Sensor holder device for invasive biosensors - Patents.com

Abstract

To provide suitable support for sensing wires of invasive biosensors. 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 guide structure, a sensor holding structure, and an electrical trace. The sensor holding structure may be sized to receive a sensor wire. The electrical trace may extend along one of the legs proximate the sensor holding structure.

Description

[Technical field]

[0001]

[0001] This application is related to and claims the benefit of priority to U.S. patent application Ser. No. 15 / 362,955, entitled "SENSOR HOLDER DEVICE FOR INVASIVE BIOSENSORS," filed Nov. 29, 2016, the entire contents of which are incorporated herein by reference.

[0002]

[0002] The present disclosure relates generally to invasive biosensors and, more particularly, to a device for supporting a sensing wire of an invasive biosensor. [Background technology]

[0003]

[0003] An invasive biosensor, such as a sensor for a wearable glucose monitoring device, includes a thin wire that can be inserted into the patient's skin. A sensing circuit reads biological information about the patient through the thin wire. When the invasive biosensor is inserted into the patient's skin, the electrical connection between the wire and the circuit is maintained under potential moisture exposure that can significantly affect the biosensor performance. For example, many electrochemical-based sensors can have performance impacts in terms of increased calibration offsets or noise floor levels due to current leakage caused by moisture in the electronics housing, which is particularly high for biosensors included in wearable devices that may be exposed to sweat on the patient's skin, weather, and other moisture sources that human skin commonly comes into contact with. 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. required to process the biological information, a wearable glucose monitoring device may include multiple parts that are bonded together to form a working device. The use of multiple parts not only makes the device bulky, but also introduces multiple areas of potential moisture ingress (e.g., seals between parts). Summary of the Invention [Means for solving the problem]

[0004]

[0004] Various examples of sensor holder devices for holding and supporting a sensor wire of an invasive biosensor are described. 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 of the rigid body. The sensor guide structure may be attached to the rigid body and extend from one side of the rigid body. The sensor guide structure may define a guide hole or 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 a distal end of a first leg of the set of legs.

[0005]

[0005] Other devices disclosed include a wearable monitoring device. 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 in a housing having an outer surface for placing the wearable monitoring device on the 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 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 a first leg of the pair of legs to a 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 a proximal portion of the sensor wire in proximity to the electrical trace. The sensor guide structure may guide a distal portion of the sensor wire past 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 insertable into the skin of a patient. The first portion may include a means for generating glucose information. The interposer device may include a sensor positioning means, a holding means, and a coupling means. The sensor positioning means may be for positioning the sensor wire such that an insertion needle can insert the first portion into the skin of the patient. 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 for determining a blood glucose level of the patient.

[0007]

[0007] These specific examples are mentioned not to limit or define the scope of the present disclosure, but to provide examples and aid in their understanding. Specific examples are discussed in the detailed description to provide further explanation. Advantages provided by the various examples can be further understood by considering this specification.

[0008]

[0008] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate one or more specific examples and, together with the description of the examples, serve to explain the principles and implementations of the particular examples. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 illustrates an exploded perspective view of an example monitoring device including a sensor holder device according to at least one example. [Diagram 2]

[0010] FIG. 1 illustrates a top perspective view of an example sensor holder device according to at least one example. [Diagram 3]

[0011] 1 illustrates a bottom perspective view of an example sensor holder device according to at least one example. [Figure 4]

[0012] 1 illustrates a side cross-sectional view of an example sensor holder device according to at least one example. [Diagram 5]

[0013] 1 illustrates a side cross-sectional view of an example sensor holder device according to at least one example. [Figure 6]

[0014] 1 illustrates a bottom perspective view of an example sensor holder device according to at least one example. [Figure 7]

[0015] FIG. 1 illustrates a top perspective view of an example sensor holder device according to at least one example. [Figure 8A]

[0016] 1 illustrates an exploded perspective view of an example monitoring device including a sensor holder device according to at least one example. [Figure 8B]

[0017] 1 illustrates an exploded perspective view of an example monitoring device including a sensor holder device according to at least one example. [Figure 8C]

