Systems and methods for forming and using an electrode with a titanium alloy strip

Abstract

Systems and methods for forming and using an electrode with a titanium alloy strip. The system may include a lead with a proximal end connectable to an implantable neural stimulator and a distal end that includes an electrode. The electrode may comprise a body and a metal strip disposed at least partially on a surface of the body. The metal strip may comprise a material that is radiopaque, weldable, and resilient.

Description

SYSTEMS AND METHODS FOR FORMING AND USING AN ELECTRODE WITH A TITANIUM ALLOY STRIPCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 530,198, filed August 1, 2023, 2024, the entire content of which is incorporated herein by reference.BACKGROUND

[0002] The present disclosure is generally directed to electrodes, and relates more particularly to electrodes with titanium alloy strip(s).

[0003] Electrical leads may be used for a variety of purposes such as, for example, neuromodulation. In the medical industry, electrical leads may be used to deliver current to an anatomical element, such as a nerve. Some electrical leads may be radiopaque, allowing them to appear on fluoroscopic images. Metal alloys are a popular material for use in the construction of electrical leads.BRIEF SUMMARY

[0004] Example aspects of the present disclosure include:

[0005] A system according to at least one embodiment of the present disclosure comprises an implantable neural stimulator; and a lead with a proximal end connectable to the implantable neural stimulator and a distal end that includes an electrode, the electrode comprising: a body; and a metal strip disposed at least partially on a surface of the body, the metal strip comprising a material that is radiopaque, weldable, and resilient.

[0006] Any of the aspects herein, wherein the material is Titanium-Tantalum-Tin alloy.

[0007] Any of the aspects herein, wherein the Titanium-Tantalum-Tin alloy comprises at least 5% Tin and 50% Ta.

[0008] Any of the aspects herein, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

[0009] Any of the aspects herein, wherein the body comprises a cylindrical portion, the cylindrical portion having an outer surface and an inner surface, and wherein the metal strip is disposed at least partially on the inner surface.

[0010] Any of the aspects herein, wherein the metal strip has a thickness between about 25pm to 100pm.

[0011] Any of the aspects herein, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a target position.

[0012] Any of the aspects herein, wherein after the metal strip is heated, the metal strip is operable to return to the first position after receiving a force to move the metal strip from the target position and after the force is released.

[0013] Any of the aspects herein, wherein the metal strip is in a ring shape in the first position and is unrolled from the ring shape in the second position.

[0014] Any of the aspects herein, wherein the body comprises an elastomer.

[0015] An electrode according to at least one embodiment of the present disclosure comprises an elastomer body having at least a cylindrical portion, the cylindrical portion having an outer surface and an inner surface; and a metal strip disposed at least partially on the inner surface, the metal strip comprising a Titanium-Tantalum-Tin alloy having at least 5% Tin and 50% Ta in weight percentage (wt%).

[0016] Any of the aspects herein, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

[0017] Any of the aspects herein, wherein the metal strip has a thickness between about 25pm to 100pm.

[0018] Any of the aspects herein, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a first position.

[0019] Any of the aspects herein, wherein the metal strip is operable to return to the first position after receiving a force to move the metal strip into a second position and after the force is released.

[0020] Any of the aspects herein, wherein the metal strip is in a ring shape in the first position and is unrolled from the ring shape in the second position.

[0021] A method of manufacturing an electrode according to at least one embodiment of the present disclosure comprises receiving a metal strip; molding an elastomer body over the metal strip to form an electrode; heating the electrode to between about 35°C to about 200°C for more than 10 hours, wherein the metal strip and at least a portion of the elastomer is heated in a target shape; and welding the electrode to a component.

[0022] Any of the aspects herein, further comprising: applying at least one of a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, or Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating or laser texturing or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating to the metal strip.

[0023] Any of the aspects herein, wherein the metal strip has a thickness between about 25 pm to 100pm.

[0024] Any of the aspects herein, wherein the elastomer body comprises at least a cylindrical portion, the cylindrical portion having an outer surface and an inner surface, and wherein the metal strip is disposed at least partially on the inner surface.

[0025] Any aspect in combination with any one or more other aspects.

[0026] Any one or more of the features disclosed herein.

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

[0028] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0029] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .

[0030] Use of any one or more of the aspects or features as disclosed herein.

[0031] 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.

[0032] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0033] 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 XI -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).

[0034] 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.

[0035] 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.

[0036] 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

[0037] 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 limiting the disclosure to only the illustrated and described examples. 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.

