JPWO2020077113A5 - - Google Patents

Description

(Cross reference to related applications)
This application claims the benefit of U.S. Provisional Patent Application No. 62/743,963, filed October 10, 2018, the entire disclosure of which is incorporated herein by reference. be

(INCORPORATION BY REFERENCE)
All publications and patent applications mentioned in this specification are incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. incorporated herein.

The present disclosure relates generally to wearable devices such as extracorporeal cardiopulmonary physiologic monitors or defibrillators. In particular, the present disclosure relates to automated external cardiopulmonary physiologic monitors or defibrillators that can be worn continuously and comfortably on a patient for extended periods of time.

US Pat. No. 6,200,000 discloses multiple embodiments of an external defibrillator that is adhesively attached to a patient and can be worn comfortably around the clock during showering, sleeping, and normal activities. The adhesive patches and batteries in these devices may have a shorter useful life than other parts of the defibrillator. Additionally, patients may need to wear defibrillators beyond the useful life of adhesive patches and batteries.

International Publication No. 2017/035502 pamphlet

The present invention relates generally to wearable devices (such as wearable external cardiopulmonary physiologic monitors or defibrillators) in which batteries and/or adhesive patient-engaging substrate(s) can be safely and easily changed by a patient. It is. One aspect of the present invention provides a wearable device having a reusable component and a disposable component, the disposable component comprising a bottom side adhesive, a bottom side electrode, a disposable electrical connector, and a disposable component. and a reusable component having a plurality of sealed housings mechanically coupled to each other and movable relative to each other, each of the plurality of housings comprising: one or more of a capacitor and a controller; a reusable component mechanical connector adapted to removably connect to the disposable component mechanical connector; and a reusable component removably connectable to the disposable component electrical connector. and reusable component electrical connectors adapted to.

In some embodiments, the reusable component further includes a flexible circuit configured to provide electrical communication between electrical components within the housing. The flexible circuit may optionally be secured to the underside of multiple housings. Additionally or alternatively, the flexible circuit may be overmolded with a flexible material to prevent water ingress.

In some embodiments, the disposable component includes a battery (e.g., a rechargeable battery, etc.) disposed within the battery housing and electrically connecting and disconnecting the battery to and from the capacitor and/or controller. and a battery mechanical connector adapted to removably connect the battery housing to the reusable component. In such embodiments, the battery mechanical connector may optionally include a cradle dock. The battery housing may also be removably connected to the top surface of the patient engaging board via a battery mechanical connector. The reusable component may also optionally include an alarm adapted to indicate that the battery is not connected to the reusable component.

In some embodiments, the disposable component includes a battery disposed within the battery housing, a battery electrical connector configured to be connected to and disconnected from the electrical connector of the reusable component, and the battery housing. to the reusable part, and a cable configured to be connected to and disconnected from the electrical connector of the disposable part. include.

In embodiments where the battery is a rechargeable battery, the reusable component may also include a port for a battery charger. Alternatively or additionally, the wearable device may also have a wireless battery charger.

In some embodiments, the reusable component may include a housing support, the housing mechanically connected to the top side of the housing support, and the reusable component mechanical connector at the housing support. is placed on the bottom side of the Disposable components of such embodiments also include a battery disposed within the battery housing, a battery electrical connector configured to electrically connect and disconnect the battery to and from the capacitor, and a battery housing. and a cradle dock adapted to removably connect to the housing support.

In some embodiments, the disposable further comprises a battery permanently attached to the disposable.

In some embodiments, at least one of the disposable component mechanical connector and the reusable component mechanical connector includes a magnet. The magnet may, for example, be disposed within a housing extending from the reusable component, the housing comprising an opening through which a mechanical connector of the disposable component can be inserted and moved into contact with the magnet. Alternatively, the magnet may be disposed within a housing extending from the disposable component, the housing comprising an opening through which a mechanical connector of the reusable component can be inserted and moved to contact the magnet.

In some embodiments, the disposable component mechanical connector and the reusable component mechanical connector include male and female mechanical snap components, male and female mechanical slide lock components, adhesive and Removable adhesive cover, hook and loop connector, key and rotatable lock, breaking part adapted to break to disconnect the mechanical connector of the disposable part from the mechanical connector of the reusable part, disposable Removable part adapted to disconnect the mechanical connector of the part from the mechanical connector of the reusable part or adapted to disconnect the mechanical connector of the disposable part from the mechanical connector of the reusable part It also has a release latch.

In some embodiments, the disposable component mechanical connector includes a spring-biased latch and the reusable component mechanical connector includes a cavity adapted to receive the latch. In some such embodiments, the disposable mechanical connector is further operably connected to move a latch to connect the disposable mechanical connector to the reusable mechanical connector. Or it may further include a latch actuator that disconnects from the mechanical connector of the reusable part.

In some embodiments, the mechanical connector of the disposable component and the mechanical connector of the reusable component allow the reusable component and the disposable component to move relative to each other while maintaining a mechanical connection. configured as

In some embodiments, at least one of the disposable component mechanical connector and the reusable component mechanical connector is adapted to align the disposable component mechanical connector and the reusable component mechanical connector. Also includes an alignment tool or mechanism. In some such embodiments, the alignment mechanism or tool is a reusable component support adapted to hold a reusable component and a disposable component carrier adapted to hold a patient-engaging substrate. a component support, the alignment tool having a first configuration in which the reusable component can be supported on the reusable component support away from the disposable component disposed on the disposable component support; and a second configuration in which the reusable component mechanical connector of the reusable component supported by the support contacts the disposable component mechanical connector of the disposable component disposed on the disposable component support.

In some embodiments, the disposable component mechanical connector and the reusable component mechanical connector both comprise a buckle and a buckle connector. In some such embodiments, the mechanical connector of the disposable component and the mechanical connector of the reusable component both further comprise a buckle release mechanism. In some such embodiments, the buckle is positioned on the patient-engaging board, the buckle connector and buckle release are positioned on the reusable component, and the buckle release flexes the patient-engaging board. It is accessible for operation only if

In some embodiments, the disposable's mechanical connector is disposed on a support element that is pivotally attached to the patient-engaging substrate.

In some embodiments, the patient-engaging substrate has a first configuration in which a connection is maintained between the mechanical connector of the disposable component and the mechanical connector of the reusable component; and a second configuration that can be disconnected from the mechanical connector of the reusable part.

Some embodiments also include a tool adapted to disconnect a reusable component mechanical connector from a disposable component mechanical connector. Such embodiments also have tool access points on the mechanical connector of the reusable part, the patient engaging substrate connecting the mechanical connector of the disposable part to the mechanical connector of the reusable part, and A first configuration in which the patient engaging board blocks the tool access point and a second configuration in which the mechanical connector of the disposable part is connected to the mechanical connector of the reusable part and the patient engaging board does not block the tool access point. configuration.

In some embodiments, when connected, the disposable component electrical connector and the reusable component electrical connector provide a waterproof electrical connection.

In some embodiments, the disposable component electrical connector and the reusable component electrical connector both include a cable, a plug at the distal end of the cable, and a receptacle adapted to receive the plug. In some such embodiments, the cable may extend from the disposable component and the receptacle is positioned on the reusable component. The receptacle may optionally extend from one of the plurality of housings, or the receptacle optionally extends from a flexible circuit configured to provide electrical communication between electrical components within the housing. may

In embodiments where the disposable component electrical connector and the reusable component electrical connector both include a cable, a plug at the distal end of the cable, and a receptacle adapted to receive the plug, the cable is reusable. Extending from the component, the receptacle may be positioned on the disposable component. In some such embodiments, the cable may extend from one of the multiple housings or from a flexible circuit configured to provide electrical communication between electrical components within the housings.

In embodiments in which the disposable electrical connector and the reusable electrical connector both include a cable, a plug at the distal end of the cable, and a receptacle adapted to receive the plug, the disposable electrical connector and The reusable component electrical connector further includes a second cable with the receptacle located at the distal end of the second cable.

In some embodiments, the disposable component electrical connector is integrated with the disposable component mechanical connector and the reusable component electrical connector is integrated with the reusable component mechanical connector. In some such embodiments, the disposable component electrical connector and the reusable component electrical connector are adapted to slide relative to each other to make an electrical and mechanical connection. In other such embodiments, the disposable component electrical connector and the reusable component electrical connector are adapted to mate to provide an electrical and mechanical connection. In some such embodiments, the mechanical connection between the disposable component mechanical connector and the reusable component electrical connector is such that the disposable component electrical connector is disconnected from the reusable component electrical connector. to prevent

In some embodiments, the disposable component includes an electronic memory adapted to receive and store user data from the controller, a mechanical interface between the mechanical connector of the disposable component and the mechanical connector of the reusable component. one of a mechanical connection indicator adapted to indicate connection and an electrical connection indicator adapted to indicate electrical connection between the disposable component electrical connector and the reusable component electrical connector. Including above.

In some embodiments, the disposable component also includes a second patient-engaging board having electrodes on the bottom side and a second patient-engaging board electrical connector.

In some embodiments, the wearable device is a cardiopulmonary physiologic monitor and/or an automated external defibrillator.

In some embodiments, the reusable component mechanical connector and the disposable component mechanical connector have a trigger configured to prevent disconnection of the reusable component mechanical connector and the disposable component mechanical connector. Equipped with a prevention mechanism. In some such embodiments, the anti-trigger mechanism comprises a protruding feature on the mechanical connector of the reusable component configured to interact with an opening or recess on the mechanical connector of the disposable component. Prepare. In some embodiments, the anti-trigger mechanism comprises a protruding feature on the mechanical connector of the disposable component configured to interact with an opening or recess on the mechanical connector of the reusable component. In some embodiments, the anti-trigger mechanism is configured to disengage by flexing a portion of at least one of the mechanical connector of the disposable component and the mechanical connector of the reusable component.

In some embodiments, the wearable device includes mechanisms that can be manually triggered to initiate, activate, or override functionality of the device. In some such embodiments, the mechanism may be manually triggered to override the delivery of therapy. In some embodiments, the mechanism can be manually triggered to initiate a status check of the device. In some embodiments, the mechanism can be manually triggered to activate the device.

Another aspect of the invention provides a method of using a wearable device, the wearable device comprising a first disposable component including a patient engaging substrate with a bottom side adhesive and electrodes; and a reusable component including a plurality of sealed housings mechanically and electrically coupled, each of the plurality of housings containing one or more of a capacitor, a battery, or a controller. In some embodiments, the method includes attaching the wearable device to a portion of the patient's skin surface for a first period of time, and monitoring the patient's ECG signals with the controller and electrodes during the first period of time. , removing the wearable device from the patient's skin surface portion at the end of the first time period; mechanically and electrically disconnecting the disposable component from the reusable component; mechanically and electrically connecting a second disposable component including a patient-engaging substrate containing an agent and electrodes; applying the second disposable component to a patient's skin portion; and monitoring the patient's ECG signal using two disposable electrodes.

