Continuous glucose monitoring device

Abstract

An apparatus includes a body, and an actuator coupled to the body. A needle is mounted to the actuator. The needle includes a slot along the length to the tip. The sensor is coupled to the plurality of wires. The base is configured to be movable by the actuator and includes a cutout, a circuit board having a microprocessor, and a plurality of contacts. Each contact is coupled to a wire of the plurality of wires. A power source is connected to the circuit board and the base. A bracket is coupled to a bottom surface of the body and is configured to receive the base. A patch is coupled to the stent and has an adhesive. The needle is configured to be movable by the actuator. The plurality of wires extend from the circuit board of the base, pass through the needles, and exit the slots.

Description

[0001] This application is a divisional application of the invention patent application with application number 201980024913.8, application date April 5, 2019, and invention name “Continuous Glucose Monitoring Device”.

[0002] Related Applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 653,821, filed on April 6, 2018, and entitled “Continuous Glucose Monitoring Device,” which is hereby incorporated by reference in its entirety. Background Art

[0004] Monitoring of glucose levels is critical for patients with diabetes. A continuous glucose monitoring (CGM) sensor is a type of device that measures glucose multiple times a day by sampling body fluids in an area just under the skin. CGM devices are administered via an applicator and typically include a small housing in which the electronics are located and adhered to the patient's skin to be worn for a period of time. A small needle within the device delivers a subcutaneous sensor, which is typically electrochemical.

[0005] Electrochemical glucose sensors operate by using electrodes that typically detect an amperometric signal caused by the oxidation of the enzyme during the conversion of glucose to gluconolactone. The amperometric signal can then be correlated to the glucose concentration. A two-electrode (also called a 2-pole) design uses a working electrode and a reference electrode, where the reference electrode provides a reference for comparison with the working electrode. A three-electrode (or 3-pole) design has a working electrode, a reference electrode, and a counter electrode. The counter electrode replenishes the ion loss at the reference electrode and is part of the ion circuit.

[0006] Glucose readings taken by the sensor can be tracked and analyzed by the monitoring device, such as by scanning the sensor with a customized receiver or by transmitting the signal from the monitoring device directly to a device (such as a smartphone or computer) with an associated software application. Software features that have been included in CGM systems include viewing glucose levels over time, indicating glucose trends, and alerting patients to high and low glucose levels. Summary of the invention

[0007] In some embodiments, the sensor includes a working electrode having a first wire with a first plane and an electrochemical element on the first plane. The reference electrode includes a second wire with a second plane, and the counter electrode includes a third wire with a third plane. Among the plurality of sensor wires, the first wire is a first sensor wire for the working electrode, the second wire is a second sensor wire for the reference electrode, and the third wire is a third sensor wire for the counter electrode. The second plane and the third plane face each other.

[0008] In some embodiments, the sensor includes a working electrode having a first wire having a first plane and an electrochemical element on the first plane. A reference electrode includes a second wire having a second plane, and a counter electrode includes a third wire having a third plane. Among the plurality of sensor wires, the first wire is a first sensor wire for the working electrode, the second wire is a second sensor wire for the reference electrode, and the third wire is a third sensor wire for the counter electrode. The first wire, the second wire, and the third wire are coupled to a core wire.

[0009] In some embodiments, a device includes a body having a bottom surface and a top surface. An actuator is coupled to the body and extends through the top surface of the body. A needle is mounted to the actuator. The needle includes an inner diameter and a slot along the length of the needle to the tip of the needle. A sensor is coupled to a plurality of wires. The sensor and the plurality of wires are sized to fit through the inner diameter of the needle. A base is configured to be movable by the actuator and includes a cutout, a circuit board having a microprocessor electrically connected to the circuit board, and a plurality of contacts. Each contact is coupled to a wire in the plurality of wires. A power source is electrically connected to the circuit board and coupled to the base. A bracket is coupled to the bottom surface of the body and configured to receive the base. A patch is coupled to the bracket and has an adhesive. The needle is configured to be movable by the actuator through the cutout on the base. The plurality of wires extend from the circuit board of the base, through the needle and out of the slot of the needle.

[0010] In some embodiments, a system includes a sensor coupled to a plurality of wires. A base includes a circuit board having a microprocessor electrically connected to the circuit board and a plurality of contacts. Each contact is coupled to a wire in the plurality of wires. A power source is electrically connected to the circuit board and coupled to the base. A needle is configured to move through a cutout on the base. The plurality of wires extend from the circuit board of the base, through the needle and out of the slot of the needle.

[0011] In some embodiments, a method for constructing a base includes coupling a sensor to a plurality of wires. The sensor and the plurality of wires are sized to fit through the inner diameter of the needle. A wire in the plurality of wires is coupled to a contact in the plurality of contacts. Each contact has an opening in a plurality of openings on a circuit board, and the opening has a metal coating. A fastener having a protrusion is attached to the opening. The diameter of the protrusion is smaller than the diameter of the opening, and the wire in the plurality of wires is between the opening and the protrusion. A power supply is connected to the circuit board. The circuit board and the power supply are assembled in a base. The base has the circuit board, the microprocessor, the contact in the plurality of contacts coupled to the wire in the plurality of wires, and the power supply is a sealed unit. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Various views of planar electrodes are shown according to some embodiments.

[0013] Figure 2A and Figure 2B A cross-sectional view of a core wire having a triangular cross-section is shown according to some embodiments.

[0014] Figure 2C and Figure 2D Depicted are a longitudinal cross-sectional view and a perspective view, respectively, of an end portion of a triangular core wire according to some embodiments.

[0015] Figure 3 An electrochemical element is shown mounted to a planar electrode according to some embodiments.

[0016] FIG. 4A to FIG. 4C are various views of a base assembly according to some embodiments.

[0017] Figure 5 is a perspective view of a vertical insertion applicator according to some embodiments.

[0018] Figure 6 and Figure 7 According to some embodiments Figure 5 A cross-sectional view of an applicator.

[0019] FIG. 8A to FIG. 8C According to some embodiments FIG. 4A to FIG. 4C A view of the components of the base assembly.

[0020] Fig. 9 A perspective view of an angled insertion applicator is shown according to some embodiments.

[0021] FIG. 10A to FIG. 10B According to some embodiments Fig. 9A cross-sectional view of an applicator.

[0022] Fig.11A , Fig. 11B and Fig.12 According to some embodiments Fig. 9 A perspective view of a subassembly of an applicator.

[0023] FIG. 13A to FIG. 13B is a perspective view of a base assembly for an angled insertion applicator, according to some embodiments.

[0024] FIG. 14A to FIG. 14B is a perspective view of a sensor base for an angled insertion applicator according to some embodiments.

[0025] FIG. 15A to FIG. 15D Various views of a base assembly are shown according to some embodiments.

[0026] FIG. 16A to FIG. 16B is a perspective view of an articulating applicator according to some embodiments.

[0027] Fig.17 According to some embodiments FIG. 16A to FIG. 16B A perspective view of a portion of an applicator.

[0028] FIG. 18A to FIG. 18B According to some embodiments, the encapsulated FIG. 16A to FIG. 16B Perspective view of the applicator.

[0029] Fig.19 According to some embodiments, a needle is deployed FIG. 16A to FIG. 16B A cross-sectional view of an applicator.

[0030] Fig. 20 is a perspective view of selected components of an articulating applicator according to some embodiments.

[0031] Fig.21 is a perspective view of a cover of an articulating applicator according to some embodiments.

[0032] Fig. 22 is a cross-sectional view of an articulating applicator in a closed position, according to some embodiments.

[0033] Fig.23 is a perspective view of an articulating applicator in a closed position, according to some embodiments.

[0034] FIG. 24A to FIG. 24C is a perspective view of a wire connection assembly according to some embodiments.

[0035] FIG. 25A to FIG. 25C is a perspective view of a wire connection assembly having a formed contact according to some embodiments.

[0036] Fig.26 is a cross-sectional view of a wire connection in a device assembly according to some embodiments.

