Implantable stimulating assembly with variable shape
By employing shape memory alloys to control the shape of electrode arrays in cochlear implants, the insertion process is optimized, reducing trauma and enhancing the effectiveness and comfort of the device.
Patent Information
- Application Number
- PCT/IB2025/056140
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-17
- Filing Date
- 2025-06-16
- Publication Date
- 2025-12-26
AI Technical Summary
Existing medical devices, such as cochlear implants, face challenges in efficiently inserting and positioning electrode arrays within the complex anatomy of the cochlea, often causing trauma and potential inflammation due to improper alignment and contact with delicate tissues.
The use of shape memory alloys (SMA) in the electrode arrays, controlled by electrical current, allows for rapid shape changes to optimize the insertion trajectory, minimizing trauma and improving alignment with the cochlear structure.
This approach reduces trauma and enhances the efficiency of electrode array placement, maintaining effective stimulation and reducing complications like impedance and fibrotic reactions, thereby improving the functionality and comfort of the implant.
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Figure IB2025056140_26122025_PF_FP_ABST
Abstract
Description
IMPLANTABLE STIMULATING ASSEMBLY WITH VARIABLE SHAPECROSS-REFERENCE TO RELATED APPLICATIONS[oooi] This application claims priority to U.S. Provisional Application No. 63 / 660,708, entitled IMPLANTABLE STIMULATING ASSEMBLY WITH VARIABLE SHAPE, filed on June 17, 2024, naming Peter GIBSON as an inventor, the entire contents of that application being incorporated herein by reference in its entirety.BACKGROUND
[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.
[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY
[0004] In an embodiment, there is a device, comprising at least a portion of an electrical conduction circuit and a carrier carrying the least a portion of the electrical conduction circuit, wherein the device is configured to change a shape of the carrier as a result of a change in a direction of direct current in the at least a portion of the electrical conduction circuit.
[0005] In an embodiment, there is a device, comprising at least a portion of an electrical conduction circuit and a carrier carrying at least a portion of the at least a portion of the electrical conduction circuit, wherein the electrical conduction circuit includes material that changes shape with temperature, the carrier carries the material that changes shape with temperature, and the at least a portion of the electrical conduction circuit has a first number of electrical inputs, any two of which inputs of electrical inputs enable closure of a circuit path of the at least a portion of the electrical conduction circuit, wherein there are more closeable circuit paths than electrical inputs.
[0006] In an embodiment, there is a device, comprising an electrically conductive path and one or more electrodes, wherein the electrically conductive path includes material that changes shape when exposed to electrical current, and the device is configured to vary a location of current application to the material and / or a location of a current path to ground / neutral from the material.
[0007] In an embodiment, there is a method, comprising inserting a variable shape medical device into a cavity of a human an applying electrical current to a portion of the medical device to vary a shape of the medical device, wherein the portion of the device includes a shape changing material that changes a shape of the device upon application of the electrical current thereto, thereby varying the shape of the medical device, the shape changing material establishes a conductive component that has a longitudinal direction, and the method includes flowing electrical current of the applied electrical current through different amounts and / or portions of the conductive component to vary the shape of the medical device.
[0008] In an embodiment, there is a device, comprising a conductive member and an output component, wherein the device is configured to enable an applied electrical current applied to the conductive member to bypass a first portion of the conductive member while flowing in a second portion of the conductive member, the conductive member is a shape changing member that changes shape when exposed to the electrical current, and the device is a medical device.
[0009] In an embodiment, there is a cochlear implant, comprising a conductive shape changing material elongate member and an array of electrodes and an inductance communication system and / or a power storage device, wherein the device is configured to enable electrical current from the inductance communication system and / or from the power storage device that is applied to the conductive shape changing material elongate member to bypass a first portionof the conductive member while flowing in a second portion of the conductive member, and the conductive member changes shape when exposed to the electrical current.BRIEF DESCRIPTION OF THE DRAWINGS[ooio] Embodiments of the present invention are described below with reference to the attached drawings, in which:
[0011] FIG. 1A is a perspective view of an exemplary hearing prosthesis utilized in some exemplary embodiments;
[0012] FIG. IB is a side view of the implantable components of the cochlear implant illustrated in FIG. 1A;
[0013] FIG. 1C is a side view of an embodiment of the electrode array illustrated in FIGs. 1 A and IB in a curled orientation;
[0014] FIG. ID is a functional schematic of a retinal implant;
[0015] FIG. 2 is a functional schematic of a cochlear implant (external and implantable components);
[0016] FIG. 3 A is a functional schematic of an electrode array including 22 electrodes spaced apart from one another;
[0017] FIG. 3B is a side view of an exemplary electrode array and a lead apparatus extending thereto;
[0018] FIG. 3C is a cross-sectional view of an electrode array;
[0019] FIGs. 4 and 6-14 and 17-26 and 33-35 are cross-sectional views of a portion of an intra- cochlear portion of a cochlear implant electrode array;
[0020] FIG. 5 shows exemplary lead and SMA component(s) according to an embodiment;
[0021] FIGs. 15 and 16 show a stimulating assembly and depending on the embodiment, additional components;
[0022] FIG. 27 is a flowchart for an exemplary method;
[0023] FIGs. 28A-28D show an exemplary cochlear implant array insertion;
[0024] FIGs. 29-32 show cross-sections of exemplary electrode arrays on a plane normal to the longitudinal axis of the array; and
[0025] FIGs. 36 and 37 show features of an alternate embodiment.DETAILED DESCRIPTION
[0026] Merely for ease of description, the techniques presented herein are described herein with reference by way of background to an illustrative medical device, namely a cochlear implant. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from setting changes based on the location of the medical device. For example, the techniques presented herein may be used to determine the viability of various types of prostheses, such as, for example, a vestibular implant and / or a retinal implant, with respect to a particular human being. And with regard to the latter, the techniques presented herein are also described with reference by way of background to another illustrative medical device, namely a retinal implant. The techniques presented herein are also applicable to the technology of vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation, etc.
[0027] Also, embodiments are directed to other types of hearing prostheses, such as middle ear implants, bone conduction devices (active transcutaneous, passive transcutaneous, percutaneous), and conventional hearing aids. Thus, embodiments are directed to devices that include implantable portions and embodiments that do not include implantable portions.
[0028] Any reference to one of the above-noted sensory prostheses corresponds to an alternate disclosure using one of the other above-noted sensory prostheses unless otherwise noted, providing that the art enables such.
[0029] FIG. 1 A is a perspective view of a totally implantable cochlear implant according to an exemplary embodiment, referred to as cochlear implant 100, with the implantable portion implanted in a recipient. The cochlear implant 100 is part of a system 10 that can include external components, as will be detailed below.
[0030] In an alternate embodiment, the cochlear implant system is not a totally implantable system. By way of example, the cochlear implant system includes an external component that includes a microphone and a sound processor. The sound processor processes signals from the microphone, and generates a signal that is transmitted transcutaneously to an implantable component which then uses the signal to stimulate tissue and evoke a hearing percept.
[0031] It is noted that in some conventional parlances, the entire system 10 is referred to as a cochlear implant, especially in the case of a cochlear implant that is not totally implantable. Herein, the phrase cochlear implant refers to the implantable component, and the phrase cochlear implant system refers to the entire system 10. That is, the phrase cochlear implant corresponds to the implantable component of a non-totally implantable cochlear implant system.
[0032] The recipient has an outer ear 101, a middle ear 105 and an inner ear 107. Components of outer ear 101, middle ear 105 and inner ear 107 are described below, followed by a description of cochlear implant 100.
[0033] In a fully functional ear, outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102. Disposed across the distal end of ear canal 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109 and the stapes 111. Bones 108, 109, and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to vibration of tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside of cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.
[0034] As shown, cochlear implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient. Cochlear implant 100 is shown in FIG. 1A with an external device 142, that is part of system 10 (along with cochlear implant 100), which, as described below, is configured to provide power to the cochlear implant. The implantable portion of the cochlear implant is implanted in the human and in signal communication with the external device / external component 142 of the cochlear implant.
[0035] In the illustrative arrangement of FIG. 1A, external device 142 may comprise a power source (not shown) disposed in a Behind-The-Ear (BTE) unit 126. External device 142 also includes components of a transcutaneous energy transfer link, referred to as an external energy transfer assembly. The transcutaneous energy transfer link is used to transfer power and / or datato cochlear implant 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used to transfer the power and / or data from external device 142 to cochlear implant 100. In the illustrative embodiments of FIG. 1A, the external energy transfer assembly comprises an external coil 130 that forms part of an inductive radio frequency (RF) communication link. External coil 130 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand / or multi-strand platinum or gold wire. External device 142 also includes a magnet (not shown) positioned within the turns of wire of external coil 130. It should be appreciated that the external device shown in FIG. 1A is merely illustrative, and other external devices may be used with embodiments of the present invention.
[0036] Cochlear implant 100 (the implantable portion of the cochlear implant) comprises an internal energy transfer assembly 132 which may be positioned in a recess of the temporal bone adjacent auricle 110 of the recipient. As detailed below, internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and / or data from external device 142. In the illustrative embodiment, the energy transfer link comprises an inductive RF link, and internal energy transfer assembly 132 comprises a primary internal coil 136. Internal coil 136 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand / or multi-strand platinum or gold wire.
[0037] Cochlear implant 100 further comprises a main implantable component 120 and an elongate stimulating assembly 118. In embodiments of the present invention, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In embodiments of the present invention, main implantable component 120 includes a sound processing unit (not shown) to convert the sound signals received by the implantable microphone in internal energy transfer assembly 132 to data signals. Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate stimulating assembly 118.
[0038] Elongate stimulating assembly 118 has a proximal end connected to main implantable component 120, and a distal end implanted in cochlea 140. Stimulating assembly 118 extends from main implantable component 120 to cochlea 140 through mastoid bone 119. In some embodiments stimulating assembly 118 may be implanted at least in basal region 116, and sometimes further. For example, stimulating assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, stimulating assembly118 may be inserted into cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through round window 121, oval window 112, the promontory 123, or through an apical turn 147 of cochlea 140.
[0039] Stimulating assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, disposed along a length thereof. As noted, a stimulator unit generates stimulation signals which are applied by stimulating contacts 148, which in an exemplary embodiment are electrodes, to cochlea 140, thereby stimulating auditory nerve 114. In an exemplary embodiment, stimulation contacts can be any type of component that stimulates the cochlea (e.g., mechanical components, such as piezoelectric devices that move or vibrate, thus stimulating the cochlea (e.g., by inducing movement of the fluid in the cochlea), electrodes that apply current to the cochlea, etc.). Embodiments detailed herein will generally be described in terms of a stimulating assembly 118 utilizing electrodes as elements 148. It is noted that alternate embodiments can utilize other types of stimulating devices. Any device, system, or method of stimulating the cochlea can be utilized in at least some embodiments.
[0040] As noted, cochlear implant 100 comprises a totally implantable prosthesis that is capable of operating, at least for a period of time, without the need for external device 142. Therefore, cochlear implant 100 further comprises a rechargeable power source (not shown) that stores power received from external device 142. The power source may comprise, for example, a rechargeable battery. During operation of cochlear implant 100, the power stored by the power source is distributed to the various other implanted components as needed. The power source may be located in main implantable component 120, or disposed in a separate implanted location.
[0041] It is noted that the teachings detailed herein and / or variations thereof can be utilized with a non-totally implantable prosthesis. That is, in an alternate embodiment of the cochlear implant 100, the cochlear implant 100, and thus system 10, is a traditional hearing prosthesis.
[0042] While various aspects of the present invention are described with reference to a cochlear implant (whether it be a device utilizing electrodes or stimulating contacts that impart vibration and / or mechanical fluid movement within the cochlea), it will be understood that various aspects of the embodiments detailed herein are equally applicable to other stimulating medical devices having an array of electrical simulating electrodes such as auditory brain implant (AB I), functional electrical stimulation (FES), spinal cord stimulation (SCS), penetrating ABI electrodes (PABI), and so on. Also, while embodiments disclosed herein are directed toelectrodes, it is noted that in other embodiments, the teachings detailed herein are applicable to non-electrical stimulation, such as by way of example only and not by way of limitation, optical stimulation, magnetic stimulation, etc. Indeed, in an exemplary embodiment, instead of or in addition to electrodes, induction coils are utilized to stimulate the tissue (e.g., the tissue inside the cochlea). Moreover, it is noted that embodiments disclosed herein are not limited to application to hearing prostheses. For example, the teachings detailed herein can be applicable to retinal stimulation, skin stimulation, etc. Note further that the teachings detailed herein are applicable to deep brain stimulation, and thus an exemplary embodiment includes a deep brain stimulator assembly utilizing the teachings detailed herein. Further, it is noted that the teachings herein are applicable to stimulating medical devices having electrical stimulating electrodes of all types such as straight electrodes, perimodiolar electrodes and short / basal electrodes. Also, various aspects of the embodiments detailed herein and / or variations thereof are applicable to devices that are non-stimulating and / or have functionality different from stimulating tissue, such as for example, any intra-body dynamic phenomenon (e.g., pressure, or other phenomenon consistent with the teachings detailed herein) measurement / sensing, etc., which can include use of these teachings to sense or otherwise detect a phenomenon at a location other than the cochlea (e.g., within a cavity containing the brain, the heart, etc.). Additional embodiments are applicable to bone conduction devices, Direct Acoustic Cochlear Stimulators / Middle Ear Prostheses, and conventional acoustic hearing aids. Any device, system, or method of evoking a hearing percept can be used in conjunction with the teachings detailed herein. The teachings detailed herein are applicable to any device, system, or method where an elongate lead having elastic properties or the like has utilitarian value with respect to positioning thereof.
[0043] Still focusing on a cochlear implant, FIG. IB is a side view of the implant table portion 144 of the cochlear implant 100 without the other components of system 10 (e.g., the external components). Cochlear implant 100 comprises a receiver / stimulator 180 (combination of main implantable component 120 and internal energy transfer assembly 132) and an elongate stimulating assembly 118. Stimulating assembly 118 includes a helix region 182 that includes a body 183 in which is embedded (e.g., in the case where the body is silicone or another biocompatible material molded around wire leads) or otherwise containing (e.g., in the case where the body is a conduit or tube) electrical lead wires 189 in a helix (more on this below), a transition region 184 (which can be part of the body 183), a proximal region 186, and an intra-cochlear region 188. The proximal region 186, in this embodiment, is connected to thetransition region 184 via a distinct connection 185, although in other embodiments, the transition region is blended into the helix region 182 (and the proximal region 186). Proximal region 186 and intra-cochlear region 188 form an electrode array 190. The portion of the stimulating assembly 118 that extends from the receiver / stimulator 180 to the electrode array 190 is referred to herein as the lead assembly, indicated by reference numeral 181 in FIG. 1 A. In an exemplary embodiment, proximal region 186 is located in the middle-ear cavity of the recipient after implantation of the intra-cochlear region 188 into the cochlea. Thus, proximal region 186 corresponds to a middle-ear cavity sub-section of the stimulating assembly 118. In some exemplary embodiments, nubs 187 are provided on the outer surface of the proximal region to aid in the manipulation of the electrode array assembly 190 during insertion of the intra-cochlear region into the cochlea. Electrode array assembly 190, and in particular, intra- cochlear region 188 of electrode array assembly 190, supports a plurality of electrode contacts 148. These electrode contacts 148 are each connected to a respective conductive pathway, such as wires, PCB traces, etc. (not shown) which are connected to receiver / stimulator 180, through which respective stimulating electrical signals for each electrode contact 148 travel.
[0044] It is noted that in some embodiments, the helix region 182 does not extend as far as that depicted in FIG. 1A, and the transition region 184 is thus longer. That is, in some exemplary embodiments, the helix region 182 does not extend substantially the full length between the receiver / stimulator 180 and the proximal region 186, but instead extends less than that (e.g., about half the distance), where the remaining distance is established by substantially straight lead wires, or at least wires that are not substantially helixed. Any arrangement of lead wires that can enable the teachings detailed herein and / or variations thereof to be practiced can be utilized in some exemplary embodiments.
[0045] FIG. 1C is a side view of a portion of stimulating assembly 118 where the electrode array of the electrode array assembly 190 is in a curled orientation, as it would be when inserted in a recipient's cochlea, with electrode contacts 148 located on the inside of the curve.
[0046] It is noted that FIG. 1 C can be, by way of example only and not by way of limitation, a perimodiolar stimulating assembly or a mid-scala assembly which assumes a mid-scala position during or following implantation.
[0047] FIG. ID presents an exemplary embodiment of a neural prosthesis in general, and a retinal prosthesis and an environment of use thereof, in particular, the components of which can be used in whole or in part, in some of the teachings herein. In some embodiments of aretinal prosthesis, a retinal prosthesis sensor-stimulator 10801 is positioned proximate the retina 11001. In an exemplary embodiment, photons entering the eye are absorbed by a microelectronic array of the sensor-stimulator 10801 that is hybridized to a glass piece 11201 containing, for example, an embedded array of microwires. The glass can have a curved surface that conforms to the inner radius of the retina. The sensor-stimulator 108 can include a microelectronic imaging device that can be made of thin silicon containing integrated circuitry that convert the incident photons to an electronic charge.
[0048] An image processor 10201 is in signal communication with the sensor-stimulator 10801 via cable 10401 which extends through surgical incision 00601 through the eye wall (although in other embodiments, the image processor 10201 is in wireless communication with the sensor-stimulator 10801). The image processor 10201 processes the input into the sensorstimulator 10801 and provides control signals back to the sensor-stimulator 10801 so the device can provide processed output to the optic nerve. That said, in an alternate embodiment, the processing is executed by a component proximate with or integrated with the sensor-stimulator 10801. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.
[0049] The retinal prosthesis can include an external device disposed in a Behind-The-Ear (BTE) unit or in a pair of eyeglasses, or any other type of component that can have utilitarian value. The retinal prosthesis can include an external light / image capture device (e.g., located in / on a BTE device or a pair of glasses, etc.), while, as noted above, in some embodiments, the sensor-stimulator 10801 captures light / images, which sensor-stimulator is implanted in the recipient.
[0050] In an embodiment, the teachings herein applicable to the electrode array are applicable to the electrode arrangement of the retinal implant, and any disclosure of the use of one corresponds to an alternate disclosure of the other in the interests of textual economy.
[0051] FIG. 2 is a functional block diagram of a cochlear implant 200 to which the teaching herein can be applicable. The cochlear implant 200 includes an implantable component 201 (e.g., implantable component 100 of FIG. 1) configured to be implanted beneath a recipient’s skin or other tissue 249, and an external device 240 (e.g., the external device 142 of FIG. 1 A).
[0052] The external device 240 can be configured as a wearable external device, such that the external device 240 is worn by a recipient in close proximity to the implantable component,which can enable the implantable component 201 to receive power and stimulation data from the external device 240. As described in FIG. 1A, magnets can be used to facilitate an operational alignment of the external device 240 with the implantable component 201. With the external device 240 and implantable component 201 in close proximity, the transfer of power and data can be accomplished through the use of near-field electromagnetic radiation, and the components of the external device 240 can be configured for use with near-field electromagnetic radiation.
[0053] Implantable component 201 can include a transceiver unit 208, electronics module 213, which module can be a stimulator assembly of a cochlear implant, and an electrode assembly 254 (which can include an array of electrode contacts disposed on lead 118 of FIG. 1). The transceiver unit 208 is configured to transcutaneously receive power and / or data from external device 240. As used herein, transceiver unit 208 refers to any collection of one or more components which form part of a transcutaneous energy transfer system. Further, transceiver unit 208 can include or be coupled to one or more components that receive and / or transmit data or power. For example, the example includes a coil for a magnetic inductive arrangement coupled to the transceiver unit 208. Other arrangements are also possible, including an antenna for an alternative RF system, capacitive plates, or any other utilitarian arrangement. In an example, the data modulates the RF carrier or signal containing power. The transcutaneous communication link established by the transceiver unit 208 can use time interleaving of power and data on a single RF channel or band to transmit the power and data to the implantable component 201. In some examples, the processor 244 is configured to cause the transceiver unit 246 to interleave power and data signals, such as is described in U.S. Patent Publication Number 2009 / 0216296 to Meskens. In this manner, the data signal is modulated with the power signal, and a single coil can be used to transmit power and data to the implanted component 201. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, can be used to transfer the power and / or data from the external device 240 to the implantable component 201.
[0054] Aspects of the implantable component 201 can require a source of power to provide functionality, such as receive signals, process data, or deliver electrical stimulation. The source of power that directly powers the operation of the aspects of the implantable component 201 can be described as operational power. There are two exemplary ways that the implantable component 201 can receive operational power: a power source internal to the implantable component 201 (e.g., a battery) or a power source external to the implantable component.However, other approaches or combinations of approaches are possible. For example, the implantable component may have a battery but nonetheless receive operational power from the external component (e.g., to preserve internal battery life when the battery is sufficiently charged).
[0055] The internal power source can be a power storage element (not pictured). The power storage element can be configured for the long-term storage of power, and can include, for example, one or more rechargeable batteries. Power can be received from an external source, such as the external device 240, and stored in the power storage element for long-term use (e.g., charge a battery of the power storage element). The power storage element can then provide power to the other components of the implantable component 201 over time as needed for operation without needing an external power source. In this manner, the power from the external source may be considered charging power rather than operational power, because the power from the external power source is for charging the battery (which in turn provides operational power) rather than for directly powering aspects of the implantable component 201 that require power to operate. The power storage element can be a long-term power storage element configured to be a primary power source for the implantable component 201.
[0056] In some embodiments, the implantable component 201 receives operational power from the external device 240 and the implantable component 201 does not include an internal power source (e.g., a battery) / internal power storage device. In other words, the implantable component 201 is powered solely by the external device 240 or another external device, which provides enough power to the implantable component 201 to allow the implantable component to operate (e.g., receive data signals and take an action in response). The operational power can directly power functionality of the device rather than charging a power storage element of the external device implantable component 201. In these examples, the implantable component 201 can include incidental components that can store a charge (e.g., capacitors) or small amounts of power, such as a small battery for keeping volatile memory powered or powering a clock (e.g., motherboard CMOS batteries). But such incidental components would not have enough power on their own to allow the implantable component to provide primary functionality of the implantable component 201 (e.g., receiving data signals and taking an action in response thereto, such as providing stimulation) and therefore cannot be said to provide operational power even if they are integral to the operation of the implantable component 201.
[0057] As shown, electronics module 213 includes a stimulator unit 214 (e.g., which can correspond to the stimulator of FIG. 1 A). Electronics module 213 can also include one or more other components used to generate or control delivery of electrical stimulation signals 215 to the recipient. As described above with respect to FIG. 1, a lead (e.g., elongate lead 118 of FIG. 1) can be inserted into the recipient’s cochlea. The lead can include an electrode assembly 254 configured to deliver electrical stimulation signals 215 generated by the stimulator unit 214 to the cochlea.
[0058] In the example system 200 depicted in FIG. 2, the external device 240 includes a sound input unit 242, a sound processor 244, a transceiver unit 246, a coil 247, and a power source 248. The sound input unit 242 is a unit configured to receive sound input. The sound input unit 242 can be configured as a microphone (e.g., arranged to output audio data that is representative of a surrounding sound environment), an electrical input (e.g., a receiver for a frequency modulation (FM) hearing system), and / or another component for receiving sound input. The sound input unit 242 can be or include a mixer for mixing multiple sound inputs together.
[0059] The processor 244 is a processor configured to control one or more aspects of the system 200, including converting sound signals received from sound input unit 242 into data signals and causing the transceiver unit 246 to transmit power and / or data signals. The transceiver unit 246 can be configured to send or receive power and / or data 251. For example, the transceiver unit 246 can include circuit components that send power and data (e.g., inductively) via the coil 247. The data signals from the sound processor 244 can be transmitted, using the transceiver unit 246, to the implantable component 201 for use in providing stimulation or other medical functionality.