[0038] Fig. 1 A is a block diagram of a system according to at least one embodiment of the present disclosure;

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

[0040] Fig. 2 is an image of a lead and electrodes according to at least one embodiment of the present disclosure;

[0041] Fig. 3 A is a stress-strain chart according to at least one embodiment of the present disclosure; and

[0042] Fig. 3B is another stress-strain chart according to at least one embodiment of the present disclosure;

[0043] Fig. 4 is a flowchart according to at least one embodiment of the present disclosure; and

[0044] Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0045] 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.

[0046] 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).

[0047] 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 Al 3 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.

[0048] 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.

[0049] 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.

[0050] Conventional leads having electrodes are commonly used for neuromodulation or neurostimulation. In particular, for Vagus nerve stimulation, at least a portion of an electrode is commonly shaped or formed into a ring shape (e.g., a cuff electrode) after molding the electrode. In order to form the ring shape, the electrode has to be heat processed and positioned in the ring shape at a polymer process temperature range. However, the ring-shaped portion of the electrode also has to have enough resilience or spring back to return to the ring shape after the ring-shaped portion is unrolled during, for example, installation of the electrode and lead. Conventional electrodes are not resilient and are not able to spring back to a target shape.

[0051] In at least one embodiment of the present disclosure, the electrode comprises a metal alloy strip comprising a beta Titanium (Ti) alloy such as, for example, Titanium-Tantalum-Tin (TiTaSn) alloy and a polymer body. During fabrication, the TiTaSn strip is capable of forming the ring shape (whether before or after molding the electrode) at a low temperature below, for example, 200°C and maintain its shape after unrolling during implant procedures. In electrodes (whether a cuff electrode, a paddle electrode, or any other electrode), the TiTaSn strip has the property to be resilient and able to spring back to a target position. The TiTaSn strip may be about 30 micrometers (pm) thick. Dueto low temperature heat setting characteristics of the TiTaSn strip within the temperature range of the polymer body remaining within a solid state, a cuff configuration can be formed after initial molding. After heat setting the TiTaSn strip and cooling the TiTaSn strip back to about 37°C or to room temperature, the TiTaSn strip (and electrode body) can now be opened allowing it to be placed on a nerve and when released, will snap back into the shape formed during the heat setting process. The TiTaSn strip will allow a user such as, for example, a surgeon to easily place an electrode and lead onto a target anatomical element such as the Vagus nerve.

[0052] In embodiments where the electrode is paddle shape for use in, for example, high displacement areas, the TiTaSn metal strip is able to endure high displacement cyclic cycles. This enables the lead having an electrode with a TiTaSn strip to be put into many high displacement and high cyclic cycle locations for electrical stimulation.

[0053] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) forming a resilient electrode that is capable of returning to a target position after being moved from the target position, (2) forming a resilient electrode at low temperatures such as, for example, a polymer process temperature, and (3) forming a resilient electrode that is also radiopaque and weldable.

[0054] Turning to Figs. 1A-1B, a system 100 may be used to control, pose, and / or otherwise manipulate an implanted device and / or an implanted electrode for the purpose of, for example, providing neuromodulation or neurostimulation and / or carry out one or more other aspects of one or more of the methods disclosed herein. The system 100 comprises a computing device 102, a database 130, a cloud or other network 134, and / or a surgical device 136. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include the database 130 and / or the cloud 134.

[0055] The computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102.

[0056] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions 122 stored in the memory 106, which instructions 122 may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the database 130, the surgical device 136, and / or the cloud 134.

[0057] The memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and / or instructions. The memory 106 may store information or data useful for completing, for example, any step of the methods 400 and / or 500 described herein, or of any other methods. The memory 106 may store, for example, instructions and / or machine learning models that support one or more functions of the surgical device 136. For instance, the memory 106 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 104, enable electrical stimulation optimization 120.

[0058] The electrical signal optimization 120 may correspond to a routine executed by the processor 104 to optimize the electrical signal used in neuromodulation. Optimization may be achieved by adjusting signal frequency, adjusting signal type (e.g., square wave, sinusoidal wave, triangle wave, etc.), adjusting duty cycle, adjusting treatment duration, etc. More specifically, the electrical signal optimization 120 may enable the processor 104 to determine one or more parameters of the electrical signal. The electrical signal optimization 120 may also enable the processor 104 to determine or adjust one or more parameters of the electrical signal based on, for example, patient feedback, medical provider input, a physiological response recorded during stimulation of the target anatomical element, etc.

[0059] Such content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. Thus, although various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate data stored in the memory 106 and / or received from or via the surgical device 136 and / or the cloud 134.

