Patent Description:
Embodiments of the present disclosure relate to methods and apparatus of wearable analyte monitoring devices used during continuous analyte monitoring.

Continuous analyte monitoring of an in-vivo sample, such as continuous glucose monitoring (CGM), has become a routine sensing operation, particularly in diabetes care. By providing real-time glucose concentrations, therapeutic and/or clinical actions may be timely applied and the glycemic condition may be better controlled.

During CGM, a biosensor is typically inserted subcutaneously and is continuously operated in an environment surrounded by interstitial fluid. The biosensor provides a signal to a processor or the like within a CGM system that is used to calculate a user's glucose level. These calculations may be made automatically many times throughout the day (e.g., every few minutes or at some other suitable interval).

The CGM system may include a wearable device that adheres to an outer surface of a user's skin. The wearable device may communicate (e.g., wirelessly) with a receiving unit, which may be a hand-held unit carried by the user. The hand-held unit may be a smart phone, for example. Further, document <CIT> discloses a method involving supporting both a sensor which measures biological information and an insertion needle at a location proximally spaced from the distal end portion of a device body, and moving the sensor and the insertion needle in the distal direction so that the detector and a portion of the insertion needle protrude distally beyond the distal end portion of the device body, separating the insertion needle from the sensor by moving the insertion needle relative to the sensor toward a proximal direction, and electrically connecting the sensor and the signal processor by operation of the device body after the insertion needle is separated from the sensor. Document <CIT> relates generally to systems and methods for measuring an analyte in a host, in particular to systems and methods for transcutaneous measurement of glucose in a host. In a first aspect of document <CIT>, an insertion device has a base that is held on a body surface throughout a period for detecting biological information while holding a sensor and a needle removed from the body surface. In addition, document <CIT> discloses a sensor assembly for detecting at least one analyte in a body fluid and a method of assembly a sensor assembly for detecting at least one analyte in a body fluid are disclosed, wherein the sensor assembly comprises at least one body mount configured for attachment to a body of a user; at least one electronics unit attachable to the body mount, having at least one electronics component for one or more of controlling the detection of the analyte or transmitting measurement data to another component; wherein the body mount includes a locking mechanism having at least one lever pivotably mounted to the body mount, the lever being configured to lock the electronics unit to the body mount. Document <CIT> relate generally to systems and methods for measuring an analyte in a host, wherein <CIT> provide sensor applicators and methods of use with pushbutton activation that implant the sensor, withdraw the insertion needle, engage the transmitter with the housing, and disengage the applicator from the housing, all in one smooth motion. Furthermore, document <CIT> provides a transcutaneous analyte sensing system and methods of installation thereof and document <CIT> discloses a sensor systems that can be used to measure an analyte concentration. Eventually, document <CIT> discloses a device which includes a bar longitudinally mobile along an axis of symmetry provided at one end with a plate; a first rigid connection and a second rigid connection which are symmetrical about the axis, each ending in a jaw, the two jaws forming a gripper clamp able to pick up an object; two pairs of flexible beams which are symmetrical about the axis, the beams each being connected by one end to one of the rigid connections, the other end being fixed, and guiding the movements of the rigid connections perpendicular to the axis, the ends of a pair of beams forming a parallelogram; two pairs of flexible beams which are symmetrical about the axis the beams each being connected by one end to one of the rigid connections, the other end being connected to the bar, and guiding the movements of the bar parallel to the axis, the ends of a pair of beams forming a parallelogram.

A coupling tool for coupling together an electronics unit and a base unit of a wearable device for continuous analyte monitoring is provided. The coupling tool includes: a carrier comprising a receiving feature and a carrier retention device, the carrier retention device configured to retain an electronics unit adjacent the receiving feature; and an activator including a first member at least partially receivable in the receiving feature, and a contact member configured to release the electronics unit from the carrier retention device in response to movement of the activator relative to the carrier. The coupling tool is in a locked configuration when the carrier retention device is configured to retain the electronics unit, and the coupling tool is in an unlocked configuration when the carrier retention device is configured to release the electronics unit from the carrier retention device.

A method of coupling an electronics unit to a base unit of a wearable device of a continuous analyte monitoring system is provided. The method includes: retaining the electronics unit to a carrier of a coupling tool by use of a carrier retention device; positioning the electronics unit adjacent the base unit; and engaging the carrier retention device with an activator of the coupling tool, wherein the engaging releases the electronics unit from the carrier retention device.

In some embodiments, a coupling tool is provided. The coupling tool includes: a carrier comprising a receiving feature; a carrier retention device attached to the carrier, the carrier retention device comprising a first arm and a second arm configured to retain an electronics unit adjacent the receiving feature; and an activator including: a first member at least partially receivable in the receiving feature and configured to contact the electronics unit in response to the coupling tool being in an unlocked configuration; and a contact member configured to release the electronics unit from the carrier retention device in response to the coupling tool being in the unlocked configuration and to couple the electronics unit to a base unit of a wearable device of a continuous analyte monitor.

Other features, aspects, and advantages of embodiments in accordance with the present disclosure will become more fully apparent from the following detailed description, the claims, and the accompanying drawings by illustrating a number of example embodiments. Various embodiments in accordance with the present disclosure may also be capable of other and different applications, and its several details may be modified in various respects, all without departing from the scope of the claims. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. The drawings are not necessarily drawn to scale.

