Implantable stimulation components

Abstract

Embodiments of the present disclosure relate to an implantable stimulation assembly. An electrode array includes a plurality of electrodes and an electrode carrier carrying the plurality of electrodes, wherein the electrode carrier is made of a viscoelastic material (such as, by way of example, viscoelastic silicone), wherein in some embodiments, the electrode carrier is free of non-viscoelastic silicone. In exemplary embodiments, the electrode carrier is configured to return from a substantially flat state to a curved, unconstrained, and relaxed state in no less than thirty seconds.

Description

[0001] This application is a divisional application of the invention patent application with an international application date of October 28, 2016, which entered the Chinese national phase on April 28, 2018, with Chinese national application number 201680063832.5 and invention name “Implantable Stimulation Component”. Background Art

[0002] Hearing loss, which can occur for many different reasons, is generally classified into two types: conductive and sensorineural. Sensorineural hearing loss is due to the loss or destruction of hair cells in the cochlea that transduce sound signals into nerve impulses. Various hearing prostheses are commercially available to improve the ability of individuals with sensorineural hearing loss to perceive sound. One example of a hearing prosthesis is a cochlear implant.

[0003] Conductive hearing loss occurs when the normal mechanical pathway that provides sound to the hair cells in the cochlea is blocked (for example, by damage to the ossicular chain or the ear canal). Because the hair cells in the cochlea may remain intact, individuals who experience conductive hearing loss may retain some form of residual hearing.

[0004] Individuals with conductive hearing loss typically receive acoustic hearing aids. Hearing aids rely on the principle of air conduction to transmit acoustic signals to the cochlea. Specifically, hearing aids typically use a device located in the ear canal or on the outer ear to amplify the sound received by the outer ear. This amplified sound reaches the cochlea, causing movement of the perilymph and stimulation of the auditory nerve.

[0005] In contrast to hearing aids, which rely primarily on the principles of air conduction, certain types of hearing prostheses, often referred to as cochlear implants, convert received sound into electrical stimulation. The electrical stimulation is applied to the cochlea, which produces the perception of the received sound. Summary of the Invention

[0006] In an exemplary embodiment, there is an electrode array comprising a plurality of electrodes and an electrode carrier carrying the plurality of electrodes, wherein the electrode carrier is made of a viscoelastic material.

[0007] In an exemplary embodiment, there is a method comprising: obtaining an implantable component and inserting the implantable component into a recipient, wherein after the implantable component is fully inserted, the implantable component transforms from a first geometry to a second geometry without release of an external force causing the transformation, release of an external pressure, a reaction force, mass transfer, and a net energy transfer.

[0008] According to another exemplary embodiment, there is a method comprising: obtaining a curved electrode array assembly; inserting a first portion of the electrode array assembly into a human cochlea in a deformed state deformed from a relaxed, unconstrained state of the electrode array assembly such that the first portion corresponds to a portion of the electrode array assembly that extends the electrode array assembly a first distance from a tip of the electrode array to a position in the cochlea proximate to the tip; and inserting the portion of the electrode array constituting the first distance into the cochlea at a first angular depth, wherein the first portion of the electrode array assembly achieves a second angular insertion depth greater than the first angular insertion depth after the first portion constituting the first distance is in the cochlea.

[0009] According to another exemplary embodiment, there is an electrode array comprising a body carrying electrodes, wherein the body is configured to elastically expand in a radial direction relative to its longitudinal axis after insertion into a recipient without any mass transfer into the expanded portions of the body, wherein the body is configured such that the body can expand from a compressed diameter perpendicular to the longitudinal axis to a diameter of at least 1.5 times the compressed diameter within a time period of not less than about 30 seconds from the time of release from full compression. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] With reference to the accompanying drawings, embodiments of the present invention are described below, in which:

[0011] Figure 1A is a perspective view of an exemplary hearing prosthesis utilized in some exemplary embodiments;

[0012] Figure 1B yes Figure 1A a side view of an implantable component of a cochlear implant as illustrated;

[0013] Figure 2 yes Figure 1A and Figure 1B A side view of an embodiment of the electrode array is shown in a curled orientation;

[0014] Figure 3A is a functional schematic diagram of an electrode array including 22 electrodes spaced apart from each other;

[0015] Figure 3B is a functional schematic diagram of an exemplary embodiment of a portion of an electrode array;

[0016] Figure 3C yes Figure 3B A functional schematic diagram of an exemplary embodiment shown in a bent state;

[0017] Figure 4is a cross-sectional view of an exemplary electrode array according to an exemplary embodiment;

[0018] Figure 5 which provides additional details Figure 2 A side view of an exemplary electrode array;

[0019] Figure 6 An exemplary flow chart of an exemplary method according to an exemplary embodiment is presented;

[0020] Figure 7 is a cross-sectional view of another exemplary electrode array according to an exemplary embodiment;

[0021] Figure 8 presents an exemplary flow chart of another exemplary method according to an exemplary embodiment;

[0022] Figure 9 Another exemplary flow chart of an exemplary method according to an exemplary embodiment is presented;

[0023] Figure 10A and Figure 10B depicts a side view of an electrode array in a first geometry after its insertion into the cochlea;

[0024] Figure 11A and Figure 11B depicts a side view of the electrode array of a second geometry after its insertion into the cochlea;

[0025] Figure 12 depicts side views of an electrode array of a first geometry and an electrode array of a second geometry after insertion thereof into the cochlea for comparison purposes;

[0026] Figure 13 is a cross-sectional view of another exemplary electrode array according to an exemplary embodiment;

[0027] Figure 14 It is in a compressed state Figure 13 a cross-sectional view of an electrode array; and

[0028] Figure 15 is a cross-sectional view of another exemplary electrode array according to an exemplary embodiment. DETAILED DESCRIPTION

[0029] Figure 1A is a perspective view of a fully implantable cochlear implant, referred to as cochlear implant 100, according to an exemplary embodiment. Cochlear implant 100 is part of a system 10, which may, in some embodiments, include external components as will be described in detail below.

[0030] In an alternative embodiment, the cochlear implant system is not a fully implantable system. By way of example, the cochlear implant system includes an external component that includes a microphone and a sound processor. The sound processor processes the signal from the microphone and generates a signal that is transmitted transcutaneously to the implantable component, which then uses the signal to stimulate tissue and evoke hearing perception.