[0060] The transceiver unit 246 can include one or more antennas or coils for transmitting the power or data signal, such as coil 247. The coil 247 can be a wire antenna coil having of multiple turns of electrically insulated single-strand or multi-strand wire. The electrical insulation of the coil 247 can be provided by a flexible silicone molding. Various types of energy transfer, such as infrared (IR), radiofrequency (RF), electromagnetic, capacitive and inductive transfer, can be used to transfer the power and / or data from external device 240 to implantable component 201.
[0061] The system 10 can include a hand-held device, such as a smartphone, that is in signal communication with the cochlear implant (with the external component in most embodiments,although some embodiments can include a handheld device that is in direct signal communication transcutaneously with the implantable portion of the cochlear implant, as opposed to communicating with the external component of the cochlear implant first).
[0062] FIG. 3 A illustrates a more detailed view, albeit functionally, of an exemplary electrode array 146 comprising a plurality of electrodes 148 labeled 1-22, in accordance with an embodiment. In an exemplary embodiment, each electrode 148 is an electrode that corresponds to a specific frequency band channel of the cochlear implant 100, where electrode 22 corresponds to the lowest frequency band (channel), and electrode 1 corresponds to the highest frequency band (channel). Briefly, it is noted that during stimulation by the electrodes to evoke a hearing percept, one or more electrodes 148 is activated at a given electrode stimulation level (e.g., current level).
[0063] In an exemplary embodiment, the electrode array assembly 190 includes at least an intra-cochlear region where the carrier of the electrodes 148 (the electrode carrier) is made of a viscoelastic material. In an exemplary embodiment, the carrier of the electrodes 148 is made of viscoelastic polyurethane foam, which in some embodiments can be a memory foam, a polyurethane with additional chemicals that increase the material’s viscosity and density, a material such as what is utilized in earplugs, etc. In an exemplary embodiment, the electrode carrier is made of viscoelastic silicone (as distinguished from non-viscoelastic silicone, such as Nusil’s
[0064] FIG. 3B presents a side view of an embodiment of the electrode array connected to lead assembly 302, which can be a silicone body in which individual electrical leads are encased extending from the electrodes.
[0065] FIG. 3C shows a cross-sectional view of the electrode array 146 through an electrode 148, showing leads 309 for electrodes and the carrier 333 that supports the electrodes (shown electrode 148). The carrier 333 can be a silicone body molded to a desired geometry.
[0066] FIG. 4 shows a side view of a portion of an electrode array according to an exemplary embodiment. An embodiment of this embodiment can achieve atraumatic insertion of the array, or at least provide for less trauma than that which would otherwise be the case with respect to arrays that do not use this embodiment. Embodiments include the utilization of electrically activated shape memory alloys (SMA) to atraumatically insert cochlear implant electrode arrays which can be curled (during insertion or after insertion where basically no more of the array will be inserted into the cochlea) to move to sit near the modiolus of thecochlea. Some embodiments include the control of the movement of the electrode array that can be enhanced through addition of some electronic components within the electrode array (within the carrier member) and / or additional wires to enhance the ability to control the movement of the array.
[0067] Embodiments include heating of the SMA (shape memory alloy) to change the shape. This can be achieved by, for example, applying a controlled current therethrough. In an embodiment, the heating is not “gradual.” In this regard, once it is decided that the electrode array should curl (be curled), and electrical current is applied to the SMA, the ultimate temperature of the SMA that is desired (this may not be known to the person who implements the teachings detailed herein vis-a-vis the insertion of the electrode array into the cochlea - this is an implementation that is likely to be transparent to the end-user) is achieved as rapidly as possible or otherwise relatively swiftly. Put another way, the SMA achieves a given geometry in correlation with the temperature thereof in some embodiments. This given geometry is achieved relatively swiftly by achieving the temperature that is desired. This is contrasted to, for example, gradually increasing the temperature in a controlled manner. Of course, upon the application of current to the SMA, the SMA will begin to heat, and the ultimate temperature increase will not be achieved instantaneously. That is not a gradual increase in temperature. That is simply the natural increase in temperature that results from the current flowing through the SMA. In an embodiment, the physical position and / or shape of the electrode array can be monitored, and the heating can be adjusted according to what is desired to be achieved with respect to the placement of the array / the insertion process. Embodiments can use gradual heating, and this can be achieved by providing pulses. In an embodiment, there is instead rapid heating. In an embodiment, the rate of heating is less than greater than and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 C or more or any value or range of values therebetween in 0.1 C increments in greater than less than and / or equal to 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35 or 40 seconds or more or any value or range of values therebetween in 0.1 second increments.
[0068] In an embodiment, the trajectory that the electrode array follows during insertion can be controlled and otherwise optimized (e.g., by setting the final shape of the electrode array). Embodiments can include heating the SMA via an electrical current so that the array bends in ways that reduce and / or eliminate the occurrence of forces on the delicate tissues in the complex three-dimensional spiral shape of the cochlea.
[0069] Some embodiments are directed to insertion of an electrode array (or other medical device - some embodiments include other devices which may or may not have electrodes) into the body can cause a level of trauma potentially resulting in inflammation and increased fibrotic reaction. These body responses can in turn cause two effects by way of example only and not by way of limitation in the case of an ear implant: (i) increased impedance of the stimulating electrode and / or reduced coupling to the cochleovestibular system which can reduce the effectiveness or efficiency of stimulation of the cochleovestibular system and / or (ii) loss of hearing for those people who still have hearing. (Briefly, note that while some embodiments herein are directed towards a cochlear implant electrode array, and in an alternate embodiment, the teachings detailed herein can be directed to a vestibular implant - any disclosure of one corresponds to an alternate disclosure of the other in the interest of textual economy unless the art fails to enables such unless otherwise noted). Embodiments can avoid such or otherwise reduce the likelihood that such would occur relative to that which would otherwise be the case. Embodiments can thus include a device system and / or method that optimizes a trajectory of the electrode array utilizing controlled activation of SMA as the array is inserted into the cochlea to reduce / minimize or otherwise avoid undesirable or otherwise less than utilitarian contact on the delicate tissues in the spiral shape of the cochlea. Embodiments utilize heating specific SMA components and / or portions of respective SMA component(s) which can enable a control of the trajectory of the electrode array during insertion. Indeed, embodiments can include heating different portions of a single SMA component at different times during insertion. This as contrasted to heating different components in their entirety at different times. Embodiments can go beyond the application of current to individual and separate disconnected components of SMA embedded in an array with respective dedicated wires to those specific components to provide electrical connection to multiple separate SMA components. Embodiments can include heating different sections of a single SMA component (other components can be present and heated later or simultaneously - more on this below) at different times.
[0070] An embodiment can include the use of an electronic component s) within the electrode array to enable heating of different sections / portions of an SMA component at different times and / or to different levels of thermal energy. The SMA components and the electronic components are biocompatible and / or sufficiently protected from the environment (e.g., through the use of a housing or sufficient coating). Note that the components that enable the transformation, such as the electronic components and the SMA components, in someembodiments, only “need” to function for the duration of the surgery or the duration in a relatively short period of time thereafter, such as an hour or a two. That said, in some embodiments, the components are designed to function for days after the implantation surgery. In an exemplary embodiment, the components that are utilized to enable shape transformation or otherwise the medical device has the functionality to shape change in a controllable manner at least during the surgery. The functionality may remain for a time. Thereafter, such as by way of example only and not by way of limitation, less than equal to and / or greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 40, 50, 60, 90, 120, 150, 180, 250, 300, 500, 1000, 1500, 2000, 3000 or 4000 minutes or more or any value or range of values therebetween in 10 second increments (e.g., two minutes 20 seconds, 187 minutes, 40 1 :55 hundred and 50 minutes, etc.). Still, in some embodiments, there little to no utilitarian value for long term survival of a functional components that enable the shape changing in the electrode array. In this regard, in at least some exemplary embodiments, the above teachings regarding the survival the components are related to the electronics components that enable the control and / or direction of current to the various components and / or portions of components the SMA. In an embodiment, the electrical leads that extend to certain electronic components may last much longer, as well as the SMA material itself.
[0071] The teachings herein are primarily directed to components using shape memory alloys, such as, for example nitinol. Any disclosure herein of an SMA corresponds to a disclosure of nitinol. However, other embodiments can use other types of materials, alloys or otherwise. Accordingly any disclosure herein of an SMA material corresponds to a disclosure of another material that can enable the teachings herein. In an embodiment, a polymer based shape memory material might be used. And note that in some embodiments, conductive polymers can be used for the leads as well. In an embodiment, any disclosure herein of an SMA corresponds to a disclosure of an SMP (Shape Memory Polymer) in the interests of textual economy and visa-versa unless otherwise noted, providing that the art enables such. Also, any other material / assembly that can enable the teachings herein can be used unless otherwise noted. In an embodiment, a type of smart material that can return to its original shape when subjected to an external stimulus is used. With respect to polymers, these can be epoxy resins and / or polyurethane resins and / or cross-linked polyethylene and / or diverse styrene-butadiene copolymers (providing that the art enables such). Embodiments include combining these materials with various nanomaterials like carbon-based, metal oxide-based, cellulose-based, and others like nano-clay, TiN, AuNRs, organic nanoparticles, sepiolite, silsesquioxane, andhydroxyapatite nanofillers. Shape memory hydrogels could be used if such can enable the teachings herein.
[0072] Embodiments can utilize a diode to enable heating of multiple portions / sections of a component. In an embodiment, the diode is utilized to pass current in one direction but not another. The diode can be configured to enable heating of different section of an SMA component based on the direction of current by way of example.
[0073] In this regard, FIG. 4 presents a portion of an electrode array showing some but not all of the electrodes 148 (in an exemplary embodiment there could be more or less electrodes), which nonshown electrodes are removed for clarity, which includes an SMA component 410 to which is connected electrical leads 405. In an embodiment, electrical current is provided to the SMA component 410 by the leads 405 by placing a current and / or voltage source into signal communication therewith so that current can flow to the SMA component 410. In an exemplary embodiment, DC current and / or AC current can be utilized as the source of electrical current to which the SMA component 410 is subjected. In an embodiment, the flow of current through the SMA component 410 heats the component by way of example only and not by way of limitation, owing to the resistance to the electrical current flow associated with the SMA material of the SMA component. In this regard, different materials and / or different geometries can be utilized to achieve different resistances or otherwise to achieve different movements or bending of the SMA component.
[0074] The shape memory component is configured as a partial loop in FIG. 4 so that the SMA component forms the return path for current, plus two legs in the SMA component. The dual legs increase the strength of the component to curl the electrode array. By way of example, because there are two portions of the SMA component that deformed that are relatively parallel to one another in this exemplary embodiment, there is at least approximately double the strength to curl the electrode array. But in an alternate embodiment, the relaxed state of the SMA component is to be curled, and the heating straightens the SMA component (at least relative to the relaxed state; the radius of curvature all the SMA component is enlarged relative to that which is the case in the relaxed state, by way of example). An exemplary embodiments is an array that is made with the silicone carrier is moulded straight. Then, after it is cured, it is curled only by the force of the SMA component (which could be deformed by mechanical application of force thereto and then when the stimulus is applied (current / the resulting heat), the SMA component forces the array back to the straight configuration, but in an alternate embodiment, the curling is a result of the SMA component being subjected to the stimulus(current / heat) and there is no mechanical force applied to the SMA component. In another embodiment, the silicone carrier is moulded in a precurled shape such that the force to curl the array has contributions from the pre-curled silicone carrier and the SMA component. This can mean that the SMA component does not have to be as strong as for the system in which the SMA component has to overcome the tendency of a straight silicone carrier to stay straight.
[0075] The SMA component is shown in solid lines. In this embodiment, the SMA component will curl in one direction. A diode 430 is connected part-way along and across the component, and the diode is linked to the SMA component 410 by lead 420 (leads / non-shape changing material are represented by dashed lines). Current injected at the top of the SMA component is indicated by solid arrow 480 and flows clockwise in this figure. This current will flow through the diode 430, thus avoiding heating of the SMA component to the right of the lead 420 (because the current will follow the path of least resistance, and here, the lead 420 has a lower electrical resistance (due to material and / or dimension / geometry properties) to enable the current to bypass the portion of the SMA component for 10 to the right of the leads 420, thus causing curling on the left hand side of the loop without curling the right side of the loop. Current injected at the bottom of the SMA loop is indicated by the dashed arrow 490 and flows anticlockwise in this figure. This current will not flow through the diode, and thus not through the lead 420 (or at least not the entire lead). The current will instead flow through to the end of the component 410, thus heating the whole of the SMA component 410 and curling the whole structure.
[0076] Thus, it can be seen that use of the diode and current direction can utilize to determine which portion / section all the SMA component will be needed based on the application of current in different directions. In this exemplary embodiment, the current is a direct current. This exemplary embodiment, the current direction corresponding to clockwise current is shunted by the diode, heating only the left-hand side of the component 410 and not heating the right hand side of the component.
[0077] In an embodiment, the diodes need only “survive” for the time needed for shape change. In an embodiments, the diode(s) are configured to last less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or 50 hours and / or days and / or weeks and / or months and / or years (in the interests of textual economy) after the device is first inserted into a human and / or after the SMA system is first activated and / or after the surgery opening is “closed.”
[0078] It is briefly noted that there can be some trace heating that occurs in the portion that is shunted off from the portion. In this regard, some of the thermal energy part of the component 410 on the left side of the lead 420 will travel via conductive heat transfer to the portion on the right side of lead 420. As used herein, the concept of heating refers to heating resulting from direct application of the current in the material that is to be deformed. The deformation that results is a result of the electrical current traveling to that component that heats the material and thus causes the deformation of the material or otherwise causes the change in shape. In an embodiment, for the SMA component to change shape, the temperature of the component / portion must exceed the transition temperature. The temperature gradient from the section taking current and the section not taking current can be calculated or measured in some embodiments and the physical position of the diode connection / shunt connection can be designed with this gradient in mind to achieve the physical profile of curling desired. Alternatively by design one could include a section of non-SMA material to isolate the two sections, or a section that has different levels of heat-sinking to manage the temperature along the structure.
[0079] For the purposes of bookkeeping and otherwise being through, it is briefly noted that in some exemplary embodiments, there can be trace current that extends through the shunted portion of the component 410, just as there can be some trace heat that reaches the component 410. In an exemplary embodiment, the utilization of the diode or otherwise the utilization of the path of least resistance, etc., and / or the other teachings detailed herein, results in a reduction of thermal energy content in a given portion of the SMA component of equal to or greater than 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 99.2, 99.4, 99.6, 99.7, 99.8, 99.85, 99.9, 99.92, 99.94, 99.96, 99.97, 99.98, 99.99 or 100% or any value or range of values therebetween in 0.001% increments relative to that which would otherwise be the case (e.g., if the current was not shunted), all other things being equal, on a mean, median and / or mode basis on a local length (the length of the “track” from the node where lead 420 connects to the component 410 at the top to the node of connection of lead 420 at the bottom), the global length (the length from the furthest node to the “tip” of the component (by analogy, the Mississippi River has a local length from the beginning to the end longer than the global length, which is the distance from the beginning to the end as the crow flies (straight line)), mass and / or volume of the component 410 to the right of the nodes, etc. Note also that this can be relative to the portion through which current flows as well.
[0080] Note also that in an embodiment, an amount of deformation (e.g., change in radius of curvature (reduction)) of the shunted portion component has any of those values in comparison to the portion to which current flows freely. Note also that in an embodiment, an amount current flow (rate) of the shunted portion component has any of those values. Also, in an embodiment, an amount of total current charge of the shunted portion can correspond to any of those percentages (all of this is in the interests of textual economy).
[0081] Accordingly, while the diode would restrict the current flowing to the bypassed section, as noted above, there would be some heat conducted to the adjacent sections even though current does not flow thereto (or the de minimus current reaches those sections). This could be utilitarian because such can create a gradual transition in the movement of the shape memory component rather than a sharp discontinuity between sections on either side of the diode connections. The dimensions of the SMA component can be further customized around this connection point to optimize the behavior of the transition area when heating only one section of the SMA component. Further, some diodes used may have a voltage drop (e.g., a drop of approximately 0.4, 0.5, 0.6, 0.7 or 0.8V or any value or range of values therebetween in 0.01 V increments) which would create a small current flow in the section of the circuit in parallel with the diode. The design of the system could be executed so that at least some embodiments make this leakage of current and associated heating small enough to be negligible / effectively zero.
[0082] Still, the current and / or heating can be managed appropriately. Indeed, various insulation and / or heat sink arrangements can be implemented. Embodiments can include utilizing sections of the SMA component that are insulated so as to increase the heating rate and / or maintain a heated level beyond that which would otherwise be the case. Conversely, heatsinks can be utilized to dissipate heat at certain locations at a rate that is faster than that which would otherwise be the case. And note that this may not necessarily be directed towards managing the residual heat / the unintended heat resulting from conduction from areas that experience the current flow to areas that do not experience the current flow (or at least areas that are not intended to have current flow that generates heat to change the shape of the material). This can be implemented as another way to achieve different bending regimes or otherwise different curling geometries relative to that which would otherwise be the case, all other things being equal.
[0083] Briefly, the steady state / non current / ambient temperature state has the array bent / curled upward (if the curl subtends an angle of more than 180 degrees, there will be a downwardcurl, but the basis for the curl is downward), and the application of current / the thermal energy bends the array downward, or if the array starts straight, the curl bends upwards in other embodiments, but in an alternate embodiment, one or both of these can be reversed / the opposite. In an embodiment, upon the halting of the current / when the temperature of the material falls below a transition temperature, the array bends back to its steady state / non- current / ambient temperature state. But that said, in an alternate embodiment, when the electrical current is halted and / or when the temperature of the material falls back below the transition temperature, nothing happens at least with respect to shape changing (there will be de minimus dimensional changes as with everything that changes temperature, but that is not the shape change that is detailed herein and otherwise covered by the meeting the shape changes and / or deformation, etc. as used herein). In an embodiment, the shape changing material is one way shape change. In this regard, in an exemplary embodiment, upon the application of the stimulus (heat and / or current), the electrode array changes shape and otherwise deforms from the shape that existed before the application of the stimulus. Thereafter, the “new” shape remains after the stimulus is removed, or at least a substantial percentage of that shape remains. In an exemplary embodiment, by way of example only and not by way of limitation, with respect to measuring a radius of curvature for example at any of the locations detailed herein, at least and / or equal to 70 75, 80, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100% or any value or range of values therebetween in 0.25% increments of the change in the given shape that resulted from the application of the stimulus remains after the stimulus is removed, all other things being equal. That said, in some other embodiments, this is not necessarily the case. Still, in at least some embodiments, materials that can be deformed via mechanical means, such as by force bending where the stimulus does not exist when such deformation occurs / is not present when such deformation occurs, where the deformation remains after the force is removed, but then upon the application of the stimulus, the shape returns back to the shape that existed before the force was imparted, can be utilized in at least some exemplary embodiments. In an exemplary embodiment, by way of example only and not by way of limitation, with respect to measuring a radius of curvature for example at any of the locations detailed herein, at least and / or equal to 35, 40, 45, 50, 55, 60, 66, 70 75, 80, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100% or any value or range of values therebetween in 0.25% increments of the deformation that resulted from the mechanical force is eliminated upon the application of the stimulus and / or such amount remains eliminated after the stimulus is removed, and the two need not be the same, all other things being equal.
[0084] The embodiment above is focused on use of direct correct, but where the direction of the directory is reversed to achieve the different curling regimes. As used herein, that is not alternating current. That said, embodiments can utilize alternating current as will be described in greater detail below. In an embodiment, a direction of current applied is maintained for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35, 40, 45, 50 or 60 seconds or any value or range of values therebetween in 0.1 second increments before a direction that is reversed. That said, in an exemplary embodiment, a direction of current in one direction is maintained for at least 70, 75, 80, 85, 90 or 95 percent of the time or more over any one or more of those time periods just noted and / or any one or more of the aforementioned percentages can correspond to the percentage of total current charge that is provided in one direction relative to another over any one or more of the just noted temporal periods. And in the interest of textual economy, any of the values detailed herein (e.g., total charge, current rate, etc.) can be the case for any of the just noted temporal periods.
[0085] And briefly, again in the interest of bookkeeping, in an embodiment where alternating current is utilized, in an exemplary embodiment, the frequency of the alternating current is at least and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 75, 100, 125, 150, 175 or 200 Hz or any value or range of values therebetween in 0.1 Hz increments. Note that the frequency could be more than or equal to 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000 Hz or more.
[0086] In an embodiment, the SMA component does not need to be configured as a partial loop. The component could be a section traversing only once through the length of the array (as shown on the top of FIG. 5 for example, where the electrode carrier is not shown, but corresponds to the relative placement relative to the SMA component of that seen in FIG. 4 for example (same with the electrodes) or selected sections of the array, chosen to customize the way the electrode array curls (or uncurls) based on the position and / or shape memory of the component. Some conceptual examples are given in FIG. 5, with the SMA component in solid lines (element 410) and the normal wire / lead (element 405) is shown in dashed lines. Again, the other components of the array have been omitted for clarity. Many different combinations of SMA and wire are possible.
[0087] In an embodiment, with respect to what is shown in the figures, there are at least and / or equal to and / or no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 or more electrodes or any value or range of values therebetween in 1increment lying in between two parallel planes located at the beginning and end, respectively, of the SMA component shown and / or the SMA component plus lead shown. In an embodiment, the electrodes are arrayed in a linear manner. In an embodiment, there can be any of the above-noted values (less than and / or equal to and / or greater than) outside the two planes (on either side). No value need be the same, and all values are presented in the interests of textual economy.
[0088] Thus, in an embodiment, there can be different shapes / layouts / geometries / lengths of the SMA component(s) so customize a deformation / curling behavior and / or trajectory of the array when current is applied / when the SMA is heated.
[0089] And to be clear, while material that heats when a current is applied thereto has been the focus of the teachings so far, other embodiments can utilize material that does not require heating for deformation when electrical current is applied thereto, providing that such can enable the teachings herein if the art enables such, unless otherwise noted.
[0090] It is noted that while one embodiment is shown that uses one (1) one diode, in other embodiments, multiple diodes can be used, such as with different connection points to further refine the behavior of the system. In an embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 or more diodes or any value or range of values therebetween in 1 increment in the system.
[0091] It is briefly noted in the interests of textual economy that any teaching herein corresponds to a feature of the intra-cochlear section of an electrode array, provided that the art enables such, unless otherwise noted. Thus, there could be 5 diodes in the intracochlear section, and two SMA components (the embodiment at the bottom of FIG. 5) in the intracochlear section. In this regard, the leads shown (lead 405) is a lead or is in signal communication with a lead that extends from the intra-cochlear section to the proximal region. And while embodiments present diodes within the intracochlear portion, in other embodiments, any one or more or all of the diodes (any number just detailed) are located outside of the intracochlear portion of the electrode array, or even in the lead assembly leading to the array, or even in the circuitry of the receiver-stimulator, such as on the opposite side of the feedthrough from the stimulating lead assembly).
