Patent Description:
<CIT> discloses multiple embodiments of an external defibrillator that is adhesively attached to the patient and that can be comfortably worn around the clock during showering, sleeping and normal activities. The adhesive patches and batteries of these devices may have useful lives that are shorter than the other components of the defibrillator. In addition, the patient may need to wear the defibrillator beyond the ends of the useful lives of the adhesive patches and/or batteries.

<CIT> discloses a defibrillator for permanent external application to a patient, with a protective shell arrangement receiving a base unit with defibrillator components, an electrode arrangement connected or connectable to the shell arrangement, and a support device. An ergonomic adaptation to the person wearing the defibrillator is achieved by the defibrillator components being spatially combined into subsidiary modules, and the shell arrangement has several subsidiary shells to which the subsidiary modules are distributed and which are movable relative to one another and connected to one another mechanically and electrically.

Further aspects and preferred embodiment of the invention are defined in the dependent claims. Any aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims are provided for illustrative purposes.

A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments of the disclosure, and the accompanying drawings of which:.

Embodiments of the invention provide an adhesively mounted wearable device, such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>, whose adhesive patient engagement substrate(s) and battery can be mechanically and electrically attached and detached from the device's reusable electronics. In particular, the devices of this invention enable a user, particularly a patient with low dexterity, poor hand/arm strength, poor vision, etc., to perform the following steps prior to wearing the device: (<NUM>) mechanically attach reusable electronics to adhesive patient engagement substrate(s); (<NUM>) electrically connect reusable electronics to adhesive patient engagement substrate(s); (<NUM>) mechanically attach a battery to the reusable electronics; and (<NUM>) electrically connect the battery to the reusable electronics. These embodiments provide waterproof electrical connections, enabling the patient to shower and perform other activities while wearing the device. The mechanical and electrical connections of these various embodiments can also withstand expected mechanical forces without detaching or disconnecting, such as when the patient moves or changes position (e.g., sits up, lies down, falls, walks), when the device engages another object (e.g., engaging a seatbelt or clothing covering the device). Embodiments of the invention provide mechanical and electrical connections between disposable and reusable components that are difficult or impossible to disconnect while the device is being worn by the patient.

The reusable component of the wearable device of this invention have multiple housings or modules each containing one or more electrical components. For example, in embodiments in which the wearable device is a cardioverter/defibrillator similar to those shown in <CIT>, the housings or modules may each contain one or more of a controller and a capacitor. A flexible electrical circuit extends between the housings or modules to provide connections among the electronic components. The flexible electrical circuit may be waterproof or covered with waterproof material. In addition, in embodiments of the invention the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device. In some embodiments, the flexible electrical circuit is exterior to the housings or modules, and waterproof electrical connections extend from the flexible electrical circuit to the electrical components in the housings or modules. In other embodiments, the flexible electrical circuit is at least partially inside one or more of the housings or modules.

An illustrative example of a wearable device having reusable and disposable components is shown in <FIG>. In this example, the wearable device is an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT> having a first adhesive patient engagement substrate <NUM>, a second adhesive patient engagement substrate <NUM>, a plurality of housings <NUM> mounted on a housing base <NUM>, a battery housing <NUM> containing a battery, a cable <NUM> extending between patient engagement substrates <NUM> and <NUM>, mechanical connectors <NUM> for attaching the housing base <NUM> to the first patient engagement substrate <NUM>, an electrical connector <NUM> for connecting the electrical components in housings <NUM> to the first patient engagement substrate and an electrical connector <NUM> for electrically connecting the battery housing <NUM> to the other housings <NUM>. The housings <NUM> each contain one or more of a controller, a capacitor or other cardiopulmonary physiologic monitor or defibrillator electronics, and the housings <NUM> together with their base <NUM> form the reusable component of the wearable device <NUM>. The first and second adhesive patient engagement substrates each have one or more electrodes on their bottom sides which, when the substrates <NUM> and <NUM> are connected to the housings <NUM>, can sense cardiac activity or, in the case of a cardioverter/defibrillator, deliver a shock from the defibrillator components to a patient to whom the substrates are adhesively attached. The first and second patient engagement substrates and the battery in the battery housing are the disposable components of the wearable device. The wearable device can comprise override functionality 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 buttons can also be used to interact with various user interface prompts, as needed (e.g., turn on, perform status check, etc.). Controls or buttons <NUM> on the reusable component can be pressed simultaneously to initiate the override function. Other mechanisms for initiating the override are also possible (e.g., buttons located on opposing surfaces of the housings and configured to be squeezed or pinched simultaneously, buttons located on other surfaces of the wearable device such as the first or second patient engagement substrate, etc.).

Various mechanical connectors, electrical connectors and device configurations are described below. Each can be used in combination with others.

One aspect of the invention is the manner in which reusable component(s) of a wearable device may be mechanically connected to, and disconnected from, disposable component(s). Embodiments of the invention provide robust, intuitive, simple to operate (even for patients with low dexterity), load-bearing mechanical attachment between the reusable component of a wearable device (such as, e.g., an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) and a disposable component of that device (such as, e.g., an adhesively attachable patient engagement substrate and/or a battery). In many of the embodiments, the reusable component can be detached from the disposable component only when the wearable device is not being worn by 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.

