Sensor holder device for invasive biosensors

Abstract

In some examples, a sensor holder apparatus is described. The sensor holder apparatus can 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 can be sized to accommodate a sensor wire. The electrical trace can extend proximate the sensor holding structure and along one leg.

Description

[0001] This application is a divisional application of Chinese patent application No. 201780073812.0, filed on November 28, 2017, entitled "Sensor Holder Device for Invasive Biosensors".

[0002] Cross-references to related applications

[0003] This application relates to and claims priority to U.S. Patent Application No. 15 / 362,955, filed November 29, 2016, entitled “SENSOR HOLDER DEVICE FORINVASIVE BIOSENSORS”, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This disclosure generally relates to invasive biosensors, and more specifically to means for supporting sensor wires of invasive biosensors. Background Technology

[0005] Invasive biosensors, such as those used in wearable glucose monitoring devices, include a thin wire that can be inserted into a patient's skin. Sensing circuitry reads biological information about the patient through this wire. Once the invasive biosensor is inserted into the patient's skin, the electrical connections between the wire and the circuitry remain exposed to potential moisture that can significantly affect the biosensor's performance. For example, many electrochemical-based sensors may have performance effects related to calibration offsets or increased noise floor levels due to current leakage caused by moisture within the electronic housing, and this is particularly true for biosensors included in wearable devices that may be exposed to sweat, weather, and other sources of moisture that human skin typically experiences. Furthermore, device size is always a practical consideration for wearable devices. To accommodate the necessary sensing circuitry, power supply, etc., to process biological information, wearable glucose monitoring devices may include multiple components connected together to form the working device. Using multiple components not only results in a bulky device but also creates multiple areas where moisture can enter (e.g., sealing between components). Summary of the Invention

[0006] Various examples of sensor holder devices for holding and supporting sensor wires of invasive biosensors are described. For example, one disclosed device may include a rigid body, a set of legs, a sensor guiding structure, and a groove formed in the rigid body, as well as an electrical trace. The set of legs may be attached to the rigid body and may extend from one side of the rigid body. The sensor guiding structure may be attached to the rigid body and may extend from said one side of the rigid body. The sensor guiding structure may define a guiding hole or guiding opening. The groove may be formed in the rigid body. The groove may extend from the sensor guiding structure and may be sized to accommodate the sensor wire. The electrical trace may extend between the groove and the distal end of a first leg of the set of legs.

[0007] Another disclosed device includes a wearable monitoring device. The wearable monitoring device may include a printed circuit board, sensing circuitry, and a sensor holder device. The printed circuit board may be housed within a housing having an outer surface for positioning the wearable monitoring device on a patient's skin. The sensing circuitry may include one or more electronic components coupled to the printed circuit board. The sensor holder device may include a body having a pair of legs, electrical traces, a sensor holding structure, and a sensor guiding 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 traces may extend along a first leg of the pair of legs to a first distal end of the first leg. The electrical traces may electrically connect the sensor wire to the printed circuit board. The sensor holding structure may be disposed on the body and may hold the proximal portion of the sensor wire close to the electrical traces. The sensor guiding structure may guide the distal portion of the sensor wire beyond the outer surface of the housing.

[0008] A disclosed system may include a sensor line and an interposer device. The sensor line may include a first portion that can be inserted into a patient's skin. The first portion may include devices for generating glucose information. The interposer device may include a sensor positioning device, a holding device, and a coupling device. The sensor positioning device may be used to position the sensor line such that an interposer needle can insert the first portion into the patient's skin. The holding device may be used to physically hold a second portion of the sensor line. The coupling device may be used to electrically connect the second portion of the sensor line to circuitry disposed on a printed circuit board for determining the patient's glucose level.

[0009] These illustrative examples are mentioned not to limit or restrict the scope of this disclosure, but to provide examples to aid in understanding it. Illustrative examples are discussed in the detailed description, which provides further description. The advantages offered by the various examples can be further understood by consulting this specification. Attached Figure Description

[0010] The accompanying drawings, which are included in and form part of this specification, illustrate one or more specific examples and, together with the description of the examples, serve to explain the principles and implementation methods of certain examples.

[0011] Figure 1 An exploded perspective view of an example of a monitoring device including a sensor holder device, according to at least one example, is shown.

[0012] Figure 2 A top perspective view of an example of a sensor holder device according to at least one example is shown.

[0013] Figure 3 A bottom perspective view of an example of a sensor holder device according to at least one example is shown.

[0014] Figure 4 A side sectional view of an example of a sensor holder device according to at least one example is shown.

[0015] Figure 5 A side sectional view of an example of a sensor holder device according to at least one example is shown.

[0016] Figure 6 A bottom perspective view of an example of a sensor holder device according to at least one example is shown.