[0092] The position of the diode(s) can be / are selected to customize a point of transition between the sections (one that curls (or uncurls) vs. one that does not, one that curls more thanthe other (or uncurls more than the other), etc.). In an embodiment, a given diode can be placed, or more accurately, the lead to and away from the diode if such leads are used, more toward the tip or more toward the base of the array relative to that which would otherwise be the case to achieve a specific geometry. And briefly, referring to figure 6, it can be seen that in some embodiments, the diode 430 is directly connected to the SMA component. This exemplary embodiment, current can really flow in the clockwise direction through the diode 430, but cannot flow in the opposite direction through the diode. As seen, there is a lead 423 which bypasses the diode 430. In this exemplary embodiment, the resistance of lead 423 is sufficiently higher than the resistance of the SMA component 410 so that the current when flowing in the clockwise direction will flow through the diode 430 and thus the SMA component 410, instead of flowing through the lead 423. But when the counterclockwise current is blocked by the diode 430, the current still has a path to ground, albeit through the lead 423 even though it has a higher resistance than the resistance of the SMA component 410. In this regard, the portion of SMA component 410 (actually, the diode 435 separates one SMA component from another SMA component of the system - there are two SMA components in the embodiment of figure 6). Between the two ends of lead 423, current will bypass the entire SMA component to the left of diode 430, and will bypass the portion of the component between diode 430 and the node of lead 423 to the right of diode 430.
[0093] By way of example only and not by way of limitation, as measured from the distal most tip of the carrier and / or the distal most portion of a circuit that includes a SMA component, there is one or more transition points 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm or any value or range of values therebetween in 0.25 mm increments, which transition point corresponds to a location where current is diverted from and / or to an SMA component and / or there is a beginning and / or end of an SMA component at those locations (in an embodiment, that is where a radius of curvature changes / is different depending on current direction (or another form of current management as detailed below)). And in this regard, by way of example, over a for example 30 mm length, there could be seven or eight transition points, and there could be multiple transition points located at the exact same on the general location (e.g., points located on a plane that is normal to the longitudinal axis of the array and / or the circuit including the SMA component(s)). Thus, to be clear, there can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47,48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 or more any value or range of values therebetween in 1 increments transition points in the intra-cochlear section.
[0094] It is noted that the connection points of the diode do not need to be at the same distance along the array. The two connections could be displaced by any amount of distance with suitable design of wire. An example of different locations is seen in FIGs 7 and 8. In an embodiment, a distance (local and / or global) between one node and another node (the “ends” of the leads in which the diode is located where such connects to the remainder of the system - shown by arrows 777A and 777B in FIG. 7 by way of example), is less than, greater than and / or equal to 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm or any value or range of values therebetween in 0.25 mm increments in the longitudinal direction (as opposed to the absolute length of the path / leads plus diode).
[0095] FIG. 8 shows another exemplary embodiment, that utilizes a diode chip 830 which can be bonded by bond 820 (using standard techniques) to, for example, a flat section of the SMA component and / or normal wire. It could be sandwiched between the two legs of a loop portion as shown. In an embodiment, the curling of the loop portion is designed (enforced) with strain relief to reduce and / or avoid shearing force on the bonds 820 to the diode chip. Alternatively, one or both contacts of the diode chip could be connected by bonding a wire to provide the strain relief. This is shown in FIG. 13 discussed below.
[0096] The embodiment of figure 8 (and it is briefly noted that the direction of the diode is reversed from the embodiments detailed above with respect to the operation thereof, in the interest of presenting a visual support for alternate embodiments) conceptually presents the legs of the SMA component 410 closer to each other relative to that which is the case with respect to the embodiments above. In this exemplary embodiment, this is done for the utilitarian value of enabling both sides of the chip 830 to be directly bonded to the SMA component. In an exemplary embodiment, a cross-sectional area of the SMA component (or the conductor that is not an SMA material) is flattened, such as that which results from plastic deformation, to provide a sufficient surface area to bond the chip utilizing a bonding pad 820 as would be utilitarian. Note that while the embodiment shown in figure 8 has the legs equidistant to each other, in an alternate embodiment, the legs of the SMA component could be end or otherwise extend downward and upwards towards the chip in the area to chip and then extend in the opposite direction to the original “altitude.” In this regard, the spacingbetween the legs can be utilized to “tune” a given deformation scenario or otherwise achieve a desired radius of curvature relative to that which would otherwise be the case if the distance between the two legs was further apart. It is briefly noted that in these exemplary embodiments, the curling that exists or otherwise occurs is in the plane of the figures as shown. In an exemplary embodiment, the figures can be considered cross-sections through the longitudinal axis of the electrode array in a section that is directly in the middle of the array. That said, this need not be the case in other embodiments. Still, with respect to the embodiments presented so far, the various components are located above and below each other as shown with respect to the vertical direction. These components have three dimensions, the embodiments disclosed are such that there is at least general symmetry with respect to the plane of the pages of the figures (i.e. into and out of the plane). The point is that in the embodiments described so far, the components are vertically aligned and do not have an offset into and out of the plane of the figures beyond their three-dimensional features.
[0097] In an exemplary embodiment, with respect to the closest that a portion of an SMA component approaches another portion of the component or another component and / or a distance between centerlines thereof, such closest approach can be a value of less than greater than and / or equal to 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1, 1.1, 1.2, 1.3. 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.5, 5, 5.5 or 6 more mm or any value or range of values therebetween in 0.01 mm increments. This does not include insulation of the like that might be located about the SMA component. That is, with reference to an SMA assembly, there could be an SMA component that is clad in insulation. The values are measured from the conductive material thereof / the shape changing material. In an embodiment, these values are measured in the vertical direction relative to the figures.
[0098] And note that these values can be different for various portions of a given component. Indeed, as noted above, and SMA component can dogleg towards another component and then extend away from that component for the purposes of providing a bond to a diode chip. To be clear, a given component can have any one or these values relative to another component of different portions providing that the art enable such. In an exemplary embodiment, the aforementioned values can be present at various locations along the longitudinal length of the array, such as any of the locations corresponding to the distance as detailed above from the distal most portion of the tip and / or the distal most portion of the SMA circuit, in the interest of textual economy, providing that the art enables such, was otherwise noted.
[0099] Any disclosure herein to SMA corresponds to an alternate disclosure of another shape changing material they can have utilitarian value with respect to implementing the teachings detailed herein vis-a-vis shape changing providing that the art enables such, unless otherwise noted. To be clear, the teachings herein are directed to SMA materials that can be heated by an electric current. For example, nitinol can carry current and "heat itself.” Again, as noted above, some polymeric SMAs can carry current. Some polymeric SMAs cannot carry current, however some embodiments include heating such SMA materials by passing a heating wire through the SMA component and / or placing a heating wire or other body next to (and in contact with to achieve conduction heat transfer) such material, where the heat from the heated wire heats the SMA materials. Thus, embodiments can include utilizing non-conducting SMAs by providing a conductive heating element. Embodiments can include a wire core through a tube formed of the non-conductive SMA material. Thus, in the interests of textual economy, any disclosure herein of a conductive SMA material (or an SMP material) corresponds to an alternate disclosure of heating a non-conductive SMA material with a component that is heated by the application of electrical current thereto.[ooioo] FIG. 9 presents a concept where a diode chip 830 is bonded between legs of respective SMA components with strain relief at the tip via a flexible lead 920 that has plenty of “slack” to accommodate movements / shifting of the structure. This is a lead and is not made of SMA material in an embodiment, although in another embodiment, this could be made of SMA material and the orientation and the positioning thereof can be such that deformation of some portions thereof counteracts each other. Note that figure 9 presents details in the third dimension / dimension in and out of the page in that the flexible lead 920 overlaps itself in the dimension in and out of the page. But note that a diode bonded on one leg of an SMA component with strain relief in a bonded wire connecting the diode to the other leg of the SMA component or another component can be implemented in some embodiments. FIG. 10 shows an exemplary arrangement of such. Here, the attachment by lead 420 to component 410 is further apical than the bond 820, but in an alternate embodiment, the attachment by lead 420 could be further basal or could be at the same location along the longitudinal axis as the bond 820. Thus, there are alternatives for physically connecting the diode and electrically connecting the diode to the portions of the circuit that includes the SMA components. And it is noted that the attachment regimes detailed herein can also be applicable to attachment to leads instead of SMA component portions.[ooioi] Various diode designs can be utilized, such as by way of example, diodes that are available in glass packages of a configuration that is suited for use in a biological environment, such as when the medical device is implanted in a cavity, such as a cochlea of a human, or some other cavity, such as an artery or vein or within the cranial cavity, etc. In an embodiment, the wire (or feedthrough) at each end is sealed to the glass, thus keeping body fluids out of the active area and isolating the materials of the diode (active materials) from the body / from body fluids. Glass and / or ceramic packaged diode or diode materials can be utilized in at least some exemplary embodiments.
[0102] It can thus be seen that in at least some exemplary embodiments, there are SMA component(s) embedded within a silicone electrode carrier by way of example only and not by way limitation, whether electrically insulated by the silicone and / or insulated utilizing additional electrical insulation material in addition to the silicone. In an exemplary embodiment, the body and the silicone carrier is molded around the SMA component(s).
[0103] Embodiments can include starting with a curling of the tip section / distal section of the electrode array before curling the base section. In this regard, FIG. 11 provides for an exemplary embodiment that enables such. Here, two diodes are included in the circuit so that current in the clockwise direction bypasses the base section so that the tip curls without the base. Current fed in an anticlockwise direction heats the whole SMA component.
[0104] Thus, as seen in FIG. 11, the utilization of two diodes and control of current direction to enable the tip section of the SMA loop to be heated first, without heating the base section, can enable curling (or uncurling / decrease in curling) of the apical section before the entire section.FIG. 12 shows an alternate design that utilizes a single diode. Here, some of the SMA component is “replaced” at the basal section with normal / non-heat generating, or at least non shape changing conductive wire. Here, only one diode is used, along with current direction application, to enable the tip section of the SMA loop to be heated first, without heating the base section, and thus without curling (or uncurling) the base section. Thus, when current flows in the clockwise direction, the current will bypass the section 555 of SMA component 410 whereas when the current flows in the anti-clockwise direction, the current flows through section 555.
[0105] Thus, the design of FIG. 12 has a double section of SMA portions in the apical side (half), and the SMA would have more strength to curl or decurl the apical half. This can beutilitarian to fit into the tighter spiral in the apical section of the cochlea. As shown, a single SMA portion in the basal section is sufficient to curl this section. This can have utilitarian value with respect to application to where the cochlea has a lower radius of curvature. And as with at least some of the embodiments above, for or example, the diode can be bonded to the SMA component at the base end of the array and a normal wire run along the electrode array to the contact point where the transition between the two segments of the system is desired. It can be utilitarian to bond the diode at the base end / section because this can be an area where the wire and / or the SMA portion has a thicker section and / or there is more space in the array (as it is wider in that section), and / or may have less movement than the apical section of the array (curvature for example). A variation of this implementation is shown in figure 13.
[0106] To be clear, the “force” of the curling or uncurling or what have you would be lower on an apples to apples comparison with respect to the more basal section, and if that is not desired, a a different geometry and / or different insulated properties can be utilized at section 555 to at least partially compensate for the differences in forces. By way of example only and not by way of limitation, the resistance in section 555 could be greater than the resistance in the section apical thereof, so that for a given current flow, the heating is greater in section 555 than that which is the case downstream, and thus the amount of force for the given section for the curling or decurling is greater in that section per unit current flow. Moreover, in an exemplary embodiment, a separate circuit could be utilized to with a separate SMA component that runs parallel to section 555 to compensate for the force imbalance.
[0107] In an embodiment, there is thus a cochlear implant that can have varied radiuses of controlled curvature (or decurvature / reduced curvature). In an embodiment, a radius of curvature at a given location along the array can be
[0108] By way of example only and not by way of limitation, as measured as measured from the distal most tip of the carrier and / or the distal most portion of a circuit that includes a SMA component, there is one or more locations having a given radius of curvature 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm or any value or range of values therebetween in 0.25 mm increments, which location corresponds to a location where the radius of curvature of the SMA component and / or the overall electrode array can be measured. And in this regard, by way of example, over a for example 30 mm length, there could be seven or eight or more locations where such can be measured.
[0109] Thus, it can be seen that in some embodiments, there are diode(s) that are utilized that include / are fixed to extended sections of normal wire, where this wire is flexible so as to reduce and / or eliminate or otherwise minimize additional stiffness of the system. In an embodiment, this can be accomplished with a single core annealed wire and / or with a multicore twisted cable or braid (any of the leads can have such). And strain relief components can be utilized in the extended wire connecting the diodes of such is useful. Strain relief componentry and methods (springs, highly flexible leads, leads with sufficient slack to take up the strain so that the leads still have slack, etc.) can be used in some embodiments.[oono] In view of the above, it can be seen that in an embodiment, there is a device, such as a medical device (e.g., a cochlear implant electrode array), comprising at least a portion of an electrical conduction circuit (technically, a circuit is a closed-loop - because the electrode array may have leads that extend to the control components of the receiver stimulator that can enable the teachings detailed herein, such as the reversal of electrical current, the circuit is not closed or otherwise complete without those components and hence the electrode array has a portion of the electrical conduction circuit whereas if the device comprises the entire implant, such would include the entire electrical conduction circuit) and a carrier carrying the at least a portion of the electrical conduction circuit. The carrier can be made of medical grade silicone or any other material that can enable the teachings herein. The device is configured to change a shape of the carrier as a result of a change in direction of direct current in the circuit. In an embodiment, when current is flowing in the circuit portion in a first direction, the device changes shape from a stabilized configuration / configuration where there is no current input (no energy input for that matter) into the circuit (or the device for that matter) / there is no current flowing through an SMA system (one or more SMA components - more on this below) to a first shape. In an embodiment, when the current is flowing in the circuit in a second direction opposite the first direction, the device changes shape from the first shape configuration to a second shape different from the first shape in different from the stabilized shape / the shape where there is no current flowing through the circuit.[oom] Note that the configuration shown in the figures shows a portion of the electrode array where the electrical leads 405 extend to the SMA components. It is electrical current input into and out of (the return) the portions of the electrical circuit shown that results in the current flow in the portions shown. Herein, input and output of current refers to the state of the electrical leads at the beginning (proximal end) of the intra-cochlear portion of the array. Current status references also refers to such.
[0112] Note that this is different than the mere application of and halting of a current to a SMA component, where that component changes shape as a result of the application of current thereto or the withholding of current thereto. Here, the change in shape is a result of a change in a direction of direct current in the at least a portion of the electrical conduction circuit. This is also different than, for example, applying current to a first SMA component via a first set of leads and then applying current to a second SMA component via a second set of leads. This is the case even if this entails bringing in the second SMA component into a circuit that includes the first SMA component. That is not changing a shape of the carrier as a result of a change in a direction of direct current. And note that even if that can be done if the direction of the direct current is changed, that is not the cause of the change in shape.
[0113] Note that an embodiment includes a total circuit that includes the circuit portions shown in the various figures and otherwise described herein and otherwise the portions in the intracochlear portion of the electrode array that includes switches and logic circuitry and / or otherwise can be controlled through the inductance coil of the receiver-stimulator of the implantable component to provide the current flows and / or energizement of the various legs all the SMA systems detailed herein so as to achieve various control curvatures or otherwise shape configurations of the medical device. In an exemplary embodiment, power to provide the electrical current is provided from a control component that also includes an inductance coil (and a magnet so that the inductance coil can be held sufficiently close to and otherwise aligned with the coil of the implantable component-the structure of the headpiece of the external component that communicates with the implantable component can be utilized in this regard as the device that outputs the mitigation signal) that is placed into inductance communication with the coil of the implantable component. This component is a device configured to control the implantable component so that the implantable component variously provides current and halts current to / from various legs. This can be achieved utilizing switches in the implantable component, such as transistors, which can be controlled by a control signal received through the inductance coil of the implantable component, which control signal is provided by the control component. In an embodiment, the control component is a modification of a standard telemetric device that is utilized during surgery to communicate with the implantable component, which device can utilize to, for example, implementing impedance spectroscopy, or other methods that utilize back telemetry from the implant during the surgery. In an embodiment, this control component or otherwise this modified standard telemetric device can also energize the electrodes concomitant with standard practices forimpedance measurements, etc. The point is that the standard devices can be modified so that they output a control signal to control transistors or otherwise switches in the implantable component and provide power to the implantable component (some embodiments, no modification is needed because such devices provide sufficient power to the implantable component to implement the SMA system teachings detailed herein) so that current direction can be controlled and modified and of course halted, and applied, and in so that current can be directed to various subportions of the SMA system in accordance with the teachings detailed herein. In an embodiment, this control component can have a series of manually operated switches which can be activated and deactivated to variously provide and halts current to various respective portions of the SMA system to implement the teachings detailed herein. In an embodiment, a computer-based system can be utilized with a GUI interface and a mouse so that various current applications and denial to the SMA system were components thereof can be implemented by clicking on icons in the GUI interface. The control component can then interpret the state of the manual switches and / or the fact that the various icon was clicked / selected or declicked / deselected and provide a control signal in a manner analogous to a control signal that would control the energizement of a given electrode for example based on captured sound, which control signal is provided to a transmitter which converts a control signal to an AC signal that is provided to the inductance coil of the control component so as to generate an inductance field that is received by the implantable component and the implantable component receives this inductance field and operates accordingly in a manner analogous to how the implantable component would operate if it was receiving a signal from the external component to evoke a hearing percept during normal operation and / or as if it was receiving a signal from a device that is utilized for telemetric purposes during surgery where the electrode array is inserted into the cochlea. There thus exists the additional circuitry and / or logic components to operate the switches / transistors of the implantable component so that the current can be variously provided and withheld in accordance with the teachings detailed herein so as to vary the shape of the medical device.
[0114] In an embodiment, the device is configured so that current travels in a first subcircuit of the circuit portion when travelling in a first direction in the circuit portion, and the current travels in a second subcircuit of the circuit portion when the current travels in a second direction in the circuit portion, the second-sub circuit being different from the first subcircuit. As seen above, the various first and second subcircuits can include portions that are common between the first and second subcircuits. To be a second subcircuit different from the first subcircuit,all that matters is that there be a path that is different from that of the first subcircuit. In an exemplary embodiment, with respect to figure 4, the first subcircuit can be the leads 405 and the entire partial loop of the SMA component 410, and the second subcircuit can be the leads 405, and the two legs of the SMA component 410 to the left of the leads 420 and the lead 420 and the diode 430. And in an exemplary embodiment, owing to the fact that the current travels through different portions of the portion of the electrical conduction circuit, and thus different portions of the SMA component and / or different SMA components for that matter, the different shapes of the device are achieved in accordance with the teachings detailed above.
[0115] In an exemplary embodiment, the current travel in the different subcircuits occurs automatically upon the reversal of the direction of the current in the at least a portion of an electrical conduction circuit. As noted above, in an exemplary embodiment, this can be the case owing to diodes in the electrode array. In an exemplary embodiment, this is executed without switches in the electrode array or even in the implant outside of the receiver stimulator housing. In an exemplary embodiment, the current travel in the different subcircuits occurs solely as a result of the direction of the current. In an exemplary embodiment, the path into and out of the cochlear implant electrode array and / or the intracochlear portion of the array is the same in both scenarios, albeit reversed. That is, the execution of the travel of current to the different subcircuits occurs utilizing the same input and output components (leads) irrespective of the direction of current travel.
[0116] In an embodiment, the first subcircuit as a local length that is shorter than a local length of the second sub-circuit. In an embodiment, the local length of any one of the subcircuits is less than, greater than and / or equal to 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100% or any value or range of values therebetween in 0.1% increments of that of another subcircuit (and thus the “another” subcircuit could be that much larger than the “any one” of the subcutis. In an embodiment, there are 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 or more or any value or range of values therebetween in 1 increments subcircuits. Note that these embodiments might not be implemented using the embodiment that relies on current reversal (or at least only such). Instead, this can be implemented using other embodiments herein (with or without current reversal). In this regard, it is noted that any embodiment or feature of any embodiment disclosed herein can be combined with any other embodiment or otherwise any other feature of any other embodiment as disclosed herein (or a feature of the same embodiment), providing that the art enable such,unless otherwise noted. Also, it is noted that any embodiment or feature of any embodiment disclosed herein can be excluded from combination / use with any other embodiment or otherwise any other feature of any other embodiment (or any feature of the same embodiment) as disclosed herein, providing that the art enable such, unless otherwise noted.
[0117] Consistent with the teachings herein, the device includes at least one diode and the at least one diode is carried by the carrier, the diode being part of the at least a portion of the circuit. In an embodiment, the at least a portion of the circuit can include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35, 40, 45, 50, 55, 60, 65, 70, 80, 90 or 100 or more diodes or any value or range of values therebetween in 1 increments. In an embodiment, any one or more or all of these are located in the electrode array in general, and the intra-cochlear portion in particular in some embodiments and / or one or more or all of these can be carried by the carrier. One or more or all of these could be embedded in the carrier. That said, one or more or all of the diodes could also be in the extracochlear portion of the electrode array and / or outside the carrier and / or not carried by the carrier and / or outside the electrode array. In an embodiment, one or more or all of the diodes could be located in the lead portion of the stimulating assembly. In an embodiment, one or more or all of the diodes could be located between the electrode array of electrode array and the end of the stimulating assembly (between or at the portion that interfaces with the feedthrough of the receiver stimulator). In an embodiment the diodes are embedded in the silicone that covers the lead wires of the stimulating assembly, while in other embodiments, the diodes outside such.
[0118] In an embodiment, the device is configured to autonomously direct current along a first path of the at least a portion of the electrical circuit when the direct current flows in a first direction and autonomously direct current along a second path of the at least a portion of the electrical circuit because the direct current flows in a second direction different from the first direction. Here, the autonomous direction is a result of the diode. Note that here, the device would be the electrode array, as opposed to the entire implant if the implant is under a control of a human (i.e., the human is controlling the direction of current, either directly or by controlling the curling that takes input from the human and, using an algorithm or simple logic circuits or even straight circuitry that reacts to say a switch being thrown by the human that reverses the current for example, or provides current to other portions of the system as will be described below with respect to other embodiments). That said, it could be that the device is configured to implement shape change in an autonomous manner, such as by way of exampleonly and not by way limitation, with respect to utilization of the device and a robotic insertion system the details of which will be described in greater detail below. In an exemplary embodiment, the system can identify a depth of insertion of the electrode array, and provide “deformation commands” or “deformation control signals” to the implant based on depth of insertion of the electrode array in an automated manner without input from the human surgeon or some other human inserting the electrode array. Still, with respect to the embodiments described above, the autonomous direction of current along the various paths is executed as a result of current direction change.
[0119] Accordingly, in an exemplary embodiment, the device is a cochlear implant electrode array, and, in some embodiments, is in intracochlear portion of a cochlear implant electrode array.
[0120] Of course, in an embodiment that uses heating of the SMA materials, the device is configured to heat different parts of the portion of the electrical conduction circuit depending on which direction the direct current is flowing.
[0121] In an embodiment, the direction of current through the different paths changes the shape of the carrier and thus causes the carrier to have respective different shapes. In an embodiment, the different shapes are static after a certain period of time of current flow at a steady rate through a subcircuit (e.g., after less than, greater than and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80 or 90 seconds or any value or range of values therebetween in 0.25 second increments) in a free body state. In an embodiment, the shape is static / steady state without external forces (or relief therefrom), external pressure (or relief therefrom), reaction force (or relief therefrom), mass transfer (or relief therefrom) and net energy transfer (or relief therefrom) other than the electrical current.
[0122] By without external force, it is meant the absence of a force applied to the electrode carrier, such as, for example, that which results when a so-called stylet is removed from the intra-cochlear portion of the electrode array,
[0123] By without external pressure, it is meant there is no pressure applied to the electrode carrier, such as, for example, that which results when the electrode array is removed from a so- called insertion sheath. By without mass transfer, it is meant that there is no component of the electrode array being transferred therefrom, such as, for example, that which results from a portion of the electrode array dissolving.