<FIG> show an embodiment employing magnets as mechanical connectors. In the illustrated embodiment, the wearable device <NUM> is an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>. Components of the wearable device <NUM> include a first patient engagement substrate <NUM>, a plurality of housings <NUM>, and a second patient engagement substrate (not shown). The first patient engagement substrate <NUM> and the second patient engagement substrate each include an adhesive for attaching the substrate to the patient and one or more electrodes (not shown) for sensing cardiac activity or, in the case of a cardioverter/defibrillator, delivering an electrical shock to the patient. The housings <NUM> each contain one or more of a battery, a capacitor or a controller. In this embodiment, housings <NUM> are movable with respect to each other and are in electrical communication with each other via, e.g., a flexible circuit (not shown). The electrical components within the housings are also in electrical communication with the electrodes in the first and second patient engagement substrates after the housings have been attached to the first patient engagement substrate, e.g., in a manner described further below. The reusable component of wearable device <NUM> includes housings <NUM>, and the disposable component includes the first patient engagement substrate <NUM> and the second patient engagement substrate.

As shown in <FIG>, magnets <NUM> are disposed on the top side <NUM> of patient engagement substrate <NUM> and on the bottom side <NUM> of housings <NUM> in corresponding positions that enable the housings to be mounted to the first patient engagement substrate as shown in <FIG>. The magnets must be strong enough to support the weight of the housings and to withstand dislodging resulting from patient movement, snagging on clothing or other objects, etc., while still enabling intended detachment of the housings from the patient engagement substrate. In this embodiment, the magnets are disposed closer to the top <NUM> of housings <NUM> so that the housings can serve as lever arms to facilitate separation of the patient engagement substrate's magnets from the housings' magnets. As an example, the magnets <NUM> shown in <FIG> each have surface areas of <NUM><NUM> (<NUM> square inch) and have a magnetic attachment strength of 90N (<NUM> lbs). The housing <NUM> has a length of <NUM> (<NUM> inches). The removal force FR applied to the end of the moment arm of the housing <NUM> (as shown in <FIG>) to separate the magnets <NUM> is <NUM>. 8N (<NUM> lbs. )-only <NUM>% of the attachment force.

<FIG> show another embodiment of a mechanical connector <NUM> employing magnets in combination with a peg and keyhole connector for connecting and disconnecting a reusable component of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component of the wearable device. In this embodiment, the mechanical connector of the disposable component <NUM> (e.g., an adhesive patient engagement substrate) has a first magnet <NUM> disposed within a housing <NUM> having an access keyhole <NUM>. The mechanical connector of the reusable component <NUM> (e.g., a cardiopulmonary physiologic monitor or defibrillator housing) has a peg <NUM> with an enlarged end <NUM> that can fit through the top <NUM> of access keyhole <NUM>. After insertion of peg <NUM> into keyhole <NUM>, peg <NUM> can be moved downward into the slotted portion <NUM> of keyhole <NUM> until a second magnet <NUM> on peg <NUM> meets and attaches to first magnet <NUM>. There may be multiple mechanical connectors on the disposable component and on the reusable component.

<FIG> show embodiments of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the mechanical connectors are male and female mechanical elements. As shown in <FIG>, reusable component <NUM> has four housings <NUM>. A male snap element <NUM> extends from each housing <NUM>. As shown, the housings <NUM> may be connected by a flexible connector <NUM>, such as a flexible circuit. Also shown is an optional electrical connector <NUM>. Disposable component <NUM> has a plurality of female mechanical snap elements <NUM> in positions corresponding to the positions of male snap elements <NUM>. Disposable component <NUM> also has an optional electrical connector <NUM>.

<FIG> show one embodiment of mechanical snaps that may be used with the wearable device shown in <FIG>. In this embodiment, the female snap element <NUM> has a spring latch <NUM> that retains the head <NUM> of the male snap element inside of female snap element <NUM> until a sufficient force is applied to remove it, as suggested by <FIG> show another embodiment of a mechanical snap in which the female snap element <NUM> has a plurality of cantilever wall sections <NUM> separated by cutouts <NUM>. Wall sections <NUM> move radially outward in response to an insertion force applied to the top <NUM> of the wall section by the head <NUM> of the male snap element during connection or a retraction force applied to the underside of a projection of the wall section by head <NUM> during disconnection.

<FIG> show front and side views of an embodiment of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) in which the mechanical connectors <NUM> of the disposable component <NUM> (such as an adhesive patient engagement substrate) are disposed on pivotable bases <NUM> with pivot points <NUM> and attachment points <NUM>. When the reusable component <NUM> (such as the cardiopulmonary physiologic monitor or defibrillator housings) are mechanically attached to the disposable component <NUM> using any of the mechanical connectors disclosed herein, the reusable component can pivot away from the reusable component, thereby providing more movement flexibility while the wearable device is worn by the patient.

