Methods and apparatus enabling coupling of an electronics unit to a base unit of a continuous analyte monitoring device
Patent Information
- Authority / Receiving Office
- TW · TW
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2021-09-06
- Publication Date
- 2022-07-16
Smart Images
Figure TWG2TA000866668_001 
Figure TWG2TA000866668_002 
Figure TWG2TA000866668_003
Abstract
Description
[Technical Field]
[0001] Cross-reference to related applications: This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 075,258, filed September 7, 2020, the disclosure of which is incorporated herein by reference in its entirety for all purposes.
[0002] Embodiments disclosed herein relate to methods and apparatus for use with a wearable analyte monitoring device during continuous analyte monitoring. [Previous Technology]
[0003] Continuous analyte monitoring of in vivo samples (e.g., continuous glucose monitoring (CGM)) has become a routine sensing procedure (especially in diabetes care). By providing immediate glucose concentrations, treatment and / or clinical actions can be applied promptly and glycemic status can be better controlled.
[0004] During CGM, biosensors are typically inserted subcutaneously and operate continuously in an environment surrounded by tissue fluid. The biosensors provide signals to a processor or similar device within the CGM system used to calculate the user's glucose levels. These calculations can be performed automatically multiple times a day (e.g., every few minutes or at some other suitable interval).
[0005] The CGM system may include: a wearable device that adheres to the outer surface of a user's skin. The wearable device may communicate with a receiving unit (e.g., wirelessly), which may be a handheld unit carried by the user. For example, the handheld unit may be a smartphone. [Summary of the Invention]
[0006] In some embodiments, a coupling tool is provided for coupling together electronic units and basic units of a wearable device for continuous analyte monitoring. The coupling tool includes: a carrier comprising: a receiving feature and a carrier holding device configured to hold an electronic unit adjacent to the receiving feature; and an actuator comprising: a first member at least partially housed in the receiving feature; and a contact member configured to release the electronic unit from the carrier holding device in response to movement of the actuator relative to the carrier. The coupling tool is in a locked configuration when the carrier holding device is configured to hold the electronic unit, and in an unlocked configuration when the carrier holding device is configured to release the electronic unit from the carrier holding device.
[0007] In some embodiments, a method is provided for coupling an electronic unit of a wearable device of a continuous analyte monitoring system to a base unit. The method includes the steps of: holding the electronic unit on a carrier of a coupling tool by using a carrier holding device; positioning the electronic unit adjacent to the base unit; and engaging the carrier holding device with an actuator of the coupling tool, wherein the engagement step releases the electronic unit from the carrier holding device.
[0008] In some embodiments, a coupling tool is provided. The coupling tool includes: a carrier including: a receiving feature; a carrier holding device attached to the carrier, the carrier holding device including: a first arm and a second arm configured to hold an electronic unit adjacent to the receiving feature; and an actuator including: a first member at least partially received in the receiving feature and configured to contact the electronic unit in response to the coupling tool being in an unlocked configuration; and a contact member configured to release the electronic unit from the carrier holding device in response to the coupling tool being in an unlocked configuration and to couple the electronic unit of a wearable device of a continuous analyte monitor to a base unit.
[0009] Other features, appearances, and advantages of the embodiments according to this disclosure will become more fully apparent from the following description, the claims, and the accompanying drawings by way of example embodiments. Various embodiments according to this disclosure may also be applicable to other different applications, and certain details may be modified in various respects without departing from the scope of the claims. Therefore, the drawings and descriptions are to be considered illustrative in nature and not restrictive. The drawings are not necessarily drawn to scale.
Implementation Method
[0035] To more closely monitor analyte levels (e.g., glucose concentration) and detect changes in analyte levels, methods and apparatus have been developed for continuous analyte monitoring (e.g., continuous glucose monitoring (CGM)). Although CGM systems generate glucose signals (e.g., continuous electrochemical signals) "continuously" during operation, the measurements of the generated glucose signals are typically performed every few minutes, rather than being truly continuous. While the description below relates to continuous glucose monitoring, the apparatus and methods described below can be readily applied to monitor other analytes (e.g., cholesterol, lactic acid, uric acid, alcohol, etc.) in other continuous analyte monitoring systems.
[0036] CGM systems typically have a wearable component ("wearable device") that communicates wirelessly with external devices (e.g., handheld monitors or other portable devices (e.g., mobile phones, computers, or servers)). The wearable device can be worn for days or even weeks (e.g., 1-2 weeks) before being removed and replaced. The wearable device includes: a biosensor inserted (implanted) under the skin. The wearable device may also include: circuitry coupled to the biosensor, configured to bias the biosensor and measure a current signal generated by an electrochemical reaction with an element of the implanted biosensor. The wearable device may also include: processing circuitry for determining the location of an analyte (e.g., glucose) based on the measured current signal, and electronic transmitter circuitry for transmitting the location of the analyte (e.g., glucose) to an external device. The wearable device can be attached (e.g., adhered) to an external surface of the skin (e.g., to the abdomen, the back of the upper arm, or another suitable location). The CGM system measures the concentration or position of an analyte (e.g., glucose) in tissue fluid or non-direct capillary blood samples.
[0037] The CGM system can provide frequent measurements of the user's analyte (e.g., glucose) position without requiring a blood sample to be drawn (e.g., by fingertip) for each such measurement. The CGM system may still occasionally be checked for calibration using a fingertip and a blood glucose measurement (BGM) system (e.g., Contour NEXT One® from Ascensia Diabetes Care AG in Basel, Switzerland).
[0038] As described above, the wearable device of the CGM system is typically worn for a period of time, then removed and replaced with a new wearable device. The need to replace the wearable device of the CGM system at designed intervals can significantly increase the cost of performing such continuous analyte monitoring.
[0039] In the embodiments described herein, the wearable device may include: a basic unit (e.g., a disposable portion) and an electronic unit (e.g., a reusable portion). In some embodiments, the basic unit may include: a power supply for the wearable device, an analyte sensor (biosensor), and / or other electronic components. The electronic unit may include: electronic circuitry used to, for example, provide a bias voltage to the analyte sensor and measure a current signal via the analyte sensor, and also to calculate an analyte concentration value (e.g., glucose concentration) based on the measured current signal, and / or transmit analyte concentration value information to an external device.
