Pre-connected analyte sensors

Abstract

To provide pre-connected analyte sensors.SOLUTION: A pre-connected analyte sensor includes a sensor carrier attached to an analyte sensor. The sensor carrier includes a substrate configured for mechanical coupling of the sensor to testing, calibration, or wearable equipment. The sensor carrier also includes conductive contacts for electrically coupling sensor electrodes to the testing, calibration, or wearable equipment.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE TO RELATED APPLICATIONS Any and all priority claims identified in the Application Data Sheet, or any amendments thereto, are incorporated herein by reference under 37 CFR 1.57. This application claims the benefit of U.S. Provisional Patent Application No. 62 / 576,560, filed October 24, 2017. The aforementioned applications are incorporated herein by reference in their entireties and expressly made a part hereof.

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

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

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

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

[0006] In the manufacturing process of analyte sensors, such as continuous analyte sensors, there are various steps in which temporary mechanical and electrical connections between the sensor and manufacturing equipment, such as testing and / or calibration equipment, are used. These connections are facilitated by precise placement and alignment of the sensor to the mechanical and electrical interfaces of the testing and / or calibration equipment. Devices such as "interconnects," "interposers," or "sensor carriers" can be attached to the elongated body of the sensor, as described below, to aid in handling and both temporary and permanent electrical and mechanical connections. The sensor carrier (also called a "sensor interposer") may also include functions of tracking, data storage, and sealing of the sensor electrodes from each other and the environment. Without limiting the scope of the present embodiments, as expressed by the claims that follow, their more prominent features will now be briefly discussed. After considering this discussion, and especially after reading the section entitled "Description of the Preferred Embodiments," one will understand how the features of the present embodiments provide the advantages described herein.

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

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

[0009] In a generally applicable embodiment of the first aspect (i.e., which can be independently combined with any of the aspects or embodiments identified herein), the method further comprises coating the sensor with a membrane after attaching the sensor to the sensor carrier.

[0010] In a generally applicable embodiment of the first aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first conductive portion and the second conductive portion are traces. The traces can extend from a distal end of the sensor carrier and terminate at a proximal end of the sensor carrier. The traces can form an exposed contact surface at the connection portion. The first and second conductive portions can be embedded in the intermediate body.

[0011] In a generally applicable embodiment of the first aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first conductive portion and the second conductive portion are solder welds. The solder welds can attach the sensor to the sensor carrier.

[0012] In a generally applicable embodiment of the first aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first conductive portion and the second conductive portion are conductive tapes. The conductive tape is capable of attaching the sensor to the sensor carrier.

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

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

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

[0016] In a generally applicable embodiment of the first aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the intermediate body further comprises a datum structure that controls the position and spatial orientation of the analyte sensor relative to the substrate of the intermediate body. The datum structure can comprise a flexible portion of the substrate folded over at least a portion of the analyte sensor.

[0017] In a generally applicable embodiment of the first aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first conductive portion and / or the second conductive portion comprise at least one of a coil spring, a leaf spring, or a conductive elastomer.

[0018] According to a second aspect, an apparatus is provided that includes 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. A sensor carrier can be attached to the analyte sensor. The sensor carrier can include an intermediate body, a first conductive portion disposed on the intermediate body, the first conductive portion in electrical communication with the first conductive contact, and a second conductive portion disposed on the intermediate body, the second conductive portion in electrical communication with the second conductive contact. The first and second conductive portions can form a connection portion configured to establish electrical communication between the first and second conductive contacts and a separate device.

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

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

[0021] In a generally applicable embodiment of the second aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first conductive portion and the second conductive portion comprise at least one of a solder weld, a conductive tape, a coil spring, a leaf spring, or a conductive elastomer.

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

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

[0024] In a generally applicable embodiment of the second aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the separate device is a component of a manufacturing station. At least one of the potentiostat measurement, the soaking process, the curing process, the calibration process, or the sensitivity measurement can be configured to be performed while an electrical connection is established between the sensor and the manufacturing station. The manufacturing station includes a calibration station configured to release the establishment of 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 a connection portion of the sensor carrier.

[0025] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any of the aspects or embodiments identified herein), the intermediate body further comprises a datum structure configured to control the position and spatial orientation of the analyte sensor relative to the substrate of the intermediate body.

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

[0027] In a generally applicable embodiment of the second aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first electrode and the second electrode may be fixed to a flexible planar substrate. In addition, the first electrical contact and the second electrical contact may be fixed to the flexible planar substrate.

[0028] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any of the aspects or embodiments specified herein), the first conductive contact and the second conductive contact are secured to the intermediate body with a conductive adhesive.

[0029] In a generally applicable embodiment of the second aspect (i.e., which can be independently combined with any of the aspects or embodiments specified herein), the first conductive contact and the second conductive contact are fixed to the intermediate body with an anisotropic conductive film.

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

[0031] In a generally applicable embodiment of the third aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first plurality of electrical contacts are aligned along the substrate. The first plurality of electrical contacts can be formed from the exposed contact surface.

[0032] In a generally applicable embodiment of the third aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the second plurality of electrical contacts are aligned along the substrate. The second plurality of electrical contacts can be formed from the exposed contact surface.

[0033] In a generally applicable embodiment of the third aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the first and second pluralities of electrical contacts are configured to connect with a separate device, which may be a component of a manufacturing station.

[0034] In a generally applicable embodiment of the third aspect (i.e., which may be independently combined with any of the aspects or embodiments identified herein), the substrate includes at least one singulation mechanism configured to facilitate singulation of the substrate into a plurality of sensor carriers, each of the plurality of sensor carriers being attached to a corresponding one of the analyte sensors.

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

[0036] In a generally applicable embodiment of the third aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the substrate includes an elongated dimension and the plurality of analyte sensors extend beyond an edge of the substrate in a direction perpendicular to the elongated dimension. The strip may further include a feed guide strip along an opposing edge of the substrate in the elongated dimension. The substrate may further include a flexible substrate configured to be wound onto a reel. The feed guide strip may be detachable from the substrate.

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

[0038] In a generally applicable embodiment of the third aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the strip further includes a first datum structure coupled to the strip, the first datum structure configured to position a plurality of analyte sensors, the first datum structure including at least one singulation mechanism configured to facilitate singulation of the first datum structure into a plurality of second datum structures, each of the plurality of second datum structures coupled to a corresponding one of a plurality of sensor carriers formed by the substrate.

[0039] In a generally applicable embodiment of the third aspect (i.e., which may be combined independently with any of the aspects or embodiments identified herein), the strip further comprises a carrier having a processing circuit configured to perform at least potentiostat measurements of the plurality of analyte sensors. The strip may further comprise a communications circuit operable by the processing circuit to transmit and receive data associated with each of the analyte sensors along with an identifier for the analyte sensor.

[0040] According to a fourth aspect, a method is provided. The method includes providing a pre-connected analyte sensor, the pre-connected analyte sensor including 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 a processing circuit of the manufacturing station by coupling the intermediate body to a corresponding mechanism of the manufacturing station. The method includes operating the processing circuit of the manufacturing station to communicate with the pre-connected analyte sensor.

[0041] In a generally applicable embodiment of the fourth aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), operating the processing circuitry includes obtaining a signal from the analyte sensor via the interface, and operating the processing circuitry includes operating an optical, infrared, or radio frequency reader of the manufacturing station to obtain the identifier.

[0042] In a generally applicable embodiment of the fourth aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the method further includes storing, with processing circuitry of the manufacturing station and in association with an identifier, sensor data corresponding to the signal. The identifier can identify any of the analyte sensor, calibration data for the analyte sensor, and history of the analyte sensor.

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

[0044] In a generally applicable embodiment of the fourth aspect (i.e., which may be independently combined with any of the aspects or embodiments identified herein), the method further includes removing the pre-connected analyte sensor from the manufacturing station and communicatively coupling the analyte sensor to a processing circuit of the wearable device by coupling a fastening mechanism of the intermediate body to a corresponding mechanism of the wearable device. The method may further include acquiring in vivo measurement data from the analyte sensor with the processing circuit of the wearable device.

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

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

[0047] According to a fifth aspect, a wearable device is provided. The wearable device comprises a housing and an electronic circuit configured to process an analyte sensor signal. The electronic circuit is enclosed within the housing. The analyte sensor has a distal portion positioned outside the housing. The intermediate body has electrical connections to both the proximal portion of the analyte sensor and the electronics, and the electrical connection between the intermediate body and the proximal portion of the analyte sensor is external to the housing.

[0048] In a generally applicable embodiment of the fifth aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the intermediate body may be positioned adjacent to an exterior surface of the housing. The device may include electrical contacts coupled to both the electronics and the intermediate body. The intermediate body may be electrically connected to the electrical contacts with a conductive epoxy. The intermediate body may be electrically connected to the electrical contacts with an anisotropic conductive film. The intermediate body may be encapsulated. The electrical contacts may extend through the housing. The intermediate body may be positioned in a recess on the exterior surface of the housing. The electrical contacts may extend through the housing within the recess and electrically couple the intermediate body to electronic circuitry encapsulated within the housing. The intermediate body may be covered with a polymer within the recess.

[0049] In a generally applicable embodiment of the fifth aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the analyte sensor is formed as an elongate body having a distal portion configured for percutaneous implantation into 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 circuit may comprise a potentiostat and / or a wireless transmitter.

[0050] According to a sixth aspect, there is provided a method of making a pre-connected analyte sensor, the method comprising mechanically and electrically connecting a proximal portion of an elongated conductor to a conductive portion of an intermediate body and, after 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 at the distal portion of the elongated conductor.

[0051] In generally applicable embodiments of the sixth aspect (i.e., can be independently combined with any of the aspects or embodiments identified herein), the method further includes testing the analyte sensor, where testing includes electrically coupling the intermediate body to a test station. The method can further include calibrating the analyte sensor, where calibrating includes electrically coupling the intermediate body to a test station. The coating may include a dip coating.

[0052] In a generally applicable embodiment of the sixth aspect (i.e., it can be independently combined with any of the aspects or embodiments specified herein), the intermediate body may be part of an array formed by a plurality of joined intermediate bodies, and the method further comprises mechanically and electrically connecting a proximal portion of each of the plurality of elongated electrodes to a conductive portion of each intermediate body of the array. The coating may be performed in parallel on each distal portion of each of the plurality of elongated electrodes connected to the intermediate body of the array. The method may comprise singulating one or more of the intermediate bodies of the array after coating.

[0053] In generally applicable embodiments of the sixth aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the mechanically and electrically connecting includes applying a conductive paste to the elongated conductor and the conductive portion of the intermediate body. In some embodiments, the mechanically and electrically connecting includes 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, testing, and calibration are all performed at a location remote from the connecting.

[0054] According to a seventh embodiment, a method of making an on-skin wearable device includes incorporating an electronic circuit within an interior volume of a housing, the electronic circuit configured for (1) detecting a signal generated from an electrochemical reaction beneath the skin of a subject at a working electrode of an analyte sensor, and (2) wirelessly transmitting data derived from the detected signal outside of the housing for processing and / or display in a separate device. After incorporating the electronic circuit within the interior volume of the housing, a proximal portion of the analyte sensor is attached to an external electrical interface coupled to the electronic circuit such that the electronic circuit is connected to the analyte sensor and receives signals therefrom without opening the housing.

[0055] In a generally applicable embodiment of the seventh aspect (i.e., capable of being independently combined with any of the aspects or embodiments identified herein), the method includes sealing the interface after attaching the proximal portion of the analyte sensor. The method may include testing the electronic circuit for functionality prior to attachment. The method may include testing the analyte sensor for functionality prior to attachment. The incorporating may occur at a location remote from attachment.

[0056] In a generally applicable embodiment of the seventh aspect (i.e., can be independently combined with any of the aspects or embodiments identified herein), the method may include coupling an intermediate body to a proximal portion of the analyte sensor, and the attaching may include attaching the intermediate body to an external electrical interface. The method may then include performing at least one manufacturing or testing procedure on the working electrode using the intermediate body prior to the attaching. The performing may include coating the working electrode of the analyte sensor. The coupling is performed at a first location, the incorporating is performed at a second location, and the performing is performed at a third location, the first, second, and third locations being remote from each other. The attaching and / or coupling may be performed with an anisotropic conductive film. The method may further include attaching an inserter to the housing for implanting the working electrode in the subject.

[0057] It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art from this disclosure, and that various configurations of the subject technology are shown and described by way of example. As will be understood, the subject technology is capable of other different configurations, and its several details can be modified in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive.

[0058] The present embodiments will now be described in detail, with an emphasis on highlighting the advantageous features. These embodiments are for illustrative purposes only and are not to scale, instead emphasizing the principles of the present disclosure. These drawings include the following figures, in which like numerals indicate like parts: [Brief description of the drawings]

[0059] [Figure 1] FIG. 1 is a schematic diagram of an analyte sensor system attached to a host and in communication with multiple exemplary devices, according to some embodiments. [Diagram 2] 2 is a block diagram illustrating electronics associated with the sensor system of FIG. 1 in accordance with some embodiments. [Figure 3A] 1 illustrates a wearable device having an analyte sensor according to some embodiments. [Figure 3B] 1 illustrates a wearable device having an analyte sensor according to some embodiments. [Figure 3C] 1 illustrates a wearable device having an analyte sensor according to some embodiments. [Figure 3D] 1 shows an example implementation of an elongated sensor connected to a potentiostat. [Figure 4A] 1 shows a schematic diagram of a pre-connected analyte sensor system according to some embodiments. [Figure 4B] FIG. 1 shows another schematic diagram of a pre-connected analyte sensor system according to some embodiments. [Figure 4C] 1 illustrates a hierarchical diagram of a pre-connected analyte sensor system according to some embodiments. [Figure 4D] FIG. 1 shows a schematic diagram of an array of pre-connected analyte sensor systems according to some embodiments. [Figure 5A] FIG. 1 illustrates a block diagram of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments. [Figure 5B] FIG. 1 illustrates a block diagram of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments. [Figure 5C] FIG. 1 illustrates a block diagram of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments. [Figure 5D] FIG. 1 illustrates a block diagram of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments. [Figure 5E] FIG. 1 illustrates a block diagram of a system having a manufacturing system and a wearable device for an analyte sensor, according to some embodiments. [Figure 6] FIG. 1 shows a schematic cross-sectional view of a wearable device with a pre-connected analyte sensor, according to some embodiments. [Figure 7] FIG. 1 shows a schematic cross-sectional view of a wearable device with a pre-connected analyte sensor, according to some embodiments. [Figure 8] FIG. 1 shows a schematic cross-sectional view of a wearable device with a pre-connected analyte sensor, according to some embodiments. [Figure 9] FIG. 1 illustrates a perspective view of an on-skin sensor assembly according to some embodiments. [Figure 10] 1 illustrates a perspective view of a sensor carrier having a spring according to some embodiments. [Figure 11] 1 illustrates a perspective view of a sensor carrier having a spring according to some embodiments. [Figure 12] 1 illustrates a cutaway perspective view of a portion of a sensor carrier according to some embodiments. [Figure 13A] FIG. 1 illustrates a perspective view of a wearable sensor assembly according to some embodiments. [Figure 13B] FIG. 1 illustrates a perspective view of a wearable sensor assembly according to some embodiments. [Figure 13C] FIG. 1 illustrates an exploded view of components of a wearable sensor assembly, according to some embodiments. [Figure 14A] FIG. 1 illustrates a perspective view of another wearable sensor assembly according to some embodiments. [Figure 14B] FIG. 1 illustrates a perspective view of another wearable sensor assembly according to some embodiments. [Figure 14C] FIG. 13 illustrates an exploded view of components of another wearable sensor assembly according to some embodiments, including an embodiment of an external electrical interface. [Figure 14D] FIG. 14D shows a top view of the external electrical interface of FIG. 14C with a pre-connected sensor assembly attached. [Figure 14E] FIG. 14E is a cross-sectional view taken along line EE of FIG. 14D. [Figure 15A]13 illustrates another embodiment of a printed circuit board for a sensor carrier. [Figure 15B] 13 illustrates an alternative embodiment for coupling a sensor and a sensor carrier to an electrical interface of a wearable sensor assembly. [Figure 15C] 13 illustrates an alternative embodiment for coupling a sensor and a sensor carrier to an electrical interface of a wearable sensor assembly. [Figure 16] 1 shows a top view of a sensor carrier attached to an analyte sensor with a conductive adhesive according to some embodiments. [Figure 17] 1 shows an end view of a sensor carrier attached to an analyte sensor with a conductive adhesive according to some embodiments. [Figure 18] 1 shows an end view of a sensor carrier with an analyte sensor attached with a conductive adhesive in a recess in a sensor carrier substrate according to some embodiments. [Figure 19] 1 shows an end view of a sensor carrier with an analyte sensor attached to a corner of the sensor carrier substrate using a conductive adhesive, according to some embodiments. [Figure 20] 1 shows an end view of a sensor carrier with an analyte sensor attached with a conductive adhesive in a round recess in a sensor carrier substrate according to some embodiments. [Figure 21A] FIG. 1 shows a perspective view of an analyte sensor mounted on a sensor carrier of a guide structure. [Figure 21B] 1 shows an end view of an analyte sensor mounted on a sensor carrier in a guide structure. [Figure 22] FIG. 1 shows a top view of a sensor carrier attached to an analyte sensor with conductive tape according to some embodiments. [Figure 23] 1 shows a top view of a sensor carrier having a substrate attached and wrapped around an analyte sensor according to some embodiments. [Figure 24] FIG. 13 shows a top view of a sensor carrier attached to an analyte sensor with welded conductive plastic, according to some embodiments. [Diagram 25]1 illustrates a manufacturing apparatus for attaching an analyte sensor to a sensor carrier using conductive plastic, according to some embodiments. [Figure 26] 1 illustrates a manufacturing apparatus for attaching an analyte sensor to a sensor carrier using conductive plastic, according to some embodiments. [Figure 27] FIG. 13 is a schematic perspective view illustrating a proximal portion of an analyte sensor having a flattened electrical connector portion according to some embodiments. [Figure 28] 25 shows a side view of the analyte sensor of FIG. 24 mounted on a sensor carrier according to some embodiments. [Figure 29] 1 shows a top view of a sensor carrier having a flexible substrate configured to wrap around an analyte sensor according to some embodiments. [Diagram 30] FIG. 1 shows a perspective view of a sensor carrier having a substrate with a flexible portion configured to wrap around an analyte sensor, according to some embodiments. [Figure 31A] 1 illustrates another embodiment of a sensor carrier attached to an analyte sensor. [Figure 31B] 1 illustrates another embodiment of a sensor carrier attached to an analyte sensor. [Diagram 32] 1A-1D show top views of a sensor carrier having movable fasteners for attaching an analyte sensor according to some embodiments. [Diagram 33] 30 shows a perspective view of the movable fastener of FIG. 29 according to some embodiments. [Diagram 34] FIG. 1 illustrates a perspective view of a sensor carrier implemented as a barrel fastener, according to some embodiments. [Figure 35A] FIG. 1 shows a front view of a sensor carrier having a flexible substrate wrapped around an analyte sensor according to some embodiments. [Figure 35B] FIG. 1 shows a perspective view of a sensor carrier having a flexible substrate wrapped around a plurality of analyte sensors according to some embodiments. [Diagram 36]1 illustrates an end view of a sensor carrier having a crimp connector according to some embodiments. [Figure 37] 1 shows an end view of a sensor carrier attached to an analyte sensor with a crimp connector according to some embodiments. [Figure 38] 1 illustrates a side view of a sensor carrier having a crimp connector according to some embodiments. [Figure 39] 1 illustrates a perspective view of a sensor carrier according to some embodiments. [Diagram 40] 1 illustrates a perspective view of a sensor carrier formed from a molded interconnect device according to some embodiments. [Diagram 41] 1 illustrates a top view of a sensor carrier formed from a molded interconnect device according to some embodiments. [Diagram 42] 1 illustrates a side view of a sensor carrier attached to an analyte sensor by a conductive coupler according to some embodiments. [Diagram 43] FIG. 1 illustrates a side view of a sensor carrier having an elongated dimension for attachment to multiple analyte sensors, according to some embodiments. [Diagram 44] FIG. 1 shows a top view of a sensor carrier having a flexible substrate for wrapping around an analyte sensor according to some embodiments. [Diagram 45] FIG. 13 shows a top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor according to some embodiments. [Diagram 46] FIG. 13 shows a top view of another sensor carrier having a flexible substrate for wrapping around an analyte sensor according to some embodiments. [Figure 47A] FIG. 13 shows a side view of a sensor carrier having feed guide strips on the elongated dimension for attachment to multiple analyte sensors, according to some embodiments. [Figure 47B] FIG. 47B illustrates a perspective view of the sensor carrier of FIG. 47A wound on a reel, according to some embodiments. [Figure 48]FIG. 47B shows a top view of the sensor carrier of FIG. 47A after the sensor carrier has been singulated from the sensor carrier, according to some embodiments. [Figure 49] FIG. 1 shows a perspective view of a sensor carrier having spring-loaded receptacles for mounting multiple analyte sensors, according to some embodiments. [Figure 50] FIG. 1 shows a perspective view of a sensor carrier having a magnetic datum feature for positioning and orienting multiple analyte sensors according to some embodiments. [Figure 51A] FIG. 1 shows a top view of a sensor carrier having a rigid-flex panel for mounting multiple analyte sensors according to some embodiments. [Figure 51B] FIG. 1 shows a top view of a sensor carrier having a rigid-flex panel for mounting multiple analyte sensors with edge card connector pads for electrical connections according to some embodiments. [Figure 52A] 49 shows a top view of a sensor carrier singulated from the sensor carrier of FIG. 48 and attached to an analyte sensor to form a pre-connected sensor, according to some embodiments. [Figure 52B] FIG. 48C illustrates a sensor carrier having a rigid-flex panel for attachment to multiple analyte sensors of FIG. 48B without the V-notch portions, according to some embodiments. [Figure 53A] 1 illustrates a pre-connected sensor attached to a wearable device, according to some embodiments. [Figure 53B] 13 illustrates a pre-connected sensor in a folded position attached to a wearable device according to some embodiments. [Figure 54] 1 illustrates a sensor carrier implemented as a daughter board for connection to an analyte sensor according to some embodiments. [Figure 55] 1 illustrates a sensor carrier mounted with a pinch clip according to some embodiments. [Figure 56] 1 illustrates a sensor carrier having clips for connection to an analyte sensor, according to some embodiments. [Figure 57] 1 is a flowchart of example operations that may be performed to manufacture and use a pre-connected sensor, according to some embodiments. [Figure 58] 1 illustrates a perspective view of a sensor retention device having a grooved flexible tube according to some embodiments. [Figure 59] 59 shows an exploded perspective view of the device of FIG. 58 according to some embodiments. [Figure 60] 56 illustrates a device including a sensor attached to the apparatus of FIG. 55 according to some embodiments. [Figure 61] 1 illustrates a diagram of a carrier for pre-connected sensors according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0060] Like numbers refer to like elements throughout and elements are not to scale unless otherwise noted.