[0018] 1 illustrates an exploded perspective view of an example monitoring device including a sensor holder device according to at least one example. [Figure 9]

[0019] 1 illustrates an exploded perspective view of an example monitoring device including a sensor holder device according to at least one example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010]

[0020] Described herein are examples of sensor holder devices for use in continuous monitoring devices. Those skilled in the art will appreciate that the following description is merely illustrative and is not intended to be limiting in any way. Reference will now be made in detail to example implementations as illustrated in the accompanying drawings. 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 of the routine features of the examples described herein are shown and described. Of course, it will be understood that in developing any such actual implementation, numerous implementation-specific decisions may be made to achieve the particular objectives of the developer, such as compliance with application and business-related constraints, and that these particular objectives will vary from implementation to implementation and developer to developer.

[0012]

[0022] In a typical example, a wearable glucose monitoring device includes a glucose sensor that can be inserted into a person's skin for continuous monitoring of the person's blood glucose level. During wearing, the wearable glucose monitoring device can be exposed to normal external forces resulting from clothing, bumping into obstacles, and other external forces. To reduce the impact of these forces and improve the comfort of the wearer, the footprint and side of the glucose monitoring device can be reduced. As a way to do 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 allowing 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 below the body. The legs are coupled to a printed circuit board ("PCB") below the body and function 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 in the cavity below the body. In this manner, the sensor holder device provides efficient utilization of space within the glucose monitoring device (e.g., allowing stacking of components and reducing the overall footprint 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 grooves in which the electrodes are disposed. The sensor holder device aligns the sensor wires by a cylindrical opening or against one of the legs, either of which extends from the body of the sensor holder device towards the back side of the device. The sensor holder device electrically connects the electrodes by electrical traces formed on the surface of the sensor holder device. The electrical traces may extend between the grooves and down the legs to the PCB. The sensor holder device is described herein with respect to a glucose monitoring device, but it will be appreciated that the sensor holder device may be implemented to support any suitable electromechanical sensor.

[0014]

[0024] Referring now to the drawings, FIG. 1 illustrates 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, for example, a glucose sensor or other electromechanical sensor used to sense a patient's bioinformation. The biosensor 104 includes a sensor wire 106, a sensing circuit 108, a power source 110, such as, for example, a battery, a printed circuit board ("PCB") 112, and an antenna 114. The sensor wire 106 includes 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 in 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 proximate to a middle area of ​​the sensor holder device 106 toward the PCB 112. During use, the distal end 106b is inserted into a patient's skin to measure a biological parameter (e.g., blood glucose level) in interstitial fluid of the subcutaneous tissue beneath the skin.

[0015]

[0025] The monitoring device 100 also includes a moisture barrier 118, such as a cap, disposed between the upper housing 120 and the lower housing 122. When assembled, the moisture barrier 118 may provide a seal that prevents moisture from penetrating the biosensor 104. When assembled, the upper housing 120 encapsulates 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 when mounted. The PCB 112 may include a corresponding opening through which the distal end 106b passes. On the opposite side to the illustrated side, the lower housing 122 may include a generally flat surface that allows the monitoring device 100 to be placed against human skin.

[0016]

[0026] The sensor holder device 102 may be suitably rigid to support the sensor wires 106 and provide 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, mounting the sensor holder device 102 to the PCB 112 may add rigidity 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, the sensor holder device 102 serves to conserve space within the monitoring device 100 because the sensor holder device 102 may be separate from the PCB 112 and above underlying components (e.g., the sensing circuitry 108, the power supply 110, etc.). As a result, the monitoring device 100 may have a smaller footprint. Also, the configuration of the sensor holder device 102 relative to the PCB 112 allows the PCB 112 to rest against human skin, unlike other monitoring devices that include standoff fixtures. This improves comfort for the wearer and reduces the bulkiness of the overall device.