[0040] In some embodiments, the electronic unit may include: a power supply for the wearable device. Example circuitry within the electronic unit may also include: an analog front-end for biasing an analyte sensor and sensing current through the analyte sensor (e.g., an operational amplifier, current sensing circuitry, etc.). Other circuitry within the electronic unit may include: processing circuitry (e.g., an analog-to-digital converter (ADC)) for digitizing the current signal; memory for storing the digitized current signal; a controller (e.g., a microprocessor, microcontroller, etc.) for calculating a glucose concentration value based on the measured current signal; and transmitter / receiver circuitry for transmitting the glucose concentration value to an external device and / or receiving instructions from an external device.
[0041] The electronic unit is usually the most expensive part of a wearable device and can last much longer than the time the wearable device is used. For example, a wearable device is usually discarded after about two weeks, while the electronic unit can be reused with 10, 20, 50, 100 basic units (or even more basic units).
[0042] Wearable devices can be very small so as not to interfere with the user's movement or cause the user annoyance. Therefore, the electronic units may be very small, which can make it difficult to manually couple the electronic units to the base unit. Therefore, a coupling tool and method for coupling reusable electronic units to a base unit is provided. These and other embodiments are described below with reference to FIG1A-11.
[0043] Referring now to 1A-1H, various views of a wearable device 100 and its components are illustrated, showing examples of its use during continuous analyte monitoring. Figures 1A-1B illustrate the wearable device 100 according to embodiments provided herein. Figure 1C illustrates an exploded isometric view of an example embodiment of components located within the wearable device 100. Figure 1D illustrates an isometric view of a basic unit 102 of the wearable device 100, without any electronic units located therein. The components of Figure 1C may be located within the basic unit 102 of Figure 1D, which may be overmolded to (e.g.) retain the components. Figures 1E-1H illustrate various isometric views of examples of base structures contained in the basic unit 102.
[0044] The wearable device 100 may include: a basic unit 102 (e.g., a disposable basic unit) that engages and couples with each other to form the wearable device 100, and an electronic unit 104 (e.g., a reusable electronic unit). The electronic unit 104 is sometimes referred to as a transmitter unit. The basic unit 102 may include: a hole or opening 106 or other coupling structure for receiving the electronic unit 104. Devices and methods are disclosed herein that enable a user to couple the electronic unit 104 to the basic unit 102. In some embodiments, the basic unit 102 is configured to be processed after a single analyte monitoring period (e.g., 7 days, 10 days, 14 days, or some other time period), while the electronic unit 104 is configured to be removed from the basic unit 102 after the single analyte monitoring period and reused with another basic unit. For example, the electronic unit 104 may be reused with 2, 5, 10, 50, 100, or more basic units.
[0045] In some embodiments, the base unit 102 is hermetically sealed. For example, an encapsulation layer 108 may be formed over the components within the base unit 102. In some embodiments, the encapsulation layer 108 may include an opening 106 that allows the electronic unit 104 to couple to the base unit 102. In some embodiments, the encapsulation layer 108 forms a waterproof seal around the base unit 102 and its internal components. The connector 110 may remain exposed (e.g., in the opening 106) so that the connector on the electronic unit 104 can be electrically connected to the connector 110. The encapsulation layer 108 may be formed of a single layer or multiple layers. For example, the encapsulation layer 108 may be formed of one or more layers of liquid silicone rubber (LSR), thermoplastic elastomer (TPE), etc. Other suitable sealing materials may be used.
[0046] The basic unit 102 may include: an analyte sensor 114 (FIG. 1C) electrically coupled to the connector 110 and operable to generate an electrical signal in response to contact and reaction with tissue fluid. The electrical signal may be transmitted to an electronics unit 104, where the electrical signal is measured. The electronics unit 104 or an external device (not shown) may determine the glucose concentration (or the concentration of another analyte) based at least in part on the measured electrical signal.
[0047] Figures 1C and 1E-1H illustrate exploded views and other isometric views (including an electronics unit 104) of example embodiments of some elements that may be located within a basic unit 102 of a wearable device 100. As shown, the basic unit 102 may include: a base structure 116, which may be a chassis or the like for holding elements within the basic unit 102. Some embodiments of the base structure 116 may have one or more power support locations 118A-118B, an electronics unit support location 120, and a sensor assembly support location 122. In some embodiments, the base structure 116 may be formed of a plastic (e.g., but not limited to: acrylonitrile-butadiene-styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polyurethane, polyetherurethane, polyetheretherketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE)). Other suitable materials may be used.
[0048] Power support locations 118A, 118B provide positions for supporting one or more power sources 124A, 124B that are used to supply power to components of the wearable device 100 (e.g., the electronics unit 104 of the wearable device 100). For example, one or more power sources 124A, 124B may be positioned at power support locations 118A, 118B. In some embodiments, one or more power sources 124A, 124B may be batteries, storage capacitors, solar cells, generators, etc. Although power sources 124A, 124B are shown as two batteries, it will be understood that fewer, more, and / or different power sources may be used. Power support locations 118A, 118B may be any suitable shape (e.g., rectangular, square, circular, etc.) to receive one or more power sources 124A, 124B. In some embodiments, power sources 124A, 124B may be located within the electronics unit 104.
[0049] The electronic unit support location 120 is configured to retain (or otherwise attach) the electronic unit 104 to the base unit 102. In some embodiments, the electronic unit support location 120 may include one or more first retaining features 126. In some embodiments, the electronic unit support location 120 may include four first retaining features 126, which are respectively referred to as first retaining features 126A-126D. The first retaining features 126 may engage with and / or press against second retaining features 128 on the electronic unit 104 (which are respectively referred to as second retaining features 128A-128D) to couple and retain the electronic unit 104 to the base structure 116 of the base unit 102 (e.g., as shown in FIG. 1G). Fewer, more, and / or different retaining features may be used to secure the electronic unit 104 to the base structure 116. The first retaining feature 126 may include, for example, a protrusion of an opening in the second retaining feature 128 of the engagement electronics unit 104. In some embodiments, the first retaining feature 126 and the second retaining feature 128 may include, for example, a magnet, a hook and loop fastener, a surface with an adhesive, etc.