<FIG> show embodiments of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. Similar to the embodiment of <FIG>, this embodiment employs a peg and keyhole connector. Housing <NUM> on the top side of disposable component <NUM> has an access keyhole <NUM>. The mechanical connector of the reusable component <NUM> (e.g., a cardiopulmonary physiologic monitor or defibrillator housing) has a peg <NUM> with an enlarged end <NUM> that can fit through the top <NUM> of access keyhole <NUM>. After insertion of peg <NUM> into keyhole <NUM>, peg <NUM> can be moved downward into the slotted portion <NUM> of keyhole <NUM>, and a lock <NUM> may be engaged to prevent peg <NUM> from moving back through slot <NUM>, as shown in <FIG>. There may be multiple mechanical connectors on the disposable component and on the reusable component. In some embodiments, the slotted portion of the keyhole may extend in two or more directions, as shown by the dogleg-shaped slot <NUM> of <FIG>.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the disposable component mechanical connector is a cradle <NUM> having an inwardly projecting lip <NUM> at its open end. A ridge <NUM> or other outwardly projecting surface on the exterior of reusable component <NUM> engage lip <NUM> during insertion and deform cradle <NUM> sufficiently to snap the reusable component <NUM> into the cradle. This embodiment may provide a waterproof connection as a mechanical connection that is easier for users to see. Also shown in <FIG> are electrical connectors <NUM> and <NUM> on the reusable component and disposable component, respectively, that provide electrical communication between the reusable component and the disposable component when the mechanical connection is made.

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

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the disposable component mechanical connectors are adhesive areas <NUM> on the top side of the disposable component <NUM> that engage the bottom side of the reusable component <NUM>. To disconnect the reusable component <NUM> from the disposable component <NUM>, one end of the reusable component <NUM> may be pivoted away from the disposable component to expose pull tabs <NUM> associated with each adhesive area <NUM>. Pulling down on pull tabs <NUM> separates the substrates beneath the adhesive areas from the disposable component, thereby allowing the removal of the reusable component from the disposable component.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. This embodiment employs hook and loop connectors <NUM> and <NUM> (such as Velcro® material) on the top of the disposable component <NUM> and the bottom of the reusable component <NUM>, respectively, to attach and detach the disposable component from the reusable component.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the reusable component mechanical connector has a post <NUM> with an elongated foot <NUM>. The disposable component mechanical connector has a rotatable housing <NUM> with an opening <NUM> shaped just larger than the foot <NUM>. After insertion of the foot <NUM> through opening <NUM> into housing <NUM>, a tab <NUM> extending from the housing <NUM> may be used to rotate housing <NUM> to change the orientation of opening <NUM> with respect to foot <NUM>, thereby preventing post <NUM> from being withdrawn from housing <NUM>. To disconnect the reusable component <NUM> from the disposable component <NUM>, tab may be used to rotate housing <NUM> to line up opening <NUM> with foot <NUM>, thereby permitting post <NUM> to be withdrawn from housing <NUM>.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component <NUM> (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the disposable component mechanical connector is a buckle <NUM> attached at one end <NUM> to the top side of the disposable component. A prong <NUM> extends in a cantilever manner from the buckle's attached end <NUM>, and a raised element <NUM> projects downwardly toward the top side of the disposable component. The reusable component mechanical connector has an opening <NUM> in a plate <NUM> disposed above the bottom side of the reusable component <NUM>. To mechanically connect the reusable component to the disposable component, the prong <NUM> is inserted between the plate <NUM> and the bottom side of the reusable component. The distance between the plate <NUM> and the bottom surface of the reusable component <NUM> is slightly greater than the distance between the bottom surface of raised element <NUM> and the top side of the disposable component, which cause prong <NUM> to bend upward as it is inserted between plate <NUM> and the bottom surface of the reusable component until the raised element <NUM> of the prong <NUM> goes into, and protrudes through, opening <NUM>, thereby mechanically locking the reusable component to the disposable component. To detach the reusable component from the disposable component, the disposable component may be bent to expose the portion of the raised element protruding through opening <NUM>, as shown in <FIG>, and the raised element may be pushed out of opening <NUM> to release the reusable component from the disposable component.

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

In the context of the claimed invention, the reusable component will have a plurality of housings, and in some embodiments there will be at least one mechanical connection between each housing and the disposable component. These mechanical connections could be spread evenly across the wearable device. Other embodiments will employ fewer mechanical connections. Furthermore, some mechanical connections may be stronger (e.g., to support the weight of the reusable portion) and some mechanical connections may be weaker (e.g., more for alignment and registration and less for supporting weight).

<FIG> shows a tool <NUM> for aligning the disposable component mechanical connectors <NUM> with the reusable component mechanical connectors <NUM>. Tool <NUM> is a hinged container holding the disposable component <NUM> in proper alignment with the reusable component <NUM> so that when the lid <NUM> is closed, the mechanical connectors attach to each other.

In addition to the snapping sound or other audible indication of a successful mechanical connection between the disposable component and the reusable component, some embodiments provide an electronically-generated feedback of successful mechanical connection, such as an indicator light, vibration or generated sound. <FIG> show a wearable device <NUM> (such as a cardiopulmonary physiologic monitor or an external cardioverter/defibrillator similar to those shown in <CIT>) with a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) and a disposable component <NUM> (such as an adhesive patient engagement substrate). The disposable component <NUM> has mechanical connectors <NUM> that connect to corresponding mechanical connectors <NUM> on the reusable component <NUM>. Each mechanical connector <NUM> on the disposable component <NUM> has a conductive element <NUM> that contact one or more conductive elements <NUM> in each of the reusable component mechanical connectors <NUM> to close a circuit <NUM> leading to a microprocessor <NUM> in the reusable component. When the microprocessor <NUM> detects that the circuit <NUM> is closed, it announces the successful mechanical connection between all of the mechanical connectors <NUM> with their corresponding mechanical connectors <NUM> by lighting one or more lights <NUM>, vibrating a motor <NUM> and/or emitting a sound via a speaker <NUM>.