[0124] By without reaction force, it is meant that there is no force that is reactive against a surface (e.g., a surface of the recipient, a surface of the electrode array, etc.), such as, for example, that which results when a portion of the electrode array springs out or otherwise extends to a location in contact with a portion of the cochlea so as to “push” the electrode array from a position that existed prior to the reaction force.
[0125] By without net energy transfer, it is meant that there is no net change in energy transfer to or from the electrode array, such as, for example, that which results when a portion of the electrode array heats or cools from a temperature thereof at the time that the electrode array was fully inserted into the cochlea.
[0126] To round things out, in view of the above, it is noted that at least a portion of the electrical conduction circuit includes a first conductor and a second conductor and the first conductor reacts differently to current flowing therethrough than the second conductor. In an embodiment, the change in direction of direct current results in more current traveling through the second conductor or less current traveling through the second conductor than that which was the case before the change in direction. In an embodiment, in the at least a portion of the circuit, the first conductor is a shape changing material, and the second conductor is a nonshape changing material. In an embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35 or 40 or more or any value or range of values therebetween in 1 increment first conductors and / or there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35 or 40 or more or any value or range of values therebetween in 1 increment second conductors (and the numbers need not be the same).
[0127] FIG. 14 shows another exemplary design that can, in some embodiments, provide a variety of control(s) of the electrode array. In this embodiment, this can be accomplished by adding one extra wire to the SMA system with a diode, and selecting between the three points of current injection and recovery (the input (which includes the return) into the intra-cochlear portion of the array, for example, to provide for a basis from which to discuss the current injection / recovery (which is applicable herein to both DC current and AC current (for AC, the injection is the “hot” and the “recovery” is the neutral)). An exemplary operation of this system will now be described where a variation of the above embodiment is implemented with an extra wire running effectively, the length of the intra-cochlear portion of the electrode array (and the length of the SMA system in the intra-cochlear portion) and a diode. Choice of the point of current injection and recovery provide alternative options for heating the segments of the SMA system.
[0128] In an exemplary embodiment, in a first regime, current (DC in this embodiment) is injected in the top lead 405 as represented by arrow 480. Recovery of current occurs at the bottom lead and is represented by the thin arrow pointing in the opposite direction of arrow 480. This heats the entire component 410. The middle lead is an open circuit during this time. This state exists for any of the temporal periods detailed herein by way of example, or others, in the interests of textual economy. In another application (a second regime - note that these are titles for ease of reference, and are not based on a temporal organization (but can correspond to such)), Current is injected at the bottom lead (represented by the thin arrow pointing to the right and recovered at the top lead (as represented by arrow 490 - the thickness of the arrows are chosen for parity for ease of visual evaluation). Here the current travels through section 555, heating that section, but then doglegs upward via lead 420, as represented by arrow 492, and then doglegs to the right along lead 420 (because the middle lead remains an open circuit), and travels through diode 430 and then continues to the SMA component 410, thus bypassing the bottom section 565 of component 410, and thus not heating such. The current then arcs upwards and to the left, still in component 410, heating section 575 of the top portion of the component 410, and then the current is recovered at the top lead as represented by arrow 490. Thus, there is no heating (due to current traveling therethrough) of section 565 of component 410. This will reduce a strength of the curling of the apical section. This can be combined with another energizement regime (such as that just immediately detailed before this regime (the first regime)) by, for example, interleaving this with such, so as to change a rate of curl of the apical section. In this regard, by way of example only and not by way of limitation, in an exemplary embodiment, the first regime can be present for any of the temporal periods detailed herein (again by way of textual economy) and then the second regime can be present for any of the temporal periods detailed herein, and then the first regime can again be present, and then the second regime can be present, and so on, all for any of the temporal periods detailed herein (and they need not be the same of course, but can be). And note that the order could be reversed. The second regime could come before the first regime and so on. In an exemplary embodiment, the first and / or second regime (and / or any of the other regimes detailed herein) is utilized less than greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100 or 125 times or more or any value or range of values therebetween in one increment, during a given insertion method (e.g., surgery) and / or within a time period lasting less than or equal to 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40 45, 50 or 60 minutes or any value or range of values in 1 second increments (orwithin 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40 45, 50 or 60 days for other devices than a cochlear implant for example), and of course the numbers need not be the same.
[0129] In a third energizement regime, current can be inj ected at the top lead 405 and recovered at the middle lead 420. Here, the bottom lead is an open circuit. This will heat section 575 (the top right portion of component 410) and will heat section 565 is well. However, as represented by arrow 492, the current will flow upwards to lead 420 at the end of section 565, and thus flow along lead 420 to exit as represented by arrow 492. And briefly, in the interests of textual economy, this third regime can be interleaved with the first regime and / or second regime, and the interleaving can be different over the total method (e.g., the first regime followed by the second regime followed by the first regime followed by the third regime followed by the second regime followed by the first regime followed by the third regime followed by the second regime followed by the first regime and so on). In a fourth energizement regime, current is injected at the middle lead 420 as represented by arrow 482 and recovered at the top lead as represented by arrow 490. The bottom lead is an open circuit. This heats only section 575. This would change the curling compared to the third regime.
[0130] In a fifth regime, the current is injected at the bottom lead and recovered at the middle lead, with the top lead an open circuit. This heats only the basal section of the array (section 555 of the SMA component 410) the current could run in the other direction with only a small leakage of current through the diode with effectively the same effect. In an embodiment, the variety of choices for heating different sections of the SMA system in the array can allow for a more sophisticated adjustment of the trajectory of the electrode array as it is inserted into the cochlea relative to that which would otherwise be the case.
[0131] FIG. 35 presents another exemplary embodiment in accordance with some of the teachings herein.
[0132] In view of the above, in an exemplary embodiment, there is a device, such as for example, a cochlear implant (specifically, in some embodiments, an intracochlear portion of such), comprising at least a portion of an electrical conduction circuit a carrier carrying at least a portion of the at least a portion of the electrical conduction circuit. In this embodiment, the electrical conduction circuit includes material that changes shape with temperature, the carrier carries the material that changes shape with temperature. The at least a portion of the electrical conduction circuit has a first number of electrical inputs (again, this includes outputs / returns), any two of which inputs of electrical inputs enable closure of a circuit path of the at least aportion of the electrical conduction circuit (which is what happens when the switches of the receiver stimulator are applied to close respective circuits vis-a-vis the inputs), wherein there are more closeable circuit paths than electrical inputs. This is seen in FIG. 14 and 15. In FIG. 14, the inputs are the leads / wires on the left side (each of which is associated with two arrows in the opposite direction). In an embodiment, this is taken normal to the longitudinal axis (the designation of inputs). In an embodiment, there is no physical feature that structurally defines an input (other than its location relative to other portions of the circuit(s) / its position relative to the flow of current to the SMA components). In an embodiment, the inputs are located at the demarcation between the intra-cochlear portion and the rest of the stimulating assembly. An exemplary embodiment, the inputs are located at the in an embodiment, the inputs are located, with respect to a plane that is normal to the longitudinal axis of the electrode array, at the distal most portion or the proximal most portion or the mid location of the proximal most electrode of the electrode array. In an exemplary embodiment, inputs are located, with respect to a plane that is normal to the longitudinal axis of the electrode array, at the proximal most portion of the proximal most SMA component of the system or, alternatively, the distal most portion of any lead and / or wire (normal wire) that leads to that proximal most portion. While the embodiments just described have been explained in terms of a longitudinally extending array, in an alternate embodiment, such as where the electrodes are not necessarily presented in a linear manner, in an embodiment, the inputs can be at the portion of the SMA component or the wire leading to such portion that is closest, with respect to the electrical path, to the power source and / or neutral / ground. This can also be the case with respect to the electrode array.
[0133] In an embodiment, the inputs can be inputs of the stimulating assembly 118, such as, for example, the proximal portions of the leads that contact the contacts of the feedthrough that provides electrical communication from the housing of the receiver-stimulator to the electrode array. In an embodiment, the inputs can be the contacts of the feedthrough, which contacts are connected to the leads of the stimulating assembly 118, at least with respect to the leads that lead to the SMA components or otherwise the portions of the circuit that are utilized for shape change. By way of example only and not by way of limitation, figure 15 presents the most distal and proximal portions of the stimulating assembly 118, where, for example, elements 720 are contacts of the feedthrough that feeds through the housing of the receiver stimulator, which are in electrical communication with leads 405 of the stimulating assembly, which leads lead to the electrode array, and thus place the SMA components into electrical communicationwith circuitry of the receiver stimulator (in the housing thereof). Here, there are inputs A, B and C. Note also that figure 15 can present the distal and proximal portions of the stimulating assembly 118, which stimulating assembly includes contacts 720. Alternatively and / or in addition to this, element 720 can instead simply be the end of leads 405. In any event, in an exemplary embodiment, the inputs can be the inputs to the stimulating assembly where the electrical signals leave the feedthrough.
[0134] Consistent with the teachings above, in an exemplary embodiment, there are a plurality of shape changing material components (as distinguished from portions - components are discrete identifiable elements) corresponding to the material that changes shape with temperature. In this embodiment, the device is configured to enable a variation of a path of electrical current through the electrical conduction circuit so that different respective components of the plurality of shape changing material components have the electrical current flowing therethrough based on the variation of the path. This can be done by utilizing reverse current techniques as detailed above. This can be done alternatively or in addition to this by using one input during one or more of the variations and then changing another input from one variation to another to achieve the variation while using the one input, or a combination of these (changing input interleaved with changing current direction for example).
[0135] In an embodiment, there are at least and / or equal to 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000 or 2500 percent or any value or range of values therebetween in 1% increments more discrete closable circuit paths than electrical inputs. In an embodiment, there are less than, greater than and / or equal to 3 (if less than, there are 2), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 or 80 or more or any value or range of values therebetween in 1 increment inputs.
[0136] In an embodiment, where for example, there are a plurality of shape changing material components corresponding to the material that changes shape with temperature (this need not be the case in other embodiments), the device is configured to variously bring two or more of the inputs into and out of electrical conductivity with a power source to controllably provide electrical current to respective one or more of the plurality of shape changing material components. Figure 16 presents an exemplary embodiment of such, where, for example, there is a circuitry shown that includes a power source 1690, which could be, for example, a battery (or a plurality of such) in the receiver stimulator and / or a capacitor for a suite of capacitors in the receiver stimulator. Element 1690 can be representative of the receiver coil of the receiverstimulator which receives power, and control signals in some embodiments (which control signals can be utilized to control the overall system to control the shape change while in other embodiments, the control of the shape change could be based on logic circuitry or software or firmware that is part of the receiver stimulator), from the external component or another device that is utilized during surgery (more on this below) to provide power and / or control signals to the implantable component of the cochlear implant (note that control signals might be provided to the receiver coil, while the implant is powered by an on-board component such as the battery). In this exemplary embodiment, the “hot” bus is element 1610, which can be an electrical lead, that leads to switches 1640. Briefly, the neutral or ground bus of the electrical system (depending on the type of electricity used, and note that the two are not mutually exclusive - the system can be configured to apply DC in some instances, and then utilize AC or otherwise apply AC current in other instances) is lead 1620. As seen, both the hot bus and the neutral / ground bus had nodes 1630 that the switch 1640 interfaces with depending on the position of the switch. In this exemplary embodiment, the switch can variously place leads 1605, which are in electrical communication with the electrically conductive components 720 of the feedthrough by way of example into electrical communication with the nodes of the neutral / ground or the nodes of the buses. Accordingly, this can enable the direction of current to be reversed through a given subcircuit as well as subcircuits to be brought into and out of electrical communication with the power source 1690.
[0137] The device is configured to control, using circuitry 1650 (which can be logic circuitry, or in other embodiments, software, or element 1650 could be a microchip, etc. - element 1650 can be in signal communication with the receiver coil of the implant and can receive control signals from the receiver coil (provided to the receiver coil from another coil, such as the coil of the external device for a device that is utilized during surgery as will be described in greater detail below) and control the position of switches 1640. In this regard, each of the switches 1640 is linked to the element 1650 via leads 1606. Element 1615 controls the position of the switch to as to move the switch from one node to the other node or to an intermediate position in which case the subcircuit is open. In an embodiment, the switches can be contained in circuitry in the receiver stimulator housing, while in other embodiments, the switches could be part of the stimulating assembly. And while embodiments of shown specific leads 1606 provided to control the switches 1640, in other embodiments, the switches can be switches that react to a signal embedded in the current provided to the portion of the circuit.
[0138] While the embodiment above has been presented in terms of bringing only two inputs into electrical conductivity with the power source at a given temporal period / at the same time, in an alternate embodiment, more than two inputs can be brought into electrical contact in signal communication with the power source at a given time providing that the art enable such, unless otherwise noted. In this regard, such as where there are four or five or six or more inputs, providing that one of the inputs is utilized as the neutral and / or ground, or vice versa for that matter, any of the other inputs can be placed into electrical communication with the hot side of the system.
[0139] In view of the above, in an embodiment, the at least a portion of the electrical conduction circuit includes material that is dimensionally stable with temperature (e.g., the leads 405 and 420). Also, there are a plurality of shape changing material components corresponding to the material that changes shape with temperature (e.g., elements 410) while there are also a plurality of dimensionally stable material components corresponding to the material that is dimensionally stable. In an embodiment, at least and / or equal to and / or no more than X number of the plurality of dimensionally stable material components respectively extends in the carrier in a serial manner with respectively at least and / or equal to and / or no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in 1 increment of plurality of shape changing material components. X equals 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in 1 increment
[0140] In an exemplary embodiment, the shape changing material components will at least one of increase or decrease a radius of curvature by a percentage that is at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 150, 200, 250 or 300 times or more or any value or range of values therebetween in one times increment less than (in a scenario where there is a decrease) or greater than (in the scenario where there is an increase) a percentage change of a radius of curvature of componentry that is not made of shape changing material (if there is no measured change, the change shall be considered to be 0.001% to avoid the division by zero scenario) for a given exposure to a voltage or current or temperature change, all other things being equal, and the curvature can be measured in accordance with any of the references detailed herein.
[0141] In an embodiment, at least and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 50 or 60 or more or any value or range of values therebetween in 1 increment of the plurality of shape changing material components have respective portionsthat are at least generally parallel to each other and extend through a plane normal to a longitudinal axis of the carrier.
[0142] Embodiments can include a portion of an electronic circuit that does not utilize electronic components (at least components other than leads and / or shape changing material components and / or starter / attachment / connectors assuming arguendo that those are considered electronic components). Instead, in an exemplary embodiment, the device utilizes a specific configuration of the SMA and wires / leads to direct current to different sections of the SMA component(s). Reference will now be made to the embodiment of figure 17, which has some analogues to the three input arrangement detailed above, but instead, there is an additional wire (in some embodiments - in this embodiments there are three additional wires, while embodiments there can be 1 or two or three or four or five or six or more additional wire as will be described in greater detail below) instead of a diode. Figure 16 presents an exemplary configuration that provides for the flexibility of the options for heating different sections of the electrode array. Specifically, this concept utilizes an extra three inputs (relative to the two inputs of the embodiment detailed above utilizing a diode) running two different points on a single SMA component. Choice of the point of current injection and recovery can provide alternate options for heating the segments of the intracochlear portion of the electrode array. In this exemplary embodiment, current direction does not matter because there are no diodes. But note that in other embodiments, this arrangement can be combined with the utilization of diodes and other components, such as switches for that matter. In an embodiment, the portion of the circuit and / or the intracochlear portion of the electrode array or the entire electrode array (as distinguished from the entire stimulating assembly 118 although in other embodiments this too can be the case) is devoid of active and passive electronic components, while in other embodiments, these portions are devoid of active electronic components but can include passive electronic components, at least with respect to the portions of the circuit that enable the shape changing.
[0143] In an embodiment, such as where for example the carrier is part of an electrode array, and / or the carrier is part of an intracochlear portion of the electrode array, the electrode array and / or the intracochlear portion can be devoid of diodes. In an exemplary embodiment, the entire stimulating assembly 118 is devoid of diodes. In an exemplary embodiment, any of these components can be devoid of active electronic components, but can include passive electronic components. In an embodiment, any of these components can exclude passive electroniccomponents (other than leads and connectors, etc., assuming that these are electronic components).
[0144] Figure 17 presents a portion of an intracochlear portion of the electrode array that includes six (6) inputs. We will briefly describe this in terms of an embodiment that has only four (4) inputs, A through D, in the interest of textual economy. In this exemplary embodiment, the portion heated depends on which pair of injection / recovery points are used. For example:
[0145] A to B: Heats only the top leg of the apical section of the SMA component 410.
[0146] A to C: Heats the whole SMA component 410, including top and bottom leg of the apical section of the SMA.
[0147] A to D: Heats both top and bottom leg of the apical section of the SMA component, but not the not the basal section.
[0148] B to C: Heats the SMA component over almost all of the length of the array, but only the bottom leg is heated
[0149] B to D: Heats only the bottom leg of the apical section of the SMA component, but does not heat the basil portion.
[0150] C to D: Heats only the basal section of the SMA component.
[0151] As seen, there are additional inputs, E and F, and these can be utilized to meet different portions of the bottom leg of the SMA component 410, or to not heat such.
[0152] FIG. 18 shows another embodiment that includes additional inputs G-I, which can be brought into the circuit and / or out of the circuit to variously heat / avoid heating various portions of the upper portion of the SMA component 410. Embodiments include bringing in any two or more of these inputs into the system at a given time to achieve various heatings and otherwise to achieve various shapes of the electrode array.
[0153] The variety of ways to activate the SMA with the configuration above can have utilitarian value by way of example only and not by way limitation, in some embodiments, at least with respect to a cochlear implant electrode array in accordance with any of the following: a. the double segment of the SMA at the apical section for a stronger curl at the tighter region of the cochlea; b. the single segment of the SMA at the basal section often needs less curl; c. there are only two (2) connection points needed for current injection wires B and D.
[0154] The exact location of the transition point between normal wire and the SMA can be adjusted / changed to change the design for the trajectory during insertion. The point where normal wire from input A connects to the SMA does not have to be at the same point along the array as the join for leg D. Either connection point may be more apical or more basal to change the behavior of the electrode array per a given current input regime.
[0155] The point where the normal wire of leg B joins the SMA may also be set so as to obtain different trajectory regimes per given settings relative to that which is otherwise the case.
[0156] Embodiments include a program of activation between all the pairs to optimize the trajectory of the electrode during insertion. The “programming” of a suitable sequence might be another broad claim. Note that one can activate different sequences swapping back and forth between the different legs as needed. It does not have to be done in one simplistic sequence of each leg fully activated in order.
[0157] Note that any one or more of the legs (e.g., D or B) can be optional. A simpler version could use just one extra wire (either B or D).
[0158] Note that in this exemplary embodiment, there is a single SMA component that is not bifurcated. But note that in an embodiment, the SMA component can be made up of two or more separate components. Note that any one or more of these components can be directly in contact with each other, and can be in direct electrical communication with each other. Alternatively, in an embodiment, any one or more of the components is only in electrical communication with one or the other components via a non-SMA component, such as a lead.
[0159] In an exemplary embodiment, there are less than greater than and / or equal to 2 (in the case ofless than, thus 1), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35 or 40 or more or any value or range of values therebetween in one increment monolithic SMA component(s) that individually and / or collectively extend a local length and / or a global length of at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350 or 400 mm or any value or range of values therebetween in 0.1 mm increments. In an embodiment, any number of these or any range of numbers of these in one increments, in the interest of textual economy, are directly electrically coupled to another one of these, while in another embodiment, any number of these or any range of numbers of these in one increments, are indirectly electrically coupled to another one of these (one end (or location between ends) could be directly coupled and another could be indirectly coupled). In an exemplary embodiment, the device isconfigured so as to channel electricity through a subset of any of the given components with a combination of given components in accordance with the teachings detailed above with respect to, for example, figure 17 or 18 for example. In an embodiment, for any given component, the device is configured so that electricity will be channeled through 100% of the length of the component and / or less than greater than and / or equal to 95, 94, 93, 92, 91, 90, 89, 88, 87, 86, 85, 80, 75, 70, 60, 50, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6 or 5% or any value or range of values therebetween in 1% increments of the local length and / or the global length of the given component, and the length of channeling need not be the same for given components. In an embodiment, there are the leads 420 that are linked electrically to the SMA components at the pertinent length thereof to achieve the aforementioned percentages.
[0160] The idea is that a continuous SMA component system can be present in the electrode that runs a substantial length of the electrode in electrically contiguous manner as opposed to separate sections that are electrically isolated from each other, each section requiring its own set of leads by way of example only and not by way limitation. In this regard, as can be seen, there can be less than greater than and / or equal to 3 (if less than, 2), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or 50 or more or any value or range of values therebetween in one increment inputs more than the number of electrically isolated SMA components.
[0161] In an embodiment, a given SMA component and / or compilation of electrically linked (directly or indirectly) SMA components can have less than greater than and / or equal to 2 (if less than, 1), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or 50 or more or any value or range of values therebetween in one increment electrical lead connections (direct connection to an electrical lead). These connections can be located, with respect to distance in the longitudinal direction from the most distal portion of the electrode array and / or the most distal portion of the portion of the circuit associated with the shape changes and / or from the most distal portion of the most distal electrode less than greater than and / or equal to 0 (if zero, no less than), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 110, 120, 130, 140 or 150 mm or more or any value or range of values therebetween in 0.01 mm increments.
[0162] The concepts above focusing on the application of diodes to provide control of the SMA material. In some embodiments, some other components can be used instead or in addition to determine the design behavior of the system, as seen above. In an embodiment, referring now to FIG. 19, Zener diodes could be used to limit the voltage across a section of the SMA component (or multiple components) thus regulating this section with a different amount ofenergy for the current in one direction, while diverting current completely around the section for current in the other direction. The voltages of Zener diodes can be selected as utilitarian. By way of example, in an embodiment, current injected at the top lead as represented by arrow 480 would flow through the Zener diode 1930, bypassing the basal section of the SMA component 410, thus heating only the more apical sections of the SMA component in this exemplary embodiment. Conversely, current inj ected at the bottom (here, into the bottom blade of the SMA component 410 with the frame of reference of the at least a portion of the circuit shown in figure 19, which current is small enough to hold the voltage across the Zener or two lower than its characteristic voltage, would not flow through the Zener diode. Instead, the current flows through the entire length of the SMA component 410 instead of flowing through lead 420 in this exemplary embodiment, which current flow as represented by the dashed arrow 490.
[0163] That said, current inj ected at the bottom of the SMA component 410 that is large enough or otherwise has a high enough magnitude that brings the voltage across the Zener diode above its characteristic voltage would allow some of the current to bypass the SMA component in the section between the contact locations of the lead 420 and the SMA component 410. This is indicated by the dashed curved arrows proximate the lead 420. This would limit the heating of the section in parallel with the Zener diode relative to that which would otherwise be the case. Conversely, the heating of the SMA component downstream of the rightmost connection of the lead 420 with the SMA component 410 would be heated more than that which is the case for the section to the left thereof, because all of the current would flow through that section.
[0164] In an embodiment, a Zener diode can set a different voltage and hence different amounts of heating along a section. Current injected at the top and recovered at the bottom would be diverted from the SMA due to the normal diode voltage of the Zener, thus restricting heating of the basal section of this circuit, equivalent to some of the designs above. Conversely, current injected at the bottom and recovered at the top would be partially diverted by the Zener once its characteristic voltage Vz has been reached. Up until this point, all current would flow through the entirety of the SMA. If the current is high enough to create a voltage across the Zener higher than its characteristic voltage Vz, this section of the circuit would be limited to that voltage, thus creating a differential in heating between the segment of SMA in parallel with the Zener and the segment of SMA beyond the Zener.