[0037] Fig. 27 Illustrations of molded contacts manufactured using printed circuit board components according to some embodiments are provided.

[0038] Fig.28 shows subsequent manufacturing stages according to some embodiments Fig. 27 of contacts.

[0039] Fig.29 Showing additional manufacturing stages according to some embodiments Fig. 27 of contacts.

[0040] Fig.30 An array of printed circuit board assemblies is shown being coated according to some embodiments.

[0041] Fig.31 Shown are stacked into assemblies according to some embodiments Fig. 27 printed circuit board components.

[0042] FIG. 32A to FIG. 32C is a perspective view of a sealed wire connection assembly according to some embodiments.

[0043] Fig.33A A perspective view of an applicator for a glucose monitoring system is shown, according to some embodiments.

[0044] Fig.33B is along Fig.33A Vertical cross-sectional view of the applicator taken at section CC.

[0045] Fig.34 is a slotted needle according to some embodiments.

[0046] Fig.35A and Fig.35B A base of an applicator is shown according to some embodiments.

[0047] Fig.36A and Fig.36B Shown are internal components of a base of an applicator according to some embodiments.

[0048] Fig.37 A cutaway front view of a circuit board with a power supply is shown according to some embodiments.

[0049] Fig.38 A perspective view of a fastener showing a contact according to some embodiments.

[0050] FIG. 39A to FIG. 39CPerspective views of a stent and a patch are shown, respectively, according to some embodiments.

[0051] Fig.40A and Fig.40B A perspective view of an actuator is depicted according to some embodiments.

[0052] Fig.40C A front view of an actuator is shown according to some embodiments.

[0053] Fig.41 is a perspective view of a bottom surface of a body according to some embodiments.

[0054] Fig.42 is a simplified flow chart of a method for constructing a susceptor according to some embodiments.

[0055] Fig.43 is a simplified schematic diagram depicting a system in an applicator according to some embodiments. DETAILED DESCRIPTION

[0056] Most CGM sensor designs are planar (flat substrate) or wire-based. The planar type is more suitable for 3-pole electrochemical designs because simple wire traces and small electrodes can be easily constructed. However, the planar type has physiological defects because the planar substrate has some directionality due to its geometry and also has sharp edges, which leads to a more aggressive biological response to the device. Wire-based systems produce better physiological responses from patients than planar systems due to the smooth nature of their geometry, but are mostly limited to single wires for insertion through needles. Due to the spatial limitations of needle-based sensor delivery, this single-wire constraint usually limits the design to a 2-pole electrochemical design. In a 2-pole design, the reference electrode is not regenerative, and therefore consumes electrode material to complete the electrochemical circuit, which limits the working life of the system.

[0057] The challenge of wire-based sensor design is making electrical connections at the distal end. Single-wire configurations require in-situ fabrication of the working membrane and chemistry, and thus limit the methods and materials that can be used in such designs. Separate wires for the working, reference, and counter electrodes are ideal for ease of manufacturing; however, this approach is limited by the inner diameter of the insertion needle.

[0058] In some embodiments, a sensor with a 3-pole design based on wires is used. The design uses a split wire configuration that enables three wires for the working electrode, reference electrode, and counter electrode to occupy the space of only two complete wires. For example, the reference electrode and counter electrode have a cross-section such that the two wires coupled together occupy the space of one complete wire while providing almost the same surface area as two complete wire electrodes. Therefore, the 3-pole design can fit within the inner diameter of a typical insertion needle instead of two complete wires.

[0059] The present embodiment discloses a wire-based 3-pole electrochemical design in which the working chemistry is made separately from the wire and then bonded to the sensor wire below. Because the components of the CGM device of the present invention can be made independently of each other, this allows for lower cost materials and methods. In addition, because the wire is made separately, 100% sensor quality testing is not required and quality testing can be performed on a monolithic or batch basis, more cost-effective large-scale manufacturing can be achieved. Some embodiments of the disclosed wire-based system use carbon-based (such as graphene-based) electrodes manufactured in large-scale sheets with working chemicals that are then attached to the working electrodes.

[0060] In addition, an applicator design and electrical connection configuration that supports simple insertion of a 2-pole or 3-pole lead design are disclosed. Embodiments of the applicator include vertical insertion and angled insertion as well as design features for improving the robustness, reliability and cost of these designs by utilizing an onboard battery included in the base of the applicator. In some embodiments, the applicator design uses a slotted needle that pierces the skin and can then be retracted by "hard-wiring" the sensor wire to the electronics (such as a circuit board and power supply in the base). This embodiment also includes a method for making electrical connections to the wire sensor in the sensor applicator. In some embodiments, a unique feature of these designs is a "flag" shaped electrical connection that moves with the wire during insertion and then locks into the base, allowing the wire to remain in place while the needle is retracted.

[0061] Figure 1An embodiment of a wire-based 3-pole system 100 of a continuous glucose monitoring sensor using a separated wire design is shown. In this embodiment, a portion of the wire (such as a half wire) is provided for a reference electrode 110. The wire is a sensor wire for the reference electrode 110 among a plurality of sensor wires. Similarly, a portion of the wire (such as a half wire) is provided for a counter electrode 120, and is a sensor wire for the counter electrode 120 among a plurality of sensor wires. The sensor wire for the reference electrode and the sensor wire for the counter electrode each have a plane roughly across their diameters, so that the wire has a semicircular cross-section. In some embodiments, the plane of the reference electrode 110 and the plane of the counter electrode 120 face each other.

[0062] Each half-wire electrode, such as reference electrode 110 and counter electrode 120, can have 82% of the surface area of ​​a full wire of the same diameter, while still allowing the reference electrode and counter electrode assembly to fit within a small diameter insertion needle 102 for insertion under the skin. In other words, the split wire configuration enables the reference electrode 110 and counter electrode 120 to provide nearly the same surface area as two full wire electrodes, but only occupy the space of one wire within the insertion needle 102 instead of two full wires. Although half-wires are depicted for the reference electrode 110 and counter electrode 120, where each wire has been separated along its diameter along the length of the wire, other fractions of the wire can be used to form a planar electrode. The planes of the reference electrode 110 and counter electrode 120 can be defined by a chord across the circular cross-section of the wire, so that the cross-sectional area of ​​the reference electrode 110 and counter electrode 120 is 30% to 70% of the cross-section of the wire. Therefore, the circular cross-section of the wire can be larger or smaller than a half circle. This enables the wire to obtain a greater percentage of the surface area of ​​the full wire.

[0063] The working electrode was fabricated by also creating a flat portion on the wire. Figure 1 Two embodiments are shown - 1-side working electrode 130 and 2-side working electrode 135 - either of which can be used. 1-side working electrode 130 has a semicircular cross-section in which half of the cross-sectional area of ​​the wire has been removed. As described with reference to reference electrode 110 and counter electrode 120, other fractions of the wire can be used to form a planar electrode defined by a chord across the circular cross-section of the wire, so that the cross-section of the wire can be 30% to 70% of the complete wire. 2-side working electrode 135 has a rectangular cross-section in which portions of the wire above and below the flat portion have been removed. The removed portions can be equal, or one portion - the top portion or the bottom portion - can be larger than the other portion. One or more flat portions of the working electrode 130 or 135 are used to support an electrochemical element, which is a reactive component for sensing glucose in the patient's tissue fluid, and the wire is a sensor wire for the working electrode among multiple sensor wires.

[0064] In some embodiments, the sensor is a 3-pole design and includes a working electrode having a first wire with a first plane and an electrochemical element on the first plane. The first wire is a first sensor wire for the working electrode. The reference electrode has a second wire with a second plane. The second wire is a second sensor wire for the reference electrode. The counter electrode has a third wire with a third plane. The third wire is a third sensor wire for the counter electrode. The first sensor wire, the second sensor wire, and the third sensor wire are multiple sensor wires.

