Wearable continuous analyte measurement device, biosensor inserter, and method of use

Abstract

A continuous analyte monitor wearable device, the wearable device including at least a primary portion including a sensor assembly including a biosensor, a secondary portion including a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening including an adhesive on an edge thereof, and a backing member provided over the adhesive, where removing the backing member exposes the adhesive, seals the sealable opening, and encapsulates the transmitter unit. A biosensor inserter and a method of using the biosensor inserter are also provided.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 140,180 filed on January 21, 2021, the disclosure of which is hereby incorporated herein in its entirety by reference for all purposes.

[0002] Technical Field The present disclosure relates to a wearable continuous analyte measurement (CAM) device and a biosensor inserter configured to insert a biosensor of the wearable CAM device. See the following prior art applications, namely, European Patent Application Publication No. 2636372 by Neinast et al. and U.S. Patent Application No. 2018 / 116570 by Simpson et al.

Background Art

[0003] Continuous glucose monitoring using a continuous glucose monitor (CGM) or the like has become a routine sensing operation for detecting blood glucose, particularly in connection with diabetes treatment. By providing real-time glucose monitoring that delivers glucose concentration readings over time, therapeutic actions such as insulin uptake or other actions can be performed in a timely manner, and blood glucose status can be better controlled.

[0004] During CGM operation, the biosensor of the transmitter and sensor assembly is inserted subcutaneously and operates continuously in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor inserted under the skin provides signals to the transmitter of the transmitter and sensor assembly, which signals can indicate, for example, the patient's blood glucose level. These measurements may be performed intermittently and automatically many times throughout the day (e.g., every few minutes, or at any other suitable interval).

[0005] The transmitter and sensor assembly are attached to the outer surface of the user's skin, such as on the abdomen or the back of the upper arm, while the biosensor is inserted through the skin to make contact with the ISF. This skin insertion process may be referred to as "insertion." The device used to perform this biosensor insertion may be referred to as a "biosensor inserter." [Overview of the Initiative]

[0006] In some embodiments, a CAM wearable device is provided configured to measure the concentration of an analyte. The CAM wearable device includes at least a primary part comprising a sensor assembly having a biosensor, and a secondary part comprising a pocket configured to receive a transmitter unit and a sealable opening into the pocket, wherein the sealable opening contains an adhesive on its edge, and a backing member provided across the adhesive, wherein removing the backing member exposes the adhesive, seals the sealable opening, and encloses the transmitter unit.

[0007] In some embodiments, a biosensor inserter is provided that is configured to insert a biosensor of a wearable device. The biosensor inserter includes a pushing member, a contact member that is translatable relative to the pushing member, and a relief portion formed within the pushing member or the contact member, the relief portion being configured to allow a secondary portion of the wearable device to be folded into the relief portion.

[0008] In a further embodiment, a method is provided for using a biosensor inserter to insert a biosensor in a wearable device. The method provides a biosensor inserter comprising: a pushing member; a contact member translatable relative to the pushing member; a trocar assembly including a trocar; a relief portion formed in the pushing member or the contact member, the relief portion being configured to allow a secondary portion of a wearable device to be folded into the relief portion; and a mechanism configured to translate the wearable device and insert the trocar, comprising: folding the secondary portion of the wearable device into the relief portion; bringing the contact member into contact with human skin; pushing the pushing member for a first portion of a stroke to cause translation and embedding of the trocar and biosensor; and continuing to push the pushing member for a second portion of a stroke to retract the trocar assembly into the mechanism while keeping the biosensor embedded.

[0009] Other features, aspects, and advantages of the embodiments of this disclosure will become more fully apparent from the following detailed description, claims, and accompanying drawings by illustrating some exemplary embodiments. Various embodiments of this disclosure may also be capable of other different uses, and their multiple details are all covered in the claims. of It may be modified in various ways without deviating from its scope. Therefore, the explanation should be considered essentially illustrative, not restrictive. [Brief explanation of the drawing]