[0165] Accordingly, embodiments include adjusting the current input to achieve different geometries and otherwise shapes of the electrode array or otherwise the medical device beyondthat which results from the resistance to the current flow through a given section of the SMA components. That is, in this exemplary embodiment, because the amount of current results in different paths of that current being taken relative to that which would otherwise be the case there is more than a one to one relationship between current flow and the heating of given sections resulting from the resistance to current flow, all other things being equal.
[0166] In an exemplary embodiment, there is a design where there are less than greater than and / or equal to 2 (if less than, then 1), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 or any value or range of values therebetween in one increments bypasses of respective sections of an SMA component or an SMA compilation. An exemplary embodiment, the medical device is configured so as to prevent and / or enable current flow to flow through the bypass and / or the section that is bypassed solely due to the amount of current being applied into the given portion of the circuit. In an embodiment, this is achieved without switches (other than switch is utilized to provide the current to the inputs and to return current from the inputs). In an exemplary embodiment, this is achieved utilizing only diodes, such as, for example, Zener diodes. In an exemplary embodiment, this is achieved utilizing only passive electronic components (at least with respect to those portions of the subportion of the circuit). In an exemplary embodiment, the just detailed scenarios and designs are for a situation where current is being applied and recovered at the same inputs during that period of time and / or the direction of current is the same during that period of time.
[0167] In an exemplary embodiment, for a given current input, the amount of current that is permitted to flow through the bypass section out of the overall current is less than, greater than and / or equal to 0 (thus no less than), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 or 90% or more or any value or range of values therebetween in 1% increments of the total amount of current inputted into the circuit portion.
[0168] Figure 20 presents yet another exemplary embodiment utilizing a circuit with a single Zener diode 1930 that also utilizes another diode 432 allow current to flow in only one direction through the diode 1930. In this exemplary embodiment, current injected at the top, as represented by arrow 480, and recovered at the bottom would not flow through diode 1930, thus heating the entire SMA component 410. Conversely, current injected at the bottom and recovered at the top, as represented by arrow 490, would, depending on the current level, behave as just detailed above.
[0169] Embodiments include any combination and / or permutations of placement of diodes and / or Zeners in the SMA circuit.
[0170] In an exemplary embodiment, any one or more or all of the bypasses detailed herein, in any number, in the interest of textual economy, can include one or diodes (normal) and / or one or more Zener diodes, and these diodes can be arranged so as to limit / control / halt current flow in any one or both directions along the bypass.
[0171] Note that in some other embodiments, other electronic components could be included such as transistors that can set a current depending on a variety of conditions as determined by the circuit design. Many options for customizing voltage across portions / components of the SMA and / or current through portions / components of the SMA are possible. These components can be fabricated into small chips that can be bonded to the SMA material and / or normal wire in a fashion similar to / analogous to the chip diodes detailed above.
[0172] In view of the above, in an embodiment, there is a device, such as any of those detailed herein, that includes an electrically conductive path, which device also includes one or more electrodes, wherein the electrically conductive path includes material that changes shape when exposed to electrical current. In this embodiment, the device is configured to vary a location of current application to the material and / or a location of a current path to ground / neutral from the material. In this exemplary embodiment, current is applied to the material before and after (immediately before and immediately after variation of the location. In an embodiment, there is a path to ground / neural from the material before and / or after the variation of the location.
[0173] In an embodiment, the material is part of a monolithic component made entirely of that material and / or an alloy that includes that material. In an exemplary embodiment, the material is part of a compilation of monolithic components that are in electrical communication with each other, directly or indirectly, which monolithic components are made entirely of that material and / or another shape changing material that changes shape when exposed to electrical current (different components can be made of different materials that have different properties vis-a-vis shape change relative to the others for a given temperature and / or current flow). In an embodiment, the device is configured to change the location (one or both of the just-noted locations) to less than, greater than and / or equal to 2 (if less than, thus 1), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45 or 50 or more or any value or range of values therebetween in 1 increments other location(s) from one location.
[0174] Note that in an exemplary embodiment, the aforementioned electric conductivity linking by a lead is executed by a simple lead without any switches or any other electronic components of the than the leads and the connectors required to establish the conductivity.
[0175] In an exemplary embodiment, the location of the path to neutral and / or ground can be varied by, for example grounding one of the inputs instead of one of the other inputs (with respect to the embodiment of figure 18 for example, grounding input D instead of C). In the interest of a more thorough disclosure, figure 21 presents another exemplary embodiment where there are two separate SMA components 410, which separate SMA components are not in electrical communication with each other, at least not if say, for example, a switching regime place is the input J into electrical conductivity with the input B, which could exist in some embodiments, although in other embodiments, the design can be configured so that it is impossible to place the SMA component at the top into electrical communication with the SMA component at the bottom (this is distinguished from, for example, energizing both components together in a parallel manner - in this regard, in an exemplary embodiment, the after mentioned electrical communications between the various components are contemplated to be in series in at least some embodiments and not parallel in other embodiments - in the interest of textual economy, any disclosure herein of components and / or portions that are not in electrical communication with another component and / or portion corresponds to a disclosure where those portions and / or components are not presented in a given circuit portion in a serial manner to each other but may be presented in a given circuit portion in a parallel manner to each other).
[0176] Embodiments include utilizing a moving wire that connects to the SMA component with, for example, a commutator. By way of example only and not by way limitation, there can be a sliding electrical connection, such as, by way of example only, that which is utilized with slot cars. This can allow selective activation of the SMA component along a length of the electrode array. Figure 22 presents an exemplary embodiment that utilizes a commutator 2220. As seen by comparing FIG. 22 to FIG. 23, the commutator 2220 can be moved (pulled in this embodiment by wire 2250) towards the basal portion of the electrode array so as to move the location where the commutator 2220 directly communicates with the SMA component 410. In this exemplary embodiment, this varies the location where the current will be inputted into the SMA component 410 and / or where the current will be recovered from the SMA component 410. This can enable the bypass of a portion of the SMA component by the current, such as where, for example, where wire 2250 has a lower resistance than the SMA component 410 (inthis embodiment, this need not be the case depending on where the current is injected / recovered).
[0177] Here, the commutator is depicted as a solid cylinder of electrically conductive material that is slip fit or slightly interference fitted over the component 410 so as to establish sufficient electrical conductivity between the two components, while still enabling the commutator to slide along the component 410, where the wire 2250 is electrically bonded to the commutator 2220. In an alternate embodiment, instead of a cylinder, the commutator could be a wire loop for example, which loop is wound sufficiently tightly around the component 410 to establish sufficient electrical conductivity between the two components.
[0178] Thus, the commutator can be a loop of the wire 2250 (or a plurality of loops - the more loops the “better” the electrical conductivity) or a separate component electrically connected a wire that can be retracted in the proximal direction of the electrode array (in some embodiments, element 2250 can be stiff enough to enable movement towards the distal end as well). When the commutator is at the position shown in FIG. 22, current injected at A will flow around to the commutator until the commutator and then divert to the wire 2250, thus heating only the most apical section of the SMA component. The wire 2250, and thus the commutator 2220 can then be retracted, such as to the position shown in FIG. 23., thus enabling activation of more of the component 410 which thus heats a larger section of the SMA component.
[0179] The wire 2250 can then be retracted more, thus enabling activation and heating of an even longer section of the SMA component 410.
[0180] In an embodiment, an alternative current path can be created by injecting current at C and recovering at B. This would allow activation and heating of the basal section / the section from the commutator 2220 to the left. Again, movement of the commutator would allow different sections of the SMA component to be activated depending on the position of the commutator.
[0181] In an embodiment, the commutator would be moved in a stepwise fashion, such as by discrete amounts from one location to another along the component 410. In an embodiment, the commutator can be moved in a figuratively infinite manner, because the commutator can be placed anywhere along the component 410, or at least retracted to be at a location anywhere along the component 410, and this retraction could be continuous / could occur at a continuous rate, and hence the locations are infinitely variable (figuratively). In an embodiment, therecould be an actuator or a winch arrangement that pulls the wire 2250 (or pulls (or pushes) a more stable rigid structure) so as to move the commutator 2220.
[0182] The two sections could be activated at the same time with different levels or pulse patterns of current to customize the bending of the SMA component on either side of the commutator. This can also be done in a sequence.
[0183] The example description above indicates the commutator is pulled out, which is appropriate for activating the apical section before the section to the left. However, again, in embodiments, it is possible also to push the commutator further in if needed for fine adjustment of the shape of the SMA component. In an embodiment, detents along the component 410 will “temporarily lock” the commutator at a pertinent location until additional force is applied to move the commutator to overcome the detent. The detent could instead be located in the carrier. In an embodiment, there are less than, greater than and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 of 20 or more discrete locations where the commutator 2220 is temporarily fixed.
[0184] In an embodiment, current can be run while the commutator is moving (in other embodiments, this is not done). The commutator need not be static when providing current. This can enable additional parameters to control the sequence of activation / heating and the movement of the electrode array.
[0185] In view of the above, in an embodiment, there is a device, such as any of those detailed above, that includes a commutator that electrically interfaces with the material that changes that changes shape when exposed to electrical current to vary the location(s). In an embodiment, the device includes a movable wire to vary the location.
[0186] In an embodiment, the variation of the location enable selective activation of the material relative to respective locations of respective electrodes of the one or more electrodes of the device. Consistent with the teachings above, the variation of the location(s) is a figuratively infinite variation.
[0187] In an embodiment, the selective activation of the material enables a shape of the electrically conductive path to vary relative to that which would otherwise be the case, all other things being equal. In an embodiment, the device includes a conductive path of material that is dimensionally stable when current is applied thereto, which conductive path of material that is dimensionally stable is a path of lower resistance relative to the electrically conductive path.In this embodiment, the current applied to the material and / or the current that travels from the material to ground / neutral travels through the material that is dimensionally stable.
[0188] Another embodiment includes the utilization of fusible links. This can allow activation of different sections of an SMA component. In these embodiments, the fusible links can only be fused (opened) once, thus not allowing a reversal of the sequence of activation. FIGs. 24 and 25 show an exemplary embodiment and use thereof, where elements 2424 and 2425 present fusible links, where the resistance therethrough, in this embodiment, increases with location from right to left. In this exemplary embodiment, starting with figure 24, these links are designed to fuse (open circuit) at different current levels (in this embodiment, fusing occurs with higher current level vis-a-vis the fuses from right to left). In an exemplary embodiment, a very short high current can fuse a link without appreciable time to heat up the SMA component. In an embodiment, such are utilized. Because it can be utilitarian to curl the apical section of the electrode array first, the links can, in some embodiments, be fused in sequence from right to left, by gradually increasing the current flow to a level that will correspond to that which would open a given link. Figure 24 shows all links intact. Current injected at A is collected at B (current injected at C is collected at A or, in an alternate embodiment, at B). The current flows of the fusible link 2424 on the right most side and thus activates / sheets the apical section of SMA component 410 to the right of the rightmost fusible link. Other than residual heating and / or the results of trace current flow therethrough, the portions of component 410 to the left of the rightmost link 2424 are not heated, and thus effectively do not deform, in contrast to the portion of component 410 to the right of the rightmost link 2424. In an exemplary scenario of use, after reaching a desired curl of the apical portion, the rightmost fuse 2424 can be blown with a high current pulse by way of example only and not by way limitation. Then, current flows through fuse 2424 A with respect to current injected at A. Upon a desired curl (or uncurling) being reached, fuse 2424A is then blown (again, with a current pulse / surge), resulting in the arrangement shown in figure 25. Here, the current injected at A flows through fuse 2425, thus bypassing the component 410 at the locations to the left of fuse 2425. This process can be continued for the fuses to the left of fuse 2425, and so on. More particularly, figure 25 shows only the three leftmost links intact. Again, these fuses can be blown with a sufficient current pulse. And note that the current pulse / surge required to blow a given fuse can be different, not just as inferred (where the current required to blow a given fuse increases with location from right to left, but instead, where, for example, a higher current / surge is required to blow fuse 2425 then to blow the remaining two intact fuses in figure 25. In anembodiment, the resistance of fuse 2425 could be higher than the resistance of, say, the fuse immediately to the left of that fuse, and thus in an embodiment, current could bypass fuse 2425, and instead flow through the fuse immediately to the left thereof, and then when it is desired that current stop flowing through the portion of the component 410 between the two fuses, a current surge can be imparted that blows the fuse immediately to the left of fuse 2425, but because fuse 2425 can withstand a higher current surge, fuse 2425 remains intact, and then, current flows through fuse 2425 (because, in this embodiment, the leftmost fuse has a higher resistance than fuse 2425), and this can be done until the section 410 achieves a given shape (or more accurately, until section 410 imparts a given shape onto the array) and then that fuse 2425 is blown, and then current flows through the leftmost fuse, until it is decided to blow that fuse, after which current flows through A and leaves through C.
[0189] In an exemplary embodiment, there are less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in one increment fuses.
[0190] Note that current / voltage manipulation is not just to blow fuses, etc. Embodiments can include using current / voltage manipulation for a system that does not physically change irrecoverably (without replacing a component). Embodiments thus include controlling current and / or voltage at the given inputs of the circuit portion of the SMA system to achieve given deformations or otherwise geometries of the electrode array. In an embodiment, the implantable component can be programmed or otherwise configured to autonomously control the current and / or voltage, and thus the orientation of a given electrode array in space, while in other embodiments, again, this is control by a device separate from the implantable component, but in signal communication there with, such as by utilization of the teachings of the 811 patent. Again, direct current and alternating current can be utilized, and the two can be interleaved or otherwise used at different times to achieve a given change in geometry. In some embodiments, the two can be utilized the same time, I will be applied at different inputs. To be clear, it is not required that only two inputs be utilized at the same time. Three or four or five or six or seven or eight or nine or 10 or more inputs can be utilized at the same time. Any application of current and / or voltage to the various inputs that can enable the teachings detailed herein can be utilized in at least some exemplary embodiments. And again, current pulsing can be utilized to achieve a given transition regime. By way of example only and not by way of limitation, current pulsing can be utilized to “pump” the temperature. In this regard, because at least some exemplary embodiments, the transition points are binary, by varying the current and / or voltage,the transition point could be repeatedly reached and retracted there from so that the “rate” of transformation or deformation is slower than that which would otherwise be the case. In this regard, the change in shape is not instantaneous. So by applying a current and / or voltage regime (any disclosure herein of a current regime corresponds to a voltage regime and vice versa, and a combination thereof, unless otherwise noted in the interest of textual economy) in a temporally varying manner (current on / current off, current at level X then current less than level X, current at X for Y seconds followed by current at less than X for Z seconds (Z can be equal to Y), etc.), different rates of transition / deformation can be achieved.
[0191] Note further that it is not merely the rate of transition, but also potentially different transitions that can be achieved by varying the current regime. For example, if a current applied to a section of the SMA component for a given temporal period is sufficient to cause the SMA component to adopt a radius of curvature that has a mean average over that section of 3 mm, pulsing the current for example, or applying the current for less than the given temporal period and then reapplying the current could cause the SMA component to adopt a radius of curvature that is a mean average over that section of 4 or 5 mm for example. That is, the current and / or voltage can be controlled so that the maximum radius of curvature (or in this case the minimum radius of curvature) is never achieved, but instead, the radius of curvature fluctuates around 4.5 mm for example, which is sufficient to achieve a given geometry in an exemplary embodiment.
[0192] Figure 26 provides another exemplary embodiment where there is a second SMA component above the SMA component presented in figure 24. As can be seen, there are additional fuses that extend from the lead to the second SMA component. The operation of these additional fuses can operate in a manner concomitant with the teachings detailed above with respect to the lower SMA component. The sequence of blown fuses can be staggered so as to achieve the desired strength of a given curl with respect to utilizing to SMA components instead of just one SMA component to implement the curling.
[0193] Other arrangements can be utilized, such as, for example, where the fusible links do not have the increasing resistance from right to left, but instead have a resistance pattern that is different, but where the fusible links will fuse at a given current level, so that, for example,
[0194] Embodiments include methods. In an embodiment, there is a method, as represented by the flowchart 2700 in FIG. 27, which includes method action 2710, which includes the action of inserting a variable shape medical device into a cavity of a human. In an exemplary embodiment, consistent with the teachings above, medical devices a cochlear implant electrodearray, and the cavity is a cochlea. In an exemplary embodiment, the cavity can be a cranial cavity adjacent the brain for example. In an exemplary embodiment, the cavity can be an artery or vein or it could be a chamber of the heart or the lungs or a bladder or a kidney, etc., And the medical device could be a corresponding implanted associated with the cavity (e.g., a lung implant to a bladder implants and so on).
[0195] The method represented by flowchart 2700 further includes method action 2720, which includes the action of applying electrical current to a portion of the medical device to vary a shape of the medical device. This can be executed utilizing any of the method actions and / or devices and / or systems detailed herein and variations thereof. In an exemplary embodiment of this method, the portion of the device includes a shape changing material that changes a shape of the device upon application of the electrical current thereto, thereby varying the shape of the medical device. Again, this is consistent with the teachings above. The shape changing material establishes a conductive component that has a longitudinal direction and the method includes flowing electrical current of the applied electrical current through different amounts and / or portions of the conductive component to vary the shape of the medical device. Flowchart 2700 (method 2700) also includes method action 2730, which includes flowing electrical current of the applied electrical current through different amounts and / or portions of the conductive component to vary the shape of the medical device.
[0196] The method of claim 31, wherein the action of flowing electrical current results in current flow bypassing a subsection of the component, which bypassed subsection remains dimensionally stable. In an embodiment, any number of the subsections detailed herein are bypassed during this action in the interests of textual economy. And corollary to this is that in an exemplary embodiment, any number of the subsections detailed herein have current flowing therethrough. In an exemplary embodiment, the action of applying the current includes reversing a direction of DC current flow, wherein the action of reversing the direction results in the flowing of electrical current of the applied electrical current through different amounts and / or portions of the conductive component.
[0197] In an embodiment, the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to adopt a first curved configuration having a first radius of curvature and adopt a second curved configuration that has a second radius of curvature different from the first radius of curvature. In an exemplary embodiment, the second radius of curvature has more curvature than the first radius of curvature. That said, in an exemplary embodiment, the secondradius of curvature has less curvature than the first radius of curvature. An exemplary embodiment, there can be a plurality of radii of curvature over the longitudinal length of the cochlear implant electrode array, wherein a mean, median and / or mode radius of curvature over the longitudinal length of the array taken from the most distal portion and / or the most distal electrode to a proximal most portion of any one of the electrodes of the electrode array (any selected electrode in the interest of textual economy) when the current flows in one direction is greater than that which is the case when the current flows in the opposite direction and / or when any one or more of the current regimes are applied relative to any one or more of the other current regimes as applied herein. Moreover, in an exemplary embodiment, the aforementioned mean, median and / or mode radius of curvature over the longitudinal length can be measured over a distance that does not necessarily start at the most distal portion of the electrode array and / or the most distal electrode. In this regard, the aforementioned mean, median and / or mode radius of curvature can be measured from the distal most portion of any one of the electrodes to the proximal most portion of any one of the other electrodes. In an exemplary embodiment, the mean median and / or mode radius of curvature over that section can have any of the radius of curvatures detailed herein in the interest of textual economy, and thus different sections of the electrode array can have different mean, median and / or mode radius of curvature at the same time.
[0198] In an exemplary embodiment, the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to pull itself into the cavity. In this regard, by way of example only and not by way limitation, there are methods that include applying a given sequence to the activation and deactivations etc. of the various SMA components, with an appropriately designed cochlear implant electrode array, where upon the application of the correct sequence, the electrode array pulls itself in the cochlea. This is represented by way of example only and not by way of limitation by figures 28A-28D. Here, figures 28A-D shows a series of diagrams presenting electrode array that pulls itself around the cochlea and into the cochlea. In figure 28A, the electrode array is initially inserted to the general position shown. This can be inserted through the round window or through a cochleostomy for example. After / at this point, more apical portions of the SMA system are activated (or deactivated depending on the at rest state of the SMA system) so as to begin curling while the electrode array is inserted by hand or by a robot so that the electrode array curves around the back of the modiolus per figure 28B. At this point, the method could entail ceasing pushing of the electrode array into the cochlea and / orsimply holding a low amount (relatively low amount) of retention to the cochlear implant electrode array at a proximal end of the electrode array.
[0199] In this exemplary method, further activation of the more apical portions of the SMA system or intermediate portions or any portion they can have utilitarian value are implemented so as to curl the electrode array further around the modiolus, which can pull the electrode array into the cochlea, such as represented by way of example only and not by way of limitation, in figures 28C and 28D.
[0200] Further activation of the more apical portions or other portions of the SMA system can cause the electrode array to curl further around the modiolus, which will keep pulling the electrode array to the cochlea without the need to push at the proximal end thereof. This can have utilitarian value with respect to avoiding over patient insertion and / or the possibility of trauma to tissue on the lateral wall from excessive over-insertion. In an embodiment, there can be sensors that provide information on the position of the electrode array at any one or more or all of the temporal periods during insertion or otherwise at any one or more or all of the spatial locations during insertion of the electrode array, and in an embodiment, such can be done utilizing a closed-loop control system as will be described in greater detail below.
[0201] Thus, in an embodiment, there is a device that includes a carrier that is a part of a cochlear implant electrode array and the device is configured to enable the cochlear implant electrode array to pull itself into the cochlea by variously applying electrical current to the components.
[0202] In an exemplary embodiment, the teachings detailed herein with respect to insertion of the electrode array can be combined utilizing, for example, an insertion sheath and / or a stylet for a pre-curved electrode array by way of example (or a non-pre-curved array for that matter). Note also that embodiments can use hydrogels as well to activate curling and / or to maintain a pre-curved electrode array straight for insertion.
[0203] Note that the different methods could be applied to different sections of the electrode array. For example, the most apical section could rely on SMA material for deformation, while the middle section could rely on pre-curved silicone. In an embodiment of such, the section with the smallest radius of curvature / the smaller radius of curvatures is actively driven by the SMA, while the middle section is curled by a passive mechanism and maybe a stylet to hold it straight. So the stylet only need reach the middle section and not go all the way to the tip, in this embodiment.
[0204] Still with reference to method 2700, where the device is an electrode array, and the electrode array has a first electrical input and a second electrical input (or any of the numbers detailed herein), the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component is executed when a first current is applied to the first input and the second input is at least one of a ground terminal or a neutral terminal vis-a-vis the first current, the first current being the current applied to a portion of the medical device.
[0205] In an embodiment, there is a device, such as any of those detailed herein. The device includes a conductive member and an output component (e.g., electrode, actuator, etc.) In an embodiment, the device is configured to enable an applied electrical current applied to the conductive member to bypass a first portion of the conductive member while flowing in a second portion of the conductive member. In an embodiment, the conductive member is a shape changing member that changes shape when exposed to the electrical current. Here, the device is a medical device. In an embodiment, the device is configured so that when the electrical current flows in a first direction in the conductive member, the current flows through the first portion and the second portion and the device is configured so that when the electrical current flows in a second direction reverse of the first direction in the conductive member, the bypassing of the first portion occurs solely do to the reversal of the direction (of course, in an embodiment, switches the like are utilized to reverse direction - the “solely” refers to the physical phenomenon that results in the bypassing). Consistent with the teachings detailed herein, the bypassing is enabled by a path that includes a diode chip in the path. That said, in an embodiment, again, the path may not have a diode chip or otherwise have no diode or otherwise maybe devoid of electronic components of the than that which establishes the path and enables the path to exist (e.g. connector and insulation, etc.).
[0206] In an embodiment, the bypassing is enabled by a path to ground and / or neutral that has lower resistance than the first portion and / or the second portion.
