Longitudinally-elastic inlay for an implantable component

Abstract

An implantable medical device includes a carrier member and an elongate resiliently flexible inlay disposed within the carrier member. The elongate resiliently flexible inlay is longitudinally-elastic to facilitate flexure of the carrier member without undergoing plastic deformation of the elongate resiliently flexible inlay.

Description

UONGITUDINAUUY-EUASTIC INEAY FOR AN IMPEANTABEE COMPONENTBACKGROUNDTechnical Field[oooi] The present disclosure relates generally to a longitudinally-elastic inlay for an implantable component.Related Art

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In one aspect, an implantable component is provided. The implantable component comprises: a carrier member; and an elongate resiliently flexible inlay disposed within the carrier member, wherein the elongate resiliently flexible inlay is longitudinally-elastic to facilitate flexure of the carrier member without plastic deformation of the elongate resiliently flexible inlay.

[0005] In another aspect, a method of manufacturing an implantable medical device is provided. The method comprises: providing an inlay with a serpentine profile; providing a wire with an electrode configured to deliver a stimulation signal; and embedding the inlay and the wire in a carrier member, wherein the carrier member is configured to flex, and wherein the serpentine profile of the inlay absorbs forces generated via flexure of the carrier member to reduce imparting of the forces onto the wire.

[0006] In another aspect, a method of implanting an elongate stimulating assembly into a recipient is provided. The method comprises: inserting the elongate stimulating assembly into a cochlea of the recipient in a straight configuration of the elongate stimulating assembly, wherein the elongate stimulating assembly comprises an elongate carrier member having an elongate inlay and a plurality of elongate wires disposed therein; and at least one of elongate stretching or compressing the elongate stimulating assembly during insertion of the elongate stimulating assembly into the cochlea of the recipient to transition the elongate stimulating assembly from the straight configuration to a curved configuration.

[0007] In another aspect, a stimulating assembly of an implantable medical device is provided. The stimulating assembly comprises: a carrier member; a wire embedded in the carrier member; and an inlay embedded in the carrier member, wherein the inlay extends along a length of the carrier member and has a plurality of sequential non-straight portions connected to one another to cumulatively extend along an extension axis of the inlay.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present disclosure are described herein in conjunction with the accompanying drawings, in which:

[0009] FIG. 1 is a perspective view of a cochlear implant system with which aspects of the techniques presented herein can be implemented;[ooio] FIG. 2A is a side view of an internal component of a cochlear implant system with which aspects of the techniques presented herein can be implemented;[ooii] FIG. 2B is a side view of a stimulating assembly of the internal component of FIG. 2A in a curved configuration;

[0012] FIG. 3 A is a side view of a sheath containing a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0013] FIG. 3B is a side view of a sheath containing a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0014] FIG. 4 is a side view of an inlay for a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0015] FIG. 5 is a schematic diagram of a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0016] FIG. 6 is a schematic diagram of a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0017] FIG. 7 is a schematic diagram of a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0018] FIG. 8 is a side view of an inlay for a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0019] FIG. 9 is a side view of a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0020] FIG. 10 is a side view of an inlay for a stimulating assembly with which aspects of the techniques presented herein can be implemented;

[0021] FIG. 11 is a flowchart of a method for forming a stimulating assembly in accordance with aspects of the techniques presented herein; and

[0022] FIG. 12 is a flowchart of a method for inserting a stimulating assembly in a recipient in accordance with aspects of the techniques presented herein.DETAILED DESCRIPTION

[0023] Presented herein are techniques for facilitating implantation of an implantable component, such as pre-curved stimulating assembly, into a recipient. A pre-curved stimulating assembly includes an elongate carrier member that is formed (e.g., molded) into a selected pre-curved arrangement / shape, one or more electrodes disposed in the carrier member, and one or more wires disposed in the carrier member that electrically connect the one or more electrodes to a stimulator unit. In accordance with embodiments presented herein, the stimulating assembly also includes a longitudinally-elastic inlay disposed in the carrier member.

[0024] There are a number of different types of devices in / with which embodiments of the present disclosure may be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific device in the form of a cochlear implant system. However, it is to be appreciated that the techniques presented herein may also be partially or fully implemented by any of a number of different types of devices, including consumer electronic device (e.g., mobile phones), wearable devices (e.g., smartwatches), hearing devices, implantable medical devices, wearable devices, etc. consumer electronic devices, wearable devices (e.g., smart watches, etc.), etc. As used herein, the term “hearing device” is to be broadly construed as any device that delivers sound signals to a recipient in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc. 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 device systems, combinations or variations thereof, etc.) or a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones, and other listening devices). In other examples, the techniques presented herein can be implemented by, or used in conjunction with, various implantable medical devices, such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc.

[0025] FIG. 1 is a schematic diagram of an exemplary cochlear implant system 100 configured to implement aspects of the techniques presented herein. The cochlear implant system 100 comprises an external component 102 and an intemal / implantable component 104. The external component 102 is directly or indirectly attached to the body of the recipient and typically comprises an external coil 106 and, generally, a magnet (not shown in FIG. 1) fixed relative to the external coil 106. The external component 102 also comprises one or more input elements / devices for receiving input signals at a sound processing unit 112. In this example, the one or more input devices include sound input devices 108 (e.g., microphones positioned by an auricle 110 of the recipient, telecoils, etc.) configured to capture / receive input signals. The one or more one or more input devices could also include, for example, one or more auxiliary input devices (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, suchas a Universal Serial Bus (USB) port, cable port, etc.), and a wireless transmitter / receiver (transceiver), each located in, on, or near the sound processing unit 112.

[0026] The sound processing unit 112 also includes, for example, at least one power source (e.g., a battery), a radio-frequency (RF) transceiver, and a processing module. The processing module can comprise, for example, one or more processors and a memory device (memory) that includes sound processing logic. The memory device may 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.

[0027] In the examples of FIG. 1, the sound processing unit 112 is a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. In general, the sound processing unit 112 comprises a housing that is shaped to be worn on the outer ear of the recipient and is connected to the separate external coil 106 via a cable, where the external coil 106 is configured to be magnetically and inductively coupled to the implantable component 104. It is to be appreciated that alternative external components could be located in the recipient’s ear canal, worn on the body, etc. It is also to be appreciated that embodiments of the present disclosure may be implemented by sound processing units having other arrangements. For instance, the sound processing unit 112 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 104. The OTE sound processing unit can have a generally cylindrical shape that is configured to be magnetically coupled to the recipient’s head (e.g., includes an integrated external magnet configured to be magnetically coupled to an intemal / implantable magnet in the implantable component 104) . The OTE sound processing unit can also include an integrated external (headpiece) coil that is configured to be inductively coupled to the implantable component 104. In further embodiments, the sound processing unit can include a mini or micro-BTE unit, an in-the-canal unit that is configured to be located in the recipient’s ear canal, a body-worn sound processing unit, etc.

[0028] Returning to the example embodiment of FIG. 1, the implantable component 104 comprises an implant body (main module) 114, a lead region 116, and an intra-cochlear stimulating assembly 118, all configured to be implanted under the skin / tissue (tissue) of therecipient. The implant body 114 generally comprises a hermetically-sealed housing 115 in which RF interface circuitry and a stimulator unit are disposed. The hermetically-sealed housing 115 can include, in certain examples, at least one power source (e.g., one or more batteries, one or more capacitors, etc.) to enable operation of the implantable component 104. The implant body 114 also includes an intemal / implantable coil 122 that is generally external to the hermetically-sealed housing 115, but which is connected to the RF interface circuitry via a hermetic feedthrough.

