Wearable continuous analyte measurement devices, biosensor inserters, and methods of use

Abstract

A continuous analyte monitor wearable device. The wearable device includes a primary portion comprising at least a sensor assembly comprising a biosensor, and a secondary portion comprising a pocket configured to receive a transmitter unit and a sealable opening to the pocket, the sealable opening containing an adhesive on edges thereof; and a backing member provided over the adhesive wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit. Biosensor inserters and method of using the biosensor inserter are also provided.

Description

[Technical Field]

[0001] This case claims priority to U.S. Provisional Patent Application No. 63 / 140,180, filed on January 21, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This case relates to a wearable continuous analytical measurement (CAM) device and a biosensor inserter configured to insert a biosensor into the wearable CAM device. [Previous Technology]

[0003] Continuous glucose monitoring, such as using a continuous glucose monitor (CGM), has become a standard sensing procedure, particularly for sensing blood glucose levels relevant to diabetes care. By providing real-time glucose monitoring that delivers glucose concentration readings over time, therapeutic actions, such as insulin intake or other interventions, can be taken immediately, and blood glucose levels can be better controlled.

[0004] During a CGM procedure, a biosensor of a transmitter and sensor assembly is inserted subcutaneously and operated continuously in an environment surrounded by tissue and interstitial fluid (ISF). The biosensor is inserted subcutaneously and provides a signal to the transmitter of the transmitter and sensor assembly, and this signal can indicate, for example, the patient's blood glucose level. These sensor measurements can be performed automatically multiple times intermittently throughout the day (e.g., every few minutes or other suitable time intervals).

[0005] The transmitter and sensor assembly are attached to the outer surface of the user's skin, such as the abdomen or the back of the upper arm, while the biosensor is inserted into the skin to contact the ISF. 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]

[0006] 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 one sensor assembly including a biosensor, and a secondary portion including a pouch configured to receive a transmitter unit and a sealable opening leading to the pouch, the sealable opening containing adhesive at its edges, and a backing member disposed on the adhesive, wherein removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit.

[0007] In some embodiments, a biosensor inserter configured to insert a biosensor of a wearable device is provided. The biosensor inserter includes a push member, a contact member translatable relative to the push member, and a relief formed in the push member or the contact member, configured to allow a secondary portion of the wearable device to fold into the relief.

[0008] In a further 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 slot formed in the push member or the contact member, the slot being configured to allow a secondary portion of the wearable device to fold into the slot; and a mechanism configured to translate the wearable device and insert the cannula into the slot, the secondary portion of the wearable device being folded into the slot; bringing the contact member into contact with a person's skin; pushing the push member during a first portion of a stroke to cause translation and implantation of the cannula and biosensor; and continuing to push the push member to cause the mechanism to retract the cannula assembly while maintaining the biosensor implanted during a second portion of the stroke.

[0009] Other features, appearances, and advantages of embodiments according to this application will become more apparent from the following detailed description, the claims, and the accompanying drawings, which illustrate a number of exemplary embodiments. Various embodiments according to this application can also be used in other and different applications, and certain details may be modified in various respects without departing from the claims and their equivalents. Therefore, this specification is to be considered illustrative in nature, not restrictive.

Implementation Method

[0035] A biosensor inserter is configured to implant (insert) a biosensor, consisting of a transmitter and a sensor assembly, into the skin of a person. In conventional biosensor inserters, a cannula is used as part of the biosensor inserter, which facilitates the insertion of the biosensor into the skin. During the biosensor insertion procedure, the cannula retracts by the operation of the biosensor inserter and is typically retained inside the biosensor inserter. Because blood can contaminate the cannula and the biosensor inserter, conventional biosensor inserters are considered biohazardous and are disposed of as medical waste, like sharp instruments.

[0036] Existing biosensor inserter designs can be large and costly to manufacture, generating 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 by using these biosensor inserters, embodiments of this invention operate to minimize the size of the biosensor inserter. In one or more embodiments described herein, the size is reduced by decreasing the coverage area of ​​the biosensor inserter. This is achieved by facilitating a foldable wearable device configured to fold into a recess or slot within the biosensor inserter. Therefore, the total coverage area of ​​the biosensor inserter can be significantly reduced, for example, by 50% or more. Consequently, the volume of the biosensor inserter's components that can be disposed of as medical waste is also greatly reduced. Therefore, the amount of medical waste to be disposed of is significantly reduced. Furthermore, less material is required for the biosensor inserter, thus significantly reducing costs.