[0031] It should be noted that in some conventional parlance, the entire system 10 is referred to as a cochlear implant, particularly in the case of a non-fully implantable cochlear implant. Herein, the phrase "cochlear implant" refers to the implantable component, while the phrase "cochlear implant system" refers to the entire system 10. That is, the phrase "cochlear implant" corresponds to the implantable component of a non-fully implantable cochlear implant system.

[0032] The recipient has an outer ear 101, a middle ear 105, and an inner ear 107. Components of the outer ear 101, the middle ear 105, and the inner ear 107 are described below, followed by a description of the cochlear implant 100.

[0033] In a fully functioning ear, the outer ear 101 includes the pinna 110 and the ear canal 102. Sound pressure or sound waves 103 are collected by the pinna 110 and directed into and through the ear canal 102. Disposed across the distal end of the ear canal 102 is the eardrum 104, which vibrates in response to the sound waves 103. This vibration is coupled to the oval or elliptical window 112 via three bones of the middle ear 105 (collectively referred to as the ossicles 106, and including the malleus 108, the incus 109, and the stapes 111). The bones 108, 109, and 111 of the middle ear 105 act to filter and amplify the sound waves 103, causing the oval window 112 to pivot or vibrate in response to the vibrations of the eardrum 104. This vibration sets up waves of fluid movement in the perilymph within the cochlea 140. In turn, this fluid movement activates tiny hair cells (not shown) inside the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transmitted through spiral ganglion cells (not shown) and the auditory nerve 114 to the brain (also not shown) where they are perceived as sound.

[0034] As shown, cochlear implant 100 includes one or more components that are temporarily or permanently implanted in a recipient. Figure 1A 1 , cochlear implant 100 is shown with an external device 142 that is part of system 10 (along with cochlear implant 100 ) and that is configured to provide power to the cochlear implant as described below.

[0035] exist Figure 1AIn the illustrative arrangement of FIG, the external device 142 may include a power source (not shown) disposed in the behind-the-ear (BTE) unit 126. The external device 142 also includes components of a transcutaneous energy transfer link (referred to as an external energy transfer assembly). The transcutaneous energy transfer link is used to transfer power and / or data to the cochlear implant 100. Various types of energy transfer (such as infrared (IR), electromagnetic, capacitive, and inductive transfer) may be used to transfer power and / or data from the external device 142 to the cochlear implant 100. Figure 1A In the illustrative embodiment of the invention, the external energy transfer assembly includes an external coil 130 that forms part of an inductive radio frequency (RF) communication link. The external coil 130 is typically a wire antenna coil composed of multiple turns of electrically insulated single / multi-strand platinum or gold wire. The external device 142 also includes a magnet (not shown) located within the multiple turns of wire of the external coil 130. It should be appreciated that Figure 1A The external devices shown are illustrative only, and other external devices may be used with embodiments of the present invention.

[0036] Cochlear implant 100 includes an internal energy delivery assembly 132 that can be located in a recess of the temporal bone adjacent to the recipient's pinna 110. As described in detail below, internal energy delivery assembly 132 is a component of a transcutaneous energy delivery link and receives power and / or data from an external device 142. In the illustrated embodiment, the energy delivery link comprises an inductive RF link, and internal energy delivery assembly 132 includes a primary internal coil 136. Internal coil 136 is typically a wire antenna coil composed of multiple turns of electrically insulated single / multi-strand platinum or gold wire.

[0037] Cochlear implant 100 also includes a main implantable component 120 and an elongated stimulation assembly 118. In an embodiment of the present invention, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In an embodiment of the present invention, main implantable component 120 includes a sound processing unit (not shown) that converts sound signals received by an implantable microphone in internal energy transfer assembly 132 into data signals. Main implantable component 120 also includes a stimulator unit (also not shown) that generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongated stimulation assembly 118.

[0038] The elongated stimulation assembly 118 has a proximal end connected to the main implantable component 120 and a distal end implanted in the cochlea 140. The stimulation assembly 118 extends from the main implantable component 120 to the cochlea 140 through the mastoid bone 119. In some embodiments, the stimulation assembly 118 can be implanted at least in the basal region 116, and sometimes deeper. For example, the stimulation assembly 118 can extend toward the top of the cochlea 140, referred to as the cochlear apex 134. In some cases, the stimulation assembly 118 can be inserted into the cochlea 140 via a cochlear fenestration 122. In other cases, the cochlear fenestration can be formed by the round window 121, the oval window 112, the promontory 123, or by the apical perimeter 147 of the cochlea 140.

[0039] The stimulation assembly 118 includes a longitudinally aligned and distally extending array 146 of electrodes 148 that are arranged along its length. As noted, the stimulator unit generates stimulation signals that are applied to the cochlea 140 through stimulation contacts 148 (which are electrodes in the exemplary embodiment), thereby stimulating the auditory nerve 114. In an exemplary embodiment, the stimulation contacts can be any type of component that stimulates the cochlea (e.g., a mechanical component, such as a piezoelectric device that moves or vibrates to stimulate the cochlea (e.g., by causing movement of fluid in the cochlea), an electrode that applies an electric current to the cochlea, etc.). The embodiments detailed herein will be described in terms of an electrode assembly 118 that utilizes electrodes as elements 148. It should be noted that alternative embodiments may utilize other types of stimulation devices. Any device, system, or method that stimulates the cochlea may be utilized in at least some embodiments.

[0040] As noted, cochlear implant 100 comprises a fully implantable prosthesis that is capable of operating, at least for a period of time, without the need for external device 142. Accordingly, cochlear implant 100 also includes a rechargeable power source (not shown) that stores power received by external device 142. The power source may comprise, for example, a rechargeable battery. During operation of cochlear implant 100, the power stored by the power source is distributed to various other implanted components as needed. The power source may be located in main implantable component 120 or provided in a separate implant location.

[0041] It should be noted that the teachings detailed herein and / or variations thereof may be utilized with non-fully implantable prostheses. That is, in alternative embodiments of the cochlear implant 100, the cochlear implant 100 and corresponding system 100 are conventional hearing prostheses.