[0029] As noted, the stimulating assembly 118 is configured to be at least partially implanted in the recipient’s cochlea 137. The stimulating assembly 118 includes a carrier member and a plurality of longitudinally spaced intra-cochlear electrical stimulating electrodes or contacts 126 that collectively form a contact or electrode array 128 for delivery of electrical stimulation (current) to the recipient’s cochlea. The stimulating assembly 118 extends through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to the stimulator unit via a lead region 116 and a hermetic feedthrough. The lead region 116 includes a plurality of conductors (wires) that electrically couple the electrodes 126 to the stimulator unit. The implantable component 104 can also include an electrode outside of the cochlea, such as an extra-cochlear electrode (ECE). As described further below, the stimulating assembly 118 includes a longitudinally-elastic inlay (not shown in FIG. 1) that disposed in the carrier member.

[0030] As noted, the cochlear implant system 100 includes the external coil 106 and the implantable coil 122. The coils 106, 122 are typically wire antenna coils each comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. Generally, a magnet is fixed relative to each of the external coil 106 and the implantable coil 122. The magnets fixed relative to the external coil 106 and the implantable coil 122 facilitate the operational alignment of the external coil with the implantable coil. This operational alignment of the coils 106, 122 enables the external component 102 to transmit data, as well as possibly power, to the implantable component 104 via a closely-coupled wireless link formed between the external coil 106 with the implantable coil 122. In certain examples, the closely- coupled wireless link is a radio frequency (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. 1 illustrates one example arrangement.

[0031] As noted above, the sound processing unit 112 includes the processing module. The processing module is configured to process received input audio signals (received at one or more of the input devices, such as the sound input devices 108 and / or the auxiliary input devices), and convert the input audio signals into stimulation control signals for use in stimulating a first ear of a recipient (i.e., the processing module is configured to perform sound processing on input audio signals received at the sound processing unit 112).

[0032] FIG. 2A is a side view of an embodiment of an intemal / implantable component 204 having an implant body 214 with a stimulator / receiver unit (not shown in FIG. 2A) that receives encoded signals from an external component and generates stimulation signals for delivery to a recipient. The implantable component 204 terminates in an elongate stimulating assembly 218 that comprises an extra-cochlear or proximal region 240 and an intra-cochlear region 242. The intra-cochlear region 242 is configured to be implanted in the recipient’s cochlea.

[0033] The stimulating assembly 218 comprises a carrier member 244 along which a plurality of electrodes is disposed. The plurality of electrodes forms a contact / electrode array 216. Each electrode is connected to one or more wires 246 that extend through an elongate length of the carrier member 244. The one or more wires 246 each have a proximal end connected to the stimulator / receiver unit in the implant body 214. In operation, stimulating electrical signals travel through the one or more wires 246 to cause the electrodes to provide electrical stimulation to the recipient.

[0034] The stimulating assembly 218 is configured to adopt a curved configuration during and / or after implantation into the recipient’s cochlea. To achieve this, in certain arrangements, the stimulating assembly 218 is pre-curved to the same general curvature of a cochlea. Such examples of the stimulating assembly 218 are typically held straight by, for instance, a stiffening stylet (not shown) or sheath that is removed during implantation, alternatively varying material combinations, etc. The stimulating assembly 218 may extend towards an apical end of the cochlea, referred to as cochlea apex. In certain circumstances, the stimulating assembly 218 may be inserted into the cochlea via a cochleostomy. In other circumstances, a cochleostomy may be formed through round window, oval window, the promontory or through an apical turn of the cochlea.

[0035] The implantable component 204 further comprises a lead region 248 coupling the stimulator / receiver unit to the stimulating assembly 218. The lead region 248 comprises a helix region 250 that is flexible. However, in alternative embodiments, such a portion of the leadregion 248 is flexible without having a helical profile. The lead region 248 also comprises a transition region 252, which connects the helix region 250 to the stimulating assembly 218. Electrical stimulation signals generated by the stimulator / receiver unit are delivered to the electrode array 216 via the lead region 248. The flexibility of the helix region 250 blocks deformation of the lead region 248 and its connection to the stimulator / receiver and the stimulating assembly 218 due to movement of the implantable component 204 that may occur, for example, during mastication by the recipient.

[0036] In some embodiments, the helix region 250 includes a body 254 in which the wire 246 is embedded. For example, the body 254 is silicone or another biocompatible material molded over the wire 246. Thus, flexure of the body 254 causes corresponding flexure of the wire 246 embedded therein.

[0037] As discussed, the stimulating assembly 218 is pre-curved to conform to a general shape of the cochlea. FIG. 2B is a side view of the stimulating assembly 218 in a curved configuration 260, which can depict the orientation of the stimulating assembly 218 in situ in the cochlea of the recipient. In the curved configuration 260, the intra-cochlear region 242 extends in a generally spiral shape, and a portion of the electrodes 262 of the electrode array 216 is located within the spiral. The arrangement of the portion of the electrode array 216 in the spiral maintains positioning against the cochlea of the recipient to enable stimulation of cells of the cochlea via the electrode array 216. As described further below, the stimulating assembly 218 includes a longitudinally-elastic inlay 210 (FIG. 2B) in accordance with embodiments presented herein.

[0038] Pre-curved stimulating assemblies are formed (e.g., molded) into the selected curved shape and then straightened for insertion / implantation into a recipient (e.g., via a stylet, sheath, etc.). During insertion, the intent is to return the stimulating assembly to its pre-curved shape, such as a shape corresponding to a cochlea spiral. Thus, the pre-curved stimulating assembly (e.g., the intra-cochlear region) can undergo different types of flexure, such as an alternation between straightening and curving, to prepare for and / or during implantation.

[0039] Presented herein are pre-curved stimulating assemblies configured to be implanted into a recipient without compromising a structural integrity of the one or more wires disposed in a carrier member of the pre-curved stimulating assembly in response to flexure of the stimulating resulting from straightening / bending of the pre-curved stimulating assembly. More specifically, in accordance with embodiments presented herein, a stimulating assembly alsoincludes a “longitudinally-elastic inlay” disposed in the carrier member. The longitudinally- elastic inlay provides a stiffness for re-curving the one or more wires and returning the stimulating assembly to the pre-curved shape (e.g., shape of the cochlea spiral) after straightening (by stylet or sheath) for insertion into the cochlea. As used herein, an “longitudinally-elastic inlay” is a shape element with a configuration that is capable of undergoing significant strains or deformation (e.g., linear deformation) caused by forces imparted along an extension axis of the shape element (e.g., linear stretching or compression), such as during flexure of the carrier member, without plastically or permanently deforming. That is, the longitudinally-elastic inlay can undergo significant flexure, such as bending or straightening, to deform in a reversible manner (e.g., elastically deform). As a result, a longitudinally-elastic inlay not only operates to return the pre-curved assembly to the precurved shape, but is also structured so as to avoid permanent deformations during flexure of the stimulating assembly. As such, a stimulating assembly presented herein can be more easily or readily transitioned to the selected curved configuration.