In embodiments in which the disposable component further comprises a battery disposed within the battery housing, the method further comprises electrically disconnecting the battery from the reusable component and connecting the replacement battery to the reusable connection. including connecting. In some embodiments, electrically disconnecting the battery from the reusable component is performed after removing the wearable device from the patient's skin surface portion. In embodiments in which the replacement battery is located in a replacement battery housing, the method further includes mechanically connecting the replacement battery housing to the reusable component. The method may also include providing an alarm if the battery or replacement battery is not connected to the reusable component.

In embodiments in which the reusable component includes a rechargeable battery, the method further includes recharging the rechargeable battery.

In some embodiments, mechanically and electrically disconnecting the disposable component from the reusable component comprises bending the patient-engaging substrate, breaking structural elements, or (e.g., release latches, squeeze buckles, , or a push button).

In some embodiments, the method includes using an alignment tool to align the second disposable component to the reusable component prior to mechanically and electrically connecting the reusable component to the second disposable component. It also includes the step of aligning.

Some embodiments of the method include preventing electrical disconnection of the disposable component from the reusable component prior to mechanical disconnection of the disposable component from the reusable component.

Some embodiments of the method include providing an indication of the mechanical connection between the disposable component and the reusable component.

In some embodiments, the wearable device is a cardiopulmonary physiologic monitor and/or an automated external defibrillator.

The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention may be had by reference to the following detailed description and accompanying drawings, which define exemplary embodiments in which the principles of the invention are employed.
to 1 shows a wearable device with reusable and disposable parts; FIG. to FIG. 1 illustrates an embodiment of a wearable device employing magnets as mechanical connectors; to FIG. 10 illustrates another embodiment of a mechanical connector employing magnets in combination with peg and keyhole connectors for connecting and disconnecting reusable parts of wearable devices. to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to FIG. 10 illustrates an embodiment of a wearable device in which a disposable mechanical connector is positioned on a pivotable base. to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; FIG. 10 illustrates a tool for aligning a mechanical connector of a disposable component with a mechanical connector of a reusable component; FIG. 10 illustrates an embodiment of a wearable device in which the disposable component includes an adhesive patient-engaging substrate and the reusable component includes a cardiopulmonary physiologic monitor or defibrillator housing. to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to [0014] Figure 1 illustrates an embodiment of an electrical connector for electrically connecting and disconnecting a reusable component of a wearable device to a disposable component of the wearable device; to FIG. 1 illustrates one embodiment of an electrical connector for electrically connecting and disconnecting a reusable component of a wearable device to a disposable component of the wearable device; to [0014] Figure 1 illustrates an embodiment of an electrical connector for electrically connecting and disconnecting a reusable component of a wearable device to a disposable component of the wearable device; to FIG. 10 illustrates an embodiment of a combined electrical and mechanical connector; FIG. 10 illustrates an embodiment of a disposable part of a wearable device with four mechanical connectors and one electrical connector; FIG. 11 is a partial view of an embodiment of a wearable device having a reusable component mechanically attached in a detachable manner to an adhesive flexible engagement substrate of a disposable component of the device; to FIG. 10 illustrates another embodiment of mechanical and electrical connectors between disposable and reusable parts of a wearable device; to FIG. 10B illustrates the bottom side of one embodiment of a reusable portion of a wearable device having four housings. FIG. 12 is a cutaway side view of another embodiment of a reusable component of a wearable device; to FIG. 3 illustrates a wearable device having a reusable component with multiple housings connected by flexible connections; to FIG. 3 is a partial view of a reusable component of a wearable device having multiple housings mechanically and electrically connected by a flexible circuit having electrical connections extending into the housings. to FIG. 1 illustrates one embodiment of a reusable component of a wearable device having multiple housings mechanically and electrically connected by flexible circuits. FIG. 10 is a partial view of another embodiment of a reusable component of a wearable device having multiple housings mechanically and electrically connected by flexible circuits; 1 is a side view of a disposable component of a wearable device (such as a cardiopulmonary physiology monitor or a heart defibrillator); FIG. to FIG. 10 illustrates an embodiment of a wearable device in which the disposable component includes an adhesive patient-engaging substrate and cable, and the reusable component includes multiple housings, each including one or more of a controller, battery, or capacitor; is. to FIG. 10 illustrates an embodiment of a wearable device with a rechargeable battery in which the reusable part has multiple housings. to FIG. 10 illustrates an embodiment of a wearable device with a rechargeable battery that allows the battery to be wirelessly recharged via a charging pad while the wearable device is worn by a patient. to 1 shows a wearable device with reusable and disposable parts; FIG. to [0014] Fig. 5 illustrates yet another embodiment of a mechanical connector for connecting and disconnecting a reusable part of a wearable device to a disposable part of the wearable device; to FIG. 10 illustrates one embodiment of an anti-trigger mechanism for preventing disconnection of a reusable component of a wearable device from a disposable component of the wearable device while the device is worn. [0014] Figure 4 illustrates an embodiment of an electrical connection between a flexible circuit and a PCBA in a reusable part of a wearable device; FIG. 2 illustrates an example of interaction between a reusable component of a wearable device and a disposable component and accompanying battery of the wearable device.

Embodiments of the present invention provide an adhesively attached wearable device such as an extracorporeal cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown in WO2017/035502, which The adhesive patient engaging substrate(s) and battery are mechanically and electrically detachable from the device's reusable electronics. In particular, the device of the present invention enables users, especially patients with low dexterity, weak hand/arm strength, poor vision, etc., to perform the following steps before wearing the device: (1) mechanically attach the reusable electronics to the adhesive patient-engaging substrate; (2) electrically connect the reusable electronics to the adhesive patient-engaging substrate; (3) reuse. (4) electrically connecting the battery to the reusable electronic device; These embodiments provide electrical connections that are waterproof so the patient can shower or perform other activities while wearing the device. The mechanical and electrical connections of these various embodiments also allow the device to engage other objects as the patient moves or changes position (e.g., sits, lies down, falls, walks). It can withstand expected mechanical forces without disengagement or breakage, such as when engaging seat belts or engaging clothing covering equipment. Embodiments of the present invention provide mechanical and electrical connections between disposable and reusable components that are difficult or impossible to disconnect while the device is on the patient.

A reusable component embodiment of the wearable device of the present invention comprises a plurality of housings or modules each containing one or more electrical components. For example, in embodiments where the wearable device is a heart defibrillator similar to that shown in WO2017/035502, the housing or module may each include one or more of a controller and a capacitor. good. In these embodiments, flexible electrical circuits extend between the housings or modules to provide connections between electronic components. The flexible electrical circuit may be waterproof or covered with a waterproof material. Further, in embodiments of the present invention, the flexible circuit can withstand flexing, twisting, stretching, bending, compression, tension, etc. that can result from patient movement while wearing the wearable device. In some embodiments, the flexible electrical circuit is sheathed in a housing or module, and waterproof electrical connections extend from the flexible electrical circuit to electrical components within the housing or module. In other embodiments, the flexible electrical circuit is at least partially within one or more of the housings or modules.

Illustrative examples of wearable devices having reusable and disposable components are shown in FIGS. 1A-D. In this example, the wearable device includes a first adhesive patient-engaging substrate 2, a second adhesive patient-engaging substrate 3, a plurality of housings 4 attached to a housing base 5, and a battery containing a battery. A housing 6, a cable 7 extending between patient-engaging boards 2 and 3, a mechanical connector 8 for attaching housing base 5 to first patient-engaging board 2, and electrical components within housing 4. WO2017/035502, having an electrical connector 1 for connecting to a first patient-engaging board and an electrical connector 9 for electrically connecting the battery housing 6 to the other housing 4; An external cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown. Housings 4 each contain one or more of a controller, capacitor, or other cardiopulmonary physiologic monitor or defibrillator electronics, and housings 4 together with their base 5 are reusable components of wearable device 10 . to form The first and second adhesive patient-engaging substrates each have one or more electrodes on the bottom side thereof for sensing cardiac activity when substrates 2 and 3 are connected to housing 4. or, in the case of a heart defibrillator, shocks can be delivered from the defibrillator component to the patient to which the substrate is adhesively attached. The first and second patient-engaging substrates and the battery within the battery housing are disposable components of the wearable device. Wearable devices may include override features for overriding a scheduled or already initiated device function or therapy. For example, in the case of a cardioverter-defibrillator, the device can be controlled to cancel a scheduled shock. In some embodiments, the same button may also be used to interact with various user interface prompts as desired (eg, turn on power, perform status checks, etc.). Simultaneously pressing multiple controls or buttons 21 on the reusable component may initiate the override function. Other mechanisms for initiating override are possible (e.g., buttons located on opposing surfaces of the housing and configured to be squeezed or pinched together, first or second patient engaging substrates, etc.). , buttons placed on other surfaces of the wearable device, etc.).

Various mechanical connectors, electrical connectors, and configurations are described below. Each may be used in combination with the other.

One aspect of the present invention is a method by which reusable part(s) of a wearable device can be mechanically connected to and disconnected from disposable part(s). Embodiments of the present invention include reusable parts of wearable devices (e.g., external cardiopulmonary physiologic monitors or cardioverter-defibrillators similar to those shown in WO2017/035502) and their Robust, intuitive, easy to operate (even for less dexterous patients), load bearing between disposable parts of the device (e.g., adhesively attachable patient-engaging substrates and/or batteries, etc.) provide a flexible mechanical attachment. In many embodiments, the reusable component can be detached from the disposable component only when the wearable device is not attached to the patient. The mechanical attachment mechanisms described herein can be used in combination with each other and with any of the embodiments described in this disclosure.

Figures 2A-E show embodiments employing magnets as mechanical connectors. In the illustrated embodiment, the wearable device 10 is an external cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown in WO2017/035502. Components of wearable device 10 include a first patient-engaging substrate 2 , a plurality of housings 4 , and a second patient-engaging substrate (not shown). The first patient-engaging board 2 and the second patient-engaging board each include an adhesive for attaching the boards to a patient and a sensor for sensing cardiac activity or, in the case of a cardioverter-defibrillator, electrical power to the patient. and one or more electrodes (not shown) for shock delivery. Housings 4 each contain one or more of a battery, a capacitor, or a controller. In this embodiment the housings 4 are movable relative to each other and are in electrical communication with each other, for example via a flexible circuit (not shown). Also, the electrical components within the housing may be connected to the electrodes and electrical components within the first and second patient-engaging substrates after the housing is attached to the first patient-engaging substrate, for example, in a manner further described below. communicate effectively. Reusable components of wearable device 10 include housing 4 and disposable components include first patient-engaging substrate 2 and second patient-engaging substrate.