[0018]

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

[0019]

[0029] The length of the sensor wire 106 may allow the sensor wire 106 to extend from under the human skin into the sensor holder device 102 with tolerance for patient movement. For example, the sensor wire 106 may be approximately 10 millimeters to 30 millimeters in length. The thickness or gauge of the sensor wire 106 may be selected to allow the sensor wire 106 to remain inserted within the skin with minimal discomfort during this period. In some examples, the sensor wire 106 includes an outer diameter of approximately 100 to 200 microns for the wire portion covered by the electrode 125 and an outer diameter of approximately 100 microns for the electrode 123. In additional examples, the sensor wire 106 may generally have a maximum outer diameter of 100 microns to 300 microns. In some examples, the sensor wire 106 may have an outer diameter of approximately 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 may 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., that may be on the surface of or embedded in a PCB assembly. Such components may 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 may be configured to receive the electrical signal from the sensor wire 106 (e.g., via the PCB 112 and the electrical traces 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, for example, a random access memory ("RAM"), coupled to the processing device. The processing device may execute computer-executable program instructions stored in the memory, such as, for example, executing one or more computer programs. Such a processing device may comprise 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 the 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] A processing device may include or be in communication with a medium, e.g., a computer-readable storage medium, that may store instructions that, when executed by the processing device, cause the processing device to perform the steps described herein as being performed 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 reads or writes information.

[0023]

[0033] The upper housing 120 and the lower housing 122 may together form a housing for holding the biosensor 104. The housing may be of a compact size for placement on human skin. The housing may be made of any suitable material for housing the biosensor 104. Non-limiting examples of materials that may be suitable for the housing may be silicone, polyethylene, polyvinyl chloride ("PVC"), polypropylene, nylon, polyurethane, polycarbonate, steel, aluminum, and other plastics and metals. The monitoring device 100 may be secured to the skin using adhesives, bands, straps, or other fastening means. In some examples, the monitoring device 100 may be worn for an extended period of time (e.g., days, weeks, months, etc.).

[0024]

[0034] 2 and 3 show top and bottom perspective views, respectively, of the sensor holder device 102 according to a particular example. The sensor holder device 102, which is a type of three-dimensional circuit component, may include a body 126 and a set of legs 128, some of which (e.g., 128a, 128b) are shown. The body 126 may include a generally flat top area (e.g., greater than 1 mm^2). This top area may be of suitable size and suitable flatness to allow a suction head of a robotic placement device (e.g., a pick-and-place device) to grasp the sensor holder device 102. For example, the top area may be located adjacent to the retaining structure 132 and the periphery of the body 126. If the retaining structure 132 is provided on the back side of the body 126 (e.g., as shown in FIG. 6), the top area may be located at any suitable location along the top surface of the body 126. Thus, the top area may be larger if the retaining structure 132 is provided on the back side of the body 126. As a result, there may be a more suitable location for the suction head to pick up the sensor holder device 102 than if the holding structure was provided on the top surface of the body 126 .

[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 source 110. Also, the height of about 3 mm may provide adequate separation between the proximal end of the sensor wire 106b and the sensing circuit 108 and other electronic components attached to or otherwise provided within the PCB 112.

[0026]

[0036] The set of legs 128 extends from one side of the body 126, extends below the body 126, and in some examples includes a corresponding set of feet 130, some of which (e.g., 130a-130c) are shown. For example, the body 126 may be oriented in a first plane and the set of feet 130 may be oriented in another, second plane. The set of legs 128 may extend between the first plane and the second plane to couple the body 126 to the set of feet 130. The body 126 may be oriented in the first plane if a substantial portion of the body 126 lies in the first plane. The set of feet 130 (e.g., the distal end of the set of legs 128) may be oriented in the second plane if a substantial portion of the set of feet lies in the second plane. In some examples, the feet 130 may include solder rings 131, some of which (e.g., 131a-131c) are shown. The sensor holder device 102 may be electrically and structurally connected to a PCB (e.g., PCB 112) or other structure using solder rings 131. For example, the electrical traces 116 that begin at the body 126 and extend along the legs 128 to the feet 130 may be electrically connected to the PCB 112 via the solder rings 131. In some examples, the feet 130 are coupled to the PCB 112 using surface mount technology.