[0040] As noted above, prior to insertion of a pre-curved stimulating assembly into a recipient, the stimulating assembly is straightened (e.g., via a stylet, sheath, etc.), which results in the flexure of the carrier member that in turn imparts forces on the longitudinally-elastic inlay. For example, the longitudinally-elastic inlay and the one or more wires are encapsulated within the carrier member in a curved configuration such that the longitudinally-elastic inlay is at an outer radius as compared to the one or more wires. Thus, when the stimulating assembly is straightened for insertion by adjusting the arc lengths of the longitudinally-elastic inlay and of the one or more wires toward one another (e.g., by reducing the arc length defined by the longitudinally-elastic inlay and / or by increasing the arc length defined by the wire(s) such that the arc length defined by the longitudinally-elastic inlay and the arc length defined by the wire(s) approximately match one another), the wire(s) are subjected to tension and the longitudinally-elastic inlay is subjected to compression. In accordance with embodiments presented herein, the longitudinally-elastic inlay is configured (e.g., shaped) to absorb compression and other forces to facilitate bending without permanently deforming (e.g., to undergo compression with relatively little resistance while avoiding buckling), thereby maintaining a structural integrity of the inlay. Additionally, absorption of the forces via the longitudinally-elastic inlay reduces an amount of force imparted onto the one or more wires. As such, a structural integrity of the one or more wires is also maintained to enable desirable operation of the wire(s), as well as positioning of the wire(s) within the recipient. The stabilityof the structural integrity of the one or more wires and / or of the longitudinally-elastic inlay reduces a likelihood that the stimulating assembly is rendered unusable as a result of permanent deformation. Thus, a cost associated with manufacture and / or purchase of additional stimulating assemblies to compensate for potential loss of permanently deformed stimulating assemblies is reduced. Moreover, the stability of the structural integrity of the wire(s) and / or of the inlay can improve an ease of implantation of the stimulating assembly in the recipient, such as by allowing the stimulating assembly to desirably conform to the cochlea of the recipient.

[0041] In certain embodiments, the longitudinally-elastic inlay includes an elongate serpentine profile formed by a plurality of sequential non-straight portions (e.g., a plurality of curved, arcuate, looped, or bent portions that iteratively or cumulatively extend or are positioned along a length of the carrier member). The elongate serpentine profile enables the inlay to absorb forces more readily. For example, flexure of the carrier member causes corresponding flexure of the longitudinally-elastic inlay, but such flexure is distributed among multiple non-straight portions of the elongate serpentine profile. In other words, multiple non-straight portions are slightly deformed (e.g., elastically deformed such that no part of the longitudinally-elastic inlay is deformed past the elastic limit of the material of the longitudinally-elastic inlay) to enable an overall flexure of the longitudinally-elastic inlay and of the carrier member. The slight deformation of the non-straight portions can help avoid a more permanent plastic deformation of the longitudinally-elastic inlay that otherwise can occur for a straighter inlay (e.g., that does not include sequential non-straight portions) in which a portion of the straighter inlay would be significantly deformed to enable an overall flexure of the straighter inlay and of the carrier member. That is, the non-straight portions enable the longitudinally-elastic inlay to flex without any one of the non-straight portions undergoing a plastic deformation. Consequently, a structural integrity of the longitudinally-elastic inlay is maintained. Additionally, the non- straight portions can more readily absorb forces generated during flexure of the carrier member. That is, the forces are better distributed among the non-straight portions. As a result, the longitudinally-elastic inlay can reduce an amount of force being imparted onto the wire(s) during flexure of the carrier member, thereby helping maintain a structural integrity of the wire(s).

[0042] The longitudinally-elastic inlay (e.g., having the sequential non-straight portions that form the elongate serpentine profde) discussed herein can improve stability of the structural integrity of the stimulating assembly as compared to, for instance, implementation of analternative shape element, such as a substantially smooth or continuous shape element that does not include sequential non-straight portions. By way of example, the alternative shape element is configured to curve (e.g., under the action of body heat) to a spiral-shape such that straightening of the alternative shape element causes compression. Such compression can cause the alternative shape element to buckle at several places along its length, experiencing high local strains and plastic deformation in the process to permanently alter the shape and properties of the longitudinally-elastic inlay, which can also alter the structural integrity of an adjacent wire. As a result, the stimulating assembly that includes the alternative shape element would lose some of its original curved shape due to this plastic (permanent) deformation.

[0043] Indeed, whereas releasing a stimulating assembly (e.g., to allow the stimulating assembly to re-curve) implemented with the alternative shape element would not enable the stimulating assembly to return (e.g., fully return) to its pre-curved shape, releasing a stimulating assembly implemented with the longitudinally-elastic inlay discussed herein enables the stimulating assembly to fully or desirably curve. In addition, because the alternative shape element may not be able to readily absorb forces (e.g., compression) during flexure of the stimulating assembly, an increased amount of force (e.g., tension) may be imparted onto the one or more wires of the stimulating assembly. As a result, the one or more wires may be broken or otherwise rendered unusable. In contrast, the longitudinally-elastic inlay can limit the amount / number of forces imparted onto the one or more wires to maintain operability and / or a useful lifespan of the one or more wires.

[0044] Although the present disclosure primarily discusses usage of the longitudinally-elastic inlay having the serpentine profile, in some embodiments, the wire can have the serpentine profile (e.g., in addition to or as an alternative to the inlay having the serpentine profile). For example, the wire and / or the carrier member can be pre-curved, and the serpentine profile can absorb forces and avoid permanent deformation to facilitate straightening.

[0045] FIG. 3A is a side view of an embodiment of a stimulating assembly 400 extending within a sheath 402. The sheath 402 is used to facilitate insertion of the stimulating assembly 400 into a cochlea of a recipient. For example, the sheath 402 maintains the stimulating assembly 400 in a straight configuration to help control the positioning of the stimulating assembly 400 (e.g., of a distal region 404 of the stimulating assembly 400) for insertion into the cochlea. During insertion of the sheath 402 and the stimulating assembly 400 contained within the sheath 402 into the cochlea, the stimulating assembly 400 curves to follow the curvature of the cochlea. For example, the stimulating assembly 400 is released from thestraight configuration (e.g., via removal of the sheath 402) to urge the stimulating assembly 400 toward the curved configuration in the cochlea.

[0046] The stimulating assembly 400 includes a carrier member 406, as well as a wire 408 (or multiple wires 408) and a longitudinally-elastic inlay 410 disposed within the carrier member 406. By way of example, the carrier member 406 includes a silicone or other biocompatible material that is molded over the wire 408 and the longitudinally-elastic inlay 410. As a result, the wire 408 and the longitudinally-elastic inlay 410 are embedded within the carrier member 406. The wire 408 is attached to contacts 412 (e.g., electrodes) and electrically couples the contacts 412 to another component, such as to a stimulator / receiver unit for receiving stimulation signals. Each of the carrier member 406, the wire 408, and the longitudinally- elastic inlay 410 has an elongate shape to facilitate insertion (e.g., full insertion) of the stimulating assembly 400 into the cochlea.

[0047] In some embodiments, absent a force imparted onto the stimulating assembly 400, the stimulating assembly 400 is urged toward its the curved configuration. Unfortunately, the wire 408 can be relatively resistant to flexure. Consequently, the wire 408 can impede transitioning of the stimulating assembly 400 from the straight configuration to the curved configuration. Additionally or alternatively, a substantial force is to be imparted onto the stimulating assembly 400, such as via the carrier member 406, for transitioning between the straight configuration and the curved configuration. For example, the wire 408 is configured to straighten to urge the stimulating assembly 400 to the straight configuration, and a force is imparted to curl the stimulating assembly 400.