[0065] Figure 1 Insertion of the electrodes into the insertion needle 102 is also shown, where it can be seen that this 3-pole design of the sensor occupies the equivalent of only two wires instead of three wires in the needle cavity. The working electrode (where a 2-sided working electrode 135 is shown in this illustration) utilizes the space of one wire, and the reference electrode 110 and the counter electrode 120 together occupy the space of another wire. For example, the combined diameter of multiple sensor wires such as the working electrode 135, the reference electrode 110, and the counter electrode 120 is less than the inner diameter of the insertion needle 102. The diameter of each of the multiple sensor wires for the reference electrode 110, the counter electrode 120, or the working electrode 135 can be, for example, 0.002 inches to 0.007 inches, while the inner diameter of a typical insertion needle can be 0.16 inches to 0.21 inches or 25 gauge to 27 gauge. The length or surface area of ​​the electrode portion itself can be customized according to the desired sensor sensitivity and the required design specifications.

[0066] FIG. 2A to FIG. 2D Other embodiments of a system for use in a continuous glucose monitoring sensor having planar electrodes and a supporting core wire 140 are shown. Figure 2A and Figure 2B A cross-sectional view of a core wire 140 having a triangular cross-section according to some embodiments is shown. For example, designs 200 and 210 are compact systems assembled with the core wire 140. A first wire of the working electrode 135, a second wire of the reference electrode 110, and a third wire of the counter electrode 120 are coupled to the core wire 140 and surround the core wire 140 having a triangular cross-section. Each of the wires for the working electrode 135, the reference electrode 110, and the counter electrode 120 has a flat surface positioned to face the surface of the triangular core wire 140. The cross-sections of the reference electrode 110 and the counter electrode 120 may be approximately semicircular, while the cross-section of the working electrode may be semicircular (e.g., Figure 2A As shown, design 200) or rectangular (as Figure 2B 210). Other cross-sectional shapes may be used for the working electrode 135, the reference electrode 110, and the counter electrode 120 when coupled to the core wire 140.

[0067] Figure 2C and Figure 2D A longitudinal cross-sectional view and a perspective view of the end of a triangular core wire 140 according to some embodiments are depicted, respectively. Schematic diagrams 220 and 230 show that the triangular design can be a completely self-inserting sensor. That is, the tip 142 of the triangular core wire 140 can be sharpened to a point or point so that the sensor can be directly inserted without the need to use a needle to place the sensor within the subcutaneous tissue.

[0068] In these various embodiments, the flat surface of the electrode provides support for a fragile electrochemical material, such as a typically brittle carbon-based sheet. In some embodiments, a support sheet may be produced (e.g., consisting of an electrodeposition of a melt extrusion of pyrrole or polyaniline), and then the carbon material is deposited onto the support sheet. The support sheet provides a substrate to which the carbon adheres well, and should also be conductive to electrically couple the electrochemical (e.g., carbon / pyrrole) sheet to the electrode wires. The conductive sheet material may then be impregnated or coated with the sensing chemical by various stretch film or spin coating techniques.

[0069] The electrochemical material sheet can be made separately from the electrode lead and then Figure 3 As shown, it is mounted on the flat surface of the electrode. Figure 3 In this example, a wire 310 having an insulator 320 surrounding a conductive core 330 has a portion of its end removed to form a flat surface 340. Carbon or carbon / graphene / pyrrole flakes 350 are cut to size and placed on the flat surface of the flat electrode wire so that the electrochemical element contains carbon. For example, when the flat flakes are made with the sensing chemical, these flakes 350 can be laser cut into small parts and then assembled onto the flat surface 340 of the wire 310.

[0070] The support sheet can be made, for example, by melt extruding a pyrrole layer to make electrical contact with the flat surface of the electrode. In other embodiments, electropolymerization of additional pyrrole can be used to attach the electrode metal to the sheet, or conductive adhesives or other electrical contact bonding methods can also be used to make electrical contact.

[0071] In other embodiments, the electrochemical component may be formed in situ on the electrode rather than being formed as a sheet separate from the electrode. For example, alternative manufacturing methods for in situ generation of sensing chemicals and membranes may include pad printing or screen printing, painting, or 3D printing directly on one or more planes of wire.

[0072] The carbon material may be in the form of, for example, an ink or paste, and the carbon may include various allotropes such as, but not limited to, graphite, graphene, fullerenes, and / or nanotubes. Materials other than pure carbon may be used, including platinum black, carbon platinum paste, carbon gold paste, or other known working electrode surface materials (e.g., carbon, platinum, gold, palladium, rhodium, iridium) used alone or in combination. In some embodiments, high surface area nanoporous materials of graphene and / or other nanomaterials may be used to increase the number of active chemical sites available for reaction.

[0073] Carbon is less expensive than the noble metals (e.g., gold and platinum) typically used for biocompatible applications. However, due to the inherent brittleness of carbon materials, carbon-based electrodes are conventionally used in planar electrodes (such as finger sticks), where the carbon can be supported by a planar substrate without placing undue mechanical loads on the electrode. Embodiments of the present invention overcome the difficulties of using carbon-based materials on wire electrodes by providing the required mechanical support for the carbon material and by eliminating the typical in-situ fabrication requirements of the working chemistry on the wire (although in-situ fabrication can be used).

[0074] After generating the sensing chemistry on the electrode, either isolated or in situ, a final dip coating can be used to seal the entire system using the hoop strength generated by shrinkage of the polymer after drying. This final polymer layer also serves as a biocompatible membrane and glucose limiting membrane required to generate a linear glucose response and provides the biosafety required for implantable sensors.

[0075] Flat wire embodiments of the present invention can also be used to optimize electrochemical substrates so that they can be tuned for direct electron transfer chemistries by keeping the redox centers near the porous carbon surface or within an encapsulated polymer. One such embodiment uses aminophenols covalently bonded to a carbon electrode by electrografting and then linked to glucose oxidase (GOX) by diazo chemistry to provide direct electron transfer. Embodiments can be used directly with conductive polymers (e.g., PEDOT-PSS, polypyrrole, polyaniline, etc.) formed in situ on porous carbon sheets, which can work with normal enzymes (glucose oxidase (GOX) or glucose dehydrogenase (GDH)) and / or enzymes with mediators to create hybrid enzyme systems that alter the need for high bias and thus reduce interference from all sources.

[0076] In some embodiments, the redox enzyme can be immobilized on the electrode surface in a new way so that direct electron transfer between the active side of the enzyme and the transducer is possible. The main unique feature of such an embodiment of the amperometric glucose sensor is that the bias potential is in the range of -0.5V to 0V, ideally about -0.1V. In contrast, the bias potential of conventional CGM sensors is typically +0.55V. There are two main methods to achieve the lower bias potential of the design of the present invention. The first method is to electropolymerize the conductive polymer with the redox enzyme in situ. The sensing layer is formed by applying a potential cycle or a sequence of suitable potential pulses with an enzyme and a monomer / comonomer solution. The advantage of this method is that the film is only formed on the electrode surface due to the electrochemical initiation of the deposition process. The second method is to incorporate the redox mediator into a polymer or prepolymer. The polymer containing the redox mediator can be physically mixed with the enzyme and then deposited on the electrode by dip coating, spin coating or other coating methods. This can also be achieved by in situ polymerization of the prepolymer containing the redox mediator with other active prepolymers in the presence of an enzyme solution and an electrode. The resulting sensing layer on the electrode comprises the matrix enzyme inside the polymer network with the covalently attached redox mediator.

[0077] Various embodiments of an applicator for inserting a CGM sensor into a patient will now be described.

[0078] FIG. 4A to FIG. 4C An embodiment of a base assembly 400 to be worn by a patient during glucose monitoring is shown. The base assembly 400 includes a cover 420 and a base 430, and may be adhered to the abdomen or arm of a patient, for example. Figure 4A It is a perspective view. Figure 4B is a top view, and Figure 4C is a side view. The base assembly 400 holds the glucose sensor 480 in place on the patient and houses the electronics to which the glucose sensor 480 is attached. The glucose sensor 480 measures glucose in the patient's interstitial fluid and Figure 4C 4, a glucose sensor 480 extending from the bottom surface of the base assembly 400 can be seen. In some embodiments, the base assembly 400 may have a length of 2.13 inches, a width of 1.50 inches, and a height of 0.27 inches. These dimensions may be smaller due to further miniaturization of electronics and reduced battery usage. To deliver the CGM sensor to the patient, the cover 420 is removed from the base 430 and the applicator is attached to the base 430. The cover 420, which is dome-shaped in this embodiment, serves as a lid for the base 430 after the applicator has been inserted into the sensor and removed from the base.