In order to more closely monitor a person's analyte level (e.g., glucose concentration) and detect changes in the analyte level, methods and apparatus for continuous analyte monitoring (e.g., continuous glucose monitoring (CGM)) have been developed. While CGM systems generate glucose signals "continuously" during operation, such as continuous electrochemical signals, measurements of the generated glucose signals are typically performed every few minutes, rather than being truly continuous. While the description below is related to continuous glucose monitoring, the apparatus and methods described below may be readily adapted to monitoring of other analytes in other continuous analyte monitoring systems, such as, e.g., cholesterol, lactate, uric acid, alcohol, or the like.

CGM systems generally have a wearable portion (a "wearable device") that communicates wirelessly with an external device, such as a hand-held monitor or another portable device such as a cell phone, a computer, or a server. The wearable device may be worn for several days or even several weeks (e.g., <NUM>-<NUM> weeks) before being removed and replaced. The wearable device includes a biosensor that is inserted (implanted) subcutaneously. The wearable device may also include circuitry coupled to the biosensor that is configured to bias the biosensor and measure current signals generated by an electrochemical reaction with components of the implanted biosensor. The wearable device may also include processing circuitry for determining analyte (e.g., glucose) levels based on measured current signals, as well as electronic transmitter circuitry for communicating analyte (e.g., glucose) levels to an external device. The wearable device may be attached (e.g., adhered) to the outer surface of the skin, such as to the abdomen, the back of the upper arm, or another suitable location. CGM systems measure analyte (e.g., glucose) concentrations or analyte levels in interstitial fluid or in samples of non-direct capillary blood.

CGM systems may provide frequent measurements of a user's analyte (e.g., glucose) levels without the need for each such measurement to be accompanied by the drawing of a blood sample, such as by finger sticks. CGM systems may still employ an occasional finger stick and the use of a blood glucose measuring (BGM) system, such as the Contour NEXT One® by Ascensia Diabetes Care AG of Basel Switzerland, for checking calibration of the CGM system.

As described above, the wearable device of a CGM system is generally worn for a period of time, and then is removed and replaced with a new wearable device. Having to replace the wearable device of a CGM system after a designed interval can significantly increase the costs of performing such continuous analyte monitoring.

In embodiments described herein, a wearable device includes a base unit (e.g., a disposable portion) and an electronics unit (e.g., a reusable portion). In some embodiments, the base unit may include a power source for the wearable device, an analyte sensor (biosensor), and/or other electronic components. The electronics unit may include electronic circuitry used, for example, to provide a bias voltage to the analyte sensor, and to measure current signals through the analyte sensor, and may also compute analyte concentration values, such as glucose concentration values, based on the measured current signals, and/or transmit the analyte concentration value information to an external device.

In some embodiments, the electronics unit may include a power supply for the wearable device. Example circuitry within the electronics unit may also include an analog front end for biasing the analyte sensor and for sensing current that passes through the analyte sensor, such as operational amplifiers, current sensing circuitry, etc. Other circuitry within the electronics unit may include processing circuitry such as analog-to-digital converters (ADCs) for digitizing current signals, memory for storing digitized current signals, a controller such as microprocessor, microcontroller or the like for computing glucose concentration values based on measured current signals, and transmitter/receiver circuitry for transmitting glucose concentration values to an external device and/or receiving instructions from the external device.

The electronics unit is generally the most expensive portion of the wearable device and can last significantly longer than the period in which the wearable device is employed. For example, wearable devices are typically discarded after about two weeks, while the electronics unit may be reused with <NUM>, <NUM>, <NUM>, <NUM> or even more base units.

The wearable device may be very small so as not to interfere with movement of the user or irritate the user. Thus, the electronics unit may be small, which may make manually coupling the electronics unit and the base unit together difficult. As such, a coupling tool and methods of coupling a reusable electronic unit to a base unit are provided. These and other embodiments are described below with reference to <FIG>.

Reference is now made to <FIG>, which illustrate various views of a wearable device <NUM> and components thereof for use during continuous analyte monitoring. <FIG> illustrate wearable device <NUM> in accordance with embodiments provided herein. <FIG> illustrates an exploded isometric view of an example embodiment of components located within the wearable device <NUM>. <FIG> illustrates an isometric view of a base unit <NUM> of the wearable device <NUM> without an electronics unit located therein. The components of <FIG> may be located within the base unit <NUM> of <FIG>, which may be overmolded, for example, to retain the components. <FIG> illustrate various isometric views of examples of base structures included in the base unit <NUM>.

The wearable device <NUM> includes the base unit <NUM> (e.g., a disposable base unit) and an electronics unit <NUM> (e.g., a reusable electronics unit) that interface and couple with each other to form the wearable device <NUM>. The electronics unit <NUM> is sometimes referred to as a transmitter unit. The base unit <NUM> may include a cavity or opening <NUM> or other coupling structure that receives the electronics unit <NUM>.

Apparatus and methods are disclosed herein that enable a user to couple the electronics unit <NUM> to the base unit <NUM>. In some embodiments, the base unit <NUM> is configured to be disposed of after a single analyte monitoring period (e.g., <NUM> days, <NUM> days, <NUM> days, or some other time period), while the electronics unit <NUM> is configured to be removed from the base unit <NUM> after the single analyte monitoring period and re-used with another base unit. For example, the electronics unit <NUM> may be re-used with <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more new base units.

In some embodiments, the base unit <NUM> is sealed. For example, an encapsulation layer <NUM> may be formed over the components within the base unit <NUM>. In some embodiments, the encapsulation layer <NUM> may include the opening <NUM> that allows the electronics unit <NUM> to be coupled to the base unit <NUM>. In some embodiments, the encapsulation layer <NUM> creates a waterproof seal around the base unit <NUM> and its internal components. A connector <NUM> may remain exposed, such as in opening <NUM>, so a connector on the electronics unit <NUM> may make an electrical connection with the connector <NUM>. The encapsulation layer <NUM> may be formed from a single layer or multiple layers. For example, the encapsulation layer <NUM> may be formed from one or more layers of liquid silicone rubber (LSR), a thermoplastic elastomer (TPE), or the like. Other suitable sealing materials may be used.

