Rechargeable implantable device

Abstract

A rechargeable implantable device is provided. The rechargeable implantable device may include a housing having a first side and a second side and a cavity and a battery positioned in the cavity. The rechargeable implantable device also includes one or more recharge coils spaced from the battery and a divider spaced between the battery and the one or more recharge coils. The one or more recharge coils may be arranged such that a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

Description

RECHARGEABLE IMPLANTABLE DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of and priority to U.S. Provisional Application No. 63 / 634,276 filed on April 15, 2024, entitled “RECHARGEABLE IMPLANTABLE DEVICE”, the entirety of which is hereby incorporated herein by reference.FIELD

[0002] The present disclosure is generally directed to rechargeable implantable devices, and relates more particularly to an arrangement of one or more components of the rechargeable implantable devices.BACKGROUND

[0003] Neuromodulation therapy may be carried out by sending an electric signal generated by a pulse generator to a stimulation target (e.g., nerves, non-neuronal cells, etc.), which may provide a stimulating or blocking therapy to the stimulation target. Such pulse generators are powered by one or more batteries that may be charged using a recharger.BRIEF SUMMARY

[0004] Example aspects of the present disclosure include:

[0005] A rechargeable implantable device according to at least one embodiment of the present disclosure comprises a housing having a first side and a second side and a cavity; a battery positioned in the cavity; one or more recharge coils spaced from the battery; and a divider spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are arranged such that a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0006] Any of the aspects herein, wherein at least a portion of the housing comprises at least one of a ceramic sheet, a glass sheet, or a crystal sheet.

[0007] Any of the aspects herein, wherein the one or more recharge coils comprise a first set of recharge traces positioned near the first side and a second set of recharge traces positioned near the second side.

[0008] Any of the aspects herein, wherein a surface area of the first set of recharge traces is less than a surface are?traces.

[0009] Any of the aspects herein, wherein the one or more recharge coils form one or more layers along a perimeter of the cavity, the one or more layers extending from the first side to the second side.

[0010] Any of the aspects herein, wherein the battery is positioned within the one or more recharge coils.

[0011] Any of the aspects herein, wherein the divider comprises a nonmetal material.

[0012] Any of the aspects herein, wherein the one or more recharge coils are maximally sized to occupy a space between the battery and at least one of the first side and the second side.

[0013] Any of the aspects herein, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a ceramic sheet, a glass sheet, or a crystal sheet, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

[0014] Any of the aspects herein, wherein at least one of the Titanium rings includes a shoulder configured to increase pressure between the ceramic sheet and the Titanium ring during a diffusion bond process.

[0015] A rechargeable implantable device according to at least one embodiment of the present disclosure comprises a housing having a first side and a second side and a cavity; a battery positioned in the cavity; one or more recharge coils spaced from the battery and positioned in the cavity; and a plastic divider spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are wrapped around an outer portion of the divider and extends from the first side to the second side such that a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0016] Any of the aspects herein, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a pair of ceramic sheets, a pair of glass sheets, or a pair of crystal sheets, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

[0017] Any of the aspects herein, wherein the one or more recharge coils form one or more layers along a perimeter of the cavity

[0018] Any of the aspects herein, wherein the battery is positioned within a center of the one or more recharge coils.

[0019] A rechargeable implantable device according to at least one embodiment of the present disclosure comprises a 1 a second side and a cavity; abattery positioned in the cavity; one or more flex circuits positioned in the cavity and extending along both the first side and the second side of the housing; a first set of recharge coils positioned on the flex circuit at the first side; and a second set of recharge coils positioned on the flex circuit at the second side, wherein a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0020] Any of the aspects herein, wherein a surface area of the first set of recharge traces is less than a surface area of the second set of recharge traces.

[0021] Any of the aspects herein, further comprising a flux concentrator positioned between the flex circuit and the battery.

[0022] Any of the aspects herein, further comprising an electrically conductive metal foil positioned behind the flux concentrator.

[0023] Any of the aspects herein, further comprising a radially-etched electrically conductive shield positioned behind the flux concentrator.

[0024] Any of the aspects herein, further comprising a stimulation-sense hybrid positioned on the first side and a power hybrid positioned on the second side, wherein the stimulation-sense hybrid and the power hybrid are connected by the flex circuit.

