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

Abstract

The present disclosure relates to a continuous analyte monitoring wearable device. The wearable device includes a primary portion comprising at least a sensor assembly including a biosensor, and a secondary portion including a recess configured to receive a transmitter unit and a sealable opening to the recess, the sealable opening including an adhesive on an edge thereof, and a backing member disposed over the adhesive, wherein removal of the backing member exposes the adhesive to seal the sealable opening and encase the transmitter unit. The present disclosure also provides a biosensor inserter and methods of using a biosensor inserter.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 140,180, filed January 21, 2021, the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure relates to a wearable continuous analyte measurement (CAM) device and a biosensor inserter configured to insert a biosensor into the wearable CAM device. Reference is made to the following prior art applications: European Application Publication No. 2636372 granted to Neinast et al. and U.S. Application No. 2018 / 116570 granted to Simpson et al. Background Technology

[0004] Continuous glucose monitoring (such as using a continuous glucose monitor (CGM)) has become a routine sensing procedure, especially for sensing blood glucose levels relevant to diabetes care. By providing real-time glucose monitoring (which provides readings of glucose concentrations over time), therapeutic actions such as insulin intake or other interventions can be taken in a timely manner, and blood glucose status can be better controlled.

[0005] During a CGM procedure, the biosensors of the transmitter and sensor assembly are inserted subcutaneously and operate continuously within an environment surrounded by tissue and interstitial fluid (ISF). The biosensors inserted under the skin provide signals to the transmitter of the transmitter and sensor assembly, which can indicate, for example, the patient's blood glucose levels. These measurements can be taken intermittently and automatically multiple times throughout the day (e.g., every few minutes or at any other suitable interval).

[0006] The transmitter and sensor assembly are adhered 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 contact the ISF (intracytoplasmic sensor). This skin insertion process can be referred to as "insertion." The device used to perform this biosensor insertion can be referred to as a "biosensor inserter." Summary of the Invention

[0007] In some embodiments, a CAM wearable device configured to measure analyte concentration is provided. The CAM wearable device includes: a main portion including at least a sensor assembly, the sensor assembly including a biosensor; a secondary portion including a recess configured to receive an emitter unit and a sealable opening leading to the recess, the sealable opening containing an adhesive at its edges; and a backing member disposed over the adhesive, wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the emitter unit.

[0008] In some embodiments, a biosensor inserter configured to insert a biosensor into a wearable device is provided. The biosensor inserter includes a push member, a contact member translatable relative to the push member, and a recess formed in the push member or the contact member, the recess being configured to allow a secondary portion of the wearable device to fold into the recess.

[0009] In another embodiment, a method is provided for inserting a biosensor into a wearable device using a biosensor inserter. The method includes: providing a biosensor inserter comprising: a push member; a contact member translatable relative to the push member; a cannula assembly including a cannula; and a recess formed in the push member or the contact member, the recess configured to allow a secondary portion of the wearable device to fold into the recess; and a mechanism configured to translate the wearable device and insert the cannula; fold the secondary portion of the wearable device into the recess; bring the contact member into contact with human skin; push the push member during a first portion of the travel to induce translation and implantation of the cannula and biosensor; and continue pushing the push member to induce the mechanism to retract the cannula assembly while implanting the biosensor during a second portion of the travel.

[0010] Other features, aspects, and advantages of embodiments according to this disclosure will become more apparent from the following detailed description, claims, and drawings, by illustrating several exemplary embodiments. Various other and different applications can also be supported according to the various embodiments of this disclosure, and several details therein may be modified in various aspects without departing from the scope of the claims. Therefore, this description is to be considered illustrative in nature and not restrictive. Attached Figure Description

[0011] The accompanying drawings are intended to be illustrative, not restrictive. The drawings are not necessarily drawn to scale. The same reference numerals are used throughout the drawings to denote the same elements.

[0012] Figure 1A This is a side perspective view of a biosensor inserter according to one or more embodiments provided herein, the biosensor inserter including an open door capable of enabling insertion of a wearable device.

[0013] Figure 1B This is a side perspective view of a biosensor inserter according to one or more embodiments provided herein, the biosensor inserter including a door capable of folding and closing into a recess in the biosensor inserter to allow a wearable device to be inserted.