[0050] In some embodiments, the electronic unit support location 120 may include a break location 131 (FIGs 1C, 1F, and 1G) (e.g., a channel, groove, scribe line, etc.) that allows the base structure 116 to bend and / or break, such that when the electronic unit 104 is to be removed from the base unit 102 and / or the base structure 116, the first retaining feature 126 disconnects and / or releases the electronic unit 104. Other release and / or break locations may be used. In some embodiments, other retaining features may be used to retain the electronic unit 104, wherein other retaining features do not require bending the base structure 116 to remove the electronic unit 104.
[0051] The substrate 130 (e.g., a circuit board, flexible circuit board, etc.) may be located within the electronics unit support location 120 and may include a connector 110 that provides an electrical interface to a similar connector (not shown) on the electronics unit 104. For example, the connector 110 may be electrically connected via conductors (not shown) to power supplies 124A, 124B to allow power supplies 124A, 124B to supply power to the electronics unit 104 when the electronics unit 104 is positioned within the electronics unit support location 120. The connector 110 may also be electrically connected to an analyte sensor 114 to supply voltage to the analyte sensor 114.
[0052] FIG. 1H illustrates an exploded isometric view of another alternative embodiment of the base structure 116A and electronic unit 104 of FIG. 1C, with further examples of a first holding feature 132 and a second holding feature 134 holding the electronic unit 104 within the base structure 116A. In the embodiment of FIG. 1H, the electronic unit 104 has a first holding feature 132, and the base structure 116A has a second holding feature 134. The first holding feature 132 on the electronic unit 104 may extend to the second holding feature 134 on the base structure 116A, which is an opening configured to receive the first holding feature 132.
[0053] The sensor assembly support location 122 provides a mounting location for at least a portion of the analyte sensor assembly 139, and may include, for example, an insertion device 140 and an insertion device cap 142. The insertion device 140 may include an insertion portion 144 comprising a pointed tip 146 (FIG. 1C) that pierces the skin to introduce the analyte sensor 114 into the subcutaneous region of the user (as described herein). The insertion portion 144 may also be referred to as an insertion shaft, needle, cannula, tip, etc.
[0054] The insertion portion 144 of the insertion device 140 may be made of, for example, metal (e.g., stainless steel) or non-metal (e.g., plastic). Other materials may be used. In some embodiments, the insertion portion 144 of the insertion device 140 may be (but is not limited to): a circular C-channel tube, a circular U-channel tube, a stamped sheet metal piece folded into a square U-shaped profile, a molded / cast piece, a laser-cut or machined metal piece with a U-shaped channel profile, or a solid metal cylinder with an etched or ground square U-shaped channel. Other insertion portion shapes may be used. The channel formed in the insertion portion 144 carries the analyte sensor 114 during insertion. In some embodiments, portions of the insertion device 140 may be formed of plastic (e.g., but not limited to: ABS, polycarbonate, nylon, acetal, PPA, polyurethane, polyetherurethane, PEEK, polypropylene, HDPE, LDPE, etc.). Other materials may be used.
[0055] For example, the insertion portion 144 may extend through the sensor opening 150 (FIG. 1F) of the sensor assembly support position 122 of the base structures 116, 116A. The analyte sensor 114 is electrically connected to a connector 110 of the substrate 130 within the electronics unit support position 120. The connector 110 electrically connects the analyte sensor 114 to the electronics unit 104 disposed within the electronics unit support position 120.
[0056] During continuous analyte monitoring, the first and second retention features 126, 128, 132, 134 described herein secure (e.g., couple) the electronic unit 104 to the base structure 116, 116A of the base unit 102, while allowing the electronic unit 104 to be removed and reused after a continuous analyte monitoring period. The base unit 102 may be configured to be disposed of after a single analyte monitoring period, while the electronic unit 104 may be configured to be detached from the base unit 102 and reused with other base units after a single analyte monitoring period. For example, the base structure 116 may be bent along a break location 131, which releases the first retention feature 126 from the electronic unit 104 (FIG. 1F). In some embodiments, a single analyte monitoring period may be at least 7 to 10 days (and, for example, up to 14 days or longer). Electronic unit 104 can be removed from basic unit 102 and reused (e.g., 5, 10, 20, 50, 100 or more times, each time using a new basic unit 102 containing a new analyte sensor 114).
[0057] FIG2 illustrates an exploded view of an example of an electronic unit 104 according to some embodiments provided herein. In the embodiment of FIG2, the electronic unit 104 may include: a substrate 202 coupled to a top cover 204, and may be covered by a bottom cover 206 (e.g., an overmolded portion) to cover and seal the substrate 202 and any components 208 thereon. The substrate 202 may be a circuit board, a flexible circuit board, or another mounting location for electronic circuitry used within the electronic unit 104. The top cover 204 and / or the bottom cover 206 may be formed from one or more layers of liquid silicone rubber (LSR), thermoplastic elastomer (TPE), molded plastic caps, etc. Other materials may be used (e.g., but not limited to: ABS, polycarbonate, nylon, acetal, PPA, polyurethane, polyether ether, PEEK, polypropylene, HDPE, LDPE, etc.).
[0058] The substrate 202 may include an interface 212 (e.g., a connector) configured to engage with the connector 110 (FIG. 1C) of the base unit 102 when the electronics unit 104 is disposed within the electronics unit support position 120 of the base structure 116. For example, an opening 214 in the bottom cover 206 may be provided to allow the interface 212 to be coupled to the connector 110 of the base unit 102. In some embodiments, one or more elements 208 may be electrically coupled to the analyte sensor 114 via the interface 212 and the connector 110 of the base unit 102.