As shown in Figures 2A-E, the magnets 8 are positioned on the top side 15 of the patient-engaging board 2 and on the top side 15 of the patient-engaging board 2 in corresponding positions that allow the housing to be attached to the first patient-engaging board as shown in Figure 1C. It is arranged on the bottom side 16 of the housing 4 . The magnets must be strong enough to support the weight of the housing and resist disengagement resulting from patient movement, catching on clothing or other objects, etc., but avoid intentional removal of the housing from the patient-engaging board. is also possible. In this embodiment, the magnet is close to the top 17 of the housing 4 so that the housing can act as a lever arm to facilitate separation of the magnets of the patient engaging board and the housing. placed in position. As an example, the magnets 8 shown in FIGS. 2D-E each have a surface area of 1 square inch and a magnetic strength of 20 pounds. Housing 4 has a length of 2.5 inches. The removal force F _R applied to the end of the moment arm of housing 4 to separate magnet 8 (as shown in FIG. 2E) is 4 pounds, only 20% of the adhesion force.

Figures 3A-B show a reusable part of the wearable device (such as an external cardiopulmonary physiologic monitor or heart defibrillator similar to that shown in WO2017/035502) to a disposable part of the wearable device. Another embodiment of a mechanical connector 8 that employs magnets in combination with peg and keyhole connectors is shown to connect and disconnect to. In this embodiment, a mechanical connector for disposable 20 (eg, an adhesive patient-engaging board) has a first magnet 22 located within a housing 24 having an access keyhole 26 . A mechanical connector for a reusable component 28 (eg, a cardiopulmonary physiology monitor or defibrillator housing) has a peg 30 with an enlarged end 32 that can fit through an upper portion 34 of access keyhole 26 . After inserting the peg 30 into the keyhole 26, move the peg 30 downward into the slot portion 36 of the keyhole 26 until the second magnet 38 on the peg 30 reaches and adheres to the first magnet 22. can be done. There may be multiple mechanical connectors on the disposable component and on the reusable component.

Figures 4A-G show a reusable component 28 (cardiopulmonary physiology monitor or defibrillator, etc.) of a wearable device (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). A mechanical connector embodiment for connecting and disconnecting a fibrillator housing, etc.) to a wearable device disposable component 20 (such as an adhesive patient-engaging substrate) is shown. In this embodiment, the mechanical connectors are male and female mechanical elements. As shown in FIG. 4A, the reusable part 28 has four housings 4 . A male snap element 48 extends from each housing 46 . As shown, the housings 4 may be connected by flexible connectors 50, such as flexible circuits. Also shown is an optional electrical connector 52 . Disposable component 20 has a plurality of female mechanical snap elements 54 at positions corresponding to the positions of male snap elements 48 . Disposable component 20 also has an optional electrical connector 56 .

Figures 4C-E illustrate one embodiment of a mechanical snap that may be used with the wearable device shown in Figures 4A-B. In this embodiment, the female snap element 54 is a spring that retains the male snap element head 60 within the female snap element 54 until sufficient force is applied to remove it, as suggested in FIG. 4E. It has a latch 58 . FIGS. 4F-G show another embodiment of a mechanical snap in which the female snap element 54 has multiple cantilevered walls 62 separated by notches 64 . The wall 62 responds to the insertion force exerted by the male snap element head 60 on the wall top 66 during connection or the retraction force exerted by the head 60 on the underside of the wall projection during disconnection to Move radially outward.

5A-B illustrate a wearable device (international device) in which the mechanical connector 8 of the disposable component 20 (such as an adhesive patient-engaging substrate) is positioned on a pivotable base 74 having a pivot point 73 and an attachment point 70. 1 shows front and side views of an embodiment of an external cardiopulmonary physiologic monitor or cardioverter-defibrillator (such as that shown in Publication No. 2017/035502). Once the reusable component 28 (such as a cardiopulmonary physiology monitor or defibrillator housing) is mechanically attached to the disposable component 20 using any of the mechanical connectors disclosed herein, it can be reused. The enablement component can pivot away from the reusable component, thereby providing more freedom of movement while the wearable device is worn on the patient.

Figures 6A-D show a reusable component 28 (such as an external cardiopulmonary physiology monitor or cardioverter defibrillator similar to that shown in WO2017/035502) of a wearable device. A mechanical connector embodiment for connecting and disconnecting a fibrillator housing, etc.) to a wearable device disposable component 20 (such as an adhesive patient-engaging substrate) is shown. Similar to the embodiment of Figures 3A-B, this embodiment employs a peg and keyhole connector. A housing 84 on the top of disposable 82 has an access keyhole 86 . A mechanical connector for reusable component 28 (e.g., a cardiopulmonary physiology monitor or defibrillator housing) includes peg 90 with enlarged end 92 that can fit through top surface 94 of access keyhole 86 . have. After inserting the peg 90 into the keyhole 86, the peg 90 can be moved down into the slot portion 96 of the keyhole 86 so that the peg 90 moves back through the slot 96 as shown in Figures 6A-C. A lock 98 can be engaged to prevent rollover. There may be multiple mechanical connectors on the disposable component and on the reusable component. In some embodiments, the keyhole slot portion may extend in more than one direction, as shown by the dogleg-shaped slot 96 in FIG. 6D.

Figures 7A-B show a reusable component 28 (such as an external cardiopulmonary physiology monitor or cardioverter defibrillator similar to that shown in WO 2017/035502) of a wearable device. 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component 20 of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, the disposable mechanical connector is a cradle 104 having an inwardly projecting lip 106 at its open end. A ridge 108 or other outwardly projecting surface on the outside of reusable component 100 engages lip 106 during insertion and deforms cradle 104 sufficiently to fit reusable component 100 into the cradle. enter. This embodiment may provide a waterproof connection as a user-friendly mechanical connection. Also shown in FIGS. 7A-B are electrical connectors 1 and 110 on the reusable and disposable components that provide electrical communication between the reusable and disposable components when a mechanical connection is made. are shown respectively.

In an alternative embodiment (not shown), the cradle may have an open end for sliding the reusable component into the cradle.

Figures 8A-B show a reusable component 28 (cardiopulmonary physiology monitor or defibrillator, etc.) of a wearable device (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component 20 of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, the mechanical connector of the disposable is the adhesive area 124 on the top side of the disposable 20 that engages the bottom side of the reusable component 28 . To disconnect reusable component 28 from disposable component 20 , one end of reusable component 28 may be pivoted away from the disposable component to expose pull tab 126 associated with each adhesive area 124 . Pulling down on the pull tab 126 separates the substrate under the adhesive area from the disposable component, thereby allowing the reusable component to be removed from the disposable component.

Figures 9A-C show a reusable component 28 (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502) of a wearable device. 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component 20 of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, hook and loop connectors 134 and 136 (Velcro®) are attached to the top of the disposable part 132 and the bottom of the reusable part 130, respectively, to attach and detach the disposable part from the reusable part. materials, etc.).

Figures 10A-C show a reusable part 28 of a wearable device (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component 20 of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, the reusable component mechanical connector has a post 144 with an elongated foot 146 . The disposable mechanical connector has a rotatable housing 148 with an opening 150 that is just larger than the foot 146 . After foot 146 is inserted into housing 148 through opening 150, tabs 152 extending from housing 148 are used to rotate housing 148 to reorient opening 150 relative to foot 146, thereby reorienting the post. 144 can be prevented from being pulled out of housing 148 . To disconnect the reusable component 28 from the disposable component 20 , the tabs are used to rotate the housing 148 so that the openings 150 are aligned with the feet 146 so that the posts 146 are withdrawn from the housing 148 . It may be possible.

Figures 11A-E show a reusable part 28 of a wearable device (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component 20 of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, the mechanical connector for the disposable is a buckle 164 attached at one end 166 to the top surface of the disposable. A prong 168 cantilevers from the buckled end 166 and a raised element 169 projects downward toward the upper side of the disposable. The reusable component mechanical connector has an opening 170 in a plate 172 located on the bottom side of the reusable component 160 . To mechanically connect the reusable component to the disposable component, prongs 168 are inserted between plate 172 and the bottom side of the reusable component. The distance between the plate 172 and the bottom surface of the reusable component 162 is slightly greater than the distance between the bottom surface of the raised element 169 and the top surface of the disposable component so that the prongs 168 can be reused with the plate 172. When inserted between the bottom surface of the reusable part, the prongs 168 flex upward until the raised elements 169 of the prongs 168 enter and project through the openings 170, thereby turning the reusable part into a disposable part. lock mechanically. To detach the reusable component from the disposable component, the disposable component is bent to expose the portion of the raised element projecting through opening 170, and the raised element is removed from opening 170, as shown in FIG. 11E. Pushing may release the reusable component from the disposable component.

In another embodiment, the disposable mechanical connector buckle may have one or more cantilevered elements extending laterally through one or more openings of the reusable mechanical connector. .

In some embodiments, the reusable component has multiple housings and at least one mechanical connection between each housing and the disposable component. These mechanical connections may be spread evenly across the wearable device. Other embodiments use fewer mechanical connections. Additionally, some mechanical connections are stronger (eg, to support the weight of the reusable part) and some mechanical connections are weaker (eg, for alignment and alignment than weight bearing). for the sake of).

FIG. 12 shows a tool 180 for aligning the mechanical connector 8 of the disposable part with the mechanical connector 8 of the reusable part. Tool 180 is a hinged container that holds disposable component 20 in proper alignment with reusable component 28 so that the mechanical connectors adhere to each other when lid 186 is closed.

In addition to a snapping sound or other audible indication that the mechanical connection between the disposable and reusable component has been successful, some embodiments provide mechanical feedback such as an indicator light, vibration or generated sound. provide electronically generated feedback of successful physical connection. Figures 33A-B show a wearable device 500 (WO2017/035502) having reusable parts 28 (such as a cardiopulmonary physiologic monitor or defibrillator housing) and disposable parts 20 (such as an adhesive patient-engaging substrate). cardiopulmonary physiologic monitor or external cardioverter-defibrillator, etc., similar to that shown in . Disposable component 20 has a mechanical connector 8 that connects to a corresponding mechanical connector 8 on reusable component 28 . Each mechanical connector 8 on the disposable component 20 contacts one or more conductive elements 512 in each of the reusable component's mechanical connectors 8 to provide circuitry 512 to a microprocessor 514 within the reusable component. has a conductive element 510 that closes the When the microprocessor 514 detects that the circuit 512 is closed, the microprocessor 514 controls all the machines by turning on one or more lights 516, vibrating the motor 518, and/or emitting a sound via the speaker 414 . announces a successful mechanical connection between the mechanical connectors 8 and their corresponding mechanical connectors 8 .