[0014] Figure 2AThis is a perspective view of a wearable device according to one or more embodiments provided herein, the wearable device having a removable and reusable transmitter unit to be inserted into and sealed into a recess.

[0015] Figure 2B This is a perspective view of a wearable device according to one or more embodiments provided herein, having a removable transmitter unit mounted in a recess, and showing various internal components as well as hinges that allow the wearable device to partially bend and thus fold.

[0016] Figure 2C This is a perspective view of a circuit board of a wearable device having a spring-loaded electrical connector according to one or more embodiments provided herein, the spring-loaded electrical connector being configured to be electrically coupled to a transmitter unit in a recess.

[0017] Figure 2D This is a perspective view of a wearable device according to one or more embodiments provided herein, showing recesses and openings configured to receive a transmitter unit.

[0018] Figure 2E This is a perspective view of a wearable device according to one or more embodiments provided herein, showing a recess and an adhesive contained in the recess on the edge of an opening.

[0019] Figure 2F This is a perspective view of a wearable device according to one or more embodiments provided herein, showing the addition of a backing member over an adhesive in an opening.

[0020] Figure 3A This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing a wearable device inserted into a receiver of a transmitter carrier.

[0021] Figure 3B This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the wearable device folding / bending around its hinge and the door closing.

[0022] Figure 3C This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the translation of a cannula assembly to receive a biosensor in a side-open recess within the cannula assembly.

[0023] Figure 3D This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the translation of the cannula assembly to insert the cannula and biosensor into the user's skin.

[0024] Figure 3E This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the retraction of the cannula assembly to allow the biosensor to be inserted into the user's skin.

[0025] Figure 3F This is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided herein, showing the separation of the biosensor inserter and the wearable device.

[0026] Figure 3G This is a perspective side view of a cannula assembly and a sensor assembly according to one or more embodiments provided herein, showing a biosensor penetrating and inserting into a side-open groove in the cannula.

[0027] Figure 3H This is a perspective side view of a cannula assembly and a sensor assembly according to one or more embodiments provided herein, showing a biosensor inserted into a side-open groove of the cannula.

[0028] Figure 4 This is a perspective view of a biosensor inserter according to one or more embodiments provided herein, showing the transmitter unit inserted into a recess in a wearable device.

[0029] Figure 5 This is a perspective view of a biosensor inserter according to one or more embodiments provided herein, showing the removal of the backing member to expose the adhesive and thus enabling a seal of the opening leading to the recess.

[0030] Figure 6 This is a perspective view of a biosensor inserter according to one or more embodiments provided herein, showing the removal of the cap and closing of the door, thereby folding a secondary portion of the wearable device, including the transmitter unit, into the recess.

[0031] Figure 7 This is a side view of a biosensor inserter according to one or more embodiments provided herein, showing a person pushing a pusher member to insert a biosensor of a wearable device into the skin.

[0032] Figure 8 This is a side view of a biosensor inserter according to one or more embodiments provided herein, showing the removal of the biosensor inserter and the exposure of the wearable device in a folded state.

[0033] Figure 9 This is a side view of a person unfolding and then attaching a secondary portion of the wearable device to the skin, according to one or more embodiments provided herein.

[0034] Figure 10This is a perspective view illustrating a recyclable component of a medical waste and biosensor inserter according to one or more embodiments provided herein.

[0035] Figure 11 A flowchart is shown of a method for inserting a biosensor using a biosensor inserter according to embodiments provided herein. Detailed Implementation

[0036] A biosensor inserter is configured to implant (insert) a biosensor, consisting of a transmitter and sensor assembly, into a person's skin. In a conventional biosensor inserter, a cannula is used as part of the inserter, facilitating the insertion of the biosensor into the skin. Once the biosensor insertion procedure is performed, the cannula is retracted by the operation of the biosensor inserter and typically remains inside the inserter. Because blood can contaminate the cannula and inserter, conventional biosensor inserters are generally treated as a biohazard and disposed of as medical waste, similar to sharps.