[0061] The following description and examples illustrate in detail some exemplary implementations, embodiments, and configurations of the disclosed invention. Those skilled in the art will recognize that there are many variations and modifications of the invention that are encompassed by the scope of the invention. Thus, the description of a particular exemplary embodiment should not be considered as limiting the scope of the invention.

[0062] definition To facilitate understanding of the various embodiments described herein, certain terms are defined below.

[0063] As used herein, the term "analyte" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a substance or chemical component in a bodily fluid (e.g., blood, interstitial fluid, cerebrospinal fluid, lymphatic fluid, or urine) that may be analyzed. Analytes may include naturally occurring substances, man-made substances, metabolites, or reaction products. In some embodiments, the analyte for measurement by the sensor head, devices, and methods is an analyte. However, other analytes are considered as well, including acarboxyprothrombin, acylcarnitines, adenine phosphoribosyltransferase, adenosine deaminase, albumin, α-fetoprotein, amino acid profile (arginine (Krebs cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan), andrenostenedione, antipyrine, arabinitol enantiomers, arginase, benzoylecgonine (cocaine), biotinidase, biopterin, c-reactive protein, carnitine, carnosinase, CD4, ceruloplasmin, chenodeoxycholic acid, chloroquine, cholesterol, cholinesterase, conjugated 1-β-hydroxycholic acid, cortisol, creatine kinase, creatine kinase MM isoenzyme, cyclosporine A, D-penicillin, Lamin, de-ethylchloroquine, dehydroepiandrosterone sulfate, DNA (acetylation polymorphisms), alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus , HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sex differentiation, 21-deoxycortisol), desbutylhalofantrine, dihydropteridine reductase, diphtheria / tetanus antitoxin, erythrocyte arginase, erythrocyte protoporphyrin, esterase D, fatty acids / acylglycines, free β-human chorionic gonadotropin, free erythrocyte porphyrin,Free thyroxine (FT4), free tri-iodothyronine (FT3), fumarylacetoacetase, galactose / gal-1-phosphate, galactose-1-phosphate uridyltransferase, gentamicin, analyte-6-phosphate dehydrogenase, glutathione, glutathione peroxidase, glycocholate, glycosylated hemoglobin, halofantrine, hemoglobin variants, hexosaminidase A, human erythrocyte carbonic anhydrase I, 17-α-hydroxyprogesterone, hypoxanthine phosphoribosyltransferase, immunoreactive trypsin, lactate, Lead, lipoproteins ((a), B / A-1, β), lysozyme, mefloquine, netilmicin, phenobarbitone, phenytoin, phytanic acid / pristanic acid, progesterone, prolactin, prolidase, purine nucleoside phosphorylase, kinin, inverted tri-iodothyronine (rT3), selenium, serum pancreatic lipase, sisomicin, somatomedin C, specific antibodies (adenovirus, antinuclear antibody, anti-zeta antibody, arbovirus, pseudorabies virus, dengue virus, dracunculia, tapeworm, cecum, entamoeba histolytica, enterovirus, Giardia lamblia (giardia duodenalisa, Helicobacter pylori, Hepatitis B virus, Herpes 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, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi / Langer, Vesicular stomatitis virus virus), Wuchereria bancrofti, Yellow fever virus), specific antigens (Hepatitis B virus, HIV-1), acetoacetate, sulfadoxine, theophylline, thyrotropin (TSH), thyroxine (T4), thyroxine-binding globulin, trace elements, transferrin, UDP-galactose-4-epimerase, urea, uroporphyrinogen I synthase, vitamin A, leukocytes, and zinc protoporphyrin.The analytes may be introduced into the body as, for example, contrast agents for diagnostic imaging, radioisotopes, chemical agents, fluorocarbon-based artificial blood, or drugs or pharmaceutical compositions, including, but not limited to, insulin, ethanol, cannabis (marijuana, tetrahydrocannabinol, hashish), inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons), cocaine (crack cocaine), stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine), depressants (barbiturates, methaqualone, tranquilizers, e.g., For example, Valium, Librium, Miltown, Serax, Equanil, Tranxene), hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin), narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil), designer drugs (fentanyl, meperidine, amphetamine, methamphetamine, and analogs of phencyclidine, e.g., Ecstasy), anabolic steroids, and nicotine can be introduced into the body. Metabolites of drugs and pharmaceutical compositions can also be considered as analytes. Analytes such as neurochemicals and other chemical intermediates produced in the body, e.g., ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA), may be analyzed.

[0064] As used herein, the term "microprocessor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a computer system, state machine, and the like that performs arithmetic and logical operations using logic circuitry that responds to and processes the basic instructions that drive a computer.

[0065] As used herein, the term "calibration" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers, without limitation, to a process of determining a relationship between sensor data and corresponding reference data that may be used to convert the sensor data into a meaningful value substantially equivalent to the reference data, with or without utilizing the reference data in real time. In some embodiments, i.e., analyte sensors, the calibration may be updated or recalibrated over time (at the factory, in real time and / or historically) as changes in the relationship between the sensor data and the reference data occur, e.g., due to changes in sensitivity, baseline, transport, metabolism, etc.

[0066] As used herein, the terms "calibrated data" and "calibrated data stream" are broad terms having their ordinary and customary meanings as indicated to those skilled in the art (and are not limited to any special or customized meanings) and refer to, but are not limited to, data that has been transformed from its raw state to another state using a function, e.g., a transformation function, including through the use of sensitivity, to provide a meaningful value to a user.

[0067] As used herein, the term "algorithm" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning), and refers to, but is not limited to, a computational process (e.g., a program) involved in transforming information from one state to another, for example, using computer processing.

[0068] As used herein, the term "sensor" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a component or region of a device that quantifies an analyte. A "lot" of sensors generally refers to a group of sensors manufactured on or about the same day and using the same processes and tools / materials. Additionally, sensors that measure temperature, pressure, etc. may be referred to as "sensors."

[0069] As used herein, the terms "glucose sensor" and "component for determining the amount of glucose in a biological sample" are broad terms and are given their ordinary and customary meanings to those of skill in the art (and are not limited to any special or customized meanings) and refer to, but are not limited to, any mechanism for quantifying glucose (e.g., enzymatic or non-enzymatic). For example, some embodiments utilize a membrane containing glucose oxidase, which catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate, as illustrated by the following chemical reaction: Glucose + O2 → Gluconate + H2O2

[0070] For each glucose molecule metabolized, there is a proportional change in the co-reactant O2 and product H2O2, so electrodes can be used to monitor the current change in the co-reactant or product to determine the glucose concentration.

[0071] As used herein, the terms "operably connected" and "operably linked" are broad terms given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings) and refer to, but are not limited to, one or more components being linked to another component(s) in a manner that allows for the transmission of a signal between the components. For example, one or more electrodes can be used to detect the amount of glucose in a sample and convert that information into a signal, e.g., an electrical or electromagnetic signal, which can then be transmitted to an electronic circuit. In this case, the electrodes are "operably linked" to the electronic circuit. These terms are broad enough to include wireless connections.

[0072] The term "determining" encompasses a variety of actions. For example, "determining" may include calculating, computing, processing, deriving, investigating, searching (e.g., searching in a table, database or other data structure), checking, and the like. "Determining" may also include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. "Determining" may also include resolving, selecting, choosing, calculating, deriving, establishing, and the like. Determining may include verifying that a parameter matches a predetermined criterion, including meeting, passing, exceeding a threshold, and the like.

[0073] As used herein, the term "substantially" is intended to be broad and have its ordinary and accustomed meaning given to those of ordinary skill in the art (and is not intended to be limited to a special or customized meaning), and refers to most, but not entirely, of what is specified.

[0074] As used herein, the term "host" is a broad term having its ordinary and customary meaning given to those of skill in the art (and is not intended to be limited to any special or customized meaning), and refers to mammals, particularly, but not limited to, humans.

[0075] As used herein, the term "continuous analyte (or glucose) sensor" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning), including, but not limited to, a device that continuously or uninterruptedly measures the concentration of an analyte, for example, over a time interval ranging from a fraction of a second to, for example, 1, 2, or 5 minutes or more. In one exemplary embodiment, the continuous analyte sensor is a glucose sensor, such as those described in U.S. Patent No. 6,001,067, which is incorporated herein by reference in its entirety.

[0076] As used herein, the term "sensing membrane" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers, without limitation, to a permeable or non-permeable membrane that may be composed of two or more domains and is typically several microns or thicker, constructed of materials that are permeable to oxygen and permeable or impermeable to glucose. In one example, the sensing membrane includes immobilized glucose oxidase enzyme, which can generate an electrochemical reaction to measure glucose concentration.

[0077] As used herein, the term "sensor data" is a broad term and is intended to have its ordinary and customary meaning as indicated to those skilled in the art (and is not limited to any special or customized meaning) and refers to any data associated with a sensor, such as a continuous analyte sensor, but is not limited to such. Sensor data includes a raw data stream, or simply a data stream, of an analog or digital signal directly related to the analyte being measured from an analyte sensor (or other signal received from another sensor), as well as calibrated and / or filtered raw data. In one example, sensor data includes digital data of "counts" converted by an A / D converter from an analog signal (e.g., voltage or amperes) and includes one or more data points representing glucose concentration. Thus, the terms "sensor data point" and "data point" generally refer to a digital representation of sensor data at a particular time. The terms broadly encompass multiple time interval data points from a sensor, such as a substantially continuous glucose sensor, including individual measurements made at time intervals ranging from a fraction of a second to, for example, one, two, or five minutes or more. In another example, sensor data includes an integrated digital value representing one or more data points averaged over a period of time. The sensor data may include calibration data, smoothed data, filtered data, conversion data, and / or other data associated with the sensor.

[0078] As used herein, the term "sensor electronics" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, the components of a device (e.g., hardware and / or software) configured to process data. As described in more detail below (see, e.g., FIG. 2), the "sensor electronics" may be arranged and configured to measure, convert, store, transmit, communicate, and / or retrieve sensor data associated with an analyte sensor.

[0079] As used herein, the term "sensitivity" or "sensor sensitivity" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, the amount of signal generated by a given concentration of the analyte being measured or the sample being measured (e.g., H2O2) associated with the analyte being measured (e.g., glucose). For example, in one embodiment, the sensor has a sensitivity of about 1 to about 300 picoamps of current per mg / dL of glucose analyte.

[0080] As used herein, the term "sample" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to a sample of a host body, such as a bodily fluid, including, but not limited to, blood, serum, plasma, interstitial fluid, cerebrospinal fluid, lymphatic fluid, ocular fluid, saliva, oral fluid, urine, excreta, or exudates.

[0081] As used herein, the term "distal to" is a broad term that is given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. In general, the term indicates that one element is relatively farther from the reference point than another element.

[0082] As used herein, the term "proximal to" is a broad term that is given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, the spatial relationship between various elements relative to a particular reference point. In general, the term indicates that an element is relatively closer to a reference point than another element.

[0083] As used herein, the terms "electrical connection" and "electrical contact" are broad terms and are given their ordinary and customary meanings to those skilled in the art (and are not limited to any special or customized meanings), and refer to, but are not limited to, any connection between two electrical conductors known to those skilled in the art. In one embodiment, the electrodes are in electrical connection (e.g., electrically connected) with the electronic circuitry of the device. In another embodiment, two materials, such as, but not limited to, two metals, can be in electrical contact with each other such that current can flow from one of the two materials to the other and / or an electrical potential can be applied.

[0084] As used herein, the term "elongated conductor" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, an elongated body formed on at least a portion of a conductive material and including any number of coatings that may be formed thereon. By way of example, an "elongated conductive body" may mean a bare elongated conductive core (e.g., a metal wire), an elongated conductive core coated with one, two, three, four, five, or more layers of material (each of which may or may not be conductive), a trace, and / or an electrode coated thereon with one, two, three, four, five, or more layers of material (each of which may or may not be conductive).

[0085] As used herein, the term "ex vivo component" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted to reside and / or exist outside the host organism.

[0086] As used herein, the term "in vivo part" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, a portion of a device (e.g., a sensor) that is adapted for insertion into and / or residing within the host's living body.

[0087] As used herein, the term "potentiostat" is a broad term given its ordinary and customary meaning to those of skill in the art (and is not intended to be limited to any special or customized meaning) and refers to, but is not limited to, an electrical device that controls the electrical potential between a working electrode and a reference electrode at one or more preset values.

[0088] As used herein, the term "processor module" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning) and refers to, but is not limited to, computer systems, state machines, processors, components thereof, and the like, designed to perform arithmetic or logical operations using logic circuitry that responds to and processes the basic instructions that drive a computer.

[0089] As used herein, the term "sensor session" is a broad term given its ordinary and customary meaning to those skilled in the art (and is not limited to any special or customized meaning), including, but not limited to, the period from implantation of a sensor (e.g., by a host) until removal of the sensor (e.g., removal of the sensor from the host's body and / or removal of the system electronics (e.g., disconnection therefrom)).

[0090] As used herein, the terms "substantial" and "substantially" are broad terms that are to be given their ordinary and accustomed meaning to those of ordinary skill in the art (and are not to be limited to any special or customized meaning), and refer to a sufficient amount to provide a desired functionality, including, but not limited to, a desired amount.

[0091] "Coaxial two-conductor based sensor": A round wire sensor consisting of a conductive central core, an insulating middle layer, and a conductive outer layer with the conductive layer exposed at one end for electrical contact.

[0092] "Pre-connected sensor": a sensor that has a "sensor interconnect / interposer / sensor carrier" connected to it. This "pre-connected sensor" therefore consists of two parts: the sensor itself and the interconnect / interposer / sensor carrier. The term "pre-connected sensor" unit refers to the unit formed by the permanent joining of these two different parts.

[0093] Other definitions are provided within the description which follows and, in some cases, from the context of the use of a term.

[0094] As used herein, the following abbreviations apply: Eq and Eq (equivalent), mEq (milli-equivalent), M (mole), mM (milli-mole), μM (micro-mole), N (normal), mol (mole), mmol (milli-mole), μmol (micro-mole), nmol (nanomole), g (gram), mg (milligram), μg (microgram), Kg (kilogram), (liter), mL (milli-liter), dL (deci-liter), μL (micro-liter), cm (centimeter), mm (millimeter), μm (micrometer), nm (nanometer), h and hr (hours), min. (minutes), s and sec (seconds), °C (Celsius) °F (Fahrenheit), Pa (pascal), kPa (kilopascal), MPa (megapascal), GPa (gigapascal), Psi (pounds per square inch), kPsi (pounds per square inch).

[0095] System Overview / Overview In vivo analyte sensing techniques may rely on in vivo sensors, which may include an elongated conductive body having one or more electrodes, such as a working electrode and a reference electrode.

[0096] For example, a tantalum wire clad with platinum metal may be used as a bare core sensing element with one or more reference or counter electrodes for an analyte sensor, which is then coated with a membrane to obtain the final sensor.

[0097] Described herein are pre-connected sensors that include an analyte sensor (also referred to herein as a "sensor interposer") mounted on a sensor carrier. The analyte sensor may include a working electrode and a reference electrode at a distal end of an elongated conductive body. The sensor carrier may include circuitry such as a substrate, one or more electrical contacts coupled to one or more electrical contacts of the sensor, and one or more additional or external electrical contacts for coupling the one or more electrical contacts coupled to the sensor contact(s) to external equipment such as a membrane dip coating station, a testing station, a calibration station, or sensor electronics of a wearable device. In some embodiments, the substrate may be referred to as an intermediate body.

[0098] The following description and examples describe the present embodiments with reference to the drawings, in which reference numbers label elements of the present embodiments, and which are reproduced below in conjunction with the description of the corresponding drawing features.

[0099] Sensor Systems FIG. 1 illustrates an exemplary system 100 according to some exemplary implementations. The system 100 includes an analyte sensor system 101 including a sensor electronics 112 and an analyte sensor 138. The system 100 may include other devices and / or sensors, such as a drug delivery pump 102 and a glucose meter 104. The analyte sensor 138 may be physically connected to the sensor electronics 112, may be integral with the sensor electronics (e.g., non-removably attached), or may be removably attached. For example, a continuous analyte sensor 138 may be connected to the sensor electronics 112 via a sensor carrier that mechanically and electrically interfaces the analyte sensor 138 with the sensor electronics. The sensor electronics 112, the drug delivery pump 102, and / or the glucose meter 104 may be coupled to one or more devices, such as display devices 114, 116, 118, and / or 120.

[0100] In some example implementations, the system 100 may include a cloud-based analyte processor 490 configured to analyze analyte data (and / or other patient-related data) provided over the network 409 (e.g., via wired, wireless, or combinations thereof) from the sensor system 101 and other devices, such as the display devices 114, 116, 118, and / or 120, associated with the host (also referred to as the patient), to generate reports that provide high-level information, such as statistics, regarding analytes measured over a particular time frame. A detailed description of the use of a cloud-based analyte processing system may be found in U.S. Patent Application No. 13 / 788,375, entitled "Cloud-Based Processing of Analyte Data," filed March 7, 2013, published as U.S. Patent Application Publication No. 2013 / 0325352, which is incorporated herein by reference in its entirety. In some implementations, one or more steps of a factory calibration algorithm may be performed in the cloud.

[0101] In some exemplary implementations, the sensor electronics 112 may include electronic circuitry associated with measuring and processing data generated by the analyte sensor 138. This generated analyte sensor data may include algorithms that can be used to process and calibrate the analyte sensor data, although these algorithms may be provided in other manners. The sensor electronics 112 may include hardware, firmware, software, or a combination thereof that provides a measurement of the level of an analyte via an analyte sensor, such as a glucose sensor. Exemplary implementations of the sensor electronics 112 are further described below with respect to FIG. 2.

[0102] In one implementation, the factory calibration algorithms described herein may be performed by the sensor electronics.

[0103] As mentioned above, the sensor electronics 112 may be coupled (e.g., wirelessly, etc.) with one or more devices, such as the display devices 114, 116, 118, and / or 120. The display devices 114, 116, 118, and / or 120 may be configured to present (and / or alert) information, such as sensor information, transmitted by the sensor electronics 112 for display on the display devices 114, 116, 118, and / or 120.

[0104] In one implementation, the factory calibration algorithms described herein may be performed at least in part by the display device.

[0105] In some example implementations, the relatively small key fob-like display device 114 may comprise a watch, a belt, a necklace, a pendant, jewelry, an adhesive patch, a pager, a key fob, a plastic card (e.g., a credit card), an identification (ID) card, and / or the like. This small display device 114 may include a relatively small display (e.g., smaller than the large display device 116) and may be configured to display a particular type of displayable sensor information, such as a numerical value, an arrow, or a color code.

[0106] In some example implementations, the relatively large handheld display device 116 may include a handheld receiver device, a palmtop computer, etc. This large display device may include a relatively large display (e.g., larger than the small display device 114) and may be configured to display information such as a graphical representation of sensor data, including current and historical sensor data, output by the sensor system 100.

