Sensor holder device for invasive biosensors

Abstract

To favorably support sensing wires of invasive biosensors.SOLUTION: In some examples, a sensor holder device is described. The sensor holder device may include a rigid body, a set of legs attached to the rigid body, a sensor guiding structure, a sensor retaining structure, and an electrical trace. The sensor retaining structure may be sized to accommodate a sensor wire. The electrical trace may extend proximately to the sensor retaining structure and along one of the legs.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001]

[0001] This application is related to and claims the benefit of priority from U.S. Patent Application No. 15 / 362,955, filed on November 29, 2016, entitled "SENSOR HOLDER DEVICE FOR INVASIVE BIOSENSORS," which is hereby incorporated by reference in its entirety.

[0002]

[0002] The present disclosure generally relates to invasive biosensors and, more particularly, to a device for supporting the sensing wires of invasive biosensors.

Background Art

[0003]

[0003] Invasive biosensors, such as sensors for wearable glucose monitoring devices, include thin wires that can be inserted into a patient's skin. A sensing circuit reads biological information about the patient via the thin wires. When an invasive biosensor is inserted into a patient's skin, the electrical connection between the wire and the circuit is maintained in a state exposed to potential moisture that can significantly affect biosensor performance. For example, many electrochemistry-based sensors can have a performance impact related to calibration offsets or increased noise floor levels due to current leakage caused by moisture within the electronics housing, particularly high for biosensors included in wearable devices that can be exposed to sweat on a patient's skin, weather, and other moisture sources that human skin generally touches. In addition to this consideration, the size of the device is always a practical consideration for wearable devices. To accommodate the sensing circuit, power source, etc. necessary to process biological information, a wearable glucose monitoring device may include multiple parts that are coupled together to form the working device. The use of multiple parts not only makes the device bulky but also results in multiple areas where moisture can enter (e.g., seals between parts).

Summary of the Invention

Means for Solving the Problems

[0004]

[0004] Various examples are described of sensor holder devices for holding and supporting the sensor wires of invasive biosensors. For example, one of the disclosed devices may include a rigid body, a set of legs, a sensor guide structure, a groove formed in the rigid body, and an electrical trace. The set of legs may be attached to the rigid body and extend from one side surface of the rigid body. The sensor guide structure may be attached to the rigid body and extend from one side surface of the rigid body. The sensor guide structure may define a guide hole or a guide opening. The groove may be formed in the rigid body. The groove may extend from the sensor guide structure and be sized to accommodate the sensor wire. The electrical trace may extend between the groove and the distal end of the first leg of the set of legs.

[0005]

[0005] Other disclosed devices include wearable monitoring devices. The wearable monitoring device may include a printed circuit board, a sensing circuit, and a sensor holder device. The printed circuit board may be provided within a housing having an outer surface for placing the wearable monitoring device on a patient's skin. The sensing circuit may include one or more electronic components coupled to the printed circuit board. The sensor holder device may include a pair of legs, an electrical trace, a sensor holding structure, and a sensor guide structure. The pair of legs may extend from one side surface of the body. The sensor holder device may be physically coupled to the printed circuit board via the pair of legs. The electrical trace may extend along the first leg of the pair of legs to the first distal end of the first leg. The electrical trace may electrically couple the sensor wire to the printed circuit board. The sensor holding structure may be provided on the body and hold the proximal portion of the sensor wire in proximity to the electrical trace. The sensor guide structure may guide the distal portion of the sensor wire to the tip of the outer surface of the housing.

[0006]

[0006] One of the disclosed systems may include a sensor wire and an interposer device. The sensor wire may include a first portion that is insertable into a patient's skin. The first portion may include means for generating glucose information. The interposer device may include sensor positioning means, holding means, and coupling means. The sensor positioning means may be for positioning the sensor wire so that an insertion needle can insert the first portion into the patient's skin. The holding means may be for physically holding a second portion of the sensor wire. The coupling means may be for electrically coupling the second portion of the sensor wire to a circuit provided on a printed circuit board to determine a patient's blood glucose level.

[0007]

[0007] These specific examples are not for limiting or defining the scope of the present disclosure, but are mentioned to provide examples and assist in their understanding. The specific examples are discussed in the form for carrying out the invention that provides further explanation. The advantages provided by various examples can be more deeply understood by considering this specification.

[0008]

[0008] The accompanying drawings incorporated herein and forming a part of this specification show one or more specific examples, and together with the description of those examples, explain the principles and implementation of the specific examples.

Brief Description of the Drawings

[0009]

Figure 1

[0009] A disassembled perspective view of an example of a monitoring device including a sensor holder device according to at least one example is shown.

Figure 2

[0010] A top perspective view of an example of a sensor holder device according to at least one example is shown.

Figure 3

[0011] A bottom perspective view of an example of a sensor holder device according to at least one example is shown.