[0025] Any of the aspects herein, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a pair of ceramic sheets, a pair of glass sheets, or a pair of crystal sheets, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

[0026] Any aspect in combination with any one or more other aspects.

[0027] Any one or more of the features disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein.

[0029] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0030] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0031] Use of any one or more of the aspects or features as disclosed herein.

[0032] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0033] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and th tures, objects, andadvantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0034] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xl-Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0035] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0036] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0037] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0038] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as 1 the illustrated and describedexamples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0039] Fig. 1 is a diagram of a neuromodulation system according to at least one embodiment of the present disclosure;

[0040] Fig. 2 is a diagram of a neuromodulation system according to at least one embodiment of the present disclosure;

[0041] Fig. 3A is an isometric view of a rechargeable implantable device according to at least one embodiment of the present disclosure;

[0042] Fig. 3B is a schematic view of the hermetic portion of the rechargeable implantable device of Fig. 3 A according to at least one embodiment of the present disclosure;

[0043] Fig. 4 is a rear, tilted view of the rechargeable implantable device of Fig. 3 A according to at least one embodiment of the present disclosure;

[0044] Fig. 5 is a side view of the rechargeable implantable device of Fig. 3 A according to at least one embodiment of the present disclosure;

[0045] Fig. 6 is a cross-sectional view of the rechargeable implantable device of Fig. 3 A taken along line D-D visible in Fig. 5 according to at least one embodiment of the present disclosure;

[0046] Fig. 7 is a cross-sectional view of the rechargeable implantable device of Fig. 3 A taken along line E-E visible in Fig. 5 according to at least one embodiment of the present disclosure;

[0047] Fig. 8 is a view of detail F, visible in Fig. 7, of the rechargeable implantable device according to at least one embodiment of the present disclosure;

[0048] Fig. 9 is a front cross-sectional view of a rechargeable implantable device according to at least one embodiment of the present disclosure;

[0049] Fig. 10 is a cross-sectional view of the rechargeable implantable device of Fig. 9 taken along line A-A according to at least one embodiment of the present disclosure;

[0050] Fig. 11 is a cross-sectional view of the rechargeable implantable device of Fig. 9 taken along line B-B according to at least one embodiment of the present disclosure;

[0051] Fig. 12 is a cross-sectional view of the rechargeable implantable device of Fig. 9 taken along line C-C according to at least one embodiment of the present disclosure;

[0052] Fig. 13 is a view of detail G, visible in Fig. 12, of the rechargeable implantable device according to at least one sclosure;

[0053] Fig. 14 is a rear cross-sectional view of the rechargeable implantable device of Fig. 9 according to at least one embodiment of the present disclosure;

[0054] Fig. 15 is a detailed cross-sectional view of a portion of the rechargeable implantable device of Fig. 9 according to at least one embodiment of the present disclosure;

[0055] Fig. 16 is a flowchart according to at least one embodiment of the present disclosure; and

[0056] Fig. 17 is a front cross-sectional view of an alternative configuration of the rechargeable implantable device of Fig. 9 according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0057] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device.

[0058] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0059] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0060] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0061] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0062] For patients that use neuromodulation therapy devices such as, for example, an implantable stimulation device, )le. For example, for power-intensive therapies such as spinal cord stimulation (SCS), rechargeable devices are often the only option. However, recharging may be time intensive and a burden on patient's lives. Conventional rechargeable devices may be temperature limited such that a decrease in recharge duration may result in undesirable and potentially unsafe temperatures in the device. Such conventional rechargeable devices may be temperature limited due to the material used to form a housing of the devices.

[0063] Thus, a device according to at least one embodiment of the present disclosure provides for a housing formed primarily from an electrically non-conductive material, such as ceramic, though other materials could be used. The housing may further include two Titanium rings, which are each pre -bonded to sheets of an electrically non-conductive material such as, for example, sapphire sheets (or other ceramic material or suitable single crystal substrate) using a high-temperature diffusion bond process. Final assembly of the device is completed by welding the Titanium rings together using laser welding to form a fully hermetic device. Because the housing is primarily formed of a non-conductive material such sapphire that is fully transparent to magnetic fields, more energy is able to reach internal recharge coils inside of the device. Further, by placing the non-conductive material on either side of the device, the device is enabled to be used with either side facing a recharge device (e.g., the device is “flippable”). The non-conductive material also enables the construction of ultraminiature feedthroughs on the device, which results in a device that is smaller than conventional devices while also having a more capacious battery.