[0042] While various aspects of the present invention are described with reference to cochlear implants (whether utilizing electrodes or devices utilizing stimulation contacts that impart vibrations and / or mechanical fluid motion within the cochlea), it should be understood that various aspects of the embodiments detailed herein are equally applicable to other stimulatory medical devices having arrays of electrical stimulation electrodes (such as auditory brain implants (ABIs), functional electrical stimulation (FES), spinal cord stimulation (SCS), penetrating ABI electrodes (PABIs), etc.). Furthermore, while the embodiments disclosed herein are directed to electrodes, it should be noted that in other embodiments, the teachings detailed herein may be applicable to non-electrical stimulation, such as, by way of example and not limitation, optical stimulation, magnetic stimulation, etc. Indeed, in exemplary embodiments, induction coils are used to stimulate tissue (e.g., tissue within the cochlea) in place of or in addition to electrodes. Furthermore, it should be noted that the embodiments disclosed herein are not limited to application to hearing prostheses. For example, the teachings detailed herein may be applicable to retinal stimulation, skin stimulation, etc. Further, it should be noted that the teachings detailed herein are applicable to deep brain stimulation, and thus exemplary embodiments include deep brain stimulator assemblies utilizing the teachings detailed herein. Further, it should be noted that the teachings herein are applicable to stimulating medical devices having all types of electrical stimulation electrodes (such as straight electrodes, peripheral modiolar electrodes, and short / basal electrodes). Also, various aspects of the embodiments detailed herein and / or variations thereof are applicable to devices that are non-stimulatory and / or have functionality different from stimulating tissue, such as, for example, any in vivo dynamic phenomenon (e.g., pressure, or other phenomenon consistent with the teachings detailed herein) measurement / sensing, etc., which may include using these teachings to sense or otherwise detect phenomena at locations other than the cochlea (e.g., within a cavity containing the brain, the heart, etc.). Additional embodiments may be applicable to bone conduction devices, direct acoustic cochlear stimulators / middle ear prostheses, and conventional acoustic hearing aids. Any device, system, or method that evokes auditory perception may be used in conjunction with the teachings detailed herein. The teachings detailed herein may be applicable to any device, system, or method in which positioning of an elongated lead having spring properties, etc., is of practical value.

[0043] Still focusing on cochlear implants, Figure 1B1 is a side view of cochlear implant 100 without other components (e.g., external components) of system 10. Cochlear implant 100 includes receiver / stimulator 180 (a combination of main implantable component 120 and internal energy delivery assembly 132) and elongated stimulation assembly 118. Stimulation assembly 118 includes: a helical region 182, which includes a body 183 in which electrical lead wires 189 (more on this below) are embedded (e.g., if the body is silicone or another biocompatible material molded around the lead wires) or otherwise contained (e.g., if the body is a catheter or tube); a transition region 184 (which can be part of the body 183); a proximal region 186; and an intra-cochlear region 188. In this embodiment, proximal region 186 is connected to transition region 184 via a distinct connection 185, but in other embodiments, the transition region is blended into helical region 182 (and proximal region 186). The proximal region 186 and the intracochlear region 188 form an electrode array 190. The portion of the stimulation assembly 118 extending from the receiver / stimulator 180 to the electrode array 190 is referred to herein as a lead assembly. Figure 1A 181 in the figure. In an exemplary embodiment, after the intracochlear region 188 is implanted in the cochlea, the proximal region 186 is located in the middle ear cavity of the recipient. Thus, the proximal region 186 corresponds to the middle ear cavity subsegment of the stimulation assembly 118. In some exemplary embodiments, a bump 187 is provided on the outer surface of the proximal region to assist in manipulating the electrode array assembly 190 during insertion of the intracochlear region into the cochlea. The electrode array assembly 190 (and in particular the intracochlear region 188 of the electrode array assembly 190) supports a plurality of electrode contacts 148. Each of these electrode contacts 148 is connected to a corresponding conductive pathway, such as a wire, PCB trace, etc. (not shown, which is connected to the receiver / stimulator 180), through which a corresponding stimulation electrical signal for each electrode contact 148 travels.

[0044] It should be noted that in some embodiments, the helix region 182 does not extend as far as Figure 1A 184. In some exemplary embodiments, the helix region 182 extends substantially not as far as depicted, and the transition region 184 is therefore longer. That is, in some exemplary embodiments, the helix region 182 does not extend substantially the full length between the receiver / stimulator 180 and the proximal region 186, but rather extends less than that full length (e.g., approximately half the distance), with the remaining distance being established by a substantially straight lead wire, or at least a wire that is not substantially coiled. Any arrangement of lead wires that enables practice of the teachings detailed herein and / or variations thereof may be utilized in some exemplary embodiments.

[0045] Figure 2is a side view of a portion of the stimulation assembly 118 with the electrode array of the electrode array assembly 190 in a curled orientation, as would be the case when inserted into the cochlea of ​​a recipient, with the electrode contacts 148 located on the inside of the curve.

[0046] It should be noted that this is for example only and not for limitation. Figure 1B and Figure 2 It can be a curved electrode stimulation component, or a mid-level component that assumes a mid-level position during or after implantation.

[0047] Figure 3A A more detailed view of an exemplary electrode array 146 is shown, functionally including a plurality of electrodes 148 labeled 1 through 22, in accordance with an embodiment. In the exemplary embodiment, each electrode 148 corresponds to a specific frequency band channel of the cochlear implant 100, with electrode 22 corresponding to the lowest frequency band (channel) and electrode 1 corresponding to the highest frequency band (channel). In short, it should be noted that during the period of evoked hearing perception during electrode stimulation, one or more electrodes 148 are activated at a given electrode stimulation level (e.g., current level).

[0048] In an exemplary embodiment, the electrode array assembly 190 includes at least one intra-cochlear region, wherein the carrier of the electrode 148 (electrode carrier) is made of a viscoelastic material. In an exemplary embodiment, the carrier of the electrode 148 is made of a viscoelastic polyurethane foam, which in some embodiments may be memory foam, polyurethane with additional chemicals that increase the viscosity and density of the material, such as materials used in earplugs, etc. In an exemplary embodiment, the electrode carrier is made of viscoelastic silicone (as distinguished from non-viscoelastic silicones, such as Nusil's 48 series medical grade liquid silicone rubber).

[0049] In an exemplary embodiment, the electrode carrier is made of a material that, on a per unit volume basis, exhibits a higher viscosity, all other conditions being equal (e.g., temperature (both the environment of the material and the temperature)), than the same electrode carrier made of conventional silicone-like and rubber-like materials that are commonly used in medical implants approved by the U.S. Food and Drug Administration since May 13, 2010, or, in some other embodiments, are part of cochlear implants that are inserted into the cochlea and permanently remain in the cochlea.