[0048] The longitudinally-elastic inlay 410 is implemented to facilitate flexure of the stimulating assembly 400 to help transition the stimulating assembly 400 between the straight configuration and the curved configuration. For instance, the longitudinally-elastic inlay 410 is composed of a resiliently flexible material configured to urge toward an undeformed state to bias the stimulating assembly 400 to the curved configuration. To this end, the longitudinally- elastic inlay 410 is pre-curved. The resiliently flexible material can include a metal (e.g., superelastic nitinol, implantable grades of steel, such as MP35N, a platinum alloy, such as with iridium, ruthenium, and / or rhodium, and / or any other suitable metal capable of elastically deforming to significant values of strain), such as the same material of the wire 408, and / or a polymer, such as silicone, polyimide, and / or polyurethane, and has a greater stiffness than the material of the carrier member 406 to urge curling of the carrier member 406 and therefore of the stimulating assembly 400. In such embodiments, the sheath 402 imparts a force that blockscurling of the stimulating assembly 400 to maintain a particular shape of the stimulating assembly 400 (e.g., the straight configuration). Removal of the sheath 402 (e.g., upon implantation of the stimulating assembly 400) removes the force imparted by the sheath 402 to urge the stimulating assembly 400 toward the curved configuration to conform to the cochlea.

[0049] Additionally or alternatively, the longitudinally-elastic inlay 410 is composed of a shape memory material (e.g., a nitinol -based shape memory alloy, an iron-based shape memory alloy, a copper-based shape memory alloy, a shape memory alloy) that is configured to transition to a particular configuration upon increasing the temperature of the shape memory material above a threshold temperature (e.g., room temperature). For instance, the longitudinally-elastic inlay 410 is configured to curl to transition the stimulating assembly 400 to the curved configuration upon increasing the longitudinally-elastic inlay 410 above a threshold temperature, such as during insertion of the stimulating assembly 400 into the cochlea. In such embodiments, the stimulating assembly 400 can be maintained in the straight configuration without usage of the sheath 402 (e.g., by blocking a temperature increase of the longitudinally-elastic inlay 410 above the threshold temperature to avoid curling of the longitudinally-elastic inlay 410). As an example, the temperature of the longitudinally-elastic inlay 410 is increased above the threshold temperature upon exposure to a body temperature of the recipient. Thus, insertion of the stimulating assembly 400 into the cochlea to expose the longitudinally-elastic inlay 410 to the body temperature activates the longitudinally-elastic inlay 410 to cause the longitudinally-elastic inlay 410 to curl and transition the stimulating assembly 400 to the curved configuration to conform to the cochlea. As another example, the temperature of the longitudinally-elastic inlay 410 is increased above the threshold temperature by directing an electrical current through the longitudinally-elastic inlay 410. Accordingly, applying the electrical current to the longitudinally-elastic inlay 410, such as during insertion of the longitudinally-elastic inlay 410 into the cochlea, activates the longitudinally-elastic inlay 410 to cause the longitudinally-elastic inlay 410 to curl and transition the stimulating assembly 400 to the curved configuration. To this end, the longitudinally-elastic inlay 410 is electrically coupled to a conductor 411 (e.g., an electrode) configured to generate and / or pass an electrical current through the longitudinally-elastic inlay 410. As such, the longitudinally-elastic inlay 410 can be selectively activated to curl by controlling whether an electrical current is directed through the longitudinally-elastic inlay 410 via the conductor 411.

[0050] In any of these implementations, the longitudinally-elastic inlay 410 can provide a sufficient force that flexes the carrier member 406, as well as the wire 408 embedded therein,thereby transitioning the stimulating assembly 400 to the curved configuration. Moreover, the longitudinally-elastic inlay 410 can absorb a force (e.g., a manually applied force) being imparted to flex the carrier member 406 (e.g., to transition the stimulating assembly 400 to the straight configuration), thereby reducing the force being imparted onto the wire 408 to maintain the structural integrity of the wire 408.

[0051] As a result, the shape and mechanical properties (e.g., deformation, such as flexure) of the stimulating assembly 400 can be better controlled with usage of the longitudinally-elastic inlay 410. Furthermore, the use of the longitudinally-elastic inlay 410 can also help with flexure of the stimulating assembly 400 without having to manufacture the wire 408 in a specific manner (e.g., using a particular material, such as a shape memory alloy, and / or to have a particular stiffness or dimension) to facilitate transition of the stimulating assembly 400 between the straight configuration and the curved configuration. Thus, the wire 408 can have more desirable properties, such as a more compact or volume efficient structure, without having to provide flexure inducing behavior for the stimulating assembly 400. Similarly, the carrier member 406 can have more desirable properties, such as a lower durometer and / or a smaller volume, without reducing flexure capabilities of the stimulating assembly 400. The usage of such a carrier member 406 can improve an ease of manufacture of the stimulating assembly 400, such as for molding over the wire 408 and the longitudinally-elastic inlay 410, and increase a useful lifespan of the stimulating assembly 400, such as by increasing resistance to tearing and / or delamination. Such properties of the carrier member 406 can also improve ease of implantation in the cochlea, such as by improving positioning control.

[0052] In the illustrated embodiment, the longitudinally-elastic inlay 410 terminates prior to a distal end 416 of the wire 408 and / or of the contacts 412 (e.g., prior to the distal region 404 of the stimulating assembly 400). Accordingly, a portion of the wire 408 and / or a certain quantity (e.g., one, two) of contacts 412 extend distally beyond the longitudinally-elastic inlay 410. As discussed further herein, such arrangement of the longitudinally-elastic inlay 410 can provide increased flexibility of the stimulating assembly 400 at a portion (e.g., the distal region 404) beyond which the longitudinally-elastic inlay 410 terminates.

[0053] However, it should be noted that the longitudinally-elastic inlay 410 can be arranged to extend to any suitable part of the wire 408 and / or the contacts 412. For example, FIG. 3B is a side view of an embodiment of a stimulating assembly 430 extending within a sheath 432, the stimulating assembly 430 having a carrier member 436 in which a wire 438, a longitudinally- elastic inlay 440, and contacts 442 attached to the wire 438 are embedded. The longitudinally-elastic inlay 440 has a serpentine profile 444. Additionally, in the illustrated embodiment, the longitudinally-elastic inlay 440 extends into a distal region 434 of the stimulating assembly 430 and distally beyond the wire 438 and the contacts 442. In other words, the wire 438 and the contacts 442 terminate prior to a distal end 446 of the longitudinally-elastic inlay 440. For example, such arrangement of the longitudinally-elastic inlay 440 relative to the wire 438 and relative to the contacts 442 may increase a stiffness of the distal region 434 of the stimulating assembly 430. In further embodiments, the longitudinally-elastic inlay 410 can be arranged in still another manner relative to the wire 408 and / or relative to the contacts 412, such as to terminate alongside one another. In other words, a distal end of the longitudinally-elastic inlay 410, of the wire 408, and / or of the contacts 412 can generally be aligned with one another side by side.

[0054] FIG. 4 is a side view of the longitudinally-elastic inlay 410 shown separate from the stimulating assembly 400. In this example, the longitudinally-elastic inlay 410 has a serpentine profile 414 that enables the longitudinally-elastic inlay 410 to absorb a greater force (e.g., imparted during flexure of the stimulating assembly 400) without permanently deforming. Accordingly, the serpentine profile 414 further helps maintain a desirable configuration of the stimulating assembly 400, such as the transitioning of the stimulating assembly 400 between the straight configuration and the curved configuration.