[0064] In addition to the housing, the device also includes an innovative recharge circuit and coil. In at least one embodiment, the recharge coil is wound of single strand or multistrand (Litz) magnet wire on a plastic cup. The recharge coil may extend to internal ring walls, or leave an airgap between the recharge coil and the internal ring walls with compartments inside the coil cup to contain an implant battery and other electronics. The recharge coil may extend from a first side to a second side of the housing such that the device can be charged from either side.

[0065] In other embodiments, the recharge coil may be flat and include recharge traces on a flexible circuit board (e.g., polyimide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE) or polypropylene) or traces printed directly onto the sapphire. Behind the recharge trace, a thin sheet with high magnetic permeability, such as ferrite, may be placed. In some embodiments, the ferrite may be integrated with the flat recharge coil. The ferrite may z ductive shield behind it toprotect internal circuitry from electrical interference. Such electrically conductive shield may also have a high permeability. Such embodiments may enable significantly higher frequencies and performance by guiding the magnetic field away from structures that create loss such as the Titanium rings and a battery housing. The device may also be charged from either side of the housing by placing recharge traces on each side of the device.

[0066] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) reducing a recharge time for a rechargeable implantable device, (2) enabling recharge from more than one side of a rechargeable implantable device, and (3) improving user recharge experience.

[0067] Turning to Figs. 1-2, diagrams of aspects of a neuromodulation system 100 (the system 100) according to at least one embodiment of the present disclosure are shown. The system 100 may be used to provide electric signals to a patient and / or carry out one or more other aspects of one or more of the methods disclosed herein. Neuromodulation techniques (e.g., technologies that act directly upon nerves of a patient, such as the alteration, or “modulation,” of nerve activity by delivering electrical impulses directly to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments (e.g., chronic pain) of a patient. As discussed herein, neuromodulation techniques may be used to relieve chronic pain. Additionally or alternatively, neuromodulation techniques may be used to stimulate or prevent other neurological signals from traveling to or from the patient’s brain for the purposes of assisting with patient treatment.

[0068] The system 100 may include at least a device 102 (which may be used for, for example, a close-loop or open spinal cord stimulation, deep brain stimulation, pelvic health, etc.) that is capable of providing a stimulation to a target anatomical element. In the illustrated embodiment, the target anatomical element is a spinal cord 114 of the patient (shown in Fig. 1), though in other embodiments the target anatomical element may be, for example, a brain 112 (shown in Fig. 2) of the patient and / or one or more nerve endings of the patient. In some examples, the device 102 may be referred to as a closeloop stimulator, an open-loop stimulator, a pulse generator, an implantable neural stimulator, an internal neural stimulator, or the like, which may be implantable in some embodiments. More specifically, the device 102 may be configured to generate a current or electrical signal that is delivered to the target anatomical element. The device 102 may be an implantable device implanted in the patient. In other embodiments, the device 102may be external to the patient. In any embodiments, the system 100 also includes a recharger 130 configured to recharge the device 102.

[0069] Additionally, the system 100 may include one or more leads 104 (e.g., electrical leads) that provide a connection between the device 102 and the spinal cord or nerves of the patient for enabling, for example, stimulation. In some embodiments, the leads 104 may be implanted wholly or partially within the patient. The leads 104 may be, for example, paddle leads and / or percutaneous leads. In some embodiments, the one or more leads 104 may include a first lead 104A that is implanted in a position to provide therapy to a first side of the spinal cord 114 of the patient and a second lead 104B implanted to provide therapy to a second side of the spinal cord 114 of the patient. It will be appreciated that in other embodiments, the one or more leads 104 may include at least the first lead 104A and the second lead 104B connected to any anatomical element such as, for example, respective vagal trunks (e.g., different trunks of the vagus nerve) or to other respective nerves in a patient. For example, the first lead 104A may be connected to a first vagal trunk of the patient (e.g., the anterior sub diaphragmatic vagal trunk at the hepatic branching point of the vagus nerve) and the second lead 104B may be connected to a second vagal trunk of the patient (e.g., the posterior sub diaphragmatic vagal trunk at the celiac branching point of the vagus nerve). The first lead 104A and / or the second lead 104B may be configured to provide an electrical stimulation signal from the device 102 to the respective first and / or second vagal trunk. The connection of the leads 104 to the respective vagal trunk (or other nerves) of the patient may permit the device 102 to measure and / or provide one or more stimulations in the patient based on the provided electrical stimulation from the device 102.