Figure 4

[0012] A side cross-sectional view of an example of a sensor holder device according to at least one example is shown.

Figure 5

[0013] Shows a side cross-sectional view of an example of a sensor holder device according to at least one example.

Figure 6

[0014] Shows a bottom perspective view of an example of a sensor holder device according to at least one example.

Figure 7

[0015] Shows a top perspective view of an example of a sensor holder device according to at least one example.

Figure 8A

[0016] Shows an exploded perspective view of an example of a monitoring device including a sensor holder device according to at least one example.

Figure 8B

[0017] Shows an exploded perspective view of an example of a monitoring device including a sensor holder device according to at least one example.

Figure 8C

[0018] Shows an exploded perspective view of an example of a monitoring device including a sensor holder device according to at least one example.

Figure 9

[0019] Shows an exploded perspective view of an example of a monitoring device including a sensor holder device according to at least one example.

DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0020] In this specification, examples related to a sensor holder device for use in a continuous monitoring device are described. Those skilled in the art will understand that the following description is for illustrative purposes only and is not intended to be limiting in any way. Hereinafter, an example implementation as shown in the accompanying drawings is referred to in detail. Throughout the drawings and the following description, the same reference numerals are used to refer to the same or similar items.

[0011]

[0021] For clarity, not all features typical of the examples described herein are shown and described. Of course, as will be understood, when developing any such actual implementation, numerous implementation-specific decisions may be made to achieve the developer's particular purposes, such as compliance with application and business-related constraints, and these particular purposes will vary for each implementation and each developer.

[0012]

[0022] In a typical example, a wearable glucose monitoring device includes a glucose sensor that can be inserted into a human's skin for continuous monitoring of the human's blood glucose level. During wear, the wearable glucose monitoring device can be subjected to normal external forces resulting from hitting clothing, obstacles, and other external forces. To reduce the impact of these forces and improve the wearer's comfort, the installation area and sides of the glucose monitoring device can be reduced. As a method for doing so, the glucose monitoring device described herein includes a sensor holder device. The sensor holder device has a unique shape that efficiently utilizes the space within the glucose monitoring device while enabling it to perform various functions. The unique shape is defined by a body supported by legs that extend from the body and form a cavity beneath the body. The legs are connected to a printed circuit board ("PCB") beneath the body and serve to isolate the body from the PCB. Components of the glucose monitoring device, such as integrated circuits and / or other sensing circuits, can be mounted within the cavity on the underside of the body. In this way, the sensor holder device results in an efficient utilization of the space within the glucose monitoring device (e.g., enables stacking of components and reduces the overall installation area of the device).

[0013]

[0023] The functions performed by the sensor holder device include structurally supporting the electrodes of the glucose sensor, aligning the sensor wires of the glucose sensor towards the human skin, and electrically connecting the electrodes to the PCB. The sensor holder device structurally supports the electrodes by means of grooves, in which the electrodes are arranged. The sensor holder device aligns the sensor wires either by means of a cylindrical opening or with respect to one of the legs, both of which extend from the body of the sensor holder device towards the back surface of the device. The sensor holder device electrically connects the electrodes by means of electrical traces formed on the surface of the sensor holder device. The electrical traces extend between the grooves and may reach the underlying PCB through the legs. The sensor holder device is described herein with respect to a glucose monitoring device, but as will be understood, the sensor holder device may be implemented to support any suitable electromechanical sensor.

[0014]

[0024] Referring now to the drawings, FIG. 1 shows a monitoring device 100 according to at least one example. The monitoring device 100 includes a sensor holder device 102 and a biosensor 104, such as a glucose sensor or other electromechanical sensor used to sense a patient's biometric information. The biosensor 104 includes sensor wires 106, a sensing circuit 108, a power source 110, such as a battery, a printed circuit board ("PCB") 112, and an antenna 114. The sensor wires 106 include a proximal end 106a and a distal end 106b. The proximal end 106a is supported by the sensor holder device 102. For example, the proximal end 106a may be disposed within a groove or channel of the sensor holder device 102. The proximal end 106a is also electrically connected to the PCB 112 via the sensor holder device 102. For example, as described in detail herein, the sensor holder device 102 may include a set of electrical traces 116a, 116b that extend proximally within the sensor holder device 106 in proximity to an intermediate area of the sensor holder device 106 towards the PCB 112. In use, the distal end 106b is inserted into the patient's skin to measure biological parameters (such as blood glucose levels) in the interstitial fluid of the subcutaneous tissue beneath the skin.

[0015]

[0025] The monitoring device 100 also includes a moisture barrier 118 provided between an upper housing 120, such as a cap, and a lower housing 122. When assembled, the moisture barrier 118 can provide a seal that prevents moisture from penetrating the biosensor 104. When assembled, the upper housing 120 encloses the biosensor 104 and the sensor holder device 102 and mates with the lower housing 122. The lower housing 122 includes an opening 124 through which the distal end 106b passes during attachment. The PCB 112 may include a corresponding opening through which the distal end 106b passes. On the opposite side of the illustrated side, the lower housing 122 may include a substantially flat surface that allows the monitoring device 100 to be placed on human skin.