In embodiments of the wearable device where the disposable component includes an adhesive patient engagement substrate, disconnection of the disposable component mechanical connector from the reusable component mechanical connector may not be possible while the patient engagement substrate is adhered to the patient. This feature helps ensure that the disposable and reusable components are connected while the wearable device is being worn. For example, <FIG> shows a side view of an embodiment of the wearable device in which the disposable component includes an adhesive patient engagement substrate <NUM> and the reusable component includes a cardiopulmonary physiologic monitor or defibrillator housing <NUM>. In order to access the mechanical connectors <NUM> with a tool <NUM>, the patient engagement substrate <NUM> must be bent more than it could be bent while adhesively attached to the patient.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component (such as an adhesive patient engagement substrate <NUM>) of the wearable device. In this embodiment, the disposable component mechanical connector includes a slot <NUM> on the top side of the substrate <NUM> and a tab <NUM> extending from a bendable plate <NUM> on the substrate (or, alternatively, extending directly from the patient engagement substrate with no intervening plate). The reusable component mechanical connector has a peg <NUM> with an enlarged end <NUM> that can be moved into slot <NUM> from an open end <NUM> of the slot to connect the mechanical connectors. When the patient engagement substrate <NUM> and bendable plate <NUM> are unbent, the tab <NUM> prevents the enlarged end <NUM> of peg <NUM> from leaving the slot <NUM>, as shown in <FIG>. When the patient engagement substrate <NUM> and bendable plate <NUM> are bent, however, tab <NUM> moves away from the enlarged end of the peg, enabling it to be removed from the slot <NUM>, thereby disconnecting the cardiopulmonary physiologic monitor or defibrillator housing from the patient engagement substrate, as shown in <FIG>.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component (such as an adhesive patient engagement substrate) of the wearable device. In this embodiment, the disposable component mechanical connector includes a plate <NUM> comprising a bendable portion <NUM> at one end of the plate, a protrusion <NUM> in a mid section of the plate <NUM>, and a locking mechanism (e.g., spring lock, detent, etc.) at another portion of the plate <NUM>. In some embodiments, the protrusion and lock may be positioned directly on the patient engagement substrate with no intervening plate. The protrusion <NUM> is configured to interact with an aperture <NUM> in a portion of the reusable component mechanical connector. To unlock the connectors, the bendable portion <NUM> of the disposable component mechanical connector is bent backwards, away from the reusable component mechanical connector. The reusable component mechanical connector can then be slid along a length of the disposable component mechanical connector, unlocking the locking mechanism. It will be appreciated that, in some embodiments, the disposable component mechanical connector can instead be slide along a length of the reusable component mechanical connector. <FIG> shows another embodiment of a disposable component mechanical connector including a plate <NUM> comprising a bendable portion <NUM> at one end of the plate, a protrusion <NUM> in a mid section of the plate <NUM>, and a spring lock <NUM> at another portion of the plate. Upon bending back the bendable portion <NUM>, the protrusion <NUM> disengages from aperture <NUM> in the reusable component mechanical connector. The plate <NUM> can then be slid along a length of the disposable component mechanical connector, disengaging spring lock <NUM>.

<FIG> show an embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM> (such as cardiopulmonary physiologic monitor or defibrillator housings) of a wearable device (such as an external cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component (such as an adhesive patient engagement substrate <NUM>) of the wearable device. In this embodiment, the disposable component mechanical connector includes a slot <NUM> on the top side of the substrate <NUM> and a tab <NUM> extending from a plate <NUM> on the substrate. The reusable component mechanical connector has a peg <NUM> with an enlarged end <NUM> that can be moved into slot <NUM> from an open end <NUM> of the slot to connect the mechanical connectors. Advancement of the enlarged portion of the peg into the slot causes the plate <NUM> to flex to move the tab <NUM> back, thereby permitting the enlarged end <NUM> of peg <NUM> to move into slot. When the patient engagement substrate <NUM> and plate <NUM> return to their unbent state, the tab <NUM> prevents the enlarged end <NUM> of peg <NUM> from leaving the slot <NUM>, as shown in <FIG>. To disconnect the reusable component from the patient engagement substrate, however, the substrate <NUM> and plate <NUM> are bent until the plate breaks, as shown in <FIG>, thereby permitting tab <NUM> to move away from the enlarged end of the peg and enabling it to be removed from the slot <NUM>, thereby disconnecting the cardiopulmonary physiologic monitor or defibrillator housing from the patient engagement substrate.

In other embodiments in which the disposable component of the wearable device includes a patient engagement substrate, perforations or seams in the patient engagement substrate may permit the user to tear the substrate to disconnect the reusable component from the substrate.

Another aspect of the invention is the manner in which reusable component(s) of a wearable device may be electrically connected to, and disconnected from, disposable component(s). Embodiments of the invention provide robust, waterproof, simple to operate (even for patients with low dexterity), reliable electrical connections between the reusable component of a wearable device (such as, e.g., an external cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) and a disposable component of that device (such as, e.g., an adhesively attachable patient engagement substrate and/or a battery). In many of the embodiments, the reusable component can be electrically disconnected from the disposable component only when the wearable device is not being worn by the patient. The electrical connection mechanisms described herein can be used in combination with each other and with any of the embodiments described in this disclosure.