[0070] The leads 104A, 104B may include one or more corresponding electrodes 108 A, 108B that receive a current or other stimulant instructions from the device 102 (e.g., via the leads 104A, 104B). In some examples, the electrodes 108 A, 108B are disposed on respective first and second sides of the spinal cord 114, where the electrodes 108 A, 108B are configured to apply the current generated by the device 102 to the spinal cord 114. It will be appreciated that in other embodiments or examples, the leads 104A, 104B may include any number of electrodes. In some examples, the electrodes 108 A, 108B may be referred to as cuff electrodes.

[0071] As previously described, the device 102 may be implanted in the patient, though in other embodiments, the device 102 may not be implanted in a patient. The device 102 may include a battery 302 (sho er the device 102, which maybe recharged by a recharge coil 304 (also shown in Figs. 3-15) and the recharger 130. The recharger 130 may include a recharge or transmitter coil. The recharger coil may be configured to charge the recharge coil 304 when the recharger coil is held in proximity to the recharge coil 304. The recharge coil 304 may be positioned or arranged relative to the battery 302 and the device 102 so as to optimize recharging of the battery 302.

[0072] Turning to Figs. 3A-8, the device 102 according to at least one embodiment of the present disclosure is provided. Figs. 3A and 4 show an isometric view and a rear, tilted view of the device 102, respectively. Fig. 3B shows an isometric schematic view of the device 102. The device 102 may include a housing 306 having a first side 308 and a second side 310. The housing 306 may be generally rectangular with rounded edges, though it will be appreciated that the housing 306 may be any shape or size. The housing 306 may be formed of sapphire, glass, silicone rubber, epoxy resin, ceramic, zirconia, titanium, plastic, or any combination thereof. It will be appreciated that the housing 306 may be formed of any solid material or any combination of solid materials. The housing 306 may be formed so as to be fully hermetic. In embodiments where the housing 306 includes ceramic or a combination of materials with ceramic, it will be appreciated that ceramic beneficially does not have any electrical conductivity and is transparent to recharge energy. Thus, the ceramic may result in an increase in recharge energy reaching the recharge coil 304 disposed within the housing 306.

[0073] Figs. 5 and 6 show a side view of the device 102 and a cross-sectional view of the device 102 taken along line D-D shown in Fig. 5, respectively. As shown, the device 102 includes a cavity 312 in which the recharge coil 304 and the battery 302 are positioned. The recharge coil 304, the battery 302, and any other components (e.g., a processor, memory, etc.) may be positioned and divided within a divider 314. For example, the other components may include a hybrid 309. The hybrid 309 may include, for example, a rigid circuit board. The rigid circuit board may, in some embodiments, be formed of FR4. The divider 314 may be a nonmetal material such as, for example, plastic. In the illustrated embodiments, the recharge coil 304 is wrapped around the divider 314 and along a perimeter of the cavity 312. In some embodiments, the recharge coil 304 may be wound of a single strand or a multi-strand magnetic wire. The recharge coil 304 may extend from the first side 308 to the second side 310 of the housing 306 so as to enable the device 102 to be operable from either the first side 308 or the second side 310. For example, if the device 102 becomes flipped from its initial position while implanted in a patient, the device 102 is still n tion (or the initial position).

[0074] Figs. 7 and 8 show a cross-sectional view of the device 102 taken along line E-E shown in Fig. 5 and a detailed view of section F (shown in Fig. 7) respectively. As illustrated and described above, the recharge coil 304 may be positioned or wrapped around an outer portion 316 of the divider 314 and along the perimeter of the cavity 312. The recharge coil 304 may also be held in place by an end piece 318 formed of, for example, two titanium rings 311 that are laser welding 315 (shown in Fig. 3B). It will be appreciated that in other embodiments, the end piece 318 may be a single piece, two pieces, or more than two pieces, and may be formed of any solid material.