[0107] In some example implementations, the analyte sensor 138 may comprise a glucose sensor configured to measure glucose in blood or interstitial fluid using one or more measurement techniques, such as enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, colorimetric, iontophoretic, radiometric, immunochemical, etc. In implementations in which the analyte sensor 138 includes a glucose sensor, the glucose sensor may comprise any device capable of measuring the concentration of glucose and may measure glucose using a variety of techniques, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring) to provide data, such as a data stream indicative of the glucose concentration in the host. The data stream may be sensor data (raw and / or filtered) that may be converted into a calibrated data stream used to provide glucose values ​​to a host, such as a user, patient, or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual interested in the health of the host). Additionally, the analyte sensor 138 may be implanted as at least one of the following types of analyte sensors: an implantable glucose sensor, a transcutaneous glucose sensor that is implanted within the host's blood vessel or externally, a subcutaneous sensor, a refillable subcutaneous sensor, and an intravascular sensor.

[0108] Although the disclosure herein refers to some implementations including an analyte sensor 138 comprising a glucose sensor, the analyte sensor 138 may include other types of analyte sensors as well. Also, while some implementations refer to the glucose sensor as an implantable glucose sensor, other types of devices capable of detecting the concentration of glucose and providing an output signal representative of the glucose concentration may be used as well. Additionally, while the description herein refers to glucose as the analyte to be measured, processed, etc., other analytes may be used as well, including, for example, ketone bodies (e.g., acetone, acetoacetate and beta-hydroxybutyrate, lactate, etc.), glucagon, acetyl-CoA, triglycerides, fatty acids, citric acid cycle intermediates, choline, insulin, cortisol, testosterone, etc.

[0109] In some manufacturing systems, the sensors 138 are manually sorted, placed in fixtures, and held in fixtures. These fixtures are manually moved from station to station during manufacturing for various process steps including interfacing with electrical measurement equipment for test and calibration operations. However, manual manipulation of the sensors can be inefficient, can cause delays due to non-ideal mechanical and electrical connections, risks damage to the sensors and / or test and calibration equipment, and can cause sensor variability that can lead to inaccurate validation data collected during manufacturing. Additionally, the process of packaging the sensors 138 with the sensor electronics 112 into a wearable device involves further manual manipulation of the sensors that can damage the sensors 138.

[0110] Various systems, devices, and methods described herein help reduce or eliminate manual interaction with sensors. For example, a pre-connected sensor may be provided that includes a sensor interconnect or sensor carrier that is electrically connected to the sensor electrodes and has mechanical and electrical features configured to precisely interface with wearable electronics, automated equipment, and / or robustly connect to measurement equipment.

[0111] Identification and other data associated with each sensor may be stored in the sensor carrier for logging and tracking of each sensor during manufacturing, testing, calibration, and in vivo operation. After testing and calibration operations, the sensor carrier may be used to connect the sensor to the sensor electronics of a wearable device, such as an on-skin sensor assembly, in a sealed, electrically robust arrangement.

[0112] 2 illustrates examples of electronics 112 that may be used in sensor electronics 112 or implemented in a manufacturing station, such as a test station, calibration station, smart carrier, or other equipment used during the manufacture of device 101, according to some example implementations. Sensor electronics 112 may include electronic components configured to process sensor information, such as sensor data, and generate, for example, via a processor module, converted sensor data and displayable sensor information. For example, the processor module may convert the sensor data into one or more of the following: filtered sensor data (e.g., one or more filtered analyte concentration values), raw sensor data, calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, acceleration / deceleration information, sensor diagnostic information, position information, alarm / alert information, calibration information as may be determined by a factory calibration algorithm, smoothing and / or filtering algorithms disclosed herein, and / or the like.

[0113] In some embodiments, the processor module 214 is configured to accomplish a significant portion, if not all, of the data processing, including data processing related to factory calibration. The processor module 214 may be integral with the sensor electronics 112 and / or may be located remotely, such as in one or more of the devices 114, 116, 118, and / or 120 and / or in the cloud 490. For example, in some embodiments, the processor module 214 may be located at least partially within the cloud-based analyte processor 490 or elsewhere in the network 409.

[0114] In some exemplary implementations, the processor module 214 may be configured to calibrate the sensor data, and the data storage memory 220 may store the calibrated sensor data points as transformed sensor data. The processor module 214 may also be configured to wirelessly receive calibration information from a display device, such as the devices 114, 116, 118, and / or 120, in some exemplary implementations to enable calibration of the sensor data from the sensor 138. Furthermore, the processor module 214 may be configured to perform additional algorithmic processing on the sensor data (e.g., the calibrated and / or filtered data and / or other sensor information), and the data storage memory 220 may be configured to store the transformed sensor data and / or sensor diagnostic information associated with the algorithm. The processor module 214 may further be configured to store and use calibration information determined from a factory calibration, as described below.

[0115] In some example implementations, the sensor electronics 112 may comprise an application specific integrated circuit (ASIC) 205 coupled to a user interface 222. The ASIC 205 may further include a potentiostat 210, a telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and / or 120, and / or other components for signal processing and data storage (e.g., a processor module 214 and a data storage memory 220). Although FIG. 2 illustrates an ASIC 205, other types of circuits may be used as well, including a field programmable gate array (FPGA), one or more microprocessors configured to provide some (if not all) of the processing performed by the sensor electronics 12, analog circuits, digital circuits, or combinations thereof.

[0116] In the example shown in FIG. 2, via a first input port 211 for sensor data, the potentiostat 210 is coupled to an analyte sensor 138, such as a glucose sensor, to generate sensor data from the analyte. The potentiostat 210 may be coupled to a working electrode 211 and a reference electrode 212 that form part of the sensor 138. The potentiostat may provide a voltage to one of the electrodes 211, 212 of the analyte sensor 138 to bias the sensor for measurement of a value (e.g., current) of the analyte concentration (also referred to as the analog part) in the host. The potentiostat 210 may have one or more connections to the sensor 138 depending on the number of electrodes (such as a counter electrode as a third electrode) incorporated in the analyte sensor 138.

[0117] In some exemplary implementations, the potentiostat 210 may include a resistor that converts the current value from the sensor 138 into a voltage value, and in some exemplary implementations, a current-to-frequency converter (not shown) may be configured to continuously integrate the measured current value from the sensor 138 using, for example, a charge counting device. In some exemplary implementations, an analog-to-digital converter (not shown) may digitize the analog signal from the sensor 138 into so-called "counts" to allow processing by the processor module 214. The resulting counts may be directly related to the current measured by the potentiostat 210, which may be directly related to an analyte level, such as a glucose level, in the host.

[0118] The telemetry module 232 may be operatively connected to the processor module 214 and may provide hardware, firmware, and / or software to enable wireless communication between the sensor electronics 112 and one or more other devices, such as a display device, a processor, a network access device, etc. Various wireless technologies that may be implemented in the telemetry module 232 include Bluetooth, Bluetooth Low-Energy, ANT, ANT+, ZigBee, IEEE 802.11, IEEE 802.16, cellular radio access technology, radio frequency (RF), infrared (IR), paging network communication, magnetic induction, satellite data communication, spread spectrum communication, frequency hopping communication, short range wireless communication, and / or the like. In some example implementations, the telemetry module 232 includes a Bluetooth chip, although Bluetooth technology may be implemented in a combination of the telemetry module 232 and the processor module 214.

[0119] The processor module 214 may control the processing performed by the sensor electronics 112. For example, the processor module 214 may be configured to process data (e.g., counts) from the sensors, filter the data, calibrate the data, perform fail-safe checks, and / or the like.

[0120] The potentiostat 210 may measure an analyte (eg, glucose, etc.) at discrete time intervals or continuously, for example, using a current-to-voltage or current-to-frequency converter.

[0121] The processor module 214 may further include a data generator (not shown) configured to generate data packages for transmission to devices such as the display devices 114, 116, 118, and / or 120. Additionally, the processor module 214 may generate data packets for transmission to these external sources via the telemetry module 232. In some example implementations, the data packages may include identifier codes for the sensors and / or sensor electronics 112, raw data, filtered data, calibrated data, rate of change information, trend information, error detection or correction, and / or the like.

[0122] The processor module 214 may also include a program memory 216 and other memory 218. The processor module 214 may be coupled to a communications interface, such as a communications port 238, and a power source, such as a battery 234. In addition, the battery 234 may be further coupled to a battery charger and / or regulator 236 to provide power to the sensor electronics 112 and / or charge the battery 234.

[0123] The program memory 216 may be implemented as a semi-static memory for storing data such as identifiers (e.g., sensor identifiers (IDs)) of the coupled sensors 138, and for storing code (also referred to as program code) for configuring the ASIC 205 to perform one or more operations / functions described herein. For example, the program code may configure the processor module 214 to process and filter data streams or counts, perform calibration methods described below, perform fail-safe checks, etc.

[0124] 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 recent sensor data received from the sensors. In some example implementations, the memory may comprise memory storage components such as read-only memory (ROM), random access memory (RAM), dynamic RAM, static RAM, non-static RAM, electrically erasable programmable read-only memory (EEPROM), rewriteable ROM, flash memory, and the like.

[0125] The data storage memory 220 may be coupled to the processor module 214 and may be configured to store various sensor information. In some example implementations, the data storage memory 220 stores one or more days' worth of analyte sensor data. The stored sensor information may include one or more of the following: timestamps, raw sensor data (one or more raw analyte concentration values), calibrated data, filtered data, converted sensor data, and / or other displayable sensor information, calibration information (e.g., reference BG values ​​and / or previous calibration information such as from a factory calibration), sensor diagnostic information, etc.

[0126] The user interface 222 may include one or more buttons 224, a liquid crystal display (LCD) 226, a vibrator 228, an audio transducer (e.g., a speaker) 230, a backlight (not shown), and / or the like. The components that make up the user interface 222 may provide controls for interacting with a user (e.g., a host).

[0127] A 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 to the sensor electronics 112. In other implementations, the receiver may be powered transcutaneously, for example, via inductive coupling.

[0128] The battery charger and / or regulator 236 may be configured to receive energy from an internal and / or external charger. In some example implementations, the battery 234 (or batteries) is configured to be charged via an inductive and / or wireless charging pad, although other charging and / or power mechanisms may also be used.

[0129] One or more communication ports 238, also referred to as external connector(s), may be provided to enable communication with other devices. For example, a PC communications (com) port may be provided to enable communication with systems separate or integrated with the sensor electronics 112. The communication port may comprise, for example, a serial (e.g., Universal Serial Bus or "USB") communication port to enable communication with another computer system (e.g., a PC, a personal digital assistant or "PDA", a server, etc.). In some example implementations, factory information may be sent from sensors or cloud data sources to the algorithm.

[0130] The one or more communication ports 238 may further include an input port 237 that can receive calibration data, and an output port 239 that can be used to transmit the calibration data or the calibration data to a receiver or mobile device. Figure 2 illustrates these aspects diagrammatically. It will be appreciated that the ports may be physically separated, although in alternative implementations a single communication port may provide the functionality of both a second input port and an output port.

[0131] In some analyte sensor systems, the on-skin portion of the sensor electronics may be simplified to minimize the complexity and size of the on-skin electronics, for example, to provide raw, calibrated, and / or filtered data to a display device configured to perform calibration and other algorithms necessary for displaying the sensor data. However, the sensor electronics 112 (e.g., via the processor module 214) may also be implemented to execute predictive algorithms used to generate the converted sensor data and / or displayable sensor information. The predictive algorithms may, for example, evaluate baseline clinical acceptability and / or sensor data, evaluate calibration data for optimal calibration based on inclusion criteria, evaluate the quality of the calibration, compare estimated analyte values ​​corresponding to measured analyte values ​​over time, analyze variability in estimated analyte values, evaluate stability of the sensor and / or sensor data, detect signal artifacts (noise), replace signal artifacts, determine rate of change and / or trends in the sensor data, perform dynamic and intelligent analyte value estimation, perform diagnostics on the sensor and / or sensor data, set operating modes, evaluate the data for anomalies, and / or the like.

[0132] 3A, 3B, and 3C illustrate an exemplary implementation of the analyte sensor system 101 implemented as a wearable device, such as an on-skin sensor assembly 600. As shown in FIG. 3, the on-skin sensor assembly includes a housing 128. An adhesive patch 126 can couple the housing 128 to the skin of a host. The adhesive 126 can be a pressure sensitive adhesive (e.g., acrylic, rubber, or other suitable type) bonded to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for attachment to the skin. The housing 128 can include a through hole 180 that cooperates with a sensor insertion device (not shown) used to implant the sensor 138 under the skin of a subject.

[0133] The wearable sensor assembly 600 can include sensor electronics 112 operable to measure and / or analyze glucose indicators sensed by a glucose sensor 138. The sensor electronics 112 in the electronic unit 600 can transmit information (e.g., measurements, analyte data, and glucose data) to a remotely located device (e.g., 114, 116, 118, 120 shown in FIG. 1). As shown in FIG. 3C, in this implementation, the sensor 138 extends from its distal end into a through-hole 180 and is routed to an electronic module 135 in the housing 128. The working electrode 211 and the reference electrode 212 are connected to a circuit in the electronic module 135 that includes a potentiostat.

[0134] 3D illustrates an exemplary embodiment of an analyte sensor 138 that includes an elongated body portion. The elongated body portion may be long and thin, yet flexible and strong. For example, in some embodiments, the smallest dimension of the elongated conductive body is less than about 0.1 inches, less than about 0.075 inches, less than about 0.05 inches, less than about 0.025 inches, less than about 0.01 inches, less than about 0.004 inches, or less than about 0.002 inches. Although the elongated conductive body is shown here as having a circular cross-section, in other embodiments, the cross-section of the elongated conductive body may be oval, rectangular, triangular, polyhedral, star-shaped, C-shaped, T-shaped, X-shaped, Y-shaped, irregular, etc.

[0135] In the implementation of FIG. 3D, the analyte sensor 138 comprises a wire core 139. At a distal in vivo portion of the sensor 138, the wire core 139 forms an electrode 211a. At a proximal in vivo portion of the sensor 138, the wire core 139 forms a contact 211b. The electrode 211a and the contact 211b are in electrical communication over the length of the wire core 139 as the wire core 139 extends along the elongated body portion of the sensor 138. The wire core can be made from a single material, such as platinum or tantalum, but may also be formed as multiple layers, such as conductive or non-conductive materials with an outer coating of a different conductive material.

[0136] Layer 104 surrounds at least a portion of wire core 139. Layer 104 may be formed of an insulating material, such as polyimide, polyurethane, parylene, or other known insulating materials. For example, in one embodiment, layer 104 is disposed over wire core 139 and configured such that electrode 211a is exposed through window 106.

[0137] In some embodiments, the sensor 138 further comprises a layer 141 surrounding the insulating layer 104, such as a sleeve constructed of a conductive material. At a distal in vivo portion of the sensor 138, the sleeve layer 141 forms an electrode 212a. At a proximal in vivo portion of the sensor 138, the sleeve layer 141 forms a contact 212b. The electrode 212a and the contact 212b are in electrical communication over the length of the sleeve layer 141 as the sleeve layer 141 extends along the elongated body portion of the sensor 138. This sleeve layer 141 may be formed from a silver-containing material that is applied onto the insulating layer 104. The silver-containing material may include any of a variety of materials and may be in a variety of forms, such as, for example, Ag / AgCl-polymer paste, paint, polymer-based conductive mixture, and / or commercially available ink. This layer 141 may be processed using a pasting / dipping / coating step, for example, using a die-metered dip coating process. In one exemplary embodiment, the Ag / AgCl polymer paste is applied to an elongated body by dip coating the body (e.g., using a meniscus coating technique) 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.

[0138] The sensor 138 shown in FIG. 3D also includes a membrane 108 covering at least a portion of the distal in vivo portion of the sensor 138. This membrane is typically formed of multiple layers that may include one or more of an interference domain, an enzyme domain, a diffusion resistance domain, and a bioprotective domain. This membrane is important for supporting the electrochemical process that allows for the detection of the analyte, and is typically meticulously manufactured by dip coating, spraying, or other manufacturing steps. It is preferred that the distal in vivo portion of the sensor 138 undergo as little handling as possible from the time the membrane 108 is formed to the time the distal in vivo portion of the sensor 138 is implanted in a subject. In some embodiments, the electrode 211a forms the working electrode of an electrochemical measurement system, and the electrode 212a forms the reference electrode of the system. In use, both electrodes may be implanted in a host for analyte monitoring.

[0139] While the above description is particularly applicable to coaxial wire type structures, the embodiments herein are also applicable to other physical configurations of the electrodes. For example, two electrodes 211a and 212a can be fixed to a distal in vivo portion of an elongated flexible strip of a planar substrate, such as a thin, flat polymer flex circuit. Two contacts 211b and 212b can be fixed to a proximal ex vivo portion of the flexible planar substrate. The electrodes 211a, 212a can be electrically connected to respective contacts 211b, 212b to circuit traces on the planar substrate. In this case, the electrodes 211a and 212a and contacts 211b and 212b may be adjacent to each other on a flat surface, rather than coaxially as shown in FIG. 3D.

[0140] Also shown in Figure 3D is a diagram of contacts 211b and 212b electrically coupled to a simple current-to-voltage converter type potentiostat 210. The potentiostat includes a battery 320 having an output coupled to an input of an operational amplifier 322. The output of the operational amplifier 322 is coupled to a contact 324 which is electrically coupled to the working electrode contact 211b through a resistor 328. The amplifier 322 couples the contact 324 to a battery voltage V band the current i required to maintain that bias. m This current flows from the working electrode 211a through the interstitial fluid surrounding the sensor 138 to the reference electrode 212a. The reference electrode contact 212b is electrically coupled to another contact 334 that is connected to the other side of the battery 320. In this circuit, the current i m is (V b -V m ) / R, where V m is the voltage measured at the output of amplifier 322. The magnitude of this current for a given bias on the working electrode 211a is a measure of the analyte concentration near the window 106.

[0141] Contacts 324 and 334 are typically conductive pads / traces on a circuit board. During testing, the surface of this board always has a certain level of parasitic leakage current i p If possible, this leakage current should not form part of the measurement of the current due to the analyte. To reduce the effect of this leakage current on the measured current, an optional additional pad / trace 336 may be provided between the bias contact 324 and the return contact 334 that is connected directly to the battery output. This optional additional pad / trace may be referred to as a "guard trace." Since they are held at the same potential, leakage current from the bias contact 324 and the guard trace 336 is not particularly significant. Furthermore, leakage current from the guard trace 336 to the return contact 334 is not included in the measurement because it does not pass through the amplifier output resistor 328. Additional aspects and implementations of the guard trace may be found in paragraphs

[0128] and

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

[0142] During manufacturing, the sensor 138 undergoes various coating, testing, calibration, and assembly operations. However, it is difficult to transport individual sensors and electrically interface the sensors to and from multiple test and calibration equipment installations. These processes also make the sensor susceptible to handling damage. To help address these issues, the sensor 138 may be provided as part of a pre-connected sensor that includes a sensor carrier, which is described in more detail below.

[0143] FIG. 4A shows a schematic diagram of a pre-connected sensor 400. As shown in FIG. 4A, the pre-connected sensor 400 includes a sensor carrier 402 permanently attached to the sensor 138. In the example of FIG. 4A, the sensor carrier 402 includes an intermediate body, such as a substrate 404, and also includes one or more contacts, such as a first internal contact 406 and a second internal contact 408. The first internal contact 406 is electrically coupled to a first contact at a proximal end of the sensor 138, and the contact internal contact 408 is electrically coupled to a second contact at a proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. The contacts 406 and 408 may correspond to the contacts 324 and 334 of FIG. 3D, for example, in some implementations.

[0144] 4A, the first internal contact 406 may be electrically coupled to a first external contact 410, and the second internal contact 408 may be electrically coupled to a second external contact 412. As described in further detail below, the external contacts 410 and 412 may be configured to electrically interface with the sensor electronics 112 of the wearable device 600. Additionally, the external contacts 410 and 412 may be configured to electrically interface with processing circuitry of manufacturing equipment, such as one or more test stations and / or one or more calibration stations. Although various examples are described herein in which two external contacts 410 and 412 on the sensor carrier are coupled to two corresponding contacts on the sensor 138, this is merely illustrative. In other implementations, the sensor carrier 402 and the sensor 138 may each include a single contact or may include more than two contacts, such as any N external contacts of the sensor carrier (e.g., three or more external contacts 410 and 412) and any M contacts of the matable sensor 138 (e.g., three or more contacts 406 and 408). In some implementations, the sensor carrier 402 and the sensor 138 may have the same number of contacts (i.e., N=M). In some implementations, the sensor carrier 402 and the sensor 138 may have different numbers of contacts (i.e., N≠M). For example, in some implementations, the sensor carrier 402 may have additional contacts for mating to or between various components of a manufacturing station.