[0059] In some embodiments, the bottom cover 206 may include a sealing member 216 (e.g., a lip or similar feature) configured to seal against the sidewall or other portion of the opening 106 of the base unit 102 (also refer to Figures 3A and 3B below) such that when the electronic unit 104 is disposed within the base unit 102, the electronic unit 104 and the base unit 102 form a sealed unit. In some embodiments, the top cover 204 may include one or more second retaining features 128 configured to engage with first retaining features 126A-126D (Figure 1C) (e.g., one or more first retaining features 126) within the electronic unit support position 120. Such first and second retaining features can engage to securely retain the electronic unit 104 to the base unit 102 and maintain contact between the connector 110 and the interface 212 during use. In other embodiments, the top cover 204 may include a sealing member, and / or the bottom cover 206 may include retaining features.
[0060] FIG3A illustrates a cross-sectional view of a wearable device 100 according to some embodiments, wherein the electronic unit 104 is removed from the base unit 102. FIG3B illustrates a cross-sectional view of the wearable device 100 of FIG3A according to some embodiments, wherein the electronic unit 104 and the base unit 102 are coupled together. As described herein, both the electronic unit 104 and the base unit 102 can be hermetically sealed units (e.g., waterproof), wherein only the interface 212 of the electronic unit 104 and the connector 110 of the base unit 102 are exposed. When the electronic unit 104 is coupled to the base unit 102, the connector 110 and the interface 212 can also be sealed to any external environment.
[0061] Referring now to FIG. 4A, an example illustrates an isometric side view of a coupling tool 400 for coupling an electronic unit 104 (FIG. 1B) of a wearable device 100 (FIG. 1B) to a base unit 102. The coupling tool 400 can be used to couple other electronic units and base units of other types of wearable devices together. The coupling tool 400 includes and is composed of an actuator 402 and a carrier 404. The coupling tool 400 can be used with an insert 406 that allows a user to attach the wearable device 100 to the user as described herein. In summary, the base unit 102 can be held within the insert 406 (see FIG. 8A) without the electronic unit 104 coupled thereto. Electronic unit 104 is held and supported by carrier 404, and carrier 404 and electronic unit 104 are inserted into opening 422 at the top of insert 406 to position carrier 404 and electronic unit 104 within insert 406 (see FIG. 9A). Then, actuator 402 moves relative to carrier 404 (e.g., within carrier 404 in some embodiments), causing actuator 402 to release electronic unit 104 from carrier 404 and couple electronic unit 104 to base unit 102 (see FIG. 9B).
[0062] When the coupling tool 400 is configured to release the electronic unit 104, the coupling tool 400 may be referred to as being in an unlocked configuration. When the coupling tool 400 is configured to retain the electronic unit 104, the coupling tool 400 may be referred to as being in a locked configuration.
[0063] Referring also to Figures 5A-5D, various views of the starter 402 are illustrated according to the embodiments provided herein. Figure 5A illustrates a side view of the starter 402, Figure 5B illustrates a front view of the starter 402, Figure 5C illustrates an isometric top view of the starter 402, and Figure 5D illustrates an isometric bottom view of the starter 402. The starter 402 may include a top 510 having a top surface 510S. The top surface 510S may be configured to be pressed by a user during coupling of the electronic unit 104 to the base unit 102.
[0064] A first member 512 may extend a length L51 from the top 510 to an end 512A. When the electronic unit 104 and the base unit 102 are coupled together, the end 512A may be configured to contact the electronic unit 104. For example, the end 512A may be configured to contact the top cover 204 of the electronic unit 104 (FIG. 2). The first member 512 may have sufficient rigidity to withstand the forces applied between the electronic unit 104 and the base unit 102 during engagement. In some embodiments, the actuator 402 may be referred to as being in a locked position or configuration when the end 512A is not in contact with the electronic unit 104, and the actuator 402 may be referred to as being in an unlocked position or configuration when the end 512A contacts the electronic unit 104. In the unlocked position, the electronic unit 104 is no longer retained. The length L51 may be long enough to push the electronic unit 104 out of the carrier 404 when the actuator 402 is in the unlocked position as described herein.
[0065] The starter 402 may also include a contact member 514 extending from the top 510. The contact member 514 may extend for a length L52 between the top 510 and an end 514A of the contact member 514. As described herein, when the starter 402 is in the unlocked configuration described herein, or when the carrier 404 changes from a locked configuration to the unlocked configuration described herein, the contact member 514 may engage a movable or flexible member of the carrier 404 to release the electronic unit 104 from the carrier 404.
[0066] Referring also to Figures 6A-6D, different views of an embodiment of the carrier 404 are illustrated. Figure 6A illustrates an isometric top view of the carrier 404, Figure 6B illustrates a front view of the carrier 404, Figure 6C illustrates a bottom isometric view of the carrier 404, and Figure 6D illustrates a side view of the carrier 404.
[0067] The carrier 404 may be configured to deliver the electronic unit 104 to the base unit 102 and / or the insert 406. The carrier 404 may have a first side 616A (e.g., bottom side) and a second side 616B (e.g., top side). A length L61 extends between the first side 616A and the second side 616B. In some embodiments, the length L61 may be slightly less than the length L51 of the first member 512 of the actuator 402 (FIG. 5A). The carrier 404 may have a receiving feature 618 (e.g., a rectangular hole as shown) extending between the first side 616A and the second side 616B. The shape and / or size of the receiving feature 618 may be designed to receive at least a portion of the first member 512 of the actuator 402 and to allow the first member 512 to move (e.g., slide) within the receiving feature 618. The receiving feature 618 may include a first receiving feature 618A and a second receiving feature 618B, wherein the electronic unit 104 is configured to be positioned adjacent to the first receiving feature 618A when the coupling tool 400 is in a locked configuration (e.g., when the electronic unit 104 is held by the carrier 404 (see Figures 7A-7B)). The receiving feature 618 is shown as a hole. In other embodiments, the receiving feature 618 may be a slot, a recess, or other features that perform the functions described herein.
[0068] When viewed from either the first side 616A or the second side 616B, the carrier 404 may have an outer surface defining the lateral shape of the carrier 404. As described herein, the lateral shape of the carrier 404 allows the carrier 404 to be received within an opening 422 (FIG. 4B) in the insert 406. For example, the carrier 404 may include a shape configured to allow the carrier 404 to slide within the opening 422. In some embodiments, the lateral shape of the carrier 404 may be the same as that of the opening 422, but slightly smaller, so that the carrier 404 can move within the opening 422 with minimal friction.