[0010] Drawings should be considered illustrative, not restrictive. Drawings are not necessarily drawn to scale. Similar figures are used throughout the drawing to represent similar elements. [Figure 1A] This is a side perspective view of a biosensor inserter, including an open door that allows insertion of a wearable device, according to one or more embodiments provided herein. [Figure 1B]This is a side perspective view of a biosensor inserter, including a closed door that allows a wearable device to be folded into a recess of the biosensor inserter, according to one or more embodiments provided herein. [Figure 2A] This is a perspective view of a wearable device having a removable and reusable transmitter unit that is inserted into and sealed in a pocket, according to one or more embodiments provided herein. [Figure 2B] This is a perspective view of a wearable device having a removable transmitter unit installed in a pocket, according to one or more embodiments provided herein, showing various internal components and hinges that enable local bending, and thus folding, of the wearable device. [Figure 2C] This is a perspective view of a circuit board of a wearable device having a pogo pin type electrical connector configured to electrically couple with a transmitter unit in a pocket, according to one or more embodiments provided herein. [Figure 2D] This is a perspective view of a wearable device according to one or more embodiments provided herein, showing a pocket and opening configured to receive a transmitter unit. [Figure 2E] This is a perspective view of a wearable device according to one or more embodiments provided herein, showing a pocket and the inclusion of adhesive on the edge of the opening to the pocket. [Figure 2F] This is a perspective view of a wearable device showing the addition of a backing member on top of an adhesive in an opening, according to one or more embodiments provided herein. [Figure 3A] This is a side cross-sectional view of a biosensor inserter showing a wearable device inserted into a receiver of a transmitter carrier, according to one or more embodiments provided herein. [Figure 3B] This is a side cross-sectional view of a biosensor inserter showing folding / bending around a hinge of a wearable device and closing of a door, according to one or more embodiments provided herein. [Figure 3C]This is a cross-sectional side view of a biosensor inserter, showing the translation of a trocar assembly for receiving a biosensor in an open groove therein, according to one or more embodiments provided herein. [Figure 3D] This is a cross-sectional side view of a biosensor inserter, showing translation of a trocar assembly for inserting a trocar and biosensor into the user's skin, according to one or more embodiments provided herein. [Figure 3E] This is a cross-sectional side view of a biosensor inserter, showing the retraction of a trocar assembly for leaving a biosensor inserted into the user's skin, according to one or more embodiments provided herein. [Figure 3F] This is a cross-sectional side view of a biosensor inserter, illustrating the separation of a biosensor inserter and a wearable device according to one or more embodiments provided herein. [Figure 3G] This is a perspective side view of a trocar assembly and a sensor assembly, showing the screwing and insertion of a biosensor into a side-open groove of the trocar according to one or more embodiments provided herein. [Figure 3H] This is a perspective side view of a trocar assembly and a sensor assembly showing a biosensor inserted into an open side groove of a trocar, according to one or more embodiments provided herein. [Figure 4] This is a perspective view of a biosensor inserter showing the insertion of a transmitter unit into the pocket of a wearable device according to one or more embodiments provided herein. [Figure 5] This is a perspective view of a biosensor inserter according to one or more embodiments provided herein, showing the removal of a backing member to expose the adhesive and thus enable sealing of the opening to the pocket. [Figure 6] This is a perspective view of a biosensor inserter according to one or more embodiments provided herein, showing the cap removed, the door closed, and thus the secondary portion including the transmitter unit of the wearable device folded into the relief section. [Figure 7]FIG. 2 is a side view of a biosensor inserter showing a person pushing a pushing member to insert a biosensor of a wearable device into the skin, in accordance with one or more embodiments provided in the present specification. [Figure 8] FIG. 3 is a side view of a biosensor inserter, illustrating removal of the biosensor inserter and exposure of the wearable device in a folded state, in accordance with one or more embodiments provided in the present specification. [Figure 9] FIG. 4 is a side view of a person unfolding the secondary portion of the wearable device and then adhering it to the skin, in accordance with one or more embodiments provided in the present specification. [Figure 10] FIG. 5 is a perspective view illustrating medical waste and recyclable components of the biosensor inserter, in accordance with one or more embodiments provided in the present specification. [Figure 11] FIG. 6 shows a flowchart of a method of using a biosensor inserter to insert a biosensor, in accordance with the embodiments provided in the present specification. Mode for Carrying Out the Invention

[0011] The biosensor inserter is configured to implant (insert) the biosensor of the transmitter and sensor assembly into a person's skin. In conventional biosensor inserters, a trocar is used as part of the biosensor inserter, and the trocar assists the insertion of the biosensor into the person's skin. When the biosensor insertion process is performed, the trocar is retracted by the operation of the biosensor inserter and generally remains inside the biosensor inserter. Since blood can contaminate the trocar and the biosensor inserter, conventional biosensor inserters are typically treated as biohazards and disposed of as medical waste such as sharps.