[0060] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving data such as neuromodulation data or other information from an external source (such as the surgical device 136, the database 130, the cloud 134, and / or any other system or component not part of the system 100), and / or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the surgical device 136, the database 130, the cloud 134, and / or any other system or component not part of the system 100). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive information via one ormore wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0061] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a medical provider or user to modify instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.

[0062] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computing device 102.

[0063] The database 130 may store information such as patient data, results of neuromodulation therapy, neuromodulation parameters, electrical signal parameters, electrode parameters, etc. The database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records.

[0064] The cloud 134 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computingdevice 102 may communicate with the database 130 and / or an external device (e.g., a computing device) via the cloud 134.

[0065] With reference to Figs. 1 A and IB, the system 100 also includes a surgical device 136 (also referred to herein as a neural stimulator, an implantable neural stimulator (INS), pulse generator, and / or implantable pulse generator) with one or more leads 140 that are implanted into a patient. 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 or pharmaceutical agents directly to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments of a patient, such as chronic pain. Accordingly, as described herein, the neuromodulation techniques may be used for blocking pain signals sent to a patient’s brain to relieve chronic pain among other applications. For example, the surgical device 136 may provide electrical stimulation to one or more nerves in the spinal cord of the patient (e.g., via the one or more leads 140) to block the pain signals from being received by the brain. In other examples, the surgical device 136 may provide electrical stimulation to the brain.

[0066] The surgical device 136 may include leads 140, electrodes 144, and / or one or more sensors 148. In some embodiments the surgical device 136 may not include one or more components such as, for example, the one or more sensors 148. The surgical device 136 may be an instrument or implantable device capable of providing electric signals to the electrodes 144 disposed on the distal ends of the leads 140 to cause the electrodes 144 to stimulate proximate patient tissue, one or more anatomical elements (e.g., the spinal cord, one or more nerves, etc.), combinations thereof, and the like. For example, the surgical device 136 may receive instructions such as the instructions 122 from the computing device 102 to generate an electrical pulse capable of providing a stimulation to a nerve 134 of the patient. While nerves and patient tissue are discussed herein, it is to be understood that the electrode may be implanted anywhere within the patient or be disposed on any exterior surface of the patient to stimulate any anatomical tissue or element. As illustrated in Fig. IB, the surgical device 136 may be a device capable of being surgically implanted within the patient. In such embodiments, the surgical device 136 may communicate with the computing device 102 or other components of the system 100 wirelessly. Alternatively, the surgical device 136 may be disposed outside the patient, with the leads 140 and the electrodes 144 being surgically implanted in instances, such as, for example, when the surgical device 136 is being tested. In some embodiments, the leads 140 may be placed parallel with the spinal column of the patient.

[0067] In some examples, the leads 140 may include one lead 140. In other embodiments, the leads 140 may include multiple leads 140. The lead 140 may be implanted on or near any targetanatomical element. In some examples, the lead 140 is implanted near the spinal cord and more specifically, in the epidural space between the spinal cord and the vertebrae. Once implanted, the lead 140 may provide an electrical signal (whether stimulating or blocking) from surgical device 136 to the target anatomical element (e.g., one or more nerves in the spinal cord, the brain, etc.).

[0068] In some examples, the leads 140 may provide the electrical signals to the respective nerves via the electrodes 144 that are connected to the nerves (e.g., sutured in place, wrapped around the nerves, etc.). In some examples, the leads 140 may be referenced as cuff electrodes or may otherwise include the cuff electrodes (e.g., at an end of the leads 140 not connected or plugged into the surgical device 136). Additionally or alternatively, while shown as physical wires that provide the connection between the surgical device 136 and the one or more nerves, the electrodes may provide the electrical signals to the one or more nerves wirelessly (e.g., with or without the surgical device 136).

[0069] In some embodiments, the electrodes 144 may be disposed on opposite sides of the nerve 134 (e.g., on opposite sides of the spinal cord of the patient). The position and / or orientation of each electrode 144 relative to nerve 134 may vary depending on, for example, the type of treatment, the type of electrode, combinations thereof, and the like. In some examples, the current being applied to each side of the nerve 134 may be different for each electrode 144. For example, a first electrode may apply a high frequency stimulation (e.g., such as a given waveform at about 5 kHz) and a second electrode may apply a low frequency stimulation (e.g., such as a square wave or other waveform at 1Hz) to provide an electrical stimulation signal to the nerve 134. The electrode 144 may also provide directional stimulation.

[0070] In some embodiments the electrodes may comprise stimulating electrodes (e.g., electrodes configured to stimulate a target anatomical element) or recording electrodes (e.g., electrodes configured to record a physiological response to the stimulation). In some embodiments, the lead 108 may comprise both stimulating electrodes and recording electrodes. Alternatively or additionally, one lead may comprise stimulating electrodes and another lead may comprise recording electrodes.