[0016]

[0026] The sensor holder device 102 may be of a rigidity suitable for supporting the sensor wire 106 and providing structural support to the PCB 112. For example, the sensor holder device 102 may be formed of a liquid crystal polymer. In some examples, the PCB 112 may be a flexible printed circuit board (“FPCB”). In this example, by attaching the sensor holder device 102 to the PCB 112, rigidity can be added to the entire monitoring device 100 in addition to the FPCB 112.

[0017]

[0027] The sensor holder device 102 may be considered an interposer device. For example, since the sensor holder device 102 is spaced apart from the PCB 112 and may be on top of components disposed below (such as the sensing circuit 108, the power source 110, etc.), the sensor holder device 102 serves a function of saving space within the monitoring device 100. As a result, the monitoring device 100 may have a smaller installation area. Also, due to the configuration of the sensor holder device 102 with respect to the PCB 112, the PCB 112 can be placed in contact with human skin, unlike other monitoring devices that include standoff fixtures. This improves the comfort of the wearer and reduces the bulkiness of the entire device.

[0018]

[0028] Sensor wire 106 may include one or more electrodes, chemical substances, or other means for generating biological information. For example, sensor wire 106 may be a coaxial sensor and includes two electrodes 123, 125 inserted into human skin to touch interstitial fluid within the subcutaneous tissue of a human. Electrode 123 includes at least a portion of sensor wire 106 made of platinum or having a platinum coating, and electrode 125 includes a silver / silver chloride ("Ag / AgCl") material that coats a portion of electrode 123. Electrodes 123, 125 can be used to generate patient blood glucose information by generating an electrical signal corresponding to the amount of glucose present in the interstitial fluid. In some examples, a reactive substance, such as glucose oxidase ("GOX"), may be coated on the distal end of electrode 123 to generate a reaction product with glucose present in the interstitial fluid. When a voltage is applied to electrodes 123, 125, a current is generated based on the amount of these reaction products generated by the glucose / GOX reaction. The current flows from sensor wire 106 to sensing circuit 108. Sensing circuit 108 may use the intensity of the current to determine glucose information, such as the patient's blood glucose level. Although the measurement of blood glucose level has been described in this example, biosensor 104 can be configured to measure other biological parameters without departing from the scope of the present disclosure. Similarly, the chemical materials applied to sensor wire 106 to form electrodes 123, 125, and the reactive substances applied to electrodes 123, 125 may be suitable for a glucose sensor, but other materials may be used according to other examples based on the use of biosensor 104.

[0019]

[0029] The length of the sensor wire 106 can enable the sensor wire 106 to extend with allowable values regarding the patient's movement from under the human skin to the sensor holder device 102. For example, the sensor wire 106 can be about 10 millimeters to 30 millimeters in length. The thickness or gauge of the sensor wire 106 can be selected to enable the sensor wire 106 to remain inserted in the skin with minimal discomfort during this period. In some examples, the sensor wire 106 includes an outer diameter of about 100 to 200 microns for the wire portion covered by the electrode 125 and an outer diameter of about 100 microns for the electrode 123. In additional examples, the sensor wire 106 can generally have a maximum outer diameter of 100 microns to 300 microns. In some examples, the sensor wire 106 can have an outer diameter of about 50 microns.

[0020]

[0030] In some examples, the sensing circuit 108 includes one or more electronic components configured for signal processing. For example, the sensing circuit 108 can include a system-on-chip (「SOC」) or system-in-package (「SIP」) including any suitable combination of components for digital signal processing, analog signal processing, mixed signal processing, etc., which can be present on or embedded in the surface of the PCB assembly. Such components can include, for example, a microcontroller, memory, a timing source, one or more digital interfaces, one or more analog interfaces, a voltage regulator, and / or any other suitable components. The sensing circuit 108 can be configured to receive an electrical signal from the sensor wire 106 (e.g., via the PCB 112 and the electrical trace 116) and process the electrical signal to determine the patient's blood glucose level.

[0021]

[0031] In some examples, the sensing circuit 108 includes a processing device and a computer-readable medium, such as random access memory (“RAM”), coupled to the processing device. The processing device may execute computer-executable program instructions stored in the memory, such as by executing one or more computer programs. Such a processing device may include a microprocessor, a digital signal processor (“DSP”), an application specific integrated circuit (“ASIC”), a field programmable gate array (“FPGA”), a state machine, or other processing means for processing electrical signals received from electrodes 123, 125 of the sensor wire 106. Such processing means may further include, for example, a PLC, a programmable interrupt controller (“PIC”), a programmable logic device (“PLD”), a programmable read only memory (“PROM”), an electronically programmable read only memory (“EPROM” or “EEPROM”), or other similar devices.