[0037] Existing biosensor inserter designs can be large, costly to manufacture, and generate significant amounts of waste, typically disposed of as medical waste. Furthermore, sensor and transmitter components tend to be rigid and relatively expensive to manufacture. To reduce the amount of medical waste generated from using these biosensor inserters, embodiments of this disclosure operate to minimize the size of the biosensor inserter. In one or more embodiments described herein, the size is reduced by minimizing the footprint of the biosensor inserter. This is achieved by facilitating a foldable wearable device configured to fold into a recess or depression within the biosensor inserter. Consequently, the total footprint of the biosensor inserter can be significantly reduced, such as by 50% or more. Consequently, the volume of the components of the biosensor inserter that can be disposed of as medical waste is also significantly reduced. Consequently, the amount of medical waste to be disposed of is significantly reduced. Furthermore, the biosensor inserter requires less material, thus significantly reducing costs.

[0038] According to some embodiments of this disclosure, and as Figure 1A and Figure 1B As shown, a biosensor inserter 100 is provided, comprising: a push member 102 configured to be pushed by a user (the person receiving the biosensor or another person); a contact member 104 configured to contact a person's skin; and an internal mechanism (310– Figures 3A to 3F This internal mechanism is part of the biosensor inserter 100 and enables the insertion of the biosensor of the wearable device 101.

[0039] To better understand the biosensor inserter 100, it is desirable to first understand in more detail an exemplary embodiment of a continuous analyte monitoring wearable device 101 (also referred to herein as "wearable device 101") that can be used with the biosensor inserter 100. Referring now to... Figures 2A to 2F An exemplary embodiment of a wearable device 101 is described. The wearable device 101 includes a main portion 101P and a secondary portion 101S that is flexible and foldable relative to the main portion 101P. The main portion 101P includes at least a sensor assembly 214, which can be mounted to a circuit board 228. Figure 2B and Figure 2C As shown, sensor assembly 214 includes biosensor 214B, which is a linear sensor element located in opening 228O and can be located in and extend within an aperture 215 formed in the body 226 of wearable device 101. A cannula assembly can be received in aperture 215. (The cannula may also be referred to as an insertion portion).

[0040] Secondary portion 101S includes a recess 216 configured to receive transmitter unit 110 and an opening 218 leading to the recess 216. The opening 218 is sealed by any suitable means, such as by including adhesive 220 on at least some of its edges 222. For example, as shown, the recess 216 may be formed by an internal space, and the opening 218 may include slit openings that form flaps 224A, 224B that are sealable to each other to form a sealed recess.

[0041] Once adhesive 220 is applied, backing member 225 can be provided on top of adhesive 220. Figure 2F The backing member 225 may be, for example, a thin plastic sheet partially folded back on itself. Other configurations of the backing member 225 are possible. After the user inserts the transmitter unit 110 into the recess 216 through the opening 218 and connects the transmitter unit 110 to the electrical connector 234 exposed in the recess 216 to establish an electrical connection, the user can remove the backing member 225 by pulling on the exposed end 225E of the backing member 225 with their thumb and fingers. This operation exposes and seals the opening 218 with the adhesive 220 and encapsulates the transmitter unit 110. The elastic rebound of the body 226 may provide sufficient force to seal the flaps 224A, 224B together, but if not, the user may apply additional pressure to completely seal the edges of the flaps 224A, 224B together.

[0042] It should be understood that transmitter unit 110 includes transmitter components configured and operable to wirelessly transmit data (such as measured analyte data) to a receiving unit (such as a reader or smartphone executing a software application) for storage and / or display of analyte concentration. Transmitter unit 110 may also include other electronic components, such as an analog front end for biasing the analyte sensor and for sensing the current passing through the biosensor, such as operational amplifiers, current sensing circuitry, etc. Other transmitter circuitry may include processing circuitry (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, microcontroller, etc.) for potentially calculating analyte concentration values ​​based on the measured current signal.

[0043] Now for reference Figures 1A to 1B as well as Figures 3A to 3H The biosensor inserter 100 and its operation are described in more detail.

[0044] The biosensor inserter 100 includes an actuating member 102 comprising an actuating element 302P extending downward from the underside of the actuating member 102, and a contact end engaging with a pivot member 316. The actuating element 302P may be a rigid member and extends downward from the underside of the actuating member 102 (e.g., Figure 3A (Oriented). Receiving within the contact member 104 is a transmitter carrier 318. The transmitter carrier 318 has a wearable device 101 coupled thereto. The wearable device 101 includes a transmitter unit 110 comprising at least transmitter electronics and radio components, and may include all or most other electronics. The wearable device further includes a biosensor 214B coupled thereto, the biosensor having a readout end received within a cannula 212T (see below) for insertion of the cannula 212T.