[0069] Referring also to FIG4B, a plan view of opening 422 is illustrated according to the embodiments provided herein. Carrier 404 may include one or more indexing devices that orient carrier 404 in a specific direction within opening 422. In the embodiments of FIG4B and 6A-6D, carrier 404 includes two guide rails (first guide rail 624A and second guide rail 624B, which extend from the outer surface and orient carrier 404 within opening 422). First guide rail 624A and second guide rail 624B may be received within first channel 426A and second channel 426B of opening 422, respectively. The positions of first guide rail 624A, second guide rail 624B, first channel 426A, and second channel 426B such that carrier 404 is received within opening 422 in only one direction. For example, in the embodiment of FIG4B, opening 422 includes a first side 422A and an opposing second side 422B. Both the first channel 426A and the second channel can be located at a length L41 from the first side 422A and a length L42 from the second side 422B, where length L41 is not equal to length L42. Therefore, the positions of the first channel 426A and the second channel 426B allow the carrier 404 to be accommodated within the opening 422 in only one orientation. This orientation provides suitable coupling between the electronic unit 104 and the basic unit 102. Other indexing and / or orientation components can be used.
[0070] The carrier 404 is configured to hold the electronic unit 104 (as shown in Figures 7A and 7B, where Figures 7A and 7B are bottom isometric views and isometric top views, respectively, of an embodiment of holding the electronic unit 104 and a carrier 404 having an actuator 402 therein). In some embodiments, the carrier 404 may have a hole 630 configured (e.g., adjusted in shape and size) to receive the electronic unit 104 (Figures 6A-C and 7C). The hole 630 may be located near a first side 616A of the carrier 404 and may intersect with the receiving feature 618 (Figure 6A) such that the end 512A (Figures 5A-5D) of the first member 512 of the actuator 402 can contact the electronic unit 104. For example, the hole 630 may be in or near the receiving feature first end 618A of the receiving feature 618. As shown in FIG9B, the first component 512 of the actuator 402 is accessible to the electronic unit 104 to drive the electronic unit 104 and the base unit 102 together. In some embodiments, the aperture 630 is configured to keep the electronic unit 104 flush with the first side 616A of the carrier 404.
[0071] In some embodiments, the carrier 404 may include one or more retaining devices configured to retain the electronic unit 104 to the carrier 404 (e.g., within the aperture 630 or additionally at an end of the carrier 404). When the carrier 404 retains (or is configured to retain) the electronic unit 104, the carrier 404 and / or the one or more retaining devices may be in a locked configuration or locked state. When the electronic unit 104 is released from the carrier 404 or the carrier 404 is configured to release the electronic unit 104, the carrier 404 and / or the one or more retaining devices may be in an unlocked configuration or unlocked state. In the embodiments of FIG. 6A-7C, the carrier 404 may include a carrier retaining device 632 configured to retain the electronic unit 104 within, for example, the aperture 630, and such that the contact member 514 of the actuator 402 (FIG. 4A) can release the electronic unit 104 from the aperture 630. For example, the contact member 514 (Figures 5A-5D and 7A-7C) can be configured to release the electronic unit 104 from the carrier holding device 632 in response to movement of the actuator 402 relative to the carrier 404.
[0072] The carrier holding device 632 may include one or more hooks for holding the electronic unit 104 to the carrier 404. In the embodiments of FIG. 6A-7C, the carrier holding device 632 may include a first arm 634 having a first hook 636A and a second arm 635 having a second hook 636B. The first arm 634 may pivot or flex about a first point 638A, and the second arm 635 may pivot or flex about a second point 638B. In some embodiments, the first point 638A and the second point 638B may be the locations where the first arm 634 and the second arm 635 are connected to the body portion of the carrier 404. In some embodiments, the first arm 634 and the second arm 635 are flexible such that when the first arm 634 and the second arm 635 interact or engage with the contact member 514 of the actuator 402, they bend (as described herein) to release the electronic unit 104 from the aperture 630. The first arm 634 and the second arm 635 may be separated from the body of the carrier 404 by a gap.
[0073] The first hook 636A and the second hook 636B can be configured to grip and / or retain the electronic unit 104 to the carrier 404 when the carrier 404 is in a locked configuration. In some embodiments, the first hook 636A and the second hook 636B can be configured to engage two of the retaining features of the electronic unit 104 (e.g., retaining features 128A-D shown in FIG. 2) to retain the electronic unit 104 in the aperture 630. In the embodiment depicted in FIG. 7A-7B, the first hook 636A is shown engaged with retaining feature 128C, and the second hook 636B is shown engaged with retaining feature 128A, which retains the electronic unit 104 in the aperture 630.
[0074] The first arm 634 may have an inner surface 634S (FIG. 6B), and the second arm 635 may have an inner surface 635S facing the inner surface 634S. The inner surfaces 634S and 635S may guide the contact member 514 of the starter 402 between the first arm 634 and the second arm 635. The first arm 634 may also have a first protrusion 634P that includes a portion of the inner surface 634S. The second arm 635 may also have a second protrusion 635P that includes a portion of the inner surface 635S. The first protrusion 634P and the second protrusion 635P may be configured to contact the contact member 514 when the starter 402 is switched to the unlocked configuration, which will cause the carrier 404 to switch to the unlocked configuration and release the electronic unit 104 (as described herein).
[0075] When the starter 402 is in the locked configuration, the carrier 404 is also in the locked configuration. In some embodiments, the first arm 634 and the second arm 635 may be biased toward each other so that the carrier 404 is normally in the locked configuration. In some embodiments, the first hook 636A and the second hook 636B may be biased toward each other so that the carrier 404 is normally in the locked configuration. When the contact member 514 of the starter 402 engages the first protrusion 634P and the second protrusion 635P, the first hook 636A and the second hook 636B disengage from each other, which puts the carrier 404 in the unlocked configuration and releases the electronic unit 104 from the opening 630. For example, the first arm 634 and the second arm 635 bend or pivot about the first point 638A and the second point 638B. Thus, the carrier 404 changes to the unlocked configuration, and the electronic unit 104 is released from the carrier 404. The position of the first protrusion 634P on the first arm 634 and the position of the second protrusion 635P on the second arm 635 determine the distance at which the contact member 514 is positioned within the carrier 404 when the actuator 402 engages the carrier holding device 632 and causes the carrier 404 to switch between a locked configuration and an unlocked configuration.
