mixtures, and / or commercially available inks. Layer 141 can be processed using a pasting / dipping / coating process (e.g., a die-metered dip coating process). In one exemplary embodiment, an 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 die to meter the coating to a precise thickness. In some embodiments, multiple coating steps are used to build up the coating to a predetermined thickness.

[0215] Figure 3D The sensor 138 shown also includes a membrane 108 covering at least a portion of the distal intracorporeal portion of the sensor 138. This membrane is typically formed of multiple layers that may include one or more of an interference domain, an enzyme domain, a diffusion resistance domain, and a bioprotection domain. This membrane is important for supporting the electrochemical process that enables analyte detection and is typically carefully manufactured by dip coating, spray coating, or other manufacturing steps. Preferably, the distal intracorporeal portion of the sensor 138 is subjected to as little treatment as possible from the time the membrane 108 is formed to the time the distal intracorporeal 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 the system. In use, the two electrodes can be implanted into the host for analyte monitoring.

[0216] While the above description applies particularly to coaxial wire type structures, the embodiments herein are also applicable to other physical configurations of electrodes. For example, the two electrodes 211a and 212a can be attached to the distal intracorporeal portion of an elongated flexible strip of a planar substrate (such as a thin, flat polymer flex circuit). The two contacts 211b and 212b can be attached to the proximal extracorporeal portion of this flexible, planar substrate. The electrodes 211a, 212a can be electrically connected to their corresponding contacts 211b, 212b (circuit traces) on the planar substrate. In this case, the electrodes 211a, 212a and contacts 211b, 212b can be adjacent to each other on a planar surface, rather than being on a flat surface as in FIG. Figure 3D As shown they are coaxial.

[0217] Figure 3D Also shown are contacts 211b and 212b electrically coupled to a simple current / voltage converter-based potentiostat 210. The potentiostat comprises 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 contact 324, which is electrically coupled to the working electrode contact 211b through a resistor 328. The amplifier 322 biases the contact 324 to the battery voltage V b and will drive the current i required to maintain this bias m This current will flow 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 i m Equal to (V b -V m ) / R, where V m is the voltage measured at the output of amplifier 322. The magnitude of this current for a given bias voltage on working electrode 211a is a measure of the analyte concentration near window 106.

[0218] Contacts 324 and 334 are typically conductive pads / traces on a circuit board. During testing, there is always a certain level of parasitic leakage current i on the surface of this board. p. If possible, leakage current due to the analyte should not form part of the measurement of the current. In order to reduce the effect of this leakage current on the measured current, an optional additional pad / trace 336 can be provided between the bias contact 324 and the return contact 334 that is directly connected to the battery output. This optional additional conductive pad / trace can be referred to as a "guard trace". Because they are maintained at the same potential, the bias contact 324 and the guard trace 336 will have essentially no leakage current. In addition, the leakage current from the guard trace 336 to the return contact 334 will not pass through the amplifier output resistor 328 and is therefore not included in the measurement. Other aspects and embodiments of the guard trace can be found in paragraphs

[0128] and

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

[0219] During the manufacturing process, various coating, testing, calibration, and assembly operations are performed on the sensor 138. However, it can be difficult to transport individual sensors and electrically interface them with various testing and calibration equipment facilities. These processes can also subject the sensor to damage from handling. To help address these issues, the sensor 138 can be provided as part of a pre-connected sensor that includes a sensor carrier, which is described in more detail below.

[0220] Figure 4A Schematic diagram of pre-connected sensor 400 is shown. Figure 4A As shown, the pre-connected sensor 400 includes a sensor carrier 402 that is permanently attached to the sensor 138. Figure 4A In the example of , sensor carrier 402 includes an intermediate body, such as substrate 404, and further includes one or more contacts, such as first internal contact 406 and second internal contact 408. First internal contact 406 is electrically coupled to a first contact on the proximal end of sensor 138, and contact internal contact 408 is electrically coupled to a second contact on the proximal end of sensor 138. The distal end of 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.

[0221] like Figure 4AAs shown, first internal contact 406 can be electrically coupled to first external contact 410, and second internal contact 408 can be electrically coupled to 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 wearable device 600. Furthermore, external contacts 410 and 412 can be configured to electrically interface with processing circuitry of manufacturing equipment (e.g., one or more test stations and / or one or more calibration stations). While various examples are described herein in which two external contacts 410 and 412 on the sensor carrier are coupled to two corresponding contacts on sensor 138, this is merely illustrative. In other embodiments, sensor carrier 402 and sensor 138 can each have a single contact, or can each have more than two 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 sensor 138 (e.g., two or more contacts 406 and 408), which can be coupled. In some embodiments, the sensor carrier 402 and the sensor 138 can have the same number of contacts (i.e., N=M). In some embodiments, the sensor carrier 402 and the sensor 138 can have different numbers of contacts (i.e., N≠M). For example, in some embodiments, the sensor carrier 402 can have additional contacts for coupling to or between various components of the manufacturing station.

[0222] As described in further detail below, substrate 404 can be configured to couple with sensor electronics 112 in wearable device 600. In some embodiments, substrate 404 can be sized and shaped to mechanically interface with housing 128 and electrically interface with sensor electronics 112 within housing 128. Additionally, substrate 404 can be sized and shaped to mechanically interface with manufacturing equipment, assembly equipment, a testing station, and / or one or more calibration stations. As described in further detail below, sensor carrier 402 can be attached and / or electrically coupled to sensor 138. The sensor 138 can be permanently coupled to a component of the sensor carrier 402 (e.g., substrate 404) by, for example, using adhesives (e.g., UV-curable, moisture-curable, multi-part activated, heat-curable, hot melt adhesives, etc.), including conductive adhesives (e.g., carbon-filled, carbon nanotube-filled, silver-filled, conductive additives, etc.), conductive inks, spring contacts, clips, wrapped flex 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, wire wrapping, wire bonding, wire threading, spot welding, swaging, crimping, stapling, cutting, soldering or brazing, plastic welding, or overmolding. In some embodiments, the sensor 138 can be permanently coupled to the substrate 404 prior to or during assembly, manufacturing, testing, and / or calibration operations using rivets, magnets, anisotropic conductive films, metal foil, or other suitable structures or materials to mechanically and electrically attach the sensor carrier 402 to the sensor 138. In some embodiments, the sensor carrier 402 can be 3-D printed around the sensor 138 to form a pre-connected sensor 400. In addition, the sensor carrier 402 can include a reference feature 430 (sometimes referred to as a reference structure), such as a recess, opening, surface, or protrusion, for aligning, positioning, and orienting the sensor 138 relative to the sensor carrier 402. The sensor carrier 402 can also include or can itself form one or more anchoring features for fixing and aligning the analyte sensor during manufacturing (e.g., relative to a manufacturing station). In addition, the sensor carrier 402 can include an identifier 450 configured to identify the sensor. In some embodiments, the identifier 450 is formed on the substrate 404. The identifier 450 will be further explained below.

[0223] Figure 4B Another schematic diagram of a pre-connected analyte sensor 400 is shown. Figure 4B The pre-connected analyte sensor 400 shown may include Figure 4A Similar components of the pre-connected analyte sensor 400 are shown. For clarity, Figure 4B Shown without optional cover 460 . Figure 4C Shown Figure 4BAn exploded view of a pre-connected analyte sensor 400 is shown.

[0224] exist Figure 4B In an example embodiment, sensor carrier 402 includes an intermediate body, such as substrate 404, and further includes one or more traces, such as first trace 414 and second trace 416. First trace 414 can include first internal contact 406 and first external contact 410. Second trace 416 can include second internal contact 408 and second external contact 412. In some embodiments, first internal contact 406 is electrically coupled to a first contact on the proximal end of sensor 138, and second internal contact 408 is electrically coupled to a second contact on the proximal end of sensor 138. The distal end of sensor 138 is a free end configured for insertion into the skin of a host. Electrical couplings, such as clips, conductive adhesives, conductive polymers, conductive inks, metal foils, conductive foams, conductive fabrics, wire wrapping, wire threading, or any other suitable method, are described in conjunction with various embodiments herein. In some embodiments, a non-conductive adhesive 426 (e.g., epoxy, cyanoacrylate, acrylic, rubber, urethane, hot melt, 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 be bonded to the substrate 404 by other methods (e.g., as described above). Figure 4A to the substrate 404 by the method described above).

[0225] like Figure 4CAs shown, pressure sensitive adhesive 428 can be configured to isolate the exposed ends of traces 414 and 416. For example, pressure sensitive adhesive 428 can laminate sensor 138 between substrate 404 and cover 460. In such cases, sensor 138, substrate 404, pressure sensitive adhesive 428 and cover 460 can form a laminated configuration. In the laminated configuration, 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). In addition, the laminated configuration can produce a moisture-tight area around sensor 138. The moisture-tight area can be produced as embodied by the 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 adhesive, pressure sensitive adhesive tape, elastomer, thermal bonding, hot plate welding, laser welding, ultrasonic welding, RF welding or any appropriate type of lamination method. Cover 460 can be comprised of a polymer sheet, structure, or film that at least partially covers substrate 404. Cover 460 can optionally include an identifier 450 that can identify sensor 138. In some embodiments, identifier 450 can incorporate various identification protocols or technologies, such as, but not limited to, NFC, RFID, QR code, barcode, Wi-Fi, adjustable resistor, capacitance value, impedance value, ROM, memory, IC, flash memory, and the like.

[0226] The guide fixture 420, an optional component, is an exemplary embodiment of an interface with a workstation (e.g., a testing station, calibration station, assembly station, coating station, manufacturing station), or as part of a wearable assembly. The guide fixture 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 the manufacturing process and for assembly into a wearable electronic assembly. In some embodiments, the reference feature 430 is a raised protrusion configured to align with a corresponding reference feature 432 of the substrate 404. The corresponding reference feature 432 of the substrate 404 can be a cutout, slot, hole, or recess. The corresponding reference feature 432 in the sensor carrier can be a placement feature that interfaces with the reference feature 430 in a workstation (e.g., a testing station, calibration station, assembly station, coating station, or other manufacturing station). The guide fixture 420 can be configured to ensure proper placement of the sensor carrier 402 so that the exposed external contacts 410 and 412 are aligned for connection to a workstation (e.g., a testing station, calibration station, assembly station, coating station, or other manufacturing station). In other embodiments, the reference feature 430 can be composed of a female feature to engage with a corresponding male reference feature 432.

[0227] Figure 4DA schematic diagram of an array 480 of pre-connected analyte sensors 400 is shown, the array having a plurality of pre-connected sensors 400 with optional identifiers 450. Figure 4D , an array is shown as a one-dimensional strip of pre-connected analyte sensors 400, but a two-dimensional array may also be implemented. In some embodiments, the pre-connected analyte sensor array 480 may be housed in a cartridge. Each of the plurality of pre-connected sensors 400 may be singulated. In some embodiments, notches 4020 may be provided to facilitate singulation into individual pre-connected sensors 400. In some embodiments, the array 480 may be used to facilitate the individual manufacture, 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 manufacture, testing, and / or calibration of a plurality of sensors 138.

[0228] Figures 5A-5E A block diagram is shown of various machines and assemblies with which the pre-connected analyte sensor 400 may be associated 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, as well as the on-skin wearable assembly 600. At least some of these are configured to receive the sensor carrier 402 and communicatively couple the machines and assemblies to the sensor 138 via the sensor carrier 402.