[0045] In some embodiments, the actuating member 102, the contact member 104, the pivot member 316, and / or the transmitter carrier 318 may be formed of a polymer, 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, etc. Other materials may be used.

[0046] More specifically, the wearable device 101 is detachably mounted to the transmitter carrier 318 via any suitable mechanism. The transmitter carrier 318 is axially translatable relative to the contact member 104 and configured to support the wearable device 101 during insertion of the biosensor 214B. As shown, the main portion 101P of the wearable device 101 may include transmitter electronics, one or more power supplies 232A, 232B (… Figure 2B ) and sensor assembly 214 including biosensor 214B.

[0047] In some embodiments, the biosensor 214B used within the main portion 101P may include two electrodes, and a bias voltage may be applied across the counter electrode. In such cases, current can be measured by 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, a bias voltage may be applied between the working electrode and the reference electrode, and current can be measured, for example, by the working electrode. The biosensor 214B may include an active region comprising one or more chemical substances that undergo an analyte-enzyme reaction with the product being detected. The enzyme is immobilized on one or more electrodes to provide a reaction with the analyte (e.g., a redox reaction) and generate a current at the electrode. Exemplary chemicals include glucose oxidase, glucose dehydrogenase, etc., for measuring glucose as an analyte. In some embodiments, a medium such as ferricyanide or ferrocene may be employed at the active region. Generally, any analyte (such as glucose, cholesterol, lactic acid, uric acid, alcohol, etc.) that can be detected and / or monitored using a suitable sensor and that has a suitable chemical composition can be measured. An analyte is defined in this document as a component, substance, chemical species, or chemical component that is measurable by analytical procedures.

[0048] Examples of biosensor 214B could be any suitable implantable sensor that can be implanted in a user’s skin, such as a linear sensor that can be received inside the cannula 312T of the cannula assembly 312 and can sense the analyte concentration reading of the interstitial fluid beneath the skin.

[0049] The operation of the biosensor inserter 100 will now be described. In the first stage, as... Figure 1A and Figure 3AAs shown, with the door 112 open, the wearable device 101 is inserted into the opening 329. The main portion 101P is received in retaining features on the side of the transmitter carrier 318 (such as a curved feature, tab, or other feature that closely matches the side of the main portion 101P, which sufficiently retains the main portion 101P so that the secondary portion 101S can be folded, but not so tightly that the wearable device 101 cannot be removed after insertion).

[0050] like Figure 3B As shown, the door 112 is then closed, thereby folding the wearable device 101 at hinge 227. The door 112 may include a suitable hinge at its lower end, formed by a post in the door opening that engages with a cavity in the lower side of the door 112 to form, for example, a pivot position for the door 112. In some embodiments, a snap-fit ​​retaining mechanism may be formed in the top of the door 112 and in the door opening to keep the door 112 closed. Other suitable constructions of the door 112 may be used.

[0051] Next, as Figure 3C As shown, cover 105 ( Figure 1A and Figure 1B The cap 328 can be removed from the bottom of the wearable device 101, such as by loosening its threaded portion, and the adhesive backing can be removed from the main portion 101P to expose the adhesive applied to that portion. The contact member 104 is positioned to contact the skin (shown as a dotted line), and a force (indicated by a thick, vertically downward-oriented arrow) is applied to the actuating member 102 by being pushed by the user (or another person). This causes the pivot member 316 to translate vertically in the first portion of its travel.

[0052] The columnar members of the pivot member 316 extending from each of its lateral sides translate along slots 321 on the side supports 323 of the transmitter carrier 318, which are formed on either side of the pivot member 316 (only one side is shown; the other side is the same). Similarly, during the first portion of the stroke of the biosensor inserter 100, the cannula assembly 312 and the cannula 312T translate toward the skin.