[0022]

[0032] The processing device may include or be in communication with a medium, such as a computer-readable storage medium, that stores instructions that, when executed by the processing device, cause the processing device to perform steps described herein as being executed or assisted by the processing device. Examples of computer-readable media may include, but are not limited to, memory chips, ROM, RAM, ASICs, or any other storage means from which the processing device can read information or write information.

[0023]

[0033] The upper housing 120 and the lower housing 122 may integrally form a housing for holding the biosensor 104. The housing may be of a compact size for placement on a human skin. The housing may be made of any suitable material for accommodating the biosensor 104. Non-limiting examples of materials suitable for the housing may be silicon, polyethylene, polyvinyl chloride ("PVC"), polypropylene, nylon, polyurethane, polycarbonate, steel, aluminum, and other plastics and metals. The monitoring device 100 may be fixed to the skin using an adhesive, a band, a strap, or other fixing means. In some examples, the monitoring device 100 may be worn for a long period (such as several days, several weeks, several months, etc.).

[0024]

[0034] Figures 2 and 3 respectively show a top perspective view and a bottom perspective view of a sensor holder device 102 according to a specific example. The sensor holder device 102, which is a kind of three-dimensional circuit component, may include a main body 126 and a set of legs 128, and some of the legs (such as 128a, 128b) are shown. The main body 126 may include a substantially flat upper area (such as larger than 1 mm^2). This upper area may be of a suitable size and suitable flatness to enable a suction head of a robot placement device (such as a pick-and-place device) to grip the sensor holder device 102. For example, the upper area may be located adjacent to the holding structure 132 and the periphery of the main body 126. When the holding structure 132 is provided on the back surface of the main body 126 (such as shown in FIG. 6), the upper area may be located at any suitable position along the upper surface of the main body 126. Thus, the upper area may be larger when the holding structure 132 is provided on the back surface of the main body 126. As a result, compared with the case where the holding structure is provided on the upper surface of the main body 126, a more suitable location where the suction head can pick up the sensor holder device 102 may occur.

[0025]

[0035] In some examples, the sensor holder device 102 may have a height of about 3 mm, a width of about 15 mm, and a length of about 20 mm. In other examples, the height, width, and / or length of the sensor holder device 102 may be greater than or less than 3 mm, 15 mm, and / or 20 mm, respectively. The height of about 3 mm may be selected to be less than the height of the power supply 110. Also, the height of about 3 mm may provide an appropriate separation between the proximal end of the sensor wire 106b and other electronic components attached to the sensing circuit 108 and the PCB 112 or otherwise provided within the PCB 112.

[0026]

[0036] The set of legs 128 extends from one side of the body 126 and extends below the body 126 and, in some examples, includes a corresponding set of feet 130, some of which (such as 130a - 130c) are illustrated. For example, the body 126 may be oriented in a first plane and the set of feet 130 may be oriented in a different second plane. The set of legs 128 may extend between the first plane and the second plane to connect the body 126 to the set of feet 130. The body 126 may be oriented in the first plane when a substantial portion of the body 126 is located in the first plane. The set of feet 130 (such as, for example, the distal end of the set of legs 128) may be oriented in the second plane when a substantial portion of the set of feet is located in the second plane. In some examples, the feet 130 may include solder rings 131, some of which (such as 131a - 131c) are illustrated. The sensor holder device 102 may be electrically and structurally connected to a PCB (such as PCB 112) or other structure using the solder rings 131. For example, an electrical trace 116 starting at the body 126 and extending along the leg 128 to the foot 130 may be electrically connected to the PCB 112 via the solder ring 131. In some examples, the feet 130 are connected to the PCB 112 using surface mount technology.

[0027]

[0037] The sensor holder device 102 can be formed by any suitable method including, for example, injection molding or other suitable techniques. The sensor holder device 102 can be formed as a single piece including at least a body 126, legs 128, feet 130, and / or a sensor retaining structure 138. The sensor holder device 102 can be formed from any suitable material including, for example, liquid crystal polymers (such as RTP 3499-3 X 113393 A sold by RTP Company, VECTRA® E840i LDS sold by Ticona, etc.), high temperature nylons, polyetheretherketone (“PEEK”), and other similar materials. In some examples, the material selected for the sensor holder device 102 can be non-conductive, solder compatible, have low moisture absorption characteristics, have a low water vapor transmission rate, and can be easily molded into very thin walls. In some examples, the material selected for the sensor holder device 102 can be capable of laser direct structuring (“LDS”) treatment. The rigidity of the sensor holder device 102 can depend on one or both of the thickness of the sensor holder device 102 and the material forming the sensor holder device 102. For example, the thickness of the sensor holder device 102 can be inversely proportional to the density of the material (e.g., a high density material can allow for a thinner sensor holder device 102 and a low density material can require a thicker sensor holder device 102).