[0055] In some embodiments, the longitudinally-elastic inlay 410 extends beyond a region (e.g., an intra-cochlear region) of the stimulating assembly 400 configured to be implanted within the cochlea of the recipient. For example, the longitudinally-elastic inlay 410 can extend to a transition region (e.g., to a handle) of the stimulating assembly 400 to provide desirable stiffness, reinforcement, and / or stability to the transition region for improved handling of the stimulating assembly 400. Such arrangement of the longitudinally-elastic inlay 410 can further facilitate implantation of the stimulating assembly 400 in the recipient.

[0056] As noted, the longitudinally-elastic inlay 410 is longitudinally-elastic and can flex without plastically deforming to help maintain a structural integrity and desired shape of the longitudinally-elastic inlay 410, and therefore of the stimulating assembly 400. To this end, the longitudinally-elastic inlay 410 includes a serpentine profile 414 defined by sequential nonstraight portions 452 that cumulatively extend or are positioned along an extension axis 454, which is shown in this example to extend in a curved direction (as the illustrated inlay 410 is in a curved configuration following implantation in a recipient). The non-straight portions 452 define bends or waves that repeatedly cross the extension axis 454. In the illustratedembodiment, the bending of the non-straight portions 452 and curving of the inlay 410 are along a common plane. By way of example, at a first region 458 (e.g., a proximal region) of the inlay 410, the non-straight portions 452 cross the extension axis 454 along a plane cooperatively formed by a first axis 460 (e.g., a vertical axis) and a second axis 462 (e.g., a longitudinal axis). Additionally, at a second region 464 (e.g., a distal region), the extension axis 454 extends along the same plane cooperatively formed by the first axis 460 and the second axis 462. In this manner, the shape of the inlay 410 is generally formed in two dimensions. Although the non-straight portions 452 of the inlay 410 are connected to form curves, in additional or alternative embodiments, the inlay 410 includes segments connected to form sharp edges (e.g., to form a square wave, a sawtooth wave, and / or a triangular wave) to define the serpentine profile generally formed in two dimensions.

[0057] FIG. 5 is a schematic diagram of a portion of an embodiment of a stimulating assembly 500 that includes a carrier member 502, along with a longitudinally-elastic inlay 510 and a wire 506 (e.g., representative of multiple wires) embedded within the carrier member 502. The illustrated longitudinally-elastic inlay 510 is longitudinally-elastic and includes a serpentine profile similar to that of the inlay 410 in which sequential non-straight portions 552 curvedly extend from one another and repeatedly cross an extension axis 511 of the longitudinally-elastic inlay 510. For example, the non-straight portions 552 cross the extension axis 511 along the same plane along which the extension axis 511 extends.

[0058] The illustrated stimulating assembly 500 is in a curved configuration 512 where the curved configuration 512 is preset by pre-curving the longitudinally-elastic inlay 510, carrier member 502, etc. In certain examples, the longitudinally-elastic inlay 510 is resiliently flexible such that the longitudinally-elastic inlay 510 is urged toward its pre-curved state to bias the stimulating assembly 500 toward the curved configuration 512. Additionally or alternatively, the longitudinally-elastic inlay 510 is configured to curve upon increasing the temperature of the longitudinally-elastic inlay 510 to above a threshold temperature, such as via exposure to body temperatures (e.g., the longitudinally-elastic inlay 510 urges the stimulating assembly 500 toward the curved configuration 512 when implanted and thus exposed to the recipient’s temperature) and / or by passing an electrical current through the longitudinally-elastic inlay 510 (e.g., via a conductor). In either case, the longitudinally-elastic inlay 510 is located more exterior to the wire 506 at the curvature of the stimulating assembly 500. In other words, the wire 506 extends more adjacent to a first side 514 of the carrier member 502 defining an inner radius of the carrier member 502 in the curved configuration 512, and the longitudinally-elasticinlay 510 extends more adjacent to a second side 516 of the carrier member 502 defining an outer radius of the carrier member 502 in the curved configuration 512.

[0059] FIG. 6 is a schematic diagram of the portion of the stimulating assembly 500 in a straight configuration 550. For example, the stimulating assembly 500 is transitioned to the straight configuration 550 for insertion into the cochlea. In the straight configuration 550, the extension axis 511 of the longitudinally-elastic inlay 510 is approximately parallel to the wire 506 such that the carrier member 502 extends substantially linearly. Such a configuration of the carrier member 502 facilitates positioning of the stimulating assembly 500 for insertion into a cochlea of a recipient.

[0060] In certain embodiments, the stimulating assembly 500 is transitioned to the straight configuration 550 by bending or straightening (e.g., via a sheath or stylet) the stimulating assembly 500 that is initially in the curved configuration 512. As such, a force is applied to the stimulating assembly 500 to bend the stimulating assembly 500. For instance, as discussed, the wire 506 extends more adjacent to the first side 514 of the carrier member 502 and the longitudinally-elastic inlay 510 extends more adjacent to the second side 516 of the carrier member 502. In the curved configuration 512, the arc length defined by the carrier member 502 to form the inner radius is shorter than the arc length defined by the carrier member 502 to form the outer radius. Therefore, the first side 514 defining the inner radius is shorter than the second side 516 defining the outer radius. However, in the straight configuration 550, each side 514, 516 extends along approximately the same length. As such, to transition the stimulating assembly 500 from the curved configuration 512 to the straight configuration 550, the first side 514 of the carrier member 502 having the relatively shorter length in the curved configuration 512 is elongated or stretched, and the second side 516 of the carrier member 502 having the relatively longer length in the curved configuration 512 is shortened or compressed. For this reason, during transition of the stimulating assembly 500 to the straight configuration 550, the wire 506 adjacent to the first side 514 can undergo tension applied by tensile forces 552, and the longitudinally-elastic inlay 510 adjacent to the second side 516 can undergo compression applied by compressive forces 554 along the extension axis 511. The respective forces 552, 554 deform the longitudinally-elastic inlay 510 and the wire 506 to enable flexure of the stimulating assembly 500 from the curved configuration 512 to the straight configuration 550.

[0061] However, the longitudinally-elastic property (e.g., effectuated by the serpentine profile) of the longitudinally-elastic inlay 510 enables the longitudinally-elastic inlay 510 to absorb thecompressive forces 554, while maintaining a desired structural integrity. For example, the compressive forces 554 are imparted onto the non-straight portions 552 along the extension axis 511 to slightly or non-permanently deform (e.g., elastically shorten) each non-straight portion 508 (e.g., to move toward one another along the extension axis 511). Accordingly, instead of the compressive forces 554 being concentrated at a part of the longitudinally-elastic inlay 510, the compressive forces 554 are distributed along the longitudinally-elastic inlay 510. By distributing the compressive forces 554 along the longitudinally-elastic inlay 510 and slightly deforming each non-straight portion 508, a larger, more significant deformation (e.g., a plastic deformation) of the longitudinally-elastic inlay 510 (e.g., a part of the longitudinally- elastic inlay 510 in which forces concentrate) can be avoided. That is, numerous small, distributed strains, instead of a high, local strain, enable overall shortening of the longitudinally-elastic inlay 510. Consequently, the structural integrity of the longitudinally- elastic inlay 510 is maintained. For instance, permanent deformation (e.g., buckling) of the longitudinally-elastic inlay 510 during flexure of the stimulating assembly 500 is avoided. Furthermore, the smaller, non-permanent deformations experienced by the non-straight portions 508 also block potential relaxation ofthe longitudinally-elastic inlay 510 (e.g., reduced urge toward the straight configuration 550) that can otherwise be caused by creep, such as prolonged exposure to an imparted force to hold the inlay in the straight configuration 550. As such, a desirable straight configuration 550 and curved configuration 512 are maintained to facilitate implantation ofthe stimulating assembly 500.