[0229] One aspect of some embodiments is that the sensor 138 is coupled to the sensor carrier 402 prior to the membrane 108 shown in the figures. In the case where the sensor 138 is attached to the sensor carrier, there may be multiple carrier mounted sensors such as Figure 4D When attached together as shown, subsequent device production steps (such as membrane coating, testing, calibration, and assembly into a wearable unit) can be performed with easier installation and removal from manufacturing and testing equipment, less sensor handling, and lower chance of damaging the membrane, resulting in an overall significant improvement in production efficiency.

[0230] Another benefit of pre-connected sensor configurations is that it is easier to separate different types of manufacturing and testing equipment between different facilities that are better equipped to handle these devices. For example, manufacturing electrodes may require various types of metal forming / extrusion machines, while film coating, testing, and calibration require a wet chemical laboratory and sensitive electronic testing equipment. Therefore, sensor electrodes can be formed and mounted on a carrier in a facility in one location and then shipped to different remote facilities that are configured for film coating, testing, and calibration. In this context, remote does not mean located in the same production facility in the same building. It may even be advantageous for different business entities to perform different tasks that specialize in appropriate manufacturing and testing technologies.

[0231] The manufacturing station 5091 can include a testing station as described herein, a calibration station as described herein, or another manufacturing station. The manufacturing station 5091 can include processing circuitry 5092 and / or mechanical components 5094 that are operable to perform testing operations, calibration operations, and / or other manufacturing operations, such as, for example, sensor alignment operations, membrane coating operations, curing operations, calibration check operations, glucose sensitivity operations (e.g., sensitivity slope, baseline, and / or noise calibration operations), and / or visual inspection operations.

[0232] The pre-connected analyte sensor 400 can be connected to one or more test stations 5002 having a processing circuitry 5012 configured to perform test operations with the sensor 138 to verify the operational integrity of the sensor 138. The test operations can include verifying electrical performance of the sensor 138, verifying communication between the working electrode and the contact 408, verifying communication between the reference electrode or additional electrode and the contact 406, and / or other electronic verification operations of the sensor 138. The processing circuitry 5012 can perform the test operations by communicatively coupling with the sensor 138 by inserting the substrate 404 into the receptacle 5006 (e.g., a recess in the housing of the test station 5002) until the contacts 410 couple to the contacts 5010 of the test station 5002 and the contacts 412 couple to the contacts 5008 of the test station 5002.

[0233] The system 5000 may include one or more calibration stations 5004 having processing circuitry 5020 configured to perform calibration operations with the sensor 138 to obtain calibration data for in vivo operation of the sensor 138. The calibration data obtained by the calibration station 5004 may be provided to the on-skin sensor assembly 600 for use during in vivo operation of the sensor 138. The processing circuitry 5020 may be communicatively coupled to the sensor 138 to perform the calibration operation by inserting the substrate 404 into the receptacle 5014 (e.g., a recess in the housing of the calibration station 5004) until the contacts 410 couple to the contacts 5018 of the test station 5002 and the contacts 412 couple to the contacts 5016 of the test station 5002.

[0234] exist Figures 5A-5E In the example shown, the test station 5002 and the calibration station 5004 include receptacles 5006 and 5014. However, this is merely illustrative, and the sensor carrier 402 can be mounted to the test station 5002, the calibration station 5004, and / or the manufacturing station 5091 using other mounting features, such as gripping, clipping, or clamping features. For example, the manufacturing station 5091 includes gripping structures 5093 and 5095, at least one of which is movable to grip the 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 the sensor carrier 402 in an electrically coupled position at the manufacturing station 5091. In other embodiments, both features 5093 and 5095 are movable.

[0235] The sensor carrier 402 may also include an identifier 450 (see, e.g. Figures 4A-4D). The identifier 450 can be formed on or embedded in the substrate 404. The identifier 450 can be implemented as a visual or optical identifier (e.g., a barcode or QR code pre-printed on the substrate 404 or printed in real time or etched into the substrate 404), a radio frequency (RF) identifier, or an electrical identifier (e.g., a laser-adjustable resistor, a capacitance identifier, an inductance identifier, or a microstorage circuit (e.g., an integrated circuit or other circuit in which the identifier is encoded in the memory of the identifier) ​​that can be programmed with the identifier and / or other data before, during, or after testing and calibration). The identifier 450 can be used to track each sensor throughout its manufacturing process (e.g., by storing a history of test and / or calibration data for each sensor). In other words, the identifier 450 identifies any one of the analyte sensor, the calibration data for the analyte sensor, and the history of the analyte sensor. For example, the identifier 450 can be used for binning of test and calibration performance data. The identifier 450 can be a discrete raw value, or information can be encoded in addition to an identification number. Identifier 450 may be used to digitally store data in a non-volatile memory on substrate 404 or as a reference number for storing data externally to sensor carrier 402 .

[0236] Test station 5002 may include a reader 5011 (e.g., an optical sensor, an RF sensor, or an 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 for sensor 138.

[0237] The calibration station 5004 can include a reader 5011 (e.g., an optical sensor, an RF sensor, or an electrical interface) that reads the identifier 450 to obtain a unique identifier for the sensor 138. Calibration data obtained by the calibration station 5004 can be stored and / or transmitted along with the identifier of the sensor 138. In some embodiments, the calibration data obtained by the calibration station 5004 can be added to the identifier 450 by the calibration station 5004 (e.g., by programming the calibration data into the identifier). In some embodiments, the calibration data obtained by the calibration station 5004 can be transmitted by the calibration station along with the identifier 450 to a remote system or device.

[0238] like Figures 5A-5EAs shown and described in further detail below, the on-skin sensor assembly 600 can include one or more contacts, such as contacts 5022, configured to couple the internal electronic circuitry to the contacts 410 and 412 of the sensor carrier 402 and, therefore, to the sensor 138. The sensor carrier 402 can be sized and shaped to be secured within a cavity 5024 in or on the housing 128 such that the sensor 138 is coupled to the electronics in the housing 128 via the sensor carrier 402, and the sensor 138 can be secured in position to extend from the housing 128 for insertion for in vivo operation.

[0239] Although Figures 5A-5E One calibration station and one test station are shown, but it should be understood that more than one test station and / or more than one calibration station can be used in the manufacturing and testing stages of production. Figures 5A-5E 5006). Although shown as distinct stations, it should be understood that in some embodiments, the calibration station and the test station can be combined into one or more calibration / test stations (e.g., a station in which the processing circuitry for performing testing and calibration operations is disposed within a common housing and coupled to a single interface 5006).

[0240] The wearable assembly 600 may also include a reader (e.g., an optical sensor, an RF sensor, or an electrical interface) that reads the identifier 450 to obtain a unique identifier for the sensor 138, the reader being positioned proximate to the contacts 5022. The sensor electronics may 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.

[0241] Figure 6-8 is a schematic diagram of various embodiments of securing the pre-connected sensor 400 within the wearable assembly 600. Figure 6 In the example of , the sensor carrier 402 is in direct contact with the base wall 605 and the housing 128, and the contacts 5022 include 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). Figure 7 In the example of FIG, a mechanical receiver 700 is provided on the base wall 605 for mechanically fixing the sensor carrier 402. Figure 8 In the example of FIG, a mechanical receiver 800 is provided on the base wall 605 for cooperating with the receiver 702 to mechanically secure the sensor carrier 402. Figure 8In the example of FIG. 4 , the receiver 702 includes additional contacts 704 for contacting the contacts 410 of the sensor carrier located on the rear surface of the sensor carrier 402 .

[0242] Figure 9 A detailed example of a sensor module 300 is shown, which includes a pre-connected sensor 400 and a sealing structure 192. As shown, the sealing structure 192 can be disposed on a substrate 404, wherein the sealing structure 192 can be configured to prevent moisture from intruding toward the contacts 410 and 412. In addition, the contacts 410 and 412 can 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. The adhesive 126 can couple the housing 128 to the host's skin 130. The adhesive 126 can be a pressure-sensitive adhesive (e.g., an acrylic type, a rubber-based type, or other suitable type) bonded to a carrier substrate (e.g., a spunlace polyester, a polyurethane film, or other suitable type) for skin attachment. As shown Figure 9 As shown, the substrate 404 can include at least one arm 202 or other mechanical feature for interfacing with a corresponding mating feature (e.g., a mechanical interlock, such as a snap fit, clip, and / or interference feature) on the base 128 to mechanically secure the substrate 404 to the housing 128. The coupling features (e.g., arms 902 and / or other features of the substrate 404) can be sized and shaped for releasably mechanically attaching the substrate 404 to a connector associated with the manufacturing equipment (e.g., a connector assembly). Figures 5A-5E 5093 / 5095) for testing and / or calibration operations during manufacturing and prior to attachment to feature 900 of housing 128.

[0243] Figure 10 A perspective view of sensor module 400 is shown in which contacts 406 and 408 are implemented using coil spring 306. Figure 10 In the example of FIG, the protrusion 308 on the substrate 404 can align the sensor 138 and fix the spring 306 to the substrate 404. (To improve Figure 10 For clarity, not all protrusions 308 are labeled.) The protrusions 308 can protrude distally.

[0244] At least three, at least four, and / or fewer than ten protrusions 308 can be configured to contact the perimeter of spring 306. Protrusions 308 can be separated by gaps. The gaps enable protrusions 308 to flex outward as spring 306 is inserted between protrusions 308. A downward force used to couple electronics unit 500 to base 128 can push spring 306 against sensor 138, electrically coupling spring 306 to sensor 138. Sensor 138 can travel between at least two of protrusions 308. Test station 5002 and / or calibration station 5004 can also have a mating connector structure that, when substrate 404 is inserted into recess 5006 or 5014, compresses spring 306 to electrically couple spring 306 between sensor 138 and processing circuitry 5012 or 5020.

[0245] Sensor 138 can include a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to sensor carrier 402, with an electrical interconnect (e.g., spring 306) mechanically coupled to substrate 404 and electrically coupled to proximal portion 138b. Spring 306 can be a conical spring, a coil spring, or any other type of spring described herein or suitable for electrical connection.

[0246] The substrate 404 can have a base portion 312 containing at least two proximal projections 308 positioned around the spring 306. The proximal projections 308 are configured to help orient the spring 306. A section of the glucose sensor 138 is positioned between the proximal projections 308 (distal to the spring 306).

[0247] The base portion 312 can be configured to mechanically couple to the housing 128, the manufacturing equipment 5091, the test equipment 5002, and / or the calibration equipment 5004. For example, the base portion 312 includes an anchoring feature, such as the arm 202. The anchoring feature can include the arm 202 and / or can include features such as one or more notches, recesses, protrusions, or other features in the base 312, the arm 202, and / or the substrate 404 that mate with, for example, a socket (e.g., Figures 5A-5E 5014 of the receptacle 5006) or by a clamping connector feature (such as Figures 5A-5E The corresponding features of the clamping connector formed by features 5093 and 5095 of the embodiment of the present invention mechanically interface to secure and align the sensor 138. In one suitable embodiment, the slidable (or otherwise operable or rotatable) features (such as Figures 5A-5EThe features 5095 of the embodiment of the present invention can be arranged to slide together over, around, or otherwise engage one or more of the arm 202, the base 312, and / or the sensor carrier 402 to secure the sensor carrier 402 to the manufacturing equipment. For example, in other embodiments of the sensor carrier 402 where the arm 202 is not provided, a socket connector (such as Figures 5A-5E 5014 of the receptacle 5006) or by a clamping connector feature (such as Figures 5A-5E The clamping connector formed by features 5093 and 5095) can include a flip-up assembly, a sliding assembly, or other movable assemblies that are supported on or cover the sensor carrier 402 to latch the sensor carrier 402 to manufacturing, testing and / or calibration equipment.