[0017] Figure 7 A top perspective view of an example of a sensor holder device according to at least one example is shown.

[0018] Figure 8A An exploded perspective view of an example of a monitoring device including a sensor holder device, according to at least one example, is shown.

[0019] Figure 8B An exploded perspective view of an example of a monitoring device including a sensor holder device, according to at least one example, is shown.

[0020] Figure 8C An exploded perspective view of an example of a monitoring device including a sensor holder device, according to at least one example, is shown.

[0021] Figure 9 An exploded perspective view of an example of a monitoring device including a sensor holder device, according to at least one example, is shown. Detailed Implementation

[0022] This document describes an example within the context of a sensor holder device for a continuous monitoring apparatus. Those skilled in the art will recognize that the following description is illustrative only and is not intended to be limiting in any way. Implementations of the examples as illustrated in the accompanying drawings will now be discussed in detail. The same reference numerals will be used throughout the drawings and the following description to refer to the same or similar items.

[0023] For clarity, not all routine features of the examples described herein are shown or described. It should be understood, of course, that in the development of any such practical implementation, many implementation-specific decisions must be made to achieve the developer’s specific goals (such as compliance with application and business-related constraints), and these specific goals will vary between implementations and between developers.

[0024] In an illustrative example, a wearable glucose monitoring device includes a glucose sensor that can be inserted into a person's skin to continuously monitor their glucose levels. When worn, the wearable glucose monitoring device may be exposed to normal external forces caused by clothing, collisions with obstacles, and other external forces. To reduce the effects of these forces and improve wearer comfort, the footprint and profile of the glucose monitoring device can be reduced. In doing so, the glucose monitoring device described herein includes a sensor holder device. The sensor holder device has a unique shape that enables it to perform various functions while also efficiently utilizing space within the glucose monitoring device. The unique shape is defined by a body supported by legs that extend from the body to form a gap beneath the body. The legs connect to a printed circuit board (“PCB”) beneath the body and serve to separate the body from the PCB. Components of the glucose monitoring device, such as integrated circuits and / or other sensing circuitry, can be mounted beneath the body, within the gap. In this way, the sensor holder device provides efficient use of space within the glucose monitoring device (e.g., allowing for stacking of components and reducing the overall footprint of the device).

[0025] 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 toward the skin, and electrically connecting the electrodes to the PCB. The sensor holder device structurally supports the electrodes via recesses in which the electrodes are placed. The sensor wires are aligned via either a cylindrical opening or abutment against a leg, either of which extends from the body of the sensor holder device toward the underside of the device. The electrodes are electrically connected via electrical traces formed in the surface of the sensor holder device. The electrical traces may extend between the recesses and downward along the leg to the PCB. Although the sensor holder device is described herein with reference to a glucose monitoring device, it should be understood that the sensor holder device can be implemented to support any suitable electromechanical sensor.

[0026] Now turn to the attached image. Figure 1 A monitoring device 100 according to at least one example is shown. The monitoring device 100 includes a sensor holder device 102 and a biosensor 104, such as a glucose sensor or other electromechanical sensor, for sensing a patient's biological information. The biosensor 104 includes a sensor line 106, sensing circuitry 108, a power source 110 such as a battery, a printed circuit board (“PCB”) 112, and an antenna 114. The sensor line 106 includes a proximal portion 106a and a distal portion 106b. The proximal portion 106a is supported by the sensor holder device 102. For example, the proximal portion 106a may be disposed within a recess or channel of the sensor holder device 102. The proximal portion 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 traces 116a, 116b extending toward the PCB 112 near a central region of the sensor holder device 106. In use, the distal portion 106b is injected into the patient's skin to measure biological parameters (e.g., glucose levels) in the interstitial fluid of the subcutaneous tissue beneath the skin.

[0027] The monitoring device 100 also includes a moisture barrier 118 disposed between a top housing 120 (e.g., a cap) and a bottom housing 122. During assembly, the moisture barrier 118 can form a seal that prevents moisture from penetrating the biosensor 104. During assembly, the top housing 120 surrounds the biosensor 104 and the sensor holder assembly 102 and mates with the bottom housing 122. The bottom housing 122 includes an opening 124 through which the distal portion 106b passes during installation. The PCB 112 may include a corresponding opening through which the distal portion 106b passes. On the opposite side shown, the bottom housing 122 may include a substantially flat surface to allow the monitoring device 100 to be placed on human skin.

[0028] The sensor holder device 102 may be suitably rigid to support the sensor line 106 and provide structural support for 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, in addition to the FPCB 112, attaching the sensor holder device 102 to the PCB 112 may increase the rigidity of the entire monitoring device 100.

