Variable shape memory element

Abstract

Presented herein are techniques for controlling / facilitating the implantation of an implantable component of a medical device, such as a stimulating assembly of a cochlear implant, with a variable shape memory element. More specifically, a stimulating assembly in accordance with embodiments presented herein comprises an elongate carrier member configured to be inserted into a body cavity of a recipient. Disposed in the carrier member is a shape memory element that has differing physical characteristics along an elongate length thereof. The differing physical characteristics of the shape memory element are configured to sequentially bend portions of the elongate carrier member during insertion into the body cavity.

Description

Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1VARIABLE SHAPE MEMORY ELEMENTBACKGROUNDField of the Invention[ooot] The present invention relates generally to use of a variable shape memory element in a flexible component, such as a stimulating assembly, of an implantable medical device.Related Art

[0002] Medical devices are devices that are intended to be used for medical purposes. They can vary in both their intended use and indications for use. Examples range from simple, low- risk medical supplies to complex, potentially high-risk devices that are implanted and / or sustain life, such as deep brain stimulators and brain-computer interfaces. Other categories of medical device include diagnostic equipment.

[0003] Hearing devices act on an actual or potential auditory perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc. In particular, a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and / or can operate to suppress all or some sound signals. As such, a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy devices, etc.) or a device for use by a person with normal hearing (e.g., a consumer device that provides audio streaming, a consumer headphone, an earphone, etc.), a hearing protection device (e.g., a noise cancellation headset, a loudness reduction apparatus, etc.), etc.SUMMARY

[0004] In one aspect, an implantable component is provided. The implantable component comprises: an elongate carrier member configured to be inserted into a body cavity of a recipient; and at least one shape memory element disposed in the elongate carrier member, wherein the shape memory element has differing physical characteristics along an elongate length thereof in order to sequentially bend portions of the elongate carrier member during insertion into the body cavity.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0005] In another aspect, an implantable component is provided. The implantable component comprises: an elongate carrier member configured to be inserted into a body cavity of a recipient; and at least one shape memory element disposed in the elongate carrier member, wherein a timing of one or more phase changes of one or more portions of the at least one shape memory element effectuates a predetermined insertion trajectory of the elongate carrier member into the body cavity of the recipient.

[0006] In another aspect, a method of implanting an elongate stimulating assembly into a body cavity of a recipient is provided. The method comprises: inserting the elongate stimulating assembly into a body cavity of a recipient, the stimulating assembly comprising an elongate carrier member and at least one elongate shape memory element; and applying an electric current to the at least one shape memory element, wherein the at least one elongate shape memory element has non-uniform physical characteristics along an elongate length thereof such that application of the electric current causes successive portions of the at least one shape memory element and the elongate stimulating assembly to bend sequentially to match an intended trajectory into the body cavity of the recipient.

[0007] In another aspect, a method of implanting an elongate stimulating assembly into a body cavity of a recipient is provided. The method comprises: inserting the elongate stimulating assembly into a body cavity of a recipient, the stimulating assembly comprising an elongate carrier member and at least one elongate variable shape memory element; and controlling an insertion trajectory of the elongate stimulating assembly by applying electric current to the at least one elongate variable shape memory element to bend a tip end of the elongate stimulating assembly before other portions of the elongate stimulating assembly bend.

[0008] In another aspect, a system for implanting an implantable component is provided. The system comprises: an implantable body comprising electronic circuitry; an elongate carrier member, electrically connected to the implantable body via a lead region and configured to be inserted into a body cavity of a recipient, the elongate carrier member comprising a variable shape memory element extending along a length of the elongate carrier member; and the variable shape memory element having at least one electrical terminal disposed at a proximal end of the of the variable shape memory element and configured to receive electric current to sequentially bend portions of the elongate carrier member during insertion into the body cavity.

[0009] In another aspect, a method of manufacturing a variable shape memory element for an implantable component is provided. The method comprises: forming a first portion of aAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 variable shape memory element; forming a second portion of a variable shape memory element; and joining the first portion and the second portion at ends thereof.[ooio] In another aspect, a method of manufacturing a variable shape memory element for an implantable component is provided. The method comprises: forming a linearly extending variable shape memory element having predetermined length; folding the linearly extending variable shape memory element at a midpoint of the predetermined length to obtain a folded variable shape memory element; and molding the folded variable shape memory element in a spiral shape.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0012] FIG. 1A is a schematic diagram illustrating a cochlear implant system with which aspects of the techniques presented herein can be implemented;

[0013] FIG. IB is a side view of a recipient wearing a sound processing unit of the cochlear implant system of FIG. 1A;

[0014] FIG. 1C is a schematic view of components of the cochlear implant system of FIG. 1 A;

[0015] FIG. ID is a block diagram of the cochlear implant system of FIG. 1A;

[0016] FIG. IE is a schematic diagram illustrating a computing device with which aspects of the techniques presented herein can be implemented;

[0017] FIG. 2A is a schematic diagram of a stimulating assembly including a variable shape memory element that has not yet been activated;

[0018] FIG. 2B is a schematic diagram of the stimulating assembly of FIG. 2A where a first portion of the variable shape memory element has been activated causing a first bend in the stimulating assembly;

[0019] FIG. 2C is a schematic diagram of the stimulating assembly of FIG. 2A where a first portion and a second portion of the variable shape memory element have been activated causing a first bend and a, sequential, second bend in the stimulating assembly;

[0020] FIG. 3A is a schematic diagram of a stimulating assembly including a variable shape memory element configured to control sequential bending thereof;Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0021] FIGs. 3B and 3C are cross sections of the stimulating assembly of FIG. 3A along lines II-II and III-III, respectively;

[0022] FIGs. 3D and 3E are other possible cross sections of the stimulating assembly of FIG. 3A along lines II-II and III-III, respectively;

[0023] FIG. 4 illustrates dimensions used to calculate the area moment of inertia of a rectangular structure;

[0024] FIG. 5 is a schematic diagram of a stimulating assembly including a variable shape memory element that includes two parallel elements separated by some distance;

[0025] FIG. 6 shows a cross section of a stimulating assembly that includes a variable shape memory element that includes two separate sub-elements;

[0026] FIG. 7 is a schematic diagram of a stimulating assembly that includes a variable shape memory element including two separate sub-elements connected via trusses;

[0027] FIG. 8 is a schematic diagram of a stimulating assembly that includes a variable shape memory element including voids to control the sequential bending time of the stimulating assembly;

[0028] FIG. 9 is a schematic diagram of a stimulating assembly including a variable shape memory element including voids arranged on different planes to control the sequential bending time of the stimulating assembly;

[0029] FIG. 10 is a schematic diagram of a stimulating assembly including a variable shape memory element and associated heat sinks to control sequential bending time of the stimulating assembly;

[0030] FIG. 11 is a schematic diagram of a stimulating assembly including a variable shape memory element that includes of a plurality of different types or forms of shape memory alloys to control the sequential bending time of the stimulating assembly;

[0031] FIG. 12 is a schematic diagram of a stimulating assembly including a variable shape memory element having an undulating or serpentine configuration;

[0032] FIG. 13 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two stacked elements;

[0033] FIG. 14 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two elements arranged side by side;Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0034] FIG. 15 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two stacked elements along with an electrode and current signal supply wires;

[0035] FIG. 16 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two elements arranged side by side along with an electrode and current signal supply wires;

[0036] FIG. 17 shows a lumen into which the variable shape memory element is disposed;

[0037] FIG. 18 shows a lumen into which the variable shape memory element is disposed along with thermal insulation material;

[0038] FIG. 19 shows a lumen provided for each one of variable shape memory elements;

[0039] FIG. 20 shows a lumen provided for each one of variable shape memory elements along with thermal insulation material;

[0040] FIGs. 21A and 2 IB show a first manufacturing method for the variable shape memory element;

[0041] FIGs. 22A and 22B show a second manufacturing method for the variable shape memory element;

[0042] FIGs. 23A and 23B show a third manufacturing method for the variable shape memory element;

[0043] FIG. 24 is a flowchart showing a series of operations for implanting a medical device; and

[0044] FIG. 25 is a schematic diagram illustrating a vestibular stimulator system with which aspects of the techniques presented herein can be implemented.DETAILED DESCRIPTION

[0045] Presented herein are techniques for controlling / facilitating the implantation of an implantable component of a medical device, such as a stimulating assembly of a cochlear implant, with a variable shape memory element (variable shape memory inlay). More specifically, a stimulating assembly in accordance with embodiments presented herein comprises an elongate carrier member configured to be inserted into a body cavity of a recipient. Disposed in the carrier member is a shape memory element that has differingAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 physical characteristics along an elongate length thereof. The differing physical characteristics of the shape memory element are configured to sequentially bend portions of the elongate carrier member during insertion into the body cavity. For example, in certain embodiments, a variable shape memory element is configured such that, when an electric current is passed therethrough, different sections or regions of the of the shape memory alloy inlay heat at different rates, and thus curl or bend at different rates, so that the inlay, and thus the stimulating assembly, curl or bend in a predetermined sequential manner that can match a curved anatomical feature of a body cavity of a recipient into which the medical device is being implanted. A shape memory element that has differing physical characteristics along the elongate length thereof is sometimes referred to herein as a variable shape memory element because the physical characteristics / properties / attributes of the shape memory element vary / change along the length of the shape memory inlay.