[0075] In the illustrated embodiment, the housing 306 may be formed of ceramic on at least the first side 308 and the second side 310 so as to enable charging on the first side 308 or the second side 310. In such embodiments, the recharge coil 304 is essentially positioned between two sheets of ceramic and wrapped around a plastic divider, and sealed by two titanium sheets or rings 313. It will be appreciated that in other embodiments, the ceramic (or other suitable single crystal substrate) sheet may be a single sheet. Thus, the recharge coil 304 is generally surrounded by nonmetal pieces, which may result in increased efficiency in transferring recharge energy to the recharge coil 304. As shown in Fig. 8, the titanium rings 313 may have a shoulder 301 (e.g., a local reduction) to increase pressure on the ceramic-titanium interface during a diffusion bonding process, while also reducing deformation in the bonded structure due to the high heat and pressure applied during the diffusion bonding process.

[0076] Turning to Figs. 9-15, the device 102 according to at least one embodiment of the present disclosure is shown. Figs. 9-11 show a front cross-sectional view of the device 102, a cross-sectional view of the device 102 taken along line A- A, and a cross-sectional view of the device 102 taken along line B-B according to at least one embodiment of the present disclosure. Similarly to the device 102 described in Figs. 3-8, the device 102 shown in Figs. 9-15 includes a housing 306 having a first side 308, a second side 310, and a cavity 312. The first side 308 is shown in Fig. 9 and represents an electrode side of the device 102. The device 102 includes the battery 302, the recharge coil 304, a stimulationsense hybrid 320 (powered by, for example, the battery 302), a power hybrid 322, and the divider 314. The stimulation-sense hybrid 320 and / or the power hybrid 322 may include, for example, a rigid circuit board. The rigid circuit board may, in some embodiments, be formed of FR4.

[0077] In the illustrated embodiment, the divider 314 is a flex circuit 324. The flex circuit 324 may be, for exampL ird, which is bendable,foldable, and configurable in any shape or size. The flex circuit 324 may be, for example, formed of polyimide or PET. As shown in Fig. 10, the flex circuit 324 connects the stimulation-sense hybrid 320 and the power hybrid 322. In some embodiments, it will be appreciated that the device 102 may not include the power hybrid 322 and may include two stimulation-sense hybrids 320 connected by, for example, board-to-board connectors. In still other embodiments, the device 102 may include one hybrid and two flex circuits that fold down toward the hybrid and connects to the hybrid via a connector. In still other embodiments, one or more flex circuits may be integrated into a single hybrid to form a rigid-flex component. In such embodiments where the device 102 includes one hybrid, the hybrid may combine the stimulation-sense and power tasks (e.g., patient sensing and therapy and power management and recharge). As shown in Fig. 11, the device 102 may also include one or more springs 326 for supporting the flex circuit 324 where the flex circuit 324 is not supported by the battery 302.

[0078] In some embodiments, the recharge coil 304 may occupy an entirety of the space between the battery 302 and the first side 308 and / or the second side 310 of the device 102, as depicted in Fig. 17. In other words, the area occupied by the recharge coil 304 may be maximized to beneficially enhance charging of the battery 302. In one embodiment, the recharge coil 304 may be maximally sized so as to cover an entirety of the surface area of the battery and / or an entirety of the surface area of the first side 308 and / or the second side 310. As used herein, the recharge coil 304 may be “maximally sized” when the recharge coil 304 covers as much surface area of the first side 308 and / or the second side 310 as possible, with the relative sizing of other components of the device 102 (e.g., the size of the battery 302) operating as constraints on the size of the recharge coil 304. In other words, a “maximally sized” recharge coil 304 would be one that covers as much surface area of the first side 308 and / or the second side 310 as possible without degradation of operation of the device 102 and / or charging of the battery 302.