[0027]

[0037] The sensor holder device 102 may be formed in any suitable manner, including, for example, injection molding or other suitable techniques. The sensor holder device 102 may be formed as a single piece including at least the body 126, the legs 128, the feet 130, and / or the sensor holding structure 138. The sensor holder device 102 may be formed from any suitable material, including, for example, liquid crystal polymers (e.g., RTP 3499-3 x 113393 A sold by RTP Company, VECTRA® E840i LDS sold by Ticon, etc.), high temperature nylon, polyetheretherketone ("PEEK"), and other similar materials. In some examples, the material selected for the sensor holder device 102 may be non-conductive, solder compatible, have low moisture absorption characteristics, have a low water vapor transmission rate, and may be easy to mold into very thin walls. In some examples, the material selected for the sensor holder device 102 may be capable of laser direct structuring ("LDS") processing. The stiffness of the sensor holder device 102 may 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 may be inversely proportional to the density of the material (e.g., a high density material may allow for a thinner sensor holder device 102, while a low density material may require a thicker sensor holder device 102).

[0028]

[0038] The sensor holder device 102 also includes a sensor retaining structure 132 disposed on the top surface of the body 126. In this example, the sensor retaining structure 132 may include a groove sized (e.g., having a U-shaped, V-shaped, etc. cross section) to receive the sensor wire 106 (shown in dashed lines). In addition to or instead of a groove, the sensor retaining structure 132 may include any suitable combination of tabs, hooks, springs, etc. configured to retain the sensor wire 106. In some examples, the sensor retaining structure 132 may be used to align the sensor wire 106 during assembly. For example, the proximal end 106a of the sensor wire 106 may be brought into contact with an end wall 134 near a first region 136a of the sensor retaining structure 132. This may cause the sensor wire 106 to be aligned laterally. Similarly, the sensor wire 106 may be disposed within the sensor retaining structure 132, such that the sensor retaining structure 132 may align the sensor wire 106 vertically.

[0029]

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

[0030]

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

[0031]

[0041] In some examples, the sensor holder device 102 may include any suitable number of electrical traces 116 to support any suitable number of electrodes. For example, both electrical traces 116a, 116b may extend along leg 128a (e.g., on the same or opposite sides of 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 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 in the sensor holder device 102 using any suitable technique. Examples of such techniques include LDS processes and corresponding techniques for depositing conductive materials, such as copper, nickel, gold, etc., into a circuit pattern. Such techniques may include electroless copper plating. For example, such techniques may include using Enplate® LDS AG-600 sold by Enthone® Corporation. 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 (e.g., 0.25 microns to 0.5 microns).

[0033]

[0043] The electrodes 123, 125 may be electrically connected to the electrical traces 116a, 116b in any suitable manner. For example, a conductive pressure sensitive adhesive ("PSA") or other conductive adhesive may be applied to the electrodes 123, 125 once the electrodes 123, 125 are placed in the sensor retaining structure 132. The conductive adhesive may form an independent electrical connection between the electrodes 123, 125 and the electrical traces 116a, 116b. In some examples, the conductive adhesive may be in any suitable form, such as a liquid, film, tape, or the like. Examples of suitable materials include Conductive Adhesive Transfer Tape ("ECATT") sold by 3M Corporation, ARclad® brand PSAs such as 8001-75, 8001-77, 9032, or 9032-70 sold by Adhesives Research®, Supreme 10HTFN sold by MasterBond®, or any other suitable material. Such conductive adhesives may be considered to be "snap cure" epoxies, polyurethanes, B-stage films, and the like.

[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 outwardly from the body 126 in generally the same direction as the legs 128. The sensor guide structure 138 may be attached to the body 126 by being formed directly from the body 126. The sensor guide structure 138 may also be formed as a separate piece and attached to the body 126 by being coupled to the body 126. The sensor guide structure 138 may include an opening or hole 140 through which the sensor wire 106 may pass. The hole 140 may have any suitable shape, for example, cylindrical, conical, rectangular, etc. The cross-section of the hole 140 may therefore vary with respect to its depth.