[0046] There are a number of different types of device in / with which the techniques presented herein can be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific device. However, it is to be appreciated that the techniques presented herein can also be partially or fully implemented by any of a number of different types of devices or systems, including consumer electronic devices (e.g., consumer hearing devices, consumer computing devices such as mobile phones and tablets, audio equipment such as home theatre and car audio systems, etc.), computing systems (e.g., servers in data centers, Intemet-of-Things (loT) devices), various types of software systems, such as databases, machine learning and artificial intelligence systems, other medical devices, such as diagnostic equipment or life sustaining equipment, etc. For example, the techniques presented herein could be used in or with sensory protheses, including hearing aids and cochlear implants, and various medical devices, such as pacemakers, drug delivery systems, implantable defibrillators, functional electrical stimulation devices, sleep disorder devices (e.g., sleep apnea devices), seizure devices (e.g., devices for monitoring and / or treating epileptic events), balance or movement disorder devices (e.g., vestibular stimulation devices), tinnitus management devices, visual implants (e.g., bionic eyes), and other neuromodulation devices (e.g., braincomputer interfaces).

[0047] FIGs. 1A-1D illustrate an example cochlear implant system 102 with which aspects of the techniques presented herein can be implemented. The cochlear implant system 102 comprises an external component 104 that is configured to be directly or indirectly attached toAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 the body of the user, and an intemal / implantable component 112 that is configured to be implanted in or worn on the head of the user. In the examples of FIGs. 1A-1D, the implantable component 112 is sometimes referred to as a “cochlear implant.” FIG. 1A illustrates the cochlear implant 112 implanted in the head 154 of a user, while FIG. IB is a schematic drawing of the external component 104 worn on the head 154 of the user. FIG. 1C is another schematic view of the cochlear implant system 102, while FIG. ID illustrates further details of the cochlear implant system 102. For ease of description, FIGs. 1A-1D will generally be described together.

[0048] In the examples of FIGs. 1A-1D, the external component 104 comprises a sound processing unit 106, an external coil 108, and generally, a magnet fixed relative to the external coil 108. The cochlear implant 112 includes an implantable coil 114, an implant body 134, and an elongate stimulating assembly 116 configured to be implanted in the user’s cochlea. In one example, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, which is configured to send data and power to the implantable component 112. In general, an OTE sound processing unit is a component having a generally cylindrically shaped housing 111 and which is configured to be magnetically coupled to the user’s head 154 (e.g., includes an integrated external magnet 150 configured to be magnetically coupled to an intemal / implantable magnet 152 in the implantable component 112). The OTE sound processing unit 106 also includes an integrated external (headpiece) coil 108 (the external coil 108) that is configured to be inductively coupled to the implantable coil 114.

[0049] It is to be appreciated that the OTE sound processing unit 106 is merely illustrative of the external devices that could operate with implantable component 112. For example, in alternative examples, the external component 104 can comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. A BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user. In certain examples, the BTE is connected to a separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil 114, while in other embodiments the BTE includes a coil disposed in or on the housing worn on the outer ear of the user. It is also to be appreciated that alternative external components could be located in the user’s ear canal, worn on the body, etc.

[0050] Although the cochlear implant system 102 includes the sound processing unit 106 and the cochlear implant 112, as described below, the cochlear implant 112 can operateAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 independently from the sound processing unit 106, for at least a period, to stimulate the user. For example, the cochlear implant 112 can operate in a first general mode, sometimes referred to as an “external hearing mode,” in which the sound processing unit 106 captures sound signals which are then used as the basis for delivering stimulation signals to the user. The cochlear implant 112 can also operate in a second general mode, sometimes referred as an “invisible hearing” mode, in which the sound processing unit 106 is unable to provide sound signals to the cochlear implant 112 (e.g., the sound processing unit 106 is not present, the sound processing unit 106 is powered-off, the sound processing unit 106 is malfunctioning, etc.). As such, in the invisible hearing mode, the cochlear implant 112 captures sound signals itself via implantable sound sensors and then uses those sound signals as the basis for delivering stimulation signals to the user. Further details regarding operation of the cochlear implant 112 in the external hearing mode are provided below, followed by details regarding operation of the cochlear implant 112 in the invisible hearing mode. It is to be appreciated that reference to the external hearing mode and the invisible hearing mode is merely illustrative and that the cochlear implant 112 could also operate in alternative modes.

[0051] In FIGs. 1A and 1C, the cochlear implant system 102 is shown with an external device 110, configured to implement aspects of the techniques presented. The external device 110, which is shown in greater detail in FIG. 1 E, is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g., smartphone), a remote control unit, etc. The external device 110 and the cochlear implant system 102 (e.g., sound processing unit 106 or the cochlear implant 112) wirelessly communicate via a bi-directional communication link 126. The bi-directional communication link 126 can comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.

[0052] Returning to the example of FIGs. 1A-1D, the sound processing unit 106 of the external component 104 also comprises one or more input devices configured to capture and / or receive input signals (e.g., sound or data signals) at the sound processing unit 106. The one or more input devices include, for example, one or more sound input devices 118 (e.g., one or more external microphones, audio input ports, telecoils, etc.), one or more auxiliary input devices 128 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a short-range wireless transmitter / receiver (wireless transceiver) 120 (e.g., for communication with the external device 110), each located in, on or near the sound processing unit 106. However, it is to be appreciated that one or more inputAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 devices can include additional types of input devices and / or less input devices (e.g., the short- range wireless transceiver 120 and / or one or more auxiliary input devices 128 could be omitted).

[0053] The sound processing unit 106 also comprises the external coil 108, a closely-coupled radio frequency transmitter / receiver (RF transceiver) 122, at least one rechargeable battery 132, and an external sound processing module 124. The external sound processing module 124 can be configured to perform a number of operations including filtering, transforming, etc. received sound signals. Such processing can be implemented with one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more uC cores, etc.), firmware, software, etc. arranged to perform such operations. That is, the sound processor 133, can be implemented as firmware element(s), partially or fully implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially or fully in software, etc.

[0054] Returning to the example of FIGs. 1A-1D, the implantable component 112 comprises an implant body (main module) 134, a lead region 136, and the stimulating assembly 116, all configured to be implanted under the skin (tissue) 115 of the user. The implant body 134 generally comprises a hermetically-sealed housing 138 that includes, in certain examples, at least one power source 125 (e.g., one or more batteries, one or more capacitors, etc.), in which the RF interface circuitry 140 and a stimulator unit 142 are disposed. The implant body 134 also includes the intemal / implantable coil 114 that is generally external to the housing 138, but which is connected to the RF interface circuitry 140 via a hermetic feedthrough (not shown in FIG. ID).

[0055] As noted, the stimulating assembly 116 is configured to be at least partially implanted in the user’s cochlea. The stimulating assembly 116 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 144 that collectively form a contact array (electrode array) 146 for delivery of electrical stimulation (current) to the recipient’s cochlea. The stimulating assembly 116 extends through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to stimulator unit 142 via lead region 136 and a hermetic feedthrough (not shown in FIG. ID). Lead region 136 includes a plurality of conductors (wires) that electrically couple the electrodes 144 to the stimulator unit 142. The implantable component 112 also includes an electrode outside of the cochlea, sometimes referred to as the extra-cochlear electrode (ECE) 139.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0056] As noted, the cochlear implant system 102 includes the external coil 108 and the implantable coil 114. The external magnet 150 is fixed relative to the external coil 108 and the intemal / implantable magnet 152 is fixed relative to the implantable coil 114. The external magnet 150 and the intemal / implantable magnet 152 fixed relative to the external coil 108 and the intemal / implantable coil 114, respectively, facilitate the operational alignment of the external coil 108 with the implantable coil 114. This operational alignment of the coils enables the external component 104 to transmit data and power to the implantable component 112 via a closely-coupled wireless link 148 formed between the external coil 108 with the implantable coil 114. In certain examples, the closely-coupled wireless link 148 is an RF link. However, various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, can be used to transfer the power and / or data from an external component to an implantable component and, as such, FIG. ID illustrates only one example arrangement.

[0057] As noted above, the sound processing unit 106 includes the external sound processing module 124. The external sound processing module 124 is configured to process the received input audio signals (received at one or more of the input devices, such as sound input devices 118 and / or auxiliary input devices 128) and convert the received input audio signals into output control signals for use in stimulating a first ear of a recipient or user (i.e., the external sound processing module 124 is configured to perform sound processing on input signals received at the sound processing unit 106). Stated differently, the one or more processors (e.g., processing element(s) implementing firmware, software, etc.) in the external sound processing module 124 are configured to execute sound processing logic in memory to convert the received input audio signals into output control signals (stimulation signals) that represent electrical stimulation for delivery to the recipient.

