Assemblies and headgear thereof for recharging implantable medical electrical systems

Devices, systems, and techniques are described for use in recharging a power source of a cranially mounted implantable medical device. In one example, a wearable medical device includes a flexible body configured to cover at least a portion of a scalp of a head of a patient. A securing member is connected to the flexible body and configured to extend around a circumference of the head to stabilize the flexible body with respect to the scalp of the patient. A fixation member is configured to mount to a location of the flexible body and couple the flexible body to a recharge coil that is configured to recharge the power source of the cranially-mountable implantable medical device.

TECHNICAL FIELD

This disclosure is related to medical devices, and, more particularly, to assemblies and headgear associated with recharging a power source of one or more of the medical devices.

BACKGROUND

Medical devices may be configured to be external, partially implanted, or fully implanted at a plurality of locations within a patient to provide various functionality such as monitoring the patient and/or providing therapy to the patient. Examples of locations at which implantable medical devices (IMDs) may be implanted include on the cranium, at a substernal location, or near the hip of a patient, though IMDs may be implanted at other locations in other examples. IMDs may include one or more processing circuits and one or more electrical components that require power in order to provide the intended functionality. Often, a power source is housed within the IMD or otherwise also implanted to provide this functionality to the IMD. An IMD may include recharging components, such as recharging coils for inductive coupling, that are capable of recharging the embedded power source by, e.g., generating and directing current from an electromagnetic field to the power source of the IMD.

SUMMARY

This disclosure is related to devices, systems, and techniques related to recharging power sources of cranially mounted medical devices (e.g., one or more implantable medical devices (IMDs)). A wearable medical device may retain one or more recharging coils at a predetermined location appropriate for delivering charging power to one or more IMDs of the patient. For example, a wearable medical device may include a fixation member (e.g., an attachment assembly) configured to couple a recharging coil to a flexible body of the wearable medical device. A second fixation member may couple a second recharging coil to the flexible body. Since the patient may wear the wearable medical device over a portion of their head, the flexible body and the fixation members may retain the recharging coils at respective locations on the head that align with respective IMDs implanted on the cranium of the patient. In this manner, the patient may place the wearable medical device on their head to reproducibly align the recharging coils with the IMDs for recharging and/or communication functionality between the coils and the IMDs. The flexible body may have shape similar to a hat in some examples.

In some examples, the wearable medical device may include a recharging device, or recharging system, that is configured to be removably secured to the wearable medical device for use on the head of the patient. In this manner, the recharging device may be repeatably removed and secured to the head of the patient at reproducible locations with respect to the head. The recharging device may include one or more recharging coils and, in some examples, may also include a power source configured to supply power to the recharging coils. In some examples, the recharging coils may be secured to the flexible body, and the power source may be coupled to a securing member that extends around the circumference of the head and is more rigid than the flexible body.

In one example, a wearable medical system includes a flexible body that is configured to cover at least a portion of each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of a scalp of a head of a patient. The wearable medical system also includes a securing member connected to the flexible body and configured to extend around a circumference of the head and stabilize the flexible body with respect to the scalp of the patient. The wearable medical system also includes a fixation member configured to mount to a location of the flexible body and configured to couple the flexible body to a recharge coil configured to recharge an implantable power source of a cranially-mountable implantable medical device.

In another example, a wearable medical system includes a flexible body configured to cover at least a portion of each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of a scalp of a head of a patient. The wearable medical system also includes a securing member connected to the flexible body and configured to extend around a circumference of the head and stabilize the flexible body with respect to the scalp of the patient. The wearable medical system also includes an external power source secured to at least one of the flexible body or the securing member. The wearable medical system also includes a first recharge coil removably configured to transmit energy from the power source to recharge a first implantable power source of a first cranially-mountable implantable medical device. The wearable medical system also includes a second recharge coil removably configured to transmit energy from the power source to recharge a second implantable power source of a second cranially-mountable implantable medical device. The wearable medical system also includes one or more cables coupling the external power source to the first and second recharge coils. The wearable medical system also includes a first fixation member configured to mount to a first location of the flexible body and configured to securely attach the first recharge coil to the flexible body. The wearable medical system also includes a second fixation member configured to mount to a second location of the flexible body. The second fixation member is configured to securely attach the second recharge coil to the flexible body.

In another example, a wearable medical system includes a curved container that is configured to house a recharge coil and defines a concave first main surface and a convex second main surface that each approximate a curvature of a scalp of a head of a patient. The first main surface is configured to interface with the scalp of the patient and the second main surface is on an opposite side of the curved container of the first main surface. The second main surface defines a ridge that extends out away from the second main surface and a bore that extends through the curved container. The wearable medical system also includes a bracket defining a cylindrical recess configured to be received by the bore and a channel that is configured to receive the ridge of the second main surface to securely attach the bracket to the curved container. The wearable medical system also includes a pin configured to extend into the cylindrical recess of the bracket to be securely received by the bracket. The pin includes a plate configured to press a mouth of the cylindrical recess when the pin is received by the recess of the bracket.

More examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

DETAILED DESCRIPTION

This disclosure is directed to devices, systems, and methods related to recharging power supplies of cranially mounted medical devices, such as implantable medical devices (IMDs). A patient may be monitored and/or treated using one or more medical devices that are located on or near the head of the patient. The medical devices may be completely external to the patient, partially implanted within the patient, or fully implanted within the patient. For example, a patient may have two cranially mounted IMDs coupled to respective electrical leads disposed within the brain, each IMD being configured to provide functionality such as monitoring or providing therapy to the brain patient (e.g., monitoring neurological signals and/or delivering deep brain stimulation to treat one or more symptoms of a brain disorder).

Each of these cranially-mounted IMDs may include a rechargeable power source that is configured to provide the power necessary to execute functionality of the IMD. The IMDs may each include a recharging coil configured to generate an electrical current to recharge the respective power sources in response to being exposed to an electromagnetic field from an external recharging coil (e.g., via inductive coupling). In addition, or alternatively, the IMD may receive communications from an external device via a coil. The efficiency, and speed, of energy transferred between the external recharging coil and the coils of the IMDs may be related to an alignment of the external recharging coil to the respective coil of the IMDs. Recharging sessions may take several minutes to over an hour. However, it may be difficult for a patient to manually hold the recharging coils to their head for the duration of the recharging session, difficult to maintain the appropriate positions of the external recharging coils for the duration of the recharging session, and/or difficult for the patient to initially find the correct position of each recharging coil with respect to the coils of the IMDs.

Aspects of this disclosure relate to removably securing a recharging device to the head of a patient via a wearable medical device, such that the wearable medical device, and the recharging device, may be repeatably secured to and removed from the head of the patient. The recharging device may be configured to create an electromagnetic field that is aligned with each recharging coil of each cranially mounted IMD each time that the charging device is secured to the head of the patient. For example, the recharging device may be attached to a wearable medical device which secured to the head of the patient. Once the wearable medical device is in place on the patient's head, the recharging coils of the recharging device can operate to create respective electromagnetic fields that are aligned with respective recharging coils of the IMDs, such that both power sources of both IMDs are simultaneously charged. In this manner, the wearable medical device may be configured to secure the recharging coils to respective locations of the wearable medical device, such that the wearable medical device assists the patient in reproducible placement of the recharging coils and maintaining the placement of the recharging coils with respect to the head of the patient for the duration of a recharging session. In some examples, the recharging coils may be removably attached to the wearable medical device using a fixation member such as an attachment assembly that may include a bracket or other structure configured to interface with the one or more recharging coils.

Examples disclosed herein are directed toward wearable medical devices and recharging devices configured to be removably secured to the head of a patient. The recharging devices are configured to facilitate the recharging of power source56in an implantable medical electrical system, such as that described above in conjunction withFIG. 1Awhen secured to the head of the patient via a wearable medical device. Examples of the wearable medical devices disclosed herein may be configured to hold a recharge coil of a recharging device or recharging system in place outside scalp16of the patient and in proximity to a rechargeable device of the medical device disposed outside of, at least partially within, or fully implanted beneath the scalp, for example, IMD14. With further reference toFIG. 1A, it should be appreciated that the location along the skull of an implant site for IMD14can vary from patient to patient, for example, depending on the type of stimulation therapy or monitoring required. Further, in some cases, a patient may require more than one IMD14, either of which may or may not be at the location depicted inFIG. 1A. Furthermore, IMD14recharging may be needed more than once per day in some examples, and the time required to recharge IMD14may be on the order of minutes, tens of minutes, greater than an hour, or at least several hours.

The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of inventive embodiments disclosed herein in any way. Rather, the following description provides practical examples, and those skilled in the art will recognize that some of the examples may have suitable alternatives. Examples will hereinafter be described in conjunction with the appended drawings, which are not to scale (unless so stated), wherein like numerals/letters denote like elements. Annotations of exemplary additional description included in the drawings are not intended to limit the scope of the illustrated embodiments. Examples of constructions, materials, dimensions and fabrication processes are provided for select elements and all other elements employ that which is known by those skilled in the art.

Certain types of implantable medical electrical systems are employed to treat nervous system conditions such as pain and/or psychological, sleep, or movement disorders. In some examples, these systems include at least one elongate implantable medical electrical lead electrically connected to an implantable pulse generator device (e.g., an IMD that includes a pulse generator), wherein the lead includes one or more electrodes that deliver electrical stimulation therapy to the patient from the generator device. For example, the electrodes may delivery deep brain stimulation, cortical stimulation, occipital nerve stimulation, or any other type of therapy. In other examples, the IMD may monitor brain activity or the activity of other anatomical structures. In other examples, the IMD may deliver drug therapy to the brain or other structure associated with the head of the patient.

FIG. 1Ais a conceptual diagram of such an exemplary system implanted, from a superior view of a scalp16of the patient. The example ofFIG. 1Aillustrates an example implantable medical device (IMD)14, to which leads28A,28B (collectively, “leads28”) are connected, wherein IMD14is implanted beneath a scalp16of the patient in a hollowed-out, or recessed, area of the patient's skull23. IMD14may be an implantable pulse generator from which leads28A,28B extend to the brain of the patient through burr holes26A,26B (collectively, “holes26”) that have been drilled through the skull23. Access to skull23of the patient for the implant may have been gained via a “C-flap” incision24formed through scalp16of the patient. “Hollowed out” may refer to any area where a portion or all of the skull was removed to make any room for IMD14, either to partially or wholly fit device within that hollowed out area.

FIG. 1Afurther illustrates IMD14including housing36, for example, formed from a relatively soft biocompatible material that contains and/or encapsulates electronic portions of IMD14. For example, IMD14may include control module34, power module32, and recharge module30as depicted inFIG. 1A. Power module32includes a rechargeable power source, for example, a rechargeable battery. Recharge module30may be coupled to power module32and include a secondary coil configured to receive energy via transcutaneous inductive energy transmission (e.g., inductive coupling).

A wearable medical device and recharging device as described herein may be removably secured to scalp16of the patient such that when secured one or more recharge coils of the recharge device are located at a predetermined location relative to the scalp, and the implanted IMDs, of the patient. The predetermined location may be a location at which an electromagnetic field created by the recharge coils of the recharge device are relatively aligned with one or more secondary coils of recharge module30of IMD14. The location may be aided by defining scalp16as different predetermined regions, such as the left anterior quadrant (LAQ), the right anterior quadrant (RAQ), the left posterior quadrant (LPQ) and the right posterior quadrant (RPQ) as labelled inFIG. 1. A “left” and “right” side of the head of the patient as per the LAQ, LPQ, RAQ, and RPQ may be divided along a longitudinal midline10of the head of the patient. In some examples, LAQ, LPQ, RAQ, and RPQ may extend across a scalp of the patient. Reference to each quadrant associated with a respective IMD may help to locate the recharge coils to the wearable medical device.

For example,FIGS. 1B and 1Cdepict conceptual diagrams illustrating head12of patient as viewed from left lateral side of the patient and viewed from the right lateral side of the patient, respectively. As depicted inFIG. 1B, LAQ and LPQ together extend from an anterior side of head12of patient to a posterior side of head12of patient to define a generally diagonal bottom interface that extends from a forehead of the patient to a location near the neck of the patient. Similarly, as depicted inFIG. 1C, RAQ and RPQ together extend from an anterior side of head12of patient to a posterior side of head12. In this way, LAQ, LPQ, RAQ, and RPQ may generally cover scalp16of patient. Although four quadrants are described herein, Fewer or more sections may be used to describe various locations of scalp16for the appropriate placement of recharge coils of the recharging device.

FIG. 1Dis a conceptual diagram illustrating an example patient with two IMDs14A and14B (hereinafter “IMDs14”) disposed on a cranium of a patient and a recharging device40configured to recharge the power sources of the IMDs14. IMDs14may be coupled to respective electrical stimulation leads15A and15B, which dispose respective electrodes within brain38of patient37. Leads15A and15B may, for example, be implanted to treat the right and left hemispheres of patient37. In other examples, three or more IMDs may be implanted in the cranium17of patient37.

In the example ofFIG. 1D, recharging device40includes power unit44coupled to recharge coils42A and42B via respective cables. Each of recharge coils42A and42B may be configured to provide charging power to respective IMDs14A and14B. For example, recharge coil42A may be able to provide charging power concurrently with or independently of recharge coil42B, and vice versa. In some examples, recharge coil42A may provide a first amount of power to IMD14A simultaneously with recharge coil42B providing a second amount of power to IMD14B, while the first amount of power is different than the second amount of power as a result of different parameters of respective IMDs14(e.g., parameters being a power level of a power source of the respective IMD14or a temperature of the IMD14as a result of the received power or the like).

As discussed herein, recharging device40may be recharge power sources of both IMDs14more efficiently when recharging coils42A,42B of recharging device40are physically aligned with IMDs14. For example, recharging device40may provide more power per second to IMDs14when respective recharge coils42A,42B are aligned with recharge coils housed within or otherwise secured to respective IMDs14. Given that recharging device40is configured to provide power to both IMDs simultaneously, it may be advantageous to thusly align both recharging coils simultaneously. Similarly, as discussed herein, given the relatively frequent (e.g., once a day) and prolonged (e.g., up to an hour) nature of charging, it may be advantageous for recharging device40to be fixedly securable to a wearable medical device that is configured to reliably align recharge coils42A,42B with respective recharge coils of each IMD14when the wearable medical device is worn (e.g., secured to patient36).