[0248] Now refer to Figure 11 and 12 , shows another embodiment of a sensor module 400, 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 the substrate 404 and electrically coupled to the proximal portion 138b. The leaf spring 306d can be configured to bend in response to pressure from the test station contacts, the calibration station contacts, and / or the electronics unit 500 coupled to the base 128 when the pre-connected sensor 400 is positioned between the electronics unit 500 coupled to the base 128.

[0249] As used herein, a cantilever spring is a type of leaf spring. As used herein, a leaf spring can be made from a number of bent metal strips that are held together on top of each other. 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, Figure 11 The leaf spring 306d in can be made of one deck metal or multiple layers of metal.In certain embodiments, the leaf spring includes one deck of flat metal (making the leaf spring be a cantilever spring) fixed at one end.

[0250] like Figure 11 and 12 As shown, the base portion 312d includes a proximal projection 320d having a channel 322d in which at least a portion of the proximal portion 138b is located. The channel 322d positions a first region of the proximal portion 138b so that the region is electrically coupled to the leaf spring 306d.

[0251] like Figure 12As shown in the cross-sectional perspective view of FIG, the leaf spring 306d is bent away from the first region and protrudes proximally to electrically couple with the test station 5002, the calibration station 5004, and / or the 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 is bent around the proximal protrusion 320d. The leaf spring 306d protrudes proximally to electrically couple with the test station 5002, the calibration station 5004, and / or the electronics unit 500. The seal 192 is configured to prevent fluid from intruding into the leaf spring 306d.

[0252] The leaf spring 306 d is oriented such that coupling the sensor carrier 402 to the test station 5002, the calibration station 5004, and / or the electronics unit 500 presses the leaf spring 306 d against the first electrical contact of the test station 5002, the calibration station 5004, and / or the electronics unit 500 and the second electrical contact of the glucose sensor 138 to electrically couple the glucose sensor 138 to the test station 5002, the calibration station 5004, and / or the electronics unit 500. The proximal height of the seal 192 can be greater than the proximal height of the leaf spring 306 d such that the test station 5002, the calibration station 5004, and / or the electronics unit 500 contacts the seal 192 before contacting the leaf spring 306 d. As shown, spring 306 and / or leaf spring 306d can cooperate with a base feature (e.g., feature 308) and / or channel 322d on substrate 404 to form a reference feature that secures and aligns sensor 138 relative to sensor carrier 402 (e.g., for manufacturing, calibration, testing, and / or in vivo operation).

[0253] Figure 13A and 13B A perspective view of an embodiment of a wearable assembly 600 including a pre-connected sensor 400 is shown. The wearable assembly 600 may include sensor electronics and an adhesive sheet (not shown). The pre-connected sensor 400 may include a sensor carrier, such as, Figures 4A-4D The sensor carrier 402 is shown. The sensor carrier 402 can be placed in or on the housing 128. The housing 128 can be composed of two housing components, namely, a top housing 520 and a bottom housing 522. The top housing 520 and the bottom housing 522 can be assembled together to form the housing 128. The top housing 520 and the bottom housing 522 can be sealed to prevent moisture from intruding into the interior cavity of the housing 128. The sealed housing can include a sealing material (e.g., epoxy, silicone, urethane, or other suitable material). In other embodiments, the housing 128 is formed as a single component encapsulant (e.g., epoxy) that is configured to house the sensor carrier 402 and the sensor electronics. Figure 13AAn aperture 524 is shown within the top shell 520 that is configured to allow an insertion component (e.g., a hypodermic needle, a C-shaped needle, a V-shaped needle, a side-opening needle, etc.) to pass through the wearable assembly 600 for insertion and / or retraction. The aperture 524 can be aligned with a corresponding aperture in the bottom shell 522. In other embodiments, the aperture 524 can extend through an off-center location of the shell 128. In other embodiments, the aperture 524 can extend through the edge of the shell 128, thereby forming a C-shaped channel. In some embodiments, the aperture 524 contains a sealing material, such as a gel, adhesive, elastomer, or other suitable material located within the aperture 524.

[0254] Figure 13B A perspective view of the bottom of the wearable assembly 600 is shown. As shown, the pre-connected sensor 400 can be disposed within the housing 128. The pre-connected sensor 400 can be mounted within the aperture 526 of the bottom housing 522. As shown, the sensor 138 can extend from the aperture 526. The aperture 526 can be sized and shaped to hold the pre-connected sensor 400. In addition, 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 elbow for insertion into the skin. It should be understood that the bottom surface of the bottom housing 522 can contain an attachment member (e.g., an adhesive patch) for adhering the wearable assembly to the skin surface of the user.

[0255] Figure 13C An exploded view of the wearable assembly 600 is shown. Various electronic components (such as Figure 2The potentiostat 210 and other components shown can be mounted on or to an electronic assembly substrate 530 (typically some form of printed circuit board). It is contemplated that the sensor carrier 402 has an electrical coupling to the electronic 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 electronic assembly substrate 530 (e.g., pins, solder, conductive elastomer, conductive adhesive, etc.). The sensor carrier 402 can be configured to interface with the electronic assembly substrate 530 through the bottom housing 522. In other embodiments, the sensor carrier 402 can be configured to interface with the electronic assembly substrate 530 through the top housing 520. In some other embodiments, the sensor carrier 402 is configured to interface with the electronic assembly substrate 530 through the side of the wearable assembly 600. As shown, an optional sealing member 528 can be configured to insulate at least a portion of the sensor carrier 402 from potential moisture intrusion. In some cases, the sealing member 528 can be a dispensed liquid (e.g., adhesive, gel) or solid material (e.g., elastomer, polymer). The sealing member 528 can 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, or other suitable adhesive) to create a sealed area. The sealing member 528 can 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.

[0256] Figures 14A-14E Another embodiment of a wearable assembly 600 is shown. Figures 14A-14E The implementation is similar to Figures 13A-13C The embodiment shown. Figure 14A As shown, the wearable assembly 600 includes housings formed as a top housing 520 and a bottom housing 522. The wearable assembly also includes a through hole 524 for use during interstitial insertion of the sensor 138 into the subject. Figure 14B , C and D, the bottom housing 522 includes a recess 726 with the bottom plate 704. The bottom plate 704 can include locating pins 784 and 786 extending upward from the bottom plate 704 and two apertures 722 and 724. The locating pins can be formed as an integral part of the bottom plate 704, for example, during molding of the housing, or they can be separate parts coupled to the bottom plate using a friction fit, adhesive, or any other means. In some embodiments, there is at least one locating pin. In some embodiments, there are at least two locating pins. In some embodiments, there are at least three locating pins. On the opposite side of the bottom plate 704 is the printed circuit board 530 (on the Figure 14E726 ), on which some or all of the sensor electronic circuitry (e.g., the potentiostat 210 or at least the traces connected to the potentiostat) is mounted. Also mounted on the printed circuit board 530 are conductive pins 712 and 714 that extend through apertures 722 and 724 in the base plate 704, thereby forming an external electrical interface that can be accessed without opening the housing. The pre-connected sensor 400 falls into this recess 726. Holes 794 and 796 fall over locating pins 784 and 786, and the conductive pins 712 and 714 extend through holes 706 and 708 in the sensor carrier substrate 404. Similar to Figures 4A to 4C As shown in different embodiments in , these holes 706 and 708 extend through electroplated metal (e.g., copper) contacts 406 and contacts 408 on the substrate 404. Generally speaking, the number of holes 706, 708 in the substrate 404 corresponds to the number of electrodes present in the sensor 138, which 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. The pins 712 and 714 can be electrically connected to the contacts 408 and 406 in various ways, such as solder, swaging, or a conductive gel, paste, adhesive, or film. After this connection is made, the electronic circuit system for detecting and / or processing the analyte sensor signal disposed within the housing becomes connected to the analyte sensor to receive the signal therefrom. Figure 14D and 14E , the connecting materials that join the sensor 138 to the sensor carrier 402 are shown as 762 and 764. These connections can be made by referring to Figure 4A Any of the methods described can be used to establish

[0257] 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 the pressure sensitive adhesive 772 to retain the proximal portion of the sensor on or near the housing before extending downwardly at the inserter opening 524. This allows for accurate sensor insertion position and controls the biasing force into the insertion needle. Various methods and / or structural features can be used to perform this retention function, such as a protrusion or shelf in the base plate 704, an overmolded portion, a snap-fit ​​additional plastic piece mounted over the sensor, or any type of gel or adhesive placed before or after the pre-connected sensor is placed in the recess 726. Figure 13CAs shown, 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, the sealing member 528 can be a dispensed liquid (e.g., adhesive, gel) or solid material (e.g., elastomer, polymer). The 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. The sealing member 528 can 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. The two sealing members 528a and 528b are partially separated by walls 766 and 768. These walls allow two different sealing methods to be used in two different parts of the recess 726 separated by the walls. For example, 528b can be a solid polymer that is press-fitted into the recess portion through the opening 524 on one side of the wall. The remainder of the recess 726 may then be filled with liquid UV curing epoxy which hardens to form the sealing member 528a.The depth of the two recessed portions on each side of the wall may be the same or different.

[0258] Figure 15A Another alternative embodiment of the sensor carrier 402 is shown, which may also take the form of a printed circuit board. In this embodiment, as shown in FIG. Figure 3D The guard trace 407 described in item 336 of FIG. 4 is provided on the substrate 404 of the sensor carrier 402. As explained above, this guard trace 407 is positioned between contacts 406 and 408 and is connected to a bias voltage by the sensor electronics. The guard trace 407 may be extended through the substrate 704 by one or more conductive pins 713 (e.g., pins 712 and 714) similar to pins 712 and 714. Figures 14A to 14E (not shown) and coupled to the sensor electronics. Figure 15A , the pins are shown connected to tower contacts on the side of substrate 404. An insulating layer 780, such as a solder mask, may be positioned over guard trace 407 to eliminate the risk of shorting the analyte sensor electrodes to the guard trace.

[0259] Figure 15B and 15C Other embodiments of connecting the sensor carrier 402 with the analyte sensor 138 mounted thereon to the electronic circuitry within the wearable sensor are shown. Figure 15B In the embodiment, the sensor 138 is as described above with reference to Figure 14C and 14DAs shown, it is coupled to sensor carrier 402 via conductive adhesives 762 and 764. On the other side of the sensor carrier substrate are conductive contact pads 812 and 814. Circuit board 530 also has contact pads 826 and 828 bonded to the circuit board, accessible through floor 704 of recess 726. Anisotropic film 820 is used to electrically and mechanically bond sensor carrier contacts 812 to circuit board contacts 826, and also to electrically and mechanically bond sensor carrier contacts 814 to circuit board contacts 828. Anisotropic film 820 is compressed between the contacts using heat, causing the conductive particles in film 820 to vertically bridge the gaps between contact pairs 812 / 826 and 814 / 828. The conductive particles in film 820 are spaced horizontally apart, preventing short circuits between the contact pairs. Electrical and mechanical bonding techniques are widely used in display applications for small electronic devices, such as smartphones, and enable simple and consistent connections in a production environment.

[0260] exist Figure 15C 8, a proximal region of the sensor 138 is coupled to contacts 812 and 814 of the sensor carrier 402 via an anisotropic film 820. Different regions of the same anisotropic film 820 can be used to connect the sensor carrier contacts 812 and 814 to circuit board contacts 826 and 828, respectively. In this embodiment, the region of the film 820 connecting the sensor 138 to the contacts 812 and 814 can be horizontally adjacent to or otherwise separate from the region of the film 820 connecting the circuit board contacts 826 and 828 to the sensor carrier contacts 812 and 814.