[0145] As described in more detail below, the substrate 404 may be configured to mate with the sensor electronics 112 of the wearable device 600. In some embodiments, the substrate 404 may be sized and shaped to mechanically interface with the housing 128 and electrically interface with the sensor electronics 112 within the housing 128. Additionally, the substrate 404 may be sized and shaped to mechanically interface with manufacturing equipment, assembly equipment, testing stations, and / or one or more calibration stations. As described in more detail below, the sensor carrier 402 may be attached to and / or electrically coupled to the sensor 138. The sensor 138 may be permanently coupled to a component of the sensor carrier 402 (e.g., the substrate 404) by using, for example, an adhesive (e.g., UV cured, moisture cured, multi-part activated, heat cured, hot melt, etc.) including a conductive adhesive (e.g., carbon filled, carbon nanotube filled, silver filled, conductive additives, etc.), conductive ink, spring contacts, clips, wrapped flexible circuits, conductive polymers (e.g., conductive elastomers, conductive plastics, carbon filled PLA, conductive graphene PLA), conductive foams, conductive fabrics, barrel connectors, molded interconnect device structures, sewing, wire wrapping, wire bonding, wire threading, spot welding, swaging, crimping, stapling, clipping, soldering or brazing, plastic welding, or overmolding. In some embodiments, the sensor 138 may be permanently coupled to the substrate 404 by rivets, magnets, anisotropic conductive film, metal foil, or other suitable structures or materials for mechanically and electrically attaching the sensor carrier 402 to the sensor 138 before or during assembly, manufacturing, testing, and / or calibration operations. In some embodiments, the sensor carrier 402 may be 3D printed around the sensor 138 to form a pre-connected sensor 400.In addition, the sensor carrier 402 may include datum features 430 (sometimes referred to as datum structures), such as recesses, openings, surfaces, or protrusions for aligning, positioning, and orienting the sensors 138 relative to the sensor carrier 402. The sensor carrier 402 may also include or form one or more fastening features for fastening and aligning the analyte sensors during manufacturing (e.g., relative to a manufacturing station). In addition, the sensor carrier 402 may include an identifier 450 configured to identify the sensor. In some embodiments, the identifier 450 is formed on the substrate 404. The identifier 450 is described further below.

[0146] Figure 4B shows another schematic diagram of a pre-connected analyte sensor 400. The pre-connected analyte sensor 400 shown in Figure 4B may include similar components to the pre-connected analyte sensor 400 shown in Figure 4A. Figure 4B is shown without the optional cover 460 for clarity. Figure 4C shows an exploded view of the pre-connected analyte sensor 400 shown in Figure 4B.

[0147] In the example of FIG. 4B, the sensor carrier 402 includes an intermediate body, such as a substrate 404, and also includes one or more traces, such as a first trace 414 and a second trace 416. The first trace 414 may include a first internal contact 406 and a first external contact 410. The second trace 416 may include a second internal contact 408 and a second external contact 412. In some embodiments, the first internal contact 406 is electrically coupled to a first contact at a proximal end of the sensor 138, and the second internal contact 408 is electrically coupled to a second contact at a proximal end of the sensor 138. The distal end of the sensor 138 is a free end configured for insertion into the skin of a host. The electrical coupling is described in connection with various embodiments herein, such as clips, conductive adhesives, conductive polymers, conductive inks, metal foils, conductive foams, conductive cloth, wire wrapping, wire threading, or other suitable methods. In some embodiments, the sensor 138 can be attached to the substrate 404 using a non-conductive adhesive 426 (e.g., epoxy, cyanoacrylate, acrylic, rubber, urethane, hot melt, etc.). The non-conductive adhesive 426 may be configured to secure, seal, insulate, or provide strain relief to the sensor 138. The sensor 138 may be attached to the substrate 404 by other methods, such as those described in FIG. 4A above.

[0148] As shown in FIG. 4C, the pressure sensitive adhesive 428 may be configured to isolate the exposed ends of the traces 414 and 416. For example, the pressure sensitive adhesive 428 may laminate the sensor 138 between the substrate 404 and the cover 460. In such a case, the sensor 138, the substrate 404, the pressure sensitive adhesive 428, and the cover 460 may form a laminated configuration. In the laminated configuration, the sensor 138 and the connection to one or more contacts (e.g., the first internal contact 406 and the second internal contact 408) are isolated from the one or more exposed contacts (e.g., the first external contact 410 and the second external contact 412). Furthermore, the laminated configuration may create a moisture seal area surrounding the sensor 138. The moisture seal may be created as embodied by a combination of the pressure sensitive adhesive 428 and the non-conductive adhesive 426. In other embodiments, the laminated structure can be made by one or a combination of the following materials and methods: non-conductive adhesives, pressure sensitive adhesive tapes, elastomers, thermal bonding, hot plate welding, laser welding, ultrasonic welding, RF welding, or any suitable type of lamination method. The cover 460 may be comprised of a polymer sheet, structure, or film that at least partially covers the substrate 404. The cover 460 may optionally include an identifier 450 that can identify the sensor 138. In some embodiments, the identifier 450 can incorporate various identification protocols or technologies such as, but not limited to, NFC, RFID, QR code, barcode, Wi-Fi, trimming resistors, capacitance values, impedance values, ROM, memory, IC, flash memory, etc.

[0149] The guide fixture 420, an optional component, is an exemplary embodiment of an interface with a work station, such as a test station, a calibration station, an assembly station, a coating station, a manufacturing station, or as part of a wearable assembly. The guide fixture 420 includes a datum feature (or datum structure) 430, such as a recess, an opening, a surface, or a protrusion, for aligning, positioning, and orienting the sensor 138 with respect to the sensor carrier 402. The datum feature 430 may be used in manufacturing and for assembly into the wearable electronic component. In some embodiments, the datum feature 430 is a raised protrusion configured to align with a corresponding datum feature 432 of the substrate 404. The corresponding datum feature 432 of the substrate 404 may feature a notch, slot, hole, or recess. The corresponding datum feature 432 in the sensor carrier may be a positioning feature that can interface with the datum feature 430 in a work station, such as a test station, a calibration station, an assembly station, a coating station, or other manufacturing station. Guide fixture 420 may be configured to ensure proper placement of sensor carrier 402 to align exposed external contacts 410 and 412 for connection to a work station, such as a testing station, a calibration station, an assembly station, a coating station, or other manufacturing station. In other embodiments, datum feature 430 may comprise a female feature that mates with a corresponding male datum feature 432.

[0150] FIG. 4D shows a schematic diagram of an array 480 of pre-connected analyte sensors 400 having a plurality of pre-connected sensors 400 with optional identifiers 450. Although FIG. 4D shows an array formed as a one-dimensional strip of pre-connected analyte sensors 400, a two-dimensional array can also be embedded. In some embodiments, the array 480 of pre-connected analyte sensors can be disposed in a cartridge. Each of the plurality of pre-connected sensors 400 can be singulated. In some embodiments, scoring 4020 can be provided to facilitate singulation into individual pre-connected sensors 400. In some embodiments, the array 480 can be used individually, sequentially or randomly to facilitate manufacturing, testing, and / or calibration of a plurality of sensors 138. In some embodiments, the array 480 can be used simultaneously to facilitate manufacturing, testing, and / or calibration of a plurality of sensors 138.

[0151] 5A-5E show block diagrams of various machines and assemblies with which the pre-connected analyte sensor 400 may be associated during its pre-implantation life. Such machines and assemblies may include manufacturing equipment such as one or more manufacturing stations 5091, one or more testing stations 5002 and / or one or more calibration stations 5004, and on-skin wearable assemblies 600, at least some of which are configured to receive the sensor carrier 402 and communicatively couple the machines and assemblies to the sensor 138 via the sensor carrier 402.

[0152] In one aspect of some embodiments, the sensor 138 is coupled to a sensor carrier 402 before the film 108 described above is applied. With the sensor 138 attached to the sensor carrier, and potentially with multiple sensors attached to the carrier as shown in FIG. 4D, subsequent device manufacturing steps such as film coating, testing, calibration, assembly into a wearable unit, etc. can be performed with easy installation and removal from manufacturing and testing equipment, reduced handling of the sensor, reduced chance of damaging the film, and a significant overall improvement in production efficiency.

[0153] Another advantage of pre-connected sensor structures is that different types of manufacturing and testing can be easily separated in different facilities equipped to handle them. For example, manufacturing of electrodes may require different types of metal forming / extrusion machines, while membrane application, testing, and calibration require wet chemistry laboratories and sensitive electronic test equipment. Thus, sensor electrodes are formed and mounted on carriers in one facility in one location, and then shipped to another remote facility equipped for membrane application, testing, and calibration. Remote in this context means not in the same production facility in the same building. It is also advantageous for different commercial entities to perform different tasks with specialization in the appropriate manufacturing and testing techniques.

[0154] The manufacturing station 5091 may comprise a testing station as described herein, a calibration station as described herein, or another manufacturing station. The manufacturing station 5091 may include processing circuitry 5092 and / or mechanical components 5094 operable to perform testing, calibration, and / or other manufacturing operations, such as sensor linearization operations, membrane application operations, curing operations, calibration check operations, glucose sensitivity operations (e.g., sensitivity slope, baseline, and / or noise calibration operations), and / or visual inspection operations.

[0155] The pre-connected analyte sensor 400 may be connected to one or more test stations 5002 having processing circuitry 5012 configured to perform test operations on the sensor 138 to verify the operational integrity of the sensor 138. The test operations may include verifying electrical characteristics of the sensor 138, verifying communication between the working electrode and the contacts 408, verifying communication between the reference or additional electrode and the contacts 406, and / or other electronic verification operations of the sensor 138. The processing circuitry 5012 may be communicatively connected to the sensor 138 for the test operations by inserting the substrate 404 into a receptacle 5006 (e.g., a recess in a housing of the test station 5002) until the contacts 410 are coupled to the contacts 5010 of the test station 5002 and the contacts 412 are coupled to the contacts 5008 of the test station 5002.

[0156] The system 5000 may include one or more calibration stations 5004 having a processing circuit 5020 configured to perform calibration operations on the sensor 138 to obtain calibration data for in vivo operation of the sensor 138. The calibration data obtained by the calibration equipment 5004 may be provided to the on-skin sensor assembly 600 for use during in vivo operation of the sensor 138. The processing circuit 5020 may be communicatively coupled to the sensor 138 for a calibration operation by inserting the substrate 404 into a receptacle 5014 (e.g., a recess in a housing of the calibration station 5004) until the contacts 410 are coupled to contacts 5018 of the test station 5002 and the contacts 412 are coupled to contacts 5016 of the test station 5002.

[0157] In the example of FIGS. 5A-5E, the test station 5002 and the calibration station 5004 include receptacles 5006 and 5014. However, this is merely illustrative and the sensor carrier 402 may be attached to the test station 5002 and the calibration station 5004 and / or the manufacturing station 5091 using other attachment mechanisms, such as gripping, clipping, or clamping shapes. 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 multiple sensor carriers and carriers with sensors). The structure 5093 may be a stationary mechanism having one or more electrical contacts, such as contact 5008. The structure 5095 may be a movable mechanism that moves (e.g., slides in direction 5097) to grip and secure the sensor carrier 402 in an electrically coupled position relative to the manufacturing station 5091. In other implementations, both features 5093 and 5095 are movable.

[0158] The sensor carrier 402 may also include an identifier 450 (see, e.g., FIGS. 4A-4D). The identifier 450 may be formed on or embedded within the substrate 404. The identifier 450 may be implemented as a visual or optical identifier (e.g., a barcode or QR code pre-printed or printed on the fly on the substrate 404 or etched within the substrate 404), a radio frequency (RF) identifier, or an electrical identifier (e.g., a laser trimmed resistor, a capacitive identifier, an inductive identifier, or a microstorage circuit (e.g., an integrated circuit or other circuit with an identifier encoded within its memory) that is programmable with identifiers and / or other data before, during, or after testing and calibration). The identifier 450 may be used to track each sensor through the manufacturing process for that sensor (e.g., by storing a history of each sensor's testing and / or calibration data). In other words, the identifier 450 identifies any of the analyte sensor, the calibration data of the analyte sensor, and the history of the analyte sensor. For example, the identifier 450 may be used for binning test and calibration performance data. The identifier 450 may be a distinct raw value or may encode information in addition to an identification number. The identifier 450 may be used as a reference number to digitally store the data in non-volatile memory on the substrate 404 or to store the data external to the sensor carrier 402.

[0159] The 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 the identifier 450 to obtain a unique identifier for the sensor 138. Test data obtained by the test station 5002 may be stored and / or transmitted along with the identifier for the sensor 138.

[0160] The calibration station 5004 may 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. The calibration data obtained by the calibration station 5004 may be stored and / or transmitted along with the identifier for the sensor 138. In some implementations, the calibration data obtained by the calibration station 5004 may be added to the identifier 450 by the calibration station 5004 (e.g., by programming the calibration data into the identifier). In some implementations, the calibration data obtained by the calibration station 5004 may be transmitted by the calibration station along with the identifier 450 to a remote system or device.

[0161] 5A-5E and described in further detail below, the on-skin sensor assembly 600 may include one or more contacts, such as contact 5022, configured to couple the internal electronic circuitry to contacts 410 and 412 of the sensor carrier 402, and thus to the sensor 138. The sensor carrier 402 may be sized and shaped to be secured within a cavity 5024 in or on the housing 128 such that the sensor 138 is coupled to electronics in the housing 128 via the sensor carrier 402, and the sensor 138 is positionally secured to extend from the housing for insertion for in vivo operation.

[0162] 5A-5E depict one calibration station and one test station, it should be understood that two or more test stations and / or two or more calibration stations may be utilized during the manufacturing and testing stages of production. Although the calibration station 5004 and the test station 5002 are depicted as separate stations in FIGURES 5A-5E, in some implementations the calibration station and the test station may be coupled into one or more calibration / test stations (e.g., stations in which processing circuitry for performing the testing and calibration operations is provided within a common housing and coupled to a single interface 5006).

[0163] The wearable assembly 600 may also include a reader (e.g., an optical sensor, an RF sensor, or an electrical interface) positioned near the contacts 5022 that reads the identifier 450 to obtain a unique identifier for the sensor 138. The sensor electronics may obtain calibration data for the 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.

[0164] 6-8 are schematic diagrams of various implementations of fixation of the pre-connected sensor 400 in the wearable assembly 600. In the example of FIG. 6, the sensor carrier 402 is in direct contact with the base wall 605 and the housing 128, and the contacts 5022 include a number of contacts on the housing 128 for contacting both contacts 410 and 412 of the sensor carrier 402 (e.g., both located on the top surface of the sensor carrier 402). In the example of FIG. 7, a mechanical receiver 700 is provided on the base wall 605 for mechanically fixing the sensor carrier 402. In the example of FIG. 8, a mechanical receiver 800 is provided on the base wall 605 for mechanically fixing the sensor carrier 402 in cooperation with the receiver 702. In the example of FIG. 8, the receiver 702 includes an additional contact 704 for contacting the contacts 410 of the sensor carrier 402 located on the rear surface of the sensor carrier.

[0165] FIG. 9 shows a detailed example of a sensor module 300 including a pre-connected sensor 400 and a sealing structure 192. As shown, the sealing structure 192 may be disposed on a substrate 404, and the sealing structure 192 may be configured to prevent moisture ingress to the contacts 410 and 412. Additionally, the contacts 410 and 412 may be implemented as leaf spring contacts for coupling to the 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 may couple the housing 128 to the host's skin 130. The adhesive 126 may be a pressure sensitive adhesive (e.g., acrylic, rubber, or other suitable type) bonded to a carrier substrate (e.g., spunlace polyester, polyurethane film, or other suitable type) for attachment to the skin. 9, the substrate 404 may include at least one arm 202 or other mechanical mechanism for interfacing with a corresponding mating mechanism (e.g., mechanical interlock, such as a snap fit, clip, and / or interference mechanism) on the base 128 to mechanically secure the substrate 404 to the housing 128. The mating mechanism, such as the arm 902, and / or other mechanism on the substrate 404 may be sized and shaped to releasably mechanically attach the substrate 404 to a connector associated with manufacturing equipment, such as one or more connectors 5006, 5014, and / or 5093 / 5095 of FIGS. 5A-5E for testing and / or calibration operations during manufacturing and prior to attachment to mechanism 900 of the housing 128.

[0166] Figure 10 shows a perspective view of the sensor module 400 in an implementation in which the contacts 406 and 408 are implemented using a coil spring 306. In the example of Figure 10, protrusions 308 on the substrate 404 can align the sensor 138 and secure the spring 306 to the substrate 404 (not all protrusions 308 are labeled to increase clarity of Figure 10). The protrusions 308 can protrude distally.

[0167] At least three, at least four, and / or less than ten protrusions 308 may be configured to contact the periphery of the spring 306. The protrusions 308 may be separated by gaps. The gaps allow the protrusions 308 to bend outward when the spring 306 is inserted between the protrusions 308. A downward force for coupling the electronic unit 500 to the base 128 may press the spring 306 against the sensor 138 to electrically couple the spring 306 to the sensor 138. The sensor 138 may fit between at least two of the protrusions 308. The test station 5002 and / or the calibration station 5004 may have a mating connector structure that compresses the spring 306 when the substrate 404 is inserted into the recess 5006 or 5014 to electrically couple the spring 306 between the sensor 138 and the processing circuit 5012 or 5020.

[0168] The sensor 138 may include a distal portion 138a configured for subcutaneous sensing and a proximal portion 138b mechanically coupled to a sensor carrier 402 having an electrical interconnect (e.g., a spring 306) that is mechanically coupled to the substrate 404 and electrically coupled to the proximal portion 138b. The spring 306 can be a conical spring, a helical spring, or any other type of spring mentioned herein or suitable for electrical connection.

[0169] The substrate 404 may have a base portion 312 that includes at least two proximal protrusions 308 disposed about the spring 306. The proximal protrusions 308 are configured to aid in orienting the spring 306. A segment of the glucose sensor 138 is disposed between the proximal protrusions 308 (distant from the spring 306).

[0170] The base portion 312 may be configured to be mechanically coupled 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 a securing mechanism, such as the arm 202. The anchoring mechanism may include the arm 202 and / or may include one or more notches, recesses, protrusions, or other mechanisms that mechanically interface with corresponding mechanisms on the base 312, the arm 202, and / or the substrate 404, such as a receptacle, such as one of the receptacles 5006 at 5014 in FIGS. 5A-5E, or a clamp connector mechanism, such as mechanisms 5093 and 5095 in FIGS. 5A-5E, to secure and align the sensor 138. In one suitable example, a slidable (or otherwise actuable or rotatable) mechanism, such as mechanism 5095 of Figures 5A-5E, may be positioned to slide or otherwise fit over or around one or more of the arms 202, the base 312, and / or the sensor carrier 402 to secure the sensor carrier 402 completely to the manufacturing equipment. For example, in other implementations of the sensor carrier 402 where no arms 202 are provided, a receptacle connector, such as one of the receptacles 5006 of 5014 of Figures 5A-5E, or a clamp connector formed by a clamp connector mechanism, such as mechanisms 5093 and 5095 of Figures 5A-5E, may include a clamshell component, a sliding component, or other moveable component that supports or covers the sensor carrier 402 to latch the sensor carrier 402 to the manufacturing, testing, and / or calibration equipment.

[0171] 11 and 12, another implementation of a sensor module 400 is shown that includes 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., 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 a test station contact, a calibration station contact, and / or an electronic unit 500 that mates with the base 128, and the pre-connected sensor 400 is disposed between the electronic unit 500 that mates with the base 128.

[0172] As used herein, a cantilever spring is a type of leaf spring. As used herein, a leaf spring can be made of multiple strips of curved metal held together one above the other. As used herein in many embodiments, a leaf spring includes only one strip (e.g., one layer) of curved metal (not multiple layers of curved metal). For example, leaf spring 306d in FIG. 11 can be made of one layer of metal or multiple layers of metal. In some embodiments, a leaf spring includes one layer of flat metal fixed at one end (such that a leaf spring is a cantilever spring).

[0173] 11 and 12, base portion 312d includes a proximal projection 320d having a channel 322d in which at least a portion of proximal portion 138b is disposed. Channel 322d positions a first region of proximal portion 138b such that the first region is electrically coupled to leaf spring 306d.

[0174] As shown in the cross-sectional perspective view of FIG. 12, the leaf spring 306d arcs 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 bends around the proximal projection 320d. The leaf spring 306d protrudes proximally to electrically couple with the test station 5002, the calibration station 5004, and / or the electronic unit 500. The seal 192 is configured to prevent ingress of fluid into the leaf spring 306d.

[0175] The leaf spring 306d is oriented to press the leaf spring 306d against a first electrical contact of the test station 5002, the calibration station 5004, and / or the electronic unit 500 and a second electrical contact of the glucose sensor 138 for electrically coupling the glucose sensor 138 to the test station 5002, the calibration station 5004, and / or the electronic unit 500 by coupling the sensor carrier 402 to the test station 5002, the calibration station 5004, and / or the electronic unit 500. The proximal height of the seal 192 may be greater than the proximal height of the leaf spring 306d such that the test station 5002, the calibration station 5004, and / or the electronic unit 500 contact the seal 192 before the test station 5002, the calibration station 5004, and / or the electronic unit 500 contact the leaf spring 306d. Spring 306 and / or leaf spring 306d may cooperate with underlying features (e.g., feature 308) and / or channel 322d on substrate 404 as shown to form a datum feature that secures and aligns sensor 138 relative to sensor carrier 402 (e.g., for manufacturing, calibration, testing, and / or in vivo operation).