[0071] In some embodiments, the surgical device 136 may include a single electrode 144, while in other embodiments, two or more electrodes 144 may be used. In one embodiment, the electrodes 144 may be disposed proximate target anatomical elements, anatomical tissue, and / or anatomical regions. Additionally, while not shown, the surgical device 136 may include one or more processors similar to the processor 104 (e.g., one or more DSPs, general purpose microprocessors, graphics processing units, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry) shown and described in Fig. 1 A that are programmed to carry out one or more aspects of the present disclosure. In someexamples, the one or more processors may include a memory or may be otherwise configured to perform the aspects of the present disclosure. For example, the one or more processors may provide instructions 122 to the surgical device 136 based on the electrical stimulation optimization 120 to perform an electrical stimulation of the nerve 134 by passing a current through the electrodes 144.

[0072] In one embodiment, the surgical device 136 may be or comprise an INS. The INS may be implanted in the patient and attached to the electrodes 144, such that the INS can send an electrical pulse to the electrodes 144 to stimulate target patient anatomical elements, regions, or tissue. Additionally or alternatively, the INS may also use the one or more sensors 148. The sensors 148 may be or comprise micro electrical-mechanical system (MEMS) sensors and / or biological sensors capable of generating information related to one or more measured parameters to enable the INS to sense one or conditions for the purposes of determining whether or not to generate an electrical pulse. For example, the sensors 148 may comprise biosensors that can detect or monitor neurophysiological signals entering or exiting specific organs proximate the INS and / or other parameters associated with the patient (e.g., heart rate, respiration rate, etc.). As another example, the sensors 148 may detect information related to physiological responses to neuromodulation and send such information to the processor 104. The processor 104 may, based on the information from the sensors 148 and using the electrical stimulation optimization 120, determine that the INS should adjust the stimulation parameters of the electrodes 144. Alternatively, the electrodes 144 may be used to sense electrical signals within the body tissue to provide for closed loop control of the electrical stimulation.

[0073] The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the methods 400 and / or 500 described herein. The system 100 or similar systems may also be used for other purposes.

[0074] It is to be understood that, while the electrodes 144 are discussed with respect to the system 100, such discussion is in no way limiting, and the electrodes 144 may be used in any other system and method not discussed herein. The electrodes 144 may also be fabricated in any context, and may be further used in any context, such as during a surgery or surgical procedure, during any medical procedure, during any non-medical procedure, etc.

[0075] Turning to Fig. 2, a lead 240 and electrodes 244 according to at least one embodiment of the present disclosure are shown. The lead 240 may be the same as or similar to the lead 140 and the electrodes 244 may be the same as or similar to the electrodes 144. The lead 240 may have a first end (not shown) connectable to a surgical device such as the surgical device 136 and a second end or distal end 212 that includes one or more electrodes 244.

[0076] The electrodes 244 may each include a body 202. The body 202 may be a solid body with a continuous surface or the body 202 may be, for example, a stent. The body 202 may be formed from a polymer material such as, for example, an elastomer, polyurethane, etc. The body 202 may have a first end 206 and a second end 208. The body may have at least a ring-shaped or cylindrical portion 210 at the first end 206 and be connected to the lead 240 at the second end 208. The cylindrical portion 210 is sized to fit over a target anatomical element such as, for example, a nerve. A diameter of the cylindrical portion 210 may be about 2mm or about 4mm. It will be appreciated that in other embodiments the diameter of the cylindrical portion 210 may be less than 3mm, greater than 4mm, or between 3mm and 4mm. The cylindrical portion 210 of the body 202 includes an inner surface 214 and an outer surface 216. The electrodes 244 may each further include at least one metal strip 218 disposed at least partially on the inner surface 214.

[0077] The metal strip 218 may have a thickness between about 25pm to about 100pm. In other embodiments, the metal strip 218 may have a thickness less than 25 pm or greater than 100 pm. The metal strip 218 may include a metal alloy that is refractory, radiopaque, weldable, and capable of being resilient after heat setting with the body 202. The metal strip 218 may include, for example, a Titanium alloy such as a Titanium-Tantalum-Tin (TiTaSn) alloy. In some embodiments, the TiTaSn alloy may comprise about 52% Ta, 5% Sn and balanced Ti, or at least 5% Tin and 50% Ta in weight percentage (wt%). It will be appreciated that in other embodiments the TiTaSn alloy may comprise less than 5% Tin. In other embodiments, the metal alloy may not be, for example, radiopaque. For example, in some embodiments, the metal strip may comprise other beta Ti alloys which contain alloy elements such as, for example, Ta, Nb, Mo, Zr, and / or Sn.