[0261] exist Figure 10-1 5, the pre-connected sensor 400 can be installed as a separate interface between the sensor 138 and the sensor electronics. However, it should be understood that in some embodiments described herein, the pre-connected sensor 400 can include a sensor carrier that is connected to an additional interface between the sensor 138 and the sensor electronics within the wearable assembly 600. For example, the channel 322d and the leaf spring 306d can be formed on a separate substrate that is mechanically attached to the base portion 312d within the seal 192 after calibration and testing operations for installation into the wearable assembly 600.

[0262] One benefit of the above-described analyte sensor connection technology is that the manufacture of the pre-connected sensor 400 can be separated from the manufacture of the electronics enclosed within the housing. As described above with reference to the pre-connected sensor structure and the subsequent coating, testing, and calibration processes, the housing containing the electronics can be manufactured in a facility separate from the facility for attaching the pre-connected sensor 400 to the sensor electrical interface. This is made possible by providing an analyte sensor electronic interface accessible from outside the housing. There is no need to open the housing to attach the sensor.

[0263] In some advantageous methods, the electrodes of the pre-connected sensor are manufactured and mounted on the substrate at a first location and then transported to a second location for coating testing and calibration. The housing with the internal electronic device is manufactured in a third location. The housing with the electronic device is transported from the third location to the second location where the complete analyte sensor is attached to the external electrical interface. These three locations can all be very far apart from each other. This can minimize the handling of the sensitive membrane-coated sensor, but still allow the other components of the entire device to be manufactured separately.

[0264] Figure 16 1 shows a top view of an embodiment of a sensor carrier 402 in which the substrate 404 is a substantially planar substrate and the sensor 138 is attached to the substrate 404 by a conductive adhesive 1500. Figure 16 As shown, conductive adhesive 1500 can be applied to contacts 1000 and 1002 of sensor 138 to mechanically attach sensor 138 to substrate 404. Once applied, conductive adhesive 1500 on contacts 1000 and 1002 can itself form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronics unit 500. Figure 17 Shown Figure 16 4 shows a side view of sensor carrier 402, in which conductive adhesive 1500 is seen covering a portion of sensor 138 at the proximal portion. In other embodiments, sensor 138 can be attached to substrate 404 by conductive adhesive 1500 or by any other suitable method using, for example, a clip, a conductive polymer, metal foil, conductive foam, conductive fabric, wire wrapping, wire threading, or by any other suitable method.

[0265] Figure 18 、 19 and 20 show Figure 16 An example of a substrate 404 having additional fiducial features for controlling the position and spatial orientation of the sensor 138 on the substrate 404. Figure 18 In the example of , substrate 404 includes a v-shaped recess 1700. Sensor 138 is partially disposed within recess 1700 so that sensor 138 is oriented in a direction along the recess, and conductive adhesive 1500 substantially covers sensor 138 and fills the portion of recess 1700 not filled by sensor 138 to secure sensor 138 within the recess. Figure 19 In the example of , 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 sensor 138 is attached at the interface of the first planar portion and the second planar portion by conductive adhesive 1500. Figure 20 In the example of , substrate 404 includes a circular recess 1900 , wherein sensor 138 is attached by conductive adhesive 1500 that substantially covers sensor 138 and fills the portion of recess 1700 not filled by sensor 138 to secure sensor 138 within the recess.

[0266] Figure 21A and 21B An example sensor carrier 402 is shown in which at least one pair of guide structures 2106 and 2108 are formed on the substrate 404, such as on one or both contacts 406 and 408. These guide structures can help place the sensor body 138 in the proper position when applying the conductive adhesive to join the sensor body 138 together. This can eliminate the need for external guide fixtures when assembling the sensor to the sensor carrier during manufacturing. The structures 2106, 2108 can be made of solder or other conductive adhesives. Although Figure 21A and 21B Not shown, additional adhesive bonding material may be provided between the guide structures to secure the sensor to the guide structures during manufacture.

[0267] The 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 at an elevated curing temperature). The conductive liquid dispensing gel may be a fast-curing adhesive. The two-component conductive liquid dispensing gel may include a base adhesive (e.g., epoxy, polyurethane, etc.) and a conductive filler (e.g., silver, carbon, nickel, etc.). The conductive adhesive 1500 may include, for example, an adhesive resin having one or more embedded conductive materials (e.g., silver, copper, or graphite). The conductive adhesive 1500 may be a heat-curing conductive adhesive.

[0268] Figure 22 1 shows a top view of an embodiment of a sensor carrier 402 in which the substrate 404 is a substantially planar substrate and the sensor 138 is attached to the substrate 404 by conductive tape 2000. Figure 22 As shown, conductive tape 2000 can be applied to one or more contacts of sensor 138 (e.g., connection areas 1000 and 1002) to mechanically attach sensor 138 to substrate 404. Once applied, conductive tape 2000 on contacts 1000 and 1002 can itself form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronics unit 500. Figure 22 As shown, the tape 200 can be applied over the sensor 138, or can be interposed between the substrate 404 and the sensor 138. In the embodiment where the tape 2000 is positioned between the substrate 404 and the sensor 138, the substrate 404 can be Figure 23 An end view of the flexible substrate is shown rolled or folded around the sensor 138. Figure 23 The rolled substrate includes an extension portion 2100 that can form one or more contacts (eg, 406 or 408).

[0269] Conductive tape 2000 can be configured as a multi-zone tape having one or more conductive tape 2000 and non-conductive tape areas. A combination of conductive and non-conductive areas can be used to electrically isolate connection areas. Using a multi-zone tape can simplify the assembly of multiple connection areas in a single assembly step. The spacing of the conductive areas on the tape can match the target connection areas of the sensor wires 138. In other embodiments, the spacing of the conductive areas of the tape is significantly smaller than the spacing of the target connection areas of the sensor wires 138. The shorter spacing allows for greater variability in tape placement while ensuring an isolated connection between the sensor 138 and the substrate 404. Conductive tape 2000 can be formed from a polymer substrate and a conductive adhesive (e.g., a carbon-impregnated adhesive or a metal-impregnated adhesive). As another example, conductive tape 2000 can be a metal substrate with a conductive and non-conductive adhesive. Some examples of non-conductive substrates include polyimides, composites, polymers, etc. Some examples of conductive substrates include metals (e.g., foils, platings, claddings, etc.), conductive polymers, and conductive elastomers. Examples of non-conductive adhesives are epoxies, cyanoacrylates, acrylics, rubbers, urethanes, hot melts, etc. Examples of conductive adhesives are carbon-filled adhesives, nanoparticle-filled adhesives, metal-filled adhesives (eg, silver), conductive inks, etc.

[0270] Figure 24 A top view of an embodiment of a sensor carrier 402 is shown in which the substrate 404 is a substantially planar substrate and the sensor 138 is attached to the substrate 404 by soldering or bonding the conductive plastic 2200 to the non-conductive (e.g., plastic) substrate 404. Figure 24 As shown, conductive plastic 2200 can be applied to contacts 1000 and 1002 of sensor 138 to mechanically attach sensor 138 to substrate 404. Once applied, conductive plastic 2200 on contacts 1000 and 1002 can itself form contacts 408 and 406 for coupling to test station 5002, calibration station 5004, and / or electronics unit 500.

[0271] Figure 25 and 26 An exemplary ultrasonic welding system is shown for welding conductive plastic 2200 to substrate 404. Figure 25As shown, substrate 404 can have a recess into which a protrusion on conductive plastic member 2200 can be received. Sensor 138 can be placed within the recess in the protrusion on conductive plastic member 2200, and conductive plastic member 2200 can be pressed in direction 2302 and vibrated by ultrasonic horn 2300 to form a melted region 2400 that solidifies when horn 2300 is removed to secure sensor 138 between substrate 404 and conductive plastic 2200, forming a conductive contact to sensor 138.

[0272] In some embodiments, the proximal end of the sensor 138 may be curled or otherwise flattened to provide additional surface area for clamping or soldering contacts to the substrate 404, such as Figure 27 As shown. Figure 27 As shown, contacts 1000F and 1002F may be flat contacts that converge into a cylindrical wire sensor 138. Figure 28 As shown in the side view of the sensor carrier 402 in FIG, the flat contacts 1000F and 1002F can be attached to the substrate 404 by conductive attachment members 2600 and 2602 (such as clips, solder, anisotropic conductive film, conductive tape, plastic members with embedded conductors, conductive springs, or elastic conductive members (as examples)).

[0273] In one example, connectors such as contacts 1000F and 1002F (and / or other forms of contacts 1000 and 1002 described herein) can be laser soldered to corresponding contacts on substrate 404. In embodiments 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 can cause pre-deposited solder material to reflow to each side of sensor 139. Guides such as borosilicate glass "horns" can be placed over the sensor and pre-deposited solder to hold the solder, thereby driving the molten solder toward the sensor. The resulting "bracket" joint can then firmly anchor the sensor to the trace on substrate 404, which can help increase or maximize the trace-solder-sensor contact wire bond area. The use of guides such as borosilicate glass corners can also protect printed circuit board assembly electronics that may be included on and / or in the substrate from solder debris during the hot portion of the soldering process.

[0274] 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, a solder wire can be pre-fed onto the tip of a soldering iron to form a droplet of molten solder on the tip. The soldering iron can then be moved downward so that the droplet touches the sensor and conductive traces on the substrate. The coating on the sensor, such as the Ag / AgCl coating described herein, can have a low thermal mass so that the sensor coating heats quickly without freezing the solder. Once the coating is heated, the solder will wet the coating. The trace will also have very little thermal mass so that it can heat quickly without freezing the solder. A solder mask can be provided around the trace to prevent solder from flowing out of the edges of the trace.

[0275] In some embodiments, substrate 404 can be formed at least in part from a flexible circuit (e.g., a polyimide substrate having conductive traces or other suitable flexible circuit) that is folded over and / or around at least a portion of sensor 138 to the conductive traces of the flexible circuit. Figure 29 A top view of a flexible circuit embodiment of substrate 404 is shown, wherein substrate 404 is a flexible circuit having a central, non-conductive, elongated portion 2702 along which sensor 138 is oriented, and having upper and lower extensions 2700 and 2704 extending from the central portion in a direction perpendicular to the elongated dimension of central portion 2702. Extensions 2700 and 2704 contain conductive contacts 2706 and 2708, respectively, 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 test, calibration, sensor electronics, or other equipment to be connected to the sensor carrier / sensor assembly in an area not occupied by the sensor. This can allow for additional connection types and / or improved electrical coupling of the connections.

[0276] Figure 30An embodiment of a sensor carrier 402 is shown in which the substrate 404 includes a wedge-shaped base portion 2800 and a foldable flexible portion 2802. Conductive contacts 2804 can extend from the base portion 2800 to the foldable portion 2802 such that 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 over and around the sensor 138, the contacts 410 and 412 are electrically coupled to the sensor 138. The base portion 2800 can be rigid and can taper in a direction away from the sensor 138. The base portion 2800 can include the conductive contacts 410 and 412 at a narrow end. The base portion 2800 can, for example, be removably inserted into the recesses 5006 and 5014 of the test station 5002 and the calibration station 5004 for testing and calibration operations. Figure 27 and 28 In an example, the flexible substrate can be folded over the sensor and secured, for example, to the sensor and / or itself to secure the sensor by soldering, mechanical crimping, spring contacts, rivets, adhesives such as epoxy, etc.