[0035]

[0045] Like the feet 130, the sensor guide structure 138 may be attached to the PCB 112 using surface mount techniques. 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 may be threaded through the PCB 112 and hole 140 before being folded and placed into the sensor retaining structure 132.

[0036]

[0046] In some examples, the potting material 144 may be disposed in the hole 140 proximate to the sensor wire 106 as shown in FIG. 2. For example, the potting material 144 may be injected on top of and around the sensor wire 106 to pot the sensor wire 106 in the hole 140. In some examples, the potting material 144 may include a non-conductive material to prevent shorts in the sensor wire 106. The potting material 144 may 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, silicone, acrylic, polyurethane, or other means for providing a moisture barrier. Although the potting material 144 is shown to be 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, a moisture seal 146 may be formed along an upper surface of the sensor holder device 102. The moisture seal 146 may act as a moisture barrier between the body 126 and the upper housing 120. The moisture seal 146 may be formed by seam welding the upper housing 120 to the body 126, with the sensor retaining structure 132 disposed within the moisture seal 146. For example, a portion of the body 126 may be welded to a portion of the upper housing 120, or a moisture barrier adhesive may be applied to the body 126 prior to attachment of the upper housing 120. In some examples, the adhesive may be pressure activated and set when an attachment force is applied to the upper housing 120 to attach the upper housing 120 to the body 126.

[0038]

[0048] 4 and 5 show examples of sensor holder device 102 according to certain examples. As shown in FIG. 4, hole 140 or another opening intersecting hole 140 may be used to align a subcutaneous insertion needle 148 of a sensor insertion tool (not shown) when inserting distal end 106b into human skin 141. For example, insertion needle 148 may be placed into hole 140 and monitoring device 100 may be pressed against human skin 141 to achieve proper alignment of insertion needle 148 for inserting sensor wire 106 into human skin 141.

[0039]

[0049] Although the sensor guide structure 138 in FIGS. 3 and 4 is shown as extending away from the body 126 in a generally orthogonal direction, it will be understood that the sensor guide structure 138 may be connected to the body 126 at any suitable angle and / or 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 may be considered a guide hole for receiving, guiding, and aligning the insertion needle 148. Meanwhile, the sensor hole 150 may also function to guide the sensor wire 106 from the body 126 to a position beyond the PCB 112. In some examples, the angle between the sensor hole 150 and the hole 140 may help stabilize the sensor wire 106 in the insertion needle 148 during insertion. For example, the sensor wire 106 may be pressed against the insertion needle 148 by passing the sensor wire 106 through the sensor hole 150.

[0040]

[0050] 6 illustrates an example of a sensor holder device 102 including a sensor retention structure 132 (e.g., a groove or equivalent structure described herein) on the underside of the body 126 according to at least one example. Thus, in this example, the sensor wire 106 is retained on the underside of the body 126 by the sensor retention structure 132. In some examples, placing the sensor wire 106 on the underside of the body 126 may provide additional mechanical protection (e.g., provided by the sensor holder device 102) and additional moisture protection (e.g., by being located further back in the monitoring device 100). Also, placing the sensor wire 106 on the underside of the body 126 may provide reduced manufacturing costs and increased throughput. For example, because all electrical traces are located on the same side of the sensor holder device 102 (e.g., no through plating is required), the sensor holder device 102 does not need to be flipped over during manufacturing.

[0041]

[0051] In the illustrated example, the sensor holder device 102 includes electrical traces 116c-116e also disposed 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 may 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 may be formed in the sensor holder device 102 to reduce current leakage between the electrical traces 116. In some examples, the insulating slot 149 may be potted with a potting material (e.g., petrolatum, paraffin wax, low temperature silicone, etc.) to provide additional electrical protection against leakage currents.