[0176] 13A and 13B show perspective views of an embodiment of a wearable assembly 600 including a pre-connected sensor 400. The wearable assembly 600 may include sensor electronics and an adhesive patch (not shown). The pre-connected sensor 400 may include a sensor carrier, such as the sensor carrier 402 described in FIGS. 4A-4D. The sensor carrier 402 may be disposed in or on the housing 128. The housing 128 may be comprised of two housing components, an upper housing 520 and a lower housing 522. The upper housing 520 and the lower housing 522 may be assembled together to form the housing 128. The upper housing 520 and the lower housing 522 may be sealed to prevent ingress of moisture into the interior cavity of the housing 128. The sealed housing may include an encapsulant 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) configured to house the sensor carrier 402 and the sensor electronics. 13A illustrates an opening 524 in the upper housing 520 configured to allow an insertion component (e.g., a hypodermic needle, a C-needle, a V-needle, an open-sided needle, etc.) to pass through the wearable assembly 600 for insertion and / or retraction. The opening 524 may be aligned with a corresponding opening in the lower housing 522. In other embodiments, the opening 524 may extend through an off-center location of the housing 128. In other embodiments, the opening 524 may extend through an edge of the housing 128 to form a C-shaped channel. In some embodiments, the opening 524 includes a sealing material, such as a gel, adhesive, elastomer, or other suitable material disposed within the opening 524.

[0177] FIG. 13B is a perspective view of the bottom of the wearable assembly 600. As shown, the pre-connected sensor 400 may be disposed within the housing 128. The pre-connected sensor 400 may be placed within the opening 526 of the lower housing 522. As shown in the figure, the sensor 138 may extend out of the opening 526. The opening 526 may be sized and shaped to hold the pre-connected sensor 400. Additionally, the opening 526 may be sized and shaped to hold the pre-connected sensor 400 with the sensor 138 extending approximately parallel to the skin surface and forming a 90 degree bend for insertion into the skin. It should be appreciated that the bottom surface of the lower housing 522 may include an attachment member (e.g., an adhesive patch) for adhering the wearable assembly to a user's skin surface.

[0178] FIG. 13C shows an exploded view of the wearable assembly 600. Various electronic components, such as the potentiostat 210 and other components shown in FIG. 2, may be mounted on or to an electronics assembly board 530, typically some form of printed circuit board. The sensor carrier 402 is considered to have an electrical coupling with the electronics assembly board 530. Various methods may be used to establish an electrical connection (e.g., pins, solder, conductive elastomer, conductive adhesive, etc.) between one or more contacts of the pre-connected sensor 400, such as the external contacts 410 and 412 and the electronics assembly board 530. The sensor carrier 402 may be configured to interface with the electronics assembly board 530 through the lower housing 522. In other implementations, the sensor carrier 402 may be configured to interface with the electronics assembly board 530 through the upper housing 520. In some other implementations, the sensor carrier 402 is configured to interface with the electronics assembly board 530 through a side of the wearable assembly 600. Also, as shown in the figure, an optional sealing member 528 may be configured to insulate at least a portion of the sensor carrier 402 from potential moisture ingress. In some examples, the sealing member 528 may be a dispensed liquid (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 528 may be an assembly that is welded (e.g., laser or ultrasonic, hot plate) or permanently attached (e.g., anisotropic adhesive film, pressure sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealed region. The sealing member 528 may be used to physically couple and / or provide a sealed region of the sensor carrier 402 to the wearable assembly 600.

[0179] 14A-14E show another implementation of the wearable assembly 600. The implementation of FIGS. 14A-14E shares some similarities with the implementation shown in FIGS. 13A-13C. As shown in FIG. 14A, the wearable assembly 600 includes a housing formed as an upper housing 520 and a lower housing 522. The wearable assembly also includes a through hole 524 for use during invasive insertion of the sensor 138 into the subject. With particular reference to FIGS. 14B, C, and D, the lower housing 522 includes a recess 726 having a floor 704. The floor 704 may include locating pins 784 and 786 extending upwardly from the floor 704 and two openings 722 and 724. The locating pins may be formed as an integral part of the floor 704, for example, during molding of the housing, or may be separate components coupled to the floor by 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 other side of the floor 704 is a printed circuit board 530 (visible in FIG. 14E) on which some or all of the sensor electronics (e.g., potentiostat 210 or at least the traces connecting to the potentiostat) are mounted. The printed circuit board 530 may be fitted with conductive pins 712 and 714 that extend through openings 722 and 724 in the floor 704 to form an external electrical interface accessible without opening the housing. The pre-connected sensor 400 drops into this recess 726. Holes 794 and 796 drop onto locating pins 784 and 786, and conductive pins 712 and 714 extend through holes 706 and 708 in the sensor carrier substrate 404. These holes 706, 708 extend through plated metal (e.g., copper) contacts 406, 408 on the substrate 404, similar to those shown in the different embodiments of Figures 4A-4C. In general, the number of holes 706, 708 in the substrate 404 corresponds to the number of electrodes present in the sensor 138, which may correspond to the number of pins 712, 714.For example, a three-electrode system with a working electrode, a reference electrode, and a counter electrode may have three holes in the substrate corresponding to three pins extending up through the floor 704. The pins 712 and 714 may be electrically connected to the contacts 408 and 406 in a variety of ways, such as soldering, swaging, or a conductive adhesive, paste, glue, or film. After this connection is made, electronic circuitry disposed within the housing for detecting and / or processing the analyte sensor signal is connected to the analyte sensor and receives signals therefrom. The connecting material that couples the sensor 138 to the sensor carrier 402 is shown at 762 and 764 in FIGS. 14D and 14E. These connections may be established by any of the methods described above with reference to FIG. 4A.

[0180] Once the substrate 404 is placed on the pins 712, 714, the proximal portion of the sensor 138 is secured to the floor 704 with a pressure sensitive adhesive 772 to hold the proximal portion of the sensor on or near the housing before extending downward in the inserter opening 524. This allows for precise sensor insertion location and controls the biasing force on the insertion needle. A variety of methods and / or structural mechanisms may be used to perform this retention function, such as a protrusion or ledge on the floor 704, an overmolded part, an additional plastic piece with a snap fit placed on the sensor, or any type of adhesive glue or adhesive placed before or after the pre-connected sensor is placed in the recess 726. As also shown in FIG. 13C, optional sealing members 528a and 528b may be configured to seal and insulate at least a portion of the sensor carrier 402 from potential moisture ingress. In some examples, the sealing member 528 may be a dispensed liquid (e.g., adhesive, gel) or a solid material (e.g., elastomer, polymer). The sealing member 528 may be an assembly part that is welded (e.g., laser or ultrasonic, hot plate) or permanently attached (e.g., pressure sensitive adhesive, cyanoacrylate, epoxy, or other suitable adhesive) to create a sealing area. The sealing member 528 may be used to physically couple and / or provide a sealing area of ​​the sensor carrier 402 to the wearable assembly 600. The two sealing members 528a and 528b are partially separated by walls 766 and 768. These walls allow for the use of two different sealing methods in the two different parts of the recess 726 separated by the walls. For example, 528b may be a solid polymer that is pressed into a recessed portion with an opening 524 on one side of the wall. The other part of the recess 726 may then be filled with a liquid UV cured epoxy that hardens to form the sealing member 528a. The depths of the two recesses on either side of the wall may be the same or different.

[0181] FIG. 15A illustrates an alternative embodiment of a sensor carrier 402, potentially also in the form of a printed circuit board. In this implementation, a guard trace 407, as described above with reference to item 336 of FIG. 3D, is provided on the substrate 404 of the sensor carrier 402. As described 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 coupled to the sensor electronics with one or more conductive pins 713 (not shown in FIGS. 14A-14E) that extend through the floor 704 in a similar manner to pins 712 and 714. In FIG. 15A, the pins are shown connected to castellation contacts on the side of the substrate 404. An insulating layer 780, such as a solder mask, may be positioned over the guard trace 407 to eliminate the risk of shorting the analyte sensor electrodes.

[0182] 15B and 15C show another implementation for connecting a sensor carrier 402 with an analyte sensor 138 mounted thereon to electronic circuitry within the wearable sensor. In FIG. 15B, the sensor 138 is bonded to the sensor carrier 402 with conductive adhesive 762 and 764, as shown above with reference to FIGS. 14C and 14D. On the other side of the sensor carrier substrate are conductive contact pads 812 and 814. The circuit board 530 also has contact pads 826 and 828 bonded thereto, which are accessible through the floor 704 of the recess 726. An anisotropic film 820 is used to electrically and mechanically bond the sensor carrier contacts 812 to the circuit board contacts 826, and to bond the sensor carrier contacts 814 to the circuit board contacts 828. The anisotropic film 820 is compressed with heat between the contacts, causing the conductive particles in the film 820 to vertically fill the gap between the contact pairs 812 / 826 and 814 / 828. The conductive particles in film 820 are spaced horizontally apart to prevent shorting between contact pairs. This electrical and mechanical bonding technique is widely used in display applications for small electronics such as smartphones and lends itself to easy and consistent connections in a production environment.

[0183] 15C , a proximal region of the sensor 138 is coupled to contacts 812 and 814 of the sensor carrier 402 with anisotropic film 820. Different regions of the same anisotropic film 820 may be used to connect the sensor carrier contacts 812 and 814 to circuit board contacts 826 and 828, respectively. In this implementation, the regions of the film 820 that connect the sensor 138 to contacts 812 and 814 may be horizontally adjacent to or otherwise separated from the regions of the film 820 that connect the circuit board contacts 826 and 828 to the sensor carrier contacts 812 and 814.

[0184] 10-15, the pre-connected sensor 400 may be installed as a stand-alone interface between the sensor 138 and the sensor electronics. However, it should be understood that in some implementations described herein, the pre-connected sensor 400 may include a sensor carrier that couples to additional interfaces between the sensor 138 and the sensor electronics within the wearable assembly 600. For example, the channel 322d and leaf spring 306d may be formed on a separate substrate that mechanically attaches to the base portion 312d in the seal 192 for installation in the wearable assembly 600 following calibration and testing operations.

[0185] One advantage of the analyte sensor connection techniques described above is that the fabrication of the pre-connected sensor 400 may be separated from the fabrication of the electronics encapsulated within the housing. As described above with reference to the pre-connected sensor structure and subsequent coating, testing, and calibration processes, the housing with the electronics contained therein may be manufactured in a facility separate from the facility where the pre-connected sensor 400 is attached to the sensor electrical interface. This is made possible by providing an analyte sensor electronic interface that is accessible from the exterior of the housing. There is no need to open the housing to attach the sensor.

[0186] In some advantageous methods, pre-connected sensor electrodes are fabricated and attached to a substrate at a first location and shipped to a second location for coating testing and calibration. A housing with integrated electronics is fabricated at a third location. The housing with electronics is shipped from the third location to the second location. At the second location, the completed analyte sensor is attached to the external electrical interface. All three locations are remote from one another. This minimizes handling of the sensitive membrane-coated sensor, but allows other components of the complete device to be fabricated separately.

[0187] 16 shows a top view of an implementation of the sensor carrier 402 where the substrate 404 is a substantially flat substrate and the sensor 138 is attached to the substrate 404 with a conductive adhesive 1500. As shown in FIG. 16, the conductive adhesive 1500 may be applied to the contacts 1000 and 1002 of the sensor 138 to mechanically attach the sensor 138 to the substrate 404. Once the conductive adhesive 1500 is applied onto the contacts 1000 and 1002, it may itself form the contacts 408 and 406 for coupling to the test station 5002, the calibration station 5004, and / or the electronic unit 500. FIG. 17 shows an end view of the sensor carrier 402 of FIG. 16, where it can be seen that the conductive adhesive 1500 covers a portion of the sensor 138 at the proximal end. In other embodiments, the sensor 138 may be attached to the substrate 404 with a conductive adhesive 1500 or in any other suitable manner, for example, by the use of clips, conductive polymers, metal foils, conductive foams, conductive fabrics, wire wrapping, wire threading.

[0188] 18, 19, and 20 show an example of the substrate 404 of FIG. 16 with additional datum features to control the position and spatial orientation of the sensor 138 on the substrate 404. In the example of FIG. 18, the substrate 404 includes a V-shaped recess 1700. The sensor 138 is partially disposed within the recess 1700 to orient the sensor 138 in a direction along the recess, and the conductive adhesive 1500 substantially covers the sensor 138 and fills the portion of the recess 1700 not filled by the sensor 138 to secure the sensor 138 within the recess. In the example of FIG. 19, the substrate 404 includes a first flat portion 1800 and a second flat portion 1802 that extends at a non-parallel angle (e.g., perpendicular) to the first flat portion, and the sensor 138 is attached at the interface of the first and second flat portions by the conductive adhesive 1500. In the example of FIG. 20, the substrate 404 includes a rounded recess 1900 attached to the sensor 138 by a conductive adhesive 1500 that substantially covers the sensor 138 and fills the portion of the recess 1700 not filled by the sensor 138 to secure the sensor 138 within the recess.

[0189] 21A and 21B show an example sensor carrier 402 having at least a pair of guide structures 2106 and 2108 formed on a substrate 404, such as one or both contacts 406 and 408. These guide structures help to place the sensor body 138 in the proper location when a conductive adhesive is applied to bond the two. This eliminates 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 adhesive. Although not shown in FIGS. 21A and 21B, additional adhesive bonding material can be provided between the guide structures to secure the sensor to the guide structures during manufacturing.

[0190] The conductive adhesive 1500 may be, for example, a conductive liquid dispensing glue. The conductive liquid dispensing glue may be a one-part or two-part adhesive that cures (e.g., at room temperature or at an elevated cure temperature). The conductive liquid dispensing glue may be a snap-cure adhesive. The two-part conductive liquid dispensing glue 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, such as silver, copper, or graphite. The conductive adhesive 1500 may be a thermosetting conductive adhesive.

[0191] 22 shows a top view of an implementation of the sensor carrier 402 in which the substrate 404 is a substantially flat substrate and the sensor 138 is attached to the substrate 404 with a conductive tape 2000. As shown in FIG. 22, the conductive tape 2000 may be applied to one or more contacts (e.g., connection areas 1000 and 1002) of the sensor 138 to mechanically attach the sensor 138 to the substrate 404. When the conductive tape 2000 is applied over the contacts 1000 and 1002, it may itself form contacts 408 and 406 for coupling to the test station 5002, the calibration station 5004, and / or the electronic unit 500. The tape 200 may be applied over the sensor 138 as shown in FIG. 22 or may be inserted between the substrate 404 and the sensor 138. In implementations in which tape 2000 is disposed between substrate 404 and sensor 138, substrate 404 may be a flexible substrate that may be wrapped or folded around sensor 138 as shown in end view in Figure 23. The wrapped substrate in Figure 23 includes an extension portion 2100 that may form one or more contacts (e.g., 406 or 408).

[0192] The conductive tape 2000 may be configured for use as a multi-zone tape having one or more conductive tape 2000 and non-conductive tape sections. A combination of conductive and non-conductive regions may be used to electrically isolate connection regions. The use of multi-zone tape simplifies the assembly of multiple connection regions in a single assembly step. The pitch of the conductive regions on the tape may be matched to the target connection regions of the sensor wire 138. In other embodiments, the pitch of the conductive regions of the tape is significantly smaller than the spacing of the target connection regions of the sensor wire 138. A shorter pitch may allow for greater variability in tape placement while still ensuring isolated connections between the sensor 138 and the substrate 404. The conductive tape 2000 may be formed from a polymer substrate with a conductive adhesive (e.g., carbon impregnated adhesive, metal impregnated adhesive). As another example, the conductive tape 2000 may be a metal substrate with conductive and non-conductive adhesives. Some examples of non-conductive substrates are polyimides, composites, polymers, etc. Some examples of conductive substrates are metals (e.g., foils, plating, cladding, 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 (e.g., silver), conductive inks, etc.

[0193] 24 illustrates a top view of an implementation of a sensor carrier 402 in which the substrate 404 is a substantially flat substrate and the sensor 138 is attached to the substrate 404 with conductive plastic 2200 welded or bonded to the non-conductive (e.g., plastic) substrate 404. As shown in FIG. 24, the conductive plastic 2200 may be applied to the contacts 1000 and 1002 of the sensor 138 to mechanically attach the sensor 138 to the substrate 404. Once the conductive plastic 2200 is applied over the contacts 1000 and 1002, it may itself form the contacts 408 and 406 for coupling to the test station 5002, the calibration station 5004, and / or the electronic unit 500.

[0194] 25 and 26 show an exemplary ultrasonic welding system for welding the conductive plastic 2200 to the substrate 404. As shown in FIG. 25, the substrate 404 may be provided with a recess capable of receiving therein a protrusion on the conductive plastic member 2200. The sensor 138 may be placed within the recess of the protrusion on the conductive plastic member 2200, which may be pressed in a direction 2302 and vibrated by an ultrasonic welding horn 2300 to form a molten region 2400 that solidifies upon removal of the horn 2300 to secure the sensor 138 between the substrate 404 and the conductive plastic 2200 and form a conductive contact to the sensor 138.

[0195] In some implementations, the proximal end of the sensor 138 may be rounded or otherwise flattened as shown in FIG. 27 to provide the sensor 138 with additional surface area for clipping or soldering the contacts to the substrate 404. As shown in FIG. 27, the contacts 1000F and 1002F may be flat contacts that converge to the cylindrical wire sensor 138. As shown in the side view of the sensor carrier 402 in FIG. 28, the flat contacts 1000F and 1002F may be attached to the substrate 404 with conductive attachment members 2600 and 2602, such as clips, solder welds, anisotropic conductive film, conductive tape, plastic members with embedded conductors, conductive springs, or elastomeric conductive members (by way of example).

[0196] In one example, connectors such as contacts 1000F and 1002F (and / or contacts 1000 and 1002 in other forms described herein) may be laser soldered to corresponding contacts on the substrate 404. In implementations in which the sensor 138 is laser soldered to the substrate 404, the trace surface of the substrate 404 may be preheated by laser irradiation at the soldering location. The thermal radiation of the surface may reflow solder material pre-deposited on either side of the sensor 139. A guide such as a borosilicate glass "angle" may be placed over the sensor, pre-deposited with solder to hold the solder and move the molten solder toward the sensor. The resulting "cradle" bond may securely secure the sensor to the trace on the substrate 404, which may help to increase or maximize the sensor contact wire bond area from the trace to the solder. The use of a guide such as a borosilicate glass angle may protect the printed circuit board assembly electronics that may be included on and / or within the substrate from solder debris during the high temperature portion of the soldering process.

[0197] In another example, connectors such as contacts 1000F and 1002F (and / or other forms of contacts 1000 and 1002 described herein) may be soldered to corresponding contacts on the substrate 404 without the use of a laser. In these examples, a solder wire may be pre-fed to the tip of a soldering iron to create a blob of molten solder at the tip. The iron may then be moved down so that the blob touches the sensor and conductive traces on the substrate. A coating on the sensor, such as the Ag / AgCl coating described herein, may be provided with low thermal mass so that the sensor coating heats up quickly without freezing the solder. As the coating heats, the solder wets the coating. Also, the traces have minimal thermal mass so that they heat up quickly without freezing the solder. A solder mask is provided around the traces to prevent the solder from flowing out the ends of the traces.

[0198] In some implementations, the substrate 404 may be formed, at least in part, by a flex circuit (e.g., a polyimide substrate with conductive traces or other suitable flex circuit) that folds over and / or around at least a portion of the sensor 138 into the conductive traces of the flex circuit. FIG. 29 shows a top view of a flex circuit implementation of the substrate 404, which is a flexible circuit having a central non-conductive elongated portion 2702 along which the 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 the central portion 2702. The extensions 2700 and 2704 each include conductive contacts 2706 and 2708 that form contacts 408 and 406. The conductive contacts 2706 and 2708 may be coupled to external contacts that form contacts 412 and 410 through traces and / or conductive vias on or within the substrate 404. In some cases, extensions 2700 and 2704 may allow for testing, calibration, sensor electronics, or other equipment to connect to the sensor carrier / sensor assembly in areas not occupied by the sensor, which may allow for additional connection types and / or improve the electrical coupling of the connections.

[0199] 30 illustrates an implementation of a sensor carrier 402 in which the substrate 404 includes a wedge-shaped base portion 2800 and a foldable flexible portion 2802. The conductive contacts 2804 may extend from the base portion 2800 to the foldable portion 2802 such that the contacts 410 and 412 are electrically coupled to the sensor 138 when the sensor 138 is disposed on the base portion 2800, and the foldable portion 2802 is optionally folded over the sensor 138 (e.g., in the direction 2820) to wrap over and around the sensor 138. The base portion 2800 may be rigid or may taper away from the sensor 138. The base portion 2800 may include the conductive contacts 410 and 412 at a narrow end. The base 2800 may be removably inserted into recesses 5006 and 5014 of the test station 5002 and the calibration station 5004, for example, for testing and calibration operations. In the example of Figures 27 and 28, the flexible substrate may be folded over and secured to the sensor (e.g., secured to the sensor and / or to itself and secured to the sensor by welding soldering, mechanical crimping, spring contacts, rivets, adhesives such as epoxy, etc.).