[0037] According to some embodiments of this case, and as shown in Figures 1A and 1B, a biosensor inserter 100 is provided, which includes a pusher 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 – see Figures 3A-3F) which is part of the biosensor inserter 100 and is capable of inserting a biosensor of a wearable device 101.

[0038] To better understand the biosensor inserter 100, an example 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 needs to be described in more detail first. Referring now to Figures 2A to 2F, an example embodiment of the wearable device 101 is described. The wearable device 101 includes a main portion 101P and a flexible and foldable secondary main portion 101S 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. As shown in Figures 2B and 2C, the sensor assembly 214 includes a biosensor 214B, which is a strand-shaped sensor element positioned in an opening 228O and can be positioned in and extend into an opening 215 formed in the body 226 of the wearable device 101. A cannula assembly can be received in the opening 215. (The cannula can also be referred to as an insertion portion.)

[0039] The secondary portion 101S includes a bag 216 configured to receive the transmitter unit 110, and an opening 218 leading to the bag 216. The opening 218 can be sealed by any suitable means, for example by including an adhesive 220 on at least some of its edges 222. For example, as shown, the bag 216 can be formed by an internal space, and the opening 218 can include slit openings forming flaps 224A, 224B, which can be sealed to each other to form a sealed bag.

[0040] Once the adhesive 220 is applied, a backing component 225 (FIG. 2F) can be provided above the adhesive 220. For example, the backing component 225 may be a thin plastic sheet partially folded back on itself. Other configurations of the backing component 225 are possible. After the user inserts the transmitter unit 110 into the bag 216 through the opening 218 and connects the transmitter unit 110 to the electrical connector 234 exposed in the bag 216 for electrical connection, the user can remove the backing component 225 by pulling the exposed end 225E with their thumb and fingers. This operation exposes the adhesive 220, seals the opening 218, and encapsulates the transmitter unit 110. The elastic rebound force of the body 226 can provide sufficient force to seal the flaps 224A, 224B together, but if not, the user can apply additional pressure to completely seal the edges of the flaps 224A, 224B together.

[0041] As should be understood, transmitter unit 110 includes transmitter components configured and operated to wirelessly transmit data (e.g., measured analyte data) to a receiving unit, such as a reader or smartphone executing a software application for storing and / or displaying analyte concentrations. Transmitter unit 110 may also include other electronic components, such as an analog front-end for biasing the analyte sensor and for sensing current passing through the biosensor, such as an operational amplifier, current sensing circuitry, etc. Other transmitter circuitry may include processing circuitry, such as an analog-to-digital converter for digitizing the current signal, memory for storing the digitized current signal, and a controller, such as a microprocessor, microcontroller, etc., for potentially calculating the analyte concentration based on the measured current signal.

[0042] Next, the biosensor inserter 100 and its operation will be described in more detail with reference to Figures 1A-1B and 3A-3H.

[0043] The biosensor inserter 100 includes a push member 102, which includes a push element 302P extending downward from the underside of the push member 102 and including a contact end that engages with a pivot member 316. The push element 302P may be a rigid member and extends downward from the underside of the push member 102 (oriented as shown in FIG3A). Received within the contact member 104 is a transmitter carrier 318. The transmitter carrier 318 has a wearable device 101 coupled to it. The wearable device 101 includes a transmitter unit 110, which includes at least transmitter electronics and radio, and may include all or most other electronic components. The wearable device also includes a biosensor 214B coupled thereto, which has a reading end received inside a cannula needle 212T (see below) for insertion of the cannula needle 212T.

[0044] In some embodiments, the pushing component 102, the contact component 104, the pivoting component 316, and / or the transmitter carrier 318 may be formed of 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, etc. Other materials may be used.

[0045] More specifically, the wearable device 101 is detachably mounted to the transmitter carrier 318 by any suitable mechanism. The transmitter carrier 318 is axially translatable relative to the contact member 104 and is 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 (FIG. 2B), and a sensor assembly 214 including the biosensor 214B.