[0277] Figure 31A and 31B Another embodiment of a sensor carrier 402 is shown. In this embodiment, the sensor carrier 402 includes a block 404 made of a non-conductive material (e.g., a polymer or ceramic). Block 404 includes a through-hole 1420 extending therethrough along the y-axis, through which the proximal, external portion of the analyte sensor 138 extends. Slots or blind holes 1410 and 1412 intersect through-hole 1420 along the z-axis, which is orthogonal to the through-hole y-axis. Conductive contact materials 406 and 408 are plated on the top surface and extend into slots 1410 and 1412. Additional holes 1430 and 1432 extending along the x-axis intersect both through-hole 1420 and slots 1410 and 1412. Each hole 1430 and 1432 extends across its respective slot and partially extends into the block material on the other side of each slot, thereby forming blind holes or recesses 1442 and 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 the wire analyte sensor contacts 212b and 211b into recesses 1442 , 1444 , causing contacts 212b and 211b to make electrical contact with sensor carrier contacts 406 and 408 .

[0278] Figure 32A top view of a sensor carrier is shown having substrate 404, datum feature 2900, and removable connector 2902 for each of contacts 406 and 408. Sensor 138 can be aligned with datum feature 2900, and removable connector 2902 can be moved to secure each of contacts 1000 and 1002 between the corresponding datum feature and removable connector. Removable connector 2902 and / or datum feature 2900 are conductively coupled to contacts 1000 and 1002. Removable connector 2902 and / or datum feature 2900 can be conductively coupled to other contacts (not shown) on substrate 404 that form contacts 410 and 412. Figure 33 2 is a perspective view of a datum feature 2900 and one of the associated movable contacts 2902 that can be moved in a direction 2904 toward the datum feature 2900 to secure the sensor 138. Contacts 1000 and 1002 can be flat to enhance contact with the datum feature 2900 and the contact 2902. If desired, additional conductive material 2906 can be formed on the substrate 404 between the datum feature 2900 and the contact 2902 to enhance electrical contact with the sensor 138. The additional conductive material can be an exposed surface of a portion of an embedded conductive layer (e.g., a copper or other conductive metal layer) within the substrate 404, or can be solder or a conductive adhesive (as examples).

[0279] Figure 34 1 shows a perspective view of a pre-connected sensor formed by a sensor carrier embodied as a barrel-shaped connector substantially surrounding the sensor 138. Figure 34 In the example of , substrate 404 can be an insulating layer formed around sensor 138 by conductive tape extending from an inner contact having contacts 1000 and 1002 to an outer surface forming contacts 410 and 412. Figure 34 As shown, the ring contacts 410 and 412 can be removably received by press-fitting into the conductive brackets 3102 and 3104 of the device 3100 (e.g., the test station 5002, the calibration station 5004, and / or the electronics unit 500). The conductive brackets 3102 and 3104 can establish electrical communication between the sensor 138 and the device 3100 (e.g., the test station 5002, the calibration station 5004, and / or the electronics unit 500).

[0280] Figure 35A 1 shows an embodiment of a sensor carrier 402 in which a flexible circuit is wrapped over the end of a sensor 138 such that a top portion 3200 and a bottom portion 3202 of the flexible substrate are formed on opposite sides of the sensor 138. Figure 35BAs shown, the top portion 3200 and the bottom portion 3202 can be wrapped around the ends of multiple sensors 138 so that the flexible circuit strip 3404 forms a common sensor carrier for the multiple sensors. The flexible circuit strip 3204 can include a pair of internal contacts for coupling to the contacts 1000 and 1002 of each sensor 138, as well as a pair of external contacts, each pair of external contacts coupled to a corresponding pair of internal contacts and forming contacts for coupling to the test station 5002 and / or calibration station 5004. In this way, multiple sensors can be transported as a group and coupled to testing and calibration equipment. The strip sensor carrier 3204 can include an identifier for each sensor 138 so that test and / or calibration data for each sensor can be recorded and stored. Individual pre-connected sensors can be formed by singulating the strip sensor carrier 3204 into individual sensor carriers for each sensor that can be installed in an electronics unit (such as the wearable sensor unit of Figures 13 and 14). The strip 3204 may include singulation features 3220 (eg, markings and / or notches that facilitate singulation into individual pre-connected sensors).

[0281] Although Figure 35A and 35B A flexible circuit strip is shown wrapped around the end of sensor 138, but this is illustrative only. It should be understood that the flexible strip carrier of one or more other sensors 138 can be attached to the one or more sensors in other ways. For example, the end or other portion of the sensor 138 can extend into the substrate of the flexible circuit strip 3204 to couple to internal conductive contacts in the strip, or the end or other portion of the sensor 138 can be attached to the surface of the flexible circuit strip 3204 (e.g., using anisotropic conductive film (ACF) or other conductive adhesive, laser solder or other solder, clips or other attachment mechanisms, and / or fiducial features to position and align the sensor).

[0282] Figure 36 An embodiment of the sensor carrier 302 is shown in which the crimp connector 3301 extends through a portion of the substrate 404. Figure 36 As shown, the press-fit connector 3301 can have a base portion 3300 extending from a first side of the substrate 404 (e.g., to form one of the contacts 410 and 412). The press-fit connector 3301 also includes an arm 3302 extending from an opposite second side of the substrate 404. Figure 37 As shown, arms 3302 may be pressed together or crimped to mechanically secure and conductively couple to sensor 138 to form, for example, contacts 406 . Figure 38 Shown Figure 36 and 374 and illustrates how two crimp connectors are provided that extend through substrate 404 and form contacts 406 and 408 on a first side and contacts 410 and 412 on a second side. Figure 38 4. Contacts 410 and 412 are formed on the second side of substrate 404, but it should be understood that contacts 410 and 412 can be formed on the first side, or on the sidewalls or edges of substrate 404 (e.g., by including one or more elbows or other conductive couplings within substrate 404).

[0283] Figure 39 An embodiment of a pre-connected sensor is shown in which the sensor carrier 402 includes a distally directed channel 358 that guides the sensor 138 distally such that the sensor 138 includes a bend of at least 45 degrees and / or less than 135 degrees. A channel cover 362 secures the glucose sensor 138 in the distally directed channel 358. Figure 39 In the example of FIG, 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., coil spring 306, leaf spring 306d). The contacts (e.g., conductive elastic member 1400) form a conductive coupling between the sensor 138 and an external device (e.g., test station 5002, calibration station 5004, and / or on-skin sensor assembly 600). As shown, the contacts can cooperate with base features (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 the sensor carrier 402 (e.g., for manufacturing, calibration, testing, and / or in vivo operation). In some embodiments, the sensor 138 can be bent, glued, or bonded to attach within the sensor carrier 402.

[0284] Figure 40 An embodiment of a sensor carrier 402 is shown in which the substrate 404 is a molded interconnect device. Figure 40 In the example of , 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. Conductive traces 3702 can be formed on the surface of substrate 404 and / or can enter and / or pass through portions of substrate 404 to form appropriate connections. Conductive traces can be formed on the molded substrate using various techniques (e.g., selective plating by laser etching, combining plateable and non-plateable substrate polymers, or other suitable methods). In other embodiments, a conductive material (e.g., a conductive polymer, a metal stamping, a plated polymer, a metal structure) can be overmolded with a non-conductive material.

[0285] In order to produce Figure 40 As shown, conductive trace 3702 electrically couples contacts (e.g., contact areas 1000 and 1002 on sensor 138) to external contacts (e.g., contacts 410 and 412). Although contacts (e.g., 410 and 412) are formed on sensor 138, Figure 37 404 to which the sensor 138 is attached, but this is illustrative only. It should be understood that the contacts (e.g., contacts 410 and 412) can be formed on opposing surfaces or edges or sidewalls of the substrate 404 and coupled to the contacts (e.g., contacts 408 and 406) through conductive materials (e.g., conductive layers, structures, adhesives, clips, solder, or interconnects) within or on the substrate 404. For example, the contacts (e.g., contacts 410 and 412) can form designated areas to interface with electrical couplings on different surfaces or areas of the substrate 404 to which the sensor 138 is attached. The designated areas can form channels, grooves, recesses, slots, or similar alignment features for orienting the sensor.

[0286] The molded thermoplastic substrate 404 can be an injection molded substrate having features that facilitate various aspects of testing, calibration, and wearable device installation of the sensor 138. For example, the molded thermoplastic substrate 404 can include a fiducial feature or other positional feature or locating feature, such as a recess 3700 having a shape complementary to the shape of the proximal end of the sensor 138. For example, the recess 3700 can include three or more stepped regions corresponding to the proximal end of the sensor 138. Figure 3D The steps between the different layers of the coaxial analyte sensor are shown. In other configurations, the molded thermoplastic substrate 404 may include Figure 18 In the example of a flat wall recess, such as Figure 19 The corner walls in the example of Figure 20 In other configurations, the molded thermoplastic substrate 404 may include raised features or protrusions on its surface that position and align the sensor 138. For example, a raised channel having a shape 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 posts may extend from the surface of the molded thermoplastic substrate 404. For example, one or more raised lines may be formed on the surface of the molded thermoplastic substrate 404, and the sensor 138 may be positioned and aligned against and / or between the raised lines. In this way, various configurations may be provided for the molded thermoplastic substrate 404, including reference features that orient the sensor 138 in a preferred location and orientation.

[0287] The molded thermoplastic substrate 404 may also include features of other shapes, such as finger holders 3720 on opposite sides of the substrate that 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 for the manufacturing device 5091, the test device 5004, and the calibration device 5004, for example, the gripping connector features 5093 / 5095 of the manufacturing device 5091 and / or the female connectors 5006 and 5014 of the test device 5002 and the calibration device 5004. The anchoring features formed on and / or by the molded thermoplastic substrate 404 itself may include one or more protrusions, such as posts, snap-fit ​​features, arms such as arms 202 (see, e.g., FIG. 2 ). Figure 11-1 4), recesses, notches, hooks and / or similar Figure 28 The tapered portion of the tapered portion is shown (as an example). In some examples, the shape of a portion of molded thermoplastic substrate 404 or the entire molded thermoplastic substrate 404 can correspond to the shape of a mounting receptacle on or within one or more of manufacturing apparatus 5091, testing apparatus 5002, calibration apparatus 5004, a carrier, and / or a wearable device.

[0288] Although the substrate 404 is Figure 40 5002, calibration equipment 5004, and / or a wearable device. The gripping portion can extend from the manufacturing equipment 5091, the testing equipment 5002, or the calibration equipment 5004 during manufacturing operations to facilitate removal of the sensor carrier 402 and the sensor 138 from the equipment after or between manufacturing operations. The gripping portion can be integrally formed with the main portion or can be a separate component extending from a surface of the molded thermoplastic substrate 404 or from within the molded thermoplastic substrate 404. The grip assembly may be a post, rod, shaft, or arched handle shaped for gripping with a grip tool or by hand (eg, by a technician).

[0289] like Figure 40As shown, the sensor 138 can be placed in the recess 3700 and secured to the substrate 404 using an adhesive 3704 (e.g., a conductive adhesive as described herein). The adhesive 3704 can be applied to couple the contacts 1000 of the sensor 138 to the first conductive traces 3702 on the substrate 404 to form contacts 408 between the sensor 138 and the sensor carrier 402. The adhesive 3704 can also be applied to couple the contacts 1002 of the sensor 138 to the second conductive traces 3702 on the substrate 404 to form contacts 406 between the sensor 138 and the sensor carrier 402. In this manner, the molded thermoplastic substrate 404 can provide a handle and / or strain relief member for moving and / or otherwise handling the sensor 138.