[0062] Additionally, the longitudinally-elastic property of the longitudinally-elastic inlay 510 can reduce the tensile forces 552 imparted onto the wire 506. By way of example, the non- straight portions 552 can readily receive a greater amount of force (e.g., as compared to the amount of force that can be received by an inlay that is straight and does not include the non- straight portions 508). Thus, the longitudinally-elastic inlay 510 is able to absorb a greater portion of a force that is imparted onto the stimulating assembly 500 during transition of the stimulating assembly 500 to the straight configuration 550. In other words, a greater portion ofthe force imparted onto the stimulating assembly 500 is received by the longitudinally-elastic inlay 510 as the compressive forces 554, rather than by the wire 506 as the tensile forces 552. Consequently, the longitudinally-elastic inlay 510 can also help block deformation of the wire 506 otherwise caused by an excessive amount of force imparted on the wire. As such, the longitudinally-elastic inlay 510 helps maintain a structural integrity of the wire 506, therebymaintaining desirable operation of stimulating assembly 500 (e.g., of a contact attached to the wire 506).

[0063] Although the description related to FIGS. 5 and 6 primarily discusses force imparted onto the stimulating assembly 500 during transition of the stimulating assembly 500 from the curved configuration 512 to the straight configuration 550, similar discussion may be relevant during transition of the stimulating assembly 500 from the straight configuration 550 to the curved configuration 512. For example, during transition of the stimulating assembly 500 from the straight configuration 550 to the curved configuration 512, the first side 514 of the carrier member 502 is to be shortened or compressed and the second side 516 of the carrier member 502 is to be elongated or stretched. As a result, compressive forces are applied to the nonstraight portions 508 and tensile forces are applied to the longitudinally-elastic inlay 510. The tensile forces are distributed to the non-straight portions 508 to slightly deform the non-straight portions 508, thereby avoiding significant deformation of the longitudinally-elastic inlay 510. Thus, a structural integrity of the longitudinally-elastic inlay 510 is maintained. Moreover, the non-straight portions 508 are able to absorb an increased amount of force, thereby reducing the compressive forces imparted onto the wire 506 to maintain a structural integrity of the wire 506.

[0064] FIG. 7 is a side view of an embodiment of a stimulating assembly 700 in a curved configuration 702. The stimulating assembly 700 includes a carrier member 704, as well as a longitudinally-elastic inlay 710 and a wire 708 (e.g., representative of multiple wires) embedded within the carrier member 704. The longitudinally-elastic inlay 710 of the illustrated stimulating assembly 700 is longitudinally-elastic and includes a serpentine profile formed by sequential non-straight portions 752 that are connected to one another. Each non-straight portion 752 is looped to form a circular, oval, and / or elliptical shape, and the non-straight portions 752 are connected to cumulatively extend or be positioned along an extension axis 711. In some embodiments, the non-straight portions 752 have different shapes from one another, such as different radii and / or major / minor axis dimensions.

[0065] The non-straight portions 752 facilitate flexure of the stimulating assembly 700. For example, each individual non-straight portion 752 can slightly deform to enable flexure of the carrier member 704. Thus, a more significant deformation of the longitudinally-elastic inlay 710 can be avoided to maintain a structural integrity of the longitudinally-elastic inlay 710. Additionally, a force used to flex the stimulating assembly 700 can be distributed among the non-straight portions 752. Consequently, the longitudinally-elastic inlay 710 can absorb agreater amount of force (e.g., imparted along the extension axis 711), thereby reducing an amount of force imparted onto the wire 708 to maintain a structural integrity of the wire 708.

[0066] FIG. 8 is a perspective view of an embodiment of the longitudinally-elastic inlay 810 has a serpentine profde, shown in a curved configuration. The longitudinally-elastic inlay 810 includes sequential non-straight portions 852 that define the serpentine profile, and the nonstraight portions 852 cumulatively extend or are positioned along an extension axis 811 in the curved configuration. The bending of the non-straight portions 852 and curving of the longitudinally-elastic inlay 810 are along different planes and are therefore transverse to one another. As such, the shape of the longitudinally-elastic inlay 810 is generally formed in three dimensions. Although the non-straight portions 852 of the longitudinally-elastic inlay 810 are connected to form curves, in additional or alternative embodiments, the longitudinally-elastic inlay 810 includes segments connected to form sharp edges (e.g., to form a square wave, a sawtooth wave, and / or a triangular wave) to define the serpentine profile generally formed in three dimensions.

[0067] A longitudinally-elastic inlay with another suitable serpentine profile can also be implemented in a stimulating assembly to facilitate flexure of the stimulating assembly. As an example, the inlay can include sequential helical or spiral portions that cumulatively extend or are positioned along an extension axis (e.g., the extension axis generally extends through openings formed by the helical portions) to resist plastic deformation caused by forces imparted along an extension axis. As another example, the inlay can include a combination of different features of serpentine profiles discussed herein to effectuate the longitudinally-elastic property. For instance, the inlay can have separate, discrete regions that respectively include bent portions and looped portions.

[0068] As discussed, a stimulating assembly can be inserted into a sheath to help with implantation in a recipient, such as to transition the stimulating assembly to the straight configuration. That is, the sheath and the stimulating assembly contained in the sheath are inserted into the cochlea of the recipient to implant the stimulating assembly in the cochlea. Thus, desirable insertion of the stimulating assembly into the sheath helps subsequent positioning of the stimulating assembly in the cochlea.

[0069] FIG. 9 illustrates a side view of an embodiment of a stimulating assembly 900 having properties that facilitate its insertion into a sheath. The stimulating assembly 900 includes a carrier member 902, as well as an inlay 910 and a wire 906 embedded within the carrier member902. The inlay 910 is longitudinally-elastic and has a serpentine profile to facilitate flexure of the stimulating assembly 900, such as to overcome a resistance to flexure of the wire 906 to urge the stimulating assembly 900 into a curved configuration. Contacts 908 (e.g., electrodes) are coupled to the wire 906 to provide stimulation to a recipient.

[0070] The stimulating assembly 900 includes a distal region 913 (e.g., a tip) configured to be inserted deepest into the cochlea (e.g., most adjacent to an apex of the cochlea) and also deepest into the sheath. In an example embodiment, the distal region 913 includes a selected quantity (e.g., two or three) of the most distal electrodes. It is desirable to control positioning of the distal region 913 to enable desirable positioning of a remainder of the stimulating assembly 900. For example, it is desirable to insert the stimulating assembly 900 into the sheath to position the distal region 913 close to (e.g., in contact with) a distal end of the sheath. However, urging of the stimulating assembly 900 to the curved configuration, as caused by the inlay 910, can reduce an ease of insertion of the stimulating assembly 900 into the sheath. For example, significant stiffness of the stimulating assembly 900 to resist straightening (e.g., transitioning from the curved configuration to the straight configuration) can cause the stimulating assembly 900 to curve, fold, twist, bend, or otherwise change geometry prior to desirable insertion into the sheath. As a result, the stimulating assembly 900 is rendered unusable for implantation.