The base unit <NUM> may include an analyte sensor <NUM> (<FIG>) that is electrically coupled to the connector <NUM> and which is operable to generate electrical signals in response to contact and reaction with interstitial fluid. The electrical signals may be transmitted to the electronics unit <NUM> where the electrical signals are measured. The electronics unit <NUM> or an external device (not shown) may determine a glucose concentration (or concentration of another analyte) based at least in part on the measured electrical signals.

<FIG> and <FIG> illustrate exploded and other isometric views of example embodiments of some components that may be located within the base unit <NUM> of the wearable device <NUM>, including the electronics unit <NUM>. As shown, the base unit <NUM> may include a base structure <NUM> that may be a chassis or the like that retains components within the base unit <NUM>. Some embodiments of base structure <NUM> may have one or more power source support locations 118A-118B, an electronics unit support location <NUM>, and a sensor assembly support location <NUM>. In some embodiments, the base structure <NUM> may be formed from a plastic, for example, such as, but not limited to, acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide (PPA), polysulfone, polyethersulfone, polyetheretherketone (PEEK), polypropylene, high-density polyethylene (HDPE), and low-density polyethelene (LDPE). Other suitable materials may be used.

The power source support locations 118A, 118B provide locations for supporting one or more power sources 124A, 124B used to supply electrical power to components of the wearable device <NUM> such as to the electronics unit <NUM>. For example, one or more power sources 124A, 124B may be positioned at the power source support locations 118A, 118B. In some embodiments, the one or more power sources 124A, 124B may be batteries, storage capacitors, solar cells, a generator, or the like. While the power sources 124A, 124B are shown as being two batteries, it will be understood that fewer, more and/or different power sources may be used. The power source support locations 118A, 118B may be any suitable shape (e.g., rectangular, square, round, etc.) to receive the one or more power sources 124A, 124B. In some embodiments, the power sources 124A, 124B may be located in the electronics unit <NUM>.

The electronics unit support location <NUM> is configured to retain the electronics unit <NUM> coupled or otherwise attached to the base unit <NUM>. In some embodiments, the electronics unit support location <NUM> may include one or more first retention features <NUM>. In some embodiments, the electronics unit support location <NUM> may include four first retention features <NUM>, which are referred to individually as first retention features 126A-126D. The first retention features <NUM> may interface with and/or press against second retention features <NUM>, referred to individually as second retention features 128A-128D, on the electronics unit <NUM> to couple and retain the electronics unit <NUM> to the base structure <NUM> of the base unit <NUM>, as shown for example in <FIG>. Fewer, more, and/or different retention features may be used to secure the electronics unit <NUM> to the base structure <NUM>. The first retention features <NUM> may include, for example, projections that engage openings of the second retention features <NUM> in the electronics unit <NUM>. In some embodiments, the first and second retention features <NUM>, <NUM> may include magnets, Velcro, surfaces with adhesives, or the like.

In some embodiments, the electronics unit support location <NUM> may include a break location <NUM> (<FIG>, <FIG>, and <FIG>), such as a channel, groove, scribe line, or the like, that allows base structure <NUM> to bend and/or break such that the first retention features <NUM> disconnect and/or release the electronics unit <NUM> when the electronics unit <NUM> is to be removed from the base unit <NUM> and/or the base structure <NUM>. Other release and/or break locations may be used. In some embodiments, other retention features may be used to retain the electronics unit <NUM> wherein the other retention features do not require bending of the base structure <NUM> to remove the electronics unit <NUM>.

A substrate <NUM>, such as a circuit board, a flexible circuit board, etc., may be located within the electronics unit support location <NUM> and may include the connector <NUM> that provides an electrical interface to a similar connector (not shown) on the electronics unit <NUM>. For example, the connector <NUM> may be electrically connected to the power sources 124A, 124B by conductors (not shown) so as to allow the power sources 124A, 124B to provide electrical power to the electronics unit <NUM> when the electronics unit <NUM> is positioned within the electronics unit support location <NUM>. The connector <NUM> may also be electrically connected to the analyte sensor <NUM> to provide a voltage to the analyte sensor <NUM>.

<FIG> illustrates an exploded isometric view of another alternative embodiment of a base structure 116A and the electronics unit <NUM> of <FIG> with other examples of first and second retention features <NUM>, <NUM> that retain the electronics unit <NUM> within the base structure 116A. In the embodiment of <FIG>, the electronics unit <NUM> has first retention features <NUM> and the base structure 116A has second retention features <NUM>. The first retention features <NUM> on the electronics unit <NUM> may extend into the second retention features <NUM> on the base structure 116A, which are openings that are configured to receive the first retention features <NUM>.

The sensor assembly support location <NUM> provides a mounting location for at least a portion of an analyte sensor assembly <NUM> that may include an insertion device <NUM> and an insertion device cap <NUM>, for example. The insertion device <NUM> may include an insertion portion <NUM> including a sharpened end <NUM> (<FIG>) that pierces skin to introduce the analyte sensor <NUM> into a subcutaneous region of a user as described herein. The insertion portion <NUM> also may be referred to as an insertion shaft, needle, trocar, sharp, or the like.