[0028]

[0038] The sensor holder device 102 also includes a sensor holding structure 132 provided on the upper surface of the main body 126. In this example, the sensor holding structure 132 may include a groove sized to receive the sensor wire 106 (shown in dashed lines) (having a cross-section such as U-shaped, V-shaped, etc.). In addition to or instead of the groove, the sensor holding structure 132 may include any suitable combination of tabs, hooks, springs, etc. configured to hold the sensor wire 106. In some examples, the sensor holding structure 132 can be used to align the sensor wire 106 during assembly. For example, the proximal end 106a of the sensor wire 106 can be made to contact the end wall 134 near the first region 136a of the sensor holding structure 132. Thereby, the sensor wire 106 can be laterally aligned. Similarly, since the sensor wire 106 can be provided within the sensor holding structure 132, the sensor holding structure 132 can align the sensor wire 106 longitudinally.

[0029]

[0039] In some examples, the sensor holding structure 132 can be defined to include a first region 136a and a second region 136b. The electrical trace 116a can extend proximate to and in some examples within the first region 136a. Similarly, the electrical trace 116b can extend proximate to and in some examples within the second region 136b. In some examples, a first dimensional measurement (such as width, depth, cross-sectional area, etc.) measured across the sensor holding structure 132 in the lateral direction within the first region 136a can be different from a second dimensional measurement measured across the sensor holding structure 132 in the lateral direction within the second region 136b. These differences can be included in the sensor holding structure 132 to accommodate the electrodes 123, 125. As described herein, the electrodes 123, 125 can be of different sizes (e.g., having different diameters). The different lateral measurements can be selected based on the respective widths of the proximal ends of the sensor wire at various positions. For example, a portion of the proximal end of the sensor wire can be the exposed platinum electrode 123, which can have a narrower gauge than another portion including a platinum wire covered with the silver / silver chloride electrode 125.

[0030]

[0040] In some examples, the sensor holder device 102 may be attached to or otherwise formed within the body 126 and / or the legs 128 and include other components (such as electronics, antennas, etc.). For example, an antenna may be printed on the body 126 and electrically coupled to other electronics (such as the sensor holder device 102, the sensing circuit 108, and / or an electronic device connected to the PCB 112) via one or more electrical traces such as the electrical trace 116.

[0031]

[0041] In some examples, the sensor holder device 102 may include any suitable number of electrical traces 116 for supporting any suitable number of electrodes. For example, both the electrical traces 116a, 116b may extend along the leg 128a (such as on the same side or opposite sides of the leg 128a). In this example, other electrical traces 116 may extend along other legs 128 of the sensor holder device 102. For example, two or more electrical traces 116 may extend along each of the legs 128a - 128c. In some examples, at least one of the electrical traces 116 may function as a guard trace to reduce current leakage of one or more other electrical traces 116.

[0032]

[0042] The electrical traces 116a, 116b may be formed within the sensor holder device 102 using any suitable technique. Examples of such techniques include LDS processing and corresponding techniques for depositing conductive materials such as copper, nickel, gold, etc. onto circuit patterns. Such techniques may include electroless copper plating. For example, such techniques may include those using Enplate® LDS AG - 600 sold by Enthone®. The electrical traces 116a, 116b may have a thickness of about 1 micron. In some examples, the electrical traces 116a, 116b have a thickness of less than 1 micron (such as 0.25 micron to 0.5 micron).

[0033]

[0043] The electrodes 123 and 125 can be electrically connected to the electrical traces 116a and 116b in any suitable manner. For example, when the electrodes 123 and 125 are disposed within the sensor holding structure 132, a conductive pressure-sensitive adhesive (''PSA'') or other conductive adhesive can be applied to the electrodes 123 and 125. The conductive adhesive can form an independent electrical connection between the electrodes 123 and 125 and the electrical traces 116a and 116b. In some examples, the conductive adhesive can be in any suitable form such as, for example, a liquid, film, tape, etc. Examples of suitable materials include conductive adhesive transfer tape (''ECATT'') sold by 3M, PSA of the ARclad (registered trademark) brand such as 8001-75, 8001-77, 9032, or 9032-70 sold by Adhesives Research (registered trademark), Supreme 10HTFN sold by MasterBond (registered trademark), or any other suitable material. Such conductive adhesives can be considered to be, for example, ''snap cure'' epoxies, polyurethanes, B-stage films, etc.

[0034]

[0044] The sensor holder device 102 also includes a sensor guide structure 138. The sensor guide structure 138 is attached to the body 126 and extends outward from the body 126 in generally the same direction as the legs 128. The sensor guide structure 138 can be attached to the body 126 by being formed directly from the body 126. The sensor guide structure 138 can be formed as a separate component and attached to the body 126 by being coupled to the body 126. The sensor guide structure 138 can include an opening or hole 140 through which the sensor wire 106 can pass. The hole 140 can have any suitable shape such as, for example, cylindrical, conical, rectangular, etc. Thus, the cross-section of the hole 140 can vary with respect to its depth.