[0058] As noted, FIG. ID illustrates an embodiment in which the external sound processing module 124 in the sound processing unit 106 generates the output control signals. In an alternative embodiment, the sound processing unit 106 can send less processed information (e.g., audio data) to the implantable component 112, and the sound processing operations (e.g., conversion of input sounds to output control signals 156) can be performed by a processor within the implantable component 112.

[0059] In FIG. ID, according to an example embodiment, output control signals (stimulation signals) are provided to the RF transceiver 122, which transcutaneously transfers the output control signals (e.g., in an encoded manner) to the implantable component 112 via the external coil 108 and the implantable coil 114. That is, the output control signals (stimulation signals)Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 are received at the RF interface circuitry 140 via the implantable coil 114 and provided to the stimulator unit 142. The stimulator unit 142 is configured to utilize the output control signals to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea via one or more of the stimulating contacts 144. In this way, cochlear implant system 102 electrically stimulates the user’s auditory nerve cells, bypassing absent or defective hair cells that normally transduce acoustic vibrations into neural activity, in a manner that causes the recipient to perceive one or more components of the input audio signals (the received sound signals).

[0060] As detailed above, in the external hearing mode, the cochlear implant 112 receives processed sound signals from the sound processing unit 106. However, in the invisible hearing mode, the cochlear implant 112 is configured to capture and process sound signals for use in electrically stimulating the user’s auditory nerve cells. In particular, as shown in FIG. ID, an example embodiment of the cochlear implant 112 can include a plurality of implantable sound sensors 165(1), 165(2) that collectively form a sensor array 160, and an implantable sound processing module 158. Similar to the external sound processing module 124, the implantable sound processing module 158 can comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic. The memory device can comprise any one or more of: Non-Volatile Memory (NVM), Ferroelectric Random Access Memory (FRAM), read only memory (ROM), random access memory (RAM), magnetic disk storage media devices, optical storage media devices, flash memory devices, electrical, optical, or other physical / tangible memory storage devices. The one or more processors are, for example, microprocessors or microcontrollers that execute instructions for the sound processing logic stored in memory device.

[0061] In the invisible hearing mode, the implantable sound sensors 165(1), 165(2) of the sensor array 160 are configured to detect / capture input sound signals 166 (e.g., acoustic sound signals, vibrations, etc.), which are provided to the implantable sound processing module 158. The implantable sound processing module 158 is configured to convert received input sound signals 166 (received at one or more of the implantable sound sensors 165(1), 165(2)) into output control signals 156 for use in stimulating the first ear of a recipient or user (i.e., the implantable sound processing module 158 is configured to perform sound processing operations). Stated differently, the one or more processors (e.g., processing element(s) implementing firmware, software, etc.) in the implantable sound processing module 158 are configured to execute sound processing logic in memory to convert the received input soundAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 signals 166 into output control signals 156 that are provided to the stimulator unit 142. The stimulator unit 142 is configured to utilize the output control signals 156 to generate electrical stimulation signals (e.g., current signals) for delivery to the user’s cochlea, thereby bypassing the absent or defective hair cells that normally transduce acoustic vibrations into neural activity.

[0062] It is to be appreciated that the above description of the so-called external hearing mode and the so-called invisible hearing mode are merely illustrative and that the cochlear implant system 102 could operate differently in different embodiments. For example, in one alternative implementation of the external hearing mode, the cochlear implant 112 could use signals captured by the sound input devices 118 and the implantable sound sensors 165(1), 165(2) of sensor array 160 in generating stimulation signals for delivery to the user.

[0063] According to the techniques of the present disclosure, the external sound processing module 124 can also include an inertial measurement unit (IMU) 170. The IMU 170 is configured to measure the inertia of the user's head, that is, motion of the user's head. As such, the IMU 170 comprises one or more sensors 175 each configured to sense one or more of rectilinear or rotatory motion in the same or different axes. Examples of sensors 175 that can be used as part of inertial measurement unit 170 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors can be implemented in, for example, micro electromechanical systems (MEMS) or with other technology suitable for the particular application.

[0064] As also illustrated in FIG. ID, in certain examples, a second IMU 180 including one or more sensors 185 is incorporated into implantable sound processing module 158 of implant body 134. The second IMU 180 can serve as an additional or alternative inertial measurement unit to the IMU 170 of external sound processing module 124. Like sensors 175, sensors 185 can each be configured to sense one or more of rectilinear or rotatory motion in the same or different axes. Examples of sensors 185 that can be used as part of inertial measurement unit 180 include accelerometers, gyroscopes, inclinometers, compasses, and the like. Such sensors can be implemented in, for example, MEMS or with other technology suitable for the particular application. For hearing devices that include an implantable sound processing module, such as implantable sound processing module 158, that includes an IMU, such as the IMU 180, the techniques presented herein can be implemented without an external processor. Accordingly, a hearing device that includes an implant body 134 and lacks an external component 104 can be configured to implement the techniques presented herein.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0065] FIG. IE is a block diagram illustrating one example arrangement for an external computing device 110 configured to perform one or more operations in accordance with certain embodiments presented herein. As shown in FIG. IE, in its most basic configuration, the external computing device 110 includes at least one processing unit 183 and a memory 184. The processing unit 183 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 183 can communicate with and control the performance of other components of the external computing device 110. The memory 184 is one or more software or hardware-based computer-readable storage media operable to store information accessible by the processing unit 183. The memory 184 can store, among other things, instructions executable by the processing unit 183 to implement applications or cause performance of operations described herein, as well as other data. The memory 184 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or combinations thereof. The memory 184 can include transitory memory or non-transitory memory. The memory 184 can also include one or more removable or non-removable storage devices. In examples, the memory 184 can include RAM, ROM) EEPROM (Electronically- Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access. By way of example, and not limitation, the memory 184 can include wired media, such as a wired network or direct-wired connection, and wireless media, such as acoustic, RF, infrared, other wireless media, or combinations thereof. In certain embodiments, the memory 184 comprises logic 195 that, when executed, enables the processing unit 183 to perform aspects of the techniques presented.

[0066] In the illustrated example of FIG. IE, the external computing device 110 further includes a network adapter 186, one or more input devices 187, and one or more output devices 188. The external computing device 110 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components. The network adapter 186 is a component of the external computing device 110 that provides network access (e.g., access to at least one network 189). The network adapter 186 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as Ethernet, cellular, Bluetooth, near-field communication, and RF, among others. The network adapter 186 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols. The one or more input devicesAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1187 are devices over which the external computing device 110 receives input from a user. The one or more input devices 187 can include physically-actuatable user-interface elements (e.g., buttons, switches, or dials), a keypad, keyboard, mouse, touchscreen, and voice input devices, among other input devices that can accept user input. The one or more output devices 188 are devices by which the external computing device 110 is able to provide output to a user. The output devices 188 can include a display 190 (e.g., a liquid crystal display (LCD)) and one or more speakers 191, among other output devices for presentation of visual or audible information to the recipient, a clinician, an audiologist, or other user.

[0067] It is to be appreciated that the arrangement for the external computing device 110 shown in FIG. IE is merely illustrative and that aspects of the techniques presented herein can be implemented at a number of different types of systems / devices including any combination of hardware, software, and / or firmware configured to perform the functions described herein. For example, the external computing device 110 can be a personal computer (e.g., a desktop or laptop computer), a hand-held device (e.g., a tablet computer), a mobile device (e.g., a smartphone), a surgical system, and / or any other electronic device having the capabilities to perform the associated operations described elsewhere herein.

[0068] As noted, the stimulating assembly 116 shown in FIG. ID is configured to be at least partially implanted in the user’s or recipient’s cochlea. The stimulating assembly 116 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 144 that collectively form a contact array (electrode array) 146 for delivery of electrical stimulation (current) to the recipient’s cochlea. During implantation, a tip end of the stimulating assembly 116 is urged through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) such that it wraps itself around the modiolus of the recipient’s cochlea. That is, the stimulating assembly 116, as it is surgically inserted further and further into the cochlea, is intended to bend, curve, or curl to match the anatomy of an anatomical cavity into which it is being place, e.g., the cochlea.