[0079] Figs. 12-13 show a cross-sectional view of the device 102 taken along line C-C and a view of detail G (shown in in Fig. 12) of the device 102, respectively. As shown, the recharge coils 304 may comprise recharge coil traces positioned on the flex circuit 324. It will be appreciated that in some embodiments, the recharge coil 304 traces may be printed directed on the housing 306. The recharge coil 304 may contain series capacitors distributed between coil turns to reduce electric fields emanating from the implant. Electrode traces 328 may also be positioned on the flex circuit 324. Further, a flux concentrator 330 may be positi 124 and the battery 302. Theflux concentrator 330 may be used to direct or intensify the recharge energy (or magnetic flux) to the recharge coils 304. In other words, the flux concentrator 330 may guide the recharge energy away from structures where loss may occur such as, for example, titanium rings and / or a housing of the battery 302. The flux concentrator 330 may be, for example, ferrite, however, it will be appreciated that the flux concentrator 330 may be any material capable of directing and / or intensifying the recharge energy. Further, the flux concentrator 330 may be an electrically non-conductive flux concentrator positioned next to the recharge coils 304.

[0080] In some embodiments, the flux concentrator 330 may also include an electrically conductive shield behind it to protect internal circuitry from electrical interference. Such electrically conductive shield may also have a high permeability. The electrically conductive shield may be, for example, an electrically conductive metal foil, which may include radial etches or cutouts. The electrically conductive metal foil may also have high magnetic permeability (e.g. metal ribbons sold under the trademark METGLASE) to further concentrate flux on the recharge coil 304 while also protecting the hybrid (whether a single hybrid, two hybrids, or more than two hybrids) from electrical interference. The device 102 may also, in other embodiments, includes a separate radially-etched electrically conductive shield added between the recharge coils 304 and the housing 306 (e.g., ceramic sheet(s)) to reduce electric fields emanating from the device 102.

[0081] Figs. 14-15 show a rear cross-sectional view of the device 102 and a detailed cross-sectional view of a portion of the device 102, respectively. As shown in Fig. 14, the second side 310 of the device 102 is shown, which includes the power hybrid 322. Fig. 15 illustrates the battery 302 positioned between a pair of flux concentrators 330 and a first set of recharge coils (or traces) 304A positioned on the first side 308 and a second set of recharge coils (or traces) 304B positioned on the second side 310. Thus, the device 102 may be rechargeable from the first side 308 or the second side 310. In some embodiments, the first set of recharge coils 304 A may have a surface area less than the second set of recharge coils 304B. In other words, the second set of recharge coils 304B may enable faster recharging, though the device 102 is enabled to be charged using either the first side 308 or the second side 310.

[0082] The first set of recharge coils 304 A may also have a surface area less than the second set of recharge coils 304B to allow space on the first side 308 for feedthroughs to exit the hermetic volume of the device 102. In some embodiments, the feedthroughs may be ultraminiature feedthroughs ich embodiments, theultraminiature feedthroughs 303 may include a titanium cylinder 305 with a flange 307 on one side of the titanium cylinder 305. The flange 307 may be diffusion-bonded to the housing 306 (e.g., to a ceramic sheet).

[0083] It will be appreciated that the device 102 as described in Figs. 9-15 enable the use of a larger battery 302 as the recharge coils 304 may be very thin (e.g., a width of a trace). Thus, the recharge coils 304 may use very little space such that a larger battery 302 can be used with the device 102. The device 102 may also include distributed capacitors which may be, for example, placed on every turn of each recharge coil 304. Such distributed capacitors may enable lower losses, which may result in higher frequencies and thus, higher recharge.

[0084] Fig. 16 depicts a method 1600 that may be used, for example, for manufacturing a device such as the device 102.

[0085] The method 1600 comprises forming at least one nonmetallic sheets (step 1604). The at least one nonmetallic sheet may be, for example, ceramic, sapphire or other suitable single crystal substrate, or plastic. The at least one nonmetallic sheet may be formed into a rectangular shape, though the at least one nonmetallic sheet may be formed into any shape. It will be appreciated that in some embodiments, the at least one nonmetallic sheet is a single sheet. In other embodiments, the at least one nonmetallic sheet includes two nonmetallic sheets. In still other embodiments, the at least one nonmetallic sheet includes more than two sheets.