[0029] The sensor retainer device 102 can be considered an inserter device. For example, because the sensor retainer device 102 is detached from the PCB 112 and can stand above components positioned below it (e.g., sensing circuitry 108, power supply 110, etc.), the sensor retainer device 102 saves space in the monitoring device 100. This results in a smaller footprint for the monitoring device 100. Additionally, due to the configuration of the sensor retainer device 102 relative to the PCB 112, the PCB 112 can be placed close to the user's skin, unlike other monitoring devices that include a standoff fixture. This provides improved wearer comfort and a smaller overall device size.

[0030] Sensor line 106 may include one or more electrodes, chemicals, or other devices for generating biological information. For example, sensor line 106 may be a coaxial sensor and include two electrodes 123, 125 inserted into human skin to expose the electrodes 123, 125 to interstitial fluid in the subcutaneous tissue. Electrode 123 includes at least a portion of sensor line 106 made of platinum or having a platinum coating, and electrode 125 includes a silver / silver chloride (“Ag / AgCl”) material covering a portion of electrode 123. Electrodes 123, 125 can be used to generate glucose information about a patient by producing an electrical signal corresponding to the amount of glucose present in the interstitial fluid. In some examples, a reactive material, such as glucose oxidase (“GOX”), may also be coated on the distal end of electrode 123 to produce reaction products 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 produced by the glucose / GOX reaction. The current is transmitted through sensor line 106 to sensing circuitry 108. Sensing circuit 108 can use the intensity of current to determine glucose information, such as a patient's glucose level. Although glucose level measurement is described in this example, biosensor 104 can be configured to measure other biological parameters without departing from the scope of this disclosure. Similarly, while the chemical materials applied to sensor lines 106 to form electrodes 123, 125 and the reactive materials coated on electrodes 123, 125 are suitable for a glucose sensor, other materials may be used based on the application of biosensor 104 according to other examples.

[0031] The length of the sensor wire 106 allows it to extend from under the skin to the sensor holder device 102 while allowing for patient movement. For example, the sensor wire 106 can be approximately 10 mm to 30 mm long. The thickness or gauge of the sensor wire 106 can be selected to allow it to remain injected into the skin during this period with minimal discomfort. In some examples, the sensor wire 106 includes an outer diameter of approximately 100-200 micrometers for the portion of the wire coated with electrode 125 and approximately 100 micrometers for the portion coated with electrode 123. In other examples, the sensor wire 106 may typically have a maximum outer diameter of approximately 100 to 300 micrometers. However, in some examples, the sensor wire 106 may have an outer diameter of approximately 50 micrometers.

[0032] In some examples, sensing circuit 108 includes one or more electronic components configured for signal processing. For example, sensing circuit 108 may include a system-on-a-chip (“SOC”) or system-in-package (“SIP”) comprising any suitable combination of components for digital signal processing, analog signal processing, mixed signal processing, and / or the like that may be present on the surface of a PCB assembly or embedded therein. These components may include, for example, a microcontroller, memory, timing sources, one or more digital interfaces, one or more analog interfaces, voltage regulators, and / or any other suitable components. Sensing circuit 108 may be configured to receive electrical signals from sensor line 106 (e.g., via PCB 112 and trace line 116) and process the electrical signals to determine the patient’s glucose level.

[0033] 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 can execute computer-executable program instructions stored in the memory, for example, 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 devices for processing electrical signals received from the electrodes 123, 125 of the sensor line 106. Such processing devices may also include programmable electronic devices such as 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.

[0034] The processing apparatus may include or be able to communicate with a medium (e.g., a computer-readable storage medium) that may store instructions that, when executed by the processing apparatus, cause the processing apparatus to perform the steps described herein that are performed or assisted by the processing apparatus. Examples of computer-readable media may include, but are not limited to, memory chips, ROM, RAM, ASICs, or any other storage device from which the processing apparatus can read or write information.

[0035] The top housing 120 and the bottom housing 122 together form a housing for retaining the biosensor 104. The housing can be compact in size for placement on human skin. The housing can be made of any suitable material for housing the biosensor 104. Non-limiting examples of materials suitable for the housing include silicone, polyethylene, polyvinyl chloride (“PVC”), polypropylene, nylon, polyurethane, polycarbonate, steel, aluminum, and other plastics and metals. The monitoring device 100 can be secured to the skin using adhesives, straps, strips, or other fastening devices. In some examples, the monitoring device 100 can be worn for extended periods (e.g., days, weeks, months, etc.).