[0290] Figure 41 Shown Figure 40 A top view of the sensor carrier 402. Figure 40 and 41 As shown, first conductive trace 3702 may extend from the portion in contact with contact 1000 within recess 3700 to form one or more exposed portions on the surface of substrate 404, the exposed portions forming external contacts 412 for coupling to test station 5002, calibration station 5004, and / or electronic device unit 500. Second conductive trace 3702 may extend from the portion in contact with contact 1002 within recess 3700 to form one or more exposed portions on the surface of substrate 404, the exposed portions forming external contacts 410 for coupling to test station 5002, calibration station 5004, and / or electronic device unit 500.

[0291] Figure 42 Shown as Figure 40 and 41 Specific embodiment of sensor carrier 402 is shown. In this embodiment of sensor carrier 402, sensor 138 is attached to substrate 404 by a conductive coupler 3900 (e.g., a clip, conductive adhesive, conductive polymer, metal foil, conductive foam, conductive fabric, wire wrap, wire threading, or by any suitable method). Figure 43As shown, substrate 4000 can have an elongated dimension along which parallel conductive strips 4001 and 4002 are formed. A plurality of sensors 138 can be attached to substrate 4000 and extend beyond the edge of the substrate in a direction perpendicular to the elongated dimension of the substrate. Singulation features, such as score 4020, can be provided to facilitate singulation of substrate 4000 into individual sensor carrier substrates 404 for each sensor and / or to electrically isolate portions of conductive strips 4001 and 4002 for each sensor. Each sensor can be attached to substrate 4000 using, for example, clip 3900 or any other method, including through the use of a conductive adhesive, a conductive polymer, metal foil, conductive foam, conductive fabric, wire wrapping, wire threading, or any other suitable method. An identifier 450 for each sensor can be provided on a corresponding portion of substrate 4000.

[0292] Sensors 138 can each have a pair of sensor electrical contacts (e.g., contacts 1000 and 1002) coupled to a corresponding pair of electrical contacts formed by strips 4001 and 4002 on the substrate. Openings in substrate 4000 and / or vias extending through substrate 4000 can provide exposed portions of strips 4001 and 4002 that form multiple pairs of electrical contacts for coupling each sensor 138 to a test station 5002, a calibration station 5004, and / or an electronics unit 500 (e.g., an electronics unit of a wearable device). Each of the multiple pairs of electrical contacts is coupled to an associated pair of portions of strips 4001 and 4002 through the substrate.

[0293] Figures 44-46 Shows that it can be Figure 43 Various contact configurations on a singulated sensor carrier of the type shown. Figure 44 In the example of FIG400 , a z-shaped contact configuration on substrate 4000 has been singulated to form pre-connected sensors on a smaller portion of the substrate, referred to as substrate 404. In this case, the z-shaped contact configuration can enable larger distances between connectors (e.g., larger pitch connections) on test, manufacturing, or calibration equipment, but a z-shaped substrate is not required to create the larger distances, and other substrate shapes can be used. Figure 45 In the example of , a square portion of substrate 4000 has been singulated to form pre-connected sensors on substrate 404. Figure 46 In the example of , a square portion of substrate 4000 has been singulated to form a pre-connected sensor, and openings 4300 (eg, air gaps) are provided in the singulated substrate 404 to improve electrical isolation between the singulated contact strip portions 4001 and 4002 .

[0294] like Figure 47AAs shown, in some embodiments, an elongated substrate 4000 forming a sensor carrier of a plurality of sensors 138 can be provided with a feed guide strip 4402 that runs along the elongated edge of the elongated substrate. The feed guide strip 4402 can include positioning features 4404 that can be accessed and manipulated to move and align a strip of pre-attached sensors through one or more manufacturing stations.

[0295] exist Figure 47A In an embodiment, the sensors 138 can be attached to the substrate 4000 in bulk and singulated on the substrate 404 after manufacturing or testing operations. Figure 47B As shown, Figure 47A The strip of pre-connected sensors shown in can be provided on a reel 4410 for bulk storage and / or shipping and, optionally, automatically pulled from the reel using a feed guide strip 4402 to move through one or more testing stations and / or one or more calibration stations. Figure 48 A pre-connected sensor is shown with a sensor carrier that has been singulated from substrate 4000 and separated from the singulated portion 4402 of feed guide strip 4402. Alternatively, feed guide strip 4402 can be separated as a strip prior to singulation of the individual pre-connected sensors. In other embodiments, the feed guides are integrated into the final product configuration and are not removed from the sensor carrier during or after singulation.

[0296] Figure 49 An embodiment of a sensor carrier 402 is shown in which multiple sets of contacts 406 and 408 are formed by a socket 4600 having slots for receiving a corresponding plurality of sensors 138. In some embodiments, the socket 4600 can be an elongated member comprising a resilient or flexible material. The socket 4600 can have slots that optionally pierce an insulating layer or deform a portion of an outer layer to facilitate contact with the sensors 138.

[0297] Figure 50 An embodiment of a sensor carrier for multiple sensors 138 is shown having recesses 4700 that form reference features to maintain precise alignment and position of each sensor. Complementary magnetic features can be provided on the sensors 138 and substrate 404 to maintain precise alignment and position of each sensor and facilitate accurate sensor handling.

[0298] Figure 51AAn embodiment of an elongated substrate 4800 is shown that is formed from a rigid, flexible, or combined rigid / flexible substrate using printed circuit board technology, from which a plurality of sensor carriers 402 can be singulated. The flexible portion of the substrate can be made of, for example, polyimide, PEEK, polyester, or any suitable type of material. The rigid portion of the substrate can be made of, for example, FR4, FR5, FR6, an insulated metal substrate (IMS), PTFE, or any suitable type of material. Figure 51A As shown, each sensor carrier can include a sensor connection portion 4804 and an interface or processing portion 4802. In some embodiments, each sensor carrier can 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, can be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 can contain anchoring or reference features for the sensor carrier 402.

[0299] Figure 51B Shown as Figure 51A Another embodiment of an elongated substrate 4800 is shown having an optional electrical connection interface 4850 for connecting to a workstation (e.g., a testing 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 disposed on one or more layers of a circuit board. Figure 51B As shown, multiple sensor carriers 402 are assembled in a panel, and each of the sensor carriers 402 can include a sensor connection portion 4804 extending from a 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, can be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 can contain anchoring or reference features for the sensor carrier 402. In some embodiments, Figure 51B The elongated substrate 4800 shown 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-shaped notches, rat teeth, or other suitable types) are included in the elongated substrate 4800 to enable removal of the bottom portion of the panel 4860 for dipping or calibration. In this embodiment, the elongated substrate 4800 can be configured for dipping or calibration, as shown. Figure 52B As stated.

[0300] Now refer to Figure 52A, 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) can be formed on the sensor carrier 402 for connecting 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 a testing and / or calibration device.

[0301] Figure 52B An example panel implementation of a plurality of sensor carriers 402 is shown having electrical connection interfaces 4850 for interfacing with electronics of a workstation (eg, a testing station, calibration station, assembly station, coating station, or other manufacturing station). Figure 52B The illustration shows that after removing the bottom panel portion 4860 (from Figure 51B ) and with the sensor 138 attached via one or more sensor contacts (e.g., contacts 406 and 408) Figure 48 B's elongated substrate 4800. In some embodiments, the sensor can be permanently connected (e.g., with a conductive adhesive, conductive polymer, conductive ink, solder, welding, brazing, or other suitable method) to the sensor carrier 402, and the two components can be calibrated together or separately. In other embodiments, the sensor can be releasably attached (e.g., with a clip, metal foil, conductive foam, conductive fabric, wire wrapping, wire threading, or any other suitable method).

[0302] After testing and / or calibration operations, flexible portion 4802 can be folded around, folded over, wrapped around, wrapped over, or manipulated to enclose portion 4804 for mounting on the on-skin sensor assembly 600. Figure 53A In the example of , portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an embodiment of sensor electronics 112). In other embodiments, portion 4802 may be coupled directly 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. Figure 53B In the example of , flexible portion 4804 is folded to enclose portion 4802 for mounting into on-skin sensor assembly 600 so as to positionally secure sensor 138 to extend (e.g., through opening 4808) for insertion for in vivo operation.

[0303] Figure 54An embodiment is shown in which the sensor carrier 402 is manufactured using printed circuit board technology as a daughter board of the main printed circuit board 5100 for the sensor electronics. Figure 54 As shown, one or more contacts, such as contacts 5104 (e.g., solder contacts), can be formed between the sensor carrier 402 and the main PCB 5100 to form a sensor electronics unit for the sensor 138 in the on-skin sensor assembly 600. The conductive traces 5102 can couple the contacts 5104 to the sensor 138 via a conductive attachment mechanism 5103 (e.g., solder, conductive adhesive, conductive tape, or other conductive attachment as discussed herein).

[0304] Figure 55 An embodiment of the sensor carrier 402 is shown in which a compression clip 5200 is configured to close an arm 5204 of a crimp connector 5202 to secure the sensor 138 to the substrate 404. The connector 5204 may be formed of a conductive material that forms one of the contacts 410 and 412. Figure 55 As shown, the compression clamp 5200 includes clamping arms 5208 having angled surfaces that push the arms outward as the compression clamp 5200 moves in direction 5206 toward the substrate 404 and rebounds to secure the compression clamp 5200 to the substrate 404. In other embodiments, the compression clamp 5200 can be provided without the clamping arms 5208, such that the compression clamp 5200 is removable after the arms 5204 are compressed closed, and such that the compression clamp 5200 does not form part of the sensor carrier. Figure 55 As shown, one or more electrode protrusions 5220 may be provided to form, for example, one or more of contacts 410 and 412 on substrate 404. Although protrusions 5220 are formed at locations adjacent to sensor 138, Figure 55 138, or on an edge or sidewall of substrate 404 and coupled to contacts 408 and 406 through conductive vias or other conductive layers, structures, or interconnects within or on substrate 404. In some embodiments, compression clamp 5200 can be used in conjunction with compression connector 5202 to apply a biasing force to sensor 138, or can be used to apply a biasing force directly to the substrate without compression connector 5202. Compression clamp 5202 can apply force radially, axially, or in an appropriate direction to provide a biasing force on sensor 138 and the conductive pathway.

[0305] Figure 56An embodiment of sensor carrier 402 is shown in which contacts 406 and 408 are formed by foldable conductive clips 5300. Sensor 138 can be inserted through opening 5302 in each clip 5300 and mechanically secured to substrate 404 and conductively coupled to clips 5300 by folding portion 5304 of each clip 5300 over sensor 138.

[0306] Portion 5304 of clip 5300 may also form contacts 410 and 412 for coupling to external equipment such as a manufacturing station (e.g., a testing station, calibration station, assembly station, coating station, or other manufacturing station). However, this is illustrative only. In other embodiments, one or more electrode protrusions conductively coupled to clip 5300 may be provided to form, for example, one or more of contacts 410 and 412 on substrate 404. Such protrusions may be formed on a surface of substrate 404 opposite the surface to which sensor 138 is attached, on the same surface as sensor 138, or on an edge or sidewall of substrate 404 and coupled to clip 5300 through conductive vias or other conductive layers, structures, or interconnects within or on substrate 404.

[0307] Clip 5300 also forms a fiducial feature for positioning and aligning sensor 138 relative to substrate 404. Substrate 404 can be sized and shaped (or can include structural features) that form anchoring features for substrate 404 relative to a manufacturing station and / or a housing of a wearable device. In this way, sensor carrier 402 can be used to easily position and align sensor 138 for manufacturing and assembly operations (e.g., using fiducial features to align the sensor relative to substrate 404 and using anchoring features to align the substrate relative to the manufacturing or wearable device).