[0050] "Made of" means that the component in question comprises at least 50.1% by weight of the material in question (excluding impurities). In exemplary embodiments, the component in question is composed of at least 60%, 70%, 80%, 90%, or 100% by weight of the material in question (excluding impurities).

[0051] In exemplary embodiments, the viscosity characteristics of the material from which the electrode carrier is made (or characteristics equivalent to or similar to the viscosity characteristics in some other embodiments) have the following viscosity characteristics on a per volume basis, all other conditions being equal: at least about 50%, 75%, 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 700%, 800%, 900%, 1000%, 1500%, 2000%, 2500%, 3000%, 3500%, 4000%, 4500%, 5000%, 5500%, 6000%, 7000%, 8000%, 9000%, 10000%, 15000%, 20000%, 25000%, 30000%, 35000%, 40000%, 45000%, 50000%, 55000%, 60000%, 70000%, 80000%, 90000%, 100000%, 15 ... 00%, 1100%, 1200%, 1300%, 1400%, 1500%, 1600%, 1700%, 1800%, 1900%, or 2000%, or any value or range of values ​​therebetween in 1% increments (e.g., 451%, 33%, 180% to 1776%, etc.) that is greater than the viscosity characteristic of the non-viscoelastic silicone and / or non-viscoelastic rubber and / or Food and Drug Administration approved silicone resin(s) referenced above.

[0052] That is, in alternative embodiments, the electrode array comprises a viscoelastic material. In some embodiments, the viscoelastic material is utilized at strategic locations. For example, Figure 3B A portion of an exemplary electrode array is functionally depicted, comprising a carrier made of a non-viscoelastic material at segment 322 and a viscoelastic material at segment 323, the viscoelastic material being in a constrained / deformed state. Figure 3C As can be seen from the above, it means that after removing the constraints Figure 3B In the embodiment of the present invention, the viscoelastic section 323 expands, while the non-viscoelastic section 322 does not expand (or expands very little). Here, the electrode carrier is such that the amount of viscoelastic material is less than 50% by weight. Some embodiments include any use of viscoelastic materials to implement the teachings and / or variations thereof detailed herein.

[0053] Figure 3B Also functionally depicted are electrical leads / wires (designated by reference numeral 343) that communicate signals between the electrodes 148 and the receiver stimulator. In at least some embodiments, the leads 343 are non-stretchable (at least compared to silicone) and thus, in at least some embodiments, will maintain the same length during bending. Thus, in some embodiments, the leads can establish a neutral bend line and thus, outside of the bend line (e.g., Figure 3B The carrier material of the lead 343 in the right side) is compressed during straightening, and the carrier material inside (e.g., Figure 3B In some exemplary embodiments, the local viscoelastic material component will be at least substantially (including completely) on the outside, or at least greater than 50% (by weight) on the outside, or at least 75% (by weight) on the outside, thereby restoring the array's compression to a bend.

[0054] Thus, in an exemplary embodiment, there is an electrode array (such as Figure 1B The electrode array 190 includes a plurality of electrodes (such as the electrode 148) and an electrode carrier (such as Figure 4 491) depicted in the figure, which is connected to the carrier 491 through Figure 1B 4-4 of FIG. 1 . In this exemplary embodiment, the electrode carrier (e.g., 491) is made of a viscoelastic material. In an exemplary embodiment, the non-metallic and / or non-conductive portion of the electrode array 190 corresponding to the intracochlear region 188 (such as the electrode carrier portion) is made of a viscoelastic material.

[0055] In an exemplary embodiment, electrode carrier 491 and / or any portion of the electrode array designated as viscoelastic above and / or described in detail below is made of viscoelastic silicone. In an exemplary embodiment, the electrode carrier of electrode array 190 and / or any portion of the electrode array designated as viscoelastic above and / or described in detail below is free of non-viscoelastic silicone.

[0056] In an exemplary embodiment, the electrode array utilizes non-viscoelastic silicone and / or non-viscoelastic non-metallic components. By way of example only and not limitation, in an exemplary embodiment, the proximal region of the electrode array 190 is made of non-viscoelastic silicone and the intra-cochlear region 188 is made of viscoelastic silicone. Further, with reference to Figure 3B , portions of the carrier made of non-viscoelastic silicone (eg, portion 322 ) are at least partially separated by portions made of viscoelastic silicone (or some other material), such as portion 323 .

[0057] In an exemplary embodiment, at least a portion of the intra-cochlear region 188 of the electrode array and / or at least a portion of the electrode carrier of the intra-cochlear region 188 is made of viscoelastic silicone. Figure 5 An exemplary embodiment is depicted in which the first portion 588' is not made of viscoelastic silicone and the second portion 588" is made of viscoelastic silicone. It should also be noted that the demarcation between the first portion 588' and the second portion 588" can be abrupt / precise and can also be more blended, as indicated by way of example by demarcation area 501. Furthermore, it should be noted that in exemplary embodiments, as Figure 5 The portion of the electrode array that is not made of viscoelastic silicone may extend into the proximal region 186 (the portion that is not inserted into the cochlea), as indicated by region 588" in FIG.

[0058] from Figure 1B and Figure 2It can be seen that in the exemplary embodiment, electrode array 190 in general (and intracochlear region 188 in particular, and in particular, the electrode carrier of intracochlear region 188 in particular) has a curved configuration in an unconstrained, fully relaxed state. Furthermore, electrode array 190 in general (and intracochlear region 188 in particular, and in particular, the electrode carrier of intracochlear region 188 in particular) is configured to return to a curved state from a substantially straight (including straight) state (this is "automatic" upon removal of the force that created the substantially straight state). Due to the viscoelastic material utilized in at least some exemplary embodiments, the electrode array 190 in general (and in particular the intracochlear region 188, and in particular the electrode carrier of the intracochlear region 188) is configured to recover from a substantially straight state resulting from a restraining force on the electrode array (which force is removed, thereby initiating the above time periods upon removal) to a curved state in an unconstrained, relaxed state in some embodiments within 30 seconds or more, in some embodiments within 1 minute or more, in some embodiments within 1.5 minutes or more, in some embodiments within 2 minutes or more, in some embodiments within 2.5 minutes or more, in some embodiments within 3 minutes or more, in some embodiments within 3.5 minutes or more, and in some embodiments within 4 minutes or more. In an exemplary embodiment, the curved electrode array is an array that subtends an angle of at least 45 degrees in the unconstrained, relaxed state. In an exemplary embodiment, the curved electrode array is an array that subtends an angle of at least 90 degrees in the unconstrained, relaxed state. In an exemplary embodiment, the curved electrode array is an array that subtends an angle of at least 135 degrees in the unconstrained, relaxed state. In an exemplary embodiment, the curved electrode array is an array that subtends an angle of at least 180 degrees in an unconstrained, relaxed state. In an exemplary embodiment, the curved electrode array is an array that subtends an angle of at least 45 degrees, 60 degrees, 90 degrees, 210 degrees, 250 degrees, 275 degrees, 300 degrees, 330 degrees, 360 degrees, 390 degrees, 410 degrees, or greater, or any value therebetween in 1-degree increments (e.g., 100 degrees, 67 degrees, 177 degrees, etc.), in an unconstrained, relaxed state.