<FIG> show an embodiment of electrical connectors for electrically connecting and disconnecting a reusable component <NUM> (such as electronic cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>) of a wearable device to a disposable component (such as first and second adhesive patient engagement substrates <NUM> and <NUM>) of the wearable device. In this embodiment, a first cable <NUM> extends from first patient engagement substrate <NUM> to the second patient engagement substrate <NUM>, and a second cable <NUM> extends from a flexible circuit <NUM> in the first patient engagement substrate <NUM> to an electrical connector <NUM>. Electrical connector <NUM> may be connected and disconnected from a mating electrical connector <NUM> in housing <NUM> of the reusable component <NUM>. Cables <NUM> and <NUM> electrically connect the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM> to electrodes <NUM> on the bottom side of patient engagement substrates <NUM> and <NUM>, allowing for sensing of cardiac activity (such as, e.g., ECG signals) or, in the case of a defibrillator, delivery of electric shocks from electrodes <NUM> on the bottom sides of patient engagement substrates <NUM> and <NUM>. A flexible circuit <NUM> provides electrical communication among the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>. In an alternative embodiment, shown in <FIG>, the electrical connector <NUM> may connect to a corresponding electrical connector <NUM> integrated into the flexible circuit <NUM>.

<FIG> show an embodiment of electrical connectors for electrically connecting and disconnecting a reusable component <NUM> (such as electronic cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>) of a wearable device to a disposable component (such as first and second adhesive patient engagement substrates <NUM> and <NUM>) of the wearable device. In this embodiment, a first cable <NUM> extends from first patient engagement substrate <NUM> to the second patient engagement substrate <NUM>, and a second cable <NUM> extends from one of the cardiopulmonary physiologic monitor or defibrillator housings <NUM> to an electrical connector <NUM>. Electrical connector <NUM> may be connected and disconnected from a mating electrical connector <NUM> extending from a flexible circuit <NUM> in the first patient engagement substrate <NUM>. Cables <NUM> and <NUM> electrically connect the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM> to electrodes <NUM> on the bottom side of patient engagement substrates <NUM> and <NUM>, allowing for sensing of cardiac activity (such as, e.g., ECG signals) or, in the case of a defibrillator, delivery of electric shocks from electrodes <NUM> on the bottom sides of patient engagement substrates <NUM> and <NUM>. A flexible circuit <NUM> provides electrical communication among the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>. In an alternative embodiment, the second cable <NUM> may extend from the flexible circuit <NUM> instead of from one of the housings <NUM>.

<FIG> show an embodiment of electrical connectors for electrically connecting and disconnecting a reusable component <NUM> (such as electronic cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>) of a wearable device to a disposable component <NUM> (such as first and second adhesive patient engagement substrates <NUM> and <NUM>) of the wearable device. In this embodiment, a first cable <NUM> extends from first patient engagement substrate <NUM> to the second patient engagement substrate <NUM>, a second cable <NUM> extends from one of the cardiopulmonary physiologic monitor or defibrillator housings <NUM> to a first electrical connector <NUM>, and a third cable <NUM> extends from a flexible circuit <NUM> of patient engagement substrate <NUM> to a second electrical connector <NUM> configured to electrically connect to, and disconnect from, the first electrical connector <NUM>, as shown. Cables <NUM>, <NUM> and <NUM> electrically connect the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM> to electrodes <NUM> on the bottom side of patient engagement substrates <NUM> and <NUM>, allowing for sensing of cardiac activity (such as, e.g., ECG signals) or, in the case of a defibrillator, delivery of electric shocks from electrodes <NUM> on the bottom sides of patient engagement substrates <NUM> and <NUM>. A flexible circuit <NUM> provides electrical communication among the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>. In an alternative embodiment, shown in <FIG>, the second cable <NUM> may extend from the flexible circuit <NUM> instead of from one of the housings <NUM>.

In examples useful for understanding the invention, the mechanical and electrical connectors connecting the reusable component to, and disconnecting the reusable component from, the disposable component are integrated so that the electrical connection occurs simultaneously with the mechanical connection. <FIG> show one embodiment of a combined electrical and mechanical connector. In <FIG>, mounted on the top side of the wearable device's disposable component (e.g., an adhesive patient engagement substrate <NUM>) is a mechanical connector housing <NUM> having a keyhole opening <NUM> with a wide portion <NUM> above a narrow portion <NUM>. An electrical connector <NUM> extends from a side of the housing <NUM> adjacent to the wide portion <NUM> of the keyhole opening <NUM>. The corresponding structure on the reusable component of the wearable device (e.g., a housing <NUM> of a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) is a peg <NUM> having an enlarged end <NUM> to form the mechanical connector of the reusable component. The reusable component's electrical connector <NUM> is shown adjacent to peg <NUM>. To connect the reusable component mechanically and electrically to the disposable component, the enlarged end <NUM> of peg <NUM> is inserted into the wide portion <NUM> of keyhole opening <NUM>, as shown in <FIG>. The peg <NUM> is then advanced in keyhole opening <NUM> until the enlarged end <NUM> is beneath the narrow portion <NUM> of the keyhole opening such that the peg can no longer be withdrawn from housing <NUM>, thereby mechanically connecting the reusable component to the disposable component. When peg <NUM> reaches the limit of its travel within keyhole opening <NUM>, as shown in <FIG>, the reusable component's electrical connector <NUM> will engage the disposable component's electrical connector <NUM> to electrically connect the reusable component to the disposable component. To disconnect the reusable component from the disposable component, a movable disconnection actuator <NUM> may be depressed to move peg <NUM> to the wide portion <NUM> of keyhole opening <NUM> to disconnect the electrical connectors <NUM> and <NUM> and to permit the enlarged end <NUM> of the peg to be removed from the keyhole opening <NUM>.