FIG. 2is a block diagram illustrating example components of IMD14. In the example ofFIG. 2, IMD14includes processing circuitry50, stimulation circuitry52, memory54, telemetry circuitry56, power source58, sensor60, and secondary coil66. In other examples, IMD14may include a greater or fewer number of components. For one example, in some instances IMD14may not include sensor60. While inFIG. 2most components of IMD14are depicted as contained within in a single substantially contiguous compartment of housing16, in other examples components of IMD14may be contained within IMD14in other configurations. For example, in some instances components of IMD may be contained within a plurality of housings of IMD14, or some components may be secured partially or fully outside of an internal hermetically sealed compartment of housing16and electrically coupled to other components within a compartment of housing16as described herein.

In general, IMD14may comprise any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the various techniques described herein attributed to IMD14and processing circuitry50. In various examples, processing circuitry50of IMD14may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. IMD14also, in various examples, may include memory54, such as random-access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Memory54may store therapy programs62, sense or stimulation electrode combinations64, or other instructions that specify therapy parameter values for the therapy provided by stimulation circuitry52and IMD14. Moreover, although processing circuitry50, stimulation circuitry52, and telemetry circuitry56are described as separate portions of circuitry, in some examples processing circuitry50, stimulation circuitry52, and/or telemetry circuitry56may be fully or partially integrated with each other. In some examples, processing circuitry50, stimulation circuitry52, and/or telemetry circuitry56correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.

Stimulation circuitry52may generate and deliver electrical stimulation under the control of processing circuitry50. In some examples, processing circuitry50controls stimulation circuitry52by accessing memory54to selectively access and load at least one therapy programs62to stimulation circuitry52. For example, in operation, processing circuitry50may access memory54to load one therapy programs62to stimulation circuitry52. In such examples, relevant stimulation parameters may include a voltage amplitude, a current amplitude, a pulse rate, a pulse width, a duty cycle, or the combination of electrodes28A,28B,28C, and28D as stored in stimulation electrode combinations64that stimulation circuitry52uses to deliver the electrical stimulation signal. Although stimulation circuitry52may be configured to generate and deliver electrical stimulation therapy via one or more of electrodes28A,28B,28C, and28D of lead28, stimulation circuitry52may be configured to provide different therapy to patient. For example, stimulation circuitry52may be configured to deliver drug delivery therapy via a catheter. These and other therapies may be provided by IMD14.

Power source58may be rechargeable through the use of secondary coil66. Secondary coil66, which may be a coil of wire or other device capable of inductive coupling with a primary coil disposed external to the patient, such as a coil secured to a wearable medical device and mounted to head12of patient as described herein. Secondary coil66may include a winding of wire configured such that an electrical current can be induced within the wire when subjected to (e.g., physically exposed to) an electromagnetic field from an external primary coil. The induced electrical current may then be used to recharge power source58. In this manner, the electrical current may be induced in secondary coil66associated with power source58. The induction may be caused by electrical current generated in the primary coil of an external charging device and based on the selected power level. The coupling between secondary coil66and the external primary coil may be dependent upon the alignment of the two coils. In some examples, the coupling efficiency increases when the two coils share a common axis and are in close proximity to each other. The external charging device and/or IMD14may provide one or more audible tones, visual indications, haptic feedback, or the like that indicates an assessment of the alignment (e.g., providing more/less/different audible tones/visual indications/haptic feedback in response to an improving or diminishing alignment).

Although inductive coupling is generally described as the method for recharging rechargeable power source58, other wireless energy transfer techniques may alternatively be used. Any of these techniques may generate heat in IMD14such that the charging process can be controlled using the calculated cumulative thermal dose as feedback.

IMD14may include one or more circuits that filter and/or transform the electrical signal induced in secondary coil66to an electrical signal capable of recharging power source58. For example, in alternating current induction, IMD14may include a half-wave rectifier circuit and/or a full-wave rectifier circuit configured to convert alternating current from the induction to a direct current for power source58. The full-wave rectifier circuit may be more efficient at converting the induced energy for power source58. However, a half-wave rectifier circuit may be used to store energy in power source58at a slower rate. In some examples, IMD14may include both a full-wave rectifier circuit and a half-wave rectifier circuit such that IMD14may switch between each circuit to control the charging rate of power source58and temperature of IMD14.

In some examples, IMD14may include a measurement circuit configured to measure the current and/or voltage induced during inductive coupling. This measurement may be used to measure or calculate the power transmitted to IMD14from an external charging device. In some examples, the transmitted power may be used to approximate the temperature of IMD14and that of the surrounding tissue. This method may be used to indirectly measure the temperature of tissue in contact with the housing of IMD14. In other examples, IMD14may estimate the transmitted power using the measured voltage or current.

Power source58may include one or more capacitors, batteries, or other energy storage devices. Power source58may then deliver operating power to the components of IMD14. In some examples, power source58may include a power generation circuit to produce the operating power. Power source58may be configured to operate through hundreds or thousands of discharge and recharge cycles. Power source58may also be configured to provide operational power to IMD14during the recharge process. In some examples, power source58may be constructed with materials to reduce the amount of heat generated during charging. In other examples, IMD14may be constructed of materials that may help dissipate generated heat at power source58and/or secondary coil66over a larger surface area of the housing of IMD14.

IMD14include one or more sensors60. Sensor60may include one or more sensing elements that sense values of a respective patient or IMD14parameter. For example, sensor60may include one or more accelerometers, optical sensors, chemical sensors, temperature sensors, pressure sensors, or any other types of sensors. IMD14may include additional sensors within the housing of IMD14and/or coupled via one of leads28or other leads. For example, IMD14may receive sensor signals wirelessly from remote sensors via telemetry circuitry56. In some examples, one or more of these remote sensors may be external to patient (e.g., carried on the external surface of the skin, attached to clothing, or otherwise positioned external to the patient). Sensor60may output patient or IMD parameter values that may be used as feedback to control delivery of therapy or to otherwise manage IMD.

For example, sensor60may be a temperature sensor that sensing temperatures during recharging. As a temperature sensor, sensor60may include one or more temperature sensors (e.g., thermocouples or thermistors) configured to measure the temperature of IMD14. As described herein, temperature sensor60may be used to directly measure the temperature of IMD14and/or tissue surrounding and/or contacting the housing of IMD14. Processing circuitry50(or an external charging device) may use this temperature measurement as the tissue temperature feedback to determine the cumulative thermal dose provided to tissue during charging of power source58. Although a single temperature sensor may be adequate, multiple temperature sensors may provide a better temperature gradient or average temperature of IMD14. The various temperatures of IMD14may also be modeled and provided to determine the cumulative thermal dose. Although processing circuitry50may continually measure temperature using sensor60, processing circuitry50may conserve energy by only measuring temperature during recharge sessions. Further, temperature may be sampled at a rate necessary to calculate the cumulative thermal dose, but the sampling rate may be reduced to conserve power as appropriate.

Processing circuitry50may also control the exchange of information with a charging device mounted to head12of patient and/or an external programmer using telemetry circuitry56. Telemetry circuitry56may be configured for wireless communication using radio frequency protocols or inductive communication protocols. Telemetry circuitry56may include one or more antennas configured to communicate with the programmer, for example. Processing circuitry50may transmit operational information and receive therapy programs62or therapy parameter adjustments via telemetry circuitry56. Also, in some examples, IMD14may communicate with other implanted devices, such as stimulators, control devices, or sensors, via telemetry circuitry56. In addition, telemetry circuitry56may be configured to transmit the measured values from sensor60. In other examples, processing circuitry50may transmit additional information to an external charging device related to the operation of power source58. For example, processing circuitry50may use telemetry circuitry56to transmit indications that power source58is completely charged, power source58is fully discharged, or any other charge status of power source58. Processing circuitry50may also transmit information to the external charging device that indicates any problems or errors with power source58that may prevent power source58from providing operational power to the components of IMD14.

Examples of local wireless communication techniques that may be employed to facilitate communication between an external device and IMD14include RF communication according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with an external charging device without needing to establish a secure wireless connection. As described herein, telemetry circuitry56may be configured to receive a measured tissue temperature from IMD14. The tissue temperature may be measured adjacent to rechargeable power source58, such as near the housing of IMD14or external of the housing. Although IMD14may measure the tissue temperature, one or more different implantable temperature sensors (e.g., standalone implantable temperature sensing devices) may independently measure the tissue temperature at different positions and transmit the temperature to an external charging device. In some examples, multiple temperature readings by IMD14may be averaged or otherwise used to produce a single temperature value that is transmitted to an external charging device. The temperature may be sampled and/or transmitted at different rates, e.g., on the order of microseconds, milliseconds, seconds, minutes, or even hours. Processing circuitry50may then use the received tissue temperature to calculate the cumulative thermal dose. Processing circuitry50may transmit feedback information to an external charging device (e.g., charging device40) regarding the alignment of external primary coil to secondary coil66. This alignment information may be used by charging device40or other device to provide feedback to the user when determining the location on the wearable medical device to position the external charging coil (e.g., the primary coil). Therefore, in some examples, IMD14may provide data that aids in the determination of the location at which the charging coil should be located with respect to the scalp of the patient. While the wearable medical device is located on the scalp of the patient, the location of the external recharging coils with respect to the wearable medical device may be determined for attachment of the recharging coils at the respective locations.

Aspects of the disclosure relate to wearable medical devices that are configured to secure a recharging device (e.g., one or more recharging coils) to a plurality of locations relative to scalp16of patient. Configuring the wearable medical device to secure recharging coils at a plurality of locations may improve an ability of the patient to repeatedly align the recharging coils of the recharging device with secondary coil66of IMD14. In this manner, for each recharge session, the wearable medical device may enable consistent locating of the recharge coils and relatively high efficiency with which the recharging device may recharge power source58of IMD14.

Further, as discussed herein, the wearable medical device may be removably securable to a predetermined location on head12of the patient, such that when secured the recharge coils of the recharge device may be reliably located at respective predetermined locations relative to scalp16of the patient. In some examples, the wearable medical device may be configured such that it secures to head12substantially only at the predetermined location in the predetermined manner (e.g., such that it is difficult, impossible, and/or uncomfortable to secure the wearable medical device to head12at a location other than the predetermined location). Further, the wearable medical device may be relatively easy to secure to head12of patient, such that it may require only a single hand and a minimum amount of motion to secure the wearable medical device to head12. Further, while secured, the wearable medical device may be relatively stable on head12of patient, such that wearable medical device may be configured to avoid being unintentionally unsecured from head12. The wearable medical device may be configured to stay secured to head12for a substantially indefinite period of time until a specific removal force is applied to the wearable medical device to remove the wearable medical device from head12. The wearable medical device may be configured to be relatively comfortable as secured to head12. In some examples, the wearable medical device may include one or more adjustment mechanisms that are configured to adjust a fit of the wearable medical device to specifically fit head12of patient.

Depending upon a shape of the wearable medical device, the recharging device may utilize different sets of coils.FIGS. 3A-Dillustrate conceptual forms of example recharging coil components that can be held by example wearable medical devices disclosed herein. Coil components may be formed by wound wire or a printed circuit board (PCB) type metal trace adhered to either a rigid or a flexible substrate, such as Kapton. Coil component may be part of a charge module that also includes recharge circuitry (e.g. as depicted inFIG. 5). The recharging coils ofFIGS. 3A-3Dmay be employed, for example, by wearable medical devices described herein, such as wearable medical devices ofFIGS. 4A, 4C, 5-6C, 8A, 8B, and 10A-34C

FIG. 3Adepicts a conceptual diagram illustrating a variety of shapes for relatively compact recharging coil components80A-80F (collectively, “coil components80”), which may be employed by wearable medical devices discussed and depicted herein. Coil components80may either be relatively rigid or relatively flexible, and may either be relatively flat or have a pre-formed curvature.

FIGS. 3B-3Ddepict a conceptual diagram illustrating example shapes for three more types of coil components82,84,86, respectively, which may be employed by wearable medical devices discussed and depicted herein. With reference toFIG. 3B, component82has a recharging coil extending just around a perimeter of the substrate. With reference toFIG. 3C, component84has either a single recharging coil extending around the perimeter of the substrate and in concentric turns within the perimeter, or has multiple concentric recharging coils. In examples of component84with multiple recharging coils, the coils may be individually turned on. With reference toFIG. 3D, component86has multiple, relatively smaller, coils distributed across the substrate, wherein the coils may be individually turned on or turned on in groups. Each of coil components82,84,86may either be relatively rigid or relatively flexible, and may either be relatively flat or have a pre-formed curvature.

FIG. 4Adepicts a conceptual diagram illustrating an unassembled view of recharging system100, which may include wearable medical device101and recharging device103, to be secured to head12of a patient. Wearable medical device101may include securing member102that is configured to extend around at least a portion of circumference of scalp16to secure wearable medical device101, and recharging device103when attached, to head12. Securing member102may be a band that is configured to extend substantially fully around an outer perimeter of scalp16along one relatively flat plane. For example, looking toFIG. 4Bwhich depicts a conceptual diagram illustrating a side view of head12of a patient, securing member102may be secured to head12along relatively flat plane104that extends from forehead106of head12to anterior middle108of the back of head12. In some examples, securing member102may be configured to secure to head12substantially only along plane104, such that it may be difficult or impossible or otherwise uncomfortable for securing member102to be secured to head12along a plane other than plane104. However, plane104upon which securing member102is secured to head12may be modifiable, such that recharging device100may be configured in different ways to identify or select different plane104.

In some examples, securing member102may be relatively inelastic, or stiff, such that securing member102may be configured to maintain a general shape in response to normal operating forces. For example, securing member102may be configured to define a relatively circular shape that generally matches the cross-sectional shape of scalp16along plane104upon which securing member102is secured to head12. Securing member102may be configured to define a circumference that is slightly smaller than the circumference of scalp16along plane104, such that securing member102stretches slightly (e.g., stretches an amount equal to the differences in cross-section) to fit on head12. In some examples, securing member102may secure wearable medical device101to head12as a result of this interference fit between head12and securing member102. The securing member102may have a cross-sectional shape of an oval, rectangle, rounded rectangle, or any other shape that promotes securing wearable medical device101to head12. A relative inelastic material of securing member102may include polyethylene, high-density polyethylene, nylon, or the like.

In other examples, securing member102may be relatively flexible, such that securing member102does not substantially hold a predetermined shape. In such examples, securing member102may define a relatively smaller circumferential length of diameter and/or be made of a relatively material that stretches more than in examples where securing member102is relatively inelastic, or stiff. A relatively more flexible securing member102may be secured to head12as a result of relatively smaller circumference and a more elastic construction in comparison to a relatively stiff securing member102. As such, securing member102may be configured to be secured to head12as a result of an interference fit relationship between a relative stiffness, a relative circumference, and a relative elasticity of securing member102.