In embodiments of the wearable device in which the disposable component includes an adhesive patient-engaging substrate, the mechanical connector of the disposable component is disconnected from the mechanical connector of the reusable component while the patient-engaging substrate is attached to the patient. may not be possible. This feature helps ensure that the disposable and reusable components are connected while wearing the wearable device. For example, FIG. 13 shows a side view of one embodiment of a wearable device in which the disposable component includes an adhesive patient-engaging substrate 20 and the reusable component includes a cardiopulmonary physiologic monitor or defibrillator housing 28. FIG. In order to access the mechanical connector 8 with the tool 206, the patient engaging substrate 20 must be flexed more than it is flexed while adhesively attached to the patient.

Figures 14A-C show a reusable part 28 of a wearable device (such as an external cardiopulmonary physiology monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). 1 illustrates one embodiment of a mechanical connector for connecting and disconnecting a fibrillator housing, etc.) to a disposable component of a wearable device (such as an adhesive patient-engaging substrate 20 ). In this embodiment, the disposable mechanical connector extends from a slot 214 in the top surface of substrate 20 and a bendable plate 218 on the substrate (or alternatively, patient-engaging with no intervening plate). tabs 216 extending directly from the substrate). The mechanical connector of the reusable part has a peg 220 with an enlarged end 222 that can be moved from the open end 224 of the slot into the slot 214 to connect the mechanical connector. When patient-engaging base plate 20 and foldable plate 218 are unfolded, tabs 216 prevent enlarged ends 222 of pegs 220 from leaving slot 214, as shown in FIG. 14B. However, when the patient-engaging base plate 20 and foldable plate 218 are folded, the tabs 216 move away from the enlarged ends of the pegs, allowing them to be removed from the slots 214, as shown in FIG. 14C. , the cardiopulmonary physiologic monitor or the defibrillator housing can be disconnected from the patient engaging base.

Figures 35A-B show reusable parts (e.g. cardiopulmonary physiology monitor or defibrillator) of a wearable device (external cardiopulmonary physiology monitor or cardioverter defibrillator similar to that shown in WO2017/035502). 1 shows one embodiment of a mechanical connector for connecting and disconnecting a mobile device housing, etc.) to a disposable part of a wearable device (such as an adhesive patient-engaging substrate). In this embodiment, the disposable mechanical connectors are a plate 3504 including a foldable portion 3506 at one end of the plate, a protrusion 3508 at the middle of the plate 3504, and a lock at another portion 3510 of the plate. mechanisms (eg, spring locks, detents, etc.). In some embodiments, the protrusions and locks may be placed directly on the patient engaging substrate without an intervening plate. Protrusions 3508 are configured to interact with openings 3512 in a portion of the mechanical connector of the reusable component. To unlock the connector, the bendable portion 3506 of the disposable mechanical connector is bent backwards away from the reusable mechanical connector. The reusable component mechanical connector can then be slid along the length of the disposable component mechanical connector to release the locking mechanism. It will be appreciated that in some embodiments, the mechanical connector on the disposable component can instead slide along the length of the mechanical connector on the reusable component. FIG. 35B shows a disposable part machine including a plate 3504 including a bendable portion 3506 at one end of the plate, a protrusion 3508 at the middle of the plate 3504, and a spring lock 3512 at another portion of the plate. 12 shows another embodiment of a target connector; When foldable portion 3506 is folded over, protrusion 3508 disengages from opening 3512 of the mechanical connector of the reusable component. The plate 3510 can then be slid along the length of the disposable mechanical connector and the spring lock 3512 can be released.

Figures 15A-C show a reusable component 28 (cardiopulmonary physiologic monitor or defibrillator) of a wearable device (such as an external cardioverter defibrillator similar to that shown in WO2017/035502). 1 shows one embodiment of a mechanical connector for connecting and disconnecting a wearable device (such as a housing, etc.) to a disposable component (such as an adhesive patient engaging substrate 20 ) of the wearable device. In this embodiment, the disposable mechanical connector includes a slot 234 in the top surface of the substrate 20 and a tab 236 extending from a plate 248 on the substrate. The reusable component mechanical connector has a peg 240 with an enlarged end 242 that can be moved from the open end 244 of the slot into the slot 234 to connect the mechanical connector. As the enlarged portion of the peg is advanced into the slot, the plate 248 flexes to retract the tab 236, thereby allowing the enlarged end 242 of the peg 240 to move into the slot. When patient-engaging base plate 20 and plate 248 are returned to their unflexed state, tabs 236 prevent enlarged ends 242 of pegs 240 from leaving slots 234, as shown in FIG. 15B. However, to disconnect the reusable component from the patient-engaging substrate, substrate 20 and plate 248 are bent until the plate breaks, thereby removing tabs 236 from the enlarged ends of the pegs, as shown in FIG. 15C. Allows release and removal from slot 234, thereby allowing the cardiopulmonary physiologic monitor or defibrillator housing to be disconnected from the patient engaging board.

In other embodiments where the disposable component of the wearable device includes a patient-engaging substrate, perforations or seams in the patient-engaging substrate allow the user to tear the substrate to disconnect the reusable component from the substrate. .

Another aspect of the invention is a method by which the reusable part(s) of the wearable device can be electrically connected to and disconnected from the disposable part(s). Embodiments of the present invention include reusable parts of wearable devices (e.g., external cardiopulmonary physiologic monitors or cardioverter-defibrillators similar to those shown in WO2017/035502) and their Robust, waterproof, easy to operate (even for less dexterous patients) and reliable between disposable parts of the device (e.g., adhesively attachable patient-engaging substrates and/or batteries, etc.) provide a highly reliable electrical connection. In many embodiments, the reusable component can be electrically disconnected from the disposable component only when the wearable device is not attached to the patient. The electrical connection mechanisms described herein may be used in combination with each other and may be used in combination with any of the embodiments described in this disclosure.

Figures 16A-B illustrate a reusable component 28 of the wearable device (such as an electronic cardiopulmonary physiologic monitor or defibrillator component in housing 4 ) and a disposable component of the wearable device (first and second adhesive patient contacts). 1 shows an embodiment of an electrical connector for electrically connecting and disconnecting to plywood boards 2 and 3 , etc.). In this embodiment, a first cable 258 extends from the first patient-engaging board 2 to the second patient-engaging board 3 and a second cable 260 extends through a flexible circuit 261 within the first patient-engaging board 2 . to electrical connector 262 . Electrical connector 262 may be connected and disconnected with a mating electrical connector 253 in housing 4 of reusable component 28 . Cables 258 and 260 electrically connect cardiopulmonary physiology monitor or defibrillator components within housing 4 to electrodes 255 on the bottom side of patient-engaging boards 2 and 3 for sensing cardiac activity (e.g., ECG signals). etc.), or in the case of a defibrillator, to allow the delivery of electrical shocks from the electrodes 257 on the bottom side of the patient-engaging boards 2 and 3 . Flexible circuit 50 provides electrical communication between cardiopulmonary physiologic monitor or defibrillator components within housing 4 . In an alternative embodiment shown in FIG. 16C, electrical connectors 262 may connect to corresponding electrical connectors 253 integrated into flexible circuit 50 .

Figures 17A-B illustrate how the wearable device's reusable component 28 (such as an electronic cardiopulmonary physiology monitor or defibrillator component in housing 4 ) is connected to the wearable device's disposable component (first and second adhesive patient-engaging substrates). 2 and 3 , etc.). In this embodiment, a first cable 258 extends from the first patient-engaging board 2 to the second patient-engaging board 3 and a second cable 260 extends out of the cardiopulmonary physiologic monitor or defibrillator housing 4 . 1 to electrical connector 262 . Electrical connector 262 may be connected and disconnected with a mating electrical connector 253 extending from flexible circuit 261 in first patient-engaging substrate 2 . Cables 258 and 260 electrically connect cardiopulmonary physiology monitor or defibrillator components within housing 4 to electrodes 255 on the bottom side of patient-engaging boards 2 and 3 for sensing cardiac activity (e.g., ECG signals). etc.), or in the case of a defibrillator, to allow the delivery of electrical shocks from the electrodes on the bottom side of the patient-engaging substrates 2 and 3 . Flexible circuit 50 provides electrical communication between cardiopulmonary physiologic monitor or defibrillator components within housing 4 . In an alternative embodiment, second cable 260 may extend from flexible circuit 50 rather than from one of housings 4 .

Figures 18A-B illustrate a reusable component 28 of the wearable device (such as an electronic cardiopulmonary physiology monitor or defibrillator components in housing 4 ) connected to a disposable component 20 of the wearable device (first and second adhesive patient engagements). 1 shows one embodiment of an electrical connector for electrically connecting and disconnecting boards 2 and 3 , etc.). In this embodiment, a first cable 258 extends from the first patient-engaging board 2 to the second patient-engaging board 3 and a second cable 310 extends out of the cardiopulmonary physiology monitor or defibrillator housing 4 . Extending from one to the first electrical connector 312, a third cable 314 electrically connects from the flexible circuit 261 of the patient-engaging board 2 to the first electrical connector 312 as shown, and the first electrical connector 312 to a second electrical connector 316 configured to disconnect. Cables 258 , 310 and 314 electrically connect the cardiopulmonary physiology monitor or defibrillator components within housing 4 to electrodes 255 on the bottom side of patient-engaging boards 2 and 3 to detect cardiac activity (e.g., ECG signals). etc.) or, in the case of a defibrillator, the delivery of an electric shock from the electrodes 257 on the bottom side of the patient-engaging boards 2 and 3 . Flexible circuit 50 provides electrical communication between cardiopulmonary physiologic monitor or defibrillator components within housing 4 . In an alternative embodiment shown in FIG. 18C, second cable 300 may extend from flexible circuit 50 rather than from one of housings 4 .