[0086] The method 1600 also comprises forming at least two titanium rings (step 1608) and bonding the at least two titanium rings to the at least one nonmetallic sheet to form two halves of a housing (step 1612). The housing may be the same as or similar to the housing 306. Each titanium ring may be bonded to a corresponding nonmetallic sheet to form two halves of the housing. In embodiments here the at least one nonmetallic sheet includes two nonmetallic sheets, each titanium ring of the two titanium rings is bonded to a corresponding nonmetallic sheet.

[0087] The method 1600 also comprises positioning one or more components in the housing (step 1616). The one or more components may include, for example, a battery such as the battery 302, a recharge coil such as the recharge coil 304, and a divider such as the divider 314. In some embodiments the divider is a plastic divider and the recharge coil is wrapped around the plastic divider. In other embodiments, the divider is a flex circuit such as the flex circuit 324 and the recharge coil is positioned on or printed on the flex circuit as recharge traces. In an >n or arrangement of therecharge coil enables recharging of the device from either a first side or a second side of the device.

[0088] The method 1600 also comprises welding the two titanium rings together (step 1620). The two titanium rings may be welded together using, for example, laser welding to seal and enclose the one or more components in the housing. Thus, once the two titanium rings are welded together, the housing is hermetic.

[0089] The present disclosure encompasses embodiments of the method 1600 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0090] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 16 (and the corresponding description of the method 1600), as well as methods that include additional steps beyond those identified in Figs 16 (and the corresponding description of the method 1600). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

[0091] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0092] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the exl late, interchangeable and / orequivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0093] A set of example statements is provided below:

[0094] Statement 1. A rechargeable implantable device comprising: a housing having a first side and a second side and a cavity; a battery positioned in the cavity; one or more recharge coils spaced from the battery; and a divider spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are arranged such that a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0095] Statement 2. The rechargeable implantable device of Statement 1, wherein at least a portion of the housing comprises at least one of a ceramic sheet, a glass sheet, or a crystal sheet.

[0096] Statement 3. The rechargeable implantable device of any of Statement 1 or 2, wherein the one or more recharge coils comprise a first set of recharge traces positioned near the first side and a second set of recharge traces positioned near the second side.

[0097] Statement 4. The rechargeable implantable device of Statement 3, wherein a surface area of the first set of recharge traces is less than a surface area of the second set of recharge traces.

[0098] Statement 5. The rechargeable implantable device of any preceding Statement, wherein the one or more recharge coils form one or more layers along a perimeter of the cavity, the one or more layers extending from the first side to the second side.

[0099] Statement 6. The rechargeable implantable device of Statement 5, wherein the battery is positioned within the one or more recharge coils.

[0100] Statement 7. The rechargeable implantable device of any preceding Statement, wherein the one or more recharge coils are maximally sized to occupy a space between the battery and at least one of the first side and the second side.

[0101] Statement 8. The rechargeable implantable device of any preceding Statement, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a ceramic sheet, a glass sheet, or a crystal sheet, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

[0102] Statement 9. The rechargeable implantable device of Statement 8, wherein at least one of the Titanium rings includes a shoulder configured to increase pressure between the ceramic sheet and fusion bond process.

[0103] Statement 10. A rechargeable implantable device comprising: a housing having a first side and a second side and a cavity; a battery positioned in the cavity; one or more recharge coils spaced from the battery and positioned in the cavity; and a plastic divider spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are wrapped around an outer portion of the divider and extends from the first side to the second side such that a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0104] Statement 11. The rechargeable implantable device of Statement 10, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a pair of ceramic sheets, a pair of glass sheets, or a pair of crystal sheets, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

[0105] Statement 12. The rechargeable implantable device of any of Statements 10 or 11 , wherein the one or more recharge coils form one or more layers along a perimeter of the cavity

[0106] Statement 13. The rechargeable implantable device of any preceding Statement, wherein the battery is positioned within a center of the one or more recharge coils.

[0107] Statement 14. A rechargeable implantable device comprising: a housing having a first side and a second side and a cavity; a battery positioned in the cavity; one or more flex circuits positioned in the cavity and extending along both the first side and the second side of the housing; a first set of recharge coils positioned on the flex circuit at the first side; and a second set of recharge coils positioned on the flex circuit at the second side, wherein a recharger can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

[0108] Statement 15. The rechargeable implantable device of Statement 14, wherein a surface area of the first set of recharge traces is less than a surface area of the second set of recharge traces.