[0059] In an exemplary embodiment, the curved electrode array is configured such that after the curved electrode array is deformed from its unconstrained relaxed state by placing at least the intracochlear portion of the electrode array in a tube (or simply by the fact that it is actually placed in the tube) and maintained therein for a time period of between about 1.5 minutes and about 7 minutes, or at least 2 minutes, 3 minutes, 4 minutes or 5 minutes, the above-mentioned time characteristics and bending characteristics are achieved after being completely removed from the tube, the tube having a constant inner diameter of no more than 3 mm, no more than 2.5 mm, no more than 2.0 mm, no more than 1.5 mm or no more than 1 mm, and having a length that is longer than the intracochlear portion of the electrode array and is effectively undeformed by forces applied to the electrode array seeking to return to its relaxed state (for example, the tube can be a stainless steel tube made of surgical stainless steel with a wall thickness of 5 mm).

[0060] Thus, in an exemplary embodiment, there is an electrode array configured such that after implanting an intracochlear region thereof in one or more of the tubes described above and maintaining the intracochlear region therein at 80 degrees Fahrenheit and one atmosphere and at a humidity level of 50% for at least five minutes, following complete removal of the intracochlear region from the tubes, the intracochlear region spends at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 75 seconds, at least 1.5 minutes, at least 2 minutes, at least 2.5 minutes, at least 3 minutes, at least 3.5 minutes, at least 4 minutes, at least 4.5 minutes, or at least 5 minutes or more, in an unconstrained, relaxed state, subtending an angle of at least 45 degrees, 60 degrees, 90 degrees, 210 degrees, 250 degrees, 275 degrees, 300 degrees, 330 degrees, 360 degrees, 390 degrees, 410 degrees, or more, or any value therebetween in 1 degree increments (100 degrees, 67 degrees, 177 degrees, etc.).

[0061] In an exemplary embodiment, the aforementioned electrode array has such dimensions that, in a relaxed, unconstrained state, the maximum outer diameter of the electrode carrier at a position adjacent to the proximal-most electrode is between about 1.1 mm and 0.15 mm, or no greater than about 1.0 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, or any value or range of values ​​therebetween in increments of 0.01 mm, and the maximum outer diameter of the electrode carrier at a position adjacent to the distal-most electrode does not exceed about 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, or 0.1 mm, or any value or range of values ​​therebetween in increments of 0.01 mm.

[0062] Figure 6An exemplary flow chart 600 of an exemplary method according to an exemplary embodiment is presented. The method 600 includes a method act 610 that entails obtaining an implantable component, such as, by way of example and not limitation, the entire implant 144 or at least the elongated array 118 thereof or at least the electrode array 190 (see Figure 1B ). Method 600 also includes method act 610, which entails inserting the implantable component into the recipient (which may be accomplished by implanting the electrode array 190 into the cochlea (i.e., into the intracochlear region 188)). Method 600 is performed using implant 144, which is configured such that following full insertion of the implantable component (relative to implant 144, following final placement of the intracochlear region into the cochlea, as described below) Figure 10A and Figure 10B ), the implantable component changes from a first geometric shape to a second geometric shape (as shown, for example, below Figure 11A and Figure 11B ) without any external force release, external pressure release, reaction force, mass transfer, or net energy transfer to cause and / or establish the transformation. In an exemplary embodiment, this is achieved due to the viscoelastic properties of the electrode carrier. In an exemplary embodiment, the transformation from the first geometry to the second geometry is entirely a result of the elastic material being free of metal.

[0063] No external force release means that the transformation does not start from and / or is not established by the removal or relaxation of forces applied to the electrode carrier, such as, for example, the forces generated when a so-called stylet is removed from the intracochlear part of the electrode array. In this respect, Figure 7 An exemplary embodiment of an electrode array including a stylet 192 is depicted ( Figure 7 and Figure 4 Accordingly, in addition to the addition of stylet 192 ), method 600 may be practiced with or without an electrode array utilizing a stylet, as long as the above-described characteristics of the transformation result in addition to any transformation resulting from removal of the stylet (partial or complete).

[0064] No external pressure release means that the transformation does not originate from and / or is not established by the removal or relaxation of pressure applied to the electrode carrier, such as, for example, the pressure generated when the electrode array is removed from a so-called insertion sheath. No mass transfer means that the transformation does not originate from and / or is not established by a component of the electrode array being transported therefrom, such as, for example, a component resulting from a portion of the electrode array dissolving.

[0065] By absence of a reaction force, it is meant that the transformation does not originate from and / or is not established by a force that reacts to a surface (e.g., the surface of the recipient, the surface of the electrode array, etc.), such as, for example, a force generated when a portion of the electrode array pops out or otherwise extends into contact with a portion of the cochlea so as to "push" the position of the electrode array from a position that existed prior to the application of the force.

[0066] No net energy transfer means that the transformation does not begin with and in some instances is not produced by a net change in energy transfer to or from the electrode array, such as, for example, a net change in energy transfer produced when a portion of the electrode array heats or cools from its temperature when the electrode array is fully inserted into the cochlea.

[0067] In an exemplary embodiment, the action of transforming from a first geometric shape to a second geometric shape is performed without moving any components relative to the implant that initiates and / or establishes the transformation. In an exemplary embodiment, no stylet is moved or otherwise removed such that the transformation is initiated. In an exemplary embodiment, no insertion sheath (or any sheath for that matter) is moved or otherwise removed such that the transformation is initiated.