[0078] The metal strip 218 may be coated with a high surface area (HSA) coating such as, for example, a Titanium-Nitride (TiN), iridium oxide (IrOx), fractal platinum (Pt), platinum black coating, or conductive polymer poly(3,4-ethylenedioxythiophene) (PEDOT)-based coating to increase a charge injection capacity of the metal strip 218. The aforementioned HSA coating shall be applied via a robust and capable processes such that coating does not flake off from the metal strip 218, and can result in more efficient stimulation and improved sensing. Alternatively, the metal strip 218 may have a surface treatment such as, for example, a laser texturing applied to the metal strip 218 for increasing the charge injection capacity of the metal strip 218. Additionally, the metal strip 218 may have smooth platinum (Pt) or platinum iridium (Ptlr) alloy coating applied to achieve sufficient charge injection capacity for chronic stimulation and sensing. The metal strip 218 may be coated or treated on, for example, a surface that contacts the target anatomical element (e.g., a Vagus nerve).

[0079] As previously described, the metal strip 218 is capable of being resilient after heat setting with the body 202. More specifically, the body 202 may be joined to or molded to or with the metal strip(s) 218. The body 202 and the metal strip 218 may then be heated to a polymer process temperature range between about 35°C to about 200°C for more than 10 hours in a target position. The target position may be, for example, a ring shape such as the cylindrical portion 210 described above. It will be appreciated that in some embodiments, the body 202 and the metal strip 218 may be heated in the target position prior to being joined or molded together. To achieve the target position or shape, the body 202 and the metal strip 218 may be wrapped around a rod with a desired diameter during the heat setting. After the heat setting, the body 202 and the metal strip 218 are removed from the rod and as a result are resilient and capable of returning to the target position when moved from the target position and released. For example, the body 202 and the metal strip 218 may be unrolled and when released, may return to the target rolled position. This is beneficial where, for example, a user such as a surgeon is placing the electrode 144 onto a nerve such as, for example, the Vagus nerve. It will be appreciated that conventional metal alloys may not be able to be heat setting at low temperatures and form such resilience in the target position. Conventional metals typically form such resilience at much higher temperatures where polymers liquify. Thus, the metal strip 218 when formed of the TiTaSn alloy beneficially enables the metal strip to be formed at low temperatures when the body 202 is a polymer in a solid state.

[0080] Though not shown, the body 202 may not include the cylindrical portion 210 and may comprise a flat paddle. In such instances, the flat paddle is not heated and is formed after the body 202 is joined with the metal strip(s) 218. The metal strip 218 beneficially provides support to the flat paddle in high-displacement or high-cyclic areas such as, for example, the wrist, knee, shoulders, etc. as the metal strip 218 is able to endure high displacement cyclic cycles.

[0081] Turning to Figs 3A and 3B, a cyclic stress-strain chart 300 and a detailed view 306 of the cyclic stress-strain chart 300 are respectively shown. The cyclic stress-strain chart 300 illustrates a cyclic tensile curve 302 for a beta-annealed TiTaSn metal strip undergoing a cyclic tensile test. The detailed view 306 of the cyclic stress-strain chart 300 illustrates that the stress begins at about 1.4 ksi. As shown, the cyclic tensile curve shows a non-elastic region up to about 1.2% 304, however, the elastic limit of TiTaSn is larger than 1.2% 304, however, the return cycles are still within the elastic limit of TiTaSn as shown in the enlarged view 306 since the cycle returns nearly to zero. Thus, this indicates that the TiTaSn has a high spring-back property or resilience, which enables the metal strip 218 to return to the target position when moved from the target position and released.

[0082] Fig. 4 depicts a method 400 that may be used, for example, for forming an electrode such as the electrode 144, 244.

[0083] The method 400 comprises receiving a metal strip (step 404). The metal strip may be received from, for example, a metal alloy supplier or manufacturer. In other instances, components of the metal strip may be received from a metal supplier and the metal alloy may be formed from the separate components. The metal strip may be the same as or similar to the metal strip 218. The metal strip, as previously described, may have a thickness between about 25pm to about 100pm. In other embodiments, the metal strip may have a thickness less than 25pm or great than 100pm. The metal strip may include a metal alloy that is refractory, radiopaque, weldable, and / or capable of being resilient after heat treatment. The metal strip may include, for example, a Titanium alloy such as a Titanium-Tantalum-Tin (TiTaSn) alloy. In some embodiments, the TiTaSn alloy may comprise 52% Ta and about 5% Tin and balance Ti or at least 50% Ta and 5% Tin in wt%. It will be appreciated that in other embodiments the TiTaSn alloy may comprise less than 50% Ta and 5% Tin. It will be appreciated that in some embodiments, the metal alloy may not be, for example, radiopaque. For example, in some embodiments, the metal strip may comprise other beta Ti alloys which contain alloy elements such as, for example, Ta, Nb, Mo, Zr, and / or Sn.