[0069] Facilitating and better controlling the implantation process is of keen interest to improve surgical and recipient outcomes. One approach to improve the implantation process is to incorporate a shape memory element, such as a shape memory alloy (SMA) (e.g., Nitinol), as an inlay into the stimulating assembly 116 that is inserted into the cochlea. The shape memory element (shape memory inlay) is then used to control the shape (e.g., a curled configuration or time bending sequence), of the stimulating assembly 116 as it is placed into a preferred position (e.g., perimodiolar position) in the cochlea.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0070] In certain examples, the shape memory effect of the shape memory inlay is triggered by resistive heating resulting from the passing of current through the shape memory inlay. The rate of the curving or bending can be controlled by applying short pulses of current, whose duration and amplitude are selected to either partly or wholly produce the phase transformation in the shape memory element that drives the shape memory effect. In this way, the stimulating assembly 116 array can be made, at least to some degree, ‘steerable’. With a shape memory inlay of nearly constant cross-sectional dimensions, however, there is limited control over the timing or sequence of bending of the array, i.e., whether the distal or proximal parts of the shape memory inlay curve first depends on the mechanical stiffness of each part of the electrode array, or stimulating assembly 116, and the resistance it presents to bending by the shape memory inlay. This lack of control does not allow the shape of the stimulating assembly 116 in its intermediate forms to be tuned to minimize contact with lateral wall and modiolus of the cochlea. As such, presented herein are techniques for controlling / facilitating the implantation of an implantable component of a medical device, such as stimulating assembly 116, with a variable shape memory element (variable shape memory inlay).

[0071] Reference is now made to FIG. 2A, which is a schematic diagram of a stimulating assembly 216 (or elongate carrier member) including a variable shape memory element 250, in accordance with embodiments presented herein, that has not yet been activated, i.e., variable shape memory element 250 is in a low temperature deformable phase and the stimulating assembly 216 has been straightened to allow insertion into a body cavity. Variable shape memory element 250 is incorporated into, inlaid, manufactured with, or otherwise attached to stimulating assembly 216. That is, variable shape memory element 250 can be encapsulated within stimulating assembly 216, which can be comprised of silicone, for example. Embodiments described further below provide details of the possible configurations of variable shape memory element 250.

[0072] FIG. 2B is a schematic diagram of the stimulating assembly 216 of FIG. 2A where a first portion 251 of the variable shape memory element 250 has been activated causing a curl or first bend 253 in the stimulating assembly 216, and FIG. 2C is a schematic diagram of the stimulating assembly 216 of FIG. 2A where a first portion 251 and a second portion 252 of the variable shape memory element 250 have been activated causing the first bend 253 and a, sequential, second bend 254 in the stimulating assembly 216, resulting in an increasingly spiral or curved or bent shape. That is, in accordance with an embodiment, the variable shape memory element 250 is configured such that the phase transformation of different portionsAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 thereof occurs at different, and perhaps successive, sequential times to effectuate a predetermined insertion trajectory of the elongate carrier member into the body cavity of the recipient.

[0073] As further shown in FIGs. 2A, 2B and 2C, electrodes 230 are disposed on stimulating assembly 216 and, when implanted in a recipient, are configured to deliver electrical stimulation signals to the recipient’s tissue. A goal of a successful implantation is to ensure that the stimulation assembly 216 extends fully into and around the modiolus without a tip end 210 folding over itself and thus precluding selected electrodes 230 from being properly positioned adjacent the recipient’s tissue. Another goal of a successful implantation is to minimize unnecessary contact, and possible trauma, to parts of the cochlea that are not intended to come into contact with stimulating assembly 216.

[0074] With those goals in mind, the embodiments described herein provide a stimulating assembly 216 including variable shape memory element 250 that has differing physical properties / characteristics along an elongate length thereof in order to sequentially, in time, bend portions of the stimulating assembly 216 during insertion into the body cavity of the recipient. As shown in FIGs. 2A, 2B and 2C, as the stimulating assembly 216 is inserted into the recipient, the first portion 251 of the variable shape memory element 250 is caused to undergo a phase transformation due, e.g., to application of an appropriate electric current (or current pulses), and then later, as the stimulating assembly 216 is further inserted into the recipient, the second portion 252 of the variable shape memory element 250 is also caused to undergo a phase transformation resulting in an overall increasingly curved configuration of stimulating assembly 216.

[0075] The controlled sequential curving or bending of variable shape memory element 216, and thus of stimulating assembly 216, enables the stimulating assembly to have an overall stiffer configuration, thus helping to avoid undesirable fold over of tip end 210. Despite the stiffer configuration, stimulating assembly 216 can nevertheless follow a desired curved insertion profile. Those skilled in the art will appreciate that, while only two separate portions of shape memory element 250 are depicted in FIGs. 2C as being sequentially bent, shape memory element 250 could be configured with any number of discrete bending portions, or with continually variable bending portions, or phase transformation regions, along a longitudinal length thereof.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0076] FIG. 3 A is a schematic diagram of a stimulating assembly 316 including a variable shape memory element 350 configured to control sequential bending thereof. As shown, variable shape memory element 350 is incorporated into, inlaid, manufactured with, or otherwise attached to stimulating assembly 316, and has an overall tapering configuration towards a tip end 310. Generally, the lower the mass of a given shape memory element, the more quickly it will heat up due to increased resistivity, and thus the more quickly it will enter its phase transformation, i.e., its bending function, compared to higher mass portions. Accordingly, by tapering the variable shape memory element 350 in the manner shown, the portions of the variable shape memory element 350 towards a tip end 310 will tend to bend sooner than portions towards a proximal end 312.

[0077] That is, in a region which is desired to curl earlier than other regions, the cross-sectional area can be reduced, which increases the local electrical resistance, and thus increases the rate of heat generation, which is given by:

[0078] Pheat = VI = I2R

[0079] Conversely, the cross section can be increased in regions where it is desired to delay curling.

[0080] Stated alternatively, variable shape memory element 350 can have a variable cross section rather than a constant cross section so that when an electric current is passed therethrough to heat it, and thereby curl it, different sections of the variable shape memory element 350 will heat at different times and therefore curl in a more controllable manner than they would if the variable shape memory element 350 were of constant cross section. Such variable cross section can be seen in FIGs. 3B and 3C, which are cross sections of the stimulating assembly of FIG. 3A taken along lines II-II and III-III, respectively. FIG. 3B shows that the variable shape memory element 350 is the form of a wire or has a shape that, in this example, is substantially circular (or oval) with a first radius 330 (or major axis), and FIG. 3C shows that the variable shape memory element 350 has a smaller second radius 332 at a position closer to tip end 310. In this tapered configuration, variable shape memory element 350, when activated, will tend to bend first near the tip end 310 rather than towards a proximal end 312. Other cross sectional shapes for the shape memory element 350 are possible.

[0081] Note that, as indicated earlier, an electric current is passed through the variable shape memory element 350 to cause it to heat and then bend. In order for such current to pass through the shape memory element material, an electrical supply (+) connection 391 is provided atAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 proximal end 312 of variable shape memory element 350 and a connection 392 is provided for an electric return (-) path 380. The return path 380 can be comprised of gold or platinum wire, for example, which does not have the shape memory characteristics of the variable shape memory element 350. A power supply 395 can be provided for supplying the necessary current, or power can be sourced from, e.g., the implant body 134 to which connections 391, 392 can be connected. Notwithstanding the low resistivity of gold or platinum, for example, there is still some non-negligible heat that is generated when electric current passes through return path 380. Not only is this heat wasteful, but the heat could also contribute to reaching a maximum safe increased temperature (e.g., 2° C) in the immediate region of surgery during implantation.

[0082] FIGs. 3D and 3E show other possible cross sections of the stimulating assembly 316 of FIG. 3A along lines II-II and III -III, respectively. In this case, variable shape memory element 350 has a substantially rectangular cross section with, in FIG. 3D, first height and width dimensions, and, in FIG. 3E second height and width dimensions that are smaller than the first height and width dimensions. Those skilled in the art will appreciate that only one of the height and width dimensions needs to change in order to achieve the tapered configuration of shape memory element 350 depicted in FIG. 3A.

[0083] One possible issue with the tapered approach for variable shape memory element 350 is that mechanical stiffness of the variable shape memory element 350 is also related to its cross-sectional dimensions, so regions that are intended to curl earlier must necessarily have low bending stiffness and are not ‘strong’ enough to bend the stimulating assembly 316. Bending stiffness is proportional to area moment of inertia. More specifically, and with reference to FIG. 4, for a rectangular section, bending stiffness is proportional to area moment of inertia in accordance with:. b3h

[0085] ly = —

[0086] One solution to this issue is to make the cross-sectional area of a shape memory element largely independent of its area moment of inertia. In this regard, and in another embodiment, this independence can be achieved by splitting a variable shape memory element into two large parallel elements separated by some distance by a web (i.e., like an I-beam), rather than being a single element having a solid rectangular (or oval, circular-like, etc.) cross section. ThisAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 approach is depicted in FIG. 5, which is a schematic diagram of a stimulating assembly 516, with electrodes 230, and including a variable shape memory element 550. In this case, variable shape memory element 550 is comprised of two separate sub-elements, namely a top shape memory element 550a and a bottom shape memory element 550b (noting that the terms “top” and “bottom” are merely used to describe relative position) that are encapsulated within stimulating assembly 516, which can be comprised of silicone for example. Top shape memory element 550a and bottom shape memory element 550b are shown as having a rectangular cross section, but stimulating assembly 516 could also be implemented with round or other cross- sectional shape for the shape memory inlay. Notably, in this approach, a connecting wire 580 connects respective distal ends 510a, 510b of top shape memory element 550a and bottom shape memory element 550b. In this way, current (+) can be supplied at proximal end 512a of top shape memory element 550a and a return (-) of the current can be received at proximal end 512b of bottom shape memory element 550b. Alternatively, the distal ends of 510a, 510b of top shape memory element 550a and bottom shape memory element 550b can be fused or directly connected together, eliminating the need for a separate connecting wire 580. The proximal ends 512a and 512b (or electrical connections thereto) can be exposed to allow temporary connection to a power supply (as shown in FIG. 3A). Alternatively, the electric connections can be incorporated with other electronic circuitry disposed in the implant body 134 that is configured to supply the necessary power to shape memory element 550.