The insertion portion <NUM> of the insertion device <NUM> may be made, for example, from a metal such as stainless steel, or a non-metal such as plastic. Other materials may be used. In some embodiments, the insertion portion <NUM> of the insertion device <NUM> may be, but is not limited to, a round C-channel tube, a round U-channel tube, a stamped sheet metal part folded into a square U-profile, a molded/cast, laser cut or machined metal part with a U-channel profile, or a solid metal cylinder with an etched or ground square U-channel. Other insertion portion shapes may be used. The channel formed in the insertion portion <NUM> carries the analyte sensor <NUM> during insertion. In some embodiments, portions of the insertion device <NUM> may be formed from a plastic, for example, such as, but not limited to, ABS, polycarbonate, nylon, acetal, PPA, polysulfone, polyethersulfone, PEEK, polypropylene, HDPE, LDPE, etc. Other materials may be used.

The insertion portion <NUM> may extend through a sensor opening <NUM> (<FIG>) in the sensor assembly support location <NUM> of the base structure <NUM>, 116A, for example. The analyte sensor <NUM> is electrically connected to the connector <NUM> of the substrate <NUM> within the electronics unit support location <NUM>. The connector <NUM> electrically connects the analyte sensor <NUM> to the electronics unit <NUM> positioned within the electronics unit support location <NUM>.

The first and second retention features <NUM>, <NUM>, <NUM>, <NUM> described herein secure (e.g., couple) the electronics unit <NUM> to the base structure <NUM>, 116A of the base unit <NUM> during continuous analyte monitoring, while allowing the electronics unit <NUM> to be removed and reused after a continuous analyte monitoring period. The base unit <NUM> may be configured to be disposed of after a single analyte monitoring period, while the electronics unit <NUM> may be configured to be separated from the base unit <NUM> after the single analyte monitoring period and re-used with other base units. For example, the base structure <NUM> may be bent along the break location <NUM>, which releases the first retention features <NUM> (<FIG>) from the electronics unit <NUM>. In some embodiments, the single analyte monitoring period may be at least <NUM> to <NUM> days (and, e.g., up to <NUM> days or longer). The electronics unit <NUM> may be removed from the base unit <NUM> and reused (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more times, each time with a new base unit <NUM> that includes a new analyte sensor <NUM>).

<FIG> illustrates an exploded view of an example of the electronics unit <NUM> according to some embodiments provided herein. In the embodiment of <FIG>, the electronics unit <NUM> may include a substrate <NUM> that couples to a top cover <NUM> and can be covered by a bottom cover <NUM> (e.g., an overmold portion) to cover and seal the substrate <NUM> and any components <NUM> thereon. The substrate <NUM> may be a circuit board, a flexible circuit board, or another mounting location for electronic circuitry used within the electronics unit <NUM>. The top cover <NUM> and/or the bottom cover <NUM> may be formed from one or more layers of liquid silicone rubber (LSR), a thermoplastic elastomer (TPE), a molded plastic cover, or the like. Other materials may be used such as, but not limited to, ABS, polycarbonate, nylon, acetal, PPA, polysulfone, polyethersulfone, PEEK, polypropylene, HDPE, LDPE, etc..

The substrate <NUM> may include an interface <NUM> (e.g., a connector) configured to interface with the connector <NUM> (<FIG>) of the base unit <NUM> when the electronics unit <NUM> is positioned within the electronics unit support location <NUM> of the base structure <NUM>. An opening <NUM> in bottom cover <NUM> may be provided to allow the interface <NUM> to couple with the connector <NUM> of the base unit <NUM>, for example. In some embodiments, one or more of the components <NUM> may electrically couple to the analyte sensor <NUM> through the interface <NUM> and the connector <NUM> of the base unit <NUM>.

In some embodiments, the bottom cover <NUM> may include a sealing member <NUM>, such as a lip or similar feature, configured to seal against a sidewall or other portion of the opening <NUM> of the base unit <NUM> (see also <FIG> below), such that the electronics unit <NUM> and the base unit <NUM> form a sealed unit when the electronics unit <NUM> is positioned within the base unit <NUM>. In some embodiments, the top cover <NUM> may include the one or more second retention features <NUM> configured to interface with first retention features 126A-126D (<FIG>) within the electronics unit support location <NUM> (e.g., one or more of first retention features <NUM>, for example). Such first and second retention features may interface to hold the electronics unit <NUM> securely to the base unit <NUM> and keep the connector <NUM> in contact with the interface <NUM> during use. In other embodiments, the top cover <NUM> may include a sealing member and/or the bottom cover <NUM> may include retention features.

<FIG> illustrates a cross-sectioned view of the wearable device <NUM> with the electronics unit <NUM> removed from the base unit <NUM> in accordance with some embodiments. <FIG> illustrates a cross-sectioned view of the wearable device <NUM> of <FIG> with the electronics unit <NUM> and the base unit <NUM> coupled together in accordance with some embodiments. As described herein, both the electronics unit <NUM> and the base unit <NUM> may be sealed units (e.g., waterproof), with only the interface <NUM> of the electronics unit <NUM> and the connector <NUM> of the base unit <NUM> exposed. When the electronics unit <NUM> is coupled with the base unit <NUM>, the connector <NUM> and the interface <NUM> may also be sealed from any external environment.