[0109] Statement 16. The rechargeable implantable device of Statements 14 or 15, further comprising a flux concentrator positioned between the flex circuit and the battery.

[0110] Statement 17. The rechargeable implantable device of Statement 16, further comprising an electrically conductive metal foil positioned behind the flux concentrator.

[0111] Statement 18. The rechargeable implantable device of Statement 16, further comprising a radially-etched electrically conductive shield positioned behind the flux concentrator.

[0112] Statement 19. The rechargeable implantable device of any preceding Statement, further comprising a stimulation-sense hybrid positioned on the first side and a power hybrid positioned on the second side, wherein the stimulation-sense hybrid and the power hybrid are connected by the flex circuit.

[0113] Statement 20. The rechargeable implantable device of any preceding Statement, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a pair of ceramic sheets, a pair of glass sheets, or a pair of crystal sheets, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

Claims

CLAIMSWhat is claimed is:

1. A rechargeable implantable device (102) comprising: a housing (306) having a first side (308) and a second side (310) and a cavity (312); a battery (302) positioned in the cavity; one or more recharge coils (304) spaced from the battery; and a divider (314) spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are arranged such that a recharger (130) can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

2. The rechargeable implantable device of claim 1, wherein at least a portion of the housing comprises at least one of a ceramic sheet, a glass sheet, or a crystal sheet.

3. The rechargeable implantable device of any of claims 1 or 2, wherein the one or more recharge coils comprise a first set of recharge traces positioned near the first side and a second set of recharge traces positioned near the second side.

4. The rechargeable implantable device of claim 3, wherein a surface area of the first set of recharge traces is less than a surface area of the second set of recharge traces.

5. The rechargeable implantable device of any preceding claim, wherein the one or more recharge coils form one or more layers along a perimeter of the cavity, the one or more layers extending from the first side to the second side.

6. The rechargeable implantable device of claim 5, wherein the battery is positioned within the one or more recharge coils, and wherein the one or more recharge coils comprises a flat recharge coil.

7. The rechargeable implantable device of claim 1, wherein the one or more recharge coils are maximally sized to occupy a space between the battery and at least one of the first side and the second side.

8. The rechargeable implantable device of any preceding claim, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a ceramic sheet, a glass sheet, or a crystal sheet, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

9. The rechargeable implantable device of claim 8, wherein at least one of the Titanium rings includes a shoulder configured to increase pressure between the ceramic sheet and the Titanium ring during a diffusion bond process.

10. A rechargeable implantable device (102) comprising: a housing (306) having a first side (308) and a second side (310) and a cavity (312); a battery (302) positioned in the cavity; one or more recharge coils (304) spaced from the battery and positioned in the cavity; and a plastic divider (314) spaced between the battery and the one or more recharge coils, wherein the one or more recharge coils are wrapped around an outer portion (316) of the divider and extends from the first side to the second side such that a recharger (130) can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

11. The rechargeable implantable device of claim 10, wherein the housing comprises at least two Titanium rings, each Titanium ring bonded to at least one of a pair of ceramic sheets, a pair of glass sheets, or a pair of crystal sheets, and wherein the two Titanium rings are welded to each other to form a hermetic seal.

12. The rechargeable implantable device of any of claims 10 or 11, wherein the one or more recharge coils form one or more layers along a perimeter of the cavity.

13. The rechargeable implantable device of any preceding claim, wherein the battery is positioned within a center of the one or more recharge coils, and wherein the one or more recharge coils comprises a flat14. A rechargeable implantable device (102) comprising: a housing (306) having a first side (308) and a second side (310) and a cavity (312); a battery (302) positioned in the cavity; one or more flex circuits (324) positioned in the cavity and extending along both the first side and the second side of the housing; a first set of recharge coils (304A) positioned on the flex circuit at the first side; and a second set of recharge coils (304B) positioned on the flex circuit at the second side, wherein a recharger (130) can be positioned adjacent to at least one of the first side or the second side to recharge the rechargeable implantable device.

15. The rechargeable implantable device of claim 14, wherein a surface area of the first set of recharge coils is less than a surface area of the second set of recharge coils.

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