[0087] Notably, for a given size of the top shape memory element 550a and bottom shape memory element 550b, and therefore given cross-sectional area, the combined bending stiffness can be increased by increasing the separation between them. This is illustrated in connection with reference to FIG. 6 and the associated equation below. wh3(w - tw) - (h - 2-tz)3

[0088] ly =12 12

[0089] That is, FIG. 6 shows a cross section of a stimulating assembly 616 that includes electrodes 230 and a variable shape memory element 650 comprised of two separate subelements, namely a top shape memory element 650a and a bottom shape memory element 650b (noting that the terms “top” and “bottom” are merely used describe relative position), similar to the configuration shown in FIG. 5. Top shape memory element 650a and bottom shape memory element 650b are shown as having a rectangular cross section, but stimulating assembly 616 could also be implemented with round or other cross-sectional shapes for the shape memory element. An “I-member” 655, which can be comprised of the same variableAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 shape memory element as top shape memory element 650a and bottom shape memory element 650b, connects the top shape memory element 650a to the bottom shape memory element 650b. Notably, when dimension tw is zero, that is, I-member 655 is not present, then the equation above represents the moment of inertia for the configuration of variable shape memory element 550 shown in FIG. 5. When I-member 655 is present, i.e., dimension tw is non-zero, the moment of inertia changes according to the equation above. It is noted that I-member 655 can be comprised of non-conductive material, and thus distal ends of top shape memory element 650a and bottom shape memory element 650b would need to be electrically connected as shown in FIG. 5. If, on the other hand, I-member 655 is electrically conductive, then an electric return path, like that shown, e.g., in FIGs. 3A-3E would be needed.

[0090] A potential problem with the approaches shown in FIG. 5 or FIG. 6 is that a variable shape memory element with two separate parallel elements can be more susceptible to buckling than a monolithic inlay of the same bending stiffness. Also, even in the absence of buckling, the bending stiffness can change as the shape memory element is straightened, as the separation between the elements will change, particularly if the material joining the top and bottom elements is relatively soft (such as silicone). Both of these issues can be controlled by adding cross members to maintain the distance between the two as shown in FIG. 7.

[0091] Specifically, FIG. 7 shows a schematic diagram of a stimulating assembly 716, with electrodes 230, and including a variable shape memory element 750. In this case, variable shape memory element 750 is comprised of two separate sub-elements, namely a top shape memory element 750a and a bottom shape memory element 750b (noting that the terms “top” and “bottom” are merely used to describe relative position) that are encapsulated within stimulating assembly 716, which can be comprised of silicone for example. Top shape memory element 750a and bottom shape memory element 750b can be connected via one or more trusses 752 that are comprised of electrically non-conductive material. Top shape memory element 750a and bottom shape memory element 750b are shown as having a rectangular cross section 770, but shape memory element 750 could also be implemented with round or other cross-sectional shapes forthe shape memory inlay. A connecting wire 780 connects, respective distal ends 710a, 710b of top shape memory element 750a and bottom shape memory element 750b. In this way, current (+) can be supplied at proximal end 712a of top shape memory element 750a and a return (-) of the current can be received at proximal end 712b of bottom shape memory element 750b. Alternatively, the distal ends 710a, 710b of top shape memory element 750a and bottom shape memory element 750b can be fused or directly connectedAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 together, eliminating the need for a separate connecting wire 780. Trusses 752 can be configured in any shape including straight or diagonal, for example, and can provide sufficient structure to preclude the buckling as the stimulating assembly is caused to bend or curl.

[0092] FIG. 8 is a schematic diagram of a stimulating assembly 816 including electrodes 230 and a variable shape memory element 850 including voids 855-1, 855-2, 855-3, 855-n to control the sequential bending time of stimulating assembly 816. In an embodiment, variable shape memory element 850 is encapsulated in stimulating assembly 816, which can be comprised of silicone, for example. Electrodes 230 are exposed on a surface of stimulating assembly 816. Variable shape memory element 850 can have a substantially uniform or smoothly tapering monolithic design, but with one or more regions including one or more voids 855-1, 855-2, 855-3, 855-n to reduce the cross-sectional area in those regions to provide for earlier shape memory effect activation in those areas or regions. That is, in one possible implementation, bigger voids are provided towards a tip end 810 thereby reducing shape memory element material in that region, and thus increasing relative electrical resistance, which results in that region going through its phase transformation earlier than regions with less shape memory element material removed. In the embodiment shown, void 855-1, closest to tip end 810, is the largest, void 855-2 can be the second largest, and void 855-n can be the smallest, the latter corresponding to where the last bending movement is desired in a sequential bending of stimulating assembly 816. Note that the voids can be of any desired shape, including rectangular and circular, as depicted. Variable shape memory element 850 with the voids as described can be fabricated using a wafer-based photolithographic process or can be laser cut from a sheet of shape memory element material.

[0093] FIG. 9 is a schematic diagram of a stimulating assembly 916 including a variable shape memory element 950 including voids 955-1, 955-2, 955-3, 955-n arranged on different planes to control the sequential bending time of stimulating assembly 916. In an embodiment, variable shape memory element 950 is encapsulated in stimulating assembly 916, which can be comprised of silicone, for example. Electrodes 230 are exposed on a surface of stimulating assembly 916. Shape memory element 950 can have a substantially uniform or smoothly tapering monolithic design, but with one or more regions including one or more voids 955-1, 955-2, 955-3, 955-n, perhaps arranged on different planes 970-1, 970-2, 970-3, to reduce the cross-sectional area in those regions to provide for earlier shape memory effect activation in those areas. That is, in one possible implementation, more closely arranged voids 955-1, 955- 2, 955-3 can be provided towards a tip end 810 thereby reducing shape memory elementAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 material in that region, and thus increasing relative electrical resistance, which results in that region going through its phase transformation earlier than regions with less shape memory element material removed, e.g., near further spaced voids 956-1, 956-2, 956-3, the latter corresponding to where the last bending movement is desired in a sequential bending of stimulating assembly 916. Note that the voids can be of any desired shape, including rectangular, circular, triangular, etc., as depicted. Variable shape memory element 950 can be fabricated using a wafer-based photolithographic process or can be laser cut from a sheet of shape memory element material.

[0094] FIG. 10 is a schematic diagram of a stimulating assembly 1016 including a shape memory element 1050 and associated heat sinks 1020 to control sequential bending time of stimulating assembly 1016. In an embodiment, variable shape memory element 1050 is encapsulated in stimulating assembly 1016, which can be comprised of silicone, for example. Electrodes 230 are exposed on a surface of stimulating assembly 1016. Variable shape memory element 1050 can have a substantially uniform or smoothly tapering monolithic design, and include one or more heat sinks 1020-1, 1020-2, 1020-3 positioned along a length thereof.

[0095] Heats sinks 1020-1, 1020-2, 1020-3 are configured to sink heat away from variable shape memory element 1050 when current is passed through the variable shape memory element. That is, in order to achieve sequential bending times of different regions of the variable shape memory element 1050, smaller (or fewer) heat sinks can be arranged in areas that are intended to bend earlier than others, such as at the tip end 1010. Thus, heat sink 1020- 1 is smaller than, e.g., heat sinks 1020-2 and 1020-3, such that the shape memory element material in the region around heat sink 1020-1 will go through its phase transformation earlier than regions associated with heat sinks 1020-2, 1020-3. Likewise, the shape memory element material in the region around heat sink 1020-2 will go through its phase transformation earlier than the region around heat sink 1020-3, but later than the region around heat sink 1020-1. In this way, a timed sequential bend of stimulating assembly 1016 can be achieved. In one possible implementation, the heat sinks are comprised of a material that is different from the shape memory element material that comprises the variable shape memory element 1050.