Reference is now made to <FIG>, which illustrates a side isometric view of a coupling tool <NUM> that may be used to couple the electronics unit <NUM> (<FIG>) to the base unit <NUM> of the wearable device <NUM> (<FIG>). The coupling tool <NUM> may be used to couple together other electronics units and base units of other types of wearable devices. The coupling tool <NUM> includes and is made up of an activator <NUM> and a carrier <NUM>. The coupling tool <NUM> may be used with an inserter <NUM> that enables a user to attach the wearable device <NUM> to the user as described herein. In summary, the base unit <NUM>, without the electronics unit <NUM> coupled thereto, may be retained within the inserter <NUM> (see <FIG>). The electronics unit <NUM> is retained and held by the carrier <NUM>, and the carrier <NUM> and the electronics unit <NUM> are inserted in opening <NUM> in the top of the inserter <NUM> so as to position the carrier <NUM> and electronics unit <NUM> within the inserter <NUM> (see <FIG>). The activator <NUM> is then moved relative to (e.g., within, in some embodiments) the carrier <NUM> causing the activator <NUM> to release the electronics unit <NUM> from the carrier <NUM> and couple the electronics unit <NUM> to the base unit <NUM> (see <FIG>).

The coupling tool <NUM> is referred to as being in an unlocked configuration when the coupling tool <NUM> is configured to release the electronics unit <NUM>. The coupling tool <NUM> is referred to as being in a locked configuration when the coupling tool <NUM> is configured to retain the electronics unit <NUM>.

Additional reference is made to <FIG>, which illustrate various views of the activator <NUM> according to embodiments provided herein. <FIG> illustrates a side elevation view of the activator <NUM>, <FIG> illustrates a front elevation view of the activator <NUM>, <FIG> illustrates a top isometric view of the activator <NUM>, and <FIG> illustrates a bottom isometric view of the activator <NUM>. The activator <NUM> may include a top portion <NUM> having a top surface <NUM>. The top surface <NUM> may be configured to be pressed by a user during coupling of the electronics unit <NUM> to the base unit <NUM>.

A first member <NUM> may extend a length L51 from the top portion <NUM> to an end 512A. The end 512A may be configured to contact the electronics unit <NUM> as the electronics unit <NUM> and the base unit <NUM> are coupled together. For example, the end 512A may be configured to contact the top cover <NUM> (<FIG>) of the electronics unit <NUM>. The first member <NUM> may be rigid enough to withstand forces applied between the electronics unit <NUM> and the base unit <NUM> during coupling. In some embodiments, the activator <NUM> may be referred to as being in a locked position or configuration when the end 512A does not contact the electronics unit <NUM> and in an unlocked position or configuration when the end 512A contacts the electronics unit <NUM>. In the unlocked position, the electronics unit <NUM> is no longer retained. The length L51 may be long enough to push the electronics unit <NUM> from the carrier <NUM> when the activator <NUM> is in the unlocked position as described herein.

The activator <NUM> also includes a contact member <NUM> extending from the top portion <NUM>. The contact member <NUM> may extend a length L52 between the top portion <NUM> and an end 514A of the contact member <NUM>. As described herein, the contact member <NUM> may engage moveable or flexible members of the carrier <NUM> to release the electronics unit <NUM> from the carrier <NUM> when the activator <NUM> is in the unlocked configuration or as the carrier <NUM> transitions from the locked configuration to the unlocked configuration as described herein.

Additional reference is made to <FIG>, which illustrate different views of an embodiment of the carrier <NUM>. <FIG> illustrates a top isometric view of the carrier <NUM>, <FIG> illustrates a front elevation view of the carrier <NUM>, <FIG> illustrates a bottom isometric view of the carrier <NUM>, and <FIG> illustrates a side elevation view of the carrier <NUM>.

The carrier <NUM> may be configured to carry the electronics unit <NUM> to the base unit <NUM> and/or the inserter <NUM>. The carrier <NUM> may have a first side 616A (e.g., a bottom side) and a second side 616B (e.g., a 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 (<FIG>) of the first member <NUM> of the activator <NUM>. The carrier <NUM> has a receiving feature <NUM> (e.g., a rectangular hole as shown) extending between the first side 616A and the second side 616B. The receiving feature <NUM> is shaped and/or sized to receive at least a portion of the first member <NUM> of the activator <NUM> and to enable the first member <NUM> to move (e.g., slide) within the receiving feature <NUM>. The receiving feature <NUM> may comprise a receiving feature first end 618A and a receiving feature second end 618B, wherein the electronics unit <NUM> is configured to be positioned adjacent the receiving feature first end 618A when the coupling tool <NUM> is in the locked configuration, such as when the electronics unit <NUM> is retained by the carrier <NUM> (see <FIG>). The receiving feature <NUM> is shown as an aperture. In other embodiments, the receiving feature <NUM> may be a slot, a groove, or other feature that performs the functions described herein.

The carrier <NUM> may have an outer surface that defines a transverse shape of the carrier <NUM> when viewed from the first side 616A or the second side 616B. The transverse shape of the carrier <NUM> enables the carrier <NUM> to be received within an opening <NUM> (<FIG>) in the inserter <NUM> as described herein. For example, the carrier <NUM> may include a shape that is configured to allow the carrier <NUM> to slide within the opening <NUM>. In some embodiments, the transverse shape of the carrier <NUM> may be the same as the opening <NUM>, but slightly smaller to enable the carrier <NUM> to move with minimal friction within the opening <NUM>.