[0012] Conventional biosensor insertor designs are large, expensive to manufacture, and can generate large amounts of waste that are typically disposed of as medical waste. Furthermore, sensor and transmitter assemblies tend to be rigid and relatively expensive to manufacture. To reduce the amount of medical waste generated through the use of these biosensor insertors, embodiments of the present disclosure work to minimize the size of the biosensor insertor. In one or more embodiments described herein, the size is reduced by reducing the footprint of the biosensor insertor. This is achieved by facilitating a foldable sensor configured to fold into a recess or relief within the wearable device insertor. Thus, the overall footprint of the biosensor insertor can be reduced by substantially, for example, 50% or more. Consequently, the volume of components of the biosensor insertor that can be disposed of as medical waste is also substantially reduced. Thus, the amount of medical waste to be disposed of is dramatically reduced. Furthermore, costs can also be significantly reduced because less material is required for the biosensor insertor.

[0013] According to some embodiments of the present disclosure, a biosensor inserter 100 is provided, as shown in Figures 1A and 1B, which includes a pressing member 102 configured to be pressed by a user (the person receiving the biosensor or another person), a contact member 104 configured to come into contact with human skin, and an internal mechanism (310 in Figures 3A to 3F) which is part of the biosensor inserter 100 and enables the insertion of a biosensor of a wearable device 101.

[0014] To better understand the biosensor inserter 100, it is desirable to first understand in more detail an exemplary embodiment of a continuous analyte monitor wearable device 101 (also referred to herein as “wearable device 101”) that can be used with the biosensor inserter 100. An exemplary embodiment of the wearable device 101 is described here with reference to Figures 2A to 2F. The wearable device 101 comprises a primary portion 101P and a secondary portion 101S that is bendable and foldable relative to the primary portion 101P. The primary portion 101P comprises at least one sensor assembly 214 that can be attached to a circuit board 228. As shown in Figures 2B and 2C, the sensor assembly 214 comprises a biosensor 214B, which is a strand-like sensor element positioned within the opening 228O and can be positioned within and extend within an opening 215 formed in the body 226 of the wearable device 101. A trocar assembly is receivable within the opening 215 (the trocar may also be referred to as the insertion portion).

[0015] The secondary portion 101S comprises a pocket 216 configured to receive a transmitter unit 110 and an opening 218 to the pocket 216. The opening 218 can be sealed by any preferred means, such as by including an adhesive 220 on at least a portion of its edge 222. For example, as shown, the pocket 216 may be formed by an internal space, and the opening 218 may comprise slit openings that form flaps 224A, 224B that can seal to each other to form a sealed pocket.

[0016] Once the adhesive 220 is applied, the backing member 225 (Figure 2F) can be placed on top of the adhesive 220. The backing member 225 may be, for example, a thin plastic sheet partially folded over itself. Other configurations of the backing member 225 are also possible. After the user inserts the transmitter unit 110 into the pocket 216 through the opening 218, connects the transmitter unit 110 to the electrical connector 234 exposed in the pocket 216, and makes the electrical connection, the user can remove the backing member 225 by pulling its exposed end 225E with their thumb and fingers. This works to expose the adhesive 220, seal the opening 218, and enclose the transmitter unit 110. The elastic restoring force of the body 226 may provide sufficient force to seal the flaps 224A and 224B together, but if not, the user can apply additional pressure to completely seal the edges of the flaps 224A and 224B together.

[0017] As should be understood, the transmitter unit 110 includes operable transmitter components configured to wirelessly transmit data, such as measured analyte data, to a receiver unit such as a reader or smartphone that runs a software application for storing and / or displaying analyte concentrations. The transmitter unit 110 may also include other electronic components, such as an analog front-end for biasing the analyte sensor and sensing the current passing through the biosensor, e.g., an operational amplifier, a current sensing circuit. Other transmitter circuits may include processing circuits such as an analog-to-digital converter for digitizing the current signal, a memory for storing the digitized current signal, and a controller such as a microprocessor or microcontroller for optionally calculating analyte concentration values ​​based on the measured current signal.

[0018] To explain the biosensor inserter 100 and its operation in more detail, please refer to Figures 1A-1B and 3A-3H.