[0207] In an embodiment, the device is configured to enable an applied second electrical current applied to the conductive member to bypass a third portion of the conductive member while flowing in the second portion of the conductive member. Here, a direction of the applied second electrical current in the section portion is the same as the direction of the applied electrical current in the second portion. In an embodiment, the current can be different. In an embodiment, there are X number of discrete portions of the conductive member that can be bypassed by current while having X number of discrete portions of the conductive memberthrough which current flows (and the two numbers need not be the same - we present this in the interests of textual economy). In an embodiment, the current travels in the same direction or different direction in the portions and / or any number less than X in 1 increment portions with respect to the portions that have current flowing therethrough.
[0208] In an embodiment, the conductive member is part of a portion of a circuit that includes a plurality of inputs and the device is configured so that a first current direction at a first input of the plurality of inputs results in current flowing in the second portion while bypassing the first portion when a second input of the plurality of inputs is connected to ground and / or neutral. In this embodiment, the device is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion when a third input of the plurality of inputs is connected to ground and / or neutral.
[0209] In an embodiment, there are X number of inputs that equal a plurality of inputs (in the interests of textual economy). In an embodiment, the device is configured to enable an applied electrical current applied to the conductive member to bypass an Jth portion of the X number of portions first portion of the conductive member while flowing in a Kth portion of the X number of portions different from the Jth portion second portion of the conductive member.
[0210] In an embodiment, the conductive member is part of a portion of a circuit that includes a plurality of inputs (any number of X that is a plurality of inputs) and the device is configured so that a first current direction at an Ith input of the plurality of inputs a first input results in current flowing in the Kth portion second portion while bypassing the Jth portion first portion when a Lth input second input of the plurality of inputs is connected to ground and / or neutral, and the device is configured so that the first current direction at the Ith input of the plurality of inputs results in current flowing in the Kth portion and the Jth portion when an Pth input of the plurality of inputs is connected to ground and / or neutral.
[0211] In an embodiment, the device is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion and bypassing a third portion of the conductive member when a fourth input of the plurality of inputs is connected to ground and / or neutral. In an embodiment, the device is configured so that the first current direction at the Ith input of the plurality of inputs results in current flowing in the second portion and the Jth portion and bypassing a Qth portion of the conductive member when a Rth input of the plurality of inputs is connected to ground and / or neutral.
[0212] In an embodiment, there are A number of different subcircuits as noted above and the medical device is configured to direct current flow variously through one or more or all or any number X subcircuits of A at a given time, where X equals 1 or A, in the interests of textual economy. In an embodiment, the current flows through any one or more subcircuit N of the A number of circuits or a combination of subcircuits M, where M equals any of A, during a given temporal period, which temporal period can equal any of those detailed herein, which temporal period can equal any of those detailed herein. In an embodiment, there is a method of activation / energizement / non-engergizement so as to achieve a controlled (arguably “hyper controlled”) curling (or decurling, or both in different portions at the same time in fact) deformation of the device, wherein during for example and not by limitation, a macrotemporal period (such as any of those noted above in the interests of textual economy) there are C number of temporal periods, where C is less than greater than and / or equal to 2 (and thus 1 if less than), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 5000, 6000, 7000, 8000, 9000 or 10000 or more or any value or range of values therebetween in one increment temporal periods (which in some embodiments are contiguous) during a medical procedure (e.g., a cochlear implant insertion procedure, or a heart stent device implantation procedure), which given temporal period has a length of less than, greater than and / or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.125, 0.15, 0.175, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6. 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.25, 4.5, 4.75, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35 or 40 seconds or any value or range of values therebetween in 0.01 second increments, and the lengths need not be the same. During this method, during a given temporal period, any one or more of the above-noted current direction (or withholding) scenarios are executed (current flow or halting / withholding of such through any one or more subcircuit N of the A number of circuits or a combination of subcircuits M). During this method, during a given temporal period, the medical device, such as a cochlear implant electrode array in general (and the intracochlear portion in particular), can adopt a respective different spatial shape in a free body state and this respective shape can be the same or different from any of the others in the other temporal periods.
[0213] Note that the use of the free body state is for apples to apples comparison. In an embodiment, any reference to a free body state corresponds to an alternate disclosure of a shapeof the device within a cochlear or a cavity of a human or otherwise in a human in the interests of textual economy.
[0214] In an embodiment, the methods and teachings herein enable a method / the ability to control a curl / decurl / spatial shape that is very unique and can be controlled with specificity. In an embodiment, there is a cochlear implant electrode array in general, and an intra-cochlear portion in particular, or another device that has an electrode array, that has, starting at a distal tip thereof and / or from the distalmost portion of the circuit portion (for shape change purposes, as opposed to the circuit for the electrodes) a length according to any of those detailed herein in the interests of textual economy, and / or a length that can be considered for purposes of reference (as opposed to identifiable sections due to specific structural elements (e.g., a node) to have D number of sections in the longitudinal direction where less than greater than and / or equal to 2 (and thus 1 if less than), 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350 or 400 or more or any value or range of values therebetween in 1 increment, which may or may not be contiguous (any subset can be contiguous or not) where a radius of curvature (mean, median and / or mode and / or maximum and / or minimum) of the array at a respective section as measured on the surface of the array falling within that section in the longitudinal direction that has a radius of curvature of greater than, less than and / or equal to 100, 90, 80, 70, 60, 50, 40, 30, 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9.5, 9, 8.5, 8, 7.5, 7, 6.5, 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.75, 1.5, 1.25, 1, 0.9, 0.8, 0.7. 0.6, 0.5, 0.4, 0.3 or 0.2 mm or any value or range of values therebetween in 0.025 mm increments. The radii of curvatures need not be the same in the sections. Note also that in an embodiment, a negative radius of curvature might be established in a given section. Any of the just-noted values can be negative (relative to the electrode side of the array and / or relative to the modiolus wall side of the array). Embodiments can enable such shapes to be achieved using the techniques detailed herein.
[0215] In an embodiment, there is a method and / or a system and / or device that enables such method, where during the various temporal periods detailed herein, the cochlear implant electrode array specifically, and any other medical device to which the teachings detailed herein are applicable to in general, takes any of the shapes detailed herein. In an exemplary embodiment, the shapes are changed from temporal period to temporal period (whether contiguous or not) so as to provide an atraumatic insertion regime for the electrode array or other medical device into the cochlea or other body cavity or other portion of the body for that matter. The idea is that in an embodiment, the overall shape of the medical device can becontrolled at specific temporal periods so that trauma can be reduced relative to that which would otherwise be the case and / or eliminated, or at least effectively eliminated.
[0216] As noted above, in some exemplary embodiments, there will be a modicum of residual heating of some portions of an SMA component owing to the fact that conduction heat transfer takes place from portions through which current flows to portions through which current does not flow. In an exemplary embodiment, on a per unit mass basis, a residual temperature increase in a section through which current does not flow (but can) is no more than 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% or less or any value or range of values therebetween in 0.1% increments relative to the portions of the SMA component that are heated to the maximum achievable temperature, which temperature is maintained for at least one minute. Corollary to this is that in some embodiments, there will be a modicum of residual voltage present in the non-energized portions of the SMA component. In an exemplary embodiment, the residual voltage will be no more than 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1% or less or any value or range of values therebetween in 0.1% increments relative to the portions of the SMA component through which current is flowing.
[0217] The embodiments above have often focused on the geometry of the electrode array / changes to the geometry of the electrode array, in general, and, specifically, radius of curvature to the electrode array. Note that the above also conveys the concept of strength. That is, it could be that the electrode array may no be able to deform to its maximum deformation (or to an undeformation - again, one can view the activation of the SMA system as something that deforms the electrode array from the relaxed / natural state and then the deactivation the SMA system undeforms the electrode array). Accordingly, the activation (or deactivation) of the SMA system can be presented in terms of the ability to apply / resist force. In this regard, by way of example, in an embodiment, as measured at a location within 2 mm from the distalmost portion of the electrode array, the SMA system can generate a force of less than, greater than and / or equal to 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.11, 0.12, 0.13, 0.14, 0.16, 0.18, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65 or 0.7 or more or any value or range of values therebetween in 0.005 increments Newtons. This could be when activated or when deactivated. In an embodiment, the force can be measured at a location 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 mm away from the distalmost end / tip / portion of the electrode array.
[0218] As discussed above, embodiments can be utilized to deform the electrode array from the at rest geometry or otherwise the geometry that exists when no part of the SMA system isenergized, which can correspond to that which is the case after the cochlear implant surgery by hours or days or weeks or months, etc. The idea is that the SMA system will not be energized after implantation at least for a relatively lengthy period of time as compared to the period of time that the electrode array will be implanted in the recipient (which will be decades in some embodiments, up to potentially a century if not more). Thus, in an embodiment, the deformations and the changes in geometry that results from the activation of the SMA system are deformations and changes in geometry that change the stable and steady state configuration of the electrode array. Accordingly, in an exemplary embodiment, there is the potentially counterintuitive action of decurling a pre-curled electrode array utilizing the SMA system, or at least reducing the curvature of the pre-curved electrode array (increasing the radius of curvature). This can be done globally or at local positions along the length of the electrode array as detailed above. In this regard, in an exemplary embodiment, say the segment 5 mm to 8 mm from the distalmost portion of the electrode array can be curled or decurled utilizing the SMA system while the portions between the tip and the 5 mm position along the longitudinal axis will be maintained in the steady state configuration and / or in the configuration resulting from activation of the SMA component which have been previously in accordance with the teachings detailed herein with respect to staggering adjustment of the location of the electrode array.
[0219] Thus, any disclosure herein of crawling corresponds to an alternate embodiment of reducing a curl and vice versa providing that the art enable such as otherwise noted. That is, any disclosure of curling corresponds to an alternate disclosure of uncurling / reducing a curl all in the interest of textual economy.
[0220] But it can be that after implantation, days or weeks or months or years later, the SMA system can be utilized to reposition or otherwise reorient the electrode array. In this regard, by way of example, it could be that after the implantation surgery, it is determined that the electrode array has migrated and / or that fibrous tissue growth has occurred that reduces the efficacy of the electrode array relative to that which would otherwise be the case and / or that a channel for a frequency of the implantable portion of the cochlear implant has failed and thus there is utilitarian value to shifting the electrodes further into the cochlea or further out of the cochlea to adjust the channels with respect to the tonotopic arrangement of the cochlea. For whatever reason, there becomes a need or otherwise there exists utilitarian value to moving the electrode array after the surgery has been closed, and such as after the electrode array has been utilized to evoke a hearing percept. In an exemplary embodiment, this can occur more than0.5, 0.75, 1, 2, 3, 4, 5, 6, 12, 24, 36 or 48 hours or 2, 3 7, 8, 9, 10, 15, 20, 25 or 30 days or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30 or more months or years after closure of the surgery that implants the implantable portion of the cochlear implant electrode array, and any of the actions detailed herein / functionalities detailed herein can be executed after / at those times. In this regard, in some exemplary embodiments, the SMA system can include an SMA component or a plurality of components within the lead assembly between the feedthrough at the receiver stimulator and the electrode array. In an exemplary embodiment, this can be utilized to move the electrode array grossly in or out of the cochlea. Note also that in an exemplary embodiment, the SMA component(s) could be in the extra cochlear portion of the electrode array which also can be utilized to move the electrode array grossly into or all of the cochlea.
[0221] FIG. 29 presents another exemplary embodiment of a cochlear implant electrode array utilizes an SMA system. Here, there are two SMA components, component 2955 and component 2910. In an embodiment, two separate components can be welded to each other (which is not a monolithic component with a component connected to each other) or connected to each other utilizing an electrically conductive connector or the two components can be separate from each other and not in electrical communication with each other consistent with other embodiments detailed herein. As seen, component 2955 is offset from the lateral center with respect to the left right location. In this regard, embodiments can include utilizing an SMA system to obtain a deformation in three dimensions as opposed to two dimensions. In this regard, up until now, for the most part, the embodiments detailed above have been directed towards changing the geometry of the electrode array in the X-Y plane / the plane of FIG. 25 for example. However, in some embodiments, such as the embodiment of figure 29, energized and of portions of the SMA component can result in deformations / geometry change in the Z direction / the direction into and out of the plane of FIG. 25. In this exemplary embodiment, this can be achieved as a result of the offset of component 2955 from the vertical central / axis 2999 as shown. In an embodiment, a center of mass, geometric center and / or bending axis of any component can be located 0, 0.25, 0.05, 0.075, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.75, 3, 3.25, or 3.5 mm or more or any value or range of values therebetween in 0.01 mm increments from axis 2999 and / or axis 2998 (the center of mass in the vertical direction / geometric center / the bending axis (these need not be the same) in the vertical direction of the array, whereas axis 2999 is that for the horizontal direction).
[0222] In this exemplary embodiment, because the component 2955 is offset from the axis 2999, when the component 2955 deforms to bend or otherwise curve the component upwards (or downward) that will also be a component of the electrode array that deforms in the Z direction (horizontal in the plane of FIG. 29). This can be result of the fact that the electrode array will twist a bit because of the offset location of the component 2955. And note that while the embodiment shown present solid cross-sections, in an alternate embodiment, there are components that are hollow, at least at some portions, or scalloped (an opening on one side for example - a U shaped component for example), so as to achieve a different bending regime for a given current. And note that the concept of offset components can be utilized in different manners than that which is the case shown in figure 29. In this regard, figure 30 shows two components 2955 that are both offset from axis 2999. Here, the current can be controlled to flow through one of the components 2955 but not the other component 2955 to achieve a geometry change in the Z direction, whereas in an embodiment, if both are energized by the same amount so as to achieve basically the same amount of deformation, the offset will be canceled out and thus there should be little to no deformation in the Z direction.
[0223] Note that the embodiments of figures 29 and 30 as well as the other embodiments detailed herein contemplate the utilization of a shape changing component that deforms in the Y direction without the forming in the Z direction when perfectly aligned and otherwise in free space and otherwise without any other stresses imparted thereto. In other embodiments, the components and material can be of a type where the deformation / change in geometry occurs in the Z direction as opposed to the Y direction. By way of example only and not by way limitation, figure 31 show an embodiment where the SMA component 3155 is configured to deform in the Z direction but does not deform in the Y direction when exposed to current / heated, and the SMA component 3110 is configured to deform in the Y direction but not the Z direction when heated / when exposed to current. Note that in this embodiment, the two components are not directly connected to each other, and there is an intervening non- SMA component to place them into electrical conductivity if such is desired. Here, as seen, the components are not circular cross-sections, but instead have a long component and a short component, where the deformation / bending occurs about the long axis in this embodiment. FIG. 32 shows another embodiment. Again, these SMA components are not connected to each other.
[0224] Consistent with the concept of enabling deformation in the Z direction, in an exemplary embodiment, the device is configured to adjust a radius of curvature at a given locationaccording to any of those detailed herein in the interest of textual economy, but measured on a plane that extends in the Z direction as opposed to the plane that extends in the Y direction with respect to the teachings above. That is, the above teachings have been generally directed towards the X-Y plane. However, those teachings are applicable, at least in part, to the X-Z plane. And in the interest of textual economy, reference is made to those teachings to describe capabilities and / or functionalities, at least in part, of the SMA system as it pertains to the X-Z plane.
[0225] Some embodiments above have focused on the use of diodes. FIG. 36 shows an embodiment that utilizes a capacitor 3630. This alternative way to control which sections of the shape memory component are activated by including capacitors and / or inductors (see FIG. 37 and element 3730) and energizing the circuit with alternating currents. The placement of the capacitors or inductors and the choice of frequency can be used to determine which sections of the shape memory component are energized.
[0226] In FIGs. 33 and 34, the dashed arrows represents low frequency current and the solid arrows represent high frequency current. In an embodiment, the frequencies are relative to each other. In an embodiment, one of the two currents has a frequency that is at least and / or equal to 1.1, 1.15, 1.2, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 times or more or any value or range of values therebetween in 0.01 times increments higher than the other.
[0227] Capacitors and / or inductors could be used instead of diodes or in combination with diodes or the other techniques described above. The capacitors and / or inductors can also be used in series with different sections of the SMA component(s) to change the way the circuit heats in response to choice of stimulation frequency. In an embodiment, the capacitors and inductors can be used together to create tuned circuits to enhance the selective heating of different sections of the SMA component. Capacitors, inductors and diodes can be used together in many circuit combinations.
[0228] In an embodiment, there can be utilitarian value with respect to the use of capacitors and inductors in that a choice of which section is heated is determined by the frequency of the energizing current fed into the system. This can avoid the complication of having to deal with the voltage drop that occurs across diodes. (A diode is not a perfect short circuit when strung across the SMA component.) Also, capacitors and / or inductors can be more power-efficient as a result.
[0229] Embodiments can include the utilization of a feedback routine to fine-tune or otherwise adjust the geometry of the electrode array and / or otherwise provide at least an estimate of a geometry of the electrode array. By way of example only and not by way limitation, thermocouples can be utilized that can provide data indicative of a temperature of one or the SMA portions, and thus can be utilized as a latent variable to indicate geometry of the electrode array. In an exemplary embodiment, a lookup table can have geometries correlated to temperatures of different components, and such can be associated with absolute temperature and / or or the length of time that a component has achieves such temperature. This is utilized in some embodiments to at least provide a good estimation of a geometry of the electrode array. In an embodiment, temperature is estimated based on a temperature coefficient of impedance, which impedance can be measured utilizing impedance techniques that are known in the art with respect to a cochlear implant electrode array, such as by way of example only and not by way of limitation, measuring impedance between one or more electrodes and one or more other electrodes.
[0230] In an embodiment, there can be a closed loop control arrangement using, for example, the back telemetry. Embodiments include measuring a geometry of the array during different points of insertion into the cochlear, and based on this data, develop algorithms for future use and use those algorithms for future insertions.
[0231] But note also that raw electrical values, such as current and / or voltage, can be utilized to estimate the geometry of the array. Again, lookup tables can be developed where a given geometry corresponds to a given electrical value scenario with respect to different portions of the SMA system. In an exemplary embodiment, the implantable component is configured to provide back telemetry to any of the systems detailed herein or any other make system configured to receive data from the implantable component, such as by way of example only and not by way of limitation, the arrangements of the 811 patent detailed in greater detail below. By way of example only and not by way limitation, back telemetry utilizing data based on, for example, the voltages and / or at different portions of the SMA system and / or temperatures of different portions of the SMA system can be provided in an exemplary embodiment, and thus in an exemplary embodiment, the implantable component is configured to provide such data by way of back telemetry. Indeed, in an exemplary embodiment, techniques analogous to the utilization of the electrodes to measure impedance, and otherwise techniques analogous with that associated with the impedance spectroscopy, can be utilized to obtain data from the implantable component, which data can be utilized to estimate the geometry or otherwise theorientation of the electrode array. That said, in an exemplary embodiment, the telemetry can be utilized to simply verify that the current control techniques are working. Another way, the back telemetry can be telemetry that can be evaluated to indicate whether or not the various current regimes are being implemented. It could be that the SMA system is simply not working. That could be very useful for the surgeon to know with respect to the surgeon adjusting his or her procedures to take in account the fact that the electrode array is not informing or otherwise changing geometry as desired.
[0232] Embodiments include the utilization of robotic insertion techniques for the insertion of the electrode array and / or automatic insertion techniques for the electrode array or otherwise automatic geometry adjustment techniques for the electrode array. In an exemplary embodiment, the implantable component of the cochlear implant in general, and the receiver stimulator in particular, is configured to communicate with a device that is utilized during surgery and / or a device that is utilized to make adjustments to the geometry of the electrode array after the implantable component is fully implanted into the recipient, or at least after the receiver stimulator is implanted in the recipient and skin is placed over the receiver stimulator. In this regard, embodiments shall be described in terms of a device that is utilized during surgery, but it is noted that any such disclosure corresponds to an alternate disclosure of a device that is utilized after the implantable component of the cochlear implant is located beneath the skin of the recipient where the device that communicates with the implantable component can communicate through the skin of the recipient so as to adjust the geometry of the electrode array after implantation. The techniques will be different and of course there would be no robotic device in at least some exemplary embodiments after the implantable component is covered with skin.
[0233] At least some of the concepts associated with the control of the electrode array during insertion / implantation can be applicable to scenarios after implantation. In an exemplary embodiment, as briefly noted above, there is a device, such as the device associated with element 7444 of US patent number 11,439,811, the contents of which is incorporated herein by reference in its entirety that is configured to communicate with the receiver stimulator. In an exemplary embodiment, any one or more of the components of the 811 patent can be utilized to communicate with the receiver stimulator, and those components can be modified so as to control the implantable component of the cochlear implant in general, and the geometry of the cochlear implant electrode array, by providing control signals to the implantable component, the control signals are utilized as a basis to implement the various current regimes with respectto the SMA components of the cochlear implant electrode array. In this regard, the device of the 811 patent pending modified so as to provide signals to the vestibular stimulator and / or electrical energy to the receiver stimulator in a manner analogous to that which is the case with respect to the external component providing such signals to the implantable component so as to control the operation of the implantable component to evoke a hearing percept. Here, instead of evoking a hearing percept, the signals that are provided to have the implantable component react to the signals to adjust the geometry of the cochlear implant electrode array. In this regard, the receiver stimulator is configured with logic circuitry or the like or a chip or the like, etc., so that the implantable component can recognize that the signals are not signals to evoke a hearing percept but instead signals that are to adjust the geometry of the cochlear implant electrode array. In an exemplary embodiment, an initial signal can be provided to the implantable component indicating that the following signals will be for geometry adjustment, and upon the conclusion of the geometry adjustment, a new signal can be provided to indicate to the implantable component that for the signals are for evoking a hearing percept.
[0234] In any event, in an exemplary embodiment, a surgical device or a device that is utilized as surgery is configured to provide control signals via an inductance link that is received by the inductance coil of the implantable component. This inductance coil of the implantable component can also receive power from the surgical device etc. so as to provide sufficient current to the SMA component so as to heat the SMA components to change the shape thereof.
[0235] In an exemplary embodiment, the robotic system of the 811 patent can be utilized during insertion, where the systems of the 811 patent can be configured so as to provide control signals to the implantable component during the insertion of the electrode array so as to adjust the geometry of the electrode array during insertion in an automated and / or manual manner (robotic device could have manual controls to allow the surgeon to adjust the geometry of the cochlear implant electrode array during implantation). In an embodiment, geometry can be correlated automatically with insertion depth (for the surgeon to do this manually or otherwise based on his or her experience in doing so). In an exemplary embodiment, a program can be developed that will automatically control the shape of the electrode array were automatically adjust the shape of the electrode array based on the progress of the electrode array with respect to insertion into the cochlea. In an embodiment, a computer can receive input with respect to location of the electrode array / insertion depth of the electrode array into the cochlea, and based on this input, the program can utilize for example a lookup table and thus apply certain current regimes to the electrode array so as to adjust the geometry in a utilitarian manner. Accordingly,in an exemplary embodiment, the teachings detailed herein can utilize with any one or more the teachings of the 811 patent with respect to insertion electrode array into the cochlea.
[0236] And again, in the interests of completeness, in an exemplary embodiment, a modification of that device can be utilized to communicate with the implanted electrode array days or months or years after implantation, by way of communication through skin of the recipient.
[0237] In an embodiment, the SMA component(s) (e.g., nitinol component) and whether the voltage drop of the diode might create some issues with how the circuit works. The resistance of the SMA component can be made to be whatever is utilitarian, within constraints, by, for example, structuring the length and / or the cross-section (e.g., area - normal to the longitudinal axis of the component) of the SMA component. Making the cross-section thinner or making it longer will increase resistance, and this will then determine the voltage and current at which the SMA component transitions in some embodiments. Also, the longitudinal distance / local distance can be set to achieve a resistance, such as, for example, making the component longer relative to that which might otherwise be the case. Also, this can be accomplished by using a serpentine pattern in the SMA component. A roughly drawn serpentine SMA component is seen in FIG. 36, which can achieve a higher resistance per global length (by extending the local length). This has higher resistance than a straight section of the same global length (all other things being equal).