[0200] 31A and 31B show another embodiment of a sensor carrier 402. In this embodiment, the sensor carrier 402 comprises a block 404 made of a non-conductive material, such as a polymer or ceramic. The block 404 includes a through hole 1420 extending along a y-axis along which the proximal in vitro portion of the analyte sensor 138 extends. Slots or blind holes 1410 and 1412 intersect the through hole 1420 on a z-axis that is orthogonal to the y-axis of the through hole. Conductive contact materials 406 and 408 are plated on the top surface and extend into the slots 1410 and 1412. Additional holes 1430 and 1432 extending along the x-axis intersect both the through hole 1420 and the slots 1410 and 1412. Each hole 1430 and 1432 extends part way across its respective slot and into the block on the opposite side of each slot forming an opposite blind hole or recess 1442, 1444. Plugs 1451 and 1453, which may be conductive or non-conductive, are inserted into the holes 1430 and 1432 to force the wire analyte sensor contacts 212b and 211b into the recesses 1442, 1444 and bring the contacts 212b and 211b into electrical contact with the sensor carrier contacts 406 and 408.

[0201] FIG. 32 shows a top view of a sensor carrier having a substrate 404, a datum feature 2900, and a movable connector 2902 for each of the contacts 406 and 408. The sensor 138 may be aligned relative to the datum feature 2900, and the movable connector 2902 may move to secure each of the contacts 1000 and 1002 between the corresponding datum feature and the movable connector. The movable connector 2902 and / or the datum feature 2900 are conductively coupled to the contacts 1000 and 1002. The movable connector 2902 and / or the datum feature 2900 may be conductively coupled to other contacts (not shown) on the substrate 404 that form the contacts 410 and 412. FIG. 33 is a perspective view of one of the datum features 2900 and an associated movable contact 2902 that is movable in a direction 2904 toward the datum feature 2900 to secure the sensor 138. Contacts 1000 and 1002 may be planarized to enhance contact with datum feature 2900 and contact 2902. If desired, additional conductive material 2906 may be formed on substrate 404 between datum feature 2900 and contact 2902 to enhance electrical contact with sensor 138. The additional conductive material may be an exposed surface of a portion of an embedded conductive layer (e.g., a copper or other conductive metal layer) in substrate 404, or may be solder or a conductive adhesive (by way of example).

[0202] FIG. 34 shows a perspective view of a pre-connected sensor formed from a sensor carrier implemented as a barrel connector that substantially encloses the sensor 138. In the example of FIG. 34, the substrate 404 may be an insulating layer formed around the sensor 138 having conductive bands extending from internal contact with the contacts 1000 and 1002 to the external surface forming the contacts 410 and 412. As shown in FIG. 34, the annular contacts 410 and 412 may be removably received by press-fit into the conductive brackets 3102 and 3104 of the device 3100 (e.g., the test station 5002, the calibration station 5004, and / or the electronic unit 500). The conductive brackets 3102 and 3104 may establish electrical communication between the sensor 138 and the device 3100 (e.g., the test station 5002, the calibration station 5004, and / or the electronic unit 500).

[0203] FIG. 35A shows an implementation of a sensor carrier 402 in which a flexible circuit is wrapped around the ends of a sensor 138 such that a top 3200 and a bottom 3202 of a flexible substrate are formed on either side of the sensor 138. As shown in FIG. 35B, the top 3200 and bottom 3202 may be wrapped around the ends of multiple sensors 138 such that a flexible circuit strip 3404 forms a common sensor carrier for multiple sensors. The flex circuit strip 3204 may include a pair of internal contacts and a pair of external contacts for coupling to the contacts 1000 and 1002 of each sensor 138, each pair of external contacts coupling to a corresponding pair of internal contacts to form contacts for coupling to a test station 5002 and / or a calibration station 5004. In this manner, multiple sensors can be transported and coupled to test and calibration equipment as a group. The strip sensor carrier 3204 may include an identifier for each sensor 138 so that test and / or calibration data for each sensor can be logged and stored. Individual pre-connected sensors may be formed by singulating the strip sensor carrier 3204 into individual sensor carriers for each sensor that can be installed in an electronic unit, such as the wearable sensor unit of Figures 13 and 14. The strip 3204 may include singulation features 3220 (e.g., markings and / or scoring that facilitate singulation into individual pre-connected sensors.

[0204] 35A and 35B show a flexible circuit strip wrapped around the ends of the sensor 138, this is merely exemplary. It should be understood that the flex strip carrier for one or more sensors 138 may be attached to the sensor(s) in other ways. For example, the ends or other portions of the sensor 138 may extend into the substrate of the flexible circuit strip 3204 and bond to internal conductive contacts within the strip, or the ends or other portions of the sensor 138 may 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 datum mechanisms to position and align the sensor).

[0205] FIG. 36 illustrates an implementation of a sensor carrier 302 in which a crimp connector 3301 extends through a portion of the substrate 404. As shown in FIG. 36, the crimp connector 3301 may have a base portion 3300 that extends from a first side of the substrate 404 (e.g., to form one of the contacts 410 and 412). The crimp connector 3301 also includes an arm 3302 that extends from an opposite second side of the substrate 404. As shown in FIG. 37, the arms 3302 may be pressed or crimped together to mechanically secure and conductively couple to the sensor 138, thereby forming, for example, contact 406. FIG. 38 illustrates a side view of the sensor carrier of FIGS. 36 and 37, illustrating how two crimp connectors may be provided that penetrate the substrate 404 to form contacts 406 and 408 on a first side and contacts 410 and 412 on a second side. In FIG. 38 , contacts 410 and 412 are formed on the second side of substrate 404, however, it should be understood that contacts 410 and 412 can be formed on the first side, or on a sidewall or edge of substrate 404 (e.g., by including one or more bends or other conductive bonds in substrate 404).

[0206] FIG. 39 illustrates an implementation of a pre-connected sensor in a sensor carrier 402 that includes a distally oriented channel 358 that directs the sensor 138 distally such that the sensor 138 includes at least a 45 degree bend and / or less than a 135 degree bend. A channel cover 362 secures the glucose sensor 138 to the distally oriented channel 358. In the example of FIG. 39, one or more contacts (e.g., 408 and 406) are implemented using a conductive elastomeric member 1400. In other embodiments, the contacts may be of any suitable type (e.g., coil spring 306, leaf spring 306d). The contacts (e.g., conductive elastomeric member 1400) form a conductive bond between the sensor 138 and an external device (e.g., a test station 5002, a calibration station 5004, and / or an on-skin sensor assembly 600). The contacts may cooperate with underlying features (e.g., protrusions 308) and / or channels 322d on the substrate 404 as shown to form datum features that secure and align the sensor 138 relative to the sensor carrier 402 (e.g., for manufacturing, calibration, testing, and / or in vivo operation). In some implementations, the sensor 138 may be bent, glued, or bonded to be secured within the sensor carrier 402.

[0207] FIG. 40 illustrates an implementation of a sensor carrier 402 in which the substrate 404 is a molded interconnect device. In the example of FIG. 40, the substrate 404 is formed from a molded thermoplastic or thermoset resin (e.g., acrylonitrile butadiene styrene, liquid crystal polymer, polyimide / polyphthalamide plastic, or other thermoplastic or thermoset polymeric material) that includes conductive traces 3702. The conductive traces 3702 may be formed on the surface of the substrate 404 and / or may pass within and / or through portions of the substrate 404 to form appropriate connections. The conductive traces may be formed on the molded substrate using various techniques (e.g., selective plating by laser etching, combination of plateable and non-plateable substrate polymers, or other suitable methods). In other embodiments, a conductive material (e.g., conductive polymer, metal stamping, plated polymer, metal structure) may be overmolded with a non-conductive material.

[0208] To create the appropriate electrical connection as shown in FIG. 40, the conductive traces 3702 are electrically coupled between the contacts (e.g., contact areas 1000 and 1002 on the sensor 138) and the external contacts (e.g., contacts 410 and 412). In the example of FIG. 37, the contacts (e.g., 410 and 412) are formed on the same surface of the substrate 404 to which the sensor 138 is attached, but this is merely illustrative. The contacts (e.g., contacts 410 and 412) are formed on opposing surfaces of the substrate 404 or on the edges or sidewalls of the substrate 404 and are coupled to the contacts (e.g., contacts 408 and 406) by conductive materials (e.g., conductive layers, structures, adhesives, clips, solder, or interconnects) in or on the substrate 404. For example, the contacts (e.g., contacts 410 and 412) may form designated areas for interfacing electrical couplings on different surfaces or areas of the substrate 404 to which the sensor 138 is attached. The designated areas may form channels, grooves, recesses, slots, or similar alignment features for orienting the sensor.

[0209] The molded thermoplastic substrate 404 may be an injection molded substrate with features that facilitate various aspects of testing, calibration, and installation of a wearable device for the sensor 138. For example, the molded thermoplastic substrate 404 may include a datum feature or other alignment or positioning feature, such as a recess 3700 having a shape that complements the shape of the proximal end of the sensor 138. For example, the recess 3700 may include three or more step regions that correspond to the steps between different layers of the coaxial analyte sensor as shown in FIG. 3D. In other configurations, the molded thermoplastic substrate 404 may include a flat walled recess as in the example of FIG. 18, a wall that forms a corner as in the example of FIG. 19, or a rounded recess as in the example of FIG. 20. In yet other configurations, the molded thermoplastic substrate 404 may include a raised feature or protrusion on the surface that positions and aligns the sensor 138. For example, a raised channel having a shape that corresponds to the shape of the sensor 138 may be provided on the surface of the molded thermoplastic substrate 404. As another example, one more post may extend from the surface of the molded thermoplastic substrate 404. For example, one or more lines of protrusions can be formed on a surface of the molded thermoplastic substrate 404 against which and / or between which the sensor 138 can be positioned and aligned. In this manner, various configurations can be provided for the molded thermoplastic substrate 404 that include datum features that orient the sensor 138 in a preferred location and in a preferred direction.

[0210] The molded thermoplastic substrate 404 may include other geometric features, such as finger holds 3720 on the opposing side of the substrate to facilitate gripping, holding, and transporting the sensor 138. The molded thermoplastic substrate 404 may also include other geometric features, such as fastening features that correspond to the geometry of connectors for the manufacturing instrument 5091, the test instrument 5004, and the calibration instrument 5004, such as gripping connector features 5093 / 5095 of the manufacturing instrument 5091 and / or recessed connectors 5006 and 5014 of the test instrument 5002 and the calibration instrument 5004. The fastening features formed on the molded thermoplastic substrate 404 and / or by the molded thermoplastic substrate 404 itself may include one or more protrusions, such as posts, snap fit features, arms, such as arm 202 (see, e.g., FIGS. 11-14), recesses, notches, hooks, and / or tapered portions (by way of example) similar to the tapered portions shown in FIG. 28. In some examples, a portion of the molded thermoplastic substrate 404 or the entire molded thermoplastic substrate 404 may have a shape that corresponds to the shape of a mounting receptacle on or within one or more of the manufacturing equipment 5091, the test equipment 5002, the calibration equipment 5004, the carrier, and / or the wearable device.

[0211] Although the substrate 404 is shown as being substantially linear in FIG. 40, the molded thermoplastic substrate 404 may be provided with an overall shape, such as a handle shape and / or mechanism 3720 for inserting, pulling, or otherwise manipulating the sensor 138 during manufacturing and assembly operations. For example, the molded thermoplastic substrate 404 may include a main portion configured to mechanically and electrically interface with the manufacturing equipment 5091, the test equipment 5002, the calibration equipment 5004, and / or the wearable device, and a gripping portion extending from the main portion. The gripping portion may extend from the manufacturing equipment 5091, the test 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 may be integrally formed with the main portion or may be a separate component extending from a surface or from within the molded thermoplastic substrate 404. The grasping component may be a post, stock, shaft, or arched handle shaped for grasping by a grasping tool or by hand (eg, by a technician).

[0212] 40, the sensor 138 may 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 may be applied to bond the contacts 1000 of the sensor 138 to a first conductive trace 3702 on the substrate 404 to form the contacts 408 between the sensor 138 and the sensor carrier 402. The adhesive 3704 may also be applied to bond the contacts 1002 of the sensor 138 to a second conductive trace 3702 on the substrate 404 to form the contacts 406 between the sensor 138 and the sensor carrier 402. In this manner, the molded thermoplastic substrate 404 may provide a handle and / or strain relief for moving and / or otherwise handling the sensor 138.

[0213] FIG. 41 shows a top view of the sensor carrier 402 of FIG. 40. As shown in FIGS. 40 and 41, the first conductive trace 3702 may extend from its contact with the contact 1000 in the recess 3700 to form one or more exposed portions on the surface of the substrate 404 that form external contacts 412 for coupling to the test station 5002, the calibration station 5004, and / or the electronic unit 500. The second conductive trace 3702 may extend from its contact with the contact 1002 in the recess 3700 to form one or more exposed portions on the surface of the substrate 404 that form external contacts 410 for coupling to the test station 5002, the calibration station 5004, and / or the electronic unit 500.

[0214] FIG. 42 illustrates a particular implementation of the sensor carrier 402 shown in FIG. 40 and FIG. 41. In this implementation of the sensor carrier 402, the sensors 138 are attached to the substrate 404 with conductive couplers 3900, such as, for example, clips, conductive adhesives, conductive polymers, metal foils, conductive foams, conductive fabrics, wire wrapping, wire threading, or any suitable method. As shown in FIG. 43, the substrate 4000 may have an elongated dimension along which parallel conductive strips 4001 and 4002 are formed. The multiple sensors 138 may be attached to the substrate 4000 and extend beyond the edge of the substrate in a direction perpendicular to the elongated dimension of the substrate. A singulation mechanism may be provided, such as scoring 4020, that facilitates singulation of the substrate 4000 into individual sensor carrier substrates 404 for each sensor and / or electrically isolates portions of the conductive strips 4001 and 4002 for each sensor. Each sensor may be attached to the substrate 4000 using, for example, clips 3900 or other methods including the use of conductive adhesives, conductive polymers, metal foils, conductive foams, conductive fabrics, wire wrapping, wire threading or any other suitable methods. An identifier 450 for each sensor may be provided on a corresponding portion of the substrate 4000.

[0215] The sensors 138 may each have a sensor electrical contact pair (e.g., contacts 1000 and 1002) coupled to a corresponding electrical contact pair formed from strips 4001 and 4002 on the substrate. Openings in and / or vias through the substrate 4000 may provide exposed portions of the strips 4001 and 4002 that form a plurality of electrical contact pairs for coupling each sensor 138 to a test station 5002, a calibration station 5004, and / or an electronic unit 500 (e.g., an electronic unit of a wearable device). Each of the plurality of electrical contact pairs is coupled to an associated pair of portions of the strips 4001 and 4002 through the substrate.

[0216] 44-46 show various contact configurations on sensor carriers that may be singulated from a sensor carrier strip of the type shown in FIG. 43. In the example of FIG. 44, a z-shaped contact configuration on a substrate 4000 is singulated to form pre-connected sensors on a smaller portion of the substrate, referred to as substrate 404. In this example, the z-shaped contact configuration may allow for a longer distance between connectors in test, manufacturing, or calibration equipment (e.g., larger pitch connections), but the longer distance is not required with a z-shaped substrate and other substrate shapes may be used. In the example of FIG. 45, a square portion of substrate 4000 is singulated to form pre-connected sensors on substrate 404. In the example of FIG. 46, a square portion of substrate 4000 is singulated to form pre-connected sensors, with openings 4300 (e.g., air gaps) provided in singulated substrate 404 to improve electrical isolation between singulated contact strip portions 4001 and 4002.

[0217] 47A, in some implementations, an elongated substrate 4000 forming a sensor carrier for a plurality of sensors 138 can be provided with a feed guide strip 4402 along an elongated edge of the elongated substrate. The feed guide strip 4402 can include a positioning mechanism 4404 that can be accessed and manipulated to move and register a strip of preconnected sensors through one or more manufacturing stations.

[0218] In the embodiment of FIG. 47A, the sensors 138 can be bulk attached to the substrate 4000 and singulated on the substrate 404 after manufacturing or testing operations. As shown in FIG. 47B, a strip of preconnected sensors as shown in FIG. 47A can be provided on a reel 4410 for bulk storage and / or transport, and can optionally be automatically unwound from the reel using the feed guide strip 4402 to move through one or more test stations and / or one or more calibration stations. FIG. 48 shows preconnected sensors with a sensor carrier singulated from the substrate 4000 and separated from the singulated portion 4402 of the feed guide strip 4402. Alternatively, the feed guide strip 4402 can be separated as a strip prior to singulating the preconnected individual 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.

[0219] 49 illustrates an implementation of a sensor carrier 402 in which multiple sets of contacts 406 and 408 are formed from a receptacle 4600 having slots for receiving multiple corresponding sensors 138. In some implementations, the receptacle 4600 may be an elongated member including a resilient or flexible material. The receptacle 4600 may optionally have slots that penetrate an insulating layer or deform a portion of an outer layer to contact the sensor 138.

[0220] 50 shows an implementation of a sensor carrier for multiple sensors 138 having recesses 4700 that form datum features to hold each sensor in precise alignment and position. Complementary magnetic features may be provided on the sensors 138 and substrate 404 to hold each sensor in precise alignment and position, thereby facilitating precise sensor processing.

[0221] FIG. 51A illustrates an implementation of an elongated substrate 4800 formed using printed circuit board technology from a rigid, flexible, or combination rigid / flexible substrate from which multiple sensor carriers 402 can be singulated. The flexible portion of the substrate may be fabricated from a material such as polyimide, PEEK, polyester, or any suitable type. The rigid portion of the substrate may be fabricated from a material such as FR4, FR5, FR6, insulated metal substrate (IMS), PTFE, or any suitable type. As shown in FIG. 51A, each sensor carrier may include a sensor connection portion 4804 and an interface or processing portion 4802. In some implementations, each sensor carrier may include a sensor connection portion 4804 extending from a rigid or flexible portion and an interface or processing portion 4802 extending from a rigid or flexible portion. In these implementations, one or more contacts, such as contacts 406 and 408, may be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 may include a fixing or datum feature for the sensor carrier 402 .

[0222] FIG. 51B illustrates another implementation of an elongated substrate 4800 as shown in FIG. 51A with an optional electrical connection interface 4850 for connecting to a work station, such as a test station, a calibration station, an assembly station, a coating station, or other manufacturing station. The optional electrical connection interface 4850 may be coupled to one or more sensor carriers 402 via electrical traces configured on one or more layers of a circuit board. As shown in FIG. 51B, multiple sensor carriers 402 are assembled into a panel, and each of the sensor carriers 402 may include a sensor connection portion 4804 extending from a flexible or rigid portion and an interface or processing portion 4802 extending from the flexible or rigid portion. In these implementations, one or more contacts, such as contacts 406 and 408, may be formed on the sensor connection portion 4804 of each sensor carrier 402. The sensor connection portion 4804 of the substrate 4800 may include a fixed or datum feature of the sensor carrier 402. In some implementations, the elongated substrate 4800 shown in FIG. 51B may be configured to allow the sensor 138 to extend beyond the edge of the substrate. This may be accomplished by removing a portion of the elongated substrate 4860 for further processing. In some embodiments, perforations (e.g., V-score, mouse bite, or other suitable type) are included in the elongated substrate 4800 to allow removal of the bottom of the panel 4860 for immersion or calibration. In this implementation, the elongated substrate 4800 may be configured for immersion or calibration as described in FIG. 52B.

[0223] 52A, an implementation of a 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. The one or more interface contacts (e.g., 410 and 412) may be formed on the sensor carrier 402 for coupling to a test station 5002, a calibration station 5004, and / or an electronic unit 500. In this configuration, testing and / or calibration operations can be performed by coupling portion 4802 to test and / or calibration equipment.

[0224] FIG. 52B illustrates an exemplary panel implementation of multiple sensor carriers 402 with electrical connection interfaces 4850 for interfacing with electronics of a work station, such as a test station, calibration station, assembly station, coating station, or other manufacturing station. The view of FIG. 52B illustrates the elongated substrate 4800 of FIG. 48B with a sensor 138 attached via one or more sensor contacts (e.g., contacts 406 and 408) after the bottom panel portion 4860 has been removed (from the view of FIG. 51B). In some implementations, the sensor can be permanently connected (e.g., conductive adhesive, conductive polymer, conductive ink, solder, welding, brazing, or other suitable method) to the sensor carrier 402, and both components can be calibrated together or separately. In other implementations, the sensor can be removably attached (e.g., via clips, metal foil, conductive foam, conductive fabric, wire wrapping, wire threading, or any other suitable method).

[0225] Following testing and / or calibration operations, the flexible portion 4802 may be folded around, folded over, wrapped around, wrapped over, or manipulated against the enclosing portion 4804 for installation within the on-skin sensor assembly 600. In the example of FIG. 53A, the portion 4802 may form a separate processing circuit for the sensor 138 (e.g., an implementation of the sensor electronics 112). In other implementations, the portion 4802 may be directly coupled to the signal processing circuit for the assembly 600, to a system-in-package (SIP) implementation of the sensor electronics, or to a main printed circuit board for the sensor electronics. In the example of FIG. 53B, the flexible portion 4804 is folded over the enclosing portion 4802 for installation within the on-skin sensor assembly 600 to have the sensor 138 positionally fixed to extend (e.g., through the opening 4808) for insertion for in vivo operation.