[0036] Figure 2 and Figure 3 Top and bottom perspective views of a sensor holder assembly 102 according to certain examples are shown. The sensor holder assembly 102 is a molded interconnect device that may include a body 126 and a set of legs 128, some of which are shown (e.g., 128a, 128b). The body 126 may include a substantially flat top side region (e.g., greater than 1 square millimeter). This top side region may be appropriately sized and flattened to allow the suction head of a robot placement device (e.g., a pick-and-place device) to grip the sensor holder assembly 102. For example, the top side region may be located near the peripheral edges of the holding structure 132 and the body 126. When the holding structure 132 is positioned on the underside of the body 126 (e.g., as shown in the image), the top side region may be positioned on the underside of the body 126. Figure 6 As shown, the top side region can be located at any suitable position along the top side of the body 126. Therefore, when the retaining structure 132 is disposed on the underside of the body 126, the top side region can be larger. This can result in the suction head being able to pick up the sensor holder device 102 at a more suitable position compared to the example where the retaining structure is disposed on the top side of the body 126.

[0037] In some examples, the sensor holder device 102 may have a height of approximately 3 mm, a width of approximately 15 mm, and a length of approximately 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 approximately 3 mm height can be selected to be less than the height of the power supply 110. The approximately 3 mm height can also provide suitable spacing between the proximal end of the sensor line 106b and the sensing circuit 108 and other electronic components attached to or otherwise disposed within the PCB 112.

[0038] 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 are shown (e.g., 130a-130c). 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 and second planes to connect the body 126 to the set of feet 130. The body 126 may be oriented in the first plane when the main portion of the body 126 is located in the first plane. The set of feet 130 (e.g., the distal ends of the set of legs 128) may be oriented in the second plane when the majority of the set of feet is located in the second plane. In some examples, the feet 130 may include weld rings 131, some of which are shown (e.g., 131a-131c). The sensor holder assembly 102 can be electrically and structurally attached to a PCB (e.g., PCB 112) or other structure using a solder ring 131. For example, an electrical trace 116 that begins in the body 126 and extends along the leg 128 and into the foot 130 can be electrically connected to the PCB 112 via the solder ring 131. In some examples, the foot 130 is attached to the PCB 112 using surface mount technology.

[0039] The sensor holder device 102 can be formed in any suitable manner, including, for example, injection molding or other suitable techniques. The sensor holder device 102 can be formed as a single piece, comprising at least a body 126, legs 128, feet 130, and / or a sensor holding structure 138. The sensor holder device 102 can be formed from any suitable material, including, for example, liquid crystal polymers (e.g., RTP 3499-3X 113393A sold by RTP Corporation, and [other materials sold by Ticon]). Materials include E840i LDS, high-temperature nylon, polyetheretherketone (“PEEK”), and other similar materials. In some examples, the material chosen for the sensor holder device 102 may be non-conductive, weld-compatible, have low hygroscopicity, low water vapor permeability, and be easily molded into very thin walls. In some examples, the material chosen for the sensor holder device 102 may be capable of laser direct fabrication (“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 higher density material may allow for a thinner sensor holder device 102, while a lower density material may require a thicker sensor holder device 102).

[0040] The sensor holder assembly 102 also includes a sensor holding structure 132 disposed in the top surface of the body 126. In this example, the sensor holding structure 132 may include a groove (e.g., having a U-shaped, V-shaped, or other cross-section) sized to receive the sensor line 106 (shown in dashed lines). In addition to or instead of a groove, the sensor holding structure 132 may include any suitable combination of tabs, hooks, springs, etc., configured to hold the sensor line 106. In some examples, the sensor holding structure 132 may be used to align the sensor line 106 during assembly. For example, the proximal portion 106a of the sensor line 106 may contact the end wall 134 near a first region 136a of the sensor holding structure 132. This allows the sensor line 106 to be aligned in the lateral direction. Similarly, because the sensor line 106 can sit within the sensor holding structure 132, the sensor holding structure 132 can be aligned in the lateral direction.

[0041] In some examples, the sensor holding structure 132 may be defined to include a first region 136a and a second region 136b. A trace 116a may be near the first region 136a and, in some examples, extend within the first region 136a. Similarly, a trace 116b may be near the second region 136b and, in some examples, extend within the second region 136b. In some examples, a first-dimensional measurement (e.g., width, depth, cross-sectional area, etc.) laterally intercepted across the sensor holding structure 132 in the first region 136a may differ from a second-dimensional measurement laterally intercepted across the sensor holding structure 132 in the second region 136b. These differences may be included in the sensor holding structure 132 to accommodate electrodes 123, 125. As described herein, electrodes 123, 125 may have different dimensions (e.g., different diameters). Different lateral measurements may be selected based on the corresponding width of the proximal end of the sensor line at different 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 specification than another portion of the platinum wire that includes a silver / silver chloride electrode 125.