Additional reference is made to <FIG>, which illustrates a plan view of the opening <NUM> in accordance with embodiments provided herein. The carrier <NUM> may include one or more indexing devices that orient the carrier <NUM> in a specific direction within the opening <NUM>. In the embodiment of <FIG> and <FIG>, the carrier <NUM> includes two rails, a first rail 624A and a second rail 624B that extend from the outer surface and orient the carrier <NUM> within the opening <NUM>. The first rail 624A and the second rail 624B may be receivable within a first channel 426A and a second channel 426B, respectively, of the opening <NUM>. The locations of the first rail 624A, the second rail 624B, the first channel 426A, and the second channel 426B provide for the carrier <NUM> to be received in only one orientation within the opening <NUM>. For example, in the embodiment of <FIG>, the opening <NUM> includes a first side 422A and an opposing second side 422B. Both the first channel 426A and the second channel may be located a length L41 from the first side 422A and a length L42 from the second side 422B, wherein the length L41 is not equal to the length L42. Accordingly, the locations of the first channel 426A and the second channel 426B enable the carrier <NUM> to be received in only one orientation within the opening <NUM>. The one orientation provides for proper coupling of the electronics unit <NUM> and the base unit <NUM>. Other indexing and/or orienting mechanisms may be used.

The carrier <NUM> is configured to retain the electronics unit <NUM> as shown in <FIG>, which are bottom and top isometric views, respectively, of embodiments of the carrier <NUM> retaining the electronics unit <NUM> and with the activator <NUM> received therein. In some embodiments, the carrier <NUM> may have a cavity <NUM> (<FIG> and <FIG>) configured (e.g., shaped and sized) to receive the electronics unit <NUM>. The cavity <NUM> may be located proximate the first side 616A of the carrier <NUM> and may intersect with the receiving feature <NUM> (<FIG>), so that the end 512A (<FIG>) of the first member <NUM> of the activator <NUM> may contact the electronics unit <NUM>. For example, the cavity <NUM> may be in or adjacent the receiving feature first end 618A of the receiving feature <NUM>. The first member <NUM> of the activator <NUM> may contact the electronics unit <NUM> to force the electronics unit <NUM> and the base unit <NUM> together as shown in <FIG>. In some embodiments, the cavity <NUM> is configured to retain the electronics unit <NUM> flush with the first side 616A of the carrier <NUM>.

The carrier <NUM> also includes one or more retention devices that are configured to retain the electronics unit <NUM> to the carrier <NUM>, such as within the cavity <NUM> or otherwise at the end of carrier <NUM>. The carrier <NUM> and/or the one or more retention devices may be in a locked configuration or a locked state when the carrier <NUM> retains or is configured to retain the electronics unit <NUM>. The carrier <NUM> and/or the one or more retention devices may be in an unlocked configuration or an unlocked state when the electronics unit <NUM> is released from the carrier <NUM> or the carrier <NUM> is configured to release the electronics unit <NUM>. In the embodiments of <FIG>, the carrier <NUM> may include a carrier retention device <NUM> that is configured to retain the electronics unit <NUM>, such as within the cavity <NUM>, and enables the contact member <NUM> (<FIG>) of the activator <NUM> to release the electronics unit <NUM> from the cavity <NUM>. For example, the contact member <NUM> (<FIG> and <FIG>) may be configured to release the electronics unit <NUM> from the carrier retention device <NUM> in response to movement of the activator <NUM> relative to the carrier <NUM>.

The carrier retention device <NUM> may include one or more hooks that retain the electronics unit <NUM> to the carrier <NUM>. In the embodiments of <FIG>, the carrier retention device <NUM> may include a first arm <NUM> having a first hook 636A and a second arm <NUM> having a second hook 636B. The first arm <NUM> may pivot about or be flexible about a first point 638A and the second arm <NUM> may pivot about or be flexible about a second point 638B. In some embodiments, the first point 638A and the second point 638B may be locations where the first arm <NUM> and the second arm <NUM> connect to a body portion of the carrier <NUM>. In some embodiments, the first arm <NUM> and the second arm <NUM> are flexible such the first arm <NUM> and the second arm <NUM> flex upon interaction or engagement with the contact member <NUM> of the activator <NUM> as described herein to release the electronics unit <NUM> from the cavity <NUM>. First arm <NUM> and the second arm <NUM> may be separated from the main body of the carrier <NUM> by a gap.

The first hook 636A and the second hook 636B may be configured to grasp and/or retain the electronics unit <NUM> to the carrier <NUM> when the carrier <NUM> is in the locked configuration. In some embodiments, the first hook 636A and the second hook 636B may be configured to engage two of the retention features (e.g., retention features 128A-D shown in <FIG>) of the electronics unit <NUM> to retain the electronics unit <NUM> in the cavity <NUM>. In the embodiment depicted in <FIG>, the first hook 636A is shown engaged with the retention feature 128C and the second hook 636B is shown engaged with the retention feature 128A, which retain the electronics unit <NUM> in the cavity <NUM>.

The first arm <NUM> may have an inner surface <NUM> (<FIG>) and the second arm <NUM> may have an inner surface <NUM> that faces the inner surface <NUM>. The inner surface <NUM> and the inner surface <NUM> may guide the contact member <NUM> of the activator <NUM> between the first arm <NUM> and the second arm <NUM>. The first arm <NUM> may also have a first protrusion 634P that includes a portion of the inner surface <NUM>. The second arm <NUM> may also have a second protrusion 635P that includes a portion of the inner surface <NUM>. The first protrusion 634P and the second protrusion 635P may be configured to be in contact with the contact member <NUM> as the activator <NUM> transitions to the unlocked configuration, which transitions the carrier <NUM> to the unlocked configuration and releases the electronics unit <NUM> as described herein.