[0053] The pivot position of the pivot member 316 can be formed between a first end and an opposite end of the pivot member 316. For example, the pivot axis can be formed by a laterally extending feature, such as a cylindrical column protruding from a corresponding laterally side of the body of the pivot member 316. The laterally extending column can be received in a slot 321 formed on the opposite side of the side support 323 of the launcher carrier 318. The pivot member 316 may include an actuating element engagement feature, which may include a pivot axis formed at the latch end 316L ( Figure 3E The pivot member 316 may be formed by a recess or other engagement feature between the two contacts, configured to engage and contact the contact end of the actuating element 102P, as further described below. Other suitable laterally extending features (such as a removable shaft) may be used to form the pivot. During the first portion of the insertion stroke, the pivot member 316 contacts the contact member 104 and is prevented from rotating until the second portion of the insertion stroke, when the pivot member 316 passes the latch 104L. Other mechanisms may be used that restrict rotation for the first portion of the stroke and then allow rotation for the retraction portion of the stroke.

[0054] In one or more embodiments, the cannula assembly 312 includes a body 312B. Figure 3G and Figure 3H The main body has a groove 331 that straddles the inner side of the opposite side support 327 (only one is shown, but the other is a mirror image) formed on the launcher carrier 318. Figure 3C The main body geometry of the cannula assembly 312. The main body geometry of the main body 312B can have a rectangular main body shape, as the main body 312B descends along the groove 331 and slot 329 with the fork-shaped portion 316F driving the wing 312W (see...). Figure 3G and Figure 3H When the cannula is in motion, the rectangular body shape allows the cannula 212T to be correctly aligned. The pivot member 316 can cross the outside of the side support 327 and engage the wing 312W. During this portion of the travel, the biosensor 214B, extending downward from the orifice 215 of the wearable device 101, aligns with and is received within a longitudinally lateral groove 332 formed in one side of the cannula 212T.

[0055] like Figure 3G and Figure 3H As shown, precise alignment between the cannula 212T and the biosensor 214B is desired as the cannula 212T descends. In some embodiments, a steering feature may be formed in the orifice 215, which can be used for steering and thus helps ensure that the biosensor 214B is properly aligned and received therein with the longitudinally open grooves 332 and body grooves 334 of the cannula 212T and body 312B, as shown. Figure 3G and Figure 3H As shown. Figure 3G The sensor assembly 214 and biosensor 214B are shown during the ascent of the cannula assembly 312 and before insertion, while Figure 3H The biosensor 214B is shown to be correctly aligned and received within the grooves 332 and 334 that open on the longitudinal sides of the cannula 212T and the body 312B after descent.

[0056] Next, as Figure 3D As shown, when the user continues to push the pusher 102, this further translates the transmitter carrier 318 and the wearable device 101 and inserts the cannula 212T and the biosensor 214B into the skin (the outer skin surface shown in dashed lines).

[0057] Next, as Figure 3E As shown, when the user continues to push the push member 102, the latch end 316L of the pivot member passes through the latch 104L, and the pivot member 316 can freely pivot around the end of the slot 321 and retract the cannula assembly 312 and the cannula 212T as shown, thereby allowing the biosensor 214B to be implanted into the skin (the outer skin surface shown in dashed lines) while still connected to the internal electronics.

[0058] The latch 104L includes a latching surface (lower latching surface) that, once passed over by movement of the latching 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 sidewall of the contact member 104. The latch 104L may include a circumferentially arranged surface that is wider than the latch end 316L of the pivot member 316. The pivot member 316 is not largely restricted from rotation until the latch end 316L passes through the latch 104L. As shown, the latch 104L is part of a vertically extending cut that may, for example, be closed at its lower end.

[0059] like Figure 3F As shown, the user can separate the biosensor inserter 100 from the wearable device 101 by pulling the contact member 104. This pulls the secondary portion 101S from the recess formed by the recess 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 adhere the adhesive to the skin (see...). Figure 9 ).

[0060] Once removed, the entire biosensor inserter 100 can be disposed of as medical waste. Because the footprint has been significantly reduced, the volume of materials and therefore the cost have also been significantly reduced.

[0061] It should be understood that the contact member 104 may be configured to be concentric with and extend and retract with the push member 102. 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, engaging the first alignment feature. Such alignment features can keep the push member 102 and the contact member 104 in rotational alignment to prevent rotation of the contact member 104 within the push member 102, for example, during the insertion and retraction portions of the stroke. The cross-sections of the push member 102 and the contact member 104 may be cylindrical, oval, rectangular, elliptical, or any other suitable shape. In some embodiments, the push member 102 and the contact member 104 may be non-concentric.