[0046] In some embodiments, the biosensor 214B used within the main portion 101P may include two electrodes, and a bias voltage may be applied to this pair of electrodes. In this case, current can be measured by the biosensor 214B. In other embodiments, the biosensor 214B may include three electrodes, such as a working electrode, a reverse electrode, and a reference electrode. In this case, for example, a bias voltage may be applied between the working electrode and the reference electrode, and current through the working electrode can be measured. The biosensor 214B may include an active region comprising one or more chemical substances that undergo an analyte-enzyme reaction with the products they detect. The enzyme system is immobilized on one or more electrodes to provide a reaction with the analyte (e.g., a redox reaction) and generates a current at the electrode. Example chemicals include glucose oxidase, glucose dehydrogenase, etc., for measuring glucose as an analyte. In some embodiments, a mediator, such as ferricyanide or ferrocene, may be used in the active region. Generally, any analyte, such as glucose, cholesterol, lactic acid, uric acid, alcohol, etc., can be detected and / or monitored by a suitable biosensor. In this case, an analyte is defined as a component, substance, chemical substance, or chemical composition that is measurable during the analysis.

[0047] An example of the biosensor 214B may be any suitable implantable sensor that can be implanted in the user’s skin, such as one that can be received inside the cannula 312T of the cannula assembly 312 and can sense readings of the concentration of the analyte in the tissue fluid under the skin.

[0048] The operation of the biosensor inserter 100 will now be described. In a first stage, the wearable device 101 is inserted into the opening 329, and the door 112 is opened as shown in Figures 1A and 3A. 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, such that the secondary portion 101S can be folded, but not so tightly that the wearable device 101 cannot be removed after insertion.

[0049] As shown in FIG3B, 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 of a door opening that engages with a hole in the lower side of the door 112 to form, for example, a pivot position of the door 112. In some embodiments, a snap-fit ​​retaining mechanism may be formed at the top of the door 112 and in the door opening to keep the door 112 closed. Other suitable configurations of the door 112 may be used.

[0050] Next, as shown in FIG3C, the cover 105 (FIGs 1A and 1B) can be removed from the biosensor inserter 100, and the cap 328 can be removed from the bottom side of the wearable device 101, for example by unscrewing its threaded portion, and an 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 is applied to the actuating member 102 by a push from the user (or another person) (indicated by a thick arrow pointing vertically downwards). This causes the pivoting member 316 to translate vertically in a first portion of the stroke.

[0051] The posts extending from each of the lateral sides of the pivot member 316 translate along slots 321 on the side supports 323 of the transmitter carrier 318 formed on either side of the pivot member 316 (only one side is shown; the other side is the same). Similarly, the cannula assembly 312 and the cannula 312T translate toward the skin during the first portion of the stroke of the biosensor inserter 100.

[0052] The pivoting position of the pivoting member 316 can be formed between a first end and an opposite end of the pivoting member 316. For example, the pivot shaft can be formed by a lateral extension feature, such as a cylindrical post protruding from the corresponding lateral side of the body of the pivoting member 316. The lateral extension post can be received in a slot 321 formed in the opposite side of the side support 323 of the conveyor carrier 318. The pivoting member 316 may include a push element interface feature, which may include a pouch or other interface feature formed between the pivot shaft and the latch end 316L (FIG. 3E), the latch end 316L being configured to engage and contact a contact end of the push element 102P, as further described below. Other suitable lateral extension features may be used to form the pivot, such as a detachable shaft, etc. During a first portion of the insertion stroke, the pivoting member 316 contacts the contact member 104 and is prevented from rotating as the pivoting member 316 passes the latch 104L until a second portion of the insertion stroke. Other mechanisms can be used that restrict rotation during the first part of the stroke and then allow rotation during the retraction part of the stroke.

[0053] In one or more embodiments, the cannula assembly 312 includes a body 312B (Figures 3G and 3H) having a body geometry spanning a recess 331 (Figure 3C), the recess 331 being formed on the inner side of the opposite side support 327 of the conveyor carrier 318 (only one is shown, but the other is a mirror image). The body geometry of the body 312B of the cannula assembly 312 may have a rectangular body shape that is suitably aligned with the cannula 212T as the body 312B descends along the recess 331 and slot 329 with the fork 316F driving the wing 312W (see Figures 3G and 3H). A pivot member 316 may be disposed across the outer side of the side support 327 and engage the wing 312W. During this portion of the stroke, the biosensor 214B, extending downward from the opening 215 of the wearable device 101, is aligned with and received in the longitudinally open side groove 332 formed on one side of the cannula needle 212T.