[0019] The biosensor inserter 100 includes a push member 102, which includes a push element 302P extending downward from the lower side of the push member 102 and having a contact end that engages with a pivot member 316. The push element 302P may be a rigid member and extends downward from the lower side of the push member 102 (as oriented in Figure 3A). A transmitter carrier 318 is received within the contact member 104. The transmitter carrier 318 has a wearable device 101 coupled thereto. The wearable device 101 includes a transmitter unit 110 including at least transmitter electronics and a radio, which may include all or most of the other electronics. The wearable device further includes a biosensor 214B coupled thereto, which has a reading end that is received inside the trocar 212T (see below) for insertion by the trocar 212T.

[0020] In some embodiments, the pushing member 102, contact member 104, pivot member 316, and / or transmitter carrier 318 may be formed from polymers, including, but not limited to, plastics such as polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyvinyl chloride, polypropylene, polystyrene, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (PEEK), polypropylene, and equivalents. Other materials may also be used.

[0021] More specifically, the wearable device 101 is detachably attached to the transmitter carrier 318 by any preferred mechanism. The transmitter carrier 318 is axially translatable with respect to the contact member 104 and is configured to support the wearable device 101 during insertion of the biosensor 214B. As shown, the primary portion 101P of the wearable device 101 may include transmitter electronics, one or more power supplies 232A, 232B (Figure 2B), and a sensor assembly 214 including the biosensor 214B.

[0022] In some embodiments, the biosensor 214B used within the primary portion 101P may include two electrodes, and a bias voltage may be applied across the pair of electrodes. In such cases, current can be measured through the biosensor 214B. In other embodiments, the biosensor 214B may include three electrodes, such as a working electrode, a counter electrode, and a reference electrode. In such cases, the bias voltage may be applied between the working electrode and the reference electrode, and current can be measured, for example, through the working electrode. The biosensor 214B may include an active region containing one or more chemicals that undergo an analytic-enzymatic reaction with the product they detect. The enzyme is immobilized on one or more electrodes to provide a reaction with the analytic (e.g., a redox reaction) and generate a current at the electrodes. Examples of chemicals include glucose oxidase and glucose dehydrogenase for measuring glucose as the analytic. In some embodiments, mediators such as ferricyanide or ferrocene may be used in the active region. In general, any analytes that can be detected and / or monitored by a suitable sensor and possess suitable chemical properties, such as glucose, cholesterol, lactate, uric acid, and alcohol, can be measured. In this specification, an analyte is defined as a component, substance, chemical species, or chemical component that can be measured in an analytical procedure.

[0023] An example of the biosensor 214B could be any suitable implantable sensor, such as a strand-shaped sensor, which can be received inside the trocar 312T of the trocar assembly 312 and can be implanted in the user's skin, capable of detecting analyte concentration readings in the interstitial fluid beneath the skin.

[0024] Next, the operation of the biosensor inserter 100 will be described. In the first stage, with the door 112 open, as shown in Figures 1A and 3A, the wearable device 101 is inserted into the opening 329. The primary portion 101P is received by a retaining feature on the side of the transmitter carrier 318, such as a curved feature, tab, or other feature that closely matches the side of the primary portion 101P, which holds the primary portion 101P sufficiently so that the secondary portion 101S can be folded, but does not hold it so tightly that the wearable device 101 cannot be removed after insertion is complete.

[0025] Next, as shown in Figure 3B, the door 112 is closed and the wearable device 101 is folded at the hinge 227. The door 112 may include a hinge suitable for the lower end formed by a post of the door opening that interfaces with a hole on the lower side of the door 112 to form a pivot position for the door 112. In some embodiments, a snap-fit ​​retaining mechanism may be formed on the upper part of the door 112 and the door opening to keep the door 112 closed. Other suitable configurations of the door 112 may be used.

[0026] Next, as shown in Figure 3C, the cover 105 (Figures 1A and 1B) may be removed from the biosensor inserter 100, the cap 328 may be removed from the bottom side of the wearable device 101 by unscrewing its threaded portion, and the adhesive backing may be removed from the primary portion 101P, exposing the adhesive applied to that portion. The contact member 104 is positioned in contact with the skin (shown as a dashed line), and a force (shown by a thick vertically downward arrow) is applied to the pushing member 102 by being pushed onto it by the user (or another person). This causes the pivot member 316 to translate vertically in the first portion of its stroke.