[0096] FIG. 11 is a schematic diagram of a stimulating assembly 1116 including a variable shape memory element 1150 that comprises of a plurality of different shape memory alloys or densities of the same shape memory element, or shape memory alloys having different transition temperatures and / or different masses, to control bend timing. In an embodiment, variable shape memory element 1150 is encapsulated in stimulating assembly 1116, which canAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 be comprised of silicone, for example. Electrodes 230 are exposed on a surface of stimulating assembly 1116. Variable shape memory element 1150 can have a substantially uniform or smoothly tapering monolithic design, and be comprised of several regions 1120-1, 1120-2, 1120-3, 1120-4 along a length thereof.

[0097] Each region 1120-1, 1120-2, 1120-3, 1120-4 can be configured with a different shape memory element or be comprised of the same type of shape memory element, but perhaps with different respective densities or transition temperatures. Thus, first regions 1120-1 can be comprised of shape memory element (SMA_1) that would bend first compared to regions 1120- 2, 1120-3, and 1120-4, region 1120-2 can be comprised of shape memory element (SMA_2), shape memory element (SMA_3), and shape memory element (SMA_4), respectively. In particular: SMA_2 in region 1120-2 bends after SMA_1 in first region 1120-1, but before SMA_3 in region 1120-3 and SMA_4 in region 1120-4; SMA_3 in region 1120-3 bends after SMA_2 in region 1120-2, but before SMA_4 in region 1120-4, and so on, when the same current is passed through the different regions. A return current path in not shown in FIG. 11. That is, in order to achieve sequential bending times of different regions of the shape memory element 1150, denser or more quickly acting shape memory element material can be arranged in areas or regions that are intended to bend earlier than others, such as at the tip end 1110. Using shape memory element material with different transition characteristics strategically arranged in variable shape memory element 1150 enables a timed sequential bend of stimulating assembly 1116.

[0098] FIG. 12 is a schematic diagram of a stimulating assembly 1216 including electrodes 230 and a variable shape memory element 1250 that is represented by a broken line. In this case, variable shape memory element 1250 has an undulating or serpentine configuration and can be comprised of any one of the variable shape memory element configurations described in connection with FIGs. 3A-3E, 5, 6, 7, 8, 9, 10, and 11. The undulating or serpentine configuration of variable shape memory element 1250 can provide strain relief as different portions of variable shape memory element 1250 sequentially bend.

[0099] FIG. 13 shows a cross section of a stimulating assembly 1316 including electrodes 230 and a variable shape memory element 1350. In this embodiment, variable shape memory element 1350 comprises two main components or elements: atop element 1350a and abottom element 1350b, each represented by broken lines. In this configuration, top element 1350a and bottom element 1350b are stacked one above the other under electrodes 230 and run along a predetermined longitudinal length of the stimulating assembly 1316. That is, top elementAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC11350a is disposed between electrodes 230 and bottom element 1350b. Each of top element 1350a and bottom element 1350b can be comprised of any one of the variable shape memory element configurations described in connection with FIGs. 3A-3E, 5, 6, 7, 8, 9, 10, and 11. That is, each of top element 1350a and bottom element 1350b is configured to provide timed sequential bending of stimulating assembly 1316.[ootoo] Top element 1350a can be used to provide supply (+) current via terminal 1355, and bottom element 1350b can be used to provide a return current (-) path via terminal 1356. It is noted that for this embodiment, and others described herein, polarity connections for current supply and return can be reversed and, in any event, the current supplied can be an alternating current. Top element 1350a and bottom element 1350b can be connected at distal ends thereof, towards a tip end of stimulating assembly 1316, with a connecting wire (not shown), or the distal ends can be directly connected or fused together (not shown).[ooiot] By stacking top element 1350a and bottom element 1350b in this manner, and supplying current to trigger the phase transformation of the variable shape memory element 1350, variable shape memory element 1350 can be activated to provide timed sequential bending of stimulating assembly 1316 with less likelihood for buckling and twisting, thereby improving the successful outcome of the surgical implantation of stimulating assembly 1316.

[0102] FIG. 14 shows a cross section of a stimulating assembly 1416 including electrodes 230 and a variable shape memory element 1450. In this embodiment, variable shape memory element 1450 comprises two main components or elements: a left element 1450a and a right element 1450b, each represented by broken lines. In this configuration, left element 1450a and right element 1450b are arranged next to each other under electrodes 230 and run along a predetermined longitudinal length of the stimulating assembly 1416. That is, left element 1450a is disposed next to right element 1450b. Each of left element 1450a and right element 1450b can be comprised of any one of the variable shape memory element configurations described in connection with FIGs. 3A-3E, 5, 6, 7, 8, 9, 10, and 11. That is, each of left element 1450a and right element 1450b is configured to provide timed sequential bending of stimulating assembly 1416.

[0103] Left element 1450a can be used to provide supply (+) current via terminal 1455, and right element 1450b can be used to provide a return current (-) path via terminal 1456. Left element 1450a and right element 1450b can be connected at distal ends thereof, towards a tipAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 end of stimulating assembly 1416, with a connecting wire (not shown), or the distal ends can be directly connected or fused together (not shown).

[0104] By arranging left element 1450a and right element 1450b in this manner, and supplying current to trigger the phase transformation of the variable shape memory element 1450, variable shape memory element 1450 can be activated to provide timed sequential bending of stimulating assembly 1416 with less likelihood of buckling or twisting, thereby improving the successful outcome of the surgical implantation of stimulating assembly 1416. It is noted that in the side-by-side configuration of FIG. 14 the separation between the left element 1450a and the right element 1450b can have little to no effect on the bending stiffness in the up / down direction.

[0105] FIG. 15 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two stacked elements along with an electrode and current signal supply wires. This view shows stimulating assembly 1516 including electrode 230 with current signal supply wires 1510 that respectively supply current to each electrode 230 along the length of stimulating assembly 1516. A variable shape memory element 1550 includes a top element 1550a and a bottom element 1550b, similar to the configuration shown in FIG. 13, except the top element 1550a and bottom element 1550b have, in this example, substantially circular cross sections. The stimulating assembly 1516 can be comprised of silicone or other flexible material. The top element 1550a and a bottom element 1550b can be electrically connected to one another at distal ends thereof. Other cross sectional shapes for the shape memory element are possible.

[0106] FIG. 16 shows a cross section of a stimulating assembly including a variable shape memory element that comprises two elements arranged side by side along with an electrode and current signal supply wires. This view shows stimulating assembly 1616 including electrode 230 with current signal supply wires 1610 that respectively supply current to each electrode 230 along the length of stimulating assembly 1616. A variable shape memory element 1650 includes a left-side element 1650a and a right-side element 1650b, similar to the configuration shown in FIG. 14, except the left-side element 1650a and right-side element 1650b have, in this example, substantially circular cross sections. The stimulating assembly 1616 can be comprised of silicone or other flexible material. The left-side element 1650a and the right-side element 1650b can be electrically connected to one another at distal ends thereof. Other cross sectional shapes for the shape memory element are possible.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0107] FIG. 17 shows a lumen 1780 into which a variable shape memory element 1750 is disposed. More specifically, this view shows stimulating assembly 1716 including electrode 230 with current signal supply wires 1710 that respectively supply current to each electrode 230 along the length of stimulating assembly 1716. A variable shape memory element 1750 includes a left-side element 1750a and a right-side element 1750b, similar to the configuration shown in FIG. 16, although those skilled in the art will appreciate that the embodiments described with respect to the side-by-side variable shape memory element configuration of FIGs. 16 and 17 can also be applicable to the top and bottom variable shape memory element configuration of FIG. 15. The stimulating assembly 1716 can be comprised of silicone or other flexible material, and a lumen 1780, or void, can be arranged inside the stimulating assembly and the variable shape memory element 1750 can be disposed inside the lumen 1780. The silicone material can collapse around variable shape memory element 1750. The left-side element 1750a and the right-side element 1750b can be electrically connected to one another at distal ends thereof.

[0108] In the example of FIG. 17, the lumen 1780 has a generally oval cross sectional shape. It is to be appreciated that this specific shape for the lumen 1780 is merely illustrative and that a lumen can have different cross sectional shapes in alternative embodiments presented herein.