[0084] The method 400 also comprises performing a treatment on the metal strip (step 408). In some embodiments the treatment may be performed by the metal or metal alloy supplier or manufacturer (which may be the same metal or metal alloy supplier or manufacturer providing the metal strip in the step 404 above). The metal strip may be cold rolled, hot rolled, heat treated, annealed, tempered, etc.

[0085] The method 400 also comprises molding an elastomer body over the metal strip to form an electrode (step 412). The body may be molded over the metal strip using a mold in a desired shape of the electrode. The body may be the same as or similar to the body 202 and the electrode may be the same as or similar to the electrode 144, 244. As previously described, the body may be a solid body with a continuous surface or the body may be, for example, a stent. The body may be formed from a polymer material such as, for example, an elastomer, polyurethane, etc. The body may have a first end such as the first end 206 and a second end such as the second end 208. The body may have at least a ring-shaped or cylindrical portion such as the cylindrical portion 210 at the first end and connected to a lead such as the lead 140, 240 at the second end. The cylindrical portion is sized to fit over a target anatomical element such as, for example, a nerve. The cylindrical portion of the body includes an inner surface such as the inner surface 214 and an outer surface such as the outer surface218. The metal strip may be disposed at least partially on the inner surface when the body is over molded onto the metal strip.

[0086] In some embodiments, the body may not include the cylindrical portion and may comprise a flat paddle. In such instances, the flat paddle is not heated and is formed after the body is joined with the metal strip(s). The metal strip beneficially provides support to the flat paddle in high- displacement or high-cyclic areas such as, for example, the wrist, knee, shoulders, etc. as the metal strip is able to endure high displacement cyclic cycles.

[0087] The method 400 also comprises heating the electrode (step 416). The electrode may be heated in, for example, an industrial oven or a conventional oven. The electrode may be heated to a polymer process temperature range between about 35°C to about 200°C for more than 10 hours in a target position. The target position may be, for example, a ring shape such as the cylindrical portion described above. After the heat setting, the body and the metal strip may be resilient and may return to the target position when moved from the target position and released. For example, the body and the metal strip may be unrolled and when released, may return to the target rolled position. The metal strip, when formed of the TiTaSn alloy, beneficially enables the metal strip to be formed at low temperatures with the body in a solid state when the body is formed from a polymer.

[0088] It will be appreciated that in some embodiments, the step 416 may occur prior to the step 412. In other words, the body and the metal strip may be heated in the target position prior to being joined or molded together.

[0089] The method 400 also comprises welding the electrode to a component (step 420). The electrode may be welded to, for example, a wire. More specifically, in some embodiments, the wire may comprise a beta Titanium alloy wire such as, for example, a Titanium-Molybdenum alloy such as Ti-15Mo. The electrode can be welded using any type of welding such as, for example, laser welding or resistance welding.

[0090] The method 400 also comprises coating the metal strip (step 424). The metal strip may be coated with a high surface area coating such as, for example, a Titanium-Nitride (TiN) for increasing a charge density of the metal strip. The Titanium-Nitride is also beneficially mechanically resilient, does not flake off, and an increased accuracy and / or efficiency of sensing. Alternatively or additionally, the metal strip may have a surface treatment such as, for example, a laser texturing applied to the metal strip for increasing the charge density of the metal strip. The metal strip may be coated or treated on, for example, a surface that contacts the target anatomical element (e.g., a Vagus nerve).

[0091] It will be appreciated that the method 400 may not include the step 424. In other words, the metal strip may not be coated in some examples.

[0092] It will also be appreciated that the step 424 may be performed prior to the step 420 and after the step 416. In other words, the step may be performed between the step 416 and the step 420 depending on the coating type applied and / or whether laser texturing is applied. For example, a TiN, IrOx, fractal Pt coating, and / or smooth Pt / Ptlr coating can be applied after the step 416 (heating the electrode) and prior to the step 420 (welding the electrode to the component). In another example, laser texturing, a conductive polymer PEDOT-based coating, and / or platinum black coating can be applied after the step 420 (welding the electrode to the component).

[0093] The present disclosure encompasses embodiments of the method 400 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0094] Fig. 5 depicts a method 500 that may be used, for example, for using a surgical device such as the surgical device 136 with an electrode such as the electrode 144, 244.