Securing member102may be made of an elastic material that is configured to stretch to match the contours of skull23as securing member102as secured to head. For example, securing member102may be made of a fabric such as a micro-polyester and/or spandex material, or materials such as poly propylene, polyethylene, silicone, polycarbonate, acrylic, acrylonitrile butadiene styrene, polystyrene, styrene acrylonitrile, whether alone or in a combination with each other, or other similar materials. In some examples securing member102may extend to an outer surface of wearable medical device101. In other examples, securing member102may be an internal component, such that securing member102is enclosed within a pocket of flexible body110.

Flexible body110may be a component of recharging device100. Flexible body104may be a relatively flexible stitched or woven fabric or sheet. Flexible body104may be fixedly secured to securing member102, such that it may be difficult to remove flexible body104from securing member102without damaging one or both of flexible body110and securing member102. For example, securing member102may be disposed within a pocket created by folding over and stitching a portion of flexible body110to itself, or securing member102may be stitched or bonded or otherwise directly connected to flexible body110.

Flexible body110may be configured to extend radially in from top edge112of securing member102, where top edge112is an edge of securing member102that extends around perimeter of securing member102. As secured to head12, top edge112may be portion of securing member102that is furthest from a face of head12(e.g., such that top edge112is near a “top” of head12of a patient as secured to head12). Flexible body110may be configured to conform to contour of at least some of each of the left anterior quadrant, the left posterior quadrant, the right posterior quadrant, and the right anterior quadrant of scalp16of the patient when securing member102is stably mounted to head12. For example, securing member102may be configured to be secured to an outer boundary of scalp16as scalp16extends around head12, and flexible body110may be configured to substantially cover most or all of scalp16as flexible body110extends radially in from the stably mounted securing member102.

Recharging device103of recharging system100may include power source compartment116(e.g., a power unit that contains electrical components such as a power source, processing circuitry, and/or other functional components). Recharging device103may be similar to recharging device40ofFIG. 1D. Power source compartment116may be coupled to one or more recharge coil containers118A,118B (collectively, “recharge coil containers118”) that may each contain a respective recharge coil80,82,84,86, where recharging device103includes the power source compartment116, recharge coil containers118, and respective recharge coils80,82,84,86. Recharge coil containers118may be similar to recharge coils42A and42B ofFIG. 1D, and power source compartment116may be similar to power unit42ofFIG. 1D. Power source compartment116may be coupled to recharge coils80,82,84,86housed within recharge coil containers118through one or more cables120A,120B (collectively, “cables120”). Power source compartment116may include a power source and may be configured to provide current to recharge coils of recharge coil containers118so that these recharge coils may create an electromagnetic field from which a secondary coil of a respective charging module of an implanted cranially-mounted medical device (e.g., secondary coil66of IMD14fromFIG. 2) may draw current to recharge a power supply (e.g., power source56) of the implanted medical device.

Power source compartment116may be configured to be secured to the wearable medical system101. Power source compartment116may be configured to be secured in a stable but temporary manner, such that power source compartment116may be attached and removed to the wearable medical system101numerous times. In some examples, wearable medical device101may define front side122and back side124that are on opposite sides of wearable medical device101, where front side122is configured to be secured to head122such that front side122is aligned with anterior of head12, and back side124is configured to be aligned with posterior of head12. In such examples, power source compartment116may be configured to be clipped or otherwise attached to securing mechanism102at back end124of wearable medical device101.

In some examples, cables120may be substantially permanently coupled between power source compartment116and one or more recharge coil containers118, such that it may be difficult or impossible to remove cables120from power source compartment116and/or recharge coil containers118without damaging cables120, power source compartment116, and/or recharge coil containers118. In other examples, cables120may be configured to be inserted into power source compartment116and/or recharge coil containers118to couple power source compartment116to recharge coil containers118. For example, cables120may utilize micro universal serial bus (USB) formats to plug into one or both of power source compartment116and recharge coil containers118.

Recharge coil containers118may include a housing that encapsulates coil components such as coil component80A ofFIG. 3A. Recharge coil containers118may be configured to be secured to flexible body110. Recharge coil containers118may be configured to be secured to a main surface of flexible body110such that recharge coil containers118contact scalp16. For example, flexible body110may define first main surface126on an external face of recharging device100and second main surface128on an opposite side of first main surface, wherein second main surface128is configured to contact scalp16once securing member102is secured to head12. In this example, recharge coil containers118may be configured to be secured to second main surface128of flexible body110.

Recharge coil containers118may define main surface130that is configured to contact scalp16as secured to second main surface128of flexible body110. Main surface130of recharge coil containers118may define a curvature that approximates a curvature of scalp16. For example,FIG. 4Cdepicts a conceptual diagram illustrating a cross sectional view of recharge coil container118B as taken along plane132shown inFIG. 4A. As depicted inFIG. 4C, main surface130of recharge coil container118B defines curvature that with radius134to a center point135that is generally at a center point of head12of the patient. In this way, radius134of a curvature of main surface130may be substantially similar to curvature of scalp16of patient. In some examples, main surface130may define a changing radius134across different portions of main surface130to better approximate a curvature of scalp16of patient (e.g., since head12of patient are not perfectly spherical). Configuring recharge coil containers118to define main surface130that contacts scalp16and approximates curvature of scalp16may improve comfort and/or alignment of the recharge coils and wearable medical device100when recharge coil containers118are disposed against scalp16.′

In some examples, wearable medical device101may include bill136configured to extend out from front122of securing member102and flexible body110. For example, when wearable medical device101is secured to head12of a patient, bill136may be configured to extend out over forehead106of patient and/or shade eyes of the patient (e.g., from the sun, when recharging device100is worn outside). Bill136may be made of a relatively stiff material such as a polymer such as high-density polyethylene or the like, such that bill136maintains its shape and the shape of flexible body110when maneuvering wearable medical device101to head12in order to locate recharge coil containers118to the one or more predetermined locations. Bill136may include a relatively compliant, or soft, material (e.g., such as a micro-polyester spandex material) covering the relatively stiff material to increase a comfort of bill136and wearable medical device101as wearable medical device101is secured to head12. In some examples, bill136may be configured to be bendable into a static “U” shape as bill136extends away from securing member102and flexible body110. In other examples, bill136may additionally or alternatively be configured to define a relatively flat plate as bill136extends away from securing member102and flexible body110. An amount that bill136extends away from securing member102and flexible body110is depicted for purposes of illustration only, as bill136may extend different lengths in different examples. In some examples, an amount of quality of material of bill136may provide a counterweight to power source comportment116when power source compartment116is secured to posterior124of wearable medical device101.

In some example, flexible body110may include a plurality of seams138that extend at least from securing member102to a central spot in flexible body110. Seams138may provide structural support, e.g., a stiffness, to flexible body110. As a result of seams138providing a stiffness to flexible body110, wearable medical device101may improve an ability of recharge coil containers118to be aligned with recharge coils of devices14implanted on head12of patient, therein improving an efficiency with which wearable medical device101and recharging device103may recharge power sources of devices14implanted on head12of the patient. Seams138may divide flexible body110into four relatively equal quadrants, though in other examples seams138may divide flexible body110into more (e.g., six) or less (e.g., two) subsections.

In some examples, power source compartment116may include a functional electrical recharging control unit to control the electrical current to the recharging coils of charging coil container118. For example, power source compartment116may include circuitry, coils, memory, or the like in order to provide functionality of recharging device103. For example,FIG. 5is a block diagram of components of recharging device103, which may include power source compartment116coupled to recharge coil container118.

ThoughFIG. 5is depicted with coil80housed within charging coil container118for purposes of clarity, it is to be understood that coil82,84,86or other types of coils may be housed within charging coil container118in other examples. Power source compartment116ofFIG. 5may include a housing that houses processing circuitry150that controls delivery of energy from rechargeable power source158by sending control signals to components such as power management circuitry162and modulating circuitry164. Each of these components, or circuitry, may include electrical circuitry that is configured to perform some or all of the functionality described herein. As shown, power source compartment116may include any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to recharging device101. Processing circuitry150may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. For example, processing circuitry150may include one or more processors configured to perform the processes discussed with respect to telemetry circuitry156.

Power management circuitry162recharges rechargeable power source158using an AC voltage received from an input port166of power source compartment116. Modulating circuitry164converts DC voltage provided by power source158into an AC voltage at a desired amplitude and frequency for delivery to charging coil80via cable120, which may be coupled to charging coil container118and therein coil80via an input/output port168. Although only a single coil80is shown as coupled to power source compartment116via cable120, two or more coils may be coupled to I/O port168of power source compartment116via the same or different respective cables120.

The example ofFIG. 5further illustrates power source compartment116including a telemetry circuitry156. Telemetry circuitry156may support wireless communication between IMD14and recharging device100under the control of processing circuitry150. Telemetry circuitry156may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry circuitry156may provide wireless communication via coil80and/or via another coil and/or other dedicated telemetry antenna (e.g., via radio frequency telemetry). For example, telemetry circuitry156may receive a signal from one or more IMDs14that indicates that a temperature of a respective IMD14exceeds a threshold as a result of an induced current, and in response to which recharging device103may reduce the power of the electromagnetic field for the respective IMD14to reduce current inducted in IMD14. Processing circuitry150may receive recharge status information via telemetry and present the information to the patient via user interface154, which may include a display, one or more buttons or dials, and/or one or more speakers. Processing circuitry150may also be configured to receive user input via user interface154.

Memory152may store information received via telemetry and may also store program instructions to be executed by processing circuitry150. Memory152may include RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, or the like. Further, memory152may store executable instructions that, when executed by processing circuitry150, cause processing circuitry150and recharging device100to provide the functionality ascribed to recharging device100throughout this disclosure. For example, memory152may include instructions that cause processing circuitry150to send current to coils80of one or more recharge coil containers118in response to a received user input.

Although processing circuitry150, telemetry circuitry156, power management circuitry162, and modulating circuitry164are described as separate circuits, in some examples, processing circuitry150, telemetry circuitry156, power management circuitry162, and/or modulating circuitry164may be functionally integrated. In some examples, processing circuitry150, telemetry circuitry156, power management circuitry162, and/or modulating circuitry164may correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.

FIGS. 6A-6Cdepict conceptual diagrams of recharge coil container118B and attachment assembly in an exploded perspective view, an exploded cross-sectional view, and an assembled cross-sectional view, respectively. Cross sectional views ofFIGS. 6B and 6Care taken along cut plane171ofFIG. 6A. Attachment assembly170includes bracket172configured to interconnect with recharge coil container118B. For example, bracket172may define cylindrical protrusion174that is configured to be received by bore176of recharge coil container118when bore cylindrical protrusion178is moved toward bore176along common axis178. Cylindrical protrusion174and bore176may define a snap fit or interference fit, where outer diameter178of cylindrical protrusion174is substantially similar or slightly larger than inner diameter178of bore176.

Further, bracket172may define channel180that is configured to receive ridge182of recharge coil container118B. Channel180may be disposed around a portion of, or completely around, cylindrical protrusion178, while ridge182is disposed partially or completely around bore176. In other examples, channel180may extend around cylindrical protrusion178(and therein ridge182may extend around bore176) in a shape other than a circle (e.g., a square, rectangle, or at multiple locations in a pattern). Channel180and ridge182may define a snap fit or interference fit such that outer dimensions of ridge182are at equal or bigger than respective inner dimensions of channel180.

Bracket172may define lip184that is configured to extend around outer edge186of coil container118B. As a result of interference fits between ridge182and channel180as well as between cylindrical protrusion174and bore176, lip184press against outer edge186to secure bracket172to coil container118B. One or more of these interference fits may be configured to secure bracket172to coil container118B in such a way that bracket172and coil container118B are unlikely to uncouple absent a user purposefully prying apart bracket172and coil container118B.

Attachment assembly170may include pin188. Pin188may be configured to be received by cylindrical recess190. Pin188may be received with a press/interference fit or the like (though interference fit is discussed below for purposes of clarity). In some examples, pin188may be configured such that pin188, by itself, does not define a press fit with cylindrical recess190, but rather pin188is received by cylindrical recess190as a result of a material of flexible body110occupying some space between pin188and cylindrical recess190. In other examples, a hole may be created in flexible body110as described below through which pin188extends unencumbered to be securely received by cylindrical recess190with an interference fit. Cylindrical recess190may be centered on assembly axis178. Cylindrical recess190may extend into cylindrical protrusion174that extends from opposite side of bracket172. In other examples, cylindrical recess190may include or be replaced with a bore that extends through bracket172. Plate192at end of pin188may be nearly flush with surface194of bracket172when pin188is received by cylindrical recess190. Pin188may be configured to extend from outer major surface (e.g., first major surface126ofFIG. 4A) of flexible body100to inner major surface (e.g., second major surface128ofFIG. 4A), such that plate192presses against the outer major surface and surface194of bracket172presses against inner major surface.

In some examples, attachment assembly170may include piercing component196configured to receive pin188. Piercing component196may include a sharp tip that is sharp enough to pierce flexible body110. Piercing component196may be configured to be received by pin188such that piercing component196may create a hole through which pin188may then extend to secure bracket172and therein coil container118B to flexible body110. For example, Coil container118B may be navigated to a specific predetermined location on inner major surface (e.g., second major surface128ofFIG. 4A), in response to which a user may use piercing component196as secured to pin188to create a hole in flexible body110by pushing piercing component196through bore176. Once the hole is created in flexible body110, piercing component196may be discarded because piercing component is not part of the completed attachment assembly170. Then, bracket172may be secured to coil container118B and pin may be pushed through the hole (which is in correct spot as a result of piercing component196making hole when coil container118B is held at the predetermined location) and secured to bracket172.

The bore176of coils118may also facilitate determining the location on the flexible body to place pin188and attach bracket172to the pin188. For example, while the patient is wearing the wearable medical device and flexible body is disposed over the scalp, a user may position coil118over the external surface of flexible body. With feedback provided by recharging device103, for example, regarding the correct alignment of coil118to the secondary coil of the IMD14under coil118, the user may insert a marker, pen, pin, or other marking device through the to place a mark or create a small hole in the flexible body

FIG. 7Adepicts a conceptual diagram of mapping201on second major surface128of flexible body110. Mapping201may include visual indications on second major surface128that correlate to a plurality of predetermined locations at which recharge coil contains118may be secured. For example, as depicted inFIG. 7A, mapping201may include circular indicators200A-200D (collectively, “indicators200”). In some examples, each of the plurality of circular indicators200may include a unique identifier such as a number, letter, or the like to identify each of the indicators200. Further, as depicted inFIG. 7A, in some examples indicators200may look visually different in different quadrants of second major surface128as divided by seams138of flexible body110. For example, indicators200of different quadrants may be colored differently, or may define relatively different shapes, or may be may be “drawn” on second major surface128with relatively different lines as depicted inFIG. 7A. Altering an appearance of indicators200across second major surface may improve an ability of a user to identify to utilize the selected indicator200and therein the selected predetermined location. The location identified by the circular indicators200of the map may be used by the patient to identify the correct location to re-attach a bracket or other fixation member used to attach recharge coils to wearable medical device101.