When the activator <NUM> is in the locked configuration, the carrier <NUM> is in the locked configuration. In some embodiments, first arm <NUM> and the second arm <NUM> may be biased toward each other, so that the carrier <NUM> may normally be in the locked configuration. In some embodiments, the first hook 636A and the second hook 636B may be normally biased toward each other so that the carrier <NUM> is normally in the locked configuration. As the contact member <NUM> of the activator <NUM> engages the first protrusion 634P and the second protrusion 635P, the first hook 636A and the second hook 636B separate from each other, which places the carrier <NUM> in the unlocked configuration and releases the electronics unit <NUM> from the cavity <NUM>. For example, the first arm <NUM> and the second arm <NUM> flex or pivot about the first point 638A and the second point 638B. Thus, the carrier <NUM> transitions to the unlocked configuration and the electronics unit <NUM> is released from the carrier <NUM>. The location of the first protrusion 634P on the first arm <NUM> and the location of the second protrusion 635P on the second arm <NUM> determine the distance the contact member <NUM> is positioned within the carrier <NUM> when the activator <NUM> engages the carrier retention device <NUM> and transitions the carrier <NUM> between the locked configuration and the unlocked configuration.

As the contact member <NUM> of the activator <NUM> releases the electronics unit <NUM> from the carrier <NUM>, the first member <NUM> of the activator <NUM> ejects the electronics unit <NUM> from the carrier <NUM>. For example, the end 512A of the first member <NUM> contacts the electronics unit <NUM> and forces the electronics unit <NUM> and the base unit <NUM> together. The length L51 of the first member <NUM> and the length L52 of the contact member <NUM> may provide for the carrier <NUM> to transition to the unlocked configuration just prior to the first member <NUM> ejecting the electronics unit <NUM> from the carrier <NUM>. In some embodiments, the locations of the first protrusion 634P and the second protrusion 635P on the first arm <NUM> and the second arm <NUM> may also provide for the carrier <NUM> transitioning to the unlocked configuration prior to the first member <NUM> ejecting the electronics unit <NUM> from the carrier <NUM>.

The electronics unit <NUM> may be retained in the carrier <NUM> by forcing the electronics unit <NUM> into the cavity <NUM>. The force may flex the first arm <NUM> and the second arm <NUM> away from each other. As the electronics unit <NUM> is further pushed into the cavity <NUM>, the first hook 636A and the second hook 636B may engage the second retention features <NUM> on the electronics unit <NUM> to retain the electronics unit <NUM> within the cavity <NUM>.

In some embodiments, the inserter <NUM> may be a device that attaches the wearable device <NUM> to the skin of a user. For example, the inserter <NUM> may enable a user to attach the wearable device <NUM> to the skin and locate the analyte sensor <NUM> in a subcutaneous region. The wearable device <NUM> may be attached to the skin of the user prior to, during, or after coupling of the electronics unit <NUM> to the base unit <NUM>.

Reference is now made to <FIG> illustrates an exploded isometric view of an embodiment of the inserter <NUM> and the coupling tool <NUM> according to embodiments provided herein. In the embodiment of <FIG>, the electronics unit <NUM> is received in the coupling tool <NUM>. <FIG> illustrates an exploded isometric view of an embodiment of the inserter <NUM> and the coupling tool <NUM> with the electronics unit <NUM> coupled to (e.g., received within) the base unit <NUM> according to embodiments provided herein. In the configuration depicted in <FIG>, the coupling tool <NUM> is in a locked configuration wherein the electronics unit <NUM> is retained by the carrier <NUM>. The inserter <NUM> depicted herein is an example of one of many inserters that may be used with the coupling tool <NUM>. The inserters used with the coupling tool <NUM> may have the opening <NUM> or the like that provides access for the coupling tool <NUM> to access an opening or the like on a base unit <NUM> that receives the electronics unit <NUM>. In some embodiments, a support or other device that supports the base unit <NUM> during coupling of the base unit <NUM> and the electronics unit <NUM> may be used instead of the inserter <NUM>.

The inserter <NUM> may include a top cover 406A that includes the opening <NUM>. As described above, the coupling tool <NUM> is at least partially receivable in the opening <NUM>. The inserter <NUM> may also include an outer sleeve 406B wherein the top cover 406A may slide over the outer sleeve 406B and couple thereto. In some embodiments, some portions of a mechanism (not shown in <FIG>) that insert the analyte sensor <NUM> (<FIG>) in a subcutaneous region of a user may be located within the outer sleeve 406B. The inserter <NUM> may include a base unit support 406C that may be at least partially receivable within an inner sleeve 406D. As shown, the base unit support 406C may be configured to support the base unit <NUM> during coupling of the electronics unit <NUM> to the base unit <NUM>. In some embodiments, the inserter <NUM> may include a cap 406E that covers a lower portion of the inserter <NUM> and/or a lower portion of the base unit <NUM>.

The opening <NUM> may provide an access between the top cover 406A and the opening <NUM> in the base unit <NUM> that receives the electronics unit <NUM>. Thus, the opening <NUM> enables the coupling tool <NUM> with the electronics unit <NUM> attached thereto, as shown in <FIG>, to pass into the opening <NUM>. The coupling tool <NUM> may then be used to couple the electronics unit <NUM> and the base unit <NUM> together as shown in <FIG>. In the example of <FIG>, the electronics unit <NUM> is inserted into the base unit <NUM>. Similarly, base unit support 406C can have an opening that enables the coupling tool <NUM> with the electronics unit <NUM> attached thereto to pass through to couple the electronics unit <NUM> to the base unit <NUM>.

Reference is now made to <FIG>, which illustrate partial cross-sectioned views of the inserter <NUM> with the base unit <NUM>, electronics unit <NUM>, and coupling tool <NUM> located therein. In the configuration of <FIG>, the coupling tool <NUM> is in the locked configuration and the electronics unit <NUM> is retained by the coupling tool <NUM>. In the configuration of <FIG>, the coupling tool <NUM> is in the unlocked configuration and the electronics unit <NUM> has been coupled with the base unit <NUM>. For example, the electronics unit <NUM> has been inserted into the base unit <NUM>.