In some embodiments, the mechanical and electrical connectors that connect the reusable component to the disposable component and disconnect the reusable component from the disposable component are integrated such that the electrical connection occurs simultaneously with the mechanical connection. It is Figures 19A-D illustrate one embodiment of a combination electrical and mechanical connector. In FIG. 19A, a mechanical connector housing 322 having a keyhole opening 324 with a wide portion 326 over a narrow portion 328 is attached to the top surface of a wearable device disposable component (eg, adhesive patient engaging substrate 20 ). It is Electrical connector 330 extends from the side of housing 322 adjacent widened portion 326 of keyhole opening 324 . Corresponding structures on a reusable part of the wearable device (e.g. housing 4 of a cardiopulmonary physiological monitor or cardioverter-defibrillator similar to that shown in WO 2017/035502) are reusable A peg 334 with an enlarged end 336 to form a mechanical connector for the parts. A reusable component electrical connector 338 is shown adjacent to the peg 334 . To mechanically and electrically connect the reusable component to the disposable component, enlarged end 336 of peg 334 is inserted into widened portion 326 of keyhole opening 324, as shown in FIG. 19C. The peg 334 is then advanced within the keyhole opening 324 until the enlarged end 336 is below the narrowed portion 328 of the keyhole opening such that the peg can no longer be pulled out of the housing 322, thereby re-engagement. A usable part is mechanically connected to the disposable part. As shown in FIG. 19D, when the peg 334 reaches its limit of travel within the keyhole opening 324, the reusable component electrical connector 338 engages the disposable component electrical connector 330 and is reusable. Electrically connect the component to the disposable component. To disconnect the reusable component from the disposable component, the movable disconnect actuator 340 is depressed to move the peg 334 to the widened portion 326 of the keyhole opening 324, disconnecting the electrical connectors 330 and 338 and disconnecting the peg. It may be possible to allow the enlarged end 336 to be removed from the keyhole opening 324 .

FIG. 20 shows an embodiment of a wearable device disposable component (such as an adhesive patient engaging substrate 20 ) having four mechanical connectors 8 (such as the snap connectors described above) and one electrical connector 1 . . A reusable part of the wearable device (e.g., a housing containing a cardiopulmonary physiologic monitor or a heart defibrillator similar to that shown in WO2017/035502 part) is mechanically attached to the mechanical connector 28 . Once attached, the electrical connector of the reusable part is automatically connected to the electrical connector 1 at the same time.

FIG. 21 shows a reusable component (e.g. housing 4 containing cardiopulmonary physiology monitor or defibrillator components) mechanically attached in a detachable manner to an adhesive flexible engagement substrate 362 of a disposable component of the device. 1 is a partial view of an embodiment of a wearable device (such as a cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown in WO2017/035502) having a . Other parts of the disposable include cable 364 and battery housing 6 which houses one or more batteries. Battery housing 6 has an electrical connector 368 and a mechanical connector 370 that can be connected and disconnected to electrical connector 9 and mechanical connector 374 provided on housing 4 , respectively. When connected, connectors 9 , 368 and cable 364 connect the cardiopulmonary physiologic monitor or defibrillator components within housing 4 to the bottom of patient-engaging board 362 and a second patient-engaging board (not shown). to the electrodes on the bottom side of the patient-engaging substrate to allow sensing of cardiac activity (e.g., ECG signals, etc.) or, in the case of a defibrillator, to deliver electrical shocks from the electrodes on the bottom side of the patient-engaging substrate. can be done. A flexible circuit (not shown) provides electrical communication between cardiopulmonary physiologic monitor or defibrillator components within housing 4 .

In various embodiments, the electrical connector may be, for example, an edge card connector (ie, USB), a spring probe connector, a ZIF (zero insertion force) connector, a pin probe insertion connector, a twist and lock connector, or the like. A sealing O-ring may be used to waterproof the electrical connection.

Figures 22A-B show the mechanical interface between disposable and reusable parts of a wearable device such as a cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown in WO2017/035502. and another embodiment of an electrical connector. A reusable component 280 (eg, a housing containing cardiopulmonary physiology monitor or defibrillator components) has a mechanical connector with a peg 282 having an enlarged end 284 located in a recess 286 on the bottom side of the housing. have. An electrical connector receptacle (not shown) is also located in the housing recess. As shown in Figure 22A, an electrical connector 262 at the end of a cable 260 extending from a wearable device disposable component (e.g., an adhesive flexible engagement substrate, not shown) provides mechanical connection between the reusable and disposable components. mated with an electrical connector on the reusable component prior to electrical connection. FIG. 22B is a bottom side view of the mechanical connector 8 of the reusable component 28 and the disposable component. The mechanical connector 8 has a wide portion 296 (allowing insertion of the enlarged ends 284 of the pegs 282) and a narrow portion into which the pegs 282 can be slid to form a mechanical connection between the parts. It has a keyhole opening 294 with 298 . When the peg 282 is positioned in the narrowed portion 298 of the opening 294, the surface 300 of the mechanical connector 8 engages the electrical connector 262 to prevent disconnection of the reusable component from the electrical connector.

Another aspect of the invention is a flexible circuit that provides waterproof electrical communication between electrical components (eg, cardiopulmonary physiology monitor or defibrillator components) within the housing of a reusable component of a wearable device. A flexible circuit can also provide a robust and flexible mechanical connection between adjacent housings. 23A-B of a reusable part of a wearable device (such as a cardiopulmonary physiologic monitor or heart defibrillator similar to that shown in WO2017/035502) having four housings 4 . The bottom side of the embodiment is shown. Across the bottom side of housing 4 is a flexible circuit 50 having a plurality of electrical conductors (not shown) and at least one electrical connector 314 (see FIG. 23B) extending from the conductors of the flexible circuit to electrical components within each housing 4 . shown in perspective) extends. Overmolding materials (such as hot melt polyamide, polyolefin, or rubber-based thermoplastic setting adhesives) provide a robust mechanical connection between the housings while allowing flexing and other relative motion between the housings. The overmolding material is also dielectric and waterproof, which can make the wearable device more secure, even during showers or other activities.

Figure 24 is a cutaway side view of another embodiment of a reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or heart defibrillator similar to that shown in WO2017/035502); be. A flexible circuit 50 extends across the housing 4 and therebetween. Flexible circuit 50 has a plurality of electrical conductors that provide communication between electrical components within housing 4 . A mechanical connector 8 extends from a bottom side 16 of the housing 4 and provides mechanical attachment to and detachment from disposable components of the wearable device, such as an adhesive patient-engaging substrate (not shown). In addition to electrical communication, flexible circuit 50 provides a robust mechanical connection between the housings while allowing flexing and other relative motion between the housings.

FIG. 36 illustrates an embodiment of an electrical connection between flexible circuits (such as the flexible circuits described above extending through and between housings of reusable components of wearable devices). Electrical connections between flex circuit 50 and PCBA 3602 in housing 4 include screws 3606 inserted through flex circuit 50 into threaded standoffs 3608 that are soldered to PCBA 3602 . Conductive material 3610 (eg, copper) is exposed around each through-hole 3612 in the flex circuit on the top and/or bottom surface of flex circuit 50 . When screws 3606 are threaded through holes 3612 and screwed into standoffs 3608, they compress the flex circuit against the standoffs, thereby making reliable electrical contact between flex circuit 50 and PCBA 3602. will be These connections are mechanically strong and capable of conducting the high voltage and high current electrical signals required for defibrillation. Additionally, the PCBA may also include low voltage connectors (eg, fine pitch multi-conductor connectors) that are simultaneously engaged upon compression of the flex circuit against the standoffs, allowing for low voltage communication lines.

In some embodiments of the wearable device, the disposable component is a patient-engaging substrate adhesively attached to the patient and the reusable component is a plurality of housings mechanically attached to the patient-engaging substrate. be. As the patient moves, the shape of the patient engaging substrate may change. Embodiments of the present invention provide a mechanical interface between a reusable component and a disposable component that accommodates changes in the shape of one of the components. Figures 25A-B have a reusable component having multiple housings 4 connected by flexible connections (such as flexible circuits as described above) and a disposable component 20 (such as an adhesive patient engaging substrate). Figure 2 shows a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter-defibrillator similar to that shown in WO2017/035502); A reusable component mechanical connector includes a peg 336 having an enlarged end 338 . The disposable mechanical connector includes slots 340 , 342 , 344 , 346 at locations corresponding to pegs 326 . The slots 340, 344, 346 are much wider than the width of the enlarged end 338 so that the patient-engaging substrate 20 bends and straightens in response to patient movement. to allow movement of enlarged end 338 at . Anchor slot 342, on the other hand, has a slightly greater width than enlarged end 338, so that as the other peg moves within the slot, the corresponding peg moves little or no. do not do. This arrangement allows some relative movement between the reusable and disposable parts of the wearable device without causing complete mechanical disconnection of the parts.

26A-B illustrate a plurality of housings 4 (each one of, for example, a controller, capacitor, or battery) mechanically and electrically connected by flexible circuits 50 having electrical connections 354 extending into the housings 4 . ) shows a partial view of a reusable part of a wearable device (such as a cardiopulmonary physiologic monitor or a heart defibrillator similar to that shown in WO2017/035502). A mechanical connector protrudes from the rear surface of the housing 4 from a position above the flexible circuit 50 . This arrangement of mechanical connectors and flexible circuits reduces the overall height of the reusable component.

In embodiments of the invention, the disposable component of the wearable device includes a replaceable battery. For example, as described above with respect to FIGS. 1A-D, the battery housing is part of a disposable component that can be electrically and mechanically connected to and disconnected from the reusable component of the wearable device.

Figures 27A-B show a wearable device (similar to that shown in WO2017/035502) having multiple housings 360, 362, 364, 366 mechanically and electrically connected by flexible circuits. Fig. 3 shows an embodiment of a reusable part of a cardiopulmonary physiology monitor or cardioverter-defibrillator; A disposable component of the wearable device includes the battery housing 6 . A reusable component mechanical connector 8 extends from the surface of the housing 366 and the battery housing 6 has a corresponding mechanical connector 374 . The battery housing also has an electrical connector 9 and the housing 366 has a corresponding electrical connector (not shown). The electrical and mechanical connections between battery housing 6 and reusable component housing 366 are made simultaneously.

FIG. 28 illustrates a wearable device (cardiopulmonary physiology similar to that shown in WO2017/035502) having multiple housings 380 and 382 mechanically and electrically connected by flexible circuits (not shown). FIG. 10 is a partial view of another embodiment of a reusable component of a medical monitor or cardioverter-defibrillator; A disposable part of the wearable device includes the battery housing 6 . The mechanical connectors 8 of the reusable part are arranged in the housings 382 (only one is shown in FIG. 28) and the battery housing 6 has corresponding mechanical connectors 374 . The battery housing also has electrical connectors 9 and housing 382 has corresponding electrical connectors 9 . The electrical and mechanical connections between battery housing 6 and reusable component housing 382 are made simultaneously.

Figure 37 shows a wearable device (cardiopulmonary physiological monitor similar to that shown in WO2017/035502) having multiple housings 4 mechanically and electrically connected by flexible circuits (not shown). or heart defibrillator, etc.). The wearable device's disposable component 20 is mechanically connected to the disposable battery 3708 . The connection between the disposable and the battery can be permanent such that the battery is discarded with the disposable. The reusable component module can be configured to be lowered onto the disposable components and batteries to make electrical connections and mechanical connections to retain them in the battery module. The reusable component can be lifted from the battery and disposable prior to disposal of the disposable.