Wearable medical device101may include securing member102A, which may be substantially similar to securing member102with the exception of any differences described herein. In some examples, wearable medical device101may include adjustment mechanism that may functionally adjust a circumferential length of securing member102A, therein adjusting a fit of wearable medical device101on head12of a respective patient. The adjustment mechanism may be located at a posterior section124of wearable medical device101. For example, as depicted inFIG. 7A, portion202of securing member102A may extend out from flexible body110. Further, flexible body110may extend out distance204from portion202of securing member102A, therein enabling securing member102A to increase or reduce a circumferential length of securing member102A.

Adjustment mechanism may include hook and loop strap206that is circumferentially aligned with portion202of securing member102. Portion202of securing member102may also have a mating hook and loop strip, such that depending upon a length of hook and loop strap206that is mated with respective hook and loop strip of portion202, a circumferential length of securing member102may be changed.

FIGS. 7B and 7Cdepict conceptual diagrams of posterior124of wearable medical device101with different example adjustment mechanisms. For example,FIG. 7Bdepicts mating strap208that defines a plurality of holes210. Holes210may correspond to differing circumferential lengths of securing member102B, which may be substantially similar to securing member102A with the exception of any differences described herein. Portion218of securing member102B may define one or more prongs or pins (not depicted) that are configured to extend out from securing member102to be securely received by holes210. By adjusting or modifying holes210through which pins of portion218of securing member102B are extending, wearable medical device101may functionally alter an internal circumferential length of securing member102B.

For another example,FIG. 7Cdepicts click wheel212that is configured to increase or decrease a circumferential length of securing member102C, which may be substantially similar to securing members102A,102B with the exception of any differences described herein. For example, when rotatable or movable portion214of click wheel212is turned in a first direction, click wheel212may collect and internally secure a length of portion220of securing member102C, therein reducing a length securing member102C (e.g., by storing an associated amount of portion220of securing member102C within click wheel212). Similarly, when rotatable or movable portion214of click wheel212is turned in a second and opposite direction, click wheel212may release and “output” a length of portion220of securing member102C, therein increasing the overall circumferential length of securing member102C by the released amount.

In some examples, wearable medical device101may include one or more clips216configured to securing cables120at one or more locations adjacent second major surface128. Clips216may be movable, such that cables120may be secured at different relative locations along wearable medical device101. Clips216may be configured to secure cables120to securing member102and/or flexible body110. Utilizing clips216to secure cables120to different areas of charging device100may increase a comfort of wearable medical device101as well as avoiding cables120“kinking” as cables120are routed between power source compartment116and charging coil containers118.

FIGS. 8A and 8Bdepict conceptual diagrams of charging system100as charging coil containers118are secured to second major surface128of flexible body110. ThoughFIGS. 8A and 8Bdepict hook and loop strap206adjustment mechanism for purposes of illustration, it is to be understood that in other examples other adjustment mechanisms may be used consistent with this disclosure. Further, indicators200are depicted without visual differences of color or line inFIGS. 8A and 8Bfor purposes of clarity, though it is to be understood that in other examples indicators200may include many different colors or line types across different indicators.

FIG. 8Adepicts power source compartment116secured to portion202of securing member102and hook and loop strap206and one recharge coil container118B secured to second major surface128of flexible body110. Put differently, bracket172may be secured to second major surface128of flexible body110as a result of pin188extending through second major surface128(not depicted) while recharge coil container118B is secured to bracket172. As depicted inFIG. 8A, cables120of recharging device103may be unsecured as cables120extend from power source compartment116to recharge coil container118B. Piercing member196may have already created hole230through which another pin188may extend to secure to another bracket172to which recharge coil container118A is secured.

In some examples, one or both coil containers118may contain marker229A that indicates a location on flexible body110at which the respective container118is to be located. For example, coil container118A includes marker229A that matches marker229B on flexible body110. While only one indicator200is depicted with marker229B inFIG. 8Afor purposes of clarity, in some examples each indicator may have a respective marker229B. Marker229B on flexible body110may be unique to indicator200, such that each indicator200may have a relative unique marker229B so that a user may remember which indicator200coil container118A is to be secured to. Though marker229A on coil container118A is depicted as substantially identical to marker229B on flexible body110for purposes of illustration, in other examples one marker229A may be different than other marker229B. Though markers229A,229B are depicted as geometric shapes (stars) inFIG. 8Afor purposes of illustration, markers229A may be any alphanumeric symbol or visual identifier consistent with the disclosure herein.

FIG. 8Bdepicts recharge coil container118A as secured to second major surface128of flexible body110. Recharge coil container118A may be secured to flexible body110through pin188extending through hole230(not depicted) to be received by bracket172secured to recharge coil container118A. As depicted inFIG. 8B, cables120may be secured to recharging device103through the use of one or more clips216. In some examples, each cable120may be secured by at least one clip216.

FIGS. 9A and 9Bdepict conceptual diagrams of power source compartment116A,116B with different securing mechanisms. For example, power source compartment116A may include button230that releases block232that pushes into clip234. When button230is depressed, block232may move back toward central housing236of power source compartment116A. In this way, an operator may secure power source compartment116A to securing member102, for example, but pressing button230and maneuvering securing member102between clip234and power source central housing236.

Alternatively, power source compartment116B may include a clip. For example, power source compartment116B includes cavity242into which pivot member240may pivot. Pivot member240may pivot such that a gap appears between pivot member240and central house236of power source compartment116B near bottom244of power source compartment116B. A person may press into top portion246of pivot member240to make gap appear near bottom244of power source compartment116B. Once pressed, a person may maneuver securing member102into gap between pivot member240and central housing236of power source compartment116B.

While wearable medical device101ofFIGS. 4A-9Bis depicted as primarily a billed cap, wearable medical device101may be constructed into different shapes while still securing recharging devices (e.g., recharging device103) to the head of a patient. For example,FIGS. 10A-31Cdepicts various conceptual diagrams of example wearable medical device, and recharging devices in some examples, that include example securing members, example bodies, example power sources, example recharge coils, and example leads connecting the power sources and leads. Recharge coils of the following recharging devices may be shaped according to recharge coils80,82,84,86ofFIGS. 3A-3D. These recharge coils may be encased in a relatively rigid or flexible housing, wherein some suitable rigid materials for the housing include, without limitation, Acrylonitrile butadiene styrene (ABS), Polyvinyl chloride (PVC), polycarbonate, high-density polyethylene (HDPE), Polyether ether ketone (PEEK), Polyethylene terephthalate (PET), and polypropylene, and some suitable flexible materials for the housing include, without limitation, silicone rubber, and thermoplastic elastomer.

FIGS. 10A-10Cdepict conceptual diagram illustrating perspective views of wearable medical device300in the form of a cap for mounting to head12of patient, on an exterior side of scalp16of the patient. Wearable medical device300may include securing member302that is substantially similar to securing member102with exception to any differences described herein. Securing member302may extend around head12in a generally horizontal plane (that is, across forehead106of patient, alongside both ears, and across the posterior portion of scalp16adjacent the neck of the patient—as illustrated inFIGS. 10A-10C). In some examples, securing member302may include a small band that extends around the perimeter of wearable medical device300. In other examples, securing member302may also include a relatively flexible material that is configured to fit over head12of patient and conform to at least a portion of each of the left anterior, right anterior, left posterior, and right posterior quadrants LAQ, RAQ, RPQ, LPQ (e.g., ofFIG. 1) of scalp16of the patient. In other examples, wearable medical device300includes flexible body310configured to conform to scalp16by extending between securing member302.FIG. 10A-10Cfurther illustrates wearable medical device300including a plurality of holding features304attached to flexible body310, wherein each holding feature304is configured to hold one of recharging coil container318. Recharging coil container318may be substantially similar to recharging coil container118. The plurality of holding features304may include at least one feature304located in each quadrant of scalp16of the patient when wearable medical device300is mounted to head12of patient, for example, holding feature304A located in the left anterior quadrant, holding feature304B located in the right anterior quadrant, holding feature304C located in the right posterior quadrant, and holding feature304D located in the left posterior quadrant.

Thus, the patient can choose the appropriate holding feature304into which a respective recharging coil container318may be inserted to correspond with the location of the implant site of the patient's medical electrical system when wearable medical device300is mounted to head12. With further reference toFIGS. 10A-10C, another holding feature306is shown included in wearable medical device300. Holding feature306may be configured to hold power source compartment316. Holding features304,306may be pockets formed between an inner layer313A and an outer layer313B of flexible body310. Holding features304,306may be configured to be accessible from inner layer313B. Alternatively, holding features304,306may be configured to be accessible from outer layer313A. In some examples, the holding features of any of the examples herein may alternatively or further comprise loop-and-hook features such as VELCRO™ brand hook-and-loop features, snaps, hooks, elastic or other stretchable bands, buttons, zippers, or any other type of holding features. Wearable medical device300may be formed from a polyester/Spandex blend, and/or Lycra, and/or cotton, so that securing member302and flexible body310are configured conform to the exterior side of scalp16of the patient to maintain a stable position of recharge coil container318.

FIGS. 11A-11Cincludes various views of wearable medical device400. Wearable medical devices400may include recharging units482into which recharge coil containers418(which are substantially similar to recharge coil containers118,318except for differences described herein) and power source compartment416(which are substantially similar to power source compartments116,316except for differences described herein) are integrated. For example, a first side of recharging unit482which is oriented toward scalp16may contain recharge coil container418and therein one of coils80,82,84,86, while the other side of recharging unit482may contain power source compartment416. These recharging units482may include a relatively rigid or flexible housing, wherein some suitable rigid materials for the housing include, without limitation, ABS, PVC, polycarbonate, HDPE, PEEK, PET, and polypropylene, and some suitable flexible materials for the housing include, without limitation, silicone rubber, and thermoplastic elastomer.

FIGS. 11A-11Cillustrates securing member402. Securing member402may be substantially similar to securing member102,302with the exception of any differences described herein. Securing member402may be formed in part by a head band for mounting to a head12of the patient, on an exterior side of scalp16of the patient, so that securing member402band may extend around head12in a generally horizontal plane, and along each of the left anterior, right anterior, left posterior, and right posterior quadrants LAQ, RAQ, RPQ, LPQ (FIG. 1) of scalp16of the patient.FIGS. 11A-11Cfurther illustrates recharging device400including flexible body410. Flexible body410may be substantially similar to flexible bodies110,310with the exception of any differences described herein. Flexible body410may be formed by a woven latticework of flexible strips attached to securing member402, wherein the latticework defines a plurality of pockets or holding features428. According to some examples, securing member410and flexible body410of wearable medical device400are made from an elasticized material, such as a polyester/Spandex blend, and/or Lycra, and/or cotton. Each holding feature428may be configured to hold one of charging units482therein, and the plurality includes at least one located in each quadrant of scalp16of the patient when securing member402is mounted to head12of the patient.

For example, holding feature428A is located in the left anterior quadrant, holding feature428B located in the right anterior quadrant, holding feature428C located in the right posterior quadrant, and holding feature428D located in the left posterior quadrant. Thus, the patient can choose the appropriate holding feature428, in which to insert each charging unit482so that the held location of each charge unit482corresponds to the location of each IMD14implant site. An orientation indicator404is shown mounted to securing member402so that once the patient has selected the appropriate holding feature(s)428, recharging device400can be donned in the proper orientation corresponding to the selected holding features428for each successive charging session.

FIGS. 12A-12Ddepict conceptual diagrams illustrating various views of wearable medical device500, which may be substantially similar to wearable medical device100,300, or400with the exception of any differences described herein. Wearable medical devices500may include recharging units582into which recharge coil containers518(which are substantially similar to recharge coil containers118,318, and418except for differences described herein) and power source compartment516(which are substantially similar to power source compartments116,316, and416except for differences described herein) are integrated. For example, a first side of recharging unit582which is oriented toward scalp16may contain recharge coil container518and therein one of coils80,82,84,86, while the other side of recharging unit582may contain power source compartment516.

FIGS. 12A-12Dillustrates wearable medical device500including securing member502in the form of a cap for mounting to head12of the patient. Securing member502may be configured to extend around and conform to head12on an exterior side of scalp16of the patient along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Securing member502may be an outer layer of wearable medical device500, while flexible body510is functionally an inner liner of wearable medical device500. Flexible body510may be made up of a latticework of flexible strips that forms a plurality of holding features to engage hooked ends502of each charge module582at any selected location along the latticework. In this way, charge module(s)582may be held in a pocket between securing member502and flexible body510. Like wearable medical device400, wearable medical device500includes orientation indicator504so that wearable medical device500can be donned in the proper orientation corresponding to the selected location of each charge module582for each successive charging session. According to some examples, flexible body510may be made from ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene, and securing member502may be made from a polyester/Spandex blend.

FIGS. 13A-13Cdepict conceptual diagrams illustrating various views of wearable medical device600, which may be substantially similar to wearable medical device100,300,400, and500with the exception of any differences described herein. Wearable medical devices600may include recharging units682into which recharge coil containers618(which are substantially similar to recharge coil containers118,318,418, and518except for differences described herein) and power source compartment616(which are substantially similar to power source compartments116,316,416, and516except for differences described herein) are integrated. For example, a first side of recharging unit682which is oriented toward scalp16may contain recharge coil container618and therein one of coils80,82,84,86, while the other side of recharging unit682may contain power source compartment616.

FIGS. 13A-13Cillustrates wearable medical device600including securing member602(which may be substantially similar to securing member102,302,402, and502except for differences described herein). Securing member602may be formed in part by a head band configured to mounting to head12of the patient on an exterior side of scalp16. As such, securing member602may be configured to extend around the head in a generally horizontal plane as mounted to head12along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient.