[0068] It should be noted that the first geometric shape is not necessarily a constrained geometric shape. Figure 7 , the stylet is located in at least a portion of the electrode array during at least a portion of the process of insertion of the electrode array into the cochlea. In this regard, in exemplary embodiments, the electrode array is inserted in a third geometry that is different from the first geometry and the second geometry. In exemplary embodiments, after the stylet is removed, the electrode array transforms from the third geometry (the geometry associated with the presence of the stylet in the electrode array) to the first geometry as a result of the stylet generally forcing the array to be straighter / less curved than it would otherwise be, all things being equal, and the viscoelastic properties of the electrode array initiate the transition and / or establish the transformation from the first geometry to the second geometry. This may also be the case in scenarios utilizing an insertion sheath or the like. The important point is that the first geometry is not necessarily the insertion geometry. In practice, in scenarios where the electrode array is inserted such that the outside of the curved array (the side away from the "center" around which the curved array extends / the side away from the electrode if the electrode does not extend completely around the outer circumference of the electrode array) and / or the tip of the array contacts the side wall of the cochlea, the insertion force will very often drive the electrode array into a geometry away from the insertion geometry (in at least some exemplary embodiments, the driven geometry is the aforementioned first geometry). Conversely, in embodiments where the insertion process causes the curved array to extend into the cochlea during the insertion process such that the curved array does not contact any of the walls in the cochlea, the insertion geometry can be the aforementioned first geometry.

[0069] In an exemplary embodiment, the electrode array is configured such that the recovery time from the third geometry to the first geometry and / or the second geometry is sufficient for a surgeon to insert the electrode array into the cochlea in a geometry that corresponds to and / or substantially corresponds to the third geometry and / or is "between" the third geometry and the first geometry. In an exemplary embodiment, this provides sufficient time for the tip of the electrode array to reach the posterior portion of the basil turn of the cochlea, thereby avoiding tip collapse.

[0070] In view of the above, in exemplary embodiments, it should be understood that with respect to method 600, the implantable component is a cochlear electrode array (e.g., array 190), and the act of inserting the implantable component into a recipient (method act 620) entails inserting the implantable component into a cochlea (e.g., a cochlea of ​​a human recipient). The first geometry is a curved geometry that is at least partially caused by the curvature of the cochlea (e.g., the electrode array contacts the sidewall of the cochlea, thereby deforming the electrode array from its geometry before the electrode array contacts the sidewall of the cochlea). In exemplary embodiments, the second geometry is a curved geometry that has an average radius of curvature that is lower than the average radius of curvature of the first geometry (e.g., the average radius of curvature within the first distance indicated above, or the average radius of curvature within a distance extending from the inner wall of the cochlea at the point where the electrode array enters the cochlea to the apex of the cochlea, etc.).

[0071] In view of the above, in exemplary embodiments of method 600, where the implantable component is a cochlear electrode array, the act of inserting the implantable component into the recipient (the act of inserting the electrode array into the cochlea) entails inserting the implantable component into the cochlea of ​​the recipient in a third geometry, wherein the first geometry is a curved geometry that is at least partially caused by the curvature of the cochlea (e.g., due to resistance from the sidewalls and the insertion geometry), and the third geometry is one of a substantially straight geometry or a negatively curved geometry relative to the curved geometry of the first geometry (it should be noted that this third geometry is not necessarily the insertion geometry - more on this below). In this regard, in exemplary embodiments, method 600 entails obtaining an electrode array that, in at least some exemplary embodiments, has a relaxed curved state such that the electrode array is substantially straight relative to the first geometry. Figure 1B and Figure 2In other words, the electrode array is bent so that the electrodes "see" each other more. Method 600 also requires deforming the electrode array from this relaxed bent state to a straight / substantially straight configuration (or the method requires obtaining an electrode array with this straight / substantially straight geometry). In an alternative embodiment, method 600 also requires deforming the electrode array from this relaxed bent state to a negatively bent state (or obtaining an electrode array in this negatively bent state), wherein the electrode array is bent relative to Figure 1B and Figure 2 The reference frame is curved clockwise. In other words, the electrodes see "less" of each other, just as the curvature of the Earth causes a person to see less structure because the Earth's curvature obscures some or all of the structure. In exemplary embodiments, there can be practical value in deforming the electrode array to a negative curvature because, in at least some exemplary embodiments, the time between releasing the force applied to the electrode array to position the electrode array and / or maintain the electrode array in the negatively curved geometry and the moment the electrode array returns to its relaxed state is longer than the time between releasing the force applied to the electrode array to position the electrode array and / or maintain the electrode array in the substantially straight geometry and the moment the electrode array returns to its relaxed state (e.g., due to, for example, the increased strain of the viscoelastic material associated with deforming it further from its relaxed configuration). In exemplary embodiments, the former is at least about 1.1 times, 1.2 times, 1.3 times, 1.4 times, 1.5 times, 1.6 times, 1.7 times, 1.8 times, 1.9 times, or 2 times or more the latter.

[0072] In an exemplary embodiment, the negative curvature is the curvature resulting from the electrode array subtending an angle opposite to the angle of its relaxed state (but not necessarily the same value). In an exemplary embodiment, the negative curvature can result in the electrode array subtending an angle greater than 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, 140 degrees, 150 degrees or more. In an exemplary embodiment, the negative curvature can result in the electrode array subtending an angle that meets and / or exceeds the above-mentioned time periods indicated above relative to the electrode array remaining in a substantially flat geometry. A corollary of this is that in an exemplary embodiment, there is a device for forcing the electrode array or otherwise maintaining the electrode array in a geometry such that it has the aforementioned negative curvature. In an exemplary embodiment, the device can be a metal and / or plastic block or structure having a path therein corresponding to the desired negative curvature. In an exemplary embodiment, the device can be provided with the electrode array. In an exemplary embodiment, the electrode array can be delivered to a surgical site, etc., wherein the electrode array is in the device. That is, in an exemplary embodiment, when the surgeon opens the package (typically a sterile sealed package) containing the electrode array, the electrode array is already in a negatively curved geometry.

[0073] While the embodiments detailed above often focus on a first geometry that is different from the insertion geometry, it should be noted that the first geometry associated with method 600 can be the insertion geometry. The fact that the insertion process deforms the electrode array into another geometry that is different from the insertion geometry does not necessarily prevent the insertion geometry from being the first geometry. Thus, any geometry designated herein as the first geometry and any geometry designated herein as the second geometry can be the specific geometry in question.