[0079] exist Figure 5, an embodiment of an applicator for a glucose monitoring system is shown in FIG. 6 , wherein the track 630 and plunger 620 are used for a vertical insertion design. In this embodiment, the applicator is coupled to the base 430 via a lug 625. Figure 5 6 is a perspective view before the needle 610 is deployed, so that the plunger 620 is raised relative to the base 430. After the needle 610 is deployed, the plunger 620 moves downward toward the base 430 guided by the track 630.

[0080] Figure 6 and Figure 7 Along Figure 5 A vertical cross-sectional view taken along sections AA and BB, wherein Figure 6 Before the needle is deployed Figure 7 is after the needle is deployed. The sensor base 401, including the CGM sensor and associated wiring, moves with the needle 610 during insertion. After the needle 610 has been deployed, when the needle is removed, the sensor base 401 locks into the base 430 and stays therein. The advantage of this vertical insertion style is that it does not rely on manual dexterity to deploy the sensor. The patient can use the palm of the hand to push down and provide the force for deployment. This vertical deployment style may be advantageous for self-insertion of the sensor by, for example, the very young or elderly.

[0081] FIG. 8A to FIG. 8C A perspective view, a side cross-sectional view, and an end cross-sectional view of the base assembly 400 are shown, respectively, after the sensor has been placed in a patient. Fig. 8A , the dome-shaped cover 420 has been removed to show the interior of the base 430, wherein the battery 450 and the installed sensor base 401 can be seen. The sensor base 401 has electrical contacts 445 for the sensor wires 460 of the glucose sensor 480. FIG. 8B to FIG. 8C A cover 420 is shown mounted on a base 430, wherein the cover 420 includes a circuit board 440 in its underside. Thus, when the cover 420 is coupled to the base 430, the circuit board 440 is placed in contact with electrical contacts 445. The circuit board 440 retrieves the ampere reading, such as by sending the reading to a mobile device. Sensor wires 460 (also referred to as leads in this disclosure) are electrically coupled to the contacts 445 (described below).

[0082] Fig. 9 A perspective view of another embodiment of an applicator for a glucose monitoring system is shown, in which a plunger assembly 900 is used to achieve angled insertion of the needle. This angled applicator style helps reduce sensor noise caused by micro-movements of the sensor tip while the sensor is monitoring a patient. Noise can come from forces transmitted down the wire from a base mounted to the skin surface, from any forces applied to the base by the action of normal wearing of the device.

[0083] Fig. 10A and Fig. 10B 9 and 9. The figures are vertical cross-sectional views of the plunger assembly 900 in an undeployed state and a deployed state, respectively. The plunger assembly 900 includes a plunger 920, a track 930, a release button 950, and a spring 960. In other embodiments, the plunger 920 may take other forms, such as a rod. The sensor base 970 moves with the needle 910 fixedly mounted to the plunger 920. The sensor wires 971 (one sensor wire for each of the working electrode, the reference electrode, and the counter electrode) are connected to the sensor base 970 at one end, and the glucose sensor 980 is formed at the opposite end of the sensor wires 971. To deploy the needle 910, the user presses the release button 950, which allows the spring 960 to contract. Thus, the plunger 920 is moved as shown in FIG. Fig. 10B The patient is shown sliding down on track 930 and inserting a lead 971 with a glucose sensor 980 through needle 910 into the patient. When the needle is inserted, the sensor base 970 locks into the base 990 so that the sensor base 970 stays in the base 990 when the needle is removed.

[0084] Fig.11A , Fig. 11B and Fig.12 is a perspective view of the angled insertion applicator during assembly. Fig.11A In FIG. 9 , a plunger 920 has a needle 910 fixedly attached thereto. The sensor base 920 is slid onto the needle 910, with the pin 925 of the plunger 920 connected to the sensor base 970. Fig. 11B In FIG. 9 , the combined subassembly of plunger 920 and sensor base 970 is mounted on track 930. Fig.12 middle, Fig. 11B The subassembly is placed onto spring 960 and installed into front cover 901.

[0085] Fig.13A and Fig. 13B is a perspective view of the base 990 for the angled insertion design prior to sensor installation. Fig.13A is an exploded view showing an O-ring gasket 992, a battery contact 994, and a battery 996 (eg, a CR 1632 type battery). Fig. 13B is an assembled view in which the battery contacts 994 serve as conduits for supplying power from the battery 996 to the circuit board and sensors.

[0086] Fig.14A and Fig. 14B A sensor base 970 is shown for an angled insertion design. Fig.14Ais an exploded view showing a sensor base frame 972 (eg, polycarbonate), sensor contacts 974 (note that the wires to the sensor are not shown for clarity), and a sensor base 976 (eg, silicone rubber).

[0087] FIG. 15A to FIG. 15D Various views of the entire base assembly 991 are shown after the sensor has been inserted into a patient. The base assembly 991 includes a base 990 and a cover 997. Fig.15A is an exploded view of the cover 997 and the circuit board 998, wherein the cover 997 with the circuit board 998 mounted therein will be provided. Fig. 15B Base 990 is shown with sensor base 970 now mounted to FIG. 13A to FIG. 13B in its original base. Fig. 15C and Fig.15D The final body-worn assembly is shown in which the applicator (including plunger 920 , front cover 901 , and rear cover 902 ) has been replaced with cover 997 . Fig. 15C Dome cover 997 is shown as transparent for illustrative purposes of the interior components, and Fig.15D The dome cover 997 is shown as a substantially opaque material. Fig. 15C It can be seen that the circuit board 998 is placed over the sensor base 970. Adhesive pads for coupling the device to a user are not shown in these figures.

[0088] Other embodiments are directed to self-inserting applicators that utilize a hinged design to insert the sensor into the skin. Such a hinged design may provide an enhanced mechanical advantage for delivering Figure 3 The self-inserting triangular needle of the TRANS-1000 is a self-inserting triangular needle, but the articulated design can also be used to insert a standard needle into the skin. In the articulated design, the needle is angled relative to the surface of the patient's skin to allow for self-insertion and needle removal.

[0089] Fig.16A and Fig. 16B is a perspective view of an embodiment of an articulating applicator 1600 having a retractable needle 1610. In this articulated design, a top assembly 1620 is hinged to a platform 1630 by hinges 1640, similar to a suitcase. Fig.16A is an exploded view, and Fig. 16B is an assembled view excluding cover 1697.

[0090] Fig.17 is a perspective view of the body-worn component, wherein the cover 1697 includes a circuit board 1698. Fig.17 The device is shown with the cover 1697 installed. Fig.18AThe packaged hinged applicator 1600 is shown (before needle deployment) with the applicator 1600 mounted on an adhesive pad 1820. A spacer 1830 with an integrated locking feature holds the applicator 1600 in an open state when packaged to prevent the needle 1610 from being deployed prior to application to the user. Although the needle 1610 is not visible in these views, the needle is attached to a user-accessible lug 1615. The needle and lug 1615 are held by the front cover 1810. Fig.18B The hinged luggage design with the needle deployed is shown where the user has pressed down on the cover 1810 causing it to close against the platform 1630. Thus, the needle 1610 has moved through the opening in the platform 1630 to insert the glucose sensor subcutaneously into the patient. The hinged design provides a mechanical advantage to the user to facilitate insertion of the needle into the patient.

[0091] Fig.19 is a side cross-sectional view in which the needle 1610 is deployed, inserted through the patient's skin 1900 to deliver the glucose sensor 1680. The needle 1610 with the lug 1615 is still in place along with the front cover 1810. Fig.19 Also shown is the relative position of battery 1696 (same as battery 996) within the base.