[0035]

[0045] Like the foot 130, the sensor guide structure 138 can be attached to the PCB 112 using surface mount technology. For example, the sensor guide structure 138 may include a solder ring 142 that provides a hermetic seal between the sensor guide structure 138 and the PCB 112 during solder reflow. During manufacturing, the sensor wire 106 can be passed through the PCB 112 and the hole 140 before being bent and disposed within the sensor holding structure 132.

[0036]

[0046] In some examples, the potting material 144 can be disposed proximate to the sensor wire 106 within the hole 140 as shown in FIG. 2. For example, the potting material 144 can be injected over and around the top of the sensor wire 106 to pot the sensor wire 106 within the hole 140. In some examples, the potting material 144 may include a non-conductive material to prevent short circuits in the sensor wire 106. The potting material 144 can provide a moisture barrier for the electrical connection between the electrical trace 116 and the electrodes 123, 125. Non-limiting examples of the potting material 144 include epoxy, wax, silicon, acrylic, polyurethane, or other means for providing a moisture barrier. Although the potting material 144 is shown as being located only proximate to the sensor wire 106, it may be applied to cover other components of the sensor holder device 102.

[0037]

[0047] In some examples, the moisture seal 146 can be formed along the upper surface of the sensor holder device 102. The moisture seal 146 can function as a moisture barrier between the body 126 and the upper housing 120. The moisture seal 146 can be formed by seam welding the upper housing 120 to the body 126, and the sensor holding structure 132 is provided within the moisture seal 146. For example, a portion of the body 126 can be welded to a portion of the upper housing 120, or a moisture barrier adhesive can be applied to the body 126 prior to attachment of the upper housing 120. In some examples, the adhesive can be pressure-activated and hardens when an attachment force for attaching the upper housing 120 to the body 126 is applied to the upper housing 120.

[0038]

[0048] Figures 4 and 5 show an example of the sensor holder device 102 according to a specific example. As shown in FIG. 4, when inserting the distal end 106b into the human skin 141, the hole 140 or another opening intersecting the hole 140 can be used to align the subcutaneous insertion needle 148 of the sensor inserter (not shown). For example, by disposing the insertion needle 148 in the hole 140 and pressing the monitoring device 100 against the human skin 141, proper alignment of the insertion needle 148 for inserting the sensor wire 106 into the human skin 141 can be achieved.

[0039]

[0049] The sensor guide structure 138 in FIGS. 3 and 4 is shown as extending away from the main body 126 in a substantially orthogonal direction. However, as can be understood, the sensor guide structure 138 may be connected to the main body 126 at any suitable angle and / or may include other openings. For example, as shown in FIG. 5, the sensor guide structure 138 may also include a sensor hole 150. In this example, the hole 140 can be considered as a guide hole for receiving, guiding, and aligning the insertion needle 148. On the other hand, the sensor hole 150 can also function to guide the sensor wire 106 from the main body 126 to a position beyond the PCB 112. In some examples, the angle between the sensor hole 150 and the hole 140 can help to stabilize the sensor wire 106 within the insertion needle 148 during insertion. For example, as the sensor wire 106 passes through the sensor hole 150, the sensor wire 106 can be pressed against the insertion needle 148.

[0040]

[0050] FIG. 6 shows an example of a sensor holder device 102 that includes a sensor retention structure 132 (e.g., a groove or equivalent structure as described herein) provided on the back surface of the body 126 according to at least one example. Thus, in this example, the sensor wire 106 is retained on the back surface of the body 126 by the sensor retention structure 132. In some examples, placing the sensor wire 106 on the back surface of the body 126 can provide additional mechanical protection (e.g., provided by the sensor holder device 102) and additional moisture protection (e.g., by being placed deeper within the monitoring device 100). Also, placing the sensor wire 106 on the back surface of the body 126 can result in reduced manufacturing costs and increased throughput. For example, since all electrical traces are located on the same side of the sensor holder device 102 (e.g., eliminating the need for through plating), the sensor holder device 102 does not need to be turned over during manufacturing.

[0041]

[0051] In the illustrated example, the sensor holder device 102 also includes electrical traces 116c - 116e provided on the back surface of the body 126. The electrical traces 116c - 116e are examples of the electrical traces 116a, 116b. In some examples, each of the electrical traces 116c - 116e corresponds to an electrode of the sensor wire 106. In other examples, the electrical trace 116d may be a guard trace and can be attached to the sensor holder device 102 to reduce current leakage between the electrical traces 116c and 116e. In some examples, the sensor holder device 102 may also include an insulating slot 149. The insulating slot 149 can be formed in the sensor holder device 102 to reduce current leakage between the electrical traces 116. In some examples, the insulating slot 149 can be injected with a potting material (e.g., petrolatum, paraffin wax, low temperature silicone, etc.) to provide additional electrical protection against leakage current.