[0027] Posts of the pivot member 316, extending from each side of the pivot member 316, translate along slots 321 on the side supports 323 of the transmitter carrier 318 formed on both sides of the pivot member (only one side is shown, the other side is identical). Similarly, the trocar assembly 312 and trocar 312T are translated toward the skin during the first portion of the stroke of the biosensor inserter 100.

[0028] The pivot position of the pivot member 316 can be formed between a first end and the opposite end of the pivot member 316. For example, the pivot axis may be formed by a laterally extending feature, such as a cylindrical post projecting from each side of the body of the pivot member 316. The laterally extending post can be received in slots 321 formed on both sides of the side support 323 of the transmitter carrier 318. The pivot member 316 may include a push element interface feature, which may comprise a pocket or other interface feature formed between the pivot axis and the latch end 316L (Figure 3E) that is configured to interface with and contact the contact end of the push element 102P, as will be further described below. The pivot can be formed using other suitable laterally extending features, such as a removable shaft. During the first portion of the insertion stroke, the pivot member 316 is in contact with the contact member 104, preventing the pivot member 316 from rotating until the second portion of the insertion stroke passes the latch 104L. Other mechanisms may be used to restrict the rotation of the first portion of the stroke and then allow the rotation of the retracted portion of the stroke.

[0029] In one or more embodiments, the trocar assembly 312 includes a body 312B (Figures 3G and 3H) having a body geometry that sits on a groove 331 (Figure 3C) formed inside the opposing side support 327 (only one is shown, the other being a mirror image) of the transmitter carrier 318. The body geometry of the body 312B of the trocar assembly 312 may have a rectangular body shape that properly aligns the trocar 212T as the body 312B descends along the groove 331 and slot 329 as the fork 316F drives the wing 312W (see Figures 3G and 3H). The pivot member 316 straddles the outside of the side support 327 and can engage with the wing 312W. During this portion of the stroke, the biosensor 214B, which extends downward from the opening 215 of the wearable device 101, is aligned with and received in a longitudinally open side groove 332 formed on the side of the trocar 212T.

[0030] As shown in Figures 3G and 3H, precise alignment between the trocar 212T and the biosensor 214B is desirable when the trocar 212T is lowered. In some embodiments, steering features may be formed within an opening 215, which can be used to help ensure that the biosensor 214B is properly aligned with and received in the longitudinal open side grooves 332 and body grooves 334 of the trocar 212T and body 312B, as shown in Figures 3G and 3H. Figure 3G shows the sensor assembly 214 and biosensor 214B before insertion while the trocar assembly 312 is raised, while Figure 3H shows the biosensor 214B properly aligned with and received in the longitudinal open side grooves 332 and body grooves 334 of the trocar 212T and body 312B after lowering.

[0031] Next, as shown in Figure 3D, when the user continues to press the push member 102, this further translates the transmitter carrier 318 and the wearable device 101, inserting the trocar 212T and biosensor 214B into the skin (outer skin surface shown by the dotted line).

[0032] Next, as shown in Figure 3E, when the user continues to press the push member 102, the latch end 316L of the pivot member passes through the latch 104L, and the pivot member 316 pivots freely around the end of the slot 321, retracting the trocar assembly 312 and trocar 212T as shown, and thus allowing the biosensor 214B to remain embedded in the skin (outer skin surface shown by the dotted line) while still connected to the internal electronics.

[0033] The latch 104L includes a latch surface (lower latch surface) that, when passed through the movement of the latch end 316L of the pivot member 316, allows the pivot member 316 to rotate (Figure 3E). The latch 104L may be formed as an opening in the side wall of the contact member 104. The latch 104L may include a circumferentially positioned surface that is wider than the latch end 316L of the pivot member 316. The rotation of the pivot member 316 is greatly restricted until the latch end 316L passes through the latch 104L. As shown, the latch 104L is, for example, part of a vertically extending cutout that can be closed at its lower end.

[0034] As shown in Figure 3F, to separate the biosensor inserter 100 from the wearable device 101, the user can pull the contact member 104. This pulls out the secondary portion 101S from the pocket formed by the relief portion 108 and the door 112. Once the inserted biosensor 100 is completely removed, the user can remove the backing from the adhesive portion applied to the secondary portion 101S, fold the secondary portion 101S onto the skin, and apply slight pressure to allow the adhesive to bond to the skin (see Figure 9).