[0092] Fig. 20 is a perspective view of selected components of the base assembly including contact pads 1674. Fig.21 is a perspective view of the interior of cover 1697 including circuit board 1698. Contact pads 1674 provide electrical connection to the leads of the glucose sensor and connect to circuit board 1698 through compression connectors 1695. Additional pin connectors 1699 on circuit board 1698 make contact with battery 1696 also located within the base.

[0093] Fig. 22 is a cross-sectional view of the body-worn device with the needle removed. Channel 1612 is the passage through which the needle is inserted. Battery 1696 is shown, which powers the circuit board and sensor. Fig. 22 Also shown are the compressed states of connectors 1695 and 1699 and both the sensor pad 1674 and battery 1696 contacts. Fig.23 yes Fig. 22 , which shows the applicator in its body-worn state via adhesive pad 1820 after the sensor has been implanted.

[0094] The electrical connection between the sensor and the device circuit will now be described, which can be used with the above applicator embodiments. An embodiment of the applicator device uniquely uses a slotted needle that allows the needle to be moved in and out of the skin without moving the wire attached to the sensor. Conventional slotted needles typically have sensors bonded to a circuit board compared to the sliding "flag" contact mechanism of the present disclosure. The embodiment also includes a unique configuration for forming and assembling wire contacts that achieves a low-cost, compact design that is beneficial for large-scale manufacturing. In some embodiments, the wire contacts have a "flag" design that allows the wire contacts and sensors to be disposable components rather than hard-wired to a long-term, durable circuit board of the entire device. The wire contacts have a contact area to which the circuit board of the device can be electrically contacted without bonding. Therefore, the circuit board (e.g., the device transceiver) can be reused, while the sensor and wire contacts can be single-use components.

[0095] FIG. 24A to FIG. 24C 24 is a perspective view of a wire connection assembly 2400 having a "flag" shaped wire contact. A needle support 2420 is shown through which a needle 2410 is inserted and to which a sensor base 2470 is attached. The needle 2410 has a slot 2415 along its length through which the leads of the sensor extend. The wire contact 2430 has a contact area 2432 and is placed into a channel 2472 of the sensor base 2470. Due to the presence of three connecting wires for a 3-pole sensor design and a limited amount of space in the overall device, the thickness of the separators 2474 between the channels 2472 may be small, for example from 0.010 inches to 0.020 inches, such as 0.015 inches. These small dimensions may be problematic for manufacturing tolerances of the sensor base 2470 and for assembling the wires 2430 into the device.

[0096] FIG. 25A to FIG. 25CAnother embodiment of a wire connection assembly 2500 is shown having flag-shaped formed contacts 2530a, 2530b, and 2530c instead of wire contacts 2430. Pin 2510 is slotted as previously described. Formed contacts 2530a / 2530b / 2530c are preformed metal parts instead of wires, and each contact 2530a / 2530b / 2530c has an arm 2534 that terminates in a contact area 2532. As can be seen, the shape of the arm 2534 is different for each contact 2530a, 2530b, and 2530c so as to space the contact areas 2532 apart on the sensor base 2570. Contact 2530a has a straight arm 2534, contact 2530b has a smaller L-shaped arm, and contact 2530c has a larger L-shaped arm. The space 2574 between the three contact areas 2532 in the sensor base 2570 can be customized by the shape of the arm 2534.

[0097] In use, the sensor wires are attached to the arm 2534 at the end opposite the contact area 2530a / 2530b / 2530c. The wires may be attached by, for example, crimping, soldering, conductive adhesive, etc.

[0098] Fig.26 26. The wiring connections in the device assembly are shown, where the sensor wire 2630 is routed through the needle 2610 to attach to the sensor base 2670. The sensor (not visible in this figure) is located at the opposite end of the sensor lead 2630 and is provided by a Figures 1 to 3 The sensor is delivered subcutaneously via a slotted needle 2610. Thus, the needle 2610 can be retracted into the device, as indicated by arrow 2615, while the sensor remains implanted because the sensor lead is secured to a sensor base 2670 that is locked into the base of the device.

[0099] Fig. 27 Shown using printed circuit board components to manufacture FIG. 25A to FIG. 25C Embodiment of the molded contact piece. Fig. 27, three contacts are shown when using a 3-pole design: a bottom contact 2730a having an L-shaped arm, a middle contact 2730b having an inverted L-shaped arm, and a top contact 2730c having a straight arm. The designations of top, middle, and bottom indicate the order in which the contacts will be stacked relative to each other using positioning holes 2780. Each contact has an arm 2734a / 2734b / 2734c and a contact area 2732a / 2732b / 2732c, where the contact area 2732a / 2732b / 2732c is where the sensor wire will be connected to. In some embodiments, when using a 2-pole design, the same technique can be used, but by using two contacts stacked together, such as a bottom contact 2730a having an L-shaped arm and a middle contact 2730b having an inverted L-shaped arm. Each type of contact 2730a / 2730b or 2730a / 2730b / 2730c may be manufactured in large quantities using PCB manufacturing methods, such as sheet 2750a, which shows a 10x10 perforated PCB grid for bottom contacts 2730a.

[0100] Fig.28 The next step of connecting the contact to the sensor is shown. The sensor wire 2701 is attached to the PCB type contact 2730a / 2730b or 2730a / 2730b / 2730c, for example by spot welding or soldering to the arms 2732a / 2732b (for 2-pole design) or 2734a / 2734b / 2734c (for 3-pole design) of the contact, respectively. The sensor wire attachment can be done in an automated manner, such as a row of ten contacts 2755a shown for the bottom contact 2730a, where the sensor wire 2701 is welded or soldered on an automated assembly line.

[0101] exist Fig.29 In the embodiment, a mounting or locating pin 2910 is attached to the PCB board, wherein the locating pin 2910 can also be a socket or a threaded insert. A contact pin or spring pin 2920 is attached to the contact area 2732a / 2732b or 2732a / 2732b / 2732c ( Fig. 27 ).

[0102] exist Fig.30 , coating application is performed. A row of printed circuit board assemblies (PCBAs) are attached to the box that coats the wire ends of the sensor wires 2701. The contacts on each PCBA are attached to the monitoring program, and each wire / PCBA is measured and recorded. The PCBAs can now be separated by quality and matched with other wires / PCBAs to achieve maximum yield or quality top pricing.

[0103] exist Fig.31, assemble the PCBA. Groups of two PCBAs 2730a / 2730b (bottom and middle for a 2-pole design) or groups of three PCBAs 2730a / 2730b / 2730c (bottom, middle, and top for a 3-pole design) are stacked on top of each other by placing contact pins 2920 through positioning holes 2780. As a result, each contact pin 2920 can be accessed from the top of the assembled PCBA stack 3100 (where a 3-pole design is shown in this illustration) to take an ampere reading. The contact pins 2920 will make an electrical connection with the device's circuit board transmitter (e.g., circuit board 440 or 998) through compression. The sensor wires 2701 are all centered on the edge of the PCBA stack 3100 and are vertically aligned to facilitate insertion of the sensor wires 2701 into the needles.

[0104] FIG. 32A to FIG. 32C The wire / PCBA assembly is shown sealed (eg, dip coated) with epoxy or other sealant to protect the electrical connections. Fig.32A is a front perspective view and Fig.32B is a rear perspective view showing that the connection between the wire 2701 and the PCBA is also sealed. Fig.32C A size comparison to a dime is shown, where in this exemplary embodiment the finished wire-connected PCB assembly has a height of 0.013 inches, a width of 0.030 inches, and a length of 0.055 inches.