[0076] When the contact member 514 of the actuator 402 releases the electronic unit 104 from the carrier 404, the first member 512 of the actuator 402 can eject the electronic unit 104 from the carrier 404. For example, the end 512A of the first member 512 can contact the electronic unit 104 and drive the electronic unit 104 and the base unit 102 together. The length L51 of the first member 512 and the length L52 of the contact member 514 can cause the carrier 404 to change to an unlocked configuration before the first member 512 ejects the electronic unit 104 from the carrier 404. In some embodiments, the positions of the first protrusion 634P and the second protrusion 635P on the first arm 634 and the second arm 635 can also cause the carrier 404 to change to an unlocked configuration before the first member 512 ejects the electronic unit 104 from the carrier 404.
[0077] The electronic unit 104 can be held in the carrier 404 by driving the electronic unit 104 into the aperture 630. The force can cause the first arm 634 and the second arm 635 to bend away from each other. As the electronic unit 104 is further pushed into the aperture 630, the first hook 636A and the second hook 636B can engage the second holding feature 128 on the electronic unit 104 to hold the electronic unit 104 within the aperture 630.
[0078] In some embodiments, the insert 406 may be a means of attaching the wearable device 100 to a user's skin. For example, the insert 406 may enable a user to attach the wearable device 100 to the skin and position the analyte sensor 114 in a subcutaneous region. The wearable device 100 may be attached to the user's skin before, during, or after the electronics unit 104 is coupled to the base unit 102.
[0079] Referring now to Figures 8A and 8B. Figure 8A is an exploded isometric view illustrating an embodiment of insert 406 and coupling tool 400 according to an example embodiment provided herein. In the embodiment of Figure 8A, electronic unit 104 is housed in coupling tool 400. Figure 8B is an exploded isometric view illustrating an embodiment of insert 406 and coupling tool 400 according to an example embodiment provided herein, wherein electronic unit 104 is coupled to base unit 102 (e.g., housed within base unit 102). In the configuration depicted in Figure 8A, coupling tool 400 is in a locked configuration, wherein electronic unit 104 is held by carrier 404. Insert 406 depicted herein is an example of one of many inserts that can be used with coupling tool 400. Inserts used with coupling tool 400 may have an opening 422 or similar, which provides the coupling tool 400 with access to an opening or similar on base unit 102 housing electronic unit 104. In some embodiments, a support member or other means for supporting the basic unit 102 during coupling of the basic unit 102 with the electronic unit 104 may be used instead of the insert 406.
[0080] Insert 406 may include: a top cover 406A including an opening 422. As described above, the coupling tool 400 may be at least partially received in the opening 422. Insert 406 may also include: an outer sleeve 406B, wherein the top cover 406A may slide on and be coupled to the outer sleeve 406B. In some embodiments, portions of a component (not shown in Figures 8A-8B) for inserting the analyte sensor 114 (FIG. 1D) into the subcutaneous region of the user may be located within the outer sleeve 406B. Insert 406 may include: a base unit support 406C, which may be at least partially received within the inner sleeve 406D. As shown, the base unit support 406C may be configured to support the base unit 102 during coupling of the electronic unit 104 to the base unit 102. In some embodiments, the insert 406 may include a cover 406E that covers the lower portion of the insert 406 and / or the lower portion of the basic unit 102.
[0081] Opening 422 provides passage between the top cover 406A and the opening 106 in the base unit 102 housing the electronic unit 104. Thus, opening 422 allows a coupling tool 400 (as shown in FIG. 8A) with the electronic unit 104 attached thereto to enter opening 422. As shown in FIG. 8B, the coupling tool 400 can then be used to couple the electronic unit 104 to the base unit 102. In the example of FIG. 8B, the electronic unit 104 is inserted into the base unit 102. Similarly, the base unit support 406C may have an opening through which the coupling tool 400 with the electronic unit 104 attached thereto can pass to couple the electronic unit 104 to the base unit 102.
[0082] Referring now to Figures 9A and 9B, an example illustrates a partial cross-sectional view of an insert 406 having a base unit 102, an electronic unit 104, and a coupling tool 400 located therein. In the configuration of Figure 9A, the coupling tool 400 is in a locked configuration, and the electronic unit 104 is held by the coupling tool 400. In the configuration of Figure 9B, the coupling tool 400 is in an unlocked configuration, and the electronic unit 104 is coupled to the base unit 102. For example, the electronic unit 104 has been inserted into the base unit 102.
[0083] In the configuration of FIG. 9A, the coupling tool 400 is at least partially located in the opening 422 and is in a locked configuration. As shown in FIG. 9A, the actuator 402 is not fully inserted into the carrier 404, so the contact member 514 does not contact the first protrusion 634P or the second protrusion 635P. Therefore, the coupling tool 400 is in a locked configuration, wherein the electronic unit 104 is held thereon.
[0084] In the configuration of FIG. 9B, the coupling tool 400 has been used to insert the electronic unit 104 into the base unit 102. As shown in FIG. 9B, the actuator 402 has been pressed into the carrier 404 in the z-direction, causing the contact member 514 to contact the first protrusion 634P and the second protrusion 635P. Contact with the first protrusion 634P and the second protrusion 635P causes the first hook 636A and the second hook 636B to move away from each other, thereby releasing the electronic unit 104 from the carrier 404. As the actuator 402 is further pressed into the carrier 404, the end 512S (FIGs 5A-5D) of the first member 512 contacts the electronic unit 104 and drives the electronic unit 104 into the opening 106 in the base unit 102. When the electronic unit 104 is coupled to the base unit 102, a waterproof seal can be formed between the base unit 102 and the electronic unit 104 to prevent contaminants from entering the opening 106.