[0071] For this reason, the flexibility of the distal region 913 is increased to facilitate insertion of the stimulating assembly 900 into the sheath. The increased flexibility of the distal region 913 can enable the curving of the stimulating assembly 900 to be more easily and desirably controlled. For example, the distal region 913 can adjust to follow the curvature of the sheath during insertion of the stimulating assembly 900 into the sheath, and undesirable curving, folding, twisting, bending, etc. of the distal region 913 can be avoided. Consequently, the distal region 913 can follow along an interior space defined by the sheath for positioning near the end of the sheath. Thus, usability of the stimulating assembly 900 is more easily achieved.

[0072] In the illustrated embodiment, the inlay 910 terminates prior to the distal region 913 to increase the flexibility of the distal region 913 such that the carrier member 902 at the distal region 913 includes the wire 906 and the contacts 908, but not the inlay 910. For instance, the inlay 910 increases the stiffness of the stimulating assembly 900 by imparting a force (e.g., to urge the stimulating assembly 900 toward the curved configuration). Thus, removing the inlay 910 from the distal region 913 removes the force imparted by the inlay 910 to increase the flexibility of the distal region 913. By way of example, the distal region 913 that is void of the inlay 910 is not urged toward the curved configuration by the inlay 910. However, the inlay910 can still extend up to the distal region 913 to provide a sufficient stiffness (e.g., impart a sufficient amount of force) onto a remainder of the carrier member 902 to overcome the resistance to flexure of the wire 906 and urge the stimulating assembly 900 to the curved configuration. The carrier member 902 can also have a reduced thickness 912 at the distal region 913 to provide the increased flexibility while sufficiently containing the wire 906 therein. Thus, the arrangement of each of the inlay 910 and the carrier member 902 helps desirable implantation of the stimulating assembly 900.

[0073] FIG. 10 illustrates a side view of an embodiment of the inlay 910 shown separate from the other components of the simulation assembly 900. As noted, the inlay 910 includes a serpentine profile, which in this example are defined by sequential non-straight portions 952 that cumulatively extend or are positioned along an extension axis 911. The non-straight portions 952 define waves that repeatedly cross the extension axis 911.

[0074] Geometric properties of the non-straight portions 952 vary at different regions of the inlay 910 to increase flexibility at a distal region 956 of the inlay 910. For example, a first thickness 958 of the non-straight portions 952 at the distal region 956 is less than a second thickness 960 of the non-straight portions 952 at a proximate region 962. Additionally or alternatively, a first amplitude 964 of the non-straight portions 952 at the distal region 956 is greater than a second amplitude 966 of the non-straight portions 952 at the proximate region 962. In further embodiments, a first wavelength 968 of the non-straight portions 952 at the distal region 956 is greater than a second wavelength 970 of the non-straight portions 952 at the proximate region 962 (e.g., a first pitch of the non-straight portions 952 at the distal region 956 is less than a second pitch of the non-straight portions 952 at the proximate region 962). Any of such differences in property of the non-straight portions 952 at the distal region 956 relative to the non-straight portions 952 at the proximate region 962 can increase flexibility at the distal region 956 to facilitate insertion of the stimulating assembly having the inlay 910 into a sheath.

[0075] Each of FIGs. 11 and 12 discussed below illustrates a respective method related to a stimulating assembly, such as any of the stimulating assembly described herein. It should be noted that each method can be performed by the same or a different entity. Additionally, any of the methods can be performed differently than depicted, For example, an additional operation can be performed, or any of the depicted operations can be performed differently, performed in a different order, or not performed.

[0076] FIG. 11 is a flowchart of an embodiment of a method 1100 for manufacturing a stimulating assembly. At block 1102, an inlay that is longitudinally-elastic is provided. For example, the inlay has a serpentine profile defined by sequential non-straight (e.g., bent, looped) portions that cumulatively extend or are positioned along an extension axis. At block 1104, a wire with an electrode is provided. The electrode is configured to provide a stimulation signal during operation.

[0077] At block 1106, the inlay and the wire are embedded in a carrier member to form the stimulating assembly. For instance, the carrier member is composed of a silicone material and is molded over the inlay and the wire. The inlay is configured to impart a force to cause flexure of the carrier member and therefore of the stimulating assembly, such as toward a curved configuration. In some embodiments, the inlay is composed of a resiliently flexible material and is pre-curved. Thus, a force (e.g., a compressive force) can be imparted onto the inlay to straighten the inlay. However, absent a force imparted onto the inlay, the inlay is configured to urge toward the pre-curved state, thereby urging the stimulating assembly into a corresponding curved configuration. In additional or alternative embodiments, the inlay is configured to curve upon a temperature increase above a threshold temperature, such as upon exposure to an elevated temperature (e.g., a body temperature of a recipient) and / or by directing an electrical current through the inlay. Thus, at above the threshold temperature, the inlay is configured to urge the stimulating assembly toward the curved configuration. In such embodiments, the inlay overcomes a resistance to flexure of the wire to facilitate flexure of the stimulating assembly.

[0078] Additionally, the longitudinally-elastic property of the inlay helps maintain a structural integrity of the inlay and / or of the wire. For instance, the non-straight portions of the inlay undergo slight deformations that collectively provide the desired amount of flexure to achieve the curved configuration of the stimulating assembly. Consequently, instead of a larger (e.g., permanent, plastic) deformation concentrated at a portion of the inlay, smaller (e.g., temporary, elastic) deformations can be distributed at different portions of the inlay, thereby avoiding permanent changes to the structural integrity of the inlay. Moreover, the non-straight portions of the inlay can absorb an increased amount of force imparted onto the stimulating assembly. As an example, the force is imparted during flexure of the stimulating assembly, such as to transition the stimulating assembly from the curved configuration to a straight configuration. By absorbing an increased amount of the force (e.g., a compressive load), the inlay reduces an amount of the force (e.g., a tensile load) imparted onto the wire. Consequently, a structuralintegrity of the wire can also be maintained. As such, the serpentine profile of the inlay helps maintain desirable transition of the stimulating assembly between the curved configuration and the straight configuration.

[0079] In some embodiments, the stimulating assembly is manufactured such that a distal region of the stimulating assembly is relatively more flexible. As an example, the inlay is embedded into the carrier member such that the inlay terminates prior to the distal region. As another example, the inlay extends into the distal region, but a geometry of the inlay is different than that at another region of the inlay. For instance, the inlay has a reduced thickness at the distal region relative to that of the inlay at a more proximal region of the inlay. Additionally or alternatively, the serpentine profde of the inlay includes a wavy geometry, and the waveform of the serpentine profde has an increased amplitude and / or an increased wavelength (e.g., a reduced pitch) at the distal region as compared to that of the inlay at the more proximal region. As a further example, the carrier member at the distal region has a reduced thickness to increase flexibility at the distal region. Increased flexibility of the stimulating assembly can improve ease of implantation, such as by using a sheath into which the stimulating assembly is inserted.

[0080] FIG. 12 illustrates an embodiment of a method 1250 for implanting a stimulating assembly into a cochlea of a recipient. At block 1252, a stimulating assembly having a carrier member with an inlay and a wire embedded therein is provided. The inlay is longitudinally- elastic to facilitate flexure of the stimulating assembly. For example, the inlay has a serpentine profde that includes sequential non-straight (e.g., bent, looped) portions.

[0081] At block 1254, the stimulating assembly is inserted into a cochlea of a recipient via a straight configuration of the stimulating assembly. For instance, the stimulating assembly is inserted into a sheath that places the stimulating assembly in the straight configuration. At block 1256, the stimulating assembly is deformed during insertion into the cochlea. Such deformation places the stimulating assembly into a curved configuration that follows the curvature of the cochlea for implantation.