[0238] In an embodiment, the SMA components are driven by an application of a volage of less than, greater than and / or equal to 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 01, 11, 12, 13, 14 or 15 volts or more or any value or range of values therebetween in 0.1 volt increments. Such a voltage can activate the SMA transition. Embodiments include effectively short circuiting (effective because of the trace currents that extend through the SMA component) and / or actually short circuiting the circuit portion (as opposed to simply applying and / or altering the supply of current thereto, such as, for example, opening and closing a switch).
[0239] In an embodiment, the voltage drop that occurs, such as by way of example, via the use of the diode, and / or inductor and / or capacitor is at least and / or equal to 70, 75, 80, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, or 99% or more or any value or range of values therebetween in 0.1% increments (e.g., from 10 volts to less than and / or equal to 0.6 volts). Accordingly, in at least some exemplary embodiments, it is not the total absence of the currentthat flows through a given section of SMA component, but instead the fact that the current that flows therethrough is below the amount that would trigger the transition or otherwise trigger a meaningful transition. Note that in some embodiments, a Schottky diode can be used to reduce any potential complications associated with the applied voltage. Still, in at least some exemplary embodiments, standard diodes that have voltage drops of saying less than 1 V or less than about a’ of a volt or less than 3 / 4ths of a volt can be used.
[0240] In an embodiment, a diameter taken normal to the longitudinal axis is less than greater than and / or equal to 2, 1.75, 1.5, 1.25, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2 or 0.1 mm or any value or range of values therebetween in 0.01 mm increments. In an embodiment, in the interest of textual economy, an area taken normal to the longitudinal axis (lying on a plane normal to the longitudinal axis) is less than, greater than and / or equal to the value that results from calculating the cross-sectional area utilizing any of the aforementioned diameters of a circle. That is, the cross-sectional area need not be a circular cross-section, but the area is that which results from calculation of such, all in the interest of textual economy. In an exemplary embodiment, any of the above values can represent the largest unit value of a given diameter (instead of mm, the given distance can represent a unit value of, for example, 0.77) and embodiments utilize diameters that are 15, 14, 23, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.75, 1.5, 1.25, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.15, 0.1, 0.075, 0.05, 0.04, 0.03 or 0.02 times or any value or range of values therebetween in 0.01 times increments that unit value. In an exemplary embodiment, the various diameters and / or corollary cross-sectional areas calculated in accordance with the teachings detailed herein can be located at any of the locations detailed herein in the interest of textual economy.
[0241] Embodiments have been described in terms of the radius of curvature that a given electrode array can adopt when the SMA component is activated. That said, in an alternate embodiment, the after mentioned radii of curvature are that which corresponds to the electrode array and / or the SMA components in a non-energized state. In this regard, energizement of the SMA system causes the given SMA component / the electrode array to deform from that radius of curvature, so as to adopt another radius of curvature, which radius of curvature could be that of a nearly straight section (or a straight section, in which case the radius of curvature would be near infinite).
[0242] In an exemplary embodiment, different sections of the SMA system are activated at different temporal periods, as noted above. In an exemplary embodiment, the SMA system is configured so that the different sections will be activated in sequence. This can be done atdifferent temporal periods during the insertion of the electrode array into the cochlea by way of example, or otherwise the medical device into the body cavity in the more broader sense. The teachings above enable this by, for example, adding components and / or wire sections so as to facilitate this activation sequence or otherwise the controlled activation of some sections before and / or after the activation of other sections. As seen above, the concept of using diodes can, in some embodiments, enable this different sequence of activation (or separation of activations) without multiplying the number of feedthrough connections to the body of the implant in the case that the implant is providing the energizing power. Some of the inventions do include more than the minimum 2 wires for injection and recovery of current.
[0243] In an embodiment, there are less than greater than and / or equal to 3 (if less than, 2), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or 50 or more or any value or range of values therebetween in one increment sections that can be activated and / or deactivated independently and / or in combination of less than greater than and / or equal to 3 (if less than, 2), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or more or any value or range of values therebetween in one increment sections. In an embodiment, with respect to global position along a longitudinal length of a cochlear implant electrode array, there are less than greater than and / or equal to 1 (if less than, 0), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40 or 45 or more or any value or range of values therebetween in one increment sections that overlap or do not overlap (the numbers need not be the same) with another section in part or in total, and there could be less than, greater than and / or equal to 2 (if less than, 1), 3, 4, 5, 6, 7, 8, 9, 10 or more global sections the electrode array in the direction of the longitudinal axis that have sections of the SMA system that can be activated and / or deactivated that overlap (e.g., with respect to a plane that is normal to the longitudinal axis, there could be any number of separate activatable and / or deactivatable sections of the SMA system passing through that plane). And in an embodiment, there are devices systems and / or methods of activating any one or of these sections while any one or the other sections are deactivated (in the interest of textual economy, in accordance with any of the aforementioned numbers) so as to achieve respective unique positioning or otherwise respective unique geometries of the electrode array.
[0244] As noted above, in an embodiment, the SMA system is controlled by electrical signals that travel through a feedthrough between the stimulating assembly and the receiver stimulator of the medical device. In an embodiment, there are only two conductors in the feedthrough that are used for the SMA system herein. In an embodiment, there are only a number ofconductors (and thus no more) of the feedthrough that are used for the SMA system as the number of inputs, which number of inputs can correspond to any of those detailed herein.
[0245] In an embodiment, there is provided a small circuit outside the hermetic package / on the outside of the system relative to the receiver-stimulator, which takes power and / or data over the 2 wire interface of the feedthrough (for example, although it could be 3 or 4 or more or any of the conductors noted herein) and then delivers the appropriate current to the multiple circuits of the SMA system where there are more than 2 connections to the SMA system (or more than the number of conductors through the feedthrough, whatever that number may be).
[0246] In an embodiment, this circuit which is external to the hermetic package / the receiverstimulator portion could be arranged so that it only needs to “survive” for the duration of the surgery and then can become non-functional (due to fluid ingress) with no negative consequence / deleterious occurrences (at least relative to the health / well being of the recipient and / or the rest of the device, where the materials are biocompatible. Such a system would support driving multiple circuits without increasing the number of feedthrough connections beyond two or at least without increasing the number of feedthrough connections relative to that which would otherwise be the case. In an embodiment, the number of additional connections / contacts of the feedthrough are I to support the SMA system (and this can be with or without the additional external circuit in the interests of textual economy) and the number of connections / contacts that would be present but for the additional external circuit is J, where I is less than, equal to and / or greater than 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 or more or any value or range of values therebetween in 1 increment and J - 1 is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 or 18 or more or any value or range of values therebetween in 1 increment.
[0247] To be clear, in an exemplary embodiment, the “additional circuitry” need not be something that becomes disabled. This is simply a feature that can be utilitarian with respect to cost and / or FDA (or whatever other regulatory body is pertinent) compliance - the device need only last for minutes or a few hours or a few days or even a few months, all vs. a half or three-quarters of a century.
[0248] Thus, in an embodiment, there is an SMA drive circuit located in a separate “external box” separate from the receiver-stimulator and from the stimulating assembly. In an embodiment, this is attached only during surgery via a connector system, or perhaps a wiring arrangement that is cut off after use. Alternatively the SMA drive circuit could be a componentof the implant system separate to the receiver-stimulator. Also, this could be a separate inductively powered circuit completely separate from the cochlear implant receiver-stimulator. In an embodiment, such as where the power comes from the receiver-stimulator (pass-through from the inductance coil thereof, or by internal power storage devices thereof), it can be utilitarian to use a supercapacitor, such as one which is gradually charged and then discharged with a higher current needed to drive the requisite energy to the SMA. Note that the power can come from a separate inductance coil in the “external box” / in signal communication with the “external box” but separate from the receiver-stimulator.
[0249] In an embodiment, a totally implantable cochlear implant system or other system with a battery in the implant could be utilitarian because it is likely to be able to provide the relatively high power required by the SMA material. This battery could be charted before implantation, and then recharge before device switch-on (or before use of the implant as a totally implantable device).
[0250] In view of the above, figure 37 shows an exemplary implantable component of a cochlear implant which includes the receiver stimulator 180 as is known in the art and described above by way of example. Here, there is a feedthrough 4010, which places the components outside the receiver stimulator in general, and the components outside the hermetically sealed portion of that component in particular (the hermetically sealed housing) into electrical signal communication with the components inside the receiver stimulator 180 / inside the hermetically sealed package (the housing). Shown in figure 37 is also the above-noted additional external component 4040. Here, component 4040 includes a housing and circuitry that enables the use of a more limited number of feedthrough connections to operate the SMA system relative to that which would otherwise be the case. By way of example only and not by way of limitation, for purposes of explanation, there are the leads 4060 which are utilized to power and otherwise provide electrical current to the electrodes of the cochlear implant electrode array as described above. These are represented by a single thick line. In an embodiment, there can be as many leads as there are electrodes, concomitant with the teachings detailed above (which may or may not include the return electrode(s)). Accordingly, if the cochlear implant electrode array is a 22 electrode array, there could be 22 leads. But there could be more leads or fewer leads depending on whether or not there is some form of multiplexing going on or whether or not redundancy features are implemented. The point is, this is not implicated in the teachings detailed herein with respect to the SMA system. Conversely, there are only two leads 4050 and thus only to feedthrough connections for the component 4040 with respect to operating theSMA system of which component 4040 is a part (note that in this embodiment, component 4040 can operate as a passthrough arrangement for the signals for the electrodes - in other embodiments, component 4040 is bypassed by the stimulating assembly or more accurately, the traditional stimulating assembly, or otherwise the leads running to the electrodes of the implantable component - in such an arrangement, leads 4050 could extend to the component 4040, and then additional leads could extend from the component 4040 to the stimulating assembly to implement the teachings herein associated with the SMA system).
[0251] In an embodiment, component 4040 includes a logic circuit which could be based in traditional circuitry or could be a computer chip or otherwise a silicone based semiconductor. In an embodiment, the control signals are provided from the external component or the device that is utilized during surgery or after surgery to the receiver stimulator, to the receiver stimulator. In an embodiment, the receiver stimulator passes through those control signals to the component 4040 via the leads 4050. In an alternative embodiment, the receiver stimulator includes circuitry that can analyze those signals and modify the signals or otherwise develop new signals based on those signals and provide such via leads 4052 component 4040. The logic circuit component 4040 analyzes or otherwise react to the control signal, and controls the SMA system accordingly. Here, two wires 4050 can be utilized, and thus two feedthrough connections can be utilized to implement an SMA system that includes more inputs than two inputs without increasing the number of feedthrough wires accordingly. In an exemplary embodiment, the signal provided to component 4040 can be a digital signal or could be an analog signal, and the circuitry can receive such and have a lookup table for example in component 4040 or have a series of transistors arranged to react to a given amplitude and / or frequency and / or a given string of zeros and ones and thus variously provide current to the various inputs and / or control the direction of current flow, etc., accordingly.
[0252] In a similar vein, power that is utilized to power the SMA system can be provided by inductance communication with the receiver stimulator, and this power can be passed through to component 4040 via leads 4050, or an alternative embodiment, the power can be utilized to power the receiver stimulator, and the receiver stimulator can then in turn power the component 4040 via leads 4050. Embodiments can include an inductance coil in signal communication with component 4040 and / or incorporated in component 4040. In an exemplary embodiment, the inductance coil could be located on top of the housing of component 4040, such as embedded in a silicone layer that encapsulates the housing. In an exemplary embodiment, the housing can be a ceramic housing, which, in at least some scenarios, is transparent to theinductance field. That said, some arrangements of the housing that are metallic could also be sufficiently transparent to the inductance field so that the inductance field capacity of the housing and thus be received by a receiver coil inside the housing.
[0253] And note that embodiments that include an inductance coil could also have control signals delivered to the electronics of the component 4040. That is, the inductance communication with component 4040, directly or indirectly, or otherwise the inductance communication with the component outside the receiver stimulator, could provide power and or control signals in a manner analogous to or otherwise the same as that which is the case with respect to providing control signals to the receiver stimulator. In an exemplary embodiment, there could be one or more capacitors such as for example, a super capacitor and / or one or batteries inside component 4040 and / or circuitry such as a logic circuit, which could be chip based work could be regular electronic components supported on a substrate for example, that is configured to receive a control signal, and react to the control signal and otherwise the output signals to the SMA system so as to implement the shape changing implementations detailed herein.
[0254] And while embodiments have focused on the utilization of an inductance field for communication and / or power, in an alternate embodiment, component 4040 could have its own feedthrough that is temporarily connected to a control system or a control device such as any of those detailed herein that have a connector that can connect to this feedthrough. In an exemplary embodiment, direct wire based or conductive based electronic communication from outside the implant to the component 4040 can be implemented so as to control the implant to shake change in accordance with the teachings detailed herein. This could completely bypass the receiver stimulator in a manner analogous to the above-noted arrangement where there is a separate inductance coil from the receiver stimulator. In an exemplary embodiment, after use or otherwise after insertion of the electrode array and after the electrode array is positioned as desired, the connection between the component 4040 and the control device could be severed, such as for example by disconnecting the connector, or cutting the wires between the two components. In an exemplary embodiment, the feedthrough might degrade shortly after implantation but that is not a problem because in some scenarios, the shape changing arrangement may not be utilized after implantation. In an exemplary embodiment, a cover could be put over the feedthrough or otherwise the feedthrough could be covered with a biocompatible material or otherwise a resin that will create a barrier between the feedthrough and the fluid of the body as might be utilitarian. Again, alternatively, it could be that thefeedthrough prongs can be permitted to corrode a bit and that would be compatible with longterm implantation of the device.
[0255] Still, as noted above, some embodiments include a component 4040 that is not in the line of communication between the receiver stimulator and the electrode array. In embodiments that utilize, for example, the component 4040 that has the communication and / or control logic circuitry that is separate from the receiver stimulator, it could be that the component 4040 is “plugged into” a separate feedthrough on the stimulating assembly, such as a feedthrough that is located along the lead portion of the stimulator assembly between the receiver stimulator, more accurately, the feedthrough of the receiver stimulator that communicates with the stimulating assembly, and the electrode array. In an exemplary embodiment, component 4040 can be attached to the stimulating assembly at the separate feedthrough and thus component 4040 can be placed into signal communication with the electrode array so as to implement the shape changing teachings detailed herein.
[0256] Further, the use of a feedthrough can implement an arrangement where a control device is temporarily directly connected to the implant and used to provide conductive communication to the implant during the implantation process so that the control device can be utilized to control the electrode array with respect to its shape during the implantation process. For example, there could be an implant that has the-just detailed feedthrough, whether on the receiver stimulator or on the stimulating assembly. A control device, such as component 4040 or any of the devices detailed herein, can be connected to this feedthrough for use during surgery, and then, the devices can be utilized to control the shape and otherwise vary the shape of the electrode array during the implantation process, and then, after the implantation process is completed, the control device could be disconnected from this feedthrough. The feedthrough could have any of the features just detailed with respect to biocompatibility or otherwise the feedthrough could be dispositioned in accordance with the teachings just detailed or any other way that would have utilitarian value and otherwise would not provide a safety issue to the recipients. And while the just detailed embodiment has focused on the utilization of a feedthrough, in an alternative embodiment, an inductance communication system could be utilized, and in this regard, by way of example, component 4040 can be considered a proxy for a device that is utilized to control the shape of the electrode array, but which is not intended to be implanted into the recipient.
[0257] Corollary to this is that in another embodiment, the electronics that permit the two leads (or however many leads) to more than two inputs is / are distributed in the stimulating assembly(along the length of the leads for example or in the cochlear implant electrode array (extra cochlear portion and / or the intracochlear portion)). Also, as noted herein, frequency control could be used.
[0258] Any method action and / or functionality disclosed herein where the art enables such corresponds to a disclosure of a code from a machine learning algorithm and / or a code of a machine learning algorithm and / or a product of machine learning for execution of such. Still as noted above, in an exemplary embodiment, the code need not necessarily be from a machine learning algorithm, and in some embodiments, the code is not from a machine learning algorithm or the like. That is, in some embodiments, the code results from traditional programming. Still, in this regard, the code can correspond to a trained neural network. In an embodiment, the trained neural network can be utilized to provide (or extract therefrom) an algorithm that can be utilized separately from the trainable neural network. In one embodiment, there is a path of training that constitutes a machine learning algorithm starting off untrained, and then the machine learning algorithm is trained and “graduates,” or matures into a usable code - code of trained machine learning algorithm. With respect to another path, the code from a trained machine learning algorithm is the “offspring” of the trained machine learning algorithm (or some variant thereof, or predecessor thereof), which could be considered a mutant offspring or a clone thereof. That is, with respect to this second path, in at least some exemplary embodiments, the features of the machine learning algorithm that enabled the machine learning algorithm to learn may not be utilized in the practice some of the method actions, and thus are not present the ultimate system. Instead, only the resulting product of the learning is used.
[0259] And to be clear, in an exemplary embodiment, there are products of machine learning algorithms (e.g., the code from the trained machine learning algorithm) that are included in any one or more of the systems / subsystems detailed herein, that can be utilized to analyze any of the data obtained or otherwise available disclosed above that can be utilized or otherwise is utilized to evaluate the data obtained herein. This can be embodied in software code and / or in computer chip(s) that are included in the system(s).
[0260] An exemplary system includes an exemplary device / devices that can enable the teachings detailed herein, which in at least some embodiments can utilize automation. That is, an exemplary embodiment includes executing one or more or all of the methods and / or functionalities detailed herein and variations thereof, at least in part, in an automated or semiautomated manner using any of the teachings herein. Conversely, embodiments includedevices and / or systems and / or methods where automation is specifically prohibited, either by lack of enablement of an automated feature or the complete absence of such capability in the first instance.
[0261] In an exemplary embodiment, there are computer chips and / or computer circuit configured to implement any one or more of the teachings herein provided that the art enable such.
[0262] Embodiments can include a system and / or simply an embodiment that includes a non- transitory computer readable medium having recorded thereon, a computer program for executing at least a portion of a method, the computer program including code for executing any one or more of the method actions and / or functionalities detailed herein. Thus, any disclosure herein of a method action or functionality corresponds to a disclosure of a non- transitory computer readable medium having programed thereon code to execute one or more of those actions and also a product to execute one or more of those actions.
[0263] Embodiments include any functionality disclosed herein and / or method action disclosed herein being executed by a computer chip, a processor, software, logic circuitry and / or electronics, and all are not mutually exclusive. Any circuit that can enable the teachings herein can be used providing that the art enables such. Thus, in the interests of textual economy, and disclosure herein of a functionality of an article of manufacture corresponds to any one or more of the aforementioned structures being configured to execute such and otherwise for such, and the same is for any method action disclosed herein, where any such action corresponds to a disclosure of any one or more of the aforementioned structures being configured to execute such and otherwise for such.
[0264] Any disclosure herein of a processor corresponds to a disclosure in an embodiment of a non-processor device or a combined processor-non-processor device where the non-processor is a result of machine learning. Embodiments can include a link from the cloud to a clinic to pass information back and forth, enabling the remote processing noted above and / or enabling the obtaining of additional data for retraining purposes. Information can be uploaded to the cloud to the clinic, where the information can be analyzed. Another exemplary system includes a smart device, such as a smart phone or tablet, etc., that is running a purpose built application to implement some of the teachings detailed herein. This can be used by the clinician, and can contain at least the front end portions of the systems and devices detailed herein. Any disclosure herein of a processor corresponds to a disclosure of a non-processing device, orincludes non-processing devices, such as a chip or the like that is a result of a machine learning algorithm or machine learning system, etc.
[0265] It is further noted that any disclosure of a device and / or system detailed herein also corresponds to a disclosure of otherwise providing that device and / or system and / or utilizing that device and / or system.
[0266] It is also noted that any disclosure herein of any process of manufacturing or providing a device corresponds to a disclosure of a device and / or system that results therefrom. Is also noted that any disclosure herein of any device and / or system corresponds to a disclosure of a method of producing or otherwise providing or otherwise making such. Any functionality of a device disclosed herein corresponds to a disclosure of a method action corresponding to that functionality. Any method action disclosed herein corresponds to a disclosure of a device and / or system for executing such, providing that the art enables such.
[0267] Any embodiment or any feature disclosed herein can be combined with any one or more or other embodiments and / or other features disclosed herein, unless explicitly indicated and / or unless the art does not enable such. Any embodiment or any feature disclosed herein can be explicitly excluded from use with any one or more other embodiments and / or other features disclosed herein, unless explicitly indicated that such is combined and / or unless the art does not enable such exclusion.
[0268] Any function or method action detailed herein corresponds to a disclosure of doing so in an automated or semi-automated manner.
[0269] While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.
Claims
CLAIMSWhat is claimed is:
1. A device, comprising: at least a portion of an electrical conduction circuit; and a carrier carrying the least a portion of the electrical conduction circuit, wherein the device is configured to change a shape of the carrier as a result of a change in a direction of direct current in the at least a portion of the electrical conduction circuit.
2. The device of claim 1, wherein: the device is configured so that current travels in a first subcircuit of the circuit portion when travelling in a first direction in the circuit portion, and the current travels in a second subcircuit of the circuit portion when the current travels in a second direction in the circuit portion, the second-sub circuit being different from the first sub-circuit.
3. The device of claims 1 or 2, wherein: the first subcircuit as a local length that is shorter than a local length of the second subcircuit.
4. The device of claims 1, 2 or 3, wherein: the device includes at least one diode; and the at least one diode is carried by the carrier, the diode being part of the at least a portion of the circuit.
5. The device of claims 1, 2, 3 or 4, wherein: the device is configured to autonomously direct current along a first path of the at least a portion of the electrical circuit when the direct current flows in a first direction and autonomously direct current along a second path of the at least a portion of the electrical circuit because the direct current flows in a second direction different from the first direction.
6. The device of claims 1, 2, 3, 4 or 5, wherein the device is configured to heat different parts of the portion of the electrical conduction circuit depending on which direction the direct current is flowing.
7. The device of claim 5, wherein the direction of current through the different paths changes the shape of the carrier and thus causes the carrier to have respective different shapes.
8. The device of claims 1, 2, 3, 4, 5, 6, or 7, wherein: the at least a portion of the electrical conduction circuit includes a first conductor and a second conductor; the first conductor reacts differently to current flowing therethrough than the second conductor; and the change in direction of direct current results in more current traveling through the second conductor or less current traveling through the second conductor than that which was the case before the change in direction.
9. The device of claim 8, wherein: the first conductor is a shape changing material, and the second conductor is a nonshape changing material.
10. The device of claims 1, 2, 3, 4, 5, 6, 7, 8 or 9, wherein: the device is a cochlear implant electrode array; and there are at least two diodes in an intra-cochlear portion of the array.
11. A device, comprising: at least a portion of an electrical conduction circuit; and a carrier carrying at least a portion of the at least a portion of the electrical conduction circuit, wherein the electrical conduction circuit includes material that changes shape with temperature, the carrier carries the material that changes shape with temperature, and the at least a portion of the electrical conduction circuit has a first number of electrical inputs, any two of which inputs of electrical inputs enable closure of a circuit path of the at least a portion of the electrical conduction circuit, wherein there are more closeable circuit paths than electrical inputs.
12. The device of claim 11, wherein:there are a plurality of shape changing material components corresponding to the material that changes shape with temperature, and the device is configured to enable a variation of a path of electrical current through the at least a portion of the electrical conduction circuit so that different respective components of the plurality of shape changing material components have the electrical current flowing therethrough based on the variation of the path.