[0054] As shown in Figures 3G and 3H, precise alignment between the cannula 212T and the biosensor 214B is ideal when the cannula 212T descends. In some embodiments, a steering feature may be formed in the opening 215, which can be used for steering and thus helps ensure that the biosensor 214B is correctly aligned with and received therein by the longitudinal opening-side grooves 332 and body grooves 334 of the cannula 212T and body 312B, as shown in Figures 3G and 3H. Figure 3G shows the sensor assembly 214 and biosensor 214B before insertion during the ascent of the cannula assembly 312, while Figure 3H shows the biosensor 214B correctly aligned with and received therein by the longitudinal opening-side grooves 332 and body grooves 334 of the cannula 212T and body 312B after descent.

[0055] Next, as shown in FIG3D, 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 is shown in dashed lines).

[0056] Next, as shown in FIG3E, when the user continues to push the pusher 102, the latch end 316L of the pivot member passes the latch 104L, and the pivot member 316 can pivot freely around the end of the slot 321, and the cannula assembly 312 and the cannula 212T are retracted as shown, thus implanting the biosensor 214B into the skin (the outer skin surface is shown in dashed lines), while still being connected to the internal electronic components.

[0057] The latch 104L includes a latching surface (lower latching surface) that allows the pivot member 316 to rotate as it passes through the latching end 316L of the pivot member 316 (FIG. 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 may be wider than the latching end 316L of the pivot member 316. The pivot member 316 is largely restricted from rotation until the latching end 316L passes through the latch 104L. As shown, the latch 104L is, for example, part of a vertically extending cutout that may close at its lower end.

[0058] As shown in FIG3F, in order to separate the biosensor inserter 100 from the wearable device 101, the user can pull the contact member 104. This pulls the secondary portion 101S out of the pocket formed by the slot 108 and the door 112. After the inserted biosensor 100 has been completely removed, the user can remove the backing from the adhesive portion coated on the secondary portion 101S, fold the secondary portion 101S onto the skin, and apply slight pressure to adhere the adhesive to the skin (see FIG9).

[0059] Upon removal, all biosensor inserters 100 can be disposed of as medical waste. Because the coverage area is significantly reduced, the volume and cost of the material are also significantly reduced.

[0060] It should be understood that the contact member 104 may be configured to be concentric with the push member 102 and may extend and retract therewith. 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 intersecting the first alignment feature, such as a vertically extending rib. Such alignment features can keep the push member 102 and the contact member 104 rotationally aligned to prevent the contact member 104 from rotating 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, elliptical, rectangular, or any other suitable shape. In some embodiments, the push member 102 and the contact member 104 may not be concentric.

[0061] Referring now to Figures 4 through 11, an embodiment of a method 1100 for inserting a biosensor (e.g., biosensor 214B) using a biosensor inserter (e.g., biosensor inserter 100) is described. 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 slot (e.g., slot 108) formed in the push member or contact member, the slot being configured to allow a primary portion (e.g., secondary portion 101S) of a wearable device (e.g., wearable device 101) to be folded into the slot, and a mechanism (e.g., mechanism 310) configured to translate the wearable device 101 and insert the cannula.

[0062] Method 1100 further includes, in block 1104, folding a secondary portion of the wearable device (e.g., secondary portion 101S) into a slot as shown in FIG. 6 via a closing door 112; in block 1106, bringing a contact member (e.g., contact member 104) into contact with human skin 750; and in block 1108, pushing the actuating member (e.g., actuating member 102) during a first portion of a stroke to cause translation of the wearable device and implantation of the cannula and biosensor.

[0063] Method 1100 includes, in block 1110, continuing to push the pusher to retract the cannula assembly, while maintaining the implanted state of the biosensor during the second part of the stroke as shown in FIG7.

[0064] Before folding the secondary portion 101S of the wearable device 101 into the slot 108, method 1100 may include inserting the transmitter unit 110 into a pouch 216 (FIG. 2F) formed in the secondary portion 101S through an opening 218, for example, through a slit opening as shown in FIG. 4. The sides of the secondary portion can be squeezed with the thumb and fingers to allow passage to the opening 218. The pouch 216 may be large enough to receive the entire volume of the transmitter unit 110 therein. Method 1100 may also include coupling the transmitter unit 110 to an electrical connector 234 disposed in the pouch 216. The electrical connector 234 may be a spring-loaded electrical connector or other suitable connector. According to method 1100, the opening 218 of the secondary portion 101S may be sealed. In some embodiments, this sealing step includes removing the backing member 225 to expose an adhesive 220 applied to the edges 222 of the opening 218 (see FIG. 5 and FIG. 2D-2F). Slight pressure on edge 222 seals opening 218 and encloses transmitter unit 110 in bag 216. After wearable device 101 is separated from biosensor inserter 100, as shown in FIG8, secondary portion 101S can unfold and adhere to skin as shown in FIG9. After biosensor inserter 100 is separated from wearable device 101, biosensor inserter 100 can be disposed of as medical waste, as can cap 105.