[0042] In some examples, the sensor holder device 102 may include other components (e.g., electronics, antennas, etc.) attached to or otherwise formed in the body 126 and / or legs 128. For example, the antenna may be printed on the body 126 and electrically connected to other electronics (e.g., electronics attached to the sensor holder device 102, sensing circuit 108, and / or PCB 112) via one or more traces (e.g., trace 116).

[0043] In some examples, the sensor holder device 102 may include any suitable number of traces 116 to support any suitable number of electrodes. For example, two traces 116a, 116b may extend along leg 128a (e.g., on the same side or opposite side of leg 128a). In this example, other traces 116 may extend along other legs 128 of the sensor holder device 102. For example, two or more traces 116 may extend along each of legs 128a-128c. In some examples, at least one of the traces 116 may serve as a protective trace to reduce current leakage from one or more other traces 116.

[0044] The electrical traces 116a, 116b can be formed in 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, and gold in circuit patterns. These techniques may include electroless copper plating. For example, these techniques may include using materials made of... Sales The technologies used in LDS AG-600 include traces 116a and 116b, which may have a thickness of approximately 1 micrometer. In some examples, traces 116a and 116b have a thickness of less than 1 micrometer (e.g., 0.25 to 0.5 micrometers).

[0045] Electrodes 123, 125 can be electrically connected to traces 116a, 116b in any suitable manner. For example, once electrodes 123, 125 are placed in sensor holding structure 132, conductive voltage-sensitive adhesive (“PSA”) or other conductive adhesive can be applied to electrodes 123, 125. The conductive adhesive can form independent electrical connections between electrodes 123, 125 and traces 116a, 116b. In some examples, the conductive adhesive can be in any suitable form, such as liquid, film, tape, etc. Examples of suitable materials include conductive adhesive transfer tape (“ECATT”) sold by 3M and by Adhesives. Sales Branded PSAs such as 8001-75, 8001-77, 9032, or 9032-70 are... Sold Supreme 10HTFN or any other suitable material. This conductive adhesive can be considered a "fast-curing" epoxy, polyurethane, B-stage film, etc.

[0046] The sensor holder assembly 102 also includes a sensor guide structure 138. The sensor guide structure 138 is attached to the body 126 and extends away from the body 126 in a direction substantially the same as the leg 128. The sensor guide structure 138 can be attached to the body 126 by being formed directly from it. Alternatively, the sensor guide structure 138 can be attached to the body 126 by being formed as a separate component and connected to it. The sensor guide structure 138 may include an opening or hole 140 through which the sensor wire 106 can pass. The hole 140 can have any suitable shape, such as cylindrical, conical, rectangular, etc. Therefore, the cross-section of the hole 140 can vary relative to its depth.

[0047] Like foot 130, sensor guide structure 138 can be attached to PCB 112 using surface mount technology. For example, sensor guide structure 138 may include solder ring 142, which creates a hermetically tight seal between sensor guide structure 138 and PCB 112 during solder reflow. During manufacturing, sensor wire 106 may pass through PCB 112 and hole 140 before being bent into place within sensor retaining structure 132.

[0048] In some examples, the potting material 144 can be positioned near the sensor line 106 within the hole 140, such as... Figure 2 As shown. For example, potting material 144 may be injected onto the top and around sensor line 106 to fill sensor line 106 into hole 140. In some examples, potting material 144 may include a non-conductive material to prevent short circuits in sensor line 106. Potting material 144 may provide moisture protection for the electrical connection between trace 116 and electrodes 123, 125. Non-limiting examples of potting material 144 include epoxy resin, wax, silicone resin, acrylic resin, polyurethane, or other devices for providing moisture protection. Although potting material 144 is shown as being positioned only near sensor line 106, potting material 144 may be applied to coat other components of sensor holder device 102.

[0049] In some examples, a moisture seal 146 may be formed along the top side surface of the sensor holder assembly 102. The moisture seal 146 may serve as a moisture barrier between the body 126 and the top housing 120. The moisture seal 146 may be formed by seaming the top housing 120 to the body 126, with the sensor holding structure 132 disposed within the moisture seal 146. For example, a portion of the body 126 may be melted together with a portion of the top housing 120, or a moisture-proof adhesive may be applied to the body 126 prior to mounting the top housing 120. In some examples, the adhesive may be pressure-activated and ready when an installation force is applied to the top housing 120 to mount it onto the body 126.

[0050] Figure 4 and 5 An example of a sensor holder device 102 according to certain examples is shown. Figure 4 As shown, during the insertion of the distal portion 106b into the skin 141 of a person, the hole 140 or a separate opening intersecting with the hole 140 can be used to align the subcutaneous insertion needle 148 (not shown) of the sensor insertion tool. For example, placing the insertion needle 148 in the hole 140 (with the monitoring device 100 pressed against the skin 141 of the person) can achieve proper alignment of the insertion needle 148 to insert the sensor wire 106 into the skin 141 of the person.