[0042]

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

[0043]

[0053] FIG. 7 illustrates an example of a sensor holder device 102 including a sensor retention structure 132 according to at least one example. The sensor retention structure 132 illustrated in FIG. 7 includes a set of tabs 152 (e.g., 152a-152d) configured to retain and align the sensor wire 106. The tabs 152 may be appropriately spaced to receive and retain the sensor wire 106 by a snap fit. For example, the tabs 152 may include a groove formed in an inwardly facing surface. The tabs 152 may also be configured to deflect laterally in response to a downward force. For example, during installation, a downward force may be applied to the sensor wire 106 in the direction of the top surface of the body 126, and the sensor wire is aligned between the tabs 152a, 152b and 152c, 152d. This downward force may cause the tabs 152 to deflect slightly laterally to accommodate the sensor wire 106, at least until the sensor wire 106 reaches the groove formed in the inwardly facing surface of the tabs 152.

[0044]

[0054] 7, the electrical traces 116 may extend between the sensor retention structure 132 and the feet 130. In some examples, the electrical traces 116 may extend within the tabs 152. In this manner, an electrical connection between the electrical traces 116 and the sensor wires 106 may be made within the inward facing surface of the tabs 152.

[0045]

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

[0046]

[0056] 8A-8C show examples of monitoring devices 800a-c including various sensor holder devices 802a-c according to certain examples. Monitoring device 800 is an example of monitoring device 100 described herein. Thus, 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] 8A, the sensor holder device 802a can be aligned with other components of the biosensor 804a such that the sensor wire 806a extends through an inner region of the biosensor 804a. For example, the sensor wire 806a can extend through an opening in the PCB 812a that is disposed within the inner region of the PCB 812a. The housing opening 824a in the lower housing 822a can correspond to the opening in the PCB 812a.

[0048]

[0058] 8B, the sensor holder device 802b can be aligned with other components of the biosensor 804b such that the sensor wire 806b extends through an outer region of the biosensor 804b. For example, the sensor wire 806b can extend through a PCB opening 854b provided in 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 perimeter of the biosensor 804c. For example, the sensor wire 806c can extend proximate to the perimeter 856c of the PCB 812c. In some examples, the perimeter 856c can include a cutout 858c to accommodate the sensor wire 806c. The bottom housing 822c can include a corresponding cutout 860c.

[0050]

[0060] FIG. 9 illustrates a monitoring device 900 according to at least one example. The monitoring device 900 is an example of the monitoring device 100. The monitoring device 900 may thus include a sensor holder device 902, a biosensor 904, and an upper housing 920. In the example illustrated in FIG. 9, features of the sensor holder device 902 may be used to align the upper housing 920 with other portions of the monitoring device 900. For example, the legs 928 and / or the feet 930 of the sensor holder device 902 may correspond with the alignment notches 962 of the upper housing 920. During installation, the upper housing 920 may 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, alignment with the alignment notches 962 and a portion of the sensor holder device 902 may result in a tighter fit between the upper housing 920 and other portions of the monitoring device 900. This is because the manufacturing tolerances for the sensor holder device 902 can be much tighter (eg, + / - 15 microns), resulting in a better overall fit.

[0051]

[0061] Alternatively, the upper housing 920 may be aligned with the periphery of the PCB 912. Typically, the PCB 912 is cut using a die and may have a relatively high tolerance (e.g., + / - 200 microns), which may result in a looser fit compared to alignment using the alignment notches 962 and feet 928.

[0052]

[0062] The foregoing description of several examples has been presented for purposes of illustration and description only, and is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed, many modifications and variations of which will become apparent to those skilled in the art without departing from the spirit and scope of the disclosure.

[0053]

[0063] Reference to an example or implementation herein means that a particular feature, structure, operation, or other characteristic described in connection with the example may be included in at least one implementation of the disclosure. The disclosure is not limited to the particular example or implementation so described. The appearance of "in one example," "in an example," "in one implementation," or "in an implementation" in various places herein, or variations of the same kind, do not necessarily refer to the same example or implementation. Any particular feature, structure, operation, or other characteristic described herein in connection with one example or implementation may be combined with other features, structures, operations, or other characteristics described in connection with any other example or implementation.

[0054]

[0064] The use of the word "or" herein is intended to include an inclusive and exclusive OR condition, i.e., A or B or C includes any or all of the following combinations of the options, as appropriate for the particular use: A only, B only, C only, A and B only, A and C only, B and C only, and all three of A, B and C.