FIGS. 13A-13Cfurther illustrates flexible body610of wearable medical device600. Flexible body610may be a cap that is attached to securing member602and is configured to extend between securing member602. Flexible body610may include an inner layer610A and an outer layer610B between which a pocket or group of pockets are formed 360 degrees around the cap perimeter, to provide a plurality of holding features for charge unit682. Thus, the patient can choose the appropriate location(s) around the perimeter of wearable medical device600between inner layer610A and outer layer610B of flexible body610in which to insert each charge module682so that the held location of each charge module682corresponds to the location of each IMD14implant site. Outer layer610B of flexible body610may further extend radially within securing member602, between which another set of one or more pockets are formed that extend 360 degrees around the perimeter of securing member602to provide another plurality of holding features for charge module682.

FIGS. 13A-13Cillustrates a plurality of charge units682held by recharging device600when securing member602is mounted to head12of the patient. For example,FIGS. 13A-13Cdepicts charge units682as secured to head12of patient in the left anterior quadrant as secured by holding feature628A, in the right anterior quadrant as secured by a holding feature628B, in the right posterior quadrant as secured by a holding feature628C, and in the left posterior quadrant as secured by holding feature628D. Recharging device600may include orientation indicator604, which may be substantially similar to orientation indicator404and504. According to some examples, securing member602and flexible body610of wearable medical device600are made from an elasticized material, such as a polyester/Spandex blend.

FIGS. 14A-14Edepict conceptual diagrams illustrating various views of wearable medical device700, which may be substantially similar to recharging device100,300,400,500, and600with the exception of any differences described herein. Wearable medical devices700may include recharging units782into which recharge coil containers718(which are substantially similar to recharge coil containers118,318,418,518, and618except for differences described herein) and power source compartment716(which are substantially similar to power source compartments116,316,416,516, and616except for differences described herein) are integrated. For example, a first side of recharging unit782which is configured to be oriented toward scalp16may contain recharge coil container718and therein one of coils80,82,84,86, while the other side of recharging unit782may contain power source compartment716.

FIGS. 14A-14Ddepict wearable medical device700as including a securing member702in the form of a cap for mounting to head12of the patient on an exterior side of scalp16of the patient. Securing member702may extend around the head in a generally horizontal plane (that is, across the patient's forehead, alongside both ears, and across the posterior portion of the scalp adjacent the patient's neck, as depicted inFIGS. 14A-14E). Wearable medical device700may substantially not include a flexible body as used herein, but rather securing member702may itself extend across at least a portion of each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient.FIGS. 14A-14Efurther illustrates securing member702as defining a plurality of holding features728, wherein each holding feature728is a recess formed in an outer surface of securing member702. In some embodiments, the recesses defining holding features728may extend all the way through to an inner surface of securing member702to form through-holes. According to the illustrated embodiment, each holding feature728has a hexagonal shape corresponding to that of charge module782. Holding features728may be configured to secure charge module782using a press fit or a snap fit or the like. The plurality of holding features728includes at least one feature728located in each quadrant of scalp16of the patient when securing member728is mounted to head12of the patient.

For example, as mounted to head, wearable medical device700may define holding feature728A located in the left anterior quadrant, holding feature728B located in the right anterior quadrant, and holding feature728C located in the left posterior quadrant. Thus, the patient can choose the appropriate holding feature728in which to insert charge module782, to correspond with the location of IMD14implant site. As a result of this functionality, recharging device700may increase an amount of which recharge coils80,82,84,86are securely aligned with secondary coils of IMD14when recharging device700is secured to head12. According to some examples, wearable medical device700may be fabricated from a sturdy and relatively lightweight foam, for example, a reinforced expanded polystyrene.

FIGS. 15A-15Ddepict conceptual diagrams illustrating various views of wearable medical device800, which may be substantially similar to recharging device100,300,400,500,600, and700with the exception of any differences described herein. Wearable medical device800may include securing member802. Securing member802may include a flexible cap that is configured to be mounted to head12of the patient on an exterior side of scalp16of the patient. Wearable medical device800may substantially not include a flexible body as used herein, but rather securing member802may be configured to itself extend around head12in a generally horizontal plane (that is, across the patient's forehead, alongside both ears, and across the posterior portion of the scalp adjacent the patient's neck along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient.

Wearable medical device800may include holding features828of headgear510. Securing member802may define at least one holding feature828on either side of midline804of wearable medical device800, where midline804extends from a forehead of the patient substantially straight back to posterior of head12. Securing member802may define one holding feature828on the left side of wearable medical device800and one holding feature828on the right side. Holding features828may be pockets formed between inner and outer layers of securing member802. Holding features may be configured to securely receive coils80,82,84,86within coil containers and coupled to power source compartments, and all components secured within.

FIGS. 15A-15Dillustrates securing member802being divided into left portion802L and a right portion802R. Left portion802L may be configured to conform to left anterior and posterior quadrants of scalp16, while right portion802R is configured to conform to right anterior and posterior quadrants of scalp16of the patient. In some examples, both left portion802L and right portion802R have a superior perimeter edge free to move away from and toward midline804plane of head12of the patient when securing member cap513is mounted to the head, for example, per arrow806. Thus, the patient may adjust the position of one or both of the securely received recharging coils. Wearable medical device800is preferably formed from an elasticized material, such as Neoprene, so that securing member cap802will conform to the exterior side of scalp16of the patient to maintain a stable position of the held recharging coils. Furthermore, the held recharging coils may be cushioned by a flexible foam layer that extends alongside within holding features828.

FIGS. 16A-16Bdepict conceptual diagrams illustrating various views of wearable medical device900, which may be substantially similar to wearable medical device100,300,400,500,600,700, and800with the exception of any differences described herein. Wearable medical device900includes securing member902, which, when mounted to head12of the patient, extends around the head in a generally horizontal plane and along each of the left anterior, right anterior, left posterior, and right posterior quadrants LAQ, RAQ, RPQ, LPQ (FIG. 1) of scalp16of the patient. Wearable medical device900includes at least two holding features928. For example, recharging device900may include right posterior pad928B and a left posterior pad928A. Both left posterior pad928A and right posterior pad928B may be attached to securing member902. In some examples, pads928A,928B may be flexible and cushioned. Further pads928A,928B may define pockets formed between inner and outer layers thereof. These pockets may be configured to hold recharging coils therein, for example, any of the above described coils80,82,84,86(FIGS. 3B-D). According to some examples, pads928A,928B may be formed from one or more of the following materials: ABS, PVC, polycarbonate, HDPE, PEEK, PET, polypropylene, silicone rubber, and thermoplastic elastomer. A power source compartment and other components stored within (e.g., as depicted inFIG. 5) may be integrated with one or both of the recharging coils. These charging assemblies may be securely received within the corresponding pad928A,928B. Alternately, some portions of the power source compartment (e.g., as depicted inFIG. 5) unit may be received within or mounted on securing member502. In some examples, anterior portion904of securing member902is formed from an elasticized material, such as a polyester/Spandex blend, and/or Lycra, and/or cotton, and posterior portion906of securing member902is formed from a relative rigid, but conformable, material, such as one or more of ABS, PVC, polycarbonate, HDPE, PEEK, PET, polypropylene, silicone rubber, and thermoplastic elastomer.

FIGS. 17A-17Hdepict conceptual diagrams illustrating various views of wearable medical device1000, which may be substantially similar to wearable medical device100,300,400,500,600,700,800, and900with the exception of any differences described herein. Wearable medical device1000may include recharging units1082into which recharge coil containers1018(which may be substantially similar to recharge coil containers118,318,418,518,618, and718except for differences described herein) and power source compartment1016(which may be substantially similar to power source compartments116,316,416,516,616, and716except for differences described herein) are integrated. For example, a first side of recharging unit1082which is configured to be oriented toward scalp16may contain recharge coil container1018and therein one of coils80,82,84,86, while the other side of recharging unit1082may contain power source compartment1016and any components stored within power source compartment1016(e.g., components ofFIG. 5).

FIGS. 17A-17Hdepict wearable medical device1000with alternative securing members1002A or1002B that each, when mounted to head12of the patient, extends around head12in a generally horizontal plane and along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Securing member1002A is shown being configured to extend around an entire perimeter of head12of the patient, while securing member1002B is shown being configured to extend around just a portion of the perimeter of head12of the patient.FIGS. 17A-17Hfurther illustrates multiple holding features1004of wearable medical device1000formed by flexible rails, which have opposing, left and right ends attached to respective securing members1002A,1002B. Holding features1004may extend in an arc superior to respective securing members1002A,1002B to span left and right quadrants of scalp16when the respective securing member1002A,1002B is mounted to head12.

In some examples, charge modules1082may include a bracket, such as bracket1012ofFIG. 17H. Brackets may be configured to enable holding features1004to securely receive charge units1082. In some examples, brackets may receive charge units1082in sliding engagement therewith, so that the patient may slide, per arrow1008ofFIG. 17C, respective charge units1082A into a selected position to correspond with IMD14implant location. In some examples, as depicted, a cross-sectional shape of holding feature rails1004may be substantially being round or flat. In other examples, holding features1004may define other cross-sectional shapes that are configured to engage with the brackets of charge modules1082. In some examples, the ends of each holding feature1004are attached with pivot joints to a respective securing member1002A,1002B so the patient can make further anterior/posterior adjustments, per arrow1006ofFIG. 17B. In some examples, securing members1002A,1002B and holding feature rails1004are formed from a relatively resilient plastic, such as ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene.

FIGS. 18A-18Ddepict conceptual diagrams illustrating various views of wearable medical device1100, which may be substantially similar to recharging device100,300,400,500,600,700,800,900, and1000with the exception of any differences described herein. Wearable medical device1100may include recharging units1182into which recharge coil containers1118(which may be substantially similar to recharge coil containers118,318,418,518,618,718, and1018except for differences described herein) and power source compartment1116(which may be substantially similar to power source compartments116,316,416,516,616,716, and1016except for differences described herein) are integrated. For example, a first side of recharging unit1182which is configured to be oriented toward scalp16may contain recharge coil container1118and therein one of coils80,82,84,86, while the other side of recharging unit1182may contain power source compartment1116and any components stored within power source compartment1116(e.g., components ofFIG. 5).

Wearable medical device1100includes securing member1102which is configured to extend around an entire perimeter of head12of the patient in a generally horizontal plane. Securing member1102is further configured to cross at least some of each the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient as mounted to patient. Wearable medical device1100further includes flexible body rails1110A,1110B. Flexible body rails1110A,1110B may include two flexible rail that are configured to extends in an arc superior to securing member1102to span left and right quadrants of scalp16of the patient when wearable medical device1100is mounted to head12. Charge units1182may be configured to mount to one or both of flexible body rails1110A,1110B.

In some examples, securing member1102may include one or more engagement zones1104A,1104B. Engagement zone1104A,1104B may be configured to extend along one side of head12. For example, engagement zone1104A extends along the left posterior and anterior quadrants of scalp16of the patient, while engagement zone1104B extends along the right posterior and anterior quadrants of scalp16of the patient. Engagement zones may be formed by a hook and loop strip and may be configured to receive a corresponding mating hook and loop strip of flexible body rail1110A. In this way, the patient may adjust the orientation of the span of flexible body rail1110A, per arrow1106. Further, a patient may slide respective charge units1182along a length of a respective flexible body rail1110A,1110B before securing charge units1182to the respective flexible body rail1110A,1110B at a location that corresponds to IMD14implant location.

In some examples flexible body rail1110B may be fixedly secured to securing member1102. For example, flexible body rail1110B may include a first end attached to securing member1102at an anterior location and a second end attached to securing member1102at a posterior location. In this way, flexible body rail1110B may be configured to generally aligned with the midline plane (FIG. 1) of head12of the patient when securing member1102is mounted to head12of the patient. In some examples both flexible body rails1110A,1110B may be connected at a pivot joint1108. Pivot joint1108may be configured to enable flexible body rail1110A to rotate according to arrow1106relative to flexible body rail1110B. In some examples, securing member1102and flexible body rails1110A,1110B may be formed from one or more of: ABS, PVC, polycarbonate, HDPE, PEEK, PET, and polypropylene.

FIGS. 19A-19Ddepict conceptual diagrams illustrating various views of wearable medical device1200, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000, and1100with the exception of any differences described herein. Wearable medical device1200may include recharging units1282into which recharge coil containers1218(which may be substantially similar to recharge coil containers118,318,418,518,618,718,1018, and1118except for differences described herein) and power source compartment1216(which may be substantially similar to power source compartments116,316,416,516,616,716,1016, and1116except for differences described herein) are integrated. For example, a first side of recharging unit1282which is configured to be oriented toward scalp16may contain recharge coil container1218and therein one of coils80,82,84,86, while the other side of recharging unit1282may contain power source compartment1216and any components stored within power source compartment1216(e.g., components ofFIG. 5).

Wearable medical device1200includes securing member1202formed by a flexible headband, which, when mounted to head12of the patient, extends around an entire perimeter of head12of the patient in a generally horizontal plane along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Securing member1202may define holding features1228that are configured to securely receive charge units1282. Holding features1228may define an aperture configured to securely receive charge unit1282. to hold charge module482in an aperture thereof. Holding feature1228may be configured to slideably engage with securing member1202for movement relative thereto in the generally horizontal plane, per arrow1204. Holding feature1228may be formed from a relatively hard plastic, for example, ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene. Securing member headband1202from an elasticized material, such as a polyester/Spandex blend, and/or Lycra, and/or cotton.

FIGS. 20A-20Hdepict conceptual diagrams illustrating various views of wearable medical device1300, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100, and1200with the exception of any differences described herein. Wearable medical device1300includes securing member1302formed by a flexible headband, which, when mounted to head12of the patient, extends around an entire perimeter of head12of the patient in a generally horizontal plane along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Wearable medical device1300includes flexible body1310that includes one or more resilient bands. Recharging coils80,82,84,86, and/or recharging units may be mounted to bands of flexible body1310. The bulk of band of flexible body1310may be pre-formed in an arc to span left and right quadrants of scalp16of the patient, or anterior and posterior quadrants of scalp16of the patient. Flexible body1310may be formed from ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene.

Bands of flexible body1310may be movable relative to securing member1302. For example, each of first and second ends1302-1,1302-2of each band of flexible body1310may be releasably secured to securing member1302via one or more engagement features1304of securing member1302. For example, engagement features1304may include a recess defined on an internal surface of securing member1302that may receive protrusions of first and second ends1302-1,1302-2, for example, via a snap fit. Securing member1302may include a plurality of engagement features1304generally evenly dispersed all along securing member1302(and therein dispersed across all quadrants of scalp16when charging device1300is mounted on head12).