[0062] Now for reference Figures 4 to 11 This describes an embodiment of a method 1100 for inserting a biosensor (e.g., biosensor 214B) using a biosensor inserter (e.g., biosensor inserter 100). Method 1100 includes: in block 1102, providing a biosensor inserter comprising: a push member (e.g., push member 102); a contact member (e.g., contact member 104) translatable relative to the push member; a cannula assembly (e.g., cannula assembly 312) including a cannula (e.g., cannula 212T); and a recess (e.g., recess 108) formed in the push member or contact member, the recess being configured to allow a secondary portion (e.g., secondary portion 101S) of a wearable device (e.g., wearable device 101) to fold into the recess; and a mechanism (e.g., mechanism 310) configured to translate the wearable device 101 and insert the cannula.

[0063] Method 1100 further includes: within frame 1104, folding a secondary portion of the wearable device (e.g., secondary portion 101S) into the recess via closing door 112, such as Figure 6 As shown; and in box 1106, a contact member (e.g., contact member 104) is brought into contact with human skin 750; and in box 1108, a push member (e.g., push member 102) is actuated during the first portion of the travel to cause translation of the wearable device and implantation of the cannula and biosensor.

[0064] Method 1100 includes: within block 1110, continuing to push the push member to retract the cannula assembly, while simultaneously implanting the biosensor during the second portion of the stroke, such as... Figure 7 As shown.

[0065] Before folding the secondary portion 101S of the wearable device 101 into the recess 108, method 1100 may involve: through opening 218, such as through... Figure 4 The slit opening shown allows the transmitter unit 110 to be inserted into the recess 216 formed in the secondary portion 101S. Figure 2F The secondary portion 101S can be squeezed with the thumb and fingers to allow access to the opening 218. The recess 216 can be large enough to receive the entire volume of the transmitter unit 110 therein. Method 1100 may further include coupling the transmitter unit 110 to an electrical connector 234 disposed in the recess 216. The electrical connector 234 can be a spring-loaded electrical connector or other suitable connector. According to method 1100, the opening 218 of the secondary portion 101S can be sealed. In some embodiments, sealing includes removing the backing member 225 to expose the adhesive 220 applied to the edge 222 of the opening 218 (see [link to documentation]). Figure 5 as well as Figures 2D to 2F Slight pressure on edge 222 can seal opening 218 and hermetically seal transmitter unit 110 into recess 216. (As shown) Figure 8 As shown, after the wearable device 101 is separated from the biosensor inserter 100, the secondary part 101S can be as follows: Figure 9 It unfolds and adheres to the skin as shown. After the biosensor inserter 100 is separated from the wearable device 101, the biosensor inserter 100 can be disposed of as medical waste, and the cap 105.

[0066] The foregoing description discloses only exemplary embodiments. Modifications to 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 wearable device (101) for continuous analyte monitoring, the wearable device for continuous analyte monitoring having: The main part (101P), which includes at least a sensor assembly (214) including a biosensor (214B), is characterized in that: The secondary portion (101S) includes a recess (216) configured to receive a reusable transmitter unit (110) and a sealable opening (218) leading to the recess (216), the sealable opening (218) including a first wing, a second wing and an adhesive (220). A backing member (225) disposed above the adhesive (220), wherein removing the backing member (225) exposes the adhesive (220) to seal the sealable opening (218) and encapsulate the reusable transmitter unit (110); and A hinge (227) is formed by a first end of the main portion (101P) and a second end of the secondary portion, the hinge being configured to allow the secondary portion to partially bend and fold at the hinge (227) such that the secondary portion is perpendicular to the main portion (101P). The wearable device for continuous analyte monitoring is configured to be fitted within a biosensor inserter by inserting the main portion (101P) into the biosensor inserter, the biosensor inserter being folded around the hinge (227) such that the secondary portion within the recess of the biosensor inserter is perpendicular to the main portion (101P).