[0226] Fig. 54 illustrates an implementation in which the sensor carrier 402 is manufactured using printed circuit board technology as a daughter board for a main printed circuit board 5100 for the sensor electronics. As shown in Fig. 54, one or more contacts (e.g., solder contacts), such as contacts 5104, may 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 may 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 means described herein).

[0227] FIG. 55 illustrates an implementation of the sensor carrier 402 in which a pinch clip 5200 is provided to close the arms 5204 of the crimp connector 5202 to secure the sensor 138 to the substrate 404. The connector 5204 may be formed from a conductive material that forms one of the contacts 410 and 412. As shown in FIG. 55, the pinch clip 5200 includes clasp arms 5208 having an inclined surface that pushes the arms outward as the pinch clip 5200 moves in a direction 5206 toward the substrate 404 and snaps back to secure the pinch clip 5200 to the substrate 404. In other implementations, the pinch clip 5200 may be provided without clasping arms 5208 such that the pinch clip 5200 is removable after the arms 5204 are pinched closed such that the pinch clip 5200 does not form part of the sensor carrier. As shown in FIG. 55, one or more electrode breakouts 5220 may be provided to form, for example, one or more contacts 410 and 412 on the substrate 404. In the example of FIG. 55, the breakouts 5220 are formed on a surface of the substrate 404 opposite the surface on which the sensor 138 is attached, but this is merely illustrative. It should be understood that the breakouts of contacts such as contacts 410 and 412 may be formed on the opposing surface, on the same surface as the sensor 138, or on an edge or sidewall of the substrate 404 and coupled to the contacts 408 and 406 by conductive vias or other conductive layers, structures, or interconnects within or on the substrate 404. In some implementations, the pinch clip 5200 may be used to apply a biasing force to the sensor 138 in combination with the crimp connector 5202 or directly to the substrate without the crimp connector 5202. The pinch clip 5202 may apply a force in a radial, axial, or appropriate direction to provide a biasing force to the sensor 138 and the conductive path.

[0228] 56 illustrates an implementation of a sensor carrier 402 in which the contacts 406 and 408 are formed from foldable conductive clips 5300. A sensor 138 may be inserted through an opening 5302 in each clip 5300, mechanically secured to the substrate 404, and conductively coupled to the clips 5300 by folding a portion 5304 of each clip 5300 over the sensor 138.

[0229] The portion 5304 of the clip 5300 may also form contacts 410 and 412 for coupling to external equipment, such as a manufacturing station (e.g., a test station, a calibration station, an assembly station, a coating station, or other manufacturing station). However, this is merely an example. In other implementations, one or more electrode breakouts may be provided that are conductively coupled to the clip 5300, for example to form one or more of the contacts 410 and 412 on the substrate 404. Such breakouts may be formed on a surface of the substrate 404 opposite to the surface on which the sensor 138 is attached, on the same surface as the sensor 138, or on an edge or sidewall of the substrate 404, and may be coupled to the clip 5300 by conductive vias or other conductive layers, structures, or interconnects in or on the substrate 404.

[0230] The clip 5300 also forms a datum feature for positioning and aligning the sensor 138 relative to the substrate 404. The substrate 404 may be sized and shaped (or may include structural features) that form a fastening feature for the substrate 404 relative to a manufacturing station and / or a housing of a wearable device. In this manner, the sensor carrier 402 may be used to easily position and align the sensor 138 during both manufacturing and assembly operations (e.g., using the datum feature to align the sensor relative to the substrate 404 and using the fastening feature to align the substrate relative to the manufacturing or wearable device).

[0231] The conductive components of the sensor carrier 402 in various embodiments described herein are electrically isolated from each other and from the environment when installed in the on-skin sensor assembly 600. For example, the contacts 406, 408, 410, and 412 may be electrically isolated from each other or from the environment using a non-conductive adhesive such as a one-part or two-part epoxy, using polyurethane, using low pressure overmolding such as moldable polyamide or moldable polyolefin, using injection overmolded thermoplastic or thermoset resins, using non-elastomers such as welded clamshell plastic, glued clamshell, one- or two-sided cavity potted with a sealant (epoxy, urethane, silicone, etc.), or using a factory pre-compressed elastomer such as a constrained two-part cavity that holds the elastomer in compression. The two-part cavity may hold the elastomer in compression by a snap fit, or an adhesive such as ultrasonic welding, laser welding, solvent bonding, heat staking, or a mechanical fastener such as a screw, rivet, clip, or other fastener.

[0232] Exemplary operations that may be performed to manufacture and use a pre-connected analyte sensor are shown in FIG.

[0233] At block 5400, an analyte sensor may be provided, such as analyte sensor 138. 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 a distal end of the elongated body). The analyte sensor may also include one or more electrical contacts at a proximal end or elsewhere along the elongated body, each coupled to a working electrode and / or a reference electrode.

[0234] At block 5402, a sensor carrier, such as one of the implementations of sensor carrier 402 described herein, may be attached, for example, to a proximal end of the elongate body. Attaching the sensor carrier includes coupling one or more contacts (e.g., on a substrate) of the sensor carrier to one or more corresponding electrical contacts on the elongate body.

[0235] At block 5403, a work station, 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 membrane 108 described above on the working electrode.

[0236] At block 5404, the analyte sensor may 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. Coupling the sensor carrier to the circuitry of the at least one test station may include mechanically coupling one or more fastening features, such as a substrate of the sensor carrier, to a mating interface of the test station such that one or more external contacts on the substrate are coupled to one or more corresponding contacts at the test station. Identifiers of the sensors on the sensor carrier may be read at the test station. Test data acquired by the test station may be stored and / or transmitted by the test station in association with the identifiers.

[0237] At block 5406, the analyte sensor may be coupled to at least one test station (e.g., calibration station 5004) by coupling the sensor carrier to the circuitry of the at least one calibration station. Coupling the sensor carrier to the circuitry of the at least one calibration station includes mechanically coupling one or more fastening features, such as a substrate of the sensor carrier, to a mating interface of the calibration station such that one or more external contacts on the substrate are coupled to one or more corresponding contacts at the calibration station. An identifier of the sensor on the sensor carrier may be read at the calibration station. Calibration data obtained by the calibration station may be stored and / or transmitted by the calibration station in association with the identifier. The calibration data may be stored in the sensor carrier or transmitted for later use by the on-skin sensor assembly 600 during in vivo use of the sensor 138.

[0238] The sensor carrier 402 may be coupled to one or more additional manufacturing stations as desired, which may include a potentiostat measurement station, a sensor linearization station, a membrane soaking station, a curing station, an analyte sensitivity measurement station, and / or an inspection station.

[0239] At block 5408, the sensor carrier may be coupled to sensor electronics of a wearable device such as on-skin sensor assembly 600 (e.g., sensor electronics 112 of electronic unit 500). Coupling the sensor carrier to the sensor electronics may 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 may include securing the sensor carrier between a base, such as base 128, and the electronic unit 500 as described herein. A reader of the on-skin sensor assembly 600 may obtain an identifier of the sensor from the sensor carrier. Calibration data for the sensor may be obtained based on the identifier.

[0240] In block 5410, an in vivo signal from the working electrode (e.g., and / or reference electrode) may be obtained and processed by the sensor electronics. The in vivo signal from the working electrode (e.g., and / or reference electrode) may be received by the sensor electronics from the sensor through circuitry of the sensor carrier.

[0241] The methods disclosed herein include one or more steps or actions for achieving the described method. The steps and / or actions of the methods may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims. For example, the actions described above in connection with blocks 5404 and 5406 may be reversed and / or performed in parallel.

[0242] In some scenarios, it may be desirable to couple the sensor 138 to one or more contacts on a substrate in a preferred location and orientation. FIG. 58 shows an exemplary device 5531 in which the sensor 138 is oriented to the substrate 5530 using an elastomeric tube. As shown in FIG. 58, the device 5531 may include a substrate 5530 having one or more conductive contacts, such as contacts 5532 and 5534 (e.g., exposed copper pads on a printed circuit board), and an elastomeric tube 5500. The elastomeric tube 5500 may be formed from a non-conductive elastomer.

[0243] As shown, the elastomeric tube 5500 may be formed with a "D", "O", elliptical, pyramidal, or hemispherical shaped cross section with an elongated cutout 5503 at the bottom of the elastomeric tube 5500 in which the sensor 138 is placed. In this manner, the sidewalls of the elongated cutout in the elastomeric tube 5500 can align the sensor 138 with respect to the substrate 5530.

[0244] The bottom portion 5502 on either side of the cutout 5503 may be attached to the substrate 5530. The bottom portion 5502 may be attached to the substrate using an adhesive 5504, such as a pressure sensitive adhesive. The elongated opening 5501 and cutout 5503 in the elastomeric tube 5500 provide sufficient space to allow the sensor 138 to be placed on the substrate 5530 while the tube 5500 is placed over the sensor 138 to assemble the device.

[0245] 59 shows an exploded perspective view of the device of FIG. 55 with contacts 5532 and 5534 visible on substrate 5530. Sensor 138 may be disposed on one or more of the contacts, such as contacts 5532 and 5534.

[0246] The sensor 138 may be loosely held within the opening 5501 of the tube 5500 when the tube is initially placed over the sensor, and then secured to the substrate 5530 by the tube when the tube is compressed (e.g., by an upper housing of a wearable device). In this manner, the sensor 138 may be communicatively coupled and mechanically secured to the substrate without soldering or other joining operations.

[0247] During manufacturing operations and / or in vivo use of the sensor 138, the sensor 138 may be held in place on the substrate 404 by external compression of the tube 5500. Figure 60 illustrates an example where the sensor 138 is held in place by compression of the tube 5500 by a housing structure. For example, the housing 5700 (e.g., a housing for a wearable device, or a lid or clip for a manufacturing station) may include protruding members 5702 that compress the tube 5500 to secure the sensor 138 in an assembled configuration.

[0248] For example, as described above in connection with FIG. 35B, FIG. 43, FIG. 47A, FIG. 47B, FIG. 50, and FIG. 51, during manufacturing operations, multiple sensors 138 may be carried by a common sensor carrier. However, in some scenarios, a common carrier, such as an intelligent carrier, may be provided for manufacturing operations of multiple pre-connected sensors. FIG. 61 shows an example of a carrier for multiple pre-connected sensors. As shown in FIG. 58, a carrier 5800 may include a housing 5802 having an interface 5804 for multiple pre-connected sensors. The housing 5802 may be a substantially solid substrate or may be a housing that forms an internal cavity in which other components are mounted and / or connected.

[0249] Each interface 5804 may be configured to receive a sensor carrier 402 in any of the implementations described herein. For example, each interface 5804 may include one or more features that interface with one or more corresponding fastening features of a sensor carrier as described herein according to various implementations. The carrier 5800 may include circuitry 5806 (e.g., one or more processors and / or memory) configured to communicate with the sensor 138 and / or an external computing device. The circuitry 5806 may include communication circuitry, such as one or more antennas for transmitting and / or receiving data from the external device. The housing 5802 may include one or more structures 5810 (e.g., clips, clasps, protrusions, recesses, notches, posts, etc.) for mechanically coupling the carrier 5800 to a manufacturing device. One or more conductive contacts 5808 may be provided on the housing 5802 that communicatively couple the manufacturing device to the sensor 138 through the carrier.

[0250] As shown, each interface 5804 is assigned a specific identification number (e.g., I1, I2, . . . I in FIG. 58). N-1 , I NThe circuitry 5806 may electronically identify a sensor attached to the interface 5804 of the carrier 5800 by an identification number associated with that interface. However, this is merely an example. In other implementations, the sensors 138 may be uniquely identified by the circuitry 5806 using a reader in each of the interfaces 5804 that reads an identifier, such as identifier 450 on the sensor carrier. Test and / or calibration data may be collected by the processing circuitry 5806 and stored and / or transmitted along with each sensor's identifier.

[0251] During manufacture, the carrier 5800 may be loaded with one or more pre-connected sensors. The carrier 5800 may secure the pre-connected sensors therein and perform potentiostat measurements of each sensor (e.g., using the circuitry 5806). The sensors 138 may be secured to the interface 5804 by individual attachment mechanisms, or the carrier 5800 may be provided with a locking mechanism, such as a slidable bar 5812. The slidable bar 5812 may be slidable (e.g., by a handle 5814) between an open position as shown, in which the sensor carrier can be inserted and removed from the interface 5804, and a closed position, in which the bar 5812 blocks removal of the sensor carrier from the interface.

[0252] In some scenarios, initial measurement testing may be performed by the carrier 5800 to test the potentiostat connections through the sensor interconnect electrodes and the sensor surface. Manufacturing operations that may be performed on a sensor 138 coupled to the carrier 5800 may include physical manipulation of the sensor, such as linearizing the sensor. The carrier 5800 may facilitate more efficient manufacturing by allowing multiple sensors to be linearized in one operation using automated linearization equipment.

[0253] The carrier 5800 may facilitate potentiostat and / or other measurements at various stages of manufacture of the sensor 138. Potentiostat measurements may be taken before, during, and / or after the linearization operation, and information regarding sensor damage or other mechanical stresses that may be introduced by linearization may be stored and / or transmitted along with the associated sensor ID.

[0254] Manufacturing operations that may be performed on sensors 138 coupled to carrier 5800 may include a membrane process in which a dipping operation is performed to form a membrane, such as membrane 508, for each sensor. Linearized sensors 138 attached to carrier 5800 may be dipped simultaneously. Potentiostat measurements may be taken before, during, and / or after the dipping operation, and information related to the sensor electrochemistry and the dipping process may be collected, processed, stored, and / or transmitted by carrier 5800.

[0255] Manufacturing operations that may be performed on the sensors 138 coupled to the carrier 5800 may include a curing process. Curing the sensors 138 mounted on the carrier 5800 may allow the curing process to take up less space, thereby reducing the footprint of the manufacturing area used by the curing equipment. Potentiostat measurements may be taken before, during, and / or after the curing operation, and information related to the electrochemistry of the sensors and the curing process may be collected, processed, stored, and / or transmitted by the carrier 5800.

[0256] Manufacturing operations that may be performed on a sensor 138 coupled to the carrier 5800 may include a calibration process. Because the carrier 5800 can perform connection testing early in the manufacturing process, improved analyte / electrochemical calibrations may be performed by the carrier 5800 itself and / or in conjunction with external manufacturing equipment. Calibration data may be collected, processed, stored, and / or transmitted by the carrier 5800.

[0257] Collecting the calibration and / or test data on the carrier 5800 can save time from connecting and disconnecting additional external equipment. Collecting the calibration and / or test data on the carrier 5800 can also reduce calibration / test errors because the data is collected by the same equipment throughout the various processes, especially if the data is automatically collected and stored in association with the sensor ID.

[0258] Manufacturing operations that may be performed on a sensor 138 coupled to the carrier 5800 may also include analyte concentration measurements. For example, the carrier 5800 may be moved by manufacturing equipment (e.g., a robotic arm) to expose the sensor 138 attached to the carrier through various analyte baths (e.g., glucose baths). The carrier 5800 may collect potential measurements during the various bath exposures. Information related to the potential measurements during the various bath exposures may be collected, processed, stored, and / or transmitted by the carrier 5800.

[0259] Manufacturing operations that may be performed on sensors 138 coupled to carrier 5800 may also include analyte sensitivity measurements. Sensitivity measurements that may be performed by carrier 5800 may include baseline measurements indicative of the signal from each sensor without analyte exposure, slope measurements indicative of the signal change in analyte amount, and / or noise measurements. These sensitivity measurements may be stored and / or transmitted by carrier 5800.

[0260] Manufacturing operations that may be performed on sensors 138 coupled to the carrier 5800 may also include visual inspection operations (e.g., by a technician). Providing a group of pre-connected sensors mounted on the carrier 5800 that have already undergone all of the above testing / calibration / manufacturing operations may allow for more efficient and / or more automated visual inspection and rejection (as the physical location of each sensor within the carrier 5800 is known). Sensors 138 that exhibit abnormal electrochemical or mechanical stresses during manufacturing operations may be flagged by the carrier 5800 (e.g., using a display, visual indicator, or transmission of the flag information to an external device) for retesting or rejection.

[0261] The connections between elements shown in the several figures represent exemplary communication paths. Additional communication paths may be included, either directly or through intermediaries, to further facilitate the exchange of information between the elements. The communication paths may be bidirectional communication paths that allow the elements to exchange information.

[0262] The various operations of the methods described above may be performed by any suitable means capable of performing the operations, such as various hardware and / or software component(s), circuits, and / or module(s). In general, any operation illustrated in the figures may be performed by a corresponding functional means capable of performing the operation.

[0263] The various example logic blocks, modules, and circuits described in connection with this disclosure (such as the blocks of FIG. 2) may be implemented or performed with 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 be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0264] In one or more aspects, the various functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored or transmitted as one or more instructions or code on a computer-readable medium. Computer-readable media includes both computer storage media and communication media, including any medium that facilitates transfer of a computer program from one place to another. A storage medium is any available medium that can be accessed by a computer. By way of example, and not limitation, such computer-readable media may include various types of RAM, ROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage, or any other medium that can be used to execute or store desired program code in the form of instructions or data structures and that can be accessed by a computer. Additionally, any connection may be properly referred to as a computer-readable medium. For example, if the software is transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, the definition of medium includes coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, WiFi, Bluetooth, RFID, NFC, microwave, and the like. As used herein, disk and disc include compact discs (CDs), laser discs, optical discs, digital versatile discs (DVDs), floppy disks, and Blu-ray discs, where disks typically reproduce data magnetically, while discs reproduce data optically with lasers. Thus, in some aspects, computer readable media may include non-transitory computer readable media (e.g., tangible media). In addition, in some aspects, computer readable media may include transitory computer readable media (e.g., signals). Combinations of the above should also be included within the scope of computer readable media.

[0265] 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 thereon (and / or encoded thereon) instructions executable by one or more processors to perform the operations described herein. In certain aspects, the computer program product may include packaging materials.

[0266] Software or instructions may be transmitted over a transmission medium. For example, if the software is transmitted from a website, server, or other remote source using coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, microwave, etc. are included in the definition of transmission media.

[0267] Furthermore, it should be understood that the modules and / or other suitable means for performing the methods and techniques described herein can be downloaded and / or obtained by a user terminal and / or a base station as appropriate. For example, such devices can be coupled to a server to facilitate the transfer of means for performing the methods described herein. Alternatively, the various methods described herein can be provided via a storage means (e.g., RAM, ROM, a physical storage medium such as a compact disk (CD) or floppy disk, etc.), and the user terminal and / or base station can obtain the various methods upon coupling or providing the storage means to the device. Furthermore, any other suitable technique for providing the methods and techniques described herein to a device can be utilized.

[0268] It should be understood that the claims are not limited to the precise configuration and components illustrated above. Various modifications, changes and variations can be made in the arrangement, operation and details of the methods and apparatus described above without departing from the scope of the claims.

[0269] Unless otherwise defined, all terms (including technical and scientific terms) shall have their ordinary and customary meanings indicated to those skilled in the art, and shall not be limited to any special or customized meanings unless expressly defined herein. It should be noted that the use of a particular term when describing a particular feature or embodiment of the present disclosure should not be interpreted as implying that the term is redefined herein to include any particular characteristic of the feature or embodiment of the present disclosure to which it pertains. Particularly in the appended claims, the terms and phrases used in this application, and variations thereof, should be interpreted as open-ended as opposed to limiting, unless expressly stated otherwise. As examples of the above, the term "including" should be interpreted to mean "including without limitation," "including but not limited to," etc.; the term "comprising," as used herein, is synonymous with "including," "containing," or "featuring," 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 "example" is used to provide illustrative examples of the items under discussion rather than an exhaustive or exclusive list of them, and should not be construed as meaning "known," "conventional," "ordinary ... Adjectives such as "standard" and terms of similar import should not be construed to limit the subject matter described to that available in a given period or at a given time, but rather should be construed to encompass known, conventional, or standard technology that may be available or known at any time now or in the future, and the use of terms such as "preferably," "preferred," "desired," or "desirable" and terms of similar import should not be understood to imply that a particular feature is critical, essential, or even important to the structure or function of the invention, but rather should be intended merely to highlight alternative or additional features that may or may not be utilized in a particular embodiment of the invention.Similarly, a group of items joined by the conjunction "and" should not be construed as requiring the presence of every single one of those items in the group, but rather, unless otherwise stated, should be construed as "and / or." Similarly, a group of items joined by the conjunction "or" should not be construed as requiring mutual exclusivity between the groups, but rather, unless otherwise stated, should be construed as "and / or."

[0270] When a range of values ​​is provided, it is understood that the upper and lower limits, and each intervening value between the upper and lower limits of that range, are included within an embodiment.