[0051] Although Figure 3 and Figure 4 The sensor guide structure 138 is shown extending substantially orthogonally away from the body 126; however, it should be understood that the sensor guide structure 138 may be connected to the body 126 at any other suitable angle and / or may include other openings. For example, as Figure 5As shown, the sensor guiding structure 138 may also include a sensor hole 150. In this example, hole 140 can be considered as a guide hole for receiving, guiding, and aligning the insertion pin 148. Alternatively, sensor hole 150 can be used to guide sensor wire 106 from body 126 to a location beyond PCB 112. In some examples, the angle between sensor hole 150 and hole 140 can help stabilize sensor wire 106 in insertion pin 148 during insertion. For example, passing sensor wire 106 through sensor hole 150 can cause sensor wire 106 to press upward against insertion pin 148.

[0052] Figure 6 An example of a sensor holder device 102 according to at least one example is shown, which includes a sensor holding structure 132 (e.g., a groove or similar structure described herein) disposed on the underside of a body 126. Thus, in this example, the sensor wire 106 is held on the underside of the body 126 by the sensor holding structure 132. In some examples, placing the sensor wire 106 on the underside of the body 126 can result in additional mechanical protection (e.g., provided by the sensor holder device 102) and additional moisture protection (e.g., preventing moisture from further entering the monitoring device 100). Additionally, placing the sensor wire 106 on the underside of the body 126 can result in reduced manufacturing costs and increased yield. For example, because all 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 during manufacturing.

[0053] In the illustrated example, the sensor holder assembly 102 includes electrical traces 116c-116e also disposed on the underside of the body 126. Electrical traces 116c-116e are examples of electrical traces 116a and 116b. In some examples, each of the electrical traces 116c-116e corresponds to an electrode of the sensor line 106. In other examples, electrical trace 116d may be a protective trace, which may be installed in the sensor holder assembly 102 to reduce current leakage between electrical traces 116c and 116e. In some examples, the sensor holder assembly 102 may also include an isolation groove 149. The isolation groove 149 may be formed in the sensor holder assembly 102 to reduce current leakage between electrical traces 116. In some examples, the isolation groove 149 may be filled with a potting material (e.g., petrolatum, paraffin wax, cryogenic silicone, etc.) to provide additional electrical protection against leakage current.

[0054] In the illustrated example, the sensor guiding structure 138 may be defined by one of the legs 128. Therefore, instead of including a separate structure, the sensor guiding structure 138 may be defined by a leg 128d, which includes a contoured shape with a guide opening 151. The guide opening 151 is used to guide the sensor wire 106 from the body 126 to the underside of the sensor holder device 100. The guide opening 151 may be defined 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 a guide hole 140. In any case, the leg 128d including the guide opening 151 can guide the sensor wire 106 from the sensor holder structure 132 to the underside of the sensor holder device 100. In this example, an insertion needle 148 may be inserted through the guide opening 151 to cross the sensor wire 106 as part of inserting the sensor wire 106 into a person's skin.

[0055] Figure 7 An example of a sensor holder device 102 including a sensor holding structure 132 according to at least one example is shown. Figure 7 The sensor holding structure 132 shown includes a set of tabs 152 (e.g., 152a-152d) configured to hold and align the sensor line 106. The tabs 152 may be appropriately spaced to receive and hold the sensor line 106 via a snap-fit ​​engagement. For example, the tabs 152 may include grooves formed on their inward-facing surfaces. Additionally, the tabs 152 may be configured to laterally deflect in response to a downward force. For example, during installation, a downward force may be applied to the sensor line 106 in the direction of the top surface of the body 126, accompanying alignment of the sensor line between the tabs 152a, 152b and 152c, 152d. This downward force may cause the tabs 152 to laterally deflect slightly to receive the sensor line 106, at least until the sensor line 106 reaches the grooves formed on the inward-facing surfaces of the tabs 152.

[0056] like Figure 7 As shown, 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 way, the electrical connection between the electrical trace 116 and the sensor line 106 may be formed within the inward-facing surface of the tab 152.

[0057] As described herein, in some examples, the sensor holding structure 132 may include a hook 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 variation of the sensor holding structure 132 described herein may be used in conjunction with the PSA described herein.

[0058] Figures 8A-8C Exemplary monitoring devices 800a-800c, including various sensor holder devices 802a-802c according to certain examples, are shown. Monitoring device 800 is an example of monitoring device 100 described herein. Thus, monitoring device 800 may include a top housing 820, a biosensor 804, a PCB 812, a bottom housing 822, and sensor lines 806.