[0105] The advantages of this PCB-style wire connection include the design shape of the contact that can be easily modified to accommodate original equipment manufacturer (OEM) variations (such as round, square and triangular). No injection molded parts are required, saving processing costs. The overall design cost is low, the assembly work required is minimal, and the entire manufacturing process can be fully automated until the sorting process. The wires can be coated in large quantities and measured or recorded individually for quality. Components can be sorted and matched based on criteria such as quality, sensor performance or maximum yield. PCB assemblies can also be sold as stand-alone products. The "flag" mounting feature enables numerous mounting options. The "flag" installation can be completed in a horizontal plane or in a vertical stack, and this provides a variety of options for assembly. Some embodiments of the assembly method may be easier to automate, especially when bonding the wire to the "flag". Other embodiments of the mounting pattern may make it easier to reduce the size of the overall profile of the applicator.

[0106] Fig.33AA perspective view of an applicator for a glucose monitoring system according to some embodiments is shown. The applicator 3300 has a vertical insertion method for implanting a sensor beneath the skin. To use the applicator 3300, the bottom surface of the applicator 3300 is placed on the patient's skin and a downward force is applied on the top surface, thereby deploying the needle with the sensor to place the sensor beneath the skin. After the sensor is implanted, the needle automatically retracts and the monitoring device adheres to the skin, and the applicator including all components is disposable. As long as the sensor is placed and the monitoring device is adhered to the skin, the monitoring device will turn on and collect data without input from the patient. The limited number of described steps - placement on the skin and pushing down on the applicator - provides a simple, hassle-free, convenient method for glucose monitoring performed in a sterile manner.

[0107] The applicator 3300 includes a body 3302 having a top surface 3304 and a bottom surface 3306, and an actuator 3308 coupled to the body 3302 and extending through the top surface 3304 of the body 3302. A cover 3310 is removably coupled to the bottom surface 3306 of the body 3302. Fig.33B is along Fig.33A A vertical cross-sectional view of the applicator 3300 taken at section CC.

[0108] Needle 3312 is mounted to actuator 3308. Fig.34 is a slotted needle 3312 according to some embodiments. The needle has an inner diameter and a slot 3314 along the length of the needle to the tip 3316 of the needle. The needle 3312 is coupled to a holder 3318 at the top of the needle 3312.

[0109] Such as 2-pole design or 3-pole design (refer to Figures 1 to 3 ) is coupled to the plurality of wires 3328 at one end thereof (see FIG. 35A to FIG. 35B ). In a non-limiting example, a 2-pole design is shown so that the sensor includes a working electrode and a reference electrode. The sensor and the plurality of wires 3328 are sized to fit through the inner diameter of the needle 3312.

[0110] The base 3320 is configured to be movable by the actuator 3308 and is coupled to the plate 3322. The plate 3322 is configured to be movable by the actuator 3308 and may be a part of the actuator 3308. Fig.35A and Fig.35B The base 3320 of the applicator 3300 is shown according to some embodiments. The base has an upper shell 3324 and a lug 3326. The lug 3326 has a Fig.35A The closed position shown and Fig.35BThe open position is shown. The base 3320 and the lugs 3326 can be composed of an elastomeric material such as silicone or polyurethane. The base 3320 has a cutout 3340 through which the needle 3312 moves. A plurality of wires 3328 extend through the upper housing 3324 of the base 3320.

[0111] Fig.36A and Fig.36B The internal components of the base 3320 of the applicator 3300 are shown according to some embodiments. In this illustration, the upper housing 3324 is removed from the base 3320 and the circuit board 3330 is shown. The circuit board 3330 has a plurality of contacts, such as 3332a and 3332b, and each contact 3332a / 3332b is coupled to a wire in a plurality of wires 3328. The wire guide 3334 is coupled to the circuit board 3330 and aligns, routes and holds the plurality of wires 3328 in place when on the circuit board 3330. The component cover 3336 protects various components 3338, such as a microprocessor 3337, a transmitter 3339, and circuits on the circuit board 3330. The cutout 3340 on the circuit board 3330 matches and corresponds to the cutout 3340 of the base 3320 and provides access through the base 3320 and the circuit board 3330. A power source 3342, such as a battery, is electrically connected to the circuit board 3330 and coupled to the base 3320 to power the system. The power source 3342 may be a low profile lithium battery.

[0112] Fig.37 A cutaway front view of a circuit board 3330 with a power supply 3342 is shown according to some embodiments. The power supply 3342 has a switch 3344 mounted on the underside of the circuit board 3330. This allows the power supply 3342 to be activated or turned on at will, such as at the beginning of a monitoring session, rather than always being in the on position.

[0113] For example, each of the plurality of contacts 3332 (eg, 3332a / 3332b) includes an opening 3346a and 3346b (in the plurality of openings 3346) on the circuit board 3330. Fig.36B ). Multiple openings 3346 (such as 3346a / 3346b) each have a metal coating on the inner diameter of the opening, such as gold plating as part of the circuit. Other types of metal coatings may be used, such as silver, nickel, rhodium or platinum. Fig.38A perspective view of a fastener 3348 of a contact 3332a / 3332b according to some embodiments is shown. The fastener 3348 has a protrusion 3350, and the diameter of the protrusion 3350 is smaller than the diameter of the opening 3346a / 3346b so that the protrusion 3350 fits into the opening 3346a / 3346b. The fastener 3348 is made to have a thin low profile, so the portion of the fastener 3348 extending from the circuit board 3330 (non-protrusion 3350) is less than 0.1 inches. This allows the base 3320 to also have a thin low profile. The wires in the plurality of wires 3328 are between the opening 3346a / 3346b and the protrusion 3350. The protrusion 3350 is sized so that it forces the wires of the plurality of wires 3328 against the metal coating in the opening 3346a / 3346b, thereby achieving an electrical connection between the wires of the plurality of wires 3328 and the circuit board 3330. In this manner, the sensor of the applicator 3300 is hardwired to the circuit board 3330 at the plurality of contacts 3332 via the plurality of wires 3328. The plurality of wires 3328 and the plurality of contacts 3332 are located within the base 3320. In the applicator 3300, the sensor, power source 3342, and circuit board 3330 are contained within the body 3302. The fastener 3348 may be composed of silicone, a composite material, a metal, or a combination thereof, and is secured in the opening 3346 by a press fit or push fit, or soldering, micro welding, and / or a conductive adhesive.

[0114] refer to Fig.33B , the bracket 3352 is coupled to the bottom surface 3306 of the body 3302 and is configured to receive the base 3320. The bracket 3352 can be composed of a rigid polymer such as polycarbonate, PVA, or nylon. The patch 3354 is coupled to the bracket 3352 on the top side of the patch 3354 and has an adhesive on the bottom side of the patch 3354. In some embodiments, the bracket 3352 fits inside the patch 3354. FIG. 39A to FIG. 39B A perspective view of a bracket 3352 and a patch 3354 are shown, respectively, according to some embodiments. The base 3320 is received in the bracket 3352. Fig.39C Depicted is a base 3320 and a patch 3354 in a stand 3352 , which serves as a wearable device 3356 .

[0115] Fig.40A and Fig.40B depicts a perspective view of actuator 3308 according to some embodiments, and Fig.40CA front view of an actuator 3308 according to some embodiments is shown. In some embodiments, the actuator 3308 includes a button 3358 and a first spring 3360, which is located above the plate 3322 and has a first uncompressed length and a first compressed length. The plate 3322 is coupled to the first spring 3360, the base 3320, and the needle 3312 (through a retainer 3318). The second spring 3362 is located below the plate 3322 and coupled to the plate 3322. The second spring 3362 has a second uncompressed length and a second compressed length. When the user desires glucose monitoring, the actuator 3308 can be activated. In a typical system, the sensor is implanted under the skin, and a wearable device that communicates with the sensor is worn on the skin.

[0116] The applicator 3300 is ready for use 'as is'. There are no preparatory steps, such as connecting the sensor to an electronic device, a power source, or a wearable device. To use the applicator 3300, the bottom surface 3306 of the applicator 3300 can be adjacent to the skin of the user, and the actuator 3308 is activated by applying a downward force on the top surface 3304 of the body 3302 (such as on the button 3358). The first spring 3360 moves from a first uncompressed length to a first compressed length, the second spring 3362 moves from a second uncompressed length to a second compressed length, and the plate 3322, the base 3320 (including the circuit board 3330, the plurality of contacts 3332 coupled to the plurality of wires 3328, the power source 3342) and the needle 3312 move in a downward direction toward the bottom surface 3306 of the body 3302 and enter the bracket 3352 coupled to the patch 3354. The needle 3312 is configured to be movable by an actuator and to travel through a cutout 3340 on the base 3320. A plurality of wires 3328 with a sensor at one end extend from the base 3320, through the needle 3312 and out of the slot 3314 of the needle 3312.