[0271] With respect to virtually any plural and / or singular term herein, one of ordinary skill in the art can convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. Various singular / plural permutations may be expressly set forth herein for clarity. The indefinite articles "a" or "an" do not exclude plurals. A single processor or other unit may accomplish the functions of several items recited in the claims. The mere fact that certain criteria are recited in mutually distinct independent claims does not indicate that a combination of these criteria cannot be used to advantage. Reference signs in the claims should not be construed as limiting the scope.

[0272] When a specific number is intended in an introduced claim statement, such intention shall be clearly stated in the claim, and it will be further understood by those skilled in the art that in the absence of such statement, no such intention exists. For example, to aid in understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the claim statement. However, the use of such phrases should not be construed as implying that the introduction of a claim statement with the indefinite article "a" or "an" limits a particular claim that includes such an introduced claim statement to an embodiment that includes only one such statement (e.g., "a" and / or "an" should typically be construed to mean "at least one" or "one or more"), even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should typically be construed to mean "at least one" or "one or more"), which also applies to the use of definite articles used to introduce claim statements. In addition, even if a specific number of recitations of an introduced claim is explicitly recited, a person skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., a mere recitation of "two recitations" without other qualifiers typically means at least two recitations, or more than two recitations). Furthermore, when a conventional expression similar to "at least one of A, B, and C, etc." is used, such a structure is generally intended in the sense that a person skilled in the art would understand the conventional expression as including any combination of the recited items, for example, including a single element (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, and C, etc.).When a conventional expression similar to "at least one of A, B, or C, etc." is used, such a structure is generally intended in the sense that one of ordinary skill in the art would understand the conventional expression (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, a system having A alone, B alone, C alone, A and B, A and C, B and C, and / or A, B, and C, etc.). It will be further understood by those of ordinary skill in the art that virtually any disjunction and / or phrase indicating two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0273] All numbers expressing quantities of ingredients, reaction conditions, and the like used herein should be understood to be modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth herein are approximations that may vary depending on the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of any claims in any application claiming priority to this application, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

[0274] 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 herein, the present specification is intended to supersede and / or take precedence over any such conflicting material.

[0275] This specification includes headings for reference and to aid in locating the various sections. These headings are not intended to limit the scope of the concepts described therein. Such concepts may have applicability throughout the entire specification.

[0276] Moreover, while the foregoing has been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced. Thus, 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 as embracing all modifications and alternatives that fall within the true scope and spirit of the invention.

[0277] The various systems and methods described may be implemented and / or controlled entirely on any number of computing devices. Typically, instructions are located on a computer-readable medium, generally non-transitory, and these instructions are sufficient to enable a processor within the computing device to perform the methods of the present invention. The computer-readable medium may be a hard drive or solid-state storage with instructions deployed to a random access memory upon execution. For example, input to the application from multiple users or any single user may be by any number of suitable computer input devices. For example, a user may use a keyboard, mouse, touch screen, joystick, track pad, other pointing device, or other computer input device to input data relevant to the calculation. Data may be input via an inserted memory chip, hard drive, flash drive, flash memory, optical media, magnetic media, or other types of file-storage media. Output may be delivered to the user by a video graphics card or integrated graphics chipset connected to a display that the user may view. Alternatively, a printer may be used to output a hard copy of the results. Given this teaching, it will be understood that any other tangible output is also contemplated by the present invention. For example, the output may be stored on a memory chip, hard drive, flash drive, flash memory, optical media, magnetic media, or other output. It should be noted that the present invention may be implemented on any number of different types of computing devices, such as, for example, personal computers, laptop computers, notebook computers, netbook computers, handheld computers, personal digital assistants, mobile phones, smartphones, tablet computers, and devices specifically designed for these purposes. In one implementation, a user of a smartphone or wi-fi connected device downloads a copy of the application from a server to the device using a wireless internet connection.Payment to the seller may be provided with appropriate authentication procedures and a secure transaction process. The application may be downloaded over a mobile connection, or over a WiFi or other wireless network connection. The application may then be executed by the user. Such a networked system may provide a suitable computing environment for implementations in which multiple users provide separate inputs to the system and method. In the following systems where a factory calibration scheme is contemplated, multiple inputs may allow multiple users to enter relevant data simultaneously. [Explanation of symbols]

[0278] 100 Systems 101 Analyte Sensor System 102 Drug delivery pump 104 Glucose Meter 108 Membrane 112 Sensor Electronics 114, 116, 118, 120 Display devices 126 Adhesive Patch 128 Housing 135 Electronic Module 138 Analyte Sensors 138a Distal part 138b Proximal part 139 Wire Core 141 Sleeve layer 180 Through hole 192 Sealing structure 1000, 1000F, 1002, 1002F contacts 1410, 1412 Slot or Blind Hole 1420 Through hole 1430 1432 Additional holes 1442, 1444 Blind hole or recess 1451, 1453 plug 1500 Conductive Adhesive 1700 Recess 1800 First flat area 1802 Second flat area 1900 Recess 202 Arm 205 Application Specific Integrated Circuits (ASIC) 210 Potentiostat 211 Working electrode 211a electrode 211b Contact 212 Reference electrode 212a electrode 212b Contact 214 Processor Module 216 Program Memory 218 Memory 220 Data storage memory 222 User Interface 224 Button 226 Liquid Crystal Display (LCD) 228 Vibrator 230 Audio Transducer 232 Telemetry Module 234 Battery 236 Battery charger and / or regulator 237 Input Port 238 communication port 239 Output Port 2000 Conductive Tape 2100 extension part 2106, 2108 Guide structure 2200 Conductive plastic materials 2300 Ultrasonic Welding Horn 2600, 2602 Conductive mounting members 2700, 2704 extension part 2702 Central part 2706, 2708 Conductive contacts 2800 Base part 2802 Foldable part 2900 Datum Mechanism 2902 Movable Connector 2906 Conductive materials 300 Sensor Module 306, 306d coil springs 308 Protrusion 312, 312d base part 320 Battery 320d protrusion 322 Operational Amplifier 322d Channel 324, 334 contacts 328 resistor 336 Guard Trace 358 Distal Oriented Channel 3100 Devices 3102, 3104 Conductive bracket 3200 Top of flexible board 3202 Bottom of flexible board 3204 Strip Sensor Carrier 3220 Singulation mechanism 3300 Base part 3301 Crimp Connector 3302 Arm 3404 Flexible Circuit Strips 3700 Recess 3702 Conductive Trace 3704 Adhesive 3720 Finger Hold 400 Sensors 402 Sensor Carrier 404 Substrate 406 First internal contact 407 Guard Trace 408 Second internal contact 409 Network 410 First external contact 412 Second external contact 414 First Trace 416 Second Trace 420 Guide fixing part 426 Non-conductive adhesive 428 Pressure Sensitive Adhesives 430, 432 datum mechanism 450 Identifier 460 Cover 480 Array of Analyte Sensors 490 Cloud-based Analyte Processor 4000 boards 4001, 4002 Conductive Strips 4020 Scoring 4300 Opening 4402 Feed Guide Strip 4404 Positioning mechanism 4600 Receptacle 4700 Recess 4800 Board 4802 Processing part 4804 Sensor connection part 4808 Opening 4860 Panel 500 Electronic Unit 520 Upper Housing 522 Lower Housing 524, 526 Opening 528, 528a, 528b Sealing member 530 Electronics Assembly Board 5002 Test Station 5004 Calibration Station 5006 Receptacle 5008, 5010 Contacts 5011 Leader 5012 Processing circuit 5014 Receptacle 5016, 5018 Contacts 5020 Processing circuit 5022 Contact 5024 Cavity 5091 Manufacturing Station 5092 Processing Circuit 5093, 5095 Gripping structure 5094 Machine components 5100 Main Printed Circuit Board 5103 Conductive mounting mechanism 5104 Contacts 5200 Pinch Clip 5202 Crimp Connector 5204 Arm 5208 Clasp Arm 5220 Electrode Breakout 5300 Conductive Clip 5302 Opening 5304 Conductive clip part 5500 Elastomer Tube 5501 Opening 5502 Bottom part 5503 Notch 5504 Adhesive 5530 PCB 5531 Equipment 5700 Housing 5702 Protruding member 5800 Carrier 5802 Housing 5804 Interface 5806 Circuit 5808 Conductive contacts 5810 One or more structures for mechanically coupling the carrier to a manufacturing device 5812 Slidable bar 5814 Handle 5532, 5534 contacts 600 On-skin sensor assembly 605 Base Wall 700, 800 Mechanical Receiver 702 Receiver 704 Contacts Holes 706 and 708 712, 714 Conductive pin 722, 724 Opening 726 Recess 762, 764 Connecting materials 766, 768 Wall 772 Pressure-sensitive adhesives 780 Insulating Layer 784, 786 Positioning pin 794, 796 Holes 812, 814 Conductive pads 820 Film 826, 828 Contact pads

Claims

1. An apparatus comprising:

1. An analyte sensor comprising: With a long, slender body, a first electrode in electrical communication with the first conductive contact; a second electrode in electrical communication with the second conductive contact; and a sensor carrier attached to the analyte sensor, An intermediate body; a first conductive portion disposed on the intermediate body, the first conductive portion being in electrical communication with the first conductive contact; a second conductive portion disposed on the intermediate body, the second conductive portion being in electrical communication with the second conductive contact; The apparatus, wherein the first and second conductive portions form a connection portion configured to establish electrical communication between the first and second conductive contacts and a separate device.

2. The apparatus of claim 1 , further comprising an identifier coupled to the intermediate body.

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

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

5. 4. The apparatus of claim 2 or 3, wherein the identifier is 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 of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor.

7. The apparatus of any one of claims 1 to 6, wherein the first conductive portion and the second conductive portion are traces.

8. The apparatus of claim 7 , wherein the traces form exposed contact surfaces at the connection portions.

9. The device according to any one of claims 1 to 8, wherein the first and second conductive portions are at least partially embedded in the intermediate body.

10. 10. The apparatus of claim 1, wherein the first conductive portion and the second conductive portion comprise at least one of a solder weld, a conductive tape, a coil spring, a leaf spring, or a conductive elastomer.

11. The apparatus of any one of claims 1 to 10, wherein the connecting portion is configured to mechanically mate with the separate device.

12. The apparatus of any one of claims 1 to 11, wherein the separate device is an electronic unit configured to measure analyte data.

13. Apparatus according to any one of the preceding claims, wherein the separate devices are components of a manufacturing station.

14. The apparatus of claim 13 , wherein the manufacturing station is configured to perform at least one of a potentiostat measurement, a soaking process, a curing process, a calibration process, or a sensitivity measurement.

15. 14. The apparatus of claim 13, wherein the manufacturing stations comprise a calibration station configured to disconnect an electrical connection between the sensor and the calibration station and to establish an electrical connection between the sensor and at least one test station via the connection portion of the sensor carrier.

16. The device of any one of claims 1 to 15, wherein the intermediate body further comprises a datum structure configured to control a 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 to 16, wherein the first electrode is positioned coaxially within the second electrode.

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

19. The device of any one of claims 1 to 16, wherein the first electrode and the second electrode are fixed to a flexible, planar substrate.

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

21. The device according to any one of claims 1 to 20, wherein the first conductive contact and the second conductive contact are fixed to the intermediate body with a conductive adhesive.

22. The device according to any one of claims 1 to 21, wherein the first conductive contact and the second conductive contact are fixed to the intermediate body with an anisotropic conductive film.

23. An array of pre-connected analyte sensors, A substrate; a first plurality of electrical contacts disposed on the substrate; a second plurality of electrical contacts disposed on the substrate; a plurality of analyte sensors disposed on the substrate, each of the plurality of analyte sensors comprising: a first sensor electrical contact coupled to a corresponding one of the first plurality of electrical contacts on the substrate; a second sensor electrical contact coupled to a corresponding one of the second plurality of electrical contacts on the substrate.

24. 24. The array of claim 23, wherein the first plurality of electrical contacts are aligned along the substrate.

25. 25. The array of claim 23 or 24, wherein the first plurality of electrical contacts are formed from exposed contact surfaces.

26. The array of any one of claims 23 to 25, wherein the second plurality of electrical contacts are aligned along the substrate.

27. The array of any one of claims 23 to 26, wherein the second plurality of electrical contacts are formed from exposed contact surfaces.

28. 28. The array of any one of claims 23 to 27, wherein the first and second pluralities of electrical contacts are configured to connect with separate devices.

29. 30. The array of claim 28, wherein the separate devices are components of a manufacturing station.

30. 30. The array of any one of claims 23 to 29, wherein the substrate comprises at least one singulation mechanism configured to facilitate singulation of the substrate into a plurality of sensor carriers, each of the plurality of sensor carriers being attached to a respective one of the analyte sensors.

31. The array of any one of claims 23 to 30, further comprising a plurality of identifiers disposed on the substrate.

32. 32. The array of any one of claims 23 to 31, wherein the substrate has an elongate dimension and the plurality of analyte sensors extend beyond an edge of the substrate in a direction perpendicular to the elongate dimension.

33. 33. The array of claim 32, further comprising feed guide strips along opposing edges of the substrate in the elongated dimension.

34. 34. The array of any one of claims 23 to 33, wherein the substrate comprises a flexible substrate configured to be wound onto a reel.

35. 34. The array of claim 33, wherein the feed guide strips are removable from the substrate.

36. 36. The array of any one of claims 23-35, wherein the substrate comprises a molded thermoplastic having a plurality of datum features that control the position and orientation of the plurality of analyte sensors, and the first plurality of electrical contacts and the second plurality of electrical contacts each comprise a conductive trace embedded in the molded thermoplastic.

37. 37. The array of any one of claims 23 to 36, further comprising a first datum structure coupled to the array, the first datum structure configured to position at least one analyte sensor.

38. 38. The array of claim 37, wherein the first datum structure includes at least one singulation mechanism configured to facilitate singulation of the first datum structure into a plurality of second datum structures, each of the plurality of second datum structures being coupled to a corresponding one of a plurality of sensor carriers formed by the substrate.

39. 39. The array of any one of claims 23 to 38, wherein the substrate comprises processing circuitry configured to perform at least potentiostat measurements on the plurality of analyte sensors.

40. 40. The array of claim 39, further comprising a communications circuit operable by the processing circuit to transmit and receive data associated with each of the analyte sensors along with an identifier for the analyte sensor.

41. 24. The array of claim 23, wherein the array comprises one or more strips.

42. 1. A method comprising:

1. A method for detecting an analyte in a biological sample, comprising: An intermediate body; an analyte sensor permanently attached to the intermediate body; an identifier coupled to the intermediate body; communicatively coupling the analyte sensor to a processing circuit of a manufacturing station by coupling the intermediate body to a corresponding mechanism of the manufacturing station; and operating the processing circuitry of the manufacturing station to communicate with the pre-connected analyte sensor.

43. 43. The method of claim 42, wherein operating the processing circuitry comprises obtaining a signal from the analyte sensor.

44. 44. The method of claim 42 or 43, wherein operating the processing circuitry comprises operating an electrical, optical, infrared, or radio frequency reader at the manufacturing station to obtain the identifier.

45. 44. The method of claim 43, further comprising storing, with the processing circuitry of the manufacturing station and in association with the identifier, sensor data corresponding to the signal.

46. The method of any one of claims 42 to 45, wherein the identifier identifies any one or more of the analyte sensor, calibration data for the analyte sensor, and a history of the analyte sensor.

47. The method of any one of claims 43 to 46, wherein the signal comprises a glucose sensitivity signal.

48. 48. The method of any one of claims 42-47, further comprising: removing the intermediate body from the manufacturing station; and communicatively coupling the analyte sensor to a processing circuit of a wearable device by coupling the intermediate body to a corresponding mechanism of a wearable device.

49. The method of any one of claims 42 to 48, wherein the analyte sensor is permanently attached to the intermediate body with a conductive adhesive.

50. The method of any one of claims 42 to 48, wherein the analyte sensor is permanently attached to the intermediate body with an anisotropic conductive film.

51. 49. The method of claim 48, further comprising acquiring in-vivo measurement data from the analyte sensor using the processing circuitry of the wearable device.

52. A wearable device, Housing and an electronic circuit configured to process an analyte sensor signal, the electronic circuit being enclosed within the housing; and an analyte sensor having a distal portion positioned outside the housing; an intermediate body having electrical connections to both a proximal portion of the analyte sensor and to electronics, wherein the electrical connection between the intermediate body and the proximal portion of the analyte sensor is external to the housing.

53. 53. The device of claim 52, wherein the intermediate body is positioned adjacent an exterior surface of the housing.

54. 54. The device of claim 52 or 53, comprising electrical contacts coupled to both the electronics and the intermediate body.

55. 55. The device of claim 54, wherein the intermediate body is electrically connected to the electrical contacts with a conductive epoxy.

56. 55. The device of claim 54, wherein the intermediate body is electrically connected to the electrical contacts with an anisotropic conductive film.

57. The device according to any one of claims 52 to 56, wherein the intermediate body is sealed.

58. The device of any one of claims 54 to 57, wherein the electrical contacts extend through the housing.

59. 59. The device of any one of claims 52-58, wherein the analyte sensor is formed as an elongate body having a distal portion configured for percutaneous implantation into a subject and a proximal portion configured for electrical connection to the intermediate body.

60. A device according to any one of claims 52 to 59, wherein the intermediate body is positioned within a recess on the outer surface of the housing.

61. 61. The device of claim 60, wherein electrical contacts extend through the housing within the recess and electrically couple the intermediate body to the electronic circuitry enclosed within the housing.

62. 62. The device of claim 60 or 61, wherein the intermediate body is coated with a polymer within the recess.

63. The device of any one of claims 52-62, wherein the distal portion of the analyte sensor extends through the housing and away from an opening.

64. A device according to any one of claims 52 to 63, wherein the electronic circuit comprises a potentiostat.

65. A device according to any one of claims 52 to 64, wherein the electronic circuitry comprises a radio transmitter.

66. 1. A method of making a pre-connected analyte sensor, comprising: mechanically and electrically connecting a proximal portion of the elongated conductor to a conductive portion of the intermediate body; and after connection, coating the distal portion of the elongated conductor with a polymer film to form an analyte sensor having a working electrode area configured to support an electrochemical reaction for analyte detection at the distal portion of the elongated conductor.

67. 67. The method of claim 66, further comprising testing the analyte sensor, the testing comprising electrically coupling the mid-body to a test station.

68. 68. The method of claim 67, further comprising calibrating the analyte sensor, the calibrating comprising electrically coupling the intermediate body to a test station.

69. The method of any one of claims 66 to 68, wherein the coating comprises dip coating.

70. 70. The method of any one of claims 66-69, wherein the intermediate body is part of an array formed by a plurality of joined intermediate bodies, the method further comprising 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.

71. 71. The method of claim 70, comprising applying the coating in parallel to each distal portion of each of the plurality of elongate electrodes connected to the intermediate body of the array.

72. 72. The method of claim 71, comprising singulating one or more of the intermediate bodies of the array after said coating.

73. The method of any one of claims 66 to 72, wherein mechanically and electrically connecting comprises applying a conductive paste to the elongated conductor and the conductive portion of the intermediate body.

74. 74. The method of any one of claims 66 to 73, wherein 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.

75. The method of any one of claims 66 to 74, wherein the connecting occurs at a location remote from the coating.

76. 76. The method of claim 75, wherein said coating, said testing, and said calibrating are all performed at a location remote from said connecting.

77. 1. A method of making an on-skin wearable device, comprising: incorporating electronic circuitry within an interior volume of a housing, the electronic circuitry configured for (1) detecting a signal generated from an electrochemical reaction beneath the subject's skin at a working electrode of an analyte sensor, and (2) wirelessly transmitting data derived from the detected signal outside of the housing for processing and / or display on a separate device; and after incorporating the electronic circuitry within the interior volume of the housing, attaching a proximal portion of the analyte sensor to an external electrical interface coupled to the electronic circuitry such that the electronic circuitry is connected to the analyte sensor and receives a signal therefrom without opening the housing.

78. 80. The method of claim 77, comprising sealing the interface after attaching the proximal portion of the analyte sensor.

79. 80. The method of claim 77 or 78, including testing the electronic circuit for functionality prior to said mounting.

80. 80. The method of any one of claims 77 to 79, comprising testing the analyte sensor for functionality prior to said mounting.

81. The method of any one of claims 77 to 80, wherein said incorporating occurs at a location remote from said attaching.

82. 82. The method of any one of claims 77-81, comprising coupling an intermediate body to the proximal portion of the analyte sensor, and wherein said attaching comprises attaching the intermediate body to the external electrical interface.

83. 83. The method of claim 82, comprising using said intermediate body to perform at least one manufacturing or testing procedure on said working electrode prior to said attaching.

84. 83. The method of claim 82, wherein the performing comprises coating the working electrode of the analyte sensor.

85. 85. The method of any one of claims 83 or 84, wherein the binding occurs at a first location, the incorporating occurs at a second location, and the performing occurs at a third location, and the first, second, and third locations are remote from one another.

86. The method of any one of claims 77 to 85, wherein the attaching is performed using an anisotropic conductive film.

87. The method of any one of claims 77 to 86, wherein the bonding is performed using an anisotropic conductive film.

88. 88. The method of any one of claims 77 to 87, comprising attaching an inserter to the housing for implanting the working electrode in a subject.

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