[0308] When installed in the on-skin sensor assembly 600, 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, the contacts 406, 408, 410, and 412 can be electrically isolated from each other and from the environment by using a non-conductive adhesive (e.g., a one-part or two-part epoxy), using polyurethane, using low-pressure overmolding (e.g., moldable polyamide or moldable polyolefin), using injection overmolded thermoplastics or thermosets, using non-elastomers (e.g., welded flap plastic, adhesively bonded flap, single-sided or double-sided cavities filled with sealants (e.g., epoxy, urethane, silicone, etc.), or using factory pre-compressed elastomers (e.g., constrained two-body cavities for holding the elastomer in a compressed state). The two-body cavities can hold the elastomer in a compressed state by snap-fitting, bonding such as ultrasonic welding, laser welding, solvent bonding, or heat staking, or mechanical fasteners such as screws, rivets, clips, or other fasteners.

[0309] Figure 57 Illustrative operations that may be performed to manufacture and use a pre-connected analyte sensor are shown.

[0310] 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 having an elongated conductive core) and a working electrode 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 at the proximal end or elsewhere along the elongated body, each coupled to the working electrode and / or the reference electrode.

[0311] In block 5402, a sensor carrier, such as one of the embodiments of the sensor carrier 402 described herein, can be attached to, for example, a 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.

[0312] In block 5403, a workstation, such as a fabrication station, is provided. As described herein, the fabrication station can be configured to perform one or more dip coating processes to form the aforementioned film 108 on the working electrode.

[0313] In block 5404, the analyte sensor can be coupled to at least one test station (e.g., test station 5002) by coupling the sensor carrier to the circuitry of the at least one test station. The circuitry for coupling the sensor carrier to the at least one test station can include mechanically coupling one or more anchoring features (e.g., a substrate of the sensor carrier) to a mating interface of the test station such that one or more external contacts on the substrate couple to one or more corresponding contacts at the test station. An identifier of the sensor 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.

[0314] In block 5406, the analyte sensor can be coupled to at least one calibration station (e.g., calibration station 5004) by coupling the sensor carrier to the circuitry of the at least one calibration station. The circuitry for coupling the sensor carrier to the at least one calibration station can include mechanically coupling one or more anchoring features (e.g., the substrate of the sensor carrier) to a mating interface of the calibration station such that one or more external contacts on the substrate couple to one or more corresponding contacts at the calibration station. The identifier of 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.

[0315] The sensor carrier 402 can be coupled to one or more additional manufacturing stations as needed. The additional manufacturing stations can include a potentiostat measurement station, a sensor alignment station, a membrane impregnation station, a curing station, an analyte sensitivity measurement station, and / or an inspection station.

[0316] In block 5408, the 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 can include coupling one or more external contacts on the sensor carrier to corresponding contacts of the sensor electronics. In some embodiments, coupling the sensor carrier to the sensor electronics can 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 an identifier of the sensor from the sensor carrier. Calibration data for the sensor can be obtained based on the identifier.

[0317] In block 5410, in vivo signals from the working electrode (e.g., and reference electrode) may be obtained and processed by the sensor electronics. The in vivo signals from the working electrode (e.g., and reference electrode) may be received from the sensor by the sensor electronics through circuitry of the sensor carrier.

[0318] The methods disclosed herein include one or more steps or actions for implementing the described methods. Method steps and / or actions may be interchangeable with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims. For example, the operations described above in conjunction with blocks 5404 and 5406 may be reversed and / or performed in parallel.

[0319] In some cases, it may be desirable to couple the sensor 138 to one or more contacts on the substrate in a preferred location and orientation. Figure 58 An exemplary device 5531 is shown in which the sensor 138 is oriented to the substrate 5530 using an elastic tube. Figure 58 As shown, device 5531 may include substrate 5530 having one or more conductive contacts, such as contacts 5532 and 5534 (eg, exposed copper pads on a printed circuit substrate), and elastic tube 5500. Elastic tube 5500 may be formed from a non-conductive elastomer.

[0320] As shown, the elastic tube 5500 can be formed with a "D," "O," elliptical, pyramidal, or hemispherical cross-section having an elongated cutout 5503 in the bottom portion of the elastic tube 5500 in which the sensor 138 is positioned. In this manner, the sidewalls of the elongated cutout of the elastic tube 5500 can align the sensor 138 relative to the substrate 5530.

[0321] 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 the cutout 5503 in the elastic tube 5500 provide sufficient space where the tube 5500 can be placed over the sensor 138 while the sensor 138 is in place on the substrate 5530 in order to assemble the device.

[0322] Figure 59 Shown Figure 55 1 and 2. An exploded perspective view of the device of FIG. 55, wherein contacts 5532 and 5534 can be seen on substrate 5530. Sensor 138 can be positioned over one or more contacts, such as contacts 5532 and 5534.

[0323] During the initial placement of the tube over the sensor, the sensor 138 can be loosely held within the opening 5501 of the tube 5500 and then secured by the tube to the substrate 5530 when the tube is compressed (e.g., by the upper housing of the wearable device). In this way, the sensor 138 can be communicatively coupled and mechanically secured to the substrate without the need for soldering or other bonding operations.

[0324] During manufacturing operations and / or during in vivo use of sensor 138 , sensor 138 may be held in position on substrate 404 by external compression of tube 5500 . Figure 60 An example of holding sensor 138 in place by compressing tube 5500 with a housing structure is shown. For example, housing 5700 (e.g., a housing for a wearable device or a cover or clip for a manufacturing station) can include a protrusion member 5702 that compresses tube 5500 to secure sensor 138 in an assembled configuration.

[0325] As mentioned above, for example Figure 35B 、 43 , 47A, 47B, 50 and 51, during the manufacturing operation, multiple sensors 138 can be carried by a common sensor carrier. However, in some cases, a common carrier such as a smart carrier can be provided for the manufacturing operation of multiple pre-connected sensors. Figure 61 An example of a carrier for multiple pre-connected sensors is shown. Figure 58As shown, carrier 5800 can include a housing 5802 with an interface 5804 for a plurality of pre-connected sensors. Housing 5802 can be a substantially solid substrate, or can be a housing that forms an interior cavity within which other components are mounted and / or connected.

[0326] Each interface 5804 can be configured to receive the sensor carrier 402 in any of the embodiments described herein. For example, each interface 5804 can 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 can 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 can include a communication circuit system for transmitting and / or receiving data from an external device, such as one or more antennas. The housing 5802 can include one or more structures 5810 (e.g., clips, buckles, protrusions, recesses, notches, posts, etc.) for mechanically coupling the carrier 5800 to a manufacturing device. One or more conductive contacts 5808 can be provided on the housing 5802 to communicatively couple the manufacturing device to the sensor 138 through the carrier.

[0327] As shown, each interface 5804 can be associated with a specific identification number (as an example, in Figure 58 Indicated as I1, I2, ..., I N-1 and I N ). Circuitry 5806 can electronically identify a sensor mounted in interface 5804 of carrier 5800 by an identification number associated with the interface. However, this is illustrative only. In other embodiments, sensor 138 can be uniquely identified by circuitry 5806 using a reader in each of interfaces 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 5806 and stored and / or transmitted along with the identifier of each sensor.

[0328] During manufacturing, one or more pre-connected sensors can be loaded onto the carrier 5800. The carrier 5800 can secure the pre-connected sensors therein and perform potentiostat measurements for each sensor (e.g., using circuit 5806). The sensors 138 can be secured to the interface 5804 by individual mounting features, or the carrier 5800 can be provided with a locking mechanism, such as a slidable rod 5812. The slidable rod 5812 can be slid between an open position (e.g., via a handle 5814) as shown, in which the sensor carrier can be inserted into and removed from the interface 5804, and a closed position in which the rod 5812 prevents the sensor carrier from being removed from the interface.

[0329] In some cases, an initial measurement test can be performed by the carrier 5800 to test the potentiostat connection through the sensor interconnect electrodes and the sensor surface. Manufacturing operations that can be performed on the sensor 138 coupled to the carrier 5800 can include physical manipulation of the sensor, such as alignment of the sensor. By allowing multiple sensors to be aligned in a single operation using automated alignment equipment, the carrier 5800 can facilitate more efficient manufacturing.

[0330] The carrier 5800 may facilitate potentiostat measurements and / or other measurements at various stages of manufacture of the sensor 138. Potentiostat measurements may be performed before, during, and / or after the alignment operation, and information regarding sensor damage or any other possible mechanical stresses that may be introduced by the alignment may be saved and / or transmitted along with an associated sensor ID.

[0331] The manufacturing operations that can be performed on the sensors 138 coupled to the carrier 5800 can also include a membrane process, in which an impregnation operation is performed to form a membrane, such as the membrane 508 of each sensor. The aligned sensors 138 mounted in the carrier 5800 can be impregnated simultaneously. Potentiostat measurements can be performed before, during, and / or after the membrane operation, and information related to the sensor's electrochemistry and the impregnation process can be collected, processed, stored, and / or transmitted by the carrier 5800.

[0332] Manufacturing operations that can be performed on sensors 138 coupled to carrier 5800 can also include a curing process. Performing curing on a group of sensors 138 mounted in carrier 5800 can allow the curing process to take up 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 electrochemistry and impregnation process of the sensors can be collected, processed, stored, and / or transmitted by carrier 5800.

[0333] Manufacturing operations that can be performed on sensors 138 coupled to carrier 5800 can also include calibration operations. Because carrier 5800 can perform connection testing early in the manufacturing process, improved analyte / electrochemical calibration can be performed by carrier 5800 itself and / or in collaboration with external manufacturing equipment. Calibration data can be collected, processed, stored, and / or transmitted by carrier 5800.

[0334] Collecting calibration and / or test data via carrier 5800 can save time connecting and disconnecting additional external devices. Collecting calibration and / or test data via carrier 5800, particularly when the data is automatically collected and stored along with the sensor ID, can also reduce calibration / testing errors because the data is collected by the same device throughout the various processes.

[0335] Manufacturing operations that can be performed on the sensor 138 connected to the carrier 5800 can also include analyte concentration measurements. For example, the carrier 5800 can 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., glucose baths). The carrier 5800 can collect potential measurements during the various bath exposures. Information associated with the potential measurements during the various bath exposures can be collected, processed, stored, and / or transmitted by the carrier 5800.

[0336] Manufacturing operations that can be performed on the sensors 138 connected to the carrier 5800 can also include analyte sensitivity measurements. Sensitivity measurements that can be performed by the carrier 5800 can include baseline measurements, which indicate the signal from each sensor when no analyte is exposed, slope measurements, and / or noise measurements. The baseline measurement indicates the signal from each sensor when no analyte is exposed, and the slope measurement indicates the change in signal for a given amount of analyte. These sensitivity measurements can be stored and / or transmitted by the carrier 5800.

[0337] Manufacturing operations that can be performed on sensors 138 coupled to carrier 5800 can also include visual inspection operations (e.g., by a technician). Providing a set of pre-connected sensors mounted in carrier 5800 that have undergone all of the above-described testing / calibration / manufacturing operations can allow for more efficient and / or automated visual inspection and rejection (e.g., because the exact physical location of each sensor within carrier 5800 is known). Sensors 138 that have exhibited abnormal electrochemical or mechanical stress during manufacturing operations can be flagged by carrier 5800 (e.g., using a display, visual indicator, or transmitting flag information to an external device) for retesting or rejection.

[0338] The connections between the elements shown in some figures illustrate exemplary communication paths. Additional communication paths (direct or through intermediaries) may be included to further facilitate information exchange between the elements. The communication paths may be bidirectional communication paths that allow the elements to exchange information.