FIG. 29 shows aspects of a disposable part of a wearable device (such as a cardiopulmonary physiologic monitor or cardioverter-defibrillator similar to that shown in WO2017/035502). In this embodiment, the disposable components are an adhesive patient-engaging substrate 2 , a cable 7 connecting to a second patient-engaging substrate (not shown), a battery housing 6 containing one or more batteries, and the wearable device. It includes a plurality of mechanical connectors 8 for connecting to corresponding mechanical connectors on the reusable part. Also, the battery housing is used to provide electrical communication between electrical components within the reusable component and other electrical components of the disposable component such as electrodes located on the bottom side of the battery and patient engaging substrate. , has an electrical connector (not shown) configured to mate with a corresponding electrical connector in the reusable component.

Figures 30A-B illustrate a plurality of housings, where the disposable component includes the adhesive patient engaging substrate 20 and cable 260 , and the reusable component each housing includes one or more of the controller 404, battery 406, or capacitor. 4 shows an embodiment of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter-defibrillator similar to that shown in WO2017/035502), comprising: An electrical connector 262 on cable 260 connects to a corresponding electrical connector 253 on one of housings 4 . In this embodiment, the connection of electrical connectors 262 and 253 provides circuitry for providing an alert via vibration motor 412, speaker 414 and/or light 416 to indicate that electrical connections have been made. Closed.

In some embodiments of the wearable device, the battery is a rechargeable battery and part of the reusable component. For example, in the embodiment shown in FIGS. 31A-B, the reusable component has a plurality of housings 420,422,424,426. A rechargeable battery is located in housing 426 and can be recharged by inserting a charger connector 430 connected to a charger (not shown) into port 432 of housing 426 . In another embodiment shown in FIGS. 32A-B, the rechargeable battery within reusable component 28 may be wirelessly charged via charging pad 442 while patient 444 is wearing the wearable device. .

Figures 34A- D show a reusable part 28 of a wearable device (such as an external cardioverter-defibrillator similar to that shown in WO 2017/035502) 603 illustrate yet another embodiment of a mechanical connector for connecting and disconnecting a wearable device ( such as a housing) to a disposable component (such as an adhesive patient engaging substrate 603) of the wearable device. In this embodiment, the disposable mechanical connector has a latch 608 supported by a latch support 606 extending from base 604 . Spring 610 biases latch 608 to the downward position shown in FIG. 34B. The corresponding mechanical connector 8 of the reusable part is shown separated from the reusable part in Figures 34B-D. The reusable part mechanical connector 8 has an opening leading to a cavity sized and configured to receive the latch 608 and the latch support 606 . When the reusable part's mechanical connector 8 is moved in the direction of arrow 616 in FIG. 34B, its opening comes into sliding contact with the underside of latch 608 and the two mechanical connectors are shown in FIGS. 34C-D. Latch 608 is moved upward against the action of spring 610 until it is in the mated position. In this position, spring 610 moves latch 608 downward into engagement with the inner surface of mechanical connector 8 of the reusable part, holding the two parts together. To disconnect the reusable component from the disposable component, detachment trigger 612 can be actuated to compress spring 610 and move latch 608 upward and into latch support 606 .

In some embodiments, the connection between the reusable component's mechanical connector 8 and the disposable component's connector allows movement in the direction indicated by arrow 630 shown in FIG. It constrains motion in the direction indicated by 632 . This capability can be allowed by concepts similar to those described with respect to Figures 25A and 25B. The width of the reusable component mechanical connector opening may be greater than the width of the latch support, with the widest width of the reusable component opening and the latch support 606 positioned within the opening. It allows sliding movement along the direction indicated by arrow 630 up to an amount equal to the difference in width between the widened portions. This connection allows the reusable component to be held firmly against the disposable component, but also allows the reusable component's housing to slide back and forth when flexed by user movement. This feature can be very important to the wearability and longevity of the device.

Reusable part 28 has four housings 4 . Three of the housings have mechanical connectors 8 as described with respect to Figures 34B-D. The fourth housing has an integral mechanical/electrical connector 620 that mates with a corresponding mechanical/electrical connector 622 on the disposable. Flexible circuit 50 provides electrical communication between housings 4 .

As used herein, when a feature or element is referred to as being “over” another feature or element, it can be directly on the other feature or element, or intervening features and/or elements can also be may exist. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as being “connected to,” “attached to,” or “coupled with” another feature or element, it is directly connected, attached, or attached to another feature or element. or combined, and that there may be intervening features or elements. In contrast, when a feature or element is referred to as being “directly connected,” “directly attached,” or “directly coupled” to another feature or element, there are no intervening features or elements present. . Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may be applied to other embodiments. Also, those skilled in the art will appreciate that a reference to a structure or feature that is located “adjacent” another feature may have portions that overlap or underlie the adjacent feature. Will.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" include plural forms unless the context clearly indicates otherwise. intended to be Further, as used herein, the terms "comprises" and/or "comprising" specify the presence of a recited feature, step, operation, element, and/or part. However, it will be understood that this does not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".

For ease of explanation, the terms “under,” “below,” “lower,” “over,” and “upper” are used herein for ease of explanation. ” can be used to describe the relationship of one element or feature to other element(s) or feature(s), as shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, an element labeled "below" or "below" other elements or features would be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an "up" orientation and a "down" orientation. Also, the device may be oriented in other ways (rotated 90 degrees, or otherwise oriented) and the spatial relative descriptors used herein may be interpreted accordingly. Similarly, terms such as “upwardly,” “downwardly,” “vertical,” “horizontal,” etc. are used for descriptive purposes only, unless otherwise indicated. used herein.

In this specification, the terms "first" and "second" are sometimes used to describe various features/elements (including steps), unless the context dictates otherwise. features/elements of are not limited by these terms. These terms may be used to distinguish one feature/element from another feature/element. Thus, without departing from the teachings of the present invention, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below. The /element may be referred to as the first feature/element.

Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprises" and variations such as "comprises" and "comprising" refer to the various components of methods and articles. (eg, compositions and devices, including instruments and methods). For example, the term "comprising" will be understood to mean including any recited element or step, but not excluding other elements or steps.

As used in the specification and claims, including as used in the examples, unless explicitly stated otherwise, all numbers refer to " may be read as if preceded by the word "about" or "approximately". The words "about" or "approximately" may be used in describing magnitudes and/or positions to indicate that the stated values and/or positions are within reasonable expectations. For example, numerical values are ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2 of the stated value (or range of values) %, ±5% of a stated value (or range of values), ±10% of a stated value (or range of values), and the like. Also, any numerical value recited herein should be understood to include about or approximately that value, unless the context indicates otherwise. For example, if a value of "10" is disclosed, "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges subsumed therein. It is also understood that where a value is disclosed, that value "less than", "greater than" and possible ranges between values are also disclosed, as one of ordinary skill in the art would properly appreciate. For example, if the value "X" is disclosed, then "less than or equal to X" as well as "greater than or equal to X" (eg, X is a number) are also disclosed. Also, throughout the application, data is provided in a number of different formats, and it is understood that this data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point “10” and a specific data point “15” are disclosed, then not only between 10 and 15, but also between 10 and 15, 10 and 15 or more, 10 and less than 15, 10 and It is understood that 15 or less and equal to 10 and 15 are also considered to be disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13 and 14 are also disclosed.

While various exemplary embodiments have been described above, many changes can be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various method steps described may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be performed entirely. May be skipped. Optional features of various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description is provided primarily for purposes of illustration and should not be construed as limiting the scope of the invention as set forth in the claims.

The examples and illustrations contained herein, by way of illustration and not limitation, show specific embodiments in which the subject matter can be practiced. As noted above, other embodiments may be utilized and derived therefrom such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to individually or collectively by the term "invention" herein merely for convenience when, in fact, multiple embodiments are disclosed herein. However, there is no intention to limit the scope of this application to any single invention or inventive concept. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to accomplish the same purpose may be substituted for the specific embodiments illustrated. This disclosure is intended to cover any adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