In some examples, flexible body1310may include two or more bands that are configured to extend between securing member1302. For example, as depicted inFIG. 20A, wearable medical device1300includes first rail of flexible body1310A and second rail of flexible body1310B. In such examples, one rail of flexible body1310A may be configured to be moved relative to securing member1302, while the other rail of flexible body1310B may be configured to be relative stationary relative to securing member1302. For example, stationary band of flexible body1310B may extends in an arc from a first end attached to securing member1302at an anterior location to a second end attached to securing member1302at a posterior location. In this way, an arc of relatively stationary band of flexible body1310B may be generally aligned with the midline plane of head12(FIG. 1) when securing member1302is mounted to head12of the patient. Similarly, in some examples, as depicted inFIG. 20D, wearable medical device1300may include one relatively stationary band of flexible body1310B along with two moveable bands of flexible body1310A,1310C.

FIGS. 21A-21Fdepict conceptual diagrams illustrating various views of wearable medical device1400, which may be substantially similar to recharging device100,300,400,500,600,700,800,900,1000,1100,1200and1300with the exception of any differences described herein. Wearable medical device1400includes securing member1402formed by a flexible headband, which, when mounted to head12of the patient, extends around an entire perimeter of head12of the patient in a generally horizontal plane along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Wearable medical device1400includes flexible body1410that includes one or more resilient bands. Recharging coils80,82,84,86, and/or recharging units may be mounted to bands of flexible body1410. The bulk of band of flexible body1410may be pre-formed in an arc to span left and right quadrants of scalp16of the patient, or anterior and posterior quadrants of scalp16of the patient. Flexible body1410may be formed from ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene.

Bands of flexible body1410may be movable relative to securing member1402. For example, each of first and second ends1402-1,1402-2of each band of flexible body1410may be releasably secured to securing member1402via one or more engagement features1404of securing member1402. For example, engagement features1404may include a recess defined on an internal surface of securing member1402that may receive protrusions1406of first and second ends1402-1,1402-2, for example, via a snap fit. Securing member1402may include a plurality of engagement features1404generally evenly dispersed all along securing member1402(and therein dispersed across all quadrants of scalp16when wearable medical device1400is mounted on head12).

Flexible body1410may include two or more bands that are configured to extend between securing member1402. Rail of flexible body1410A may be configured to be secured to securing member1402at a plurality of locations such that rail of flexible body1410A may functionally be moved relative to securing member1402. Similarly, the other rail of flexible body1410B may be configured to be secured to securing member1402at only one or relatively fewer locations along securing member1302. Bands of flexible body1410may be secured together by a pivot joint1408, so that bands of flexible body1410can be rotated relative to one another, per arrows1412. For example, stationary band of flexible body1410B may be configured to only be secured to securing member1402such that stationary band of flexible body1410B extends in an arc from a first end attached to securing member1402at an anterior location to a second end attached to securing member1402at a posterior location (e.g., to be generally aligned with the midline plane of head as depicted inFIG. 21C). In other examples, all or many rails of flexible body1410are configured to be secured to securing member1402at a plurality of locations, similar to band of flexible body1410A. Securing member1402may be formed from an elasticized material, such as a polyester/Spandex blend, and/or Lycra, and/or cotton.

FIGS. 22A-22Cdepict conceptual diagrams illustrating various views of wearable medical device1500, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300, and1400with the exception of any differences described herein. Wearable medical device1500includes securing member1502formed by a flexible headband, which, when mounted to head12of the patient, extends around an entire perimeter of head12of the patient in a generally horizontal plane along each of the left anterior, right anterior, left posterior, and right posterior quadrants (FIG. 1) of scalp16of the patient. Wearable medical device1500includes two panels of flexible body1510A,1510B. Recharging coils80,82,84,86, and/or recharging units may be mounted to panels of flexible body1510. Flexible body1510may be formed from ABS, PVC, polycarbonate, HDPE, PEEK, PET, or polypropylene.

Panels of flexible body1510A,1510B may be movable relative to securing member1502. For example, each panel of flexible body1510may be configured to move per arrow1504to approach or move away from midline1506. Panels of flexible body1410may be relatively stiff, such that once moved to a position relative to midline1506the panels of flexible body may stay in their relative position as mounted on head14. Securing member1402may be formed from an elasticized material, such as a polyester/Spandex blend, and/or Lycra, and/or cotton.

FIGS. 23A-23Ddepict conceptual diagrams illustrating various views of wearable medical device1600, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400, and1500with the exception of any differences described herein. Wearable medical device1600includes a securing member1602for mounting to head12of the patient on an exterior side of scalp16. Securing member1602includes resilient band1602A and ear hook1602B attached to a first end of band1602A.

Wearable medical device1600further includes conformable member1604. Conformable member1604may include one or more charging coil80,82,84,86, as well as one or more components of power source compartment (e.g., components ofFIG. 5). Conformable member1604may be attached to second end of securing member band1602A. In some examples, conformable member1604may be configured to at least one of the quadrants of scalp16of the patient when securing member1602is mounted to head12of the patient.

In some examples, securing member band1602A is movable relative to ear hook1602B. In this way, securing member band1602A may be moved relative to scalp16in order to move conformable member1604relative to scalp16. In some examples, securing member band1604may extend at least partially over head12of the patient in an arc along a generally vertical plane with an inward tension to generally conform and fit snug to the exterior side of scalp16when securing member1602is mounted to head12.

FIGS. 24A-24Ddepict conceptual diagrams illustrating various views of wearable medical device1700, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500, and1600with the exception of any differences described herein. Wearable medical device1700may include securing members1702A,1702B,1702C (collectively “securing members1702”). Securing members1702may be joined together at pivot junction1704. Recharging coils80,82,84,86and/or charge units may be secured to securing members1702. Securing members1702may be predominantly formed from one or more of ABS, PVC, polycarbonate, HDPE, PEEK, PET, polypropylene, silicone rubber, and thermoplastic elastomer.

In some examples, each of securing members1702may be movable and conformable to any one the quadrants of scalp16of the patient. For example, pivot joint1704may be configured to rest on a top portion of head12when wearable medical device1700is mounted to head12, after which each of securing members1702may be configured to extend down one side of head12in an arc along a generally vertical plane. In this way, securing members1702may secure wearable medical device1700to head12of the patient. Further, as a result of pivot joint1704enabling securing members1702to move relative to one another, wearable medical device1700may be adjusted to position one or more recharging coils at each of the location(s) corresponding to the IMD14implant site(s).

FIGS. 25A-25Hdepict conceptual diagrams illustrating various views of wearable medical device1800, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600, and1700with the exception of any differences described herein. Wearable medical device1800may include securing members1802A,1802B (collectively, “securing members1802”). Each of securing members1802may have two ends, and each end may be secured to another end of another securing member1802pivot junction1804. Recharging coils80,82,84,86and/or components of charge units (e.g., as depicted inFIG. 5) may be secured to or housed within securing members1802. In some examples, each securing member1802that includes a recharging coil may also include some or all components of a control unit integrated into the respective securing member1802. In other examples, one control unit may control multiple coils integrated into or otherwise secured to multiple securing members1802. Securing members1802may be predominantly formed from one or more of ABS, PVC, polycarbonate, HDPE, PEEK, PET, and polypropylene.

In some examples, each of securing members1802may be movable and conformable to any one the quadrants of scalp16of the patient. For example, pivot joint1804may be configured to be located near ears of head12of patient, while securing members1802extend over head12of the patient in an arc along a generally horizontal plane to secure wearable medical device1800to head12of the patient. The patient may move securing members1802relative to one another, per arrow1806, to adjust locations of the recharging coils thereof to correspond with implant sites. In some examples, flexible housing1810may extend between securing members1802as securing members1802flex along arrow1806. Flexible housing1810may define an accordion structure that compresses and expands in response to the flexure of securing members1802.

FIGS. 26A-26Bdepict conceptual diagrams illustrating various views of wearable medical device1900, which may be substantially similar to recharging device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700, and1800with the exception of any differences described herein. Wearable medical device1900may include securing member1902. Securing member1902may include resilient band1904and a pair of terminating pads1906secured to each end of resilient band1904. Pads1906are configured to press against ears of head12while resilient band1904extends over head12. Wearable medical device1900may include conformable members1908that extend from pads1906. Conformable members1908may be attached to securing member1902via a hidden internal pivot joint that enables conformable members1908to pivot relative to pads1906. Conformable members1908may be secured to pads1906such that conformable members1908extending in an arc away from pads1906. For example, one of the conformable members1908may define an arc range that spans the right posterior quadrant of scalp16of the patient, and the other of the conformable members1908defines an arc range that spans the left posterior quadrant of scalp16of the patient.

Recharging coils80,82,84,86and/or components of charge units (e.g., as depicted inFIG. 5) may be secured to or housed within conformable members1908. In some examples, each of conformable member1908may include both a recharging coil and also some or all components of a charge unit in the respective conformable member1908. In other examples, one charge unit may control multiple coils integrated into or otherwise secured to multiple conformable members1908. In some examples, conformable members may predominantly be formed from one or more of ABS, PVC, polycarbonate, HDPE, PEEK, PET, polypropylene, silicone rubber, and thermoplastic elastomer.

FIGS. 27A-27Ddepict conceptual diagrams illustrating various views of wearable medical device2000, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700,1800, and1900with the exception of any differences described herein. Wearable medical device2000may include two conformable members2004attached to opposite ends of two securing members2002. Securing members2002may each include adjustable resilient bands that are configured to allow movement of conformable members2004relative thereto, per arrow2006. As depicted, securing member2002are configured to extend in an arc in a generally vertical plane are shown over head12when mounted to head12of the patient. Further, when wearable medical device2000is mounted to head12, one of conformable members2004is configured to conform to one or both right quadrants of scalp16of the patient, while the other of conformable members2004is configured to conform to one of both left quadrants of scalp16of the patient.

In some examples, each conformable member2004is relatively flexible and cushioned. For example, each of conformable members2004may be formed from a silicone rubber or a thermoplastic elastomer. Conformable members2004may define a pocket between inner and outer layers thereof. This pocket defined by each of conformable members2004may be configured to hold one or more recharging coils therein, for example, any of the above described components of control unit (e.g., as inFIG. 5).

FIGS. 28A-28Edepict conceptual diagrams illustrating various views of wearable medical device2100, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700,1800,1900, and2000with the exception of any differences described herein. Wearable medical device2100may include a plurality of recharging coils80,82,84,86mounted between inner and outer layers of a covering that is sized to cover a portion of each quadrants of scalp16. Wearable medical device2100may include securing member2102, which may itself include a stretchable cap. Securing member2102may be made of Neoprene or the like. Flexible body2110may extend out away from securing member2102to define a plurality of pockets. For example, securing member2102may substantially extend across most or all of scalp16, substantially contacting and conforming to scalp16as securing member2102does so. Flexible body2110may extend radially away from securing member2102to define pockets between itself and securing member2102.

One or more pockets as created by securing member2102and flexible body2110may be configured to hold coils80,82,84,86and or recharging components (e.g., as inFIG. 5). Each pocket as defined by securing member2102and flexible body2110may be centered over a different quadrant (LAQ, RAQ, RPQ, LPQ) of scalp16, substantially covering that quadrant. is shown located for coverage of each quadrant.

Wearable medical device2100may include including docking fob2104that is configured for attachment of electronic charging unit2182. Charging unit2182may include circuitry configured to control charging coils, such as circuitry and components ofFIG. 5. Once attached to docking fob2104, charging unit2182may be electrically coupled with each recharging coil secured within pockets defined by securing member2102and flexible body2110. control unit2185thereto for coupling with the recharging coils of headgear910.

FIGS. 29A-29Edepict conceptual diagrams illustrating various views of wearable medical device2200, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700,1800,1900,2000, and2100with the exception of any differences described herein. Wearable medical device2200may include a plurality of recharging coils80,82,84,86mounted between inner and outer layers of a covering that is sized to cover a portion of each quadrants of scalp16. Wearable medical device2200may include securing member2202, which may itself include a helmet in which recharging coils80,82,84,86are embedded and to which an electronic recharge control unit2282is mounted. Electrical recharge control unit2282may include components of a power source compartment as described herein (e.g., as depicted inFIG. 5). Securing member2202may be formed from one of more of ABS, PVC, polycarbonate, HDPE, PEEK, PET, polypropylene, silicone rubber, and thermoplastic elastomer.

Wearable medical device2200may include size adjustment member2204. Size adjustment member2204may be configured to modify an internal size of securing member2202using a mechanism such as a twist mechanism. Size adjustment member2204may be secured to wearable medical device2200at a posterior inferior edge of securing member2202. In some examples, recharge control unit2282may be configured to detect the location of one or more cranially mounted IMDs14. In response to detecting a location of IMDs14, control unit2282may identify and activate (e.g., send current to) recharging coils that are aligned with these IMDS14.

FIGS. 30A-30Ddepict conceptual diagrams illustrating various views of wearable medical device2300, which may be substantially similar to wearable medical device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700,1800,1900,2000,2100, and2200with the exception of any differences described herein. Wearable medical device2300may include securing member2302, which may be include a cap configured to reach down to a neck of the patient. Securing member2302may be configured to integrate recharging coils80,82,84,86, between an inner and outer layer of securing member2302. In some examples, securing member2302may include a plurality of charging coils embedded across securing member2302, such that charging coils would be distributed among all quadrants of scalp16when wearable medical device2300is mounted to head12of patient.

Wearable medical device2300may include collar member2304secured to securing member2302. Collar member2304may be attached to a posterior inferior edge of securing member2302. Collar member2304may contain an electronic recharge control unit that contains components configured to control recharging coils (e.g., components ofFIG. 5). Securing member2302may be formed from one or more of polyester, Spandex, cotton, and Lycra.

FIGS. 31A-31Cdepict conceptual diagrams illustrating various views of wearable medical device2400, which may be substantially similar to recharging device100,300,400,500,600,700,800,900,1000,1100,1200,1300,1400,1500,1600,1700,1800,1900,2000,2100,2200, and2300with the exception of any differences described herein. Wearable medical device2400may include securing member2402, which may be include a hood configured to drape over scalp16and reach down to a neck of the patient. Securing member2402may be configured to integrate recharging coils80,82,84,86, between an inner and outer layer of securing member2402. In some examples, securing member2402may include a plurality of charging coils embedded across securing member2402, such that charging coils would be distributed among all quadrants of scalp16when wearable medical device2400is mounted to head12of patient.

Wearable medical device2400may include tassels2404secured to securing member2402. Tassels2404may be attached near a posterior inferior edge of securing member2402. Tassels2404may be configured to tighten or loosen securing member2402. In some examples, wearable medical device2400may be integrated into a sweatshirt, where securing member2402is functionally the hood of the sweatshirt. Securing member2402may be formed from one or more of polyester, Spandex, cotton, and Lycra.