In the configuration of <FIG>, the coupling tool <NUM> is located at least partially in the opening <NUM> and is in the locked configuration. As shown in <FIG>, the activator <NUM> is not fully inserted into the carrier <NUM>, so the contact member <NUM> is not contacting either the first protrusion 634P or the second protrusion 635P. Accordingly, the coupling tool <NUM> is in the locked configuration with the electronics unit <NUM> retained thereto.

In the configuration of <FIG>, the coupling tool <NUM> has been used to insert the electronics unit <NUM> into the base unit <NUM>. As shown in <FIG>, the activator <NUM> has been pressed in the z-direction into the carrier <NUM>, which has caused the contact member <NUM> to contact the first protrusion 634P and the second protrusion 635P. The 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, which releases the electronics unit <NUM> from the carrier <NUM>. As the activator <NUM> is pressed further into the carrier <NUM>, the end <NUM> (<FIG>) of the first member <NUM> contacts the electronics unit <NUM> and forces the electronics unit <NUM> into the opening <NUM> in the base unit <NUM>. When the electronics unit <NUM> is coupled to the base unit <NUM>, a waterproof seal may be formed between the base unit <NUM> and the electronics unit <NUM> that prevents contaminants from entering the opening <NUM>.

As the electronics unit <NUM> and the base unit <NUM> are coupled together, the second retention features <NUM> (<FIG>) of the electronics unit <NUM> engage with the first retention features <NUM> of the base unit <NUM> and couple the electronics unit <NUM> and the base unit <NUM> together. After the electronics unit <NUM> and the base unit <NUM> are coupled together, the coupling tool <NUM> may be removed from the inserter <NUM>, and the wearable device <NUM>, including the electronics unit <NUM> and the base unit <NUM>, may be applied (e.g., attached or adhered) to a user. In some embodiments, the coupling tool <NUM> may be used to couple the electronics unit <NUM> and the base unit <NUM> together after the base unit <NUM> has been applied to a user.

The wearable device <NUM> (<FIG>) may be worn by a user for a period, such as two weeks or such time as the base unit <NUM> needs to be replaced and/or removed from the user. During this period, the wearable device <NUM> may be monitoring/measuring analytes, such as in a subcutaneous region of the user. Following analyte monitoring, the wearable device <NUM> may be detached from the user. The electronics unit <NUM> of the wearable device <NUM> may then be disconnected/decoupled from the base unit <NUM>. For example, the electronics unit <NUM> may be decoupled from the base unit <NUM> and the base unit <NUM> may be discarded. In general, the electronics unit <NUM> may be decoupled from the base unit <NUM> before or after the base unit <NUM> is removed from the user. Thereafter, the electronics unit <NUM> may be coupled to a new base unit using the coupling tool <NUM> as described herein. The new base unit may include a new power source and a new analyte sensor.

While the electronics unit <NUM> is shown as being coupled to the top surface of the base unit <NUM>, it will be understood that in other embodiments, electronics unit <NUM> may be removable and/or coupled to other surfaces of a base unit. For example, <FIG> illustrates a bottom view of a base unit <NUM> of a wearable device <NUM> having an opening <NUM> that allows the electronics unit <NUM> and the base unit <NUM> to be coupled together using the coupling tool <NUM> (<FIG>) in accordance with embodiments described herein. In some embodiments, the base unit <NUM> may be placed in a device other than an inserter that enables the coupling tool <NUM> to access the opening <NUM>.

Reference is now made to <FIG>, which is a flowchart depicting an example of a method <NUM> of coupling together an electronics unit (e.g., electronics unit <NUM>) and a base unit (e.g., base unit <NUM>) of a wearable device (e.g., wearable device <NUM>) for using during continuous analyte monitoring. The method <NUM> includes, at process block <NUM>, retaining the electronics unit to a carrier (e.g., carrier <NUM>), by use of a carrier retention device (e.g., carrier retention device <NUM>). The method <NUM> also includes, at process block <NUM>, positioning the electronics unit adjacent the base unit. The method further includes, at process block <NUM>, engaging the carrier retention device with an activator (e.g., activator <NUM>), wherein the engaging releases the electronics unit from the carrier retention device. Further motion of the activator couples the electronics unit to the base unit.

Claim 1:
A coupling tool (<NUM>) for coupling together an electronics unit (<NUM>) and a base unit (<NUM>) of a wearable device (<NUM>) for continuous analyte monitoring, comprising:
a carrier (<NUM>) comprising a receiving feature (<NUM>) and a carrier retention device (<NUM>), the carrier retention device (<NUM>) configured to retain the electronics unit (<NUM>) adjacent the receiving feature (<NUM>); wherein the coupling tool (<NUM>) is in a locked configuration when the carrier retention device (<NUM>) is configured to retain the electronics unit (<NUM>), and the coupling tool (<NUM>) is in the unlocked configuration when the carrier retention device (<NUM>) is configured to release the electronics unit (<NUM>) from the carrier retention device (<NUM>), and characterised in that the coupling tool (<NUM>) further comprises:
an activator (<NUM>) comprising:
a first member (<NUM>) at least partially receivable in the receiving feature (<NUM>) and configured to contact the electronics unit (<NUM>) to force the electronics unit (<NUM>) and the base unit (<NUM>) together in response to the coupling tool (<NUM>) being in an unlocked configuration; and
a contact member (<NUM>) configured to release the electronics unit (<NUM>) from the carrier retention device (<NUM>) in response to engaging the carrier retention device (<NUM>) with the activator (<NUM>).