<FIG> shows an embodiment of a wearable device's disposable component (such as, e.g., an adhesive patient engagement substrate <NUM>) with four mechanical connectors <NUM> (such as, e.g., the snap connectors described above) and an electrical connector <NUM>. When the wearable device's reusable component (e.g., housings containing cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT> components) are mechanically attached to mechanical connectors <NUM>, the reusable component's electrical connector will automatically connect to electrical connector <NUM> at the same time.

<FIG> shows a partial view of an embodiment of a wearable device (such as a cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) having a reusable component (e.g., housings <NUM> containing cardiopulmonary physiologic monitor or defibrillator components) mechanically attached in a detachable manner to an adhesive flexible engagement substrate <NUM> of the device's disposable component. Other parts of the disposable component include cable <NUM> and battery housing <NUM> containing one or more batteries. Battery housing <NUM> has an electrical connector <NUM> and a mechanical connector <NUM> which may be connected and disconnected to an electrical connector <NUM> and a mechanical connector <NUM>, respectively, on the housings <NUM>. Once connected, connectors <NUM> and <NUM> and cable <NUM> electrically connect the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM> to electrodes on the bottom side of patient engagement substrate <NUM> and a second patient engagement substrate (not shown), allowing for sensing of cardiac activity (such as, e.g., ECG signals) or, in the case of a defibrillator, delivery of electric shocks from electrodes on the bottom sides of the patient engagement substrates. A flexible circuit (not shown) provides electrical communication among the cardiopulmonary physiologic monitor or defibrillator components within housings <NUM>.

In the various embodiments, the electrical connectors may be, e.g., edge card connectors (i.e., USB), spring probe connectors, Zero Insertion Force (ZIF) connectors, pin-probe insertion connectors, twist and lock connectors, etc. Sealing O-rings may be used to waterproof the electrical connection.

<FIG> show another embodiment of mechanical and electrical connectors between disposable and reusable components of a wearable device, such as a cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>. Reusable component <NUM> (e.g., a housing containing cardiopulmonary physiologic monitor or defibrillator components) has a mechanical connector with a peg <NUM> having an enlarged end <NUM> disposed in a recess <NUM> on the bottom side of the housing. An electrical connector receptacle (not shown) is also disposed in the housing recess. As shown in <FIG>, an electrical connector <NUM> at the end of a cable <NUM> extending from a disposable component (e.g., an adhesive flexible engagement substrate, not shown) of the wearable device has been mated with the reusable component's electrical connector prior to mechanical connection between the reusable and disposable components. <FIG> is a view of the bottom side of the reusable component <NUM> and the mechanical connector <NUM> of the disposable component. Mechanical connector <NUM> has a keyhole opening <NUM> with a wide portion <NUM> (permitting insertion of the enlarged end <NUM> of peg <NUM>) and a narrow portion <NUM> into which peg <NUM> can be slid to form the mechanical connection between the components. When peg <NUM> is disposed in the narrow portion <NUM> of opening <NUM>, a surface <NUM> of mechanical connector <NUM> engages electrical connector <NUM>, preventing it from being disconnected from the reusable component's electrical connector.

Another aspect of the disclosure is a flexible circuit providing a waterproof electrical communication among the electrical components (e.g., cardiopulmonary physiologic monitor or defibrillator components) in the housings of the wearable device's reusable component. The flexible circuit may also provide a robust and flexible mechanical connection between adjacent housings. <FIG> show the bottom side of an embodiment of a reusable portion of a wearable device (such as a cardiopulmonary physiologic monitor or cardioverter/defibrillator similar to those shown in <CIT>) with four housings <NUM>. Extending across the bottom surfaces of the housings <NUM> is a flexible circuit <NUM> having multiple electrical conductors (not shown) and at least one electrical connector <NUM> (shown in phantom in <FIG>) extending from the conductors in the flexible circuit to the electrical components in each of the housings <NUM>. An overmold material (such as hot melt polyamide, polyolefin, or rubber-based thermoplastic setting adhesives) provides a robust mechanical connection between the housings while permitting flexing and other relative movement between the housings. The overmold material also has dielectric and waterproof properties enhancing the safety of the wearable device even during showering or other activities.

<FIG> shows a cut-away side view of another embodiment of a reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>). A flexible circuit <NUM> extends through and between housings4. Flexible circuit <NUM> has multiple electrical conductors providing communication among the electrical components within the housings <NUM>. Mechanical connectors <NUM> extend from the bottom sides <NUM> of housings <NUM> to provide mechanical attachment to, and detachment from, a disposable component of the wearable device, such as an adhesive patient engagement substrate (not shown). In addition to the electrical communication, flexible circuit <NUM> provides a robust mechanical connection between the housings while permitting flexing and other relative movement between the housings.