Claims

1. The main body, a set of PCB mounting features attached to the body and extending from one side of the body; a sensor guide opening on a side of the body, the body including a groove extending from the sensor guide opening and sized to receive a sensor; a conductive material extending between the groove and a distal end of a first PCB mounting feature of the set of PCB mounting features; A sensor holder device comprising: the sensor guide opening is configured to receive a first portion of the sensor and guide the first portion of the sensor under the body and within the groove; the groove is configured to retain a second portion of the sensor beneath the body; The conductive material is disposed within the groove for electrically coupling to the second portion of the sensor.

2. 2. The sensor holder device of claim 1, wherein the groove defines a first region having a first cross-sectional area and sized to accommodate the first portion of the sensor and a second region having a second cross-sectional area and sized to accommodate the second portion of the sensor, the first cross-sectional area being different from the second cross-sectional area.

3. The sensor holder device of claim 1 , wherein the sensor guide opening intersects the groove.

4. The sensor holder device of claim 1 , wherein the sensor holder device has a height measured from the body to the distal end of the first PCB mounting feature of no more than 3 mm.

5. The sensor holder device of claim 1 , wherein the body is formed from a first material using injection molding techniques.

6. A wearable monitoring device, comprising: a sensor having a distal portion and a proximal portion; a printed circuit board having a sensing circuit mounted thereon; a housing for containing the printed circuit board and the proximal portion of the sensor, the housing including a substantially flat bottom surface to allow the wearable monitoring device to be placed against human skin; a sensor holder contained within the housing and electrically and mechanically coupled to the printed circuit board, the sensor holder including a top surface and a bottom surface, the bottom surface facing toward the generally flat bottom surface of the housing of the wearable monitoring device; a groove in the bottom surface of the sensor holder, the proximal portion of the sensor being retained within the groove; an electrical contact associated with the groove that electrically connects with an electrode on the proximal portion of the sensor, the electrical contact being electrically coupled to the printed circuit board; Equipped with A wearable monitoring device, wherein the distal portion of the sensor is configured to extend into the human skin generally perpendicular to the generally flat bottom surface of the housing, and the sensor bends to extend generally horizontally within the groove within the housing.

7. The wearable monitoring device of claim 6 , wherein the sensor holder has a height of 3 mm or less.

8. The wearable monitoring device of claim 6 , wherein the sensing circuit includes a battery, and the height of the sensor holder is less than the height of the battery.

9. The wearable monitoring device of claim 6 , wherein the top surface of the sensor holder is configured to be grasped by a suction head of a robotic mounting device.

10. The wearable monitoring device of claim 6 , wherein the groove includes an end wall.

11. The wearable monitoring device of claim 10 , wherein the proximal end of the sensor is disposed adjacent the end wall.

12. The wearable monitoring device of claim 6 , wherein the sensor is retained in the groove by a snap fit.

13. The wearable monitoring device of claim 6 , wherein the housing includes an alignment feature in contact with the sensor holder.

14. A wearable monitoring device, comprising: a sensor having a distal portion and a proximal portion; a printed circuit board having a sensing circuit mounted thereon; a housing for containing the printed circuit board and the proximal portion of the sensor, the housing including a substantially flat bottom surface to allow the wearable monitoring device to be placed against human skin; a sensor holder housed within the housing and electrically and mechanically coupled to the printed circuit board; a groove in the sensor holder, the proximal portion of the sensor being retained within the groove; and an electrical contact associated with the groove that electrically connects with an electrode on the proximal portion of the sensor, the electrical contact being electrically coupled to the printed circuit board, the electrical contact including a tab that deflects laterally to receive and retain the sensor within the groove; A wearable monitoring device comprising:

15. 15. The wearable monitoring device of claim 14, wherein the sensor holder includes a top surface and a bottom surface, the bottom surface facing toward the generally flat bottom surface of the housing of the wearable monitoring device, and the groove of the sensor holder extending upward from the bottom surface of the sensor holder.

Images