[0042]

[0052] In the illustrated example, the sensor guide structure 138 can be defined by one of the legs 128. Thus, rather than including an independent structure, the sensor guide structure 138 can be defined by a leg 128d that includes a contour that includes the guide opening 151. The guide opening 151 can be used to guide the sensor wire 106 from the body 126 toward the back surface of the sensor holder device 100. The guide opening 151 can be defined to be provided between two feet 130e and 130d of the leg 128d. In some examples, the leg 128d can include a single foot 130 that includes a guide hole, such as the guide hole 140. In any event, the leg 128d that includes the guide opening 151 can guide the sensor wire 106 from the sensor holding structure 132 toward the back surface of the sensor holder device 100. In this example, the insertion needle 148 can be inserted through the guide opening 151 so as to intersect the sensor wire 106 as part of the insertion of the sensor wire 106 into the human skin.

[0043]

[0053] FIG. 7 shows an example of a sensor holder device 102 that includes a sensor holding structure 132 according to at least one example. The sensor holding structure 132 shown in FIG. 7 includes a set of tabs 152 (such as 152a-152d) configured to hold and align the sensor wire 106. The tabs 152 can be spaced appropriately to receive and hold the sensor wire 106 by a snap fit. For example, the tabs 152 can include grooves formed in the inward-facing surface. Also, the tabs 152 can be configured to deflect laterally in response to a downward force. For example, during installation, a downward force can be applied to the sensor wire 106 in the direction of the upper surface of the body 126, and the sensor wire is aligned between the tabs 152a, 152b and 152c, 152d. Due to this downward force, the tabs 152 can deflect slightly laterally to accommodate the sensor wire 106 until the sensor wire 106 reaches at least the grooves formed in the inward-facing surface of the tabs 152.

[0044]

[0054] As shown in FIG. 7, the electrical trace 116 may extend between the sensor holding structure 132 and the foot 130. In some examples, the electrical trace 116 may extend within the tab 152. In this manner, the electrical connection between the electrical trace 116 and the sensor wire 106 may be made within the inward-facing surface of the tab 152.

[0045]

[0055] As described herein, the sensor holding structure 132 may, in some examples, include hooks configured to hold the sensor wire 106. The sensor holding structure 132 may also include a spring, such as an overmolded leaf spring, configured to hold the sensor wire 106. Any of the variations of the sensor holding structure 132 described herein may be used with the PSA described herein.

[0046]

[0056] FIGS. 8A-8C show examples of monitoring devices 800a-800c that include various sensor holder devices 802a-802c according to a particular example. The monitoring device 800 is an example of the monitoring device 100 described herein. Thus, the monitoring device 800 may include an upper housing 820, a biosensor 804, a PCB 812, a lower housing 822, and a sensor wire 806.

[0047]

[0057] In the example shown in FIG. 8A, the sensor holder device 802a may be aligned relative to other components of the biosensor 804a such that the sensor wire 806a extends through the inner region of the biosensor 804a. For example, the sensor wire 806a may extend through an opening in the PCB 812a provided within the inner region of the PCB 812a. The housing opening 824a of the lower housing 822a may correspond to the opening in the PCB 812a.

[0048]

[0058] In the example shown in FIG. 8B, the sensor holder device 802b can be aligned with other components of the biosensor 804b such that the sensor wire 806b extends through the outer region of the biosensor 804b. For example, the sensor wire 806b can extend through a PCB opening 854b provided within the outer region of the PCB 812b. The housing opening 824b of the lower housing 822b can correspond to the PCB opening 854b.

[0049]

[0059] In the example shown in FIG. 8CB, the sensor holder device 802c can be aligned with other components of the biosensor 804c such that the sensor wire 806c extends proximate to the outer periphery of the biosensor 804c. For example, the sensor wire 806c can extend proximate to the periphery 856c of the PCB 812c. In some examples, the periphery 856c can include a cutout 858c for accommodating the sensor wire 806c. The lower housing 822c can include a corresponding cutout 860c.

[0050]

[0060] FIG. 9 shows a monitoring device 900 according to at least one example. The monitoring device 900 is an example of the monitoring device 100. Thus, the monitoring device 900 can include a sensor holder device 902, a biosensor 904, and an upper housing 920. In the example shown in FIG. 9, the features of the sensor holder device 902 can be used to align the upper housing 920 with other portions of the monitoring device 900. For example, the legs 928 and / or feet 930 of the sensor holder device 902 can correspond to the alignment notches 962 of the upper housing 920. During installation, the upper housing 920 can be brought into contact with the sensor holder device 902 such that the legs 928 are received within the alignment notches 962. In some examples, the alignment using the alignment notches 962 and a portion of the sensor holder device 902 can result in a more tightly fitting engagement between the upper housing 920 and other portions of the monitoring device 900. This is because the manufacturing tolerances of the sensor holder device 902 can be made significantly tighter (e.g., + / - 15 microns), resulting in a better overall fit.