FIGS. 32A-34C32B depict conceptual diagrams illustrating perspective views of recharge assemblies2500A,2500B,2500C that include securing members2502A,2502B,2502C,2502D,2502E (collectively “securing members2502”) of conformable caps2502A,2502B,2502D,2502E and elastic head band2502C and associated charge modules2504A,2504B,2504C,2504D (collectively “charge modules2504”). Each securing member2502may be formed from any of the aforementioned suitable materials and is configured to conform to at least a portion of each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of scalp16when the respective securing member2502is mounted to head12. Further, each securing member2502includes attachment means distributed throughout for the attachment of one or more charge modules2504at or near power source compartment and relevant power source and recharging circuitry (e.g., power management circuit162and rechargeable power source158ofFIG. 5) is located within securing members2502. For example, as depicted inFIGS. 34A-34C, securing members2502E may include Velcro near a location with the power source and power management circuit for the securing members2502E, such that a respective charge module2504D may be directly attached to the respective securing member2502E. In another example as depicted inFIGS. 33A-33C, securing member2502D may include a magnetic element configured to magnetically hold one of charging modules2504C to a location adjacent the power source and power management circuit housing of securing member2502D. Charging modules2504may work substantially similar to recharging device103described herein, such that charging modules2504may be used to recharge power sources of IMDs14as depicted inFIG. 33.

In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims. Furthermore, various combinations of elements described above in conjunction with the specific embodiments, are within the scope of the present invention, for example, according to the appended claims

This disclosure is primary directed to specific systems and methods related to wearable medical devices for securing recharging coils to a head of a patient. However, one or more aspects of this disclosure may also be applicable to other types of wearable medical devices that may be secured to other areas of a patient. For example, aspects of this disclosure may be applicable to a sleeve that may be used to secure one or more charging coils at one or more locations that are aligned with one or more IMDs located at a patient's side, or at a subclavical location, or the like.

The following examples describe various examples and combinations contemplated and discussed herein.

A wearable medical system comprising: a flexible body configured to cover at least a portion of each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of a scalp of a head of a patient; a securing member connected to the flexible body, the securing member configured to extend around a circumference of the head and stabilize the flexible body with respect to the scalp of the patient; and a fixation member configured to mount to a location of the flexible body, the fixation member configured to couple the flexible body to a recharge coil configured to recharge an implantable power source of a cranially-mountable implantable medical device.

The wearable medical system of example 1, further comprising: an external power source secured to at least one of the flexible body or the securing member; the recharge coil removably secured to a first surface of the flexible body, the recharge coil configured to transmit energy from the power source to recharge the implantable power source of the cranially-mountable implantable medical device; and a cable coupling the external power source to the recharge coil.

The wearable medical system of example 1, wherein: the fixation member is a first fixation member; the location is a first location; the recharge coil is a first recharge coil; the implantable power source is a first implantable power source; and the cranially-mountable implantable medical device is a first cranially-mounted implantable medical device, further comprising: a second fixation member configured to mount to a second location of the flexible body, the second fixation member configured to couple the flexible body to a second recharge coil configured to recharge an second implantable power source of a second cranially-mountable implantable medical device.

The wearable medical system of example 3, further comprising: an external power source secured to at least one of the flexible body or the securing member; the first recharge coil removably secured to a first surface of the flexible body, the first recharge coil configured to transmit energy from the power source to recharge the first implantable power source of the first cranially-mountable implantable medical device; the second recharge coil removably secured to a second surface of the flexible body, the second recharge coil configured to transmit energy from the power source to recharge the second implantable power source of the second cranially-mountable implantable medical device; and one or more cables configured to couple the external power source to the first and second recharge coils.

The wearable medical system of either example 3 or 4, wherein the first recharge coil and the second recharge coil are configured to simultaneously transmit energy from the power source to recharge both the implantable power source of the first cranially-mountable implantable medical device and the second implantable power source of the second cranially-mountable implantable medical device.

The wearable medical system of any of examples 3-5, wherein: the first fixation member is secured to the first surface of the flexible body at a third location adjacent the first location such that the first recharge coil will be aligned with a first implanted recharge coil of the first cranially-mountable implantable medical system when coupled to the first fixation member; and the second fixation member is secured to the first surface of the flexible body at a fourth location adjacent the second location such that the second recharge coils will be aligned with a second implanted recharge coil of the second cranially-mountable implantable medical system when coupled to the second fixation member.

The wearable medical system of any of examples 3-5, wherein: the flexible body comprises a map identifying a plurality of locations; both the first location and the second location are in the plurality of locations; the first recharge coil includes a first identifying that identifies the first location; and the second recharge coil includes a second identifying that identifies the second location.

The wearable medical system of any of examples 3-7, wherein the one or more cables are removably couplable to the first and second recharge coils.

The wearable medical system of example 1, further comprising: a first external power source secured to at least one of the flexible body or the securing member; the first recharge coil removably secured to a first surface of the flexible body, the first recharge coil configured to transmit energy from the first power source to recharge the first implantable power source of the first cranially-mountable implantable medical device; a second external power source secured to at least one of the flexible body or the securing member; the second recharge coil removably secured to a second surface of the flexible body, the second recharge coil configured to transmit energy from the second power source to recharge the second implantable power source of the second cranially-mountable implantable medical device.

The wearable medical system of any of examples 1-9, wherein the securing member comprises a band that is relatively more rigid than the flexible body.

The wearable medical system of any of examples 1-10, wherein the flexible body comprises a map identifying a plurality of locations, wherein the location is one of the plurality of locations.

The wearable medical system of any of examples 1-11, further comprising a bill that is configured to extend radially out from the flexible body, wherein the bill is connected to the flexible body along at least a portion of the left anterior quadrant and the right anterior quadrant.

The wearable medical system of any of examples 1-12, wherein the flexible body includes at least two seams that are configured to secure a shape of the flexible body when covering at least a portion of the scalp by extending substantially straight across the flexible body between the securing member, wherein a first seam of the least two seams extends from the left anterior quadrant to the right posterior quadrant and a second seam of the least two seams extends from the right anterior quadrant to the left posterior quadrant.

The wearable medical system of any of examples 1-13, wherein the securing member comprises an adjustable mechanism configured to adjust a circumference of the securing member.

The wearable medical system of example 14, wherein the securing member comprises a click wheel configured to increase the circumference of the securing member when the click wheel is turned in a first direction and configured to decrease the circumference when the click wheel is turned in a second direction opposite the first direction.

The wearable medical system of example 15, wherein the securing member includes a band with overlapping ends, wherein an adjustable amount of overlap between the overlapping ends defines the circumference of the securing member.

The wearable medical system of any of examples 1-16, wherein the power source comprises an attachment mechanism configured to attach the power source to the securing member adjacent the left posterior quadrant and the right posterior quadrant.

The wearable medical system of any of examples 1-17, further comprising a curved housing configured to house the external power source, wherein the curved housing defines a first main surface configured to interface with the scalp and a second main surface that is on an opposite side of the curved housing of the first main surface, where the first main surface and the second main surface define substantially similar curvatures that approximate a curvature of a back of the head of the patient.

The wearable medical system of any of examples 1-18, further comprising a curved container that is configured to house the recharge coil, wherein the curved container defines a concave main surface that approximates a curvature of the scalp of the patient and is configured to interface with the scalp of the patient.

The wearable medical system of example 19, wherein the main surface is a first main surface, wherein the curved container defines a second main surface that is on an opposite side of the curved container of the first main surface and approximates the curvature of the scalp of the patient, wherein the second main surface defines a ridge that extends out away from the second main surface, wherein the flexible body includes a first surface configured to contact the scalp and a second surface that is on an opposite side of the flexible body relative to the first surface, wherein the fixation member includes: an attachment assembly for securing the curved housing for the recharge coil to the flexible body, the attachment assembly including: a bracket defining a recess and a channel configured to receive the ridge of the second main surface to securely attach the bracket to the curved container; and a pin configured to extend through a hole in the flexible body from the second surface of the flexible body past the first surface of the flexible body into the recess of the bracket to be securely received by the bracket, the pin including a plate configured to press against the second surface of the flexible body when the pin is received by the recess of the bracket.

The wearable medical system of example 20, wherein the curved container includes a bore that extends through the curved container and is centered within the ridge, wherein the bore is configured to receive the recess of the bracket when the bracket is securely attached to the curved container, where the bore is configured to accept a marking pen to enable positioning of the curved housing over the cranially-mountable implantable medical device to visibly mark the location on the first main surface flexible body.

The wearable medical system of either example 20 or 21, further comprising a piercing element configured to be removably coupled to the pin, the piercing element including a piercing tip configured to pierce the flexible body from the first surface through to the second surface to create the hole in the flexible body.

A wearable medical system, comprising: a flexible body configured to cover at least a portion of each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of a scalp of a head of a patient; a securing member connected to the flexible body, the securing member configured to extend around a circumference of the head and stabilize the flexible body with respect to the scalp of the patient; an external power source secured to at least one of the flexible body or the securing member; a first recharge coil removably configured to transmit energy from the power source to recharge a first implantable power source of a first cranially-mountable implantable medical device; a second recharge coil removably configured to transmit energy from the power source to recharge a second implantable power source of a second cranially-mountable implantable medical device; one or more cables coupling the external power source to the first and second recharge coils; a first fixation member configured to mount to a first location of the flexible body, the first fixation member configured to securely attach the first recharge coil to the flexible body; and a second fixation member configured to mount to a second location of the flexible body, the second fixation member configured to securely attach the second recharge coil to the flexible body.

The wearable medical system of example 23, wherein the securing member comprises a band that is relatively more rigid than the flexible body.

The wearable medical system of either example 23 or 24, wherein the flexible body comprises a map identifying a plurality of locations, wherein the location is one of the plurality of locations.

The wearable medical system of any of examples 23-25, further comprising a bill that is configured to extend radially out from the flexible body, wherein the bill is connected to the flexible body along at least a portion of the left anterior quadrant and the right anterior quadrant.

The wearable medical system of any of examples 23-26, wherein the flexible body includes at least two seams that are configured to secure a shape of the flexible body when covering at least a portion of the scalp by extending substantially straight across the flexible body between the securing member, wherein a first seam of the least two seams extends from the left anterior quadrant to the right posterior quadrant and a second seam of the least two seams extends from the right anterior quadrant to the left posterior quadrant.

The wearable medical system of any of examples 23-27, wherein the securing member comprises an adjustable mechanism configured to adjust a circumference of the securing member.

The wearable medical system of any of examples 23-28, further comprising a curved housing configured to house the external power source, wherein the curved housing defines a first main surface configured to interface with the scalp and a second main surface that is on an opposite side of the curved housing of the first main surface, where the first main surface and the second main surface define substantially similar curvatures that approximate a curvature of the scalp of the patient.

The wearable medical system of any of examples 23-29, further comprising a first and second curved container that are configured to house the first and second recharge coils, wherein each of the first and second curved containers defined a concave first main surface that approximates a curvature of the scalp and a second main surface that approximates a curvature of the scalp, the first main surface configured to interface with the scalp of the patient and the second main surface on an opposite side of the respective curved container of the first main surface, wherein the second main surface defines a ridge that extends out away from the second main surface, wherein the flexible body includes a first surface configured to contact the scalp and a second surface that is on an opposite side of the flexible body relative to the first surface, the wearable medical system further comprising: a first and second attachment assembly for securing the first and second curved housing for the first and second recharge coil to the flexible body, each attachment assembly including: a bracket defining a recess and a channel configured to receive the ridge of the second main surface to securely attach the bracket to the curved container; and a pin configured to extend through a hole in the flexible body from the second surface of the flexible body past the first surface of the flexible body into the recess of the bracket to be securely received by the bracket, the pin including a plate configured to press against the second surface of the flexible body when the pin is received by the recess of the bracket.

A wearable medical system, comprising: a curved container that is configured to house a recharge coil and defines a concave first main surface and a convex second main surface that each approximate a curvature of a scalp of a head of a patient, the first main surface configured to interface with the scalp of the patient and the second main surface is on an opposite side of the curved container of the first main surface, wherein the second main surface defines a ridge that extends out away from the second main surface and a bore that extends through the curved container; a bracket defining a cylindrical recess configured to be received by the bore and a channel that is configured to receive the ridge of the second main surface to securely attach the bracket to the curved container; and a pin configured to extend into the cylindrical recess of the bracket to be securely received by the bracket, the pin including a plate configured to press a mouth of the cylindrical recess when the pin is received by the recess of the bracket.

The wearable medical device of example 31, further comprising a recharge coil housed within the curved container that is configured to transmit energy to recharge an implantable power source of a cranially-mountable implantable medical device.

The wearable medical device of example 32, further comprising: a curved housing configured to house an external power source, wherein the curved housing defines a first main surface configured to interface with the scalp and a second main surface that is on an opposite side of the curved housing of the first main surface, where the first main surface and the second main surface define substantially similar curvatures that approximate a curvature of the scalp of the patient; and a cable coupling the external power source to the recharge coil.

The wearable medical device of example 33, further comprising processing circuitry configured to cause the recharge coil to transmit energy from the external power source to recharge the implantable power source of the cranially-mountable implantable medical device.

The wearable medical device of example 31, wherein the curved container is a first curved container and the bracket is a first bracket and the pin is a first pin, further comprising: a second curved container that is substantially similar to the first curved container; a second bracket that is substantially similar to the first bracket; a second pin that is substantially similar to the first pin; a first recharge coil housed within the first curved container that is configured to transmit energy to recharge a first implantable power source of a first cranially-mountable implantable medical device; a second recharge coil housed within the second curved container that is configured to transmit energy to recharge a second implantable power source of a second cranially-mountable implantable medical device; a curved housing configured to house an external power source, wherein the curved housing defines a first main surface configured to interface with the scalp and a second main surface that is on an opposite side of the curved housing of the first main surface, where the first main surface and the second main surface define substantially similar curvatures that approximate a curvature of the scalp of the patient; and one or more cables coupling the external power source to the first and second recharge coils.

The wearable medical device of example 35, further comprising processing circuitry configured to cause the first and second recharge coils to transmit energy from the external power source to recharge the first and second implantable power sources of the first and second cranially-mountable implantable medical devices.

The wearable medical device of any of examples 1-35, further comprising telemetry circuitry configured to communicate with the cranially-mountable implantable medical device.

A method of securing recharge coils at a location of the wearable medical devices of any of examples 1-37 according to the methods described herein.