[0059] exist Figure 8A In the example shown, the sensor holder device 802a can be aligned relative to other components of the biosensor 804a such that the sensor line 806a extends through an internal region of the biosensor 804a. For example, the sensor line 806a can extend through an opening in the PCB 812a within an internal region of the PCB 812a. The housing opening 824a of the bottom housing 822a can correspond to an opening in the PCB 812a.

[0060] exist Figure 8B In the example shown, the sensor holder device 802b can be aligned relative to other components of the biosensor 804b such that the sensor line 806b extends through an external region of the biosensor 804b. For example, the sensor line 806b can extend through a PCB opening 854b located in an external region of the PCB 812b. The housing opening 824b of the bottom housing 822b can correspond to the PCB opening 854b.

[0061] exist Figure 8C In the example shown, the sensor holder device 802c can be aligned relative to other components of the biosensor 804c such that the sensor line 806c extends near the outer periphery of the biosensor 804c. For example, the sensor line 806c may extend near the peripheral edge 856c of the PCB 812c. In some examples, the peripheral edge 856c may include a cut-off portion 858c to accommodate the sensor line 806c. The bottom housing 822c may include a corresponding cut-off portion 860c.

[0062] Figure 9 A monitoring device 900 according to at least one example is shown. Monitoring device 900 is an example of monitoring device 100. Therefore, monitoring device 900 may include a sensor holder device 902, a biosensor 904, and a top housing 920. Figure 9In the example shown, features of the sensor holder device 902 can be used to align the top housing 920 with other parts of the monitoring device 900. For example, the legs 928 and / or feet 930 of the sensor holder device 902 may correspond to alignment notches 962 in the top housing 920. During installation, the top housing 920 may contact the sensor holder device 902 such that the legs 928 are received into the alignment notches 962. In some examples, the alignment using the alignment notches 962 and the alignment of portions of the sensor holder device 902 can result in a tighter fit between the top housing 920 and other parts of the monitoring device 900. This could be due to tighter manufacturing tolerances in the sensor holder device 902 (e.g., + / - 15 micrometers), which may result in a better overall fit.

[0063] Alternatively, the top housing 920 can be aligned with the peripheral edge of the PCB 912. Typically, the PCB 912 will be die-cut, which can have relatively high tolerances (e.g., + / - 200 microns). This can result in a looser fit compared to alignment using the alignment notch 962 and legs 928.

[0064] The foregoing description of some examples is presented for illustrative and descriptive purposes only and is not intended to be exhaustive or to limit this disclosure to its precise form. Many modifications and adaptations thereto will be apparent to those skilled in the art without departing from the spirit and scope of this disclosure.

[0065] References to examples or embodiments herein mean that a particular feature, structure, operation, or other characteristic described in connection with that example may be included in at least one embodiment of this disclosure. This disclosure is not limited to the particular examples or embodiments described herein. The phrases “in one example,” “in an example,” “in one embodiment,” or “in one embodiment,” or variations thereof, appearing in various places throughout the specification, do not necessarily refer to the same example or embodiment. Any particular feature, structure, operation, or other characteristic described in this specification with respect to one example or embodiment may be combined with other features, structures, operations, or other characteristics described with respect to any other example or embodiment.

[0066] The word “or” as used in this article is intended to cover both inclusive and exclusive OR conditions. In other words, A or B or C includes any or all of the following alternative combinations suitable for a particular purpose: A alone; B alone; C alone; A and B only; A and C only; B and C only; and all three A and B and C.

Claims

1. A sensor holder device, comprising: ontology; A set of legs, which are attached to the body and extend from one side of the body; A sensor guiding structure is attached to the body and extends from said side of the body, the sensor guiding structure defining a guiding hole or guiding opening; A groove that extends from the sensor guiding structure and is sized to accommodate sensor wires; as well as Electrical traces, which electrically connect the groove to the distal end of the first leg of the set of legs; in: The guiding structure is configured to receive the first portion of the sensor line and guide the first portion of the sensor line below the body; The groove is configured to hold the second portion of the sensor line; and The electrical trace is positioned to be electrically connected to the second part of the sensor line.

2. The sensor holder device according to claim 1, wherein, The groove is formed on one side of the body or on the side of the body opposite to the stated side.

3. The sensor holder device according to claim 1, wherein, The groove defines: A first region having a first cross-sectional area and dimensions suitable for accommodating a first portion of the sensor line; as well as The second region has a second cross-sectional area and is sized to accommodate a second portion of the sensor line, the first cross-sectional area being different from the second cross-sectional area.

4. The sensor holder device according to claim 1, wherein, The guide hole intersects with the groove and terminates at the far end of the sensor guide structure located below the body.