[0051]

[0061] Instead, the upper housing 920 can be aligned with the periphery of the PCB 912. Generally, the PCB 912 is cut out using a die and can have relatively high tolerances (e.g., + / -200 microns). As a result, a loose fit can occur compared to alignment using the alignment notch 962 and the legs 928.

[0052]

[0062] The above description of several examples is presented for purposes of illustration and explanation only and is not intended to be exhaustive or to limit the present disclosure to the forms disclosed as such. Numerous modifications and adaptations will be apparent to those skilled in the art without departing from the spirit and scope of the present disclosure.

[0053]

[0063] References to examples or implementations in this specification mean that the particular features, structures, operations, or other characteristics described in connection with the examples may be included in at least one implementation of the present disclosure. The present disclosure is not limited to the particular examples or implementations so described. The phrases "in one example," "in an example," "in one implementation," or "in an implementation," or variations of the same, at various places in this specification are not necessarily referring to the same example or implementation. Any particular feature, structure, operation, or other characteristic described in connection with one example or implementation may be combined with any other feature, structure, operation, or other characteristic described in connection with any other example or implementation.

[0054]

[0064] The use of the word "or" in this specification is intended to include both inclusive and exclusive OR conditions. That is, A or B or C includes any or all of the combinations of options of only A, only B, only C, only A and B, only A and C, only B and C, and all three of A and B and C, as required for a particular use.

Claims

1. A sensor (104) including a first portion (106b) insertable into a patient's skin (141), the first portion (106b) including means for generating glucose information, the sensor (104); A printed circuit board (112); An interposer device (102); A glucose monitoring system (100) comprising: The interposer device (102) is A body (126) supported by legs (128), the legs (128) extending from the body (126) so as to form a void under the body (126), the legs (128) being connected to the printed circuit board (112) under the body (126) and serving to isolate the body (126) from the printed circuit board (112), the body (126); A sensor guide structure (138) defining a guide hole (140) or a guide opening (151); Holding means (132) for physically holding a second portion (106a) of the sensor (104); Coupling means for electrically coupling the second portion (106a) of the sensor (104) to a circuit (108) provided on the printed circuit board (112) for determining a blood glucose level of the patient; A glucose monitoring system (100).

2. The glucose monitoring system (100) according to claim 1, wherein the holding means (132) defines at least one of a groove, a set of opposing tabs (152), or one or more springs.

3. The glucose monitoring system (100) according to claim 1 or 2, wherein the coupling means comprises one or more electrical traces (116) provided on the interposer device (102).

4. The glucose monitoring system (100) according to claim 3, wherein the one or more electrical traces (116) are defined within the holding means (132).

5. The means for generating the glucose information comprises one or more electrodes (123, 125) configured to generate an electrical signal corresponding to the amount of glucose present in the interstitial fluid under the patient's skin (141), the glucose monitoring system (100) according to any one of claims 1 to 4.

6. The coupling means comprises one or more electrical traces (116) provided on the interposer device (102), each of the electrical traces (116) corresponding to one of the electrodes (123, 125) of the sensor (104), the glucose monitoring system (100) according to claim 5.

7. The means for generating the glucose information comprises glucose oxidase provided on the first portion (106b) of the sensor (104), the glucose monitoring system (100) according to any one of claims 1 to 6.

8. The sensor guide structure (138) also includes a sensor hole (150) configured to guide the sensor (104) from the body (126) to a position beyond the printed circuit board (112), the glucose monitoring system (100) according to any one of claims 1 to 7.

9. The interposer device (102) is a three-dimensional circuit component including the set of the body (126) and the legs (128), the glucose monitoring system (100) according to any one of claims 1 to 8.

10. The set of the legs (128) extends from one side surface of the body (126) and extends under the body (126), the glucose monitoring system (100) according to any one of claims 1 to 9.

11. At least the body (126), the legs (128) and the holding means (132) are formed as a single piece, the glucose monitoring system (100) according to any one of claims 1 to 10.

12. The holding means (132) is provided on the back surface of the body (126), the glucose monitoring system (100) according to any one of claims 1 to 11.

13. The coupling means comprises one or more electrical traces (116) provided on the interposer device (102), and the electrical traces (116) are also provided on the back surface of the body (126), the glucose monitoring system (100) according to any one of claims 1 to 12.

14. The interposer device (102) is spaced apart from the printed circuit board (112) and may be over components disposed therebelow, the components including, for example, the circuit (108) and / or the power supply (110), of the glucose monitoring system (100) according to any one of claims 1 to 13.

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