[0117] The mating of the base 3320 into the bracket 3352 and the patch 3354 activates the switch 3344 of the power source 3342 and turns the system on, which confirms that the system has been deployed on the skin. For example, the switch 3344 is mounted on the bottom side of the circuit board 3330 so that when the switch 3344 contacts the bracket 3352 during actuation, the switch 3344 is pressed and an electrical connection is formed with the circuit board 3330 and therefore with the power source 3342. The ability to turn on the power source 3342 is unconventional, as opposed to turning the device on all the time. In known systems, the power source (e.g., battery) is always on, so a larger, more powerful battery is required, so the battery has a large footprint, making the design bulky and uncomfortable. In other known systems, the battery can be manually activated by connecting the sensor to the electronics in the wearable device.

[0118] Fig.41 3306 of the body 3302 according to some embodiments. The bottom surface 3306 of the body 3302 has a hole 3364 to which the patch 3354 is removably attached and configured to slide through the hole 3364. Due to the force applied to the button 3358 of the actuator 3308 and the compression of the first spring 3360 and the second spring 3362, the patch 3354 with the base 3320 attached in the bracket 3352 is pushed out of the hole 3364 of the bottom surface 3306 of the body 3302 and adheres to the user's skin. At the same time, the sensor attached to the plurality of wires 3328 and wired through the needle 3312 is implanted 6mm to 10mm below the user's skin. Due to the bias of the first spring 3360 and the second spring 3362, the needle 3312 automatically retracts from the skin, and the plurality of wires 3328 pass through the slot 3314 to vacate the needle 3312, thereby leaving the sensor under the skin. The needle 3312 fixed to the plate 3322 moves a distance equal to the difference between the second uncompressed length and the second compressed length (eg, 12 mm to 20 mm).

[0119] In short, by placing the applicator 3300 "as is" on the skin and pressing the button 3358 of the actuator 3308, the sensor is implanted beneath the skin and the wearable device 3356 is adhered to the skin. The applicator 3300, the wearable device 3356 (including the electronics and power source) are disposable. The patch 3354 can be composed of a flexible material such as silicone or polyurethane to aid in removal from the bottom surface 3306 of the body 3302 and also to provide comfort when adhered to the user's skin. Fig.40B As shown, the lug 3326 is in an open position in the actuator 3300. When the wearable device 3356 is attached to the skin, the lug 3326 remains in the open position and can be rotated to a closed position to cover the cutout 3340 in the base 3320 (see Fig.35A and Fig.35B ). In some embodiments, the profile of lug 3326 inserts into cutout 3340 and the system is sealed and waterproof.

[0120] The base 3320 with the circuit board 3330, the microprocessor 3337, each of the multiple contacts 3332 coupled to the wires in the multiple wires 3328, and the power supply 3342 forms a sealed unit. Optionally, the transmitter 3339 may also be included in the base. This is possible because the power supply 3342 and each of the multiple contacts 3332 coupled to the wires in the multiple wires 3328 are hardwired to the circuit board 3330 in the base 3320, which means that there is no switching. For example, hard wiring occurs during the manufacturing process without input from the user. In the absence of switching, that is, in the case of mechanically and / or electrically connecting the wires of the sensor to the electronic device (circuit board and power supply), the system is sealed, robust, reliable and durable. In some embodiments, the base can be coated with a material by dipping or spraying of polyurethane, silicone or acrylic or a polymer vapor deposition process (C-type or N-type polyparaxylene) to achieve further protection and benefits, such as impermeable or waterproof. Sealing and coating can be done during manufacturing, which enables the use of reliable processes and advanced technologies while maintaining a sterile environment for the components.

[0121] Hard-wiring the multiple wires 3328 of the sensor to the base 3320 that becomes part of the wearable device 3356 is a paradigm shift for conventional systems. In conventional systems, the system is designed so that the wires of the sensor are mechanically and / or electrically connected to the electronics (e.g., circuit boards and power supplies) when in use or application and most likely through input from the user. This adds steps to the application process and introduces contaminants to the system, creating a non-sterile environment. The design can be such that the electronics are in the applicator or already installed on the skin, and then the wires of the sensor are connected to the electronics. This switching creates defects in conventional designs.

[0122] For example, known systems may use an O-ring or gasket after connecting the sensor's wires to attempt to seal the electronics. As the unit ages, the O-ring or gasket wears and becomes damaged, becoming a potential entry path for water or debris, causing the electronics to fail. In contrast, hard-wiring the sensor's wires to the electronics and power supply in the applicator 3300 (such as during manufacturing) produces a more securely sealed unit with little risk of mechanical or electrical failure due to water or debris. Additionally, in known systems, connecting the sensor to the circuit board and / or power supply at the time of application creates another potential weak link because the integrity of the connection is unknown, a non-sterile environment may be created, and there is the possibility of user error.

[0123] The base 3320, wearable device 3356, applicator 3300, needle 3312 and sensor including all parts are designed to be disposable. In conventional systems, due to the high cost of parts and assembly process, the electronic devices are usually designed to be reusable. In contrast, the applicator 3300 hardwires the multiple wires 3328 of the sensor to the base 3320 within the body 3302, which uses fewer cheap parts and processes (such as fasteners 3348 pushed into openings 3346a / 3346b) instead of more expensive parts and processes (such as soldering, welding or crimping). No need to reuse parts.

[0124] In other embodiments, various data may be collected by the wearable device through sensors and managed by the microprocessor 3337. The transmitter 3339 is configured to transmit data via communication technology (such as WiFi system, Wireless technology, The data is transmitted by a wireless communication device such as a wireless communication device (such as a wireless communication device, ...

[0125] Fig.42 4200 for constructing a base 3320 according to some embodiments. The method 4200 for constructing the base 3320 begins at step 4210 by coupling a sensor to a plurality of wires. The sensor and the plurality of wires are sized to fit through the inner diameter of the needle. At step 4220, a wire in the plurality of wires is coupled to a contact in a plurality of contacts. Each contact has an opening in a plurality of openings on a circuit board, and the opening has a metal coating. At step 4230, a fastener having a protrusion is attached to the opening. The wire in the plurality of wires is between the opening and the protrusion. At step 4240, a power supply is connected to the circuit board. At step 4250, the circuit board and the power supply are assembled in the base. The base has the circuit board, the microprocessor, the contact in the plurality of contacts coupled to the wire in the plurality of wires, and the power supply is a sealed unit. In this manner, each of the plurality of contacts coupled to the wires of the plurality of wires and the power source are hardwired to the circuit board of the base. The method 4200 may also include connecting a transmitter to the circuit board prior to the assembling step. The transmitter is configured to transmit data.

[0126] Applicator 3300 is comprised of three major systems, components of which have been described herein. Fig.433300 according to some embodiments. The base 3320 includes a circuit board 3330, a plurality of contacts 3332 with a plurality of wires 3328, a power source 3342, a microprocessor 3337, and a transmitter 3339. These components within the base 3320 form a sealed unit.

[0127] The system 3370 may include a sensor coupled to a plurality of wires 3328. The base 3320 includes a circuit board 3330 having a microprocessor 3337 electrically connected to the circuit board 3330 and a plurality of contacts 3332. Each contact 3332 is coupled to a wire in the plurality of wires 3328. A power source 3342, such as a battery, is electrically connected to the circuit board 3330 and coupled to the base 3320. The needle 3312 is configured to be movable through a cutout 3340 on the base 3320. The plurality of wires 3328 extend from the circuit board 3330 of the base 3320, through the needle 3312, and out of the slot 3314 of the needle 3312. As disclosed herein, each of the plurality of contacts 3332 coupled to a wire in the plurality of wires 3328 and the power source 3342 are hardwired to the circuit board 3330 of the base 3320. Thus, the system 3370 includes a sensor, a needle 3312, and a base 3320. The system 3370 may be housed within the applicator 3300 (such as within the body 3302).