[0082] In some embodiments, a force is applied to transition the stimulating assembly between the curved configuration and the straight configuration. The serpentine profde of the inlay enables the inlay to absorb an increased amount of the force, thereby reducing an amount of the force absorbed by the wire to maintain a structural integrity of the wire. Additionally, the deformation of the stimulating assembly during transition between the curved configuration and the straight configuration is achieved by slightly deforming the non-straight portions of theinlay. As such, the overall deformation is distributed to avoid a more permanent deformation of the inlay, thereby maintaining a structural integrity of the inlay. The improved stability of the inlay facilitates implantation of the stimulating assembly, such as to desirably position the stimulating assembly into the cochlea and / or to avoid having to discard a permanently deformed stimulating assembly.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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, twoor 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.

[0088] 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.

[0089] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments may be combined with another in any of a number of different manners.

Claims

CLAIMSWhat is claimed is:

1. An implantable component, comprising: a carrier member; and an elongate resiliently flexible inlay disposed within the carrier member, wherein the elongate resiliently flexible inlay is longitudinally-elastic to facilitate flexure of the carrier member without plastic deformation of the elongate resiliently flexible inlay.

2. The implantable component of claim 1, wherein the carrier member is composed of a silicone material.

3. The implantable component of claim 1, wherein the elongate resiliently flexible inlay is composed of a metal.

4. The implantable component of claim 1, 2, or 3, wherein the elongate resiliently flexible inlay comprises a plurality of sequential non-straight portions that repeatedly cross an extension axis of the elongate resiliently flexible inlay along the carrier member.

5. The implantable component of claim 4, wherein the plurality of sequential non-straight portions at a first region of the elongate resiliently flexible inlay crosses the extension axis along a plane, and wherein the extension axis of the elongate resiliently flexible inlay along the carrier member at a second region of the elongate resiliently flexible inlay extends along the plane.

6. The implantable component of claim 4, wherein the plurality of sequential non-straight portions at a first region of the elongate resiliently flexible inlay crosses the extension axis along a plane, and wherein the extension axis of the elongate resiliently flexible inlay along the carrier member at a second region of the elongate resiliently flexible inlay is transverse to the plane.

7. The implantable component of claim 1, 2, or 3, wherein a distal region of the implantable component is more flexible than a remainder of the implantable component.

8. The implantable component of claim 7, wherein the elongate resiliently flexible inlay terminates prior to the distal region of the implantable component.

9. The implantable component of claim 7, wherein the elongate resiliently flexible inlay comprises a plurality of sequential non-straight portions that define a plurality of waves, and wherein an amplitude and / or a wavelength of the plurality of waves is relatively greater at the distal region of the implantable component.

10. The implantable component of claim 7, wherein a thickness of the elongate resiliently flexible inlay and / or of the carrier member is reduced at the distal region of the implantable component.

11. The implantable component of claim 1, 2, or 3, further comprising: at least one elongate wire disposed in the carrier member.

12. A method of manufacturing an implantable medical device, comprising: providing an inlay with a serpentine profile; providing a wire with an electrode configured to deliver a stimulation signal; and embedding the inlay and the wire in a carrier member, wherein the carrier member is configured to flex, and wherein the serpentine profile of the inlay absorbs forces generated via flexure of the carrier member to reduce imparting of the forces onto the wire.

13. The method of claim 12, wherein the carrier member is composed of a silicone material, and wherein embedding the inlay and the wire in the carrier member comprises molding the silicone material around the inlay and the wire.

14. The method of claim 12, wherein the inlay is composed of a resiliently flexible material, and the method further comprises: pre-curving the inlay to cause the resiliently flexible material of the inlay to urge toward a curved configuration.

15. The method of claim 12, 13, or 14, wherein providing the inlay with the serpentine profile comprises forming a plurality of sequential non-straight portions that define a plurality of waves, and wherein an amplitude and / or a wavelength of the plurality of waves is relativelygreater at a distal region of the implantable medical device to increase flexibility of the distal region relative to a remainder of the implantable medical device.

16. A method of implanting an elongate stimulating assembly into a recipient, comprising: inserting the elongate stimulating assembly into a cochlea of the recipient in a straight configuration of the elongate stimulating assembly, wherein the elongate stimulating assembly comprises an elongate carrier member having an elongate inlay and a plurality of elongate wires disposed therein; and at least one of elongate stretching or compressing the elongate stimulating assembly during insertion of the elongate stimulating assembly into the cochlea of the recipient to transition the elongate stimulating assembly from the straight configuration to a curved configuration.

17. The method of claim 16, comprising: inserting the elongate stimulating assembly into a sheath; and straightening the sheath to place the elongate stimulating assembly in the straight configuration.

18. The method of claim 17, comprising: inserting the sheath into the cochlea of the recipient to insert the elongate stimulating assembly into the cochlea.

19. The method of claim 16, wherein the elongate inlay is composed of a resiliently flexible material configured to urge toward a curved configuration, and wherein the method further comprises: releasing the elongate stimulating assembly from the straight configuration during insertion of the elongate stimulating assembly into the cochlea of the recipient to urge the elongate stimulating assembly toward the curved configuration and cause the at least one of elongate stretching or compressing of the elongate stimulating assembly.

20. The method of claim 16, wherein the elongate inlay is composed of a shape memory material configured to curve upon a temperature increase above a threshold temperature, wherein insertion of the elongate stimulating assembly exposes the shape memory material to a body temperature of the recipient that increases a temperature of the shape memory materialabove the threshold temperature to cause curving of the elongate inlay and the at least one of elongate stretching or compressing of the elongate stimulating assembly.

21. The method of claim 16, 17, 18, 19, or 20, wherein the at least one of elongate stretching or compressing the elongate stimulating assembly comprises at least one of elongate stretching or compressing the elongate inlay, and wherein the elongate inlay is longitudinally-elastic to resist plastic deformation during the at least one of elongate stretching or compressing of the elongate inlay.

22. A stimulating assembly of an implantable medical device, comprising: a carrier member; a wire embedded in the carrier member; and an inlay embedded in the carrier member, wherein the inlay extends along a length of the carrier member and has a plurality of sequential non-straight portions connected to one another to cumulatively extend along an extension axis of the inlay.

23. The stimulating assembly of claim 22, wherein the plurality of sequential non-straight portions defines a plurality of waves, and wherein an amplitude and / or a wavelength of the plurality of waves is varies along the inlay.

24. The stimulating assembly of claim 23, wherein the amplitude and / or the wavelength of the plurality of waves at a distal region of the stimulating assembly is greater than the amplitude and / or the wavelength, respectively, of the plurality of waves at a proximal region of the stimulating assembly.

25. The stimulating assembly of claim 22, wherein the inlay is composed of a shape memory material configured to curve upon a temperature increase above a threshold temperature.

26. The stimulating assembly of claim 22, wherein the inlay is pre-curved such that flexure of the stimulating assembly to straighten the stimulating assembly imparts a compressive load onto the inlay.

27. The stimulating assembly of claim 26, wherein the plurality of sequential non-straight portions is configured to deform to distribute the compressive load and avoid buckling of the inlay.

28. The stimulating assembly of claim 22, 23, 24, 25, 26, or 27, wherein the inlay is composed of a resiliently flexible polymer material.

29. The stimulating assembly of claim 28, wherein the resiliently flexible polymer material comprises silicone.

30. The stimulating assembly of claim 22, 23, 24, 25, 26, or 27, wherein the plurality of sequential non-straight portions is configured to reduce a tensile load on the wire during flexure of the stimulating assembly.

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