[0065] The foregoing description discloses only exemplary embodiments. Modifications to the above-described apparatus and methods that fall within the scope of this case will be readily apparent to those skilled in the art. [Simplified Explanation of the Diagram]

[0010] The accompanying drawings should be considered illustrative, not restrictive. The accompanying drawings are not necessarily drawn to scale. The same numbers are used throughout the accompanying drawings to represent the same elements.

[0011] FIG1A is a side perspective view of a biosensor inserter according to one or more embodiments provided in this case, the biosensor inserter including an open door capable of inserting a wearable device.

[0012] FIG1B is a side perspective view of a biosensor inserter according to one or more embodiments provided in this case, the biosensor inserter including a closed door that enables a wearable device to fold into a recess in the biosensor inserter.

[0013] FIG2A is a perspective view of a wearable device having a removable and reusable transmitter unit to be inserted into and sealed into a bag according to one or more embodiments provided in this case.

[0014] FIG2B is a perspective view of a wearable device having a removable transmitter unit mounted in a bag according to one or more embodiments provided in this case, and illustrates various internal components and hinges that allow partial bending and thus folding of the wearable device.

[0015] FIG2C 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 in this case, the electrical connector being configured to electrically couple with a transmitter unit in a bag.

[0016] FIG2D is a perspective view of a bag and an opening of a wearable device configured to receive a transmitter unit according to one or more embodiments provided in this case.

[0017] FIG2E is a perspective view of a wearable device according to one or more embodiments provided in this case, showing a bag and adhesive contained on the edge of the opening of the bag.

[0018] FIG2F is a perspective view of a wearable device according to one or more embodiments provided in this case, showing a backing component attached to an adhesive in an opening.

[0019] FIG3A is a cross-sectional side view of a biosensor inserter, illustrating a wearable device inserted into a receiver of a transmitter carrier according to one or more embodiments provided in this invention.

[0020] Figure 3B is a cross-sectional side view of a biosensor inserter, illustrating the folding / bending of a wearable device around its hinge and the closing of a door according to one or more embodiments provided in this case.

[0021] FIG3C is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, showing the translation of the cannula assembly to receive the biosensor in an open-side recess therein.

[0022] Figure 3D is a cross-sectional side view of the biosensor inserter, showing the translation of the cannula assembly according to one or more embodiments provided in this case to insert the cannula and biosensor into the user's skin.

[0023] FIG3E is a cross-sectional side view of a biosensor inserter according to one or more embodiments provided in this case, showing the retraction of the cannula assembly to allow the biosensor to be inserted into the user's skin.

[0024] FIG3F is a cross-sectional side view of the biosensor inserter, showing the separation of the biosensor inserter from the wearable device according to one or more embodiments provided in this case.

[0025] FIG3G is a perspective side view of a cannula assembly and a sensor assembly according to one or more embodiments provided in this case, showing the threads of the biosensor and the biosensor being inserted into the opening-side groove of the cannula.

[0026] FIG3H is a perspective side view of a cannula assembly and a sensor assembly according to one or more embodiments provided in this case, showing a biosensor inserted into an open-side groove of the cannula.

[0027] Figure 4 is a perspective view of a biosensor inserter according to one or more embodiments provided in this case, showing the insertion of a transmitter unit into a pouch of a wearable device.

[0028] Figure 5 is a perspective view of a biosensor inserter according to one or more embodiments provided in this case, showing the removal of the backing component to expose the adhesive and thus enable sealing to the opening of the bag.

[0029] Figure 6 is a perspective view of the biosensor inserter, showing the removal of the cover and the closing of the door according to one or more embodiments provided in this case, thereby folding a secondary portion of the transmitter unit including the wearable device into the slot.

[0030] Figure 7 is a side view of a biosensor inserter according to one or more embodiments provided in this case, showing a person pushing a pusher to insert a biosensor of a wearable device into the skin.