[0085] When the electronic unit 104 and the base unit 102 are coupled together, the second retaining feature 128 (FIG. 1F) of the electronic unit 104 engages with the first retaining feature 126 of the base unit 102, thus coupling the electronic unit 104 to the base unit 102. After coupling the electronic unit 104 to the base unit 102, the coupling tool 400 can be removed from the insert 406, and the wearable device 100 (which includes the electronic unit 104 and the base unit 102) can be applied (e.g., attached or adhered) to the user. In some embodiments, the coupling tool 400 can be used to couple the electronic unit 104 and the base unit 102 together after the base unit 102 has been applied to the user.
[0086] The wearable device 100 (FIG. 1A) may be worn by a user for a period of time (e.g., two weeks or the time required for replacement and / or removal of the base unit 102 from the user). During this period, the wearable device 100 may monitor / measure analytes (e.g., in the user's subcutaneous area). After analyte monitoring, the wearable device 100 may be detached from the user. The electronic unit 104 of the wearable device 100 may then be disconnected / detached from the base unit 102. For example, the electronic unit 104 may be detached from the base unit 102, and the base unit 102 may be discarded. Generally, the electronic unit 104 may be detached from the base unit 102 before or after removal from the user. Thereafter, the electronic unit 104 may be coupled to a new base unit using the coupling tool 400 described herein. The new base unit may include: a new power source and a new analyte sensor.
[0087] Although the electronic unit 104 is shown coupled to the top surface of the base unit 102, it will be understood that in other embodiments, the electronic unit 104 may be removable and / or coupled to other surfaces of the base unit. For example, FIG10 illustrates a bottom view of a base unit 1002 of a wearable device 1000 with an opening 1006 that allows coupling of the electronic unit 104 to the base unit 1002 using a coupling tool 400 (FIG. 4). In some embodiments, the base unit 1002 may be placed in a device other than an insert that allows the coupling tool 400 to enter the opening 1006.
[0088] Referring now to FIG11, it is a flowchart illustrating an example of a method 1100 for coupling an electronic unit (e.g., electronic unit 104) and a base unit (e.g., base unit 102) of a wearable device (e.g., wearable device 100) to be used during continuous analyte monitoring. Method 1100 includes the step of holding the electronic unit to a carrier (e.g., carrier 404) at program block 1102 by using a carrier holding device (e.g., carrier holding device 632). Method 1100 also includes the step of positioning the electronic unit adjacent to the base unit at program block 1104. The method further includes the step of engaging the carrier holding device with an actuator (e.g., actuator 402) at program block 1106, wherein the engagement step releases the electronic unit from the carrier holding device. Further action of the actuator couples the electronic unit to the base unit.
[0089] The foregoing description only discloses exemplary embodiments. Modifications to the apparatus and methods disclosed herein that fall within the scope of this disclosure will be readily apparent to those skilled in the art. [Simplified Explanation of the Diagram]
[0010] Figures 1A and 1B illustrate, respectively, a top isometric view and a side view of a wearable device used during continuous analyte monitoring, according to embodiments provided herein.
[0011] FIG1C illustrates an exploded isometric view of an example embodiment provided herein, showing some elements constituting a wearable device used during continuous analyte monitoring.
[0012] FIG1D illustrates an isometric view of the basic unit of a wearable device according to an example embodiment provided herein, wherein the wearable device has no electronic units coupled thereto.
[0013] FIG1E is an enlarged isometric view illustrating the base structure of the basic unit of FIG1C according to the embodiment provided herein.
[0014] FIG1F illustrates an enlarged, isometric, partially exploded view of the basic unit and electronic unit of FIG1C according to the embodiment provided herein, wherein the electronic unit is disposed above the base structure.
[0015] FIG1G is an isometric top view illustrating another embodiment of the basic unit and electronic unit according to the example embodiments provided herein, wherein electronic units are disposed within the base structure of the basic unit.
[0016] FIG1H is an exploded view illustrating alternative embodiments of the base structure and electronic unit according to the examples provided herein.
[0017] Figure 2 illustrates an exploded view of the electronic unit of a wearable device used during continuous analyte monitoring, based on an example embodiment provided herein.
[0018] FIG3A illustrates a cross-sectional side view of a wearable device used during continuous analyte monitoring according to an example embodiment provided herein, showing the electronic unit removed from the basic unit.
[0019] FIG3B illustrates a cross-sectional side view of the wearable device of FIG3A according to an example embodiment provided herein, having electronic components and basic units coupled together.
[0020] Figure 4A illustrates an isometric top view of a coupling tool and an insert, wherein the coupling tool is used to couple the electronic unit of a wearable device used during continuous analyte monitoring to a base unit and the insert is used to attach the wearable device to a user.
[0021] FIG4B illustrates a plan view in the opening of the insert of FIG4A according to an example embodiment provided herein.
[0022] FIG5A illustrates a side view of the initiator of a coupling tool according to an example embodiment provided herein, which is used to couple the electronic unit of a wearable device used during continuous analyte monitoring to a base unit.
[0023] Figures 5B-5D illustrate the front view, isometric top view, and bottom isometric view of the starter of Figure 5A, respectively, according to the embodiments provided herein.
[0024] FIG6A illustrates an isometric top view of a carrier of a coupling tool provided herein, which is used to couple the electronic unit of a wearable device used during continuous analyte monitoring to a base unit.
[0025] Figures 6B-6D illustrate, respectively, the front view, bottom isometric view, and side view of the carrier of Figure 6A according to the embodiments provided herein.
[0026] FIG7A illustrates a bottom isometric view of the carrier and initiator components of a coupling tool provided herein, according to an example embodiment. The coupling tool is used to couple the electronic unit of a wearable device used during continuous analyte monitoring to a base unit, wherein the coupling tool is shown as holding the electronic unit and the initiator is housed in the carrier.
[0027] FIG7B illustrates an isometric top view of the coupling tool including the carrier and the initiator of FIG7A, according to an embodiment provided herein.
[0028] FIG7C illustrates an isometric top view of the carrier of FIG7A according to an example embodiment provided herein, wherein an initiator is housed within the carrier, but no electronic unit is held by a coupling tool.