[0035] Once removed, the entire biosensor inserter 100 can be disposed of as medical waste. Because the footprint is dramatically reduced, the volume of material, and therefore the cost, is also dramatically reduced.

[0036] As can be understood, the contact member 104 may be configured to be concentric with the push member 102 and may be extendable and retractable together. In some embodiments, the push member 102 may include a first alignment feature, such as a vertically extending groove or recess, and the contact member 104 may include a second alignment feature, such as a vertically extending rib, interface with the first alignment feature. Such alignment features may hold the push member 102 and the contact member 104 in a rotational alignment position to prevent the contact member 104 from rotating within the push member 102, such as between the insertion and retraction portions of the stroke. The push member 102 and the contact member 104 may have a cylindrical, oval, rectangular, elliptical, or any other preferred shape in cross-section. In some embodiments, the push member 102 and the contact member 104 may not be concentric.

[0037] Referring here to Figures 4 to 11, an embodiment of Method 1100 is described, which uses a biosensor inserter (e.g., biosensor inserter 100) to insert a biosensor (e.g., biosensor 214B). Method 1100 includes, in block 1102, a biosensor inserter comprising: a pushing member (e.g., pushing member 102); a contact member (e.g., contact member 104) that is translatable relative to the pushing member; a trocar assembly (e.g., trocar assembly 312) including a trocar (e.g., trocar 212T); a relief portion (e.g., relief portion 108) formed in the pushing member or contact member, configured to allow a secondary portion (e.g., secondary portion 101S) of a wearable device (e.g., wearable device 101) to be folded into the relief portion; and a mechanism (e.g., mechanism 310) configured to translate the wearable device 101 and insert the trocar.

[0038] Method 1100 further includes, in block 1104, folding the secondary portion of the wearable device (e.g., secondary portion 101S) into the relief portion by closing the door 112, as shown in Figure 6; in block 1106, bringing the contact member (e.g., contact member 104) into contact with the skin 750 of a person; and in block 1108, pushing the pushing member (e.g., pushing member 102) during the first portion of the stroke to cause translation of the wearable device and implantation of the trocar and biosensors.

[0039] Method 1100 includes, in block 1110, continuing to push the pushing member during the second portion of the stroke while keeping the biosensor embedded, as shown in Figure 7, to retract the trocar assembly into the mechanism.

[0040] Before folding the secondary portion 101S of the wearable device 101 into the relief portion 108, Method 1100 may include inserting the transmitter unit 110 into a pocket 216 (Figure 2F) formed in the secondary portion 101S through an opening 218, such as a slit opening shown in Figure 4. The sides of the secondary portion can be squeezed with a thumb and fingers to allow access to the opening 218. The pocket 216 may be large enough to accommodate the entire volume of the transmitter unit 110. Method 1100 may further include coupling the transmitter unit 110 to an electrical connector 234 provided in the pocket 216. The electrical connector 234 may be a pogo-type electrical connector or another suitable connector. According to Method 1100, the opening 218 of the secondary portion 101S can be sealed. In some embodiments, sealing involves removing the backing member 225 to expose the adhesive 220 applied to the edge 222 of the opening 218 (see Figures 5 and 2D-2F). A slight pressure on the edge 222 can seal the opening 218 and hermetically seal the transmitter unit 110 within the pocket 216. After separating the wearable device 101 from the biosensor inserter 100, as shown in Figure 8, the secondary portion 101S can be spread out and adhered to the skin as shown in Figure 9. After separating the biosensor inserter 100 from the wearable device 101, the biosensor inserter 100 can be disposed of as medical waste, while the cover 105 can be disposed of as medical waste.

[0041] The foregoing description discloses only illustrative embodiments. Modifications of the apparatus and methods disclosed above that fall within the scope of this disclosure will be readily apparent to those skilled in the art.

Claims

1. A continuous analyte monitor wearable device (101) having a primary portion (101P) which includes at least a sensor assembly (214) containing a biosensor (214B), wherein the continuous analyte monitor wearable device (101) is A secondary portion (101S) comprising a pocket (216) configured to receive a transmitter unit (110) and an opening (218) capable of sealing the pocket (216), wherein the opening (218) includes adhesive (220) on its edge (222), A hinge (227) is positioned between the primary portion (101P) and the secondary portion (101S), enabling the secondary portion (101S) to be folded relative to the primary portion (101P) at the hinge (227), A continuous analyzer monitor wearable device (101) characterized by a backing member (225) provided on the adhesive (220), wherein when the backing member (225) is removed, the adhesive (220) is exposed, and the opening (218) is sealed by sealing its edges (222) together, thereby enclosing the transmitter unit (110).