[0074] In exemplary embodiments in which the implantable component is a cochlear electrode array, the act of inserting the implantable component into the recipient entails inserting the electrode array into the recipient's cochlea in a first geometry (e.g., a flat or straightened geometry (relative to its natural / unconstrained / relaxed geometry), such as can be achieved via utilization of a stylet and / or insertion sheath, etc.).

[0075] In an exemplary embodiment in which the implantable component is a curved cochlear electrode array, the act of inserting the implantable component into the recipient requires inserting the implantable component into the recipient's cochlea in a third geometry, and the aforementioned second geometry is a curved geometry. The third geometry is one of a substantially straight geometry or a negatively curved geometry relative to the curved geometry of the second geometry, and the second geometry is closer to the relaxed state of the electrode array than the third geometry. That is, in exemplary embodiments, the second geometry is not necessarily the relaxed state. This is for at least three reasons, as will now be briefly explained.

[0076] Generally speaking, in some exemplary embodiments, the aforementioned performance characteristics are characteristics associated with inserting an electrode array into the cochlea. In this regard, the aforementioned performance characteristics may be characteristics achieved via laboratory testing, etc., where the electrode array has never been inserted into the cochlea. In this regard, the electrode array is placed into the various geometries and / or maintained in the various geometries detailed herein (e.g., utilizing the tubes noted above, etc.), and then allowed to fully relax / recover to its relaxed state in a controlled environment (e.g., an environment with 50% relative humidity, 80 degrees Fahrenheit temperature, and 1 barometric pressure, etc.). Thus, in exemplary embodiments, the second geometry is the relaxed geometry. However, regarding at least three exemplary reasons why the second geometry is not necessarily the relaxed geometry, in exemplary embodiments (the first reason), the second geometry may be considered for the purpose of evaluating at least a product having a geometry corresponding to a portion of the relaxed geometry. By way of example only, and not limitation, the second geometry may be a geometry corresponding to a geometry in which the electrode array has recovered to 70%, 75%, 80%, 85%, 90%, or 90% of its relaxed geometry. For example, in an exemplary embodiment where the electrode array subtends an angle in a relaxed state of 360 degrees, the second geometry may be 324 degrees (90% of its relaxed geometry) or 288 degrees (80% of its relaxed geometry), etc.

[0077] Regarding the second reason, such as with respect to the scenario in which the electrode array is actually inserted into the cochlea, the modiolar wall of the cochlea may prevent the electrode array from achieving a completely relaxed state. In this regard, depending on the specific geometry of a given cochlea, the cochlea may have an average radius of curvature at the modiolar wall (or the portion of the cochlea around which the electrode array extends / the portion of the cochlea facing the electrode, where the electrode does not extend completely around the outer circumference of the electrode array, etc.) that is greater than the average radius of curvature of the electrode array in its relaxed state at portions of the portion of the electrode array that may face the cochlea associated with the average radius of curvature of the cochlea in question.

[0078] With respect to the third reason, even in scenarios where the cochlea would permit such an outcome, there may be embodiments where the electrode array is prevented from achieving a geometry corresponding to its relaxed state.

[0079] Thus, in some instances, the aforementioned second geometry is the relaxed state of the electrode array. In some instances, the aforementioned second geometry is a portion of the relaxed state of the electrode array. In some instances, the aforementioned second geometry is the final geometry of the electrode array when located in the cochlea, which is governed by the geometry of the cochlea (and the insertion geometry). Still further, in some instances, the aforementioned second geometry is the final geometry of the electrode array when located in the cochlea, which is governed by the overall structure of the implant (which may or may not be influenced by the cochlea).

[0080] In an exemplary embodiment, the transformation from any of the first geometries detailed herein (whether the insertion geometry, the geometry resulting from contact with the cochlear lateral wall, the pre-insertion geometry, etc.) to any of the second geometries detailed herein takes at least about 30 seconds. In an exemplary embodiment, the transformation from the first geometry to the second geometry takes at least about one minute. In an exemplary embodiment, the transformation from the first geometry (insertion geometry) to the second geometry takes at least about 30 seconds, at least about 45 seconds, at least about 90 seconds, at least about 105 seconds, at least about 120 seconds, at least about 135 seconds, at least about 150 seconds, at least about 165 seconds, at least about 180 seconds, at least about 3.5 minutes, at least about 4 minutes, at least about 4.5 minutes, at least about 5 minutes, or more, or any value therebetween in one-second increments.

[0081] It should be further noted that, in exemplary embodiments, any of the first geometric shapes may be any of the negatively curved geometries disclosed herein.

[0082] It should also be noted that while method 600 relates to inserting an implantable component (cochlear electrode array) into the cochlea, in alternative embodiments, method 600 can be modified to instead be a testing method for determining whether a given implantable component meets given criteria. In this regard, in exemplary embodiments, any disclosure herein of inserting an implantable component into a recipient can be replaced with an action that does not constrain the implantable component. More specifically, Figure 8 Exemplary methods for determining whether an implantable component corresponds to the teachings detailed herein are described. Figure 8Method 800 is described in detail, which includes method act 810, which requires obtaining an implantable component. Method 800 also includes method act 810, which requires constraining the implantable component. In this regard, it should be noted that in some embodiments of method 800, the implantable component obtained is an implantable component that has been placed in a constrained condition such that it is deformed from its relaxed state. Further in this regard, it should be noted that in some other embodiments of method 800, the implantable component obtained is an implantable component in its relaxed state, and at some point between method act 810 and method act 820, the implantable component is deformed from the relaxed state.

[0083] In an exemplary embodiment, the deformation from its relaxed state can be any of the deformations detailed herein, such as the deformations detailed herein with respect to the case where the implantable component is a cochlear electrode array. In an exemplary embodiment, the deformation from its relaxed state is a deformation corresponding to any of the first and / or third geometric shapes detailed herein.

[0084] Method 800 also includes method act 830, which entails determining a time period from the time the implantable component is unconstrained, or from the time after the implantable component is unconstrained, to the time the implantable component reaches a given geometry, which, in at least some exemplary embodiments, can be any of the second geometries described in detail herein. If the determined time period corresponds to a specified time period (e.g., any of the time periods described in detail herein), the implantable component is considered to correspond to a given configuration (e.g., a configuration described in detail herein). It should be noted that method 800 does not necessarily need to be performed in a manner such that the implantable component is placed in a recipient. In this regard, method 800 can be performed in a laboratory, etc. With respect to embodiments in which method 800 is performed during surgery to implant the implantable component, the time period involved can be determined using X-rays or markers located on the implantable component (e.g., such as at the tip and at the beginning of the intracochlear region of the electrode array).