13. The device of claim 12, wherein there are at least 25% more discrete closable circuit paths than electrical inputs.
14. The device of claims 11, 12 or 13, wherein: there are a plurality of shape changing material components corresponding to the material that changes shape with temperature, and the device is configured to variously bring two or more of the inputs into and out of electrical conductivity with a power source to controllably provide electrical current to respective one or more of the plurality of shape changing material components.
15. The device of claims 11, 12, 13 or 14, wherein: the carrier is part of an electrode array; and the electrode array is devoid of diodes.
16. The device of claims 11, 12, 13, 14 or 15, wherein: the carrier is part of a cochlear implant electrode array; and the device is configured to enable the cochlear implant electrode array to pull itself into the cochlea by variously applying electrical current to the components.
17. The device of claim 11, wherein: the at least a portion of the electrical conduction circuit includes material that is dimensionally stable with temperature; there are a plurality of shape changing material components corresponding to the material that changes shape with temperature; there are a plurality of dimensionally stable material components corresponding to the material that is dimensionally stable;at least one of the plurality of dimensionally stable material components extends in the carrier in a serial manner with at least one of the plurality of shape changing material components.
18. The device of claim 17, wherein: at least two of the plurality of shape changing material components have respective portions that are at least generally parallel to each other and extend through a plane normal to a longitudinal axis of the carrier.
19. The device of claims 11, 12, 13, 14, 15, 16, 17 or 18, wherein the at least a portion of the electrical conduction circuit has at least four electrical inputs and there are at least five closable circuit paths.
20. The device of claims 11, 12, 13, 14, 15, 16, 17 or 18, wherein the device is an intracochlear portion of a cochlear implant electrode array.
21. A device, comprising: an electrically conductive path; and one or more electrodes, wherein the electrically conductive path includes material that changes shape when exposed to electrical current, and the device is configured to vary a location of current application to the material and / or a location of a current path to ground / neutral from the material.
22. The device of claim 21, wherein: the device includes a commutator that electrically interfaces with the material to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material.
23. The device of claims 21 or 22, wherein: the device includes a movable wire to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material.
24. The device of claims 21, 22 or 23, wherein:the variation of the location of current application to the material and / or the location of the current path to ground / neutral from the material enables selective activation of the material relative to respective locations of respective electrodes of the one or more electrodes of the device.
25. The device of claims 21, 22, 23 or 24, wherein: the variation of the location is a figuratively infinite variation.
26. The device of claims 21, 22, 23 or 24, wherein: the device includes a conductive path of material that is dimensionally stable when current is applied thereto, which conductive path of material that is dimensionally stable is a path of lower resistance relative to the electrically conductive path; and the current applied to the material and / or the current that travels from the material to ground / neutral travels through the material that is dimensionally stable.
27. The device of claims 21, 22, 23, 24, 25 or 26, wherein: the selective activation of the material enables a shape of the electrically conductive path to vary relative to that which would otherwise be the case, all other things being equal.
28. The device of claims 21, 22, 23, 24, 25, 26 or 27, wherein: the device includes one or more fusable links which will blow upon application of a given current to vary the location of current application to the material.
29. The device of claims 21, 22, 23, 24, 25, 26, 27 or 28, wherein: the device is configured to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material by changing a frequency of the current.
30. The device of claim 29, wherein: the device utilizes a capacitor and / or an inductor to enable the variation of the location of current application to the material and / or the location of the current path to ground / neutral from the material by changing the frequency of the current.
31. A method, comprising:inserting a variable shape medical device into a cavity of a human; and applying electrical current to a portion of the medical device to vary a shape of the medical device, wherein the portion of the device includes a shape changing material that changes a shape of the device upon application of the electrical current thereto, thereby varying the shape of the medical device, the shape changing material establishes a conductive component that has a longitudinal direction, and the method includes flowing electrical current of the applied electrical current through different amounts and / or portions of the conductive component to vary the shape of the medical device.
32. The method of claim 31, wherein: the medical device is a cochlear implant electrical array; and the cavity is a cochlea of a human.
33. The method of claims 31 or 32, wherein: the action of flowing electrical current results in current flow bypassing a subsection of the component, which bypassed subsection remains dimensionally stable.
34. The method of claim 33, wherein: the action of applying the current includes reversing a direction of DC current flow, wherein the action of reversing the direction results in the flowing of electrical current of the applied electrical current through different amounts and / or portions of the conductive component.
35. The method of claims 31, 32, 33 or 34, wherein: the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to adopt a first curved configuration having a first radius of curvature and adopt a second curved configuration that has at a second radius of curvature different from the first radius of curvature.
36. The method of claims 31, 32, 33, 34 or 35, wherein:the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to pull itself into the cavity.
37. The method of claims 31, 32, 33 or 34, wherein: the device is an electrode array; the electrode array has a first electrical input and a second electrical input; and the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component is executed when a first current is applied to the first input and the second input is at least one of a ground terminal or a neutral terminal vis-a-vis the first current , the first current being the current applied to a portion of the medical device.
38. A device, comprising: a conductive member; and an output component, wherein the device is configured to enable an applied electrical current applied to the conductive member to bypass a first portion of the conductive member while flowing in a second portion of the conductive member, the conductive member is a shape changing member that changes shape when exposed to the electrical current, and the device is a medical device.
39. The device of claim 38, wherein: the device is configured so that when the electrical current flows in a first direction in the conductive member, the current flows through the first portion and the second portion; and the device is configured so that when the electrical current flows in a second direction reverse of the first direction in the conductive member, the bypassing of the first portion occurs solely do to the reversal of the direction.
40. The device of claims 38 or 39, wherein: the bypassing is enabled by a path to ground and / or neutral that has lower resistance than the first portion and the second portion.
41. The device of claims, 38, 39 or 40, wherein: the bypassing is enabled by a path that includes a diode chip in the path.
42. The device of claims, 38, 39, 40 or 41, wherein: the device is configured to enable an applied second electrical current applied to the conductive member to bypass a third portion of the conductive member while flowing in the second portion of the conductive member; and a direction of the applied second electrical current in the section portion is the same as the direction of the applied electrical current in the second portion.
43. The device of claims 38, 39, 40, 41 or 42, wherein: the conductive member is part of a portion of a circuit that includes a plurality of inputs; the device is configured so that a first current direction at a first input of the plurality of inputs results in current flowing in the second portion while bypassing the first portion when a second input of the plurality of inputs is connected to ground and / or neutral; the device is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion when a third input of the plurality of inputs is connected to ground and / or neutral.
44. The device of claims 38, 39, 40, 41, 42 or 43, wherein: the device is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion and bypassing a third portion of the conductive member when a fourth input of the plurality of inputs is connected to ground and / or neutral.
45. The device of claims 38, 39, 40, 41, 42, 43 or 44, wherein: the device is configured to apply a DC current through an inductor and / or a capacitor to apply the electrical current to the first portion of the conductive member and apply an AC current through the inductor and / or the capacitor to bypass the first portion of the conductive member.
46. A cochlear implant, comprising:a conductive shape changing material elongate member; an array of electrodes; and an inductance communication system and / or a power storage device, wherein the device is configured to enable electrical current from the inductance communication system and / or from the power storage device that is applied to the conductive shape changing material elongate member to bypass a first portion of the conductive member while flowing in a second portion of the conductive member, the conductive member changes shape when exposed to the electrical current.
47. A device and / or system and / or a method and / or code, wherein at least one of: the device and / or system includes at least a portion of an electrical conduction circuit; the device and / or system includes a carrier carrying the least a portion of the electrical conduction circuit; the device is configured to change a shape of the carrier as a result of a change in a direction of direct current in the at least a portion of the electrical conduction circuit; the device and / or system is configured so that current travels in a first subcircuit of the circuit portion when travelling in a first direction in the circuit portion, and the current travels in a second subcircuit of the circuit portion when the current travels in a second direction in the circuit portion, the second-sub circuit being different from the first subcircuit; the first subcircuit as a local length that is shorter than a local length of the second subcircuit; the device and / or system includes at least one diode; the at least one diode is carried by the carrier, the diode being part of the at least a portion of the circuit; the device and / or system is configured to autonomously direct current along a first path of the at least a portion of the electrical circuit when the direct current flows in a first direction and autonomously direct current along a second path of the at least a portion of the electrical circuit because the direct current flows in a second direction different from the first direction; a portion of the electrical conduction circuit depending on which direction the direct current is flowing;the device and / or system is configured so that the direction of current through the different paths changes the shape of the carrier and thus causes the carrier to have respective different shapes; the at least a portion of the electrical conduction circuit includes a first conductor and a second conductor; the first conductor reacts differently to current flowing therethrough than the second conductor; the change in direction of direct current results in more current traveling through the second conductor or less current traveling through the second conductor than that which was the case before the change in direction; the first conductor is a shape changing material, and the second conductor is a nonshape changing material; the device is a cochlear implant electrode array; and there are at least two diodes in an intra-cochlear portion of the array; the device and / or system includes at least a portion of an electrical conduction circuit; the device and / or system includes a carrier carrying at least a portion of the at least a portion of the electrical conduction circuit; the electrical conduction circuit includes material that changes shape with temperature, the carrier carries the material that changes shape with temperature; the at least a portion of the electrical conduction circuit has a first number of electrical inputs, any two of which inputs of electrical inputs enable closure of a circuit path of the at least a portion of the electrical conduction circuit, wherein there are more closeable circuit paths than electrical inputs; there are a plurality of shape changing material components corresponding to the material that changes shape with temperature; the device is configured to enable a variation of a path of electrical current through the at least a portion of the electrical conduction circuit so that different respective components of the plurality of shape changing material components have the electrical current flowing therethrough based on the variation of the path; there are at least 25% more discrete closable circuit paths than electrical inputs; there are a plurality of shape changing material components corresponding to the material that changes shape with temperature;the device and / or system is configured to variously bring two or more of the inputs into and out of electrical conductivity with a power source to controllably provide electrical current to respective one or more of the plurality of shape changing material components; the carrier is part of an electrode array;; the electrode array is devoid of diodes; the carrier is part of a cochlear implant electrode array; the device is configured to enable the cochlear implant electrode array to pull itself into the cochlea by variously applying electrical current to the components; the at least a portion of the electrical conduction circuit includes material that is dimensionally stable with temperature; there are a plurality of shape changing material components corresponding to the material that changes shape with temperature; there are a plurality of dimensionally stable material components corresponding to the material that is dimensionally stable; at least one of the plurality of dimensionally stable material components extends in the carrier in a serial manner with at least one of the plurality of shape changing material components; at least two of the plurality of shape changing material components have respective portions that are at least generally parallel to each other and extend through a plane normal to a longitudinal axis of the carrier; the at least a portion of the electrical conduction circuit has at least four electrical inputs and there are at least five closable circuit paths; the device and / or system is an intracochlear portion of a cochlear implant electrode array; the device and / or system includes an electrically conductive path; the device and / or system includes one or more electrodes; the electrically conductive path includes material that changes shape when exposed to electrical current; the device is configured to apply a DC current through an inductor and / or a capacitor to apply the electrical current to the first portion of the conductive member and apply an AC current through the inductor and / or the capacitor to bypass the first portion of the conductive member.the device is configured to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material by changing a frequency of the current; the device utilizes a capacitor and / or an inductor to enable the variation of the location of current application to the material and / or the location of the current path to ground / neutral from the material by changing the frequency of the current; the device and / or system is configured to vary a location of current application to the material and / or a location of a current path to ground / neutral from the material; the device and / or system includes a commutator that electrically interfaces with the material to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material; the device and / or system includes a movable wire to vary the location of current application to the material and / or the location of the current path to ground / neutral from the material; the variation of the location of current application to the material and / or the location of the current path to ground / neutral from the material enables selective activation of the material relative to respective locations of respective electrodes of the one or more electrodes of the device; the variation of the location is a figuratively infinite variation; the device and / or system includes a conductive path of material that is dimensionally stable when current is applied thereto, which conductive path of material that is dimensionally stable is a path of lower resistance relative to the electrically conductive path; the current applied to the material and / or the current that travels from the material to ground / neutral travels through the material that is dimensionally stable; the selective activation of the material enables a shape of the electrically conductive path to vary relative to that which would otherwise be the case, all other things being equal; the device includes one or more fusable links which will blow upon application of a given current to vary the location of current application to the material; the device and / or system is configured to enable the insertion of a variable shape medical device into a cavity of a human and the application of electrical current to a portion of the medical device to vary a shape of the medical device; the portion of the device includes a shape changing material that changes a shape of the device upon application of the electrical current thereto, thereby varying the shape of the medical device;the shape changing material establishes a conductive component that has a longitudinal direction; the method includes flowing electrical current of the applied electrical current through different amounts and / or portions of the conductive component to vary the shape of the medical device; the device and / or system is a medical device; the medical device is a cochlear implant electrical array; the cavity is a cochlea of a human; the action of flowing electrical current results in current flow bypassing a subsection of the component, which bypassed subsection remains dimensionally stable; the action of applying the current includes reversing a direction of DC current flow, wherein the action of reversing the direction results in the flowing of electrical current of the applied electrical current through different amounts and / or portions of the conductive component; the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to adopt a first curved configuration having a first radius of curvature and adopt a second curved configuration that has at a second radius of curvature different from the first radius of curvature; the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component causes the medical device to pull itself into the cavity; the electrode array has a first electrical input and a second electrical input; the action of flowing the electrical current of the applied electrical current through different amounts and / or portions of the conductive component is executed when a first current is applied to the first input and the second input is at least one of a ground terminal or a neutral terminal vis-a-vis the first current , the first current being the current applied to a portion of the medical device; the device and / or system includes a conductive member; the device and / or system includes an output component; the device is configured to enable an applied electrical current applied to the conductive member to bypass a first portion of the conductive member while flowing in a second portion of the conductive member;the conductive member is a shape changing member that changes shape when exposed to the electrical current; the device and / or system is configured so that when the electrical current flows in a first direction in the conductive member, the current flows through the first portion and the second portion; the device and / or system is configured so that when the electrical current flows in a second direction reverse of the first direction in the conductive member, the bypassing of the first portion occurs solely do to the reversal of the direction; the bypassing is enabled by a path to ground and / or neutral that has lower resistance than the first portion and the second portion; the bypassing is enabled by a path that includes a diode chip in the path; the device and / or system is configured to enable an applied second electrical current applied to the conductive member to bypass a third portion of the conductive member while flowing in the second portion of the conductive member; a direction of the applied second electrical current in the section portion is the same as the direction of the applied electrical current in the second portion; the conductive member is part of a portion of a circuit that includes a plurality of inputs; the device is configured so that a first current direction at a first input of the plurality of inputs results in current flowing in the second portion while bypassing the first portion when a second input of the plurality of inputs is connected to ground and / or neutral; the device and / or system is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion when a third input of the plurality of inputs is connected to ground and / or neutral; the device and / or system is configured so that the first current direction at the first input of the plurality of inputs results in current flowing in the second portion and the first portion and bypassing a third portion of the conductive member when a fourth input of the plurality of inputs is connected to ground and / or neutral; wherein the shape changing material is nitinol; wherein the shape changing material is an electrically conductive polymer; the conductive material is a partial loop; at least one of the conductors is a shape memory alloy; a relaxed state of the shape memory alloy is curled;some trace heating occurs in the portion that is shunted off from a portion of the circuit through which current flows; some of the thermal energy part of the SMA component through which current flows travels via conductive heat transfer to a portion where current is not flowing through; the component that changes shape when current flows therethrough deforms when a transition temperature is reached and when the temperature of the material goes below the transition temperature, the component returns to its below-transition temperature shape; the device and / or system is configured to shunt current from a portion of the circuit; the device and / or system is configured so that utilization of the diode or otherwise the utilization of the path of least resistance and / or a shunt arrangement results in a reduction of thermal energy content in a given portion of the SMA component of equal to or greater than 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 99.2, 99.4, 99.6, 99.7, 99.8, 99.85, 99.9, 99.92, 99.94, 99.96, 99.97, 99.98, 99.99 or 100% or any value or range of values therebetween in 0.001% increments relative to that which would otherwise be the case, all other things being equal, on a mean, median and / or mode basis on a local length, the global length, mass and / or volume of the SMA component and / or an amount of deformation (e.g., change in radius of curvature (reduction)) of the shunted portion component has any of those values in comparison to the portion to which current flows freely and / or an amount current flow (rate) of the shunted portion component has any of those values and / or an amount of total current charge of the shunted portion can correspond to any of those percentages; the device and / or system is configured so that trace current present in the shunted portion has a deminmus, if any, effect on the shape thereof; the device and / or system has varied amounts of thermal insulation, including no insulation, at various portions of the circuit so as to increase and / or decrease an amount of time needed to reach a transition temperature and / or an amount of current needed to reach a transition temperature of the SMA component; a direction of current applied to an input of the circuit portion is maintained for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35, 40, 45, 50 or 60 seconds or any value or range of values therebetween in 0.1 second increments before a direction that is reversed and / or a direction of current in one direction is maintained for at least 70, 75, 80, 85, 90 or 95 percent of the time or more over any one or more of those time periods just noted and / or any one or more of the aforementioned percentages can correspond to the percentage of total current charge that is provided in one direction relative to another over any one or more of the just noted temporal periods. And inthe interest of textual economy, any of the values detailed herein (e.g., total charge, current rate, etc.) can be the case for any of the just noted temporal periods and / or where alternating current is utilized, the frequency of the alternating current is at least and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 75, 100, 125, 150, 175 or 200 Hz or any value or range of values therebetween in 0.1 Hz increments; there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 or 50 or more diodes or any value or range of values therebetween in 1 increment in an SMA system of an embodiment; the diodes can be within the intracochlear portion of the electrode array and / or the diodes (any number just detailed) are located outside of the intracochlear portion of the array; position of the diode(s) / electrical communication between the diodes and the remainer of the system is selected to customize a point of transition between the sections (one that curls (or uncurls) vs. one that does not, one that curls more than the other (or uncurls more than the other); as measured from the distal most tip of the carrier and / or the distal most portion of a circuit that includes a SMA component, there is one or more transition points 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm or any value or range of values therebetween in 0.25 mm increments, which transition point corresponds to a location where current is diverted from and / or to an SMA component and / or there is a beginning and / or end of an SMA component at those locations; there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 or more any value or range of values therebetween in 1 increments transition points in the intra-cochlear section; the diode is a diode chip; the diode chip is bonded to a flattened portion of the conductive component; the device and / or system is configured so that with respect to the closest that a portion of an SMA component approaches another portion of the component or another component and / or a distance between centerlines thereof, such closest approach can be a value of less than greater than and / or equal to 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1, 1.1, 1.2, 1.
3. 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4,4.5, 5, 5.5 or 6 more mm or any value or range of values therebetween in 0.01 mm increments; a diode chip is bonded between legs of respective SMA components with strain relief at the tip via a flexible lead that has plenty of slack to accommodate movements / shifting of the structure; the diodes are glass packaged diodes; the diodes are ceramic packaged diodes;SMA component(s) are embedded within a silicone electrode carrier, whether electrically insulated by the silicone and / or insulated utilizing additional electrical insulation material in addition to the silicone and / or the body and the silicone carrier is molded around the SMA component s); the device has a double section of SMA portions in the apical side (half), and the SMA has have more strength to curl or decurl the apical half; as measured as measured from the distal most tip of the carrier and / or the distal most portion of a circuit that includes a SMA component, there is one or more locations having a given radius of curvature 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm or any value or range of values therebetween in 0.25 mm increments, which location corresponds to a location where the radius of curvature of the SMA component and / or the overall electrode array can be measured; the local length of any one of the subcircuits is less than, greater than and / or equal to 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100% or any value or range of values therebetween in 0.1% increments of that of another subcircuit; there are 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 or more or any value or range of values therebetween in 1 increments subcircuits; the at least a portion of the circuit can include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35, 40, 45, 50, 55, 60, 65, 70, 80, 90 or 100 or more diodes or any value or range of values therebetween in 1 increments;any one or more or all of the diodes these are located in the electrode array in general, and the intra-cochlear portion in particular in some embodiments and / or one or more or all of these can be carried by the carrier and / or embedded in the carrier; one or more or all of the diodes could be in the extracochlear portion of the electrode array and / or outside the carrier and / or not carried by the carrier and / or outside the electrode array and / or one or more or all of the diodes could be located in the lead portion of the stimulating assembly; and / or one or more or all of the diodes could be located between the electrode array of electrode array and the end of the stimulating assembly; the array is configured to adopt a different shape owing to the current flow, which different shape is static after a certain period of time of current flow at a steady rate through a subcircuit (e.g., after less than, greater than and / or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80 or 90 seconds or any value or range of values therebetween in 0.25 second increments) in a free body state; there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35 or 40 or more or any value or range of values therebetween in 1 increment first conductors and / or there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35 or 40 or more or any value or range of values therebetween in 1 increment second conductors (and the numbers need not be the same); there are at least and / or equal to and / or no more than X number of the plurality of dimensionally stable material components respectively extends in the carrier in a serial manner with respectively at least and / or equal to and / or no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in 1 increment of plurality of shape changing material components, where X equals 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in 1 increment; the diodes are Zener diodes;2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 or more or any value or range of values therebetween in 1 increment sections could be activated at the same time with different levels or pulse patterns of current to customize the bending of the SMA component on either side of the commutator and / or any number of these can be activated in sequence; the device is configured to temporarily lock or permanently lock a given shape after current flow;there are less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90 or 100 or more or any value or range of values therebetween in one increment fuses; there are X number of inputs that equal a plurality of inputs and the device is configured to enable an applied electrical current applied to the conductive member to bypass an Jth portion of the X number of portions first portion of the conductive member while flowing in a Kth portion of the X number of portions different from the Jth portion second portion of the conductive member, wherein the conductive member is part of a portion of a circuit that includes a plurality of inputs (any number of X that is a plurality of inputs) and the device is configured so that a first current direction at an Ith input of the plurality of inputs a first input results in current flowing in the Kth portion second portion while bypassing the Jth portion first portion when a Lth input second input of the plurality of inputs is connected to ground and / or neutral, and the device is configured so that the first current direction at the Ith input of the plurality of inputs results in current flowing in the Kth portion and the Jth portion when an Pth input of the plurality of inputs is connected to ground and / or neutral; a capacitor and / or an inductor is utilized to shunt current, and one of the two currents has a frequency that is at least and / or equal to 1.1, 1.15, 1.2, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 times or more or any value or range of values therebetween in 0.01 times increments higher than the other current; the device includes an additional component external from the receiver stimulator where the component includes a housing and circuitry that enables the use of a more limited number of feedthrough connections to operate the SMA system relative to that which would otherwise be the case; there are only two leads / connectors of the feedthrough of the receiver-stimulator used to control the SMA system; the extra component includes a logic circuit which could be based in traditional circuitry or could be a computer chip or otherwise a silicone based semiconductor that is used to control the SMA system; control signals are provided from the external component or the device that is utilized during surgery or after surgery to the receiver stimulator, to the receiver stimulator to control the SMA system; the receiver stimulator passes through those control signals to the control component;the receiver stimulator includes circuitry that can analyze those signals and modify the signals or otherwise develop new signals based on those signals and provide such to the control component; the logic circuit of the extra component analyzes or otherwise react to the control signal, and controls the SMA system accordingly; power that is utilized to power the SMA system can be provided by inductance communication with the receiver stimulator, and this power can be passed through to component via leads or an alternative embodiment, the power can be utilized to power the receiver stimulator, and the receiver stimulator can then in turn power the component via leads; there is an inductance coil in signal communication with the extra component component and / or incorporated in the extra component to receive power and / or control signals to power / control the SMA system; the method includes using any one or more of the devices / systems above and / or a method of implementing any one or more of the functionality detailed above; the code includes code for executing any one or more of the functionalities above; and / or the code includes code for a machine learning algorithm and / or a code of a machine learning algorithm and / or a product of machine learning to implement any one or more of the functionalities above.
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