<FIG> shows an embodiment of electrical connections between a flexible circuit (such as the flexible circuits described above, extending through and between housings of the wearable device's reusable component. The electrical connections between the flex circuit <NUM> and the PCBAs <NUM> in the housing <NUM> comprise screws <NUM> inserted through the flex circuit <NUM> into threaded standoffs <NUM> that are soldered to the PCBAs <NUM>. Conductive material <NUM> (e.g., copper) is exposed around each through hole <NUM> in the flex circuit on the top and/or bottom surfaces of the flex circuit <NUM>. When the screw <NUM> is passed through the hole <NUM> and threads into the standoff <NUM>, it compresses the flex circuit against the standoff, thereby making reliable electrical contact between the flex circuit <NUM> and the PCBAs <NUM>. These connections are mechanically strong and able to conduct high-voltage and high-current electrical signals necessary for defibrillation. Additionally, the PCBAs can also comprise a low voltage connector (e.g., a fine-pitch multi-conductor connector) that is simultaneously engaged upon compression of the flex circuit against the standoff, enabling low-voltage communication lines.

In some embodiments of the wearable device, the disposable component is a patient engagement substrate adhesively attached to a patient and the reusable component is a plurality of housings mechanically attached to the patient engagement substrate. As the patient moves, the shape of the patient engagement substrate may change. Embodiments of the invention provide mechanical connection features between the reusable and disposable components accommodating changes in shape of one of the components. <FIG> show a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) having a reusable component with a plurality of housings <NUM> connected by a flexible connection (such as a flexible circuit, as described above) and a disposable component <NUM> (such as an adhesive patient engagement substrate). The mechanical connectors of the reusable component include pegs <NUM> having enlarged ends <NUM>. The mechanical connectors of the disposable component include slots <NUM>, <NUM>, <NUM> and <NUM> in positions corresponding to pegs <NUM>. Slots <NUM>, <NUM> and <NUM> are much wider than the width of enlarged end <NUM>, permitting movement of enlarged end <NUM> within slots <NUM>, <NUM> and <NUM> as patient engagement substrate <NUM> bends and straightens with the patient's movement. Anchor slot <NUM>, on the other hand, has a width only slightly larger than enlarged end <NUM>, so that its corresponding peg moves only slightly or not at all as the other pegs move within their slots. This arrangement permits some relative movement between the reusable and disposable components of the wearable device without causing complete mechanical disconnection of the components.

<FIG> show partial views of the reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) having a plurality of housings <NUM> (each containing, e.g., one or more of a controller, a capacitor or a battery) mechanically and electrically connected by a flexible circuit <NUM> having electrical connections <NUM> extending into the housings <NUM>. Mechanical connectors project from the back sides of housings <NUM> from positions above the flexible circuit <NUM>. This arrangement of mechanical connectors and flexible circuit 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 discussed above with respect to <FIG>, the battery housing is part of the disposable component that may be electrically and mechanically connected to, and disconnected from, the reusable component of the wearable device.

<FIG> show an embodiment of a reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) having a plurality of housings <NUM>, <NUM>, <NUM> and <NUM> mechanically and electrically connected by a flexible circuit. The disposable component of the wearable device includes a battery housing <NUM>. A reusable component mechanical connector <NUM> extends from a surface of housing <NUM>; battery housing <NUM> has a corresponding mechanical connector <NUM>. Battery housing also has an electrical connector <NUM>, and housing <NUM> has a corresponding electrical connector (not shown). The electrical and mechanical connections between battery housing <NUM> and reusable component housing <NUM> occur simultaneously.

<FIG> shows a partial view of another embodiment of a reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) having a plurality of housings <NUM> and <NUM> mechanically and electrically connected by a flexible circuit (not shown). The disposable component of the wearable device includes a battery housing <NUM>. Reusable component mechanical connectors <NUM> are disposed in housing <NUM> (only one is shown in <FIG>); battery housing <NUM> has corresponding mechanical connectors <NUM>. Battery housing also has an electrical connector <NUM>, and housing <NUM> has a corresponding electrical connector <NUM>. The electrical and mechanical connections between battery housing <NUM> and reusable component housing <NUM> occur simultaneously.

<FIG> shows an embodiment of a reusable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) having a plurality of housings <NUM> mechanically and electrically connected by a flexible circuit (not shown). The disposable component <NUM> of the wearable device is mechanically connected to a disposable battery <NUM>. The connection between the disposable component and the battery can be permanent, such that the battery is disposed of along with the disposable component. The reusable component modules can be configured to be lowered onto the disposable component and battery such that they make an electrical connection, and a mechanical connection to hold onto the battery module. The reusable component can be lifted off of the battery and disposable component prior to disposal of the disposable component.

<FIG> shows aspects of a disposable component of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>). In this embodiment, the disposable component includes an adhesive patient engagement substrate <NUM>, a cable <NUM> connecting to a second patient engagement substrate (not shown), a battery housing <NUM> containing one or more batteries, and a plurality of mechanical connectors <NUM> for connecting to corresponding mechanical connectors on a reusable component of the wearable device. The battery housing also has an electrical connector (not shown) configured to mate with a corresponding electrical connector in the reusable component for providing electrical communication between the electrical components in the reusable component and the battery and other electrical components of the disposable component, such as an electrode disposed on the bottom side of the patient engagement substrate.