[0031] FIG8 is a side view of a biosensor inserter according to one or more embodiments provided in this case, showing the removal of the biosensor inserter and the exposure of the wearable device in a folded state.

[0032] Figure 9 is a side view of a person unfolding and then attaching a secondary part of the wearable device to the skin according to one or more embodiments provided in this case.

[0033] Figure 10 is a perspective view showing medical waste and recyclable components of a biosensor inserter according to one or more embodiments provided in this case.

[0034] Figure 11 illustrates a flowchart of a method for inserting a biosensor into a user's body using a biosensor inserter according to an embodiment provided in this case. [Biomaterial Storage]

[0067] Domestic Storage Information (Please note in order of storage institution, date, and number) None

[0068] Overseas Deposit Information (Please note in the order of deposit country, institution, date, and number) None

Claims

1. A wearable device for continuous analyte monitoring, comprising: A primary component includes at least one sensor assembly, the sensor assembly including a biosensor; a secondary component includes a bag configured to receive a transmitter unit and a sealable opening leading to the bag, the sealable opening including an adhesive on its edge; and a backing member disposed above the adhesive, wherein the step of removing the backing member exposes the adhesive to seal the sealable opening and encapsulate the transmitter unit.

2. The wearable continuous analyte monitor as claimed in claim 1, comprising a hinge formed at an interface between the primary portion and the secondary portion, the hinge being configured to allow the secondary portion to partially bend at the hinge and fold relative to the primary portion.

3. The wearable device for a continuous analyzer monitor as claimed in claim 2, wherein the hinge includes a foldable portion of a circuit board.

4. The wearable device for a continuous analyte monitor as claimed in claim 2, wherein the hinge includes a groove formed in a body and extending between the sides of the body of the wearable device for the continuous analyte monitor.

5. The wearable device for a continuous analyte monitor as claimed in claim 1, wherein the main component further includes one or more power sources.

6. The wearable device for continuous analyte monitoring as claimed in claim 1, wherein the pouch in the secondary portion further includes an electrical connector.

7. The wearable device for a continuous analyte monitor as claimed in claim 6, wherein the electrical connector includes a spring-loaded pin connector.

8. The wearable device for continuous analyte monitoring as claimed in claim 1, wherein the biosensor is received through an opening in a circuit board.

9. The wearable device for a continuous analyte monitor as claimed in claim 1, wherein the bag contains the transmitter unit.

10. A biosensor inserter configured to insert a biosensor into a wearable device, comprising: One driving component; One contact component can be translated relative to the pushing component; And a slot is formed in the pushing member or the contact member, the slot being configured to allow a primary portion of the wearable device to be folded into the slot.

11. The biosensor inserter as claimed in claim 10, wherein the slot is large enough to receive a transmitter unit disposed in the secondary portion of the wearable device.

12. The biosensor inserter as claimed in claim 10, wherein the actuating member or the contacting member includes a door for access to and from the slot.

13. The biosensor inserter as claimed in claim 12, wherein the wearable device can be inserted into the biosensor inserter when the door is open.

14. A method of inserting a biosensor using a biosensor inserter, comprising the following steps: providing the biosensor inserter, including: A pusher, a contactor that can translate relative to the pusher, a cannula assembly including a cannula, and a slot formed in the pusher or the contactor, the slot being configured to allow a primary portion of a wearable device to be folded into the slot, and a mechanism configured to translate the wearable device and insert the cannula. Fold the secondary portion of the wearable device into the slot; The contact component is brought into contact with a person's skin; during a first portion of a stroke, the actuating component is pushed to cause translation of the wearable device and implantation of the cannula and the biosensor; and the actuating component is continued to be pushed to cause the mechanism to retract the cannula assembly while the biosensor remains implanted during the second portion of the stroke.

15. The method of claim 14, comprising the step of: inserting the transmitter unit through an opening into a pouch formed in the secondary portion before folding the secondary portion of the wearable device into the slot.

16. The method of claim 15, comprising the step of: coupling the transmitter unit to an electrical connector in the bag.

17. The method of claim 15, comprising the step of: sealing the opening of the secondary portion.

18. The method of claim 17, wherein the sealing step includes the step of: removing a backing portion to expose the adhesive on the edge of the opening.

19. The method of claim 14, comprising the step of: unfolding the secondary portion and adhering it to the person's skin.

20. The method of claim 14, comprising the step of: discarding the biosensor inserter after separation from the wearable device.

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