A method of assembling any of the wearable medical device of any of examples 1-37.

A method of charging implantable power sources of one or more implantable medical devices using the wearable medical device of any of examples 1-37.

Headgear for one or more recharging coils of an implantable medical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient, and the headgear comprising: a securing member for mounting to head of the patient, on an exterior side of the scalp, the securing member being configured to extend around the head, in a generally horizontal plane, and along each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, and to generally conform to the exterior side of the scalp, when mounted to the head; and a plurality of holding features attached to the securing member, a first holding feature of the plurality being located along one or both of the left quadrants of the scalp, when the securing member is mounted to the head, and a second holding feature of the plurality being located along one or both of the right quadrants of the scalp when the securing member is mounted to the head, and each holding feature being configured to hold a recharging coil.

The headgear of example 41, wherein: the securing member comprises a flexible cap having an inner layer, an outer layer; and each holding feature of the plurality comprises a pocket formed between the inner layer and outer layer of the cap.

The headgear of example 42, wherein one or both of the inner and outer layers of the cap comprise a latticework of flexible strips.

The headgear of any of examples 1-43, wherein the securing member comprises an inner layer and an outer layer; and each holding feature comprises a pocket between the inner layer and the outer layer.

The headgear of any of examples 1-44, wherein: the securing member comprises a cap, and each holding feature comprises a recess formed in an outer surface of the cap.

The headgear of any of examples 1-45, wherein: the securing member comprises a flexible cap divided into a left portion and a right portion, the left portion being conformable to the left anterior and posterior quadrants of the scalp, the right portion being conformable to the right anterior and posterior quadrants of the scalp, the left and right portions each having an inner layer and an outer layer, and the left and right portions each having a superior perimeter edge free to move away from and toward a midline plane of head of the patient, when the securing member is mounted to the head; and each holding feature comprises a pocket formed between the inner layer and the outer layer of the corresponding portion of the cap.

The headgear of any of examples 1-46, wherein each holding feature comprises a flexible rail extending in an arc superior to the securing member, each rail having left and right ends attached to the securing member so that the arc of each rail spans left and right quadrants of the scalp, when the securing member is mounted to the head.

The headgear of example 47, wherein each flexible rail is free to move in anterior and posterior directions.

The headgear of any of examples 1-48, wherein the plurality of holding features are distributed along all of the quadrants of the scalp when the securing member is mounted to the head.

The headgear of any of examples 1-49, further comprising: a right posterior pad and a left posterior pad, the left and right pads being attached to the securing member and extending inferior thereto, and each pad being flexible and cushioned and including an inner layer and an outer layer; and wherein each holding feature comprises a pocket formed between the inner and outer layer of one of the pads.

A recharge assembly comprising the headgear of any of examples 41-50, and a charge module, the charge module comprising the recharging coil, an electronic recharge control unit coupled to the coil, and a housing containing the coil and control unit, the housing being configured to be held by each holding feature of the headgear.

A recharge assembly comprising the headgear of any of examples 41-50 and a charge module, the charge module comprising the recharging coil, an electronic recharge control unit, and a lead coupling the coil to the control unit; and wherein the headgear further comprises another holding feature attached to the securing member, the other holding feature configured to hold the control unit of the charge module.

Headgear for one or more recharging coils of an implantable medical electrical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient, and the headgear comprising: a securing member for mounting to head of the patient on an exterior side of the scalp, the securing member being configured to extend around the head, in a generally horizontal plane, and along each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, and to generally conform to the exterior side of the scalp, when mounted to the head; and a holding feature being configured to hold an individual recharging coil and being moveably attached to the securing member for positioning in any one of the quadrants of the scalp, when the securing member is mounted to head of the patient.

The headgear of example 53, wherein the holding feature is slideably engaged around the securing member for movement relative thereto in the generally horizontal plane.

The headgear of either example 53 or 54, wherein: the securing member includes a left engagement zone and a right engagement zone, the left engagement zone extending along the left posterior quadrant and the left anterior quadrant of the scalp, when the securing member is mounted to head of the patient, the right engagement zone extending along the right posterior quadrant and the right anterior quadrant of the scalp, when the securing member is mounted to head of the patient; the holding feature comprises a flexible rail, the rail having a first end configured for reversible/releasable attachment anywhere along one of the securing member engagement zones, and a second end configured for reversible/releasable attachment anywhere along the other of the securing member engagement zones; and when each end of the holding feature rail is attached to the corresponding securing member engagement zone and the securing member is mounted to head of the patient, the rail extends in an arc superior to the securing member, the arc spanning left and right quadrants of the scalp.

The headgear of example 55, wherein the holding feature is further configured to allow movement of a held recharging coil along a length thereof between the first and second ends.

A recharge assembly comprising the headgear of any of examples 53-56, and a charge module, the charge module comprising the recharging coil, an electronic recharge control unit coupled to the coil, and a housing containing the coil and control unit, the housing being configured to be held by the holding feature of the headgear.

Headgear for recharging an implantable medical electrical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient, and the headgear comprising: a securing member for mounting to head of the patient on an exterior side of the scalp, the securing member being configured to extend around the head, in a generally horizontal plane, and along each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, and to generally conform to the exterior side of the scalp, when mounted to the head; and a resilient band attached to the securing member and having a recharging coil mounted therein, the band extending in an arc superior to the securing member and being moveable relative to the securing member, the arc spanning left and right quadrants of the scalp, or anterior and posterior quadrants of the scalp, when the securing member is mounted to head of the patient.

The headgear of example 58, wherein: the securing member includes engagement features generally evenly dispersed along the left posterior quadrant, the left anterior quadrant, the right posterior quadrant and the right anterior quadrant of the scalp, when the securing member is mounted to head of the patient; and the band has a first end configured for reversible/releasable attachment with one or more of the securing member engagement features, and a second end configured for reversible/releasable attachment with another one or more the securing member engagement features.

The headgear of example 58, wherein the band spans anterior and posterior quadrants of the scalp, when the securing member is mounted to head of the patient and is movable away from and toward a midline plane of head of the patient.

The headgear of any of examples 58-60, wherein the band also has an electronic recharge control unit mounted therein, the control unit being coupled to the recharging coil.

Headgear for recharging an implantable medical electrical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient, and the headgear comprising: a securing member for mounting to head of the patient on an exterior side of the scalp, the securing member comprising a resilient band configured to extend, from a first end thereof to a second end thereof, over head of the patient in an arc along a generally vertical plane, and to generally conform to the exterior side of the scalp, when mounted to the head; and at least one conformable member being attached to one or both of the first and second ends of the securing member band for conforming to at least one of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, when the securing member is mounted to head of the patient, each of the at least one conformable member having a recharging coil mounted therein.

The headgear of example 62, wherein: the securing member further comprises an ear hook; the first end of the securing member band is attached to the ear hook so that the band is moveable relative to the ear hook; and the at least one conformable member comprises a single conformable member attached to the second end of the securing member band.

The headgear of either example 62 of 63, wherein: the resilient band of the securing member has another recharging coil mounted therein; the at least one conformable member comprises a pair of resilient bands, each of the pair being movable relative to the securing member band; a first band of the pair extends from a first end thereof to a second end thereof in an arc, the first end of the first band being attached to the second end of the securing member band so that the first band is moveable relative to the securing member band, and the arc of the first band spanning any one of the quadrants of scalp of the patient, when the securing member is mounted to head of the patient; and a second band of the pair extends from a first end thereof to a second end thereof in an arc, the first end of the second band being attached to the second end of the securing member band and to the first end of the first band so that the second band is movable relative to the securing member band and to the first band, and the arc of the second band spanning any one of the quadrants of scalp of the patient, when the securing member is mounted to head of the patient.

The headgear of any of examples 62-64, wherein the at least one conformable member comprises a single resilient band extending, from a first end thereof to a second end thereof, in an arc, the first end of the single resilient band being attached to the first end of the securing member band, the second end of the single resilient band being attached to the second end of the securing member band, the single resilient band being moveable relative to the securing member band, and the arc of the single resilient band spanning the left and right quadrants of the scalp, when the securing member is mounted to head of the patient.

The headgear of any of examples 62-65, wherein: the at least one conformable member comprises a pair of resilient bands, each of the pair being movable relative to the securing member band; a first band of the pair extends from a first end thereof to a second end thereof in an arc, the first end of the first band being attached to the first end of the securing member band, and the arc of the first band spanning a left posterior quadrant of scalp of the patient, when the securing member is mounted to head of the patient; and a second band of the pair extends from a first end thereof to a second end thereof in an arc, the first end of the second band being attached to the second end of the securing member band, and the arc of the second band spanning a right posterior quadrant of scalp of the patient, when the securing member is mounted to head of the patient.

The headgear of any of examples 62-66, wherein the at least one conformable member comprises a pair of cushioned pads, a first of the pair of pads being attached to the first end of the securing member band and conforming to one or both of the left quadrants of the scalp, when the securing member is mounted to head of the patient, a second of the pair of pads being attached to the second end of the securing member band and conforming to one or both of the right quadrants of the scalp, when the securing member is mounted to head of the patient.

The headgear of any of examples 62-67, wherein each of the at least one conformable member also has an electronic recharge control unit mounted therein, each control unit being coupled to the corresponding recharging coil.

Headgear for recharging an implantable medical electrical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient in a hollowed out area of the patient's skull, and the headgear comprising: a covering sized to cover, on an exterior side of the scalp, all of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, the covering including an inner layer and an outer layer; a plurality of recharging coils mounted between the inner and outer layers of the covering and distributed throughout; and an electronic recharge control unit coupled to each of the plurality of recharging coils.

The headgear of example 69, further comprising a collar member attached to a posterior inferior edge of the covering, the collar member containing the electronic recharge control unit.

A recharge assembly for an implantable medical electrical system, the system comprising a power module, a control module, a recharge module, and a housing that contains all the modules, the housing being configured for implantation beneath a scalp of the patient in a hollowed out area of the patient's skull, and the recharge assembly comprising: a securing member for mounting to head of the patient on an exterior side of the scalp, the securing member being conformable to a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, when the securing member is mounted to the head, the securing member having attachment means distributed throughout; and a charge module comprising a recharging coil, an electronic recharge control unit coupled to the coil, and a housing containing the coil and the control unit, the housing including an attachment means configured to mate with the attachment means of the securing member at a selected location along any one of the quadrants of the scalp, when the securing member is mounted to the head.

The assembly of example 71, wherein the attachment means of the securing member and of the charge module housing comprise magnetic elements.

The assembly of example 71, wherein the attachment means of the securing member and the charge module housing comprise Velcro.

A medical system, comprising: an implantable medical device; a recharger configured to charge a power source of the implantable medical device, the recharger comprising a charging coil; and headgear comprising: a securing member for mounting to head of the patient, on an exterior side of the scalp, the securing member being configured to extend around the head and along each of a left anterior quadrant, a left posterior quadrant, a right posterior quadrant, and a right anterior quadrant of the scalp, and to generally conform to the exterior side of the scalp, when mounted to the head; and a plurality of holding features attached to the securing member, a first holding feature of the plurality being located along one or both of the left quadrants of the scalp, when the securing member is mounted to the head, and a second holding feature of the plurality being located along one or both of the right quadrants of the scalp when the securing member is mounted to the head, and each holding feature being configured to hold the charging coil.

The medical system of example 74, wherein: the securing member comprises a flexible cap having an inner layer, an outer layer; and each holding feature of the plurality comprises a pocket formed between the inner layer and outer layer of the cap.

The medical system of example 75, wherein one or both of the inner and outer layers of the cap comprise a latticework of flexible strips.

The medical system of example 74, wherein the securing member comprises an inner layer and an outer layer; and each holding feature comprises a pocket between the inner layer and the outer layer.

The medical system of example 74, wherein: the securing member comprises a cap; and each holding feature comprises a recess formed in an outer surface of the cap.

The medical system of example 74, wherein: the securing member comprises a flexible cap divided into a left portion and a right portion, the left portion being conformable to the left anterior and posterior quadrants of the scalp, the right portion being conformable to the right anterior and posterior quadrants of the scalp, the left and right portions each having an inner layer and an outer layer, and the left and right portions each having a superior perimeter edge free to move away from and toward a midline plane of head of the patient, when the securing member is mounted to the head; and each holding feature comprises a pocket formed between the inner layer and the outer layer of the corresponding portion of the cap.

The medical system of example 74, wherein each holding feature comprises a flexible rail extending in an arc superior to the securing member, each rail having left and right ends attached to the securing member so that the arc of each rail spans left and right quadrants of the scalp, when the securing member is mounted to the head.

The medical system of example 80, wherein each flexible rail is free to move in anterior and posterior directions.

The medical system of any of examples 74-81, wherein the plurality of holding features are distributed along all of the quadrants of the scalp when the securing member is mounted to the head.

The medical system of example 74, further comprising: a right posterior pad and a left posterior pad, the left and right pads being attached to the securing member and extending inferior thereto, and each pad being flexible and cushioned and including an inner layer and an outer layer; and wherein each holding feature comprises a pocket formed between the inner and outer layer of one of the pads.

The medical system of any of examples 74-83, wherein the recharger further comprises a control unit that is separately housed from the charging coil, and wherein the headgear further comprises another holding feature attached to the securing member configured to hold the control unit of the recharger.

The medical system of any of examples 74-84, wherein the medical device is configured to deliver deep brain stimulation therapy to a patient.

A medical system, comprising: a recharger configured to charge a power source of an implantable medical device, the recharger comprising a charging coil; and headgear comprising: a securing member for mounting to head of the patient, on an exterior side of the scalp, the securing member being configured to extend around the head and to generally conform to the exterior side of the scalp, when mounted to the head; and a plurality of holding features attached to the securing member, a first holding feature of the plurality being located along one or both quadrants of the scalp, when the securing member is mounted to the head, and a second holding feature of the plurality being located along one or both of the right quadrants of the scalp when the securing member is mounted to the head, and each holding feature being configured to hold the charging coil.

Various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as physician or patient programmers, electrical stimulators, or other devices. The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry or any other equivalent circuitry. In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media forming a tangible, non-transitory medium. Instructions may be executed by one or more processors, such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry. Accordingly, the terms “processor” or “processing circuitry” as used herein may refer to one or more of any of the foregoing structures or any other structure suitable for implementation of the techniques described herein. In addition, in some aspects, the functionality described herein may be provided within dedicated hardware and/or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements. The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including an IMD, an external programmer, a combination of an IMD and external programmer, an integrated circuit (IC) or a set of ICs, and/or discrete electrical circuitry, residing in an IMD and/or external programmer.