[0339] The various operations of the above methods can be performed by any suitable means capable of performing the operations, such as various hardware and / or software components, circuits and / or modules. Generally, any operation shown in the drawings can be performed by corresponding functional means capable of performing the operations.

[0340] The various illustrative logical blocks, modules, and circuits described herein (e.g., Figure 2The blocks) may be implemented or performed using a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array signal (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, the processor may be any commercially available processor, controller, microcontroller, or state machine. The processor may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0341] In one or more aspects, the various functions described may be implemented as hardware, software, firmware, or any combination thereof. If implemented as software, these functions may be stored or transmitted as one or more instructions or codes on a computer-readable medium. Computer-readable media include both computer storage media and communication media, and communication media include any media that facilitates the transfer of computer programs from one place to another. Storage media can be any available media that can be accessed by a computer. As an example and not a limitation, such computer-readable media may include various types of RAM, ROM, CD-ROM or other optical disk storage, disk storage or other magnetic storage devices, or any other media that can be used to carry or store desired program codes in the form of instructions or data structures that can be accessed by a computer. 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 a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technology (such as infrared, radio, WiFi, RFID, NFC and microwaves). As used herein, disk and disc include compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray disc. Optical disks, where magnetic disks typically reproduce data magnetically, and optical disks reproduce data optically using lasers. Thus, in some aspects, computer-readable media may include non-transitory computer-readable media (e.g., tangible media). Additionally, in some aspects, computer-readable media may include transitory computer-readable media (e.g., signals). Combinations of the above are also intended to be within the scope of computer-readable media.

[0342] Certain aspects may include a computer program product 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, the instructions being executable by one or more processors to perform the operations described herein. For certain aspects, the computer program product may include packaging materials.

[0343] The software or instructions may also be transmitted over a transmission medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies (such as infrared, radio, and microwave), then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies (such as infrared, radio, and microwave) are included in the definition of transmission medium.

[0344] In addition, it should be understood that the modules and / or other appropriate devices for performing the methods and techniques described herein can be downloaded and / or otherwise obtained by the user terminal and / or base station when applicable. For example, such a device can be coupled to a server to facilitate the transmission of a device for performing the methods described herein. Alternatively, the various methods described herein can be provided by a storage device (e.g., RAM, ROM, a physical storage medium such as a compact disc (CD) or a floppy disk) so that the user terminal and / or base station can obtain the various methods when the storage device is coupled or provided to the device. In addition, any other appropriate technology for providing the methods and techniques described herein to a device can be utilized.

[0345] It should be understood that the claims are not limited to the precise configuration and components described above. Various modifications, changes and variations may be made to the arrangement, operation and details of the methods and apparatus described above without departing from the scope of the claims.

[0346] Unless otherwise defined, all terms (including technical and scientific terms) should have the common and customary meanings to those of ordinary skill in the art and are not limited to special or customized meanings unless expressly defined herein. It should be noted that when describing certain features or aspects of the present disclosure, the use of a particular term should not be taken as implying that the term is redefined herein to be limited to any specific characteristics of the features or aspects associated with the term. Unless expressly stated otherwise, the terms and phrases used in this application and variations thereof, especially the terms and phrases and variations thereof in the appended claims, should be interpreted as open-ended and not restrictive. As an example of the foregoing, the term "comprising" should be understood to mean "including, but not limited to," etc.; as used herein, the term "including" is synonymous with "comprising," "containing," or "characterized by" and is inclusive or open-ended and does not exclude additional unrecited elements or method steps; the term "having" should be interpreted as "having at least"; the term "including" should be interpreted as "including, but not limited to"; the term "examples" is used to provide illustrative examples of the items discussed, rather than an exhaustive or limiting list thereof; adjectives such as "known," "common," "standard," and terms of similar import should not be construed to limit the described items to items available at a specified time period or at a specified time, but rather should be construed to encompass known, common, or standard technology available or known at any time now or in the future; and the use of terms such as "preferably," "preferred," "required," or "desired," and words of similar import should not be construed to imply that certain features are critical, required, or even essential to the structure or function of the invention, but rather should be understood to merely highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention. Similarly, a group of items linked with the conjunction "and" should not be read as requiring mutual exclusivity among the grouping, but rather should be read as "and / or," unless expressly stated otherwise. Similarly, a group of items linked with the conjunction "or" should not be read as requiring mutual exclusivity among the grouping, but rather should be read as "and / or," unless expressly stated otherwise.

[0347] When a range of values ​​is provided, it is understood that the upper and lower limits of that range and every intervening value therebetween is encompassed within the embodiments.

[0348] With regard to the use of substantially any plural and / or singular terms herein, a person skilled in the art can convert the plural to the singular and / or the singular to the plural when appropriate to the context and / or application. For the sake of clarity, various singular / plural arrangements may be explicitly set forth herein. The indefinite article "a / an" does not exclude a plurality. A single processor or another unit may fulfil the functions of several items described in a claim. The mere fact that certain measures are recited in mutually different dependent 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 understood as limiting the scope.

[0349] Those skilled in the art will also understand that if a specific number of introduced claim recitations is intended, such intention will be explicitly stated in the claim, and in the absence of such recitation, no such intention is present. For example, as an aid to understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be interpreted as implying that a claim recitation introduced by the indefinite articles "a, an" will limit any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim contains the introductory phrases "one or more" or "at least one" and an indefinite article such as "a, an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); this is also true for the use of definite articles used to introduce claim recitations. Furthermore, even if a specific number of introduced claim recitations is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least that number (e.g., the simple recitation "two recitations" without other modifiers typically means at least two recitations, or two or more recitations). Additionally, in those instances where a convention similar to “at least one of A, B, and C” is used, such syntactical construction is generally intended to be in the conventional sense that one skilled in the art would understand, e.g., encompassing any combination of the listed items, encompassing individual members (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 those instances where a convention similar to “at least one of A, B, or C” is used, such syntactical construction is generally intended to be in the conventional sense that one skilled in the art would understand (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.). Those skilled in the art will further understand that almost any transitional word and / or phrase indicating two or more alternative terms, whether in the description, claims, or drawings, should be understood to include the possibility of one, either, or both of the terms. For example, the phrase "A or B" should be understood to include the possibility of "A" or "B" or "A and B."

[0350] All numerals representing the amount of components, reaction conditions, etc. used in this specification should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters set forth herein are approximate values, which can vary depending on the desired properties sought to be obtained. At the very least, and without attempting 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 ordinary rounding methods.

[0351] All references cited herein are incorporated herein by reference in their entirety. To the extent that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in this specification, this specification is intended to supersede and / or take precedence over any such conflicting material.

[0352] This document includes headings for reference and to assist in locating various sections. These headings are not intended to limit the scope of the concepts described herein. Such concepts may have applicability throughout the specification.

[0353] In addition, although the above content has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be made. Therefore, the description 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.

[0354] The various systems and methods described herein can be fully implemented and / or controlled in any number of computing devices. Typically, instructions are provided 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 present invention. The computer-readable medium can be a hard drive or solid-state memory containing instructions that are loaded into random access memory at runtime. Input to an application, for example, from multiple users or from any one user, can be provided through any number of suitable computer input devices. For example, a user can use a keyboard, mouse, touch screen, joystick, trackpad, other pointing device, or any other such computer input device to input data related to the computation. Data can also be input via an inserted memory chip, hard drive, flash drive, 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 visible to the user. Alternatively, a printer can be used to output a hard copy of the results. Given this teaching, any number of other tangible outputs are also understood to be contemplated by the present invention. For example, the output can be stored on a memory chip, hard drive, flash drive, 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 designed specifically for these purposes. In one embodiment, a user of a smartphone or Wi-Fi connected device can use a wireless Internet connection to download a copy of the application from a server to their device. Appropriate authentication procedures and secure transaction processes can dictate that payment be made to the seller. The application can be downloaded via a 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 embodiments in which multiple users provide separate inputs to the system and method. In the following system in anticipation of a factory calibration solution, multiple inputs can allow multiple users to enter relevant data simultaneously.

Claims

1. A device comprising: An analyte sensor comprising: an elongated body; a first electrode in electrical communication with the first conductive contact; and a second electrode in electrical communication with the second conductive contact; and a sensor carrier attached to the analyte sensor, the sensor carrier comprising: intermediates; a first conductive portion disposed on the intermediate body, the first conductive portion being in electrical communication with the first conductive contact and forming a first exposed contact surface; a second conductive portion disposed on the intermediate body, the second conductive portion being in electrical communication with the second conductive contact and forming a second exposed contact surface; wherein the first conductive portion and the second conductive portion form a connecting portion, the connecting portion including the first exposed contact surface and the second exposed contact surface, and the first exposed contact surface and the second exposed contact surface are configured to establish electrical communication between the first conductive contact and the second conductive contact and a separate device; The first conductive contact and the second conductive contact are coplanar with the first exposed contact surface and the second exposed contact surface.

2. The apparatus according to claim 1, further comprising: An identifier coupled to the intermediate.

3. The device of claim 2, wherein the identifier, the sensor, and the intermediate body form a laminated configuration.

4. The device according to claim 2 or 3, wherein the identifier is a QR code table.

5. The apparatus according to claim 2 or 3, wherein the identifier is any one of an optical identifier, a radio frequency identifier or a memory-encoded identifier.

6. The apparatus of claim 2 or 3, wherein the identifier is configured to identify any one of the analyte sensor, calibration data of the analyte sensor, and a history of the analyte sensor.

7. The apparatus of any one of claims 1-3, wherein the first conductive portion and the second conductive portion are traces. The apparatus of claim 7 , wherein the trace forms an exposed contact surface in the connecting portion.

9. The device of any one of claims 1-3, wherein the first conductive portion and the second conductive portion are at least partially embedded in the intermediate body.

10. The apparatus of any one of claims 1-3, wherein the first conductive portion and the second conductive portion comprise at least one of a solder joint, a conductive tape, a coil spring, a leaf spring, or a conductive elastomer.

11. The apparatus of any one of claims 1-3, wherein the connecting portion is configured to mechanically cooperate with the separate device.

12. The apparatus of any one of claims 1-3, wherein the separate device is an electronics unit configured to measure analyte data.

13. Apparatus according to any one of claims 1 to 3, wherein the separate device is a component of a manufacturing station.

14. The apparatus of claim 13, wherein the fabrication 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.

15. The apparatus of claim 13, wherein the manufacturing station comprises a calibration station configured to release the electrical connection between the sensor and the calibration station and to establish an electrical connection between the sensor and at least one testing station via the connecting portion of the sensor carrier.

16. The apparatus of any one of claims 1-3, wherein the intermediate body further comprises a reference structure configured to control the position and spatial orientation of the analyte sensor relative to a substrate of the intermediate body.

17. The apparatus of any one of claims 1-3, wherein the first electrode is coaxially positioned within the second electrode.

18. The apparatus of claim 17, wherein the first conductive contact and the second conductive contact are longitudinally aligned and spaced apart along a longitudinal axis of the sensor.

19. The device of any one of claims 1-3, wherein the first electrode and the second electrode are attached to a flexible planar substrate.

20. The apparatus of claim 19, wherein the first conductive contact and the second conductive contact are attached to the flexible planar substrate.

21. The apparatus of any one of claims 1-3, wherein the first conductive contact and the second conductive contact are attached to the intermediate body by a conductive adhesive.

22. The device of any one of claims 1-3, wherein the first conductive contact and the second conductive contact are attached to the intermediate body by an anisotropic conductive film.

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