[0095] The method 500 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 described above. The at least one processor may be part of a surgical device such as the surgical device 136. A processor other than any processor described herein may also be used to execute the method 500. The at least one processor may perform the method 500 by executing elements stored in a memory such as the memory 106. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 500. One or more portions of a method 500 may be performed by the processor executing any of the contents of memory, such as electrical stimulation optimization 120.

[0096] The method 500 comprises inserting an electrode into a surgical site (step 504). The electrode may be formed using the method 400 described above. The electrode may be the same as or similar to the electrode 144, 244. The electrode may be disposed at an end of a lead such as the lead 140, 240. In other embodiments, the electrode may be disposed on any portion of the lead. The electrode may have a body such as the body 202 and a cylindrical portion such as the cylindrical portion 210. As previously described, a metal strip such as the metal strip 218 may be disposed on an inner surface of the cylindrical portion. The electrode (e.g., the body and the metal strip) may be resilient so as to return to the cylindrical shape when unrolled and released. Thus, during installation, the cylindrical portion of the electrode can be unrolled, placed over a target anatomical element suchas, for example, a nerve, and released such that the electrode returns to the cylindrical shape over the nerve.

[0097] The lead may be connected to a surgical device such as the surgical device 136. As previously described, the surgical device may be an instrument or implantable device capable of providing electric signals to the electrodes disposed on the distal ends of the leads to cause the electrodes to stimulate proximate patient tissue, one or more anatomical elements (e.g., the spinal cord, one or more nerves, etc.), combinations thereof, and the like. For example, the surgical device may receive instructions such as the instructions 122 from a computing device such as the computing device 102 to generate an electrical pulse capable of providing a stimulation to a nerve of the patient via the electrode. The surgical device may be implantable or may be positioned external to the patient.

[0098] The electrodes may comprise stimulating electrodes (e.g., electrodes configured to stimulate a target anatomical element) or recording electrodes (e.g., electrodes configured to record a physiological response to the stimulation). In some embodiments, the lead may comprise both stimulating electrodes and recording electrodes. Alternatively or additionally, one lead may comprise stimulating electrodes and another lead may comprise recording electrodes.

[0099] The method 500 also comprises receiving information associated with one or more parameters of neuromodulation (step 508). The information may be received as user input from, for example, a user interface such as the user interface 110. The user input may include desired parameters of the neuromodulation, a duration of the neuromodulation, a frequency of the neuromodulation, etc. Additionally or alternatively, the information may be received from a recording electrode. In other embodiments, the received information may be from one or more sensors (e.g., sensors 148). The information (whether from a user, the recording electrode, or sensors) may be used by a processor such as the processor as input into an electrical stimulation optimization such as the electrical stimulation optimization 120. The electrical stimulation optimization may output one or more parameters and / or one or more adjusted parameters of the neuromodulation.

[0100] The method 500 also comprises causing the surgical device to implement the neuromodulation (step 512). The processor may send one or more instructions such as the instructions 122 to the surgical device to cause the surgical device to perform the neuromodulation. More specifically, the surgical device may cause the electrodes to emit an electrical stimulation for a duration to a target anatomical element. The instructions 122 may be based on the one or moreparameters and / or the one or more adjusted parameters outputted by the electrical stimulation optimization.

[0101] The present disclosure encompasses embodiments of the method 500 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0102] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Figs. 4 and 5 (and the corresponding description of the methods 400 and 500), as well as methods that include additional steps beyond those identified in Figs. 4 and 5 (and the corresponding description of the methods 400 and 500). 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.

[0103] 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.

[0104] 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 extent permitted, including alternate, interchangeable and / or equivalent 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.

[0105] Example 1. A system, comprising:an implantable neural stimulator; and a lead with a proximal end connectable to the implantable neural stimulator and a distal end that includes an electrode, the electrode comprising: a body; and a metal strip disposed at least partially on a surface of the body, the metal strip comprising a material that is radiopaque, weldable, and resilient.

[0106] Example 2. The system of example 1, wherein the material is Titanium-Tantalum-Tin alloy.

[0107] Example 3. The system of example 2, wherein the Titanium-Tantalum-Tin alloy comprises at least 5% Tin and 50% Ta.

[0108] Example 4. The system of example 1, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

[0109] Example 5. The system of example 1, wherein the body comprises a cylindrical portion, the cylindrical portion having an outer surface and an inner surface, and wherein the metal strip is disposed at least partially on the inner surface.

[0110] Example 6. The system of example 1, wherein the metal strip has a thickness between about 25 pm to 100pm.