[0109] FIG. 18 shows a lumen 1880 into which a variable shape memory element 1880 is disposed along with thermal insulation material. More specifically, this view shows stimulating assembly 1816 including electrode 230 with current signal supply wires 1810 that respectively supply current to each electrode 230 along the length of stimulating assembly 1816. A variable shape memory element 1850 includes a left-side element 1850a and a rightside element 1850b, similar to the configuration shown in FIGs. 16 and 17, although those skilled in the art will appreciate that the embodiments described with respect to the side-by- side variable shape memory element configuration of FIGs. 16-18 can also be applicable to the top and bottom variable shape memory element configuration of FIG. 15. The stimulating assembly 1816 can be comprised of silicone or other flexible material, and a lumen 1880, or void, can be arranged inside the stimulating assembly and the variable shape memory element 1850 can be disposed inside the lumen 1880. In addition, thermal insulating material 1860 such as foam, or different grade of silicone, etc., can fill any part of the void that is not taken up by the variable shape memory element 1880. The thermal insulating material 1860 can help to reduce or eliminate adverse effects to adjacent tissue of a recipient when the variable shape memory element 1850 is heated to cause a state and thus shape transition. The left-side elementAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC11850a and the right-side element 1850b can be electrically connected to one another at distal ends thereof.[ooito] In the example of FIG. 18, the lumen 1880 has a generally oval cross sectional shape. It is to be appreciated that this specific shape for the lumen 1880 is merely illustrative and that a lumen can have different cross sectional shapes in alternative embodiments presented herein.[oom] FIG. 19 shows a respective lumen provided for each one of variable shape memory elements. More specifically, this view shows stimulating assembly 1916 including electrode 230 with current signal supply wires 1910 that respectively supply current to each electrode 230 along the length of stimulating assembly 1916. A variable shape memory element 1950 includes a left-side element 1950a and a right-side element 1950b, similar to the configuration shown in FIGs. 16-18, although those skilled in the art will appreciate that the embodiments described with respect to the side-by-side variable shape memory element configuration of FIGs. 16-18 can also be applicable to the top and bottom variable shape memory element configuration of FIG. 15. The stimulating assembly 1916 can be comprised of silicone or other flexible material, and a first lumen 1980a and a second lumen 1980b, or voids, can be arranged inside the stimulating assembly and the elements of the variable shape memory element 1950 can be disposed inside the lumens 1980a, 1980b.

[0112] In addition, as shown in FIG. 20, thermal insulating material 1960 such as foam, or different grade of silicone, etc., can fill any part of the void that is not taken up by the variable shape memory elements 1980a, 1980b. The thermal insulating material 1960 can help to reduce or eliminate adverse effects to adjacent tissue of a recipient when the variable shape memory element 1950 is heated to cause a state, and thus shape, transition. The left-side element 1950a and the right-side element 1950b can be electrically connected to one another at distal ends thereof. In the case of separate lumens, the components of the variable shape memory element 1950 can be inserted through its respective lumen, and distal ends thereof can exit the lumens at distal ends thereof where the distal ends of the components of the variable shape memory element can be joined or fused or connected to one another. Additional silicone can then be over-molded on top of the connection area to seal the components of the variable shape memory element 19050 inside the stimulating assembly 1916.

[0113] In the examples of FIGs. 19 and 20, the lumens 1980 have generally / substantially circular cross sectional shapes. It is to be appreciated that this specific shape for the lumens 1980 is merely illustrative and that a lumen can have different cross sectional shapes inAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 alternative embodiments presented herein. In addition, it is to be appreciated that the embodiments disclosing a configuration with lumen, with or without thermal insulation, can also be applied to a variable shape memory element with a single elongate member (i.e., not paired with another elongate member), like that shown in, e.g., FIG. 3B or FIG. 3D.

[0114] FIGs. 21A and 2 IB show a first manufacturing method for the variable shape memory element. In this first method, nitinol, or other shape memory material 2100, is molded from a linear shape into a spiral shape to match, e.g., a cochlea or a recipient, as shown in FIG. 21 A. The shape memory material 2100 canthen, as shown in FIG. 21B, be heated to return the shape memory material 2100 to its unrolled, original, linear shape, upon which ends thereof can be joined at connection point 2150. The joined assembly can then be folded to be in parallel and then inserted into lumen 1780 as shown in, e.g., FIG. 17.

[0115] FIGs. 22 A and 22B show a second manufacturing method for the variable shape memory element. In this second method, two pieces of nitinol, or other shape memory material 2200, are molded into corresponding or matching spiral shapes to match, e.g., a cochlea or a recipient, as shown in FIG. 22A. The two spiral shapes can then be joined at connection point 2250, as shown in FIG. 22B. The joined assembly can then be unfolded (not shown) and then inserted into lumen 1780 as shown in, e.g., FIG. 17.

[0116] FIGs. 23A and 23B show a third manufacturing method for the variable shape memory element. In this third method, a single piece of nitinol, or other shape memory material 2300, is prepared a linear shape, folded upon itself at midpoint 2310, as shown in FIG. 23 A, and then molded into a spiral shape with two layers. The spiral shape is configured to match, e.g., a cochlea or a recipient, as shown in FIG. 23B. The two-layer spiral shape can then be uncurled and then inserted into lumen 1780 as shown in, e.g., FIG. 17.

[0117] FIG. 24 is a flow chart depicting a series of operations for implanting a medical device according to embodiments described herein. At 2410, an operation includes inserting an elongate stimulating assembly into a body cavity of a recipient, the stimulating assembly comprising an elongate carrier member and at least one elongate shape memory element. At 2412, an operation includes applying an electric current to the at least one shape memory element, wherein the at least one shape memory element has non-uniform physical characteristics along an elongate length thereof such that application of the electric current causes successive portions of the at least one shape memory element and the elongateAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 stimulating assembly to bend sequentially to match an intended trajectory into the body cavity of the recipient.

[0118] The described approaches can also include feedback (e.g., to a surgeon) regarding the current shape of the electrode during implantation. This can be implemented using strain gauges or similar devices integrated into the stimulating assembly.

[0119] As previously described, the technology disclosed herein can be applied in any of a variety of circumstances and with a variety of different devices. Example devices that can benefit from technology disclosed herein are described in more detail in FIG. 25. The techniques of the present disclosure can be applied to other devices, such as neurostimulators, cardiac pacemakers, cardiac defibrillators, sleep apnea management stimulators, seizure therapy stimulators, tinnitus management stimulators, and vestibular stimulation devices, as well as other medical devices that deliver stimulation to tissue. Further, technology described herein can also be applied to consumer devices. These different systems and devices can benefit from the technology described herein.

[0120] FIG. 25 illustrates an example vestibular stimulator system 2502, with which embodiments presented herein can be implemented. As shown, the vestibular stimulator system 2502 comprises an implantable component (vestibular stimulator) 2512 and an external device / component2504 (e.g., external processing device, battery charger, remote control, etc.). The external device 2504 comprises a transceiver unit 2560. As such, the external device 1004 is configured to transfer data (and potentially power) to the vestibular stimulator 2512.

[0121] The vestibular stimulator 1252 comprises an implant body (main module) 2534, a lead region 2536, and a stimulating assembly 2516, all configured to be implanted under the skin / tissue (tissue) 2515 of the recipient. The implant body 2534 generally comprises a hermetically-sealed housing 2538 in which RF interface circuitry, one or more rechargeable batteries, one or more processors, and a stimulator unit are disposed. The implant body 134 also includes an intemal / implantable coil 1614 that is generally external to the housing 1038, but which is connected to the transceiver via a hermetic feedthrough (not shown).

[0122] The stimulating assembly 2516 comprises a plurality of electrodes 2544(l)-(3) disposed in a carrier member (e.g., a flexible silicone body). In this specific example, the stimulating assembly 2516 comprises three (3) stimulation electrodes, referred to as stimulation electrodes 2544(1), 2544(2), and 2544(3). The stimulation electrodes 2544(1), 2544(2), and 2544(3)Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 function as an electrical interface for delivery of electrical stimulation signals to the recipient’s vestibular system.

[0123] The stimulating assembly 2516 is configured such that a surgeon can implant the stimulating assembly adjacent the recipient’s otolith organs via, for example, the recipient’s oval window. It is to be appreciated that this specific embodiment with three stimulation electrodes is merely illustrative and that the techniques presented herein can be used with stimulating assemblies having different numbers of stimulation electrodes, stimulating assemblies having different lengths, etc.

[0124] In operation, the vestibular stimulator 2512, the external device 2504, and / or another external device can be configured to implement the techniques presented herein. That is, the vestibular stimulator 2512, possibly in combination with the external device 1604 and / or another external device, can include an evoked biological response analysis system, as described elsewhere herein.

[0125] FIG. 25 is merely illustrative of devices / systems that can implement aspects of the techniques presented herein. In other embodiments, the techniques presented herein can be implemented in / by / with sleep disorder devices (e.g., sleep apnea devices), seizure devices (e.g., devices for monitoring and / or treating epileptic events), other balance or movement disorder devices (e.g., vestibular stimulation devices), other tinnitus management devices, visual implants (e.g., bionic eyes) and other neuromodulation devices (e.g., brain-computer interfaces). For example, certain devices can include a stimulating assembly that is implemented in a manner as described above with reference to any of the above example s / embodiments. That is, the stimulating assemblies presented herein can be implemented in / with any of a number of different devices, such as sleep disorder device, seizure devices, balance or movement disorder device, tinnitus management device, visual implant, and / or another neuromodulation device).

[0126] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1

[0127] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0128] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0129] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitory computer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0130] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

[0131] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0132] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments can be combined with another in any of a number of different manners.