[0029] FIG8A illustrates an exploded isometric view of an insert for use during continuous analyte monitoring and a coupling tool configured to couple the electronic unit of the wearable device to a base unit, according to an embodiment provided herein, wherein the coupling tool and the electronic unit are housed in the insert.
[0030] FIG8B illustrates an exploded isometric view of an insert for use during continuous analyte monitoring and a coupling tool configured to couple the electronic unit of the wearable device to a base unit, according to an embodiment provided herein, wherein the electronic unit is housed in the base unit and the coupling tool is retracted.
[0031] FIG9A illustrates a cross-sectional side view of the insert of FIG8A according to an example embodiment provided herein, which includes a coupling tool in a locked configuration, wherein the electronic unit is held by the coupling tool.
[0032] FIG9B illustrates a cross-sectional side view of the insert of FIG9A according to an embodiment example provided herein, wherein a coupling tool in an unlocked configuration and electronic units and basic units coupled together are provided.
[0033] Figure 10 is a bottom isometric view illustrating another example of a wearable device used during continuous analyte monitoring, based on the embodiments provided herein, showing the relationship between the electronic unit and the basic unit.
[0034] FIG11 is a flowchart illustrating an example method of coupling the electronic unit of a wearable device used in a continuous analyte monitoring device to a basic unit, according to an embodiment provided herein. [Biomaterial Storage]
[0091] Domestic storage information (please note in order of storage institution, date, and number): None. International storage information (please note in order of storage country, institution, date, and number): None.
Claims
1. A coupling tool for coupling an electronic unit and a basic unit of a wearable device for continuous analyte monitoring, comprising: a carrier including: a receiving feature and a carrier holding device configured to hold an electronic unit adjacent to the receiving feature; and an actuator including: a first member at least partially housed in the receiving feature; and a contact member configured to release the electronic unit from the carrier holding device in response to movement of the actuator relative to the carrier; wherein: When the carrier holding device is configured to hold the electronic unit, the coupling tool is in a locked configuration, and when the carrier holding device is configured to release the electronic unit from the carrier holding device, the coupling tool is in an unlocked configuration.
2. The coupling tool as claimed in claim 1, wherein the carrier holding device comprises: one or more hooks configured to hold the electronic unit when the coupling tool is in the unlocked configuration.
3. The coupling tool as claimed in claim 1, wherein the receiving feature comprises: a first receiving feature end and a second receiving feature end, and the electronic unit is configured to be positioned adjacent to the first receiving feature end when the coupling tool is in the locked configuration.
4. The coupling tool as described in claim 1, wherein the first component is configured to contact the electronic unit.
5. The coupling tool as claimed in claim 1, wherein the contact member is configured to contact at least a portion of the carrier holding device in response to the coupling tool being in the unlocked configuration.
6. The coupling tool as claimed in claim 1, wherein the carrier holding device comprises: a first arm and a second arm configured to hold the electronic unit in response to the coupling tool being in the locked configuration, and configured to be contacted by the contact member in response to the coupling tool being in the unlocked configuration.
7. The coupling tool as claimed in claim 6, wherein the first arm and the second arm are flexible such that the first arm and the second arm bend in response to the coupling tool being in the unlocked configuration to release the electronic unit.
8. The coupling tool as claimed in claim 1, wherein the coupling tool is configured to be housed within an insert, and the insert is configured to attach the basic unit to a user.
9. The coupling tool as claimed in claim 8, wherein the insert comprises: a basic unit support configured to support the basic unit within the insert.
10. A method for coupling an electronic unit of a wearable device of a continuous analyte monitoring system to a base unit, comprising the steps of: holding the electronic unit on a carrier of a coupling tool by using a carrier holding device; positioning the electronic unit adjacent to the base unit; and engaging the carrier holding device with an actuator of the coupling tool, wherein the engagement step releases the electronic unit from the carrier holding device.
11. The method of claim 10, wherein the starter comprises: a first component configured to contact the electronic unit, and the method further comprises the step of: using the first component to couple the electronic unit to the base unit.
12. The method of claim 11, wherein the starter includes a contact member, and the step of engaging the carrier holding device with the starter includes the step of using the contact member to contact at least a portion of the carrier holding device.
13. The method of claim 10, wherein the carrier holding device comprises a first arm and a second arm configured to hold the electronic unit, and the step of engaging the carrier holding device with the actuator comprises the step of using the actuator to contact at least one of the first arm or the second arm to release the electronic unit from the carrier holding device.
14. The method of claim 13, wherein the actuator comprises: a contact member, and the step of contacting at least one of the first arm or the second arm using the actuator comprises the step of: contacting at least one of the first arm or the second arm using the contact member to release the electronic unit from the carrier holding device.
15. The method of claim 14, wherein the first arm and the second arm are flexible, and the step of contacting at least one of the first arm or the second arm using the contact member comprises the step of: using the contact member to bend at least one of the first arm or the second arm, wherein the bending step releases the electronic unit from the carrier holding device.
16. The method of claim 10, wherein the initiator comprises: a contact member, and the method further comprises the step of: using the contact member to release the electronic unit from the carrier.
17. The method as described in claim 16 further comprises the step of pressing the electronic unit and the basic unit together using the contact member.
18. The method as described in claim 10, wherein: The carrier includes: a receiving feature; and the step of holding the electronic unit on the carrier includes the following steps: holding the electronic unit adjacent to the receiving feature.
19. The method of claim 10 further comprises the steps of: positioning the basic unit in an insert configured to attach the basic unit to a user; and accommodating at least a portion of the carrier in the insert.
20. A coupling tool comprising: a carrier including: a receiving feature; a carrier holding device attached to the carrier, the carrier holding device including: a first arm and a second arm configured to hold an electronic unit adjacent to the receiving feature; and an actuator including: a first member at least partially received in the receiving feature and configured to contact the electronic unit in response to the coupling tool being in an unlocked configuration; and a contact member configured to release the electronic unit from the carrier holding device in response to the coupling tool being in the unlocked configuration, and to couple the electronic unit of a wearable device of a continuous analyte monitor to a base unit.