[0111] Example 7. The system of example 1, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a target position.

[0112] Example 8. The system of example 7, wherein after the metal strip is heated, the metal strip is operable to return to the first position after receiving a force to move the metal strip from the target position and after the force is released.

[0113] Example 9. The system of example 8, wherein the metal strip is in a ring shape in the first position and is unrolled from the ring shape in the second position.

[0114] Example 10. The system of example 1, wherein the body comprises an elastomer.

[0115] Example 11. An electrode comprising: an elastomer body having at least a cylindrical portion, the cylindrical portion having an outer surface and an inner surface; and a metal strip disposed at least partially on the inner surface, the metal strip comprising a Titanium-Tantalum-Tin alloy having at least 5% Tin and 50% Ta in weight percentage (wt%).

[0116] Exa,[;e 12. The electrode of example 11, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

[0117] Example 13. The electrode of example 11, wherein the metal strip has a thickness between about 25 pm to 100pm.

[0118] Example 14. The electrode of example 11, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a first position.

[0119] Example 15. The electrode of example 14, wherein the metal strip is operable to return to the first position after receiving a force to move the metal strip into a second position and after the force is released.

[0120] Example 16. The electrode of example 15, wherein the metal strip is in a ring shape in the first position and is unrolled from the ring shape in the second position.

[0121] Example 17. A method of manufacturing an electrode comprising: receiving a metal strip; molding an elastomer body over the metal strip to form an electrode; heating the electrode to between about 35°C to about 200°C for more than 10 hours, wherein the metal strip and at least a portion of the elastomer is heated in a target shape; and welding the electrode to a component.

[0122] Example 18. The method of example 17, further comprising:

[0123] applying at least one of a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, or Conductive Polymer Poly (3,4- ethylenedioxythiophene) (PEDOT)-based coating or laser texturing or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating to the metal strip.

[0124] Example 19. The method of example 17, wherein the metal strip has a thickness between about 25 pm to 100pm.

[0125] Example 20. The method of example 17, wherein the elastomer body comprises at least a cylindrical portion, the cylindrical portion having an outer surface and an inner surface, and wherein the metal strip is disposed at least partially on the inner surface.

Claims

CLAIMSWhat is claimed is:

1. A system (100), comprising: an implantable neural stimulator (136); and a lead (140) with a proximal end connectable to the implantable neural stimulator and a distal end (212) that includes an electrode (144, 244), the electrode comprising: a body (202); and a metal strip (218) disposed at least partially on a surface (214) of the body, the metal strip comprising a material that is radiopaque, weldable, and resilient.

2. The system of claim 1, wherein the material is Titanium-Tantalum-Tin alloy.

3. The system of claim 2, wherein the Titanium-Tantalum-Tin alloy comprises at least 5% Tin and 50% Ta.

4. The system of claim 1, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

5. The system of claim 1, wherein the body comprises a cylindrical portion (210), the cylindrical portion having an outer surface (216) and an inner surface (214), and wherein the metal strip is disposed at least partially on the inner surface.

6. The system of claim 1, wherein the metal strip has a thickness between about 25pm to 100pm.

7. The system of claim 1, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a target position.

8. The system of claim 7, wherein after the metal strip is heated, the metal strip is operable to return to the first position after receiving a force to move the metal strip from the target position and after the force is released.

9. The system of claim 8, wherein the metal strip is in a ring shape in the first position and is unrolled from the ring shape in the second position.

10. The system of claim 1, wherein the body comprises an elastomer.

11. An electrode (144) comprising: an elastomer body (202) having at least a cylindrical portion (210), the cylindrical portion having an outer surface (216) and an inner surface (214); and a metal strip (218) disposed at least partially on the inner surface, the metal strip comprising a Titanium-Tantalum-Tin alloy having at least 5% Tin and 50% Ta in weight percentage (wt%).

12. The electrode of claim 11, wherein at least one of a laser texturing or a coating of at least one of Titanium-Nitride (TiN), Iridium Oxide (IrOx), Fractal Platinum (Pt), Platinum (Pt) black coating, Conductive Polymer Poly (3,4-ethylenedioxythiophene) (PEDOT)-based coating, or smooth Platinum (Pt) or Platinum Iridium (Ptlr) alloy coating is applied to a surface of the metal strip.

13. The electrode of claim 11, wherein the metal strip has a thickness between about 25pm to 100pm.

14. The electrode of claim 11, wherein the metal strip is heated to between about 35°C to about 200°C for more than 10 hours in a first position.

15. The electrode of claim 14, wherein the metal strip is operable to return to the first position after receiving a force to move the metal strip into a second position and after the force is released.

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