Claims

Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1CLAIMSWhat is claimed is:

1. An implantable component, comprising: an elongate carrier member configured to be inserted into a body cavity of a recipient; and at least one shape memory element disposed in the elongate carrier member, wherein the shape memory element has differing physical characteristics along an elongate length thereof in order to sequentially bend portions of the elongate carrier member during insertion into the body cavity.

2. The implantable component of claim 1, wherein the at least one shape memory element is at least partially comprised of nitinol.

3. The implantable component of claim 1, wherein the at least one shape memory element has a non-uniform cross-sectional area along the elongate length thereof.

4. The implantable component of claim 1, 2, or 3, wherein the at least one shape memory element comprises a first elongate member disposed along a length of the elongate carrier member and second elongate member disposed along the length of the elongate carrier member and at least one cross member connecting the first elongate member to the second elongate member.

5. The implantable component of claim 4, wherein at least one of the first elongate member and the second elongate member has a round cross-section.

6. The implantable component of claim 4, wherein at least one of the first elongate member and the second elongate member has a rectangular cross-section.

7. The implantable component of claim 4, wherein the at least one shape memory element comprises a first shape memory member and a second shape memory member arranged substantially in parallel with the first shape memory member, wherein distal ends of the first shape memory member and the second shape memory member are electrically connected to one another and other portions of the first shape memory member and the second shape memory member are electrically insulated from one another.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC18. The implantable component of claim 4, wherein the at least one cross member is comprised of electrically non-conductive material.

9. The implantable component of claim 1, 2, or 3, wherein the at least one shape memory element comprises at least one void.

10. The implantable component of claim 1, 2, or 3, wherein the at least one shape memory element is configured to have an undulating shape to alleviate strain upon bending.

11. The implantable component of claim 1, 2, or 3, wherein the at least one shape memory element is comprised of at least one of different grades or masses of a shape memory alloy.

12. The implantable component of claim 1, 2, or 3, further comprising one or more heat sinks disposed adjacent the at least one shape memory element at one or more locations to effectuate controlled bending of the at least one shape memory element compared to a time of bending of a portion of the at least one shape memory element without a heat sink adjacent thereto.

13. The implantable component of claim 1, 2, or 3, further comprising an electrical connection to the shape memory element that enables an electric current to be supplied to the shape memory element.

14. The implantable component of claim 13, further comprising an electric current return path comprising at least one of a return path wire or a return path that is part of the shape memory element.

15. The implantable component of claim 1, 2, 3, wherein the elongate carrier member comprises a lumen, and the at least one shape memory element is disposed in the lumen.

16. The implantable component of claim 15, wherein the lumen is at least partially filled with a thermal insulating material.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC117. The use of the implantable component according to any of claims 1-16 in a hearing device, a sleep disorder device, a seizure device, a balance or movement disorder device, a tinnitus management device, or a visual device.

18. The implantable component according to any of claims 1-16, wherein the implantable component is part of a hearing device, a sleep disorder device, a seizure device, a balance or movement disorder device, a tinnitus management device, or a visual device.

19. An implantable component, comprising: an elongate carrier member configured to be inserted into a body cavity of a recipient; and at least one shape memory element disposed in the elongate carrier member, wherein a timing of one or more phase changes of one or more portions of the at least one shape memory element effectuates a predetermined insertion trajectory of the elongate carrier member into the body cavity of the recipient.

20. The implantable component of claim 19, wherein the timing of the one or more phase changes is controlled by a physical structure of the at least one shape memory element.

21. The implantable component of claim 20, wherein the physical structure of the at least one shape memory element comprises voids.

22. The implantable component of claim 20, wherein the physical structure of the at least one shape memory element comprises a first shape memory member and a second shape memory member arranged substantially in parallel with the first shape memory member, wherein distal ends of the first shape memory member and the second shape memory member are electrically connected to one another, and other portions of the first shape memory member and the second shape memory member are electrically insulated from one another.

23. The implantable component of claim 19, 20, 21, or 22, wherein the shape memory element is configured to have an undulating shape to alleviate strain upon bending.

24. The implantable component of claim 19, wherein the elongate carrier member comprises a lumen, and the at least one shape memory element is disposed in the lumen.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC125. The implantable component of claim 24, wherein the lumen is at least partially filled with a thermal insulating material.

26. A method of implanting an elongate stimulating assembly into a body cavity of a recipient, comprising: inserting the elongate stimulating assembly into a body cavity of a recipient, the stimulating assembly comprising an elongate carrier member and at least one elongate shape memory element; and applying an electric current to the at least one shape memory element, wherein the at least one elongate shape memory element has non-uniform physical characteristics along an elongate length thereof such that application of the electric current causes successive portions of the at least one shape memory element and the elongate stimulating assembly to bend sequentially to match an intended trajectory into the body cavity of the recipient.

27. The method of claim 26, wherein the at least one shape memory element comprises a first shape memory member and a second shape memory member arranged substantially in parallel with the first shape memory member, wherein distal ends of the first shape memory member and the second shape memory member are electrically connected to one another, the method further comprising applying the electric current to the first shape memory member and receiving return current via the second shape memory member.

28. The method of claim 26 or 27, wherein inserting the elongate stimulating assembly into a body cavity of a recipient comprises: inserting the elongate stimulating assembly into a cochlea of the recipient.

29. The method of claim 26 or 27, further comprising applying the electric current such that a tip end of the elongate stimulating assembly bends before other portions of the elongate stimulating assembly.

30. The method of claim 26 or 27, wherein the at least one shape memory element comprises potions that have a serpentine configuration.

31. A method of implanting an elongate stimulating assembly into a body cavity of a recipient, comprising:Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 inserting the elongate stimulating assembly into a body cavity of a recipient, the stimulating assembly comprising an elongate carrier member and at least one elongate variable shape memory element; and controlling an insertion trajectory of the elongate stimulating assembly by applying electric current to the at least one elongate variable shape memory element to bend a tip end of the elongate stimulating assembly before other portions of the elongate stimulating assembly bend.

32. The method of claim 31, wherein the at least one elongate variable shape memory element is comprised of nitinol.

33. The method of claim 31, further comprising, before inserting, removing portions of the at least one elongate variable shape memory element to create at least one void therein to control a sequential bending of the at least one elongate variable shape memory element.

34. The method of claim 31, further comprising applying the electric current to a proximal end of the at least one elongate variable shape memory element.

35. The method of claim 31, 32, 33, or 34, wherein the at least one elongate variable shape memory element comprises a first shape memory member and a second shape memory member arranged substantially in parallel with the first shape memory member, wherein distal ends of the first shape memory member and the second shape memory member are electrically connected to one another, the method further comprising applying the electric current to the first shape memory member and receiving return current via the second shape memory member.

36. A system for implanting an implantable component, comprising: an implantable body comprising electronic circuitry; an elongate carrier member, electrically connected to the implantable body via a lead region and configured to be inserted into a body cavity of a recipient, the elongate carrier member comprising a variable shape memory element extending along a length of the elongate carrier member; and the variable shape memory element having at least one electrical terminal disposed at a proximal end of the of the variable shape memory element and configured to receiveAtty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC1 electric current to sequentially bend portions of the elongate carrier member during insertion into the body cavity.

37. The system of claim 36, wherein the variable shape memory element has differing physical characteristics along an elongate length thereof that cause different portions of the variable shape memory element to pass through a phase change at different times.

38. The system of claim 36 or 37, further comprising a power supply that is configured to supply the electric current.

39. The system of claim 36 or 37, wherein the electric current is supplied from the electronic circuitry in the implantable body.

40. The system of claim 36 or 37, wherein the variable shape memory element is comprised of nitinol.

41. The system of claim 36 or 37, wherein the wherein the variable shape memory element comprises a first elongate member disposed along a length of the elongate carrier member and second elongate member disposed along the length of the elongate carrier member and at least one cross member connecting the first elongate member to the second elongate member.

42. The system of claim 36 or 37, wherein the variable shape memory element comprises at least one void.

43. The system of claim 36 or 37, wherein the variable shape memory element is configured to have an undulating shape to alleviate strain upon bending.

44. A method of manufacturing a variable shape memory element for an implantable component, comprising: forming a first portion of a variable shape memory element; forming a second portion of a variable shape memory element; and joining the first portion and the second portion at ends thereof.Atty. Docket No. 3065.0847i Client Ref. No. CID03925WOPC145. The method of claim 44, further comprising: forming the first portion and forming the second portion into respective spiral shapes.

46. The method of claim 45, further comprising unrolling the spiral shapes before joining the first portion and the second portion at ends thereof.

47. A method of manufacturing a variable shape memory element for an implantable component, comprising: forming a linearly extending variable shape memory element having predetermined length; folding the linearly extending variable shape memory element at a midpoint of the predetermined length to obtain a folded variable shape memory element; and molding the folded variable shape memory element in a spiral shape.

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