<FIG> show an embodiment of a wearable device (such as a cardiopulmonary physiologic monitor or a cardioverter/defibrillator similar to those shown in <CIT>) in which the disposable component includes an adhesive patient engagement substrate <NUM> and a cable <NUM>, and the reusable component includes a plurality of housings <NUM> each containing one or more of a controller <NUM>, a battery <NUM> or a capacitor. An electrical connector <NUM> on cable <NUM> connects to a corresponding electrical connector <NUM> on one of the housings <NUM>. In this embodiment, connection of electrical connectors <NUM> and <NUM> closes a circuit to provide an alert via a vibration motor <NUM>, a speaker <NUM> and/or a light <NUM> to show that the electrical connection has been made.

In some embodiments of the wearable device, the battery is a rechargeable battery and is part of the reusable component. For example, in the embodiment shown in <FIG>, the reusable component has a plurality of housings <NUM>, <NUM>, <NUM> and <NUM>. The rechargeable battery is disposed in housing <NUM>, and it can be charged by inserting a charger connector <NUM> connected to a charger (not shown) into a port <NUM> in housing <NUM>. In another embodiment, shown in <FIG>, the rechargeable battery in the reusable component <NUM> may be charged wirelessly via a charging pad <NUM> while the patient <NUM> is wearing the wearable device.

<FIG> show yet another embodiment of mechanical connectors for connecting and disconnecting a reusable component <NUM>(such as cardiopulmonary physiologic monitor or defibrillator housings ) of a wearable device (such as an external cardioverter/defibrillator similar to those shown in <CIT>) to a disposable component (such as an adhesive patient engagement substrate <NUM>) of the wearable device. In this embodiment, the disposable component mechanical connector has a latch <NUM> supported by a latch support <NUM> extending from a base <NUM>. A spring <NUM> biases the latch <NUM> in the downward position shown in <FIG>. The corresponding reusable component mechanical connector <NUM> is shown apart from the reusable component in <FIG>. Reusable component mechanical connector <NUM> has an opening leading to a cavity sized and configured to receive the latch <NUM> and latch support <NUM>. When reusable component mechanical connector 8is moved in the direction of arrow <NUM> in <FIG>, its opening will make sliding contact with the lower face of latch <NUM>, moving latch <NUM> upward against the action of spring <NUM> until the two mechanical connectors are in their mating position, shown in <FIG>. In this position, spring <NUM> moves latch <NUM> downward to engage an inner surface of reusable component mechanical connector <NUM> to hold the two components together. To disconnect the reusable component from the disposable component, a removal trigger <NUM> can be actuated to compress spring <NUM> and move latch <NUM> upwards into latch support <NUM>.

In some embodiments, the connection between the reusable component mechanical connector <NUM> and the disposable component connectors is that they allow motion in the direction indicated by arrows <NUM> shown in <FIG>, but constrain motion in the direction indicated by arrows <NUM> in <FIG>. This capability may be allowed by a similar concept as that described with respect to <FIG>. The width of the opening in the reusable component mechanical connector can be greater than the width of the latch support, allowing sliding movement along the direction indicated by arrows <NUM> up to an amount equal to the difference in width between the opening in the reusable component and the widest portion of the latch support <NUM> positioned within the opening. This connection allows the reusable component to be held securely against the disposable component, but also allows the reusable component housings to slide back and forth during flexing caused by user movement. This capability can be very important for wear comfort and longevity of the device.

The reusable component <NUM> has four housings <NUM>. Three of the housings have the mechanical connector <NUM> described with respect to <FIG>. A fourth housing has an integrated mechanical/electrical connector <NUM> that mates with a corresponding mechanical/electrical connector <NUM> in the disposable component. A flexible circuit <NUM> provides electrical communication among housings <NUM>.

For example, a numeric value may have a value that is +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/- <NUM>% of the stated value (or range of values), +/-<NUM>% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise.

Claim 1:
A wearable device comprising:
a reusable component (<NUM>) and a disposable component (<NUM>),
the disposable component (<NUM>) comprising a patient engagement substrate (<NUM>) comprising adhesive on a bottom side, an electrode (<NUM>, <NUM>) on the bottom side, a disposable component electrical connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>), and a disposable component mechanical connector (<NUM>),
wherein the reusable component (<NUM>) comprises:
a plurality of sealed housings (<NUM>) mechanically coupled to each other and movable with respect to each other and a flexible circuit (<NUM>) configured to provide electrical communication among electrical components within the housings, each of the plurality of housings (<NUM>) containing one or more of a capacitor and a controller,
a reusable component mechanical connector (<NUM>) adapted to removably connect to the disposable component mechanical connector to provide a load-bearing mechanical attachment between a bottom side of the reusable component (<NUM>) and a top side of the disposable component (<NUM>) such that the disposable component (<NUM>) is able to mechanically support and removably retain the weight of the reusable component (<NUM>) on a patient at least partially through the mechanical connector (<NUM>), and
a reusable component electrical connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) adapted to removably connect to the disposable component electrical connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>),
characterized in that:
the disposable component electrical connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is separate from the disposable component mechanical connector (<NUM>),
the reusable component electrical connector (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is separate from the reusable component mechanical connector (<NUM>), and
the disposable component mechanical connector (<NUM>) and the reusable component mechanical connector (<NUM>) are configured to allow the reusable component (<NUM>) and the disposable component (<NUM>) to move relative to one another while still maintaining a mechanical connection.