5. The sensor holder device according to claim 4, wherein: The body is oriented in the first plane; and The distal end of the sensor-guided structure and the distal end of the first leg are oriented in a second plane, which is different from the second plane.

6. The sensor holder device according to claim 1, wherein, The height of the sensor holder device measured from the body to the distal end of the first leg is 3 mm or less.

7. The sensor holder device according to claim 1, wherein, The body includes a top surface adapted to grasp the sensor holder device via the suction head of a robotic placement device.

8. The sensor holder device according to claim 1, wherein: The body, the set of legs, the sensor guiding structure, and the groove are formed from a first material using injection molding technology; and The electrical traces are formed using laser direct structuring technology, and the electrical traces include a second material.

9. A wearable monitoring device, comprising: A printed circuit board, housed in a housing with an outer surface, is used to position a wearable monitoring device on a patient's skin. A sensing circuit, which includes one or more electronic components connected to a printed circuit board; as well as Sensor holder device, comprising: A pair of legs, which are attached to the body and extend from one side of the body; A sensor guiding structure is attached to the body and extends from said side of the body, the sensor guiding structure defining a guiding hole or guiding opening; A groove, extending from the sensor guiding structure and sized to accommodate a sensor line; and Electrical traces, which electrically connect the groove to the distal end of the first leg of the pair of legs; in: The guiding structure is configured to receive the first portion of the sensor line and guide the first portion of the sensor line below the body; The groove is configured to hold the second part of the sensor line; and The electrical trace is positioned to be electrically connected to the second part of the sensor line.

10. The wearable monitoring device according to claim 9, wherein, The housing includes a cover that encloses the sensing circuitry and the sensor holder device.

11. The wearable monitoring device according to claim 10, wherein, The cover includes a set of alignment notches disposed within the cover, the set of alignment notches corresponding to the pair of legs, and when the cover is mounted on the wearable monitoring device, the set of alignment notches aligns the cover with the sensor holder device.

12. The wearable monitoring device of claim 10 further includes a moisture-proof element formed between the top surface of the body and the cover.

13. The wearable monitoring device according to claim 12, wherein, The moisture-proof component is formed by seam welding.

14. The wearable monitoring device according to claim 9, wherein, The sensor line includes a first electrode and a second electrode.

15. The wearable monitoring device according to claim 14, wherein: The electrical trace is a first electrical trace that electrically connects the first electrode to the printed circuit board; and The sensor holder device also includes a second electrical trace extending along the second leg of the pair of legs to a second distal end of the second leg, the second electrical trace electrically connecting the second electrode to a printed circuit board.

16. The wearable monitoring device according to claim 14, wherein: The electrical trace is a first electrical trace that electrically connects the first electrode to the printed circuit board; and The sensor holder device also includes a second electrical trace extending along the first leg, which electrically connects the second electrode to the printed circuit board.

17. The wearable monitoring device according to claim 9, wherein, The sensor retaining structure is set on the first surface of the body near the printed circuit board.

18. The wearable monitoring device according to claim 9, wherein, The sensor holder device is physically attached to the printed circuit board at an attachment location via a sensor guide structure, the attachment location including an airtight seal between the sensor guide structure and the printed circuit board.

19. The wearable monitoring device according to claim 9, wherein, The sensor guiding structure defines a guide hole, the guide hole including a potting material disposed in the guide hole, the potting material passing through at least a portion of the guide hole around an extension of the sensor line.

20. The wearable monitoring device according to claim 9, wherein: The sensor guiding structure defines a guide hole, along which a sensor line extends, with its distal portion extending through an opening in a printed circuit board located below the guide hole. and The opening is defined within the internal area of ​​the printed circuit board or the external area of ​​the printed circuit board.

21. The wearable monitoring device according to claim 9, wherein: The sensor guiding structure defines a leg, the leg including a guiding opening, a sensor line extending along the leg and through the guiding opening, and a distal portion of the sensor line extending through an opening in a printed circuit board disposed below the guiding opening. and The opening is defined within the internal area of ​​the printed circuit board or the external area of ​​the printed circuit board.

22. The wearable monitoring device according to claim 9, wherein, The sensor guiding structure defines a leg, which includes a guiding opening. A sensor line extends along the leg and through the guiding opening, with a distal portion of the sensor line extending close to the peripheral edge of the printed circuit board.

23. The wearable monitoring device according to claim 9, wherein, The sensor guiding structure defines a guide hole, the size of which is adapted to receive an insertion needle for inserting the distal portion of the sensor wire into the patient's skin.

24. The wearable monitoring device according to claim 23, wherein, The sensor guiding structure defines a sensor hole that intersects the guide hole at an angle, and the size of the sensor hole is suitable for receiving sensor lines.

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