2. The wearable device (101) for continuous analyte monitoring according to claim 1, wherein the hinge (227) is formed at the interface between the main portion (101P) and the secondary portion (101S), the hinge being configured to allow the secondary portion (101S) to partially bend at the hinge (227) and fold relative to the main portion (101P).

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

4. The wearable device (101) for continuous analyte monitoring according to claim 2, wherein the hinge (227) includes a groove formed in the body (226) and extending between the sides of the body (226) of the wearable device for continuous analyte monitoring.

5. The wearable device (101) for continuous analyte monitoring according to claim 1, wherein the main part (101P) further includes one or more power sources (232).

6. The wearable device (101) for continuous analyte monitoring according to claim 1, wherein the recess (216) in the secondary portion (101S) further includes an electrical connector (234).

7. The wearable device (101) for continuous analyte monitoring according to claim 6, wherein the electrical connector (234) comprises a spring pin connector.

8. The wearable device (101) for continuous analyte monitoring according to claim 1, wherein the biosensor (214B) is received through an opening (228O) in the circuit board (228).

9. The wearable device (101) for continuous analyte monitoring according to claim 1, wherein the recess (216) comprises the reusable transmitter unit (110).

10. A biosensor inserter configured to be inserted into a wearable device, the wearable device comprising: Main part (101 pages); Secondary section (101S); A hinge (227) is located between the main portion (101P) and the secondary portion (101S), allowing the secondary portion (101S) to fold relative to the main portion (101P) at the hinge (227) such that the secondary portion is perpendicular to the main portion. The biosensor inserter includes: A pushing member; a contact member, the contact member being translatable relative to the pushing member; and a recess formed in the contact member, the recess being configured to allow the secondary portion (101S) to be received into the recess when the secondary portion (101S) is folded at the hinge (227).

11. The biosensor inserter of claim 10, wherein the pushing member or the contact member includes a gate providing access to the recess.

12. The biosensor inserter of claim 11, wherein the wearable device is insertable into the biosensor inserter when the door is open.

13. A method for inserting a biosensor (214B) using a biosensor inserter (100), the method comprising: Provides a wearable device for continuous analyte monitoring, the wearable device for continuous analyte monitoring comprising: The main part (101P) includes at least a sensor assembly, which includes the biosensor (214B); Secondary portion (101S), said secondary portion including a recess; and A hinge, formed at the interface between the main portion (101P) and the secondary portion (101S), is configured to allow the secondary portion to be partially bent and folded at the hinge, such that the secondary portion (101S) is perpendicular to the main portion (101P). The biosensor inserter (100) is provided, the biosensor inserter comprising: Propulsion component (102); Contact member (104), the contact member being translatable relative to the pushing member (102); and A recess (108) is formed in the push member (102) or the contact member (104), the recess (108) being configured to allow the secondary portion (101S) of the wearable device (101) to fold into the recess (108). A cannula assembly including a cannula (212T) and a mechanism are provided, the mechanism being configured to translate the wearable device (101) and insert the cannula (212T); The secondary portion (101S) of the wearable device (101) is folded into the recess (108) such that the secondary portion (101S) is perpendicular to the main portion (101P). The contact member (104) is brought into contact with human skin; During the first part of the journey, the actuating member (102) is pushed to cause translation of the wearable device (101) and implantation of the cannula (212T) and biosensor (214B); and Continue pushing the pusher (102) to cause the mechanism to retract the cannula assembly, while implanting the biosensor (214B) during the second part of the stroke.

14. The method according to claim 13, wherein the method comprises: Before folding the secondary portion (101S) of the wearable device (101) into the recess (108), the transmitter unit (110) is inserted into the recess (216) formed in the secondary portion (101S) through the opening (218).

15. The method of claim 14, wherein the method comprises: The transmitter unit (110) is coupled to the electrical connector (234) in the recess (216).

16. The method of claim 14, wherein the method comprises: The opening (218) of the secondary portion (101S) is sealed.

17. The method of claim 16, wherein the seal comprises: Remove the backing portion to expose the adhesive (220) on the edge (222) of the opening (218).

18. The method of claim 13, wherein the method comprises: Unfold the secondary portion (101S) and adhere it to the person's skin.

19. The method of claim 13, wherein the method comprises: After being detached from the wearable device (101), the biosensor inserter (100) is discarded.

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