2. The continuous analyte monitor wearable device (101) according to claim 1, wherein the hinge (227) includes a foldable portion of the circuit board (228).

3. The continuous analyte monitor wearable device (101) according to claim 1, wherein the hinge (227) is formed within the main body (226) and comprises a trough extending between the sides of the main body (226) of the continuous analyte monitor wearable device.

4. The primary portion (101P) further comprises one or more power sources (232), the continuous analyte monitor wearable device (101) according to claim 1.

5. The continuous analyte monitor wearable device (101) according to claim 1, wherein the pocket (216) in the secondary portion (101S) further comprises an electrical connector (234).

6. The electrical connector (234) includes a pogo pin connector, as described in claim 5, for the continuous analyte monitor wearable device (101).

7. The biosensor (214B) is received through an opening (215) in the circuit board (228) in the continuous analyte monitoring wearable device (101) according to claim 1.

8. The pocket (216) includes the transmitter unit (110), as described in claim 1, for a continuous analyzer monitor wearable device (101).

9. A biosensor inserter configured to insert a biosensor of a wearable device (101), The wearable device (101) Primary part (101P); Secondary part (101S); and A hinge (227) is positioned between the primary portion (101P) and the secondary portion (101S), enabling the secondary portion (101S) to be folded relative to the primary portion (101P) at the hinge (227); The biosensor inserter, Pushing member and A contact member that is translatable relative to the pushing member, A biosensor inserter comprising: a relief portion formed in the contact member, wherein the relief portion is configured to allow the secondary portion (101S) to be received within the relief portion when the secondary portion (101S) is folded at the hinge (227), and the relief portion is large enough to accommodate a transmitter unit provided in the secondary portion of the wearable device (101).

10. The biosensor inserter according to claim 9, wherein the pushing member or the contact member is provided with a door that provides access to the relief portion.

11. The biosensor inserter according to claim 10, wherein the wearable device (101) can be inserted into the biosensor inserter when the door is open.

12. A method using a biosensor inserter (100), The aforementioned method, Primary part (101P); Secondary part (101S); and The invention includes providing a wearable device (101) comprising: a hinge (227) positioned between the primary portion (101P) and the secondary portion (101S), which enables the secondary portion (101S) to be folded relative to the primary portion (101P) at the hinge (227); The method includes providing a biosensor inserter (100) comprising: a pushing member (102); a contact member (104) that is translatable relative to the pushing member (102); and a relief portion (108) formed on the pushing member (102) or the contact member (104), wherein the relief portion (108) is configured to allow the secondary portion (101S) of a wearable device (101) to be folded into the relief portion (108) at the hinge (227) of the wearable device (101); and the method includes providing a biosensor inserter (100) comprising: a pushing member (102); a contact member (104) that is translatable relative to the pushing member (102); and a relief portion (108) that is configured to allow the secondary portion (101S) of a wearable device (101) to be folded into the relief portion (108) at the hinge (227) of the wearable device (101). To provide a trocar assembly including a trocar (212T) and a mechanism configured to translate the wearable device (101), The secondary portion (101S) of the wearable device (101) is folded into the relief portion (108) at the hinge (227), A method characterized by further comprising the following.

13. The method according to claim 12, comprising inserting a transmitter unit (110) into a pocket (216) formed in the secondary portion (101S) through an opening (218) before folding the secondary portion (101S) of the wearable device (101) into the relief portion (108).

14. The method according to claim 13, comprising coupling the transmitter unit (110) to an electrical connector (234) in the pocket (216).

15. The method according to claim 13, comprising sealing the opening (218) of the secondary portion (101S).

16. The method according to claim 15, wherein the sealing includes removing the backing portion so as to expose the adhesive (220) on the edge (222) of the opening (218).

17. The method according to claim 12, comprising spreading out the secondary portion (101S) and adhering it to the surface.

18. The method according to claim 12, comprising discarding the biosensor inserter (100) after separation from the wearable device (101).

Images