[Appendix 1]
A wearable device,
comprising reusable parts and disposable parts,
the disposable component comprises a patient engaging substrate including an adhesive on a bottom side, an electrode on the bottom side, an electrical connector of the disposable component, and a mechanical connector of the disposable component;
The reusable component includes a plurality of sealed housings mechanically coupled to each other and movable relative to each other, each of the plurality of housings including one or more of a capacitor and a controller and a mechanical housing for the disposable component. A reusable component mechanical connector adapted to removably connect to a connector and a reusable component electrical connector adapted to removably connect to said disposable component electrical connector and housing. wearable devices.
[Appendix 2]
Clause 1. The wearable device of Clause 1, wherein the reusable component further comprises a flexible circuit configured to provide electrical communication between electrical components within the housing.
[Appendix 3]
3. The wearable device of Claim 2, wherein the flexible circuit is secured to back surfaces of the plurality of housings.
[Appendix 4]
4. The wearable device of appendix 2 or appendix 3, wherein the flexible circuit is overmolded with a flexible material to prevent ingress of water.
[Appendix 5]
a battery electrical connector wherein said disposable component is configured to electrically connect said battery to a capacitor and/or controller and to disconnect said battery from said capacitor and/or controller; and a battery disposed within a battery housing. and a battery mechanical connector adapted to removably connect the battery housing to the reusable component.
[Appendix 6]
6. The wearable device of clause 5, wherein the battery mechanical connector comprises a cradle dock.
[Appendix 7]
Clause 6. The wearable device of Clause 5, wherein the battery housing is removably connected to the top surface of the patient engaging substrate via the battery mechanical connector.
[Appendix 8]
8. The wearable device of any of Clauses 5-7, wherein the reusable component further comprises an alarm adapted to indicate that a battery is not connected to the reusable component.
[Appendix 9]
a battery electrical connector wherein the disposable component is configured to be connected to and disconnected from a battery disposed within a battery housing and an electrical connector of the reusable component; a battery mechanical connector adapted to removably connect the battery housing to the reusable component; and a battery mechanical connector connected to and disconnected from the electrical connector of the disposable component. 5. The wearable device according to any one of Appendixes 1 to 4, further comprising a cable configured to:
[Appendix 10]
5. The wearable device of any of Clauses 1-4, wherein the reusable component further comprises a rechargeable battery.
[Appendix 11]
11. The wearable device of clause 10, wherein the reusable component further comprises a port for a battery charger.
[Appendix 12]
11. The wearable device of clause 10, further comprising a wireless battery charger.
[Appendix 13]
The reusable component further comprises a housing support, the housing mechanically connected to the top side of the housing support, and the reusable component mechanical connector to the bottom side of the housing support. 13. The wearable device according to any one of appendices 1 to 12, arranged.
[Appendix 14]
the disposable component comprises a battery disposed within the battery housing; a battery electrical connector configured to electrically connect the battery to the capacitor and disconnect the battery from the capacitor; and the battery housing. 14. The wearable device of Clause 13, further comprising a cradle dock adapted to removably connect a to the housing support.
[Appendix 15]
5. A wearable device according to any one of Clauses 1 to 4, wherein the disposable part further comprises a battery permanently attached to the disposable part.
[Appendix 16]
16. The wearable device of any preceding clause, wherein at least one of the disposable mechanical connector and the reusable mechanical connector comprises a magnet.
[Appendix 17]
The magnet is disposed within a housing extending from the reusable component, the housing having an opening through which a mechanical connector of the disposable component can be inserted and moved into contact with the magnet. , Supplementary Note 16.
[Appendix 18]
17. Clause 17, wherein the magnet is disposed in a housing extending from the disposable component, the housing comprising an opening into which a mechanical connector of the reusable component can be inserted and moved into contact with the magnet. wearable devices.
[Appendix 19]
15. The wearable device of any of the clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector comprise both male and female mechanical snap components.
[Appendix 20]
15. The wearable device of any of Clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector comprise both male and female mechanical slide lock components.
[Appendix 21]
15. The wearable device of any of Clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector both comprise an adhesive and a removable adhesive cover.
[Appendix 22]
15. The wearable device of any of Clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector both comprise hook and loop connectors.
[Appendix 23]
15. Clause 1-14, wherein the disposable component mechanical connector comprises a spring-biased latch and the reusable component mechanical connector comprises a cavity adapted to receive the latch. wearable devices.
[Appendix 24]
The disposable component mechanical connector connects the disposable component mechanical connector to the reusable component mechanical connector or disconnects the disposable component mechanical connector from the reusable component mechanical connector. Clause 24. The wearable device of Clause 23, further comprising a latch actuator operably connected to move the latch to do so.
[Appendix 25]
wherein the disposable component mechanical connector and the reusable component mechanical connector allow the reusable component and the disposable component to move relative to each other while maintaining a mechanical connection. 25. The wearable device of any one of Clauses 1-24, wherein the wearable device is configured.
[Appendix 26]
At least one of the disposable component mechanical connector and the reusable component mechanical connector includes an alignment mechanism adapted to align the disposable component mechanical connector and the reusable component mechanical connector. 26. The wearable device according to any one of Appendices 1 to 25, further comprising:
[Appendix 27]
15. The wearable device of any of Clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector both include a key and a rotatable lock.
[Appendix 28]
15. The wearable device of any of Clauses 1-14, wherein the disposable component mechanical connector and the reusable component mechanical connector both comprise a buckle and a buckle connector.
[Appendix 29]
29. The wearable device of clause 28, wherein the disposable component mechanical connector and the reusable component mechanical connector both further include a buckle release mechanism.
[Appendix 30]
The buckle is positioned on the patient-engaging board, the buckle connector and the buckle release are positioned on the reusable component, the buckle release for activation only when the patient-engaging board is flexed. 30. The wearable device of Clause 29, wherein the wearable device is accessible to
[Appendix 31]
15. The wearable device of any of Clauses 1-14, wherein the disposable mechanical connector is disposed on a support element pivotally attached to the patient-engaging substrate.
[Appendix 32]
15. The wearable device of any of Clauses 1-14, further comprising an alignment tool adapted to align a mechanical connector of the disposable component with a mechanical connector of the reusable component.
[Appendix 33]
said alignment tool comprising a reusable component support adapted to hold said reusable component and a disposable component support adapted to hold said patient engaging substrate, said alignment tool a first configuration in which the reusable component can be supported on the reusable component support apart from a disposable component disposed on the disposable component support; 33. The wearable device of Clause 32, wherein a reusable component mechanical connector of a reusable component contacts a disposable component mechanical connector of a disposable component disposed on the disposable component support.
[Appendix 34]
a first configuration in which the patient engaging substrate maintains a connection between a mechanical connector of the disposable component and a mechanical connector of the reusable component; 15. A wearable device according to any preceding clause, comprising a second configuration that can be disconnected from the mechanical connector of the flexible part.
[Appendix 35]
15. The wearable device of any of Clauses 1-14, further comprising a tool adapted to disconnect a mechanical connector of the reusable component from a mechanical connector of the disposable component.
[Appendix 36]
Further comprising a tool access point on the reusable component mechanical connector, wherein the patient engaging substrate is configured such that the disposable component mechanical connector is connected to the reusable component mechanical connector and the patient engaging A first configuration in which the substrate blocks tool access points and a second configuration in which the mechanical connector of the disposable component is connected to the mechanical connector of the reusable component and the patient engaging substrate does not block the tool access point. 36. The wearable device of clause 35, comprising:
[Appendix 37]
wherein said disposable component mechanical connector and said reusable component mechanical connector are adapted to break to disconnect said disposable component mechanical connector from said reusable component mechanical connector. 15. The wearable device according to any one of Appendixes 1 to 14, both comprising:
[Appendix 38]
The disposable component mechanical connector and the reusable component mechanical connector together form a removable component adapted to disconnect the disposable component mechanical connector from the reusable component mechanical connector. 15. The wearable device according to any one of appendices 1 to 14, comprising:
[Appendix 39]
wherein the disposable component mechanical connector and the reusable component mechanical connector both include a release latch adapted to disconnect the disposable component mechanical connector from the reusable component mechanical connector. 15. The wearable device according to any one of Appendices 1 to 14.
[Appendix 40]
15. The wearable device of any of Clauses 1-14, wherein when connected, the electrical connector of the disposable component and the electrical connector of the reusable component provide a waterproof electrical connection.
[Appendix 41]
Clauses 1-1, wherein the disposable component electrical connector and the reusable component electrical connector both comprise the cable, a plug at a distal end of the cable, and a receptacle adapted to receive the plug. 14. The wearable device according to any one of 14.
[Appendix 42]
42. The wearable device of clause 41, wherein the cable extends from the disposable component and the receptacle is positioned over the reusable component.
[Appendix 43]
42. The wearable device of clause 41, wherein the receptacle extends from one of the plurality of housings.
[Appendix 44]
Clause 42. The wearable device of Clause 41, wherein the receptacle extends from a flexible circuit configured to provide electrical communication between electrical components within the housing.
[Appendix 45]
42. The wearable device of clause 41, wherein the cable extends from the reusable component and the receptacle is positioned over the disposable component.
[Appendix 46]
46. The wearable device of clause 45, wherein the cable extends from one of the plurality of housings.
[Appendix 47]
46. The wearable device of clause 45, wherein the cable extends from a flexible circuit configured to provide electrical communication between electrical components within the housing.
[Appendix 48]
42. Clause 41, wherein the disposable component electrical connector and the reusable component electrical connector further comprise a second cable together, the receptacle being disposed at a distal end of the second cable. wearable devices.
[Appendix 49]
Clauses 1-14, wherein the disposable component electrical connector is integrated with the disposable component mechanical connector and the reusable component electrical connector is integrated with the reusable component mechanical connector Wearable device according to any one of.
[Appendix 50]
50. The wearable device of clause 49, wherein the disposable component electrical connector and the reusable component electrical connector are adapted to slide relative to each other to make an electrical and mechanical connection.
[Appendix 51]
50. The wearable device of clause 49, wherein the electrical connector of the disposable component and the electrical connector of the reusable component are matingly adapted to provide an electrical and mechanical connection.
[Appendix 52]
A mechanical connection between the mechanical connector of the disposable component and the electrical connector of the reusable component prevents the electrical connector of the disposable component from being disconnected from the electrical connector of the reusable component. 49. The wearable device according to appendix 49.
[Appendix 53]
53. The wearable device of any of Clauses 1-52, wherein the disposable component further comprises an electronic memory adapted to receive and store user data from the controller.
[Appendix 54]
54. The wearable of any of Clauses 1-53, further comprising a mechanical connection indicator adapted to indicate a mechanical connection between the mechanical connector of the disposable component and the mechanical connector of the reusable component. machine.
[Appendix 55]
55. The wearable of any of Clauses 1-54, further comprising an electrical connection indicator adapted to indicate an electrical connection between an electrical connector of the disposable component and an electrical connector of the reusable component. machine.
[Appendix 56]
56. The wearable device of any of Clauses 1-55, wherein the disposable component further comprises a second patient engaging board having electrodes on the bottom side and a second patient engaging board electrical connector.
[Appendix 57]
57. The wearable device of any of Clauses 1-56, wherein the wearable device comprises a cardiopulmonary physiology monitor.
[Appendix 58]
58. The wearable device of any of Clauses 1-57, wherein the wearable device comprises an automated external defibrillator.
[Appendix 59]
wherein the reusable component mechanical connector and the disposable component mechanical connector include a trigger prevention mechanism configured to prevent disconnection of the reusable component mechanical connector and the disposable component mechanical connector; 59. A wearable device according to any one of Appendixes 1 to 58, comprising:
[Appendix 60]
59, wherein the anti-trigger mechanism comprises a protruding formation on the mechanical connector of the reusable component configured to interact with an opening or recess on the mechanical connector of the disposable component; Wearable devices listed.
[Appendix 61]
Clause 59, wherein said anti-trigger mechanism comprises a protruding formation on said mechanical connector of said disposable component configured to interact with an opening or recess on said mechanical connector of said reusable component. wearable device described in .
[Appendix 62]
60. The wearable device of clause 59, wherein the anti-trigger mechanism is configured to disengage by bending at least one portion of the mechanical connector of the disposable component and the mechanical connector of the reusable component. .
[Appendix 63]
63. A wearable device according to any of the clauses 1-62, further comprising a mechanism that can be manually triggered to initiate, activate or override a function of the device.
[Appendix 64]
64. The wearable device of Clause 63, wherein the mechanism can be manually activated to override delivery of therapy.
[Appendix 65]
65. A wearable device according to any of clauses 63 or 64, wherein said mechanism can be manually triggered to initiate a status check of the device.
[Appendix 66]
66. A wearable device according to any of clauses 63-65, wherein the mechanism can be manually triggered to activate the device.
[Appendix 67]
A method of using a wearable device, the wearable device comprising: a first disposable component including a patient engaging substrate including adhesive and electrodes on a bottom side; and a reusable component comprising a sealed housing of each of the plurality of housings, each containing one or more of a capacitor, a battery, or a controller, the method comprising:
adhering the wearable device to a skin surface portion of a patient for a first period of time;
monitoring a patient's ECG signal using the controller and the electrodes during the first time period;
removing the wearable device from the patient's skin surface when the first time period expires;
mechanically and electrically disconnecting the disposable component from the reusable component;
mechanically and electrically connecting to the reusable component a second disposable component comprising a patient engaging substrate comprising adhesive and electrodes on the bottom side thereof;
applying the second disposable component to a skin area of the patient;
monitoring a patient's ECG signals using the controller and the electrodes of the second disposable;
method including.
[Appendix 68]
The disposable component further includes a battery disposed within a battery housing, and the method electrically disconnects the battery from the reusable component and connects a replacement battery to the reusable connection. 68. The method of clause 67, further comprising the steps of:
[Appendix 69]
69. The method of clause 68, wherein electrically disconnecting the battery from the reusable component is performed after removing the wearable device from the patient's skin surface portion.
[Appendix 70]
69. The method of clause 68, wherein the replacement battery is disposed within a replacement battery housing, the method further comprising mechanically connecting the replacement battery housing to the reusable component.
[Appendix 71]
71. The method of any of clauses 68-70, further comprising providing an alarm if the battery or replacement battery is not connected to the reusable component.
[Appendix 72]
Clause 68. The method of Clause 67, wherein the reusable component comprises a rechargeable battery, the method further comprising recharging the rechargeable battery.
[Appendix 73]
73. The method of any of Clauses 67-72, wherein mechanically and electrically disconnecting the disposable component from the reusable component comprises bending the patient engaging substrate.
[Appendix 74]
73. The method of any of clauses 67-72, wherein mechanically and electrically disconnecting the disposable component from the reusable component comprises breaking a structural element.
[Appendix 75]
73. The method of any of clauses 67-72, wherein mechanically and electrically disconnecting the disposable component from the reusable component comprises operating a release mechanism.
[Appendix 76]
76. The method of clause 75, wherein the release mechanism comprises a release latch.
[Appendix 77]
76. The method of clause 75, wherein the release mechanism comprises a squeeze buckle.
[Appendix 78]
76. The method of clause 75, wherein the release mechanism comprises a push button.
[Appendix 79]
Further comprising aligning the second disposable component to the reusable component using an alignment tool prior to mechanically and electrically connecting the reusable component to the second disposable component. , Supplements 67-72.
[Appendix 80]
73. The method of any of Clauses 67-72, further comprising preventing electrical disconnection of the disposable component from the reusable component prior to mechanical disconnection of the disposable component from the reusable component. .
[Appendix 81]
81. The method of any of Clauses 67-80, further comprising providing an indication of a mechanical connection between the disposable component and the reusable component.
[Appendix 82]
82. The method of any of Clauses 67-81, wherein the wearable device comprises a cardiopulmonary physiologic monitor.
[Appendix 83]
83. The wearable device of any of Clauses 67-82, wherein the wearable device comprises an automated external defibrillator.