[0128] The body 3302 includes a base 3320, a system 3370, and an actuator 3308 as described herein. In further embodiments, other actuator designs, such as a lever or a sliding actuator, may be used. The applicator 3300 includes a base 3320, a system 3370, and a body 3302.

[0129] Reference has been made in detail to the embodiments of the disclosed invention, one or more examples of which have been shown in the accompanying drawings. Each example has been provided by way of illustration of the present technology, rather than by way of limitation. In fact, although this specification has been described in detail with respect to specific embodiments of the present invention, it should be understood that those skilled in the art, after obtaining an understanding of the foregoing, can easily think of alternative forms, variations and equivalents to these embodiments. For example, a feature shown or described as part of one embodiment can be used together with another embodiment to produce yet another embodiment. Therefore, it is intended that this subject matter covers all such modifications and variations within the scope of the attached claims and their equivalents. Without departing from the scope of the present invention as more specifically set forth in the attached claims, those of ordinary skill in the art may practice these and other modifications and variations of the present invention. In addition, those of ordinary skill in the art will appreciate that the foregoing description is merely an example and is not intended to limit the present invention.

Claims

1. A three-pole lead-based electrochemical sensor for subcutaneous insertion, comprising: a working electrode comprising a first separated wire having a first plane along the length of the first separated wire and an electrochemical element on the first plane, the first plane being created by an intact wire having a circular cross-section and with a portion removed; a reference electrode comprising a second separated wire having a second plane along a length of the second separated wire, the second plane being defined by a second chord across a circular cross-section of the second separated wire; and a counter electrode comprising a third separated wire having a third plane along the length of the third separated wire, the third plane being defined by a third chord across a circular cross-section of the third separated wire; wherein, among the plurality of sensor wires, the first separated wire is a first sensor wire for the working electrode, the second separated wire is a second sensor wire for the reference electrode, and the third separated wire is a third sensor wire for the counter electrode; wherein the first separated wire, the second separated wire, and the third separated wire are coupled to a core wire; wherein the core wire has a triangular cross section; wherein the first plane, the second plane and the third plane each face a different surface of the triangular cross section of the core wire; Wherein, the cross-sectional diameter of the first separated wire, the second separated wire, the third separated wire and the core wire coupled together is smaller than the inner diameter of the insertion needle.

2. The sensor of claim 1, wherein The tip of the core wire is pointed.

3. The sensor according to claim 1, wherein: The electrochemical element includes carbon. 4 . The sensor according to claim 1 , further comprising a support sheet located between the electrochemical element and the first plane, the support sheet comprising graphene, pyrrole or polyaniline.

5. The sensor according to claim 1, wherein: The cross section of the second separated wire of the reference electrode is a semicircular cross section; The cross section of the third separated wire of the counter electrode is a semicircular cross section; and The cross section of the first separated wire of the working electrode is a semicircular cross section.

6. The sensor according to claim 1, wherein: The second separated wire of the reference electrode has a semicircular cross-section; The third separated wire of the counter electrode has a semicircular cross-section; and The first separated wire of the working electrode has a rectangular cross-section.

7. A three-pole lead-based electrochemical sensor for subcutaneous insertion, comprising: a working electrode comprising a first separated wire having a first plane along the length of the first separated wire and a support sheet on the first plane, the first plane being created by a first intact wire having a circular cross-section and with a portion removed; a reference electrode comprising a second separated wire having a second plane along the length of the second separated wire, the second plane being created by a second full wire defined by a second chord spanning a circular cross-section of the second separated wire; and a counter electrode comprising a third separated wire having a third plane along the length of the third separated wire, the third plane being created by a third complete wire defined by a third chord across a circular cross-section of the third separated wire; wherein the second plane and the third plane face each other; Wherein, the cross-sectional diameters of the first separated wire, the second separated wire, and the third separated wire coupled together are smaller than the inner diameter of the insertion needle.

8. The sensor according to claim 7, wherein: The support sheet includes carbon.

9. The sensor according to claim 7, wherein: The support sheet includes graphene, pyrrole or polyaniline.

10. The sensor according to claim 7, wherein: The support sheet is electrically conductive and electrically coupled to the plane of the first separated conductive lines.

11. The sensor of claim 7, further comprising a sensing chemistry deposited on the support sheet.

12. The sensor of claim 7, further comprising a polymer layer on the support sheet.

13. The sensor according to claim 7, wherein: The circular cross section of the working electrode from which the first separated wire is removed forms a semicircular cross section; a second chord of the circular cross-section of the second separated wire across the reference electrode forming a semicircular cross-section; and A third chord of the circular cross-section of the third separated wire across the counter electrode forms a semicircular cross-section.

14. The sensor according to claim 7, wherein: The circular cross section of the working electrode from which the first separated wire is removed forms a rectangular cross section; a second chord of the circular cross-section of the second separated wire across the reference electrode forming a semicircular cross-section; and A third chord of the circular cross-section of the third separated wire across the counter electrode forms a semicircular cross-section.

15. The sensor according to claim 7, wherein: The second separated wire and the third separated wire each have a surface area that is 82% of an intact wire having the same diameter.

16. The sensor according to claim 7, wherein: The cross-sectional area of ​​the second separated wire of the reference electrode is 30% to 70% of the cross-sectional area of ​​the second intact wire; and The cross-sectional area of ​​the third separated wire of the counter electrode is 30% to 70% of the cross-sectional area of ​​the third complete wire.

17. A three-pole lead-based electrochemical sensor for subcutaneous insertion, comprising: a working electrode comprising a first separated wire having a first plane along the length of the first separated wire and a support sheet comprising carbon on the first plane, and a sensing chemical deposited on the support sheet, the first plane being created by a first intact wire having a circular cross-section and having a portion removed; a reference electrode comprising a second separated wire having a second plane along the length of the second separated wire, the second plane being created by a second full wire defined by a second chord spanning a circular cross-section of the second separated wire; and a counter electrode comprising a third separated wire having a third plane along the length of the third separated wire, the third plane being created by a third complete wire defined by a third chord across a circular cross-section of the third separated wire; wherein the second plane and the third plane face each other; Wherein, the cross-sectional diameters of the first separated wire, the second separated wire, and the third separated wire coupled together are smaller than the inner diameter of the insertion needle.

18. The sensor according to claim 17, wherein: The support sheet further includes graphene, pyrrole or polyaniline.

19. The sensor according to claim 17, wherein: The support sheet is electrically conductive and electrically coupled to the plane of the first separated conductive lines.

20. The sensor of claim 17, further comprising a polymer layer on the support sheet.

21. The sensor of claim 17, wherein: The circular cross section of the working electrode from which the first separated wire is removed forms a semicircular cross section; a second chord of the circular cross-section of the second separated wire across the reference electrode forming a semicircular cross-section; and A third chord of the circular cross-section of the third separated wire across the counter electrode forms a semicircular cross-section.

22. The sensor of claim 17, wherein: The circular cross section of the working electrode from which the first separated wire is removed forms a rectangular cross section; a second chord of the circular cross-section of the second separated wire across the reference electrode forming a semicircular cross-section; and A third chord of the circular cross-section of the third separated wire across the counter electrode forms a semicircular cross-section.

23. The sensor according to claim 17, wherein: The second separated wire and the third separated wire each have a surface area that is 82% of an intact wire having the same diameter.

24. The sensor of claim 17, wherein: The cross-sectional area of ​​the second separated wire of the reference electrode is 30% to 70% of the cross-sectional area of ​​the second intact wire; and The cross-sectional area of ​​the third separated wire of the counter electrode is 30% to 70% of the cross-sectional area of ​​the third complete wire.

Images