2, 12, 304 first adhesive patient engaging substrate 3, 306 second adhesive patient engaging substrate 4, 14, 310 housing 5 housing base 6, 370, 384, 454 battery housing 7, 290, 401, 452 Cables 9, 52, 56, 110, 112, 288, 314, 330, 408, 410 Electrical Connectors 10 Wearable Device 15 Top Side 16 Magnet 17 Top 20, 44, 72, 82, 102, 162, 3706 Disposable Part 21 First Magnet 24, 46, 84, 148, 302, 360, 362, 364, 366, 380, 382, 402, 420, 422, 424, 426, 3702 Housing 26, 86 Access Key Hole 30, 90, 220 Peg 32, 92 enlarged end 36 slot portion 28, 42, 76, 80, 100, 120, 160, 280, 300 reusable component 48 male snap element 50 flexible connector 54 female mechanical snap element 58 spring latch 60 head 62 cantilever wall 64 notch 70, 204, 292, 388, 456, 614 mechanical connector
74 pivotable base 96, 98, 214 slot 98 lock 104 cradle 106 lip 108 ridge 124 adhesive area 126 pull tab 134, 136 hook and loop connector 144 post 146 foot 150 opening 152, 216 tab 164 buckle 168 prong 169 ridge Elements 172, 3504 Plates 200, 602 Cardiopulmonary Physiology Monitor or Defibrillator Housing 206 Tools 212, 400, 450, 603 Adhesive Patient Engagement Substrate 218 Bendable Plate 224 Open End 282 Peg 284 Enlarged End 286 Recess 294 Keyhole openings 296, 316 Wide parts 305, 312, 368 Flexible circuit 308 First cable 310 Second cable 322 Mechanical connector housing 324 Opening 328 Narrow part 404 Controller 406 Battery 412 Vibration motor 414 Speaker 416 Light 430 Charger Connector 432 Port 442 Charging Pad 604 Base 606 Latch Support 608 Latch 610 Spring 612 Removal Trigger 3504, 3510 Plate 3506 Bendable Portion 3508 Protrusion 3512 Opening 3708 Disposable Battery

Claims (33)

A wearable device,
comprising reusable parts and disposable parts,
the disposable component comprises a patient engaging substrate including an adhesive on a bottom side, an electrode on the bottom side, an electrical connector of the disposable component, and a mechanical connector of the disposable component;
said reusable component comprising a plurality of sealed housings mechanically coupled to each other and movable relative to each other ; and a flexible circuit configured to provide electrical communication between electrical components within said housings ; Each of the plurality of housings is removable to a capacitor , a controller , a mechanical connector of the reusable component adapted to removably connect to the mechanical connector of the disposable component, and an electrical connector of the disposable component. a reusable component electrical connector adapted to connect to
wearable devices. 2. The wearable device of Claim 1, wherein the flexible circuit is fixed to the back surface of the plurality of housings. 2. The wearable device of Claim 1, wherein the flexible circuit is overmolded with a flexible material to prevent water ingress. a battery electrical connector wherein said disposable component is configured to electrically connect said battery to a capacitor and/or controller and to disconnect said battery from said capacitor and/or controller; and a battery disposed within a battery housing. and a battery mechanical connector adapted to removably connect the battery housing to the reusable component. a battery electrical connector wherein the disposable component is configured to be connected to and disconnected from a battery disposed within a battery housing and an electrical connector of the reusable component; a battery mechanical connector adapted to removably connect the battery housing to the reusable component; and a battery mechanical connector connected to and disconnected from the electrical connector of the disposable component. 2. The wearable device of claim 1, further comprising a cable configured to. 3. The wearable device of claim 1, wherein said reusable component further comprises a rechargeable battery. The reusable component further comprises a housing support, the housing mechanically connected to the top side of the housing support, and the reusable component mechanical connector to the bottom side of the housing support. 2. The wearable device of claim 1, deployed. the disposable component comprises a battery disposed within the battery housing; a battery electrical connector configured to electrically connect the battery to the capacitor and disconnect the battery from the capacitor; and the battery housing. 8. The wearable device of claim 7, further comprising a cradle dock adapted to removably connect a to the housing support. 2. The wearable device of Claim 1, wherein the disposable component further comprises a battery permanently attached to the disposable component. 2. The wearable device of claim 1, wherein the disposable component mechanical connector and the reusable component mechanical connector comprise both male and female mechanical snap components. 2. The wearable device of claim 1, wherein the disposable component mechanical connector comprises a spring-biased latch and the reusable component mechanical connector comprises a cavity adapted to receive the latch. The disposable component mechanical connector connects the disposable component mechanical connector to the reusable component mechanical connector or disconnects the disposable component mechanical connector from the reusable component mechanical connector. 12. The wearable device of claim 11, further comprising a latch actuator operably connected to move the latch to do so. wherein the disposable component mechanical connector and the reusable component mechanical connector allow the reusable component and the disposable component to move relative to each other while maintaining a mechanical connection. 2. The wearable device of claim 1, configured. At least one of the disposable component mechanical connector and the reusable component mechanical connector includes an alignment mechanism adapted to align the disposable component mechanical connector and the reusable component mechanical connector. 11. The wearable device of claim 1, further comprising. 2. The wearable device of claim 1, wherein the disposable component mechanical connector and the reusable component mechanical connector both comprise a buckle and a buckle connector. 2. The wearable device of claim 1, wherein the disposable mechanical connector is disposed on a support element pivotally attached to the patient-engaging substrate. 2. The wearable device of claim 1, further comprising an alignment tool adapted to align mechanical connectors of the disposable component with mechanical connectors of the reusable component. a first configuration in which the patient engaging substrate maintains a connection between a mechanical connector of the disposable component and a mechanical connector of the reusable component; and a second configuration that can be disconnected from the mechanical connector of the flexible part. 2. The wearable device of claim 1, further comprising a tool adapted to disconnect the reusable component mechanical connector from the disposable component mechanical connector. wherein said disposable component mechanical connector and said reusable component mechanical connector are adapted to break to disconnect said disposable component mechanical connector from said reusable component mechanical connector. 3. The wearable device of claim 1, together comprising: The disposable component mechanical connector and the reusable component mechanical connector together form a removable component adapted to disconnect the disposable component mechanical connector from the reusable component mechanical connector. 3. The wearable device of claim 1, comprising: 2. The wearable device of claim 1, wherein when connected, the disposable component electrical connector and the reusable component electrical connector provide a waterproof electrical connection. 2. The method of claim 1, wherein the disposable component electrical connector is integrated with the disposable component mechanical connector and the reusable component electrical connector is integrated with the reusable component mechanical connector. Wearable devices listed. A mechanical connection between the mechanical connector of the disposable component and the electrical connector of the reusable component prevents the electrical connector of the disposable component from being disconnected from the electrical connector of the reusable component. 24. The wearable device of claim 23. 2. The wearable device of Claim 1, wherein the disposable component further comprises electronic memory adapted to receive and store user data from the controller. 2. The wearable device of claim 1, further comprising a mechanical connection indicator adapted to indicate a mechanical connection between the disposable component mechanical connector and the reusable component mechanical connector. 2. The wearable device of claim 1, further comprising an electrical connection indicator adapted to indicate an electrical connection between the disposable component electrical connector and the reusable component electrical connector. 3. The wearable device of claim 1, wherein the disposable component further comprises a second patient-engaging board having electrodes on the bottom side and a second patient-engaging board electrical connector. 11. The wearable device of Claim 1, wherein the wearable device comprises a cardiopulmonary physiology monitor. 2. The wearable device of Claim 1, wherein the wearable device comprises an automated external defibrillator. wherein the reusable component mechanical connector and the disposable component mechanical connector include a trigger prevention mechanism configured to prevent disconnection of the reusable component mechanical connector and the disposable component mechanical connector; 11. The wearable device of claim 1, comprising: 32. The anti-trigger mechanism comprises a protruding formation on the mechanical connector of the reusable component configured to interact with an opening or recess on the mechanical connector of the disposable component. wearable device described in . 11. The wearable device of Claim 1, further comprising a mechanism that can be manually triggered to initiate, activate or override a function of the device.

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