[0085] Figure 9 A flow chart of another exemplary method is presented. Figure 9In the embodiment of the present invention, method 900 includes method act 910, which entails obtaining a curved electrode array assembly. The curved electrode array assembly is an electrode array that is curved in a relaxed, unconstrained state. This is true regardless of whether the obtained electrode array is in a straight geometry or in a non-curved geometry (e.g., because it is constrained by its relaxed state). Method 900 also includes method act 920, which entails inserting a first portion of the electrode array assembly into a human cochlea in a deformed state, the deformed state being deformed from the relaxed, unconstrained state of the electrode array assembly. In an exemplary embodiment, the deformed state is a state in which the electrode array, or at least the intra-cochlear portion 188, is substantially straight. As noted above, in an exemplary embodiment, the deformed state is a state in which the electrode array has a negative curvature relative to its relaxed state. That is, in an alternative embodiment, the deformed state is a state in which the electrode array is bent. The curvature is less than the curvature of its relaxed state.

[0086] In the embodiments detailed herein, method act 920 is performed such that the first portion corresponds to a portion of the electrode array assembly that extends the electrode array assembly a first distance, the first distance extending from the tip of the electrode array to a location within the cochlea proximal to the tip. In an exemplary embodiment, the first distance is the distance of the intra-cochlear portion of the electrode array 190. Method act 920 is performed such that the portion of the electrode array constituting the first distance is inserted into the cochlea at a first angular depth. Figure 10A and Figure 10B Such exemplary angular depths are depicted where a first distance is measured from the tip of the electrode array to X through the longitudinal axis of the intracochlear electrode portion 188 of the electrode array. More specifically, Figure 10A and Figure 10B Depicted is a cross-sectional compressed view of a human cochlea having lateral walls 1010 and a modiolar wall 1020, wherein the electrode array herein is in a first geometry. Figure 10A In the example, the orientation of the electrode array is 90 degrees plus A1 relative to the position where the electrode array starts to bend, which is based on Figure 10A The ratio is approximately 170 degrees. With respect to the resting axes 1001 and 1002, this is because the electrode array subtends an angle of 180 degrees based on the geometry of the cochlea (centered on the modiolus, with axis 1002 parallel to the insertion direction of the electrode array at the point where the electrode array enters the cochlea of ​​the first geometry). In other words, the angular depth is such that the electrode array in general (and in particular the intra-cochlear portion) subtends an angle of approximately 180 degrees.

[0087] about Figure 10B (and Figure 11B), which depicts a reference frame depicting a first insertion depth as measured from an axis 1078 passing through a round window 1077 (e.g., using a round window to establish one of the axes depicts a conventional reference frame for angular insertion depth, as distinguished from Figure 10A 1078 and 1079 extend through the conventional center for calculating insertion depth. The initial insertion depth is approximately 250 degrees. This is because the electrode array subtends an angle A1B relative to the stationary axes 1078 and 1079, which is based on the geometry of the cochlea (centered on the modiolus, with axis 1078 passing through the round window 1077). That is, the angular insertion depth is such that, when fully inserted into the cochlea, the electrode array, in general (and in particular, the intra-cochlear portion), subtends an angle of approximately 250 degrees.

[0088] With respect to full insertion into the cochlea, it should be noted that in either case, this is insertion corresponding to insertion through the round window or insertion through a cochleostomy. In this regard, a given electrode array is configured for a particular insertion depth. That is, a given electrode array has a given length, and in some embodiments (such as Figure 2 In some embodiments, the electrode array includes a "stop" surface that prevents further insertion of the electrode array into the cochlea, wherein during the surgical procedure, the surgeon installs the electrode array as far as possible into the cochlea until the stop contacts the outer surface of the cochlea or other structure.

[0089] In an exemplary embodiment, method 900 further includes an act of securing the electrode array assembly (directly or via securing another portion of the implant, such as elongated assembly 118) such that the entire portion of the electrode array assembly positioned in the cochlea corresponds to the first portion. Although, in at least some exemplary embodiments, the act of securing the electrode array may or may not be performed before the electrode array transitions from the first geometry to the second geometry, the linear insertion of the electrode array corresponding to the act that occurs after the act of securing the electrode array is identical to the act that occurred immediately before securing the electrode array, which in some embodiments is in turn the electrode array corresponding to the first portion.

[0090] In some embodiments, the electrode array and / or another portion of the stimulation assembly 118 is secured to the recipient's structure so that the electrode array does not further enter or move out of the cochlea after being inserted to the desired depth. With respect to method 900, the first distance of method action 920 is the full insertion depth of the electrode array being used (wherein the actual depth may vary depending on the type of electrode array and / or the recipient's anatomical structure). That is, the first distance may be subjective, i.e., it may be the distance at which the surgeon wishes to insert the electrode array. In an exemplary embodiment, the distance from X to the tip as measured along the longitudinal axis of the electrode array (the first distance) is approximately 15 mm, or approximately 16 mm, or approximately 17 mm, or approximately 18 mm, or approximately 19 mm, or approximately 20 mm, or approximately 21 mm. In some embodiments, the first distance is between approximately 12 mm and approximately 24 mm, or any value or range of values ​​therebetween in increments of approximately 0.1 mm.

[0091] In any event, method 900 is performed such that, with respect to insertion depth / first distance, the first portion of the electrode array assembly achieves a second angular insertion depth greater than the first angular insertion depth after the first portion constituting the first distance is positioned in the cochlea. Figure 11A As can be seen in FIG, the intracochlear portion of the electrode array is 90 degrees relative to the original orientation plus A2 (which is in Figure 11A With respect to axes 1001 and 1002, the electrode array subtends an angle of approximately 270 degrees, whereas it previously subtended an angle of 180 degrees ( Figure 10A The distance between the tip and X is Figure 10A Same as in , but the angular insertion depth has been increased. Figure 11B , which depicts a reference frame depicting the image as viewed from through the round window 1077 (the traditional reference frame, Figure 10B The second insertion depth is measured by the reference frame of the axis 1078 of the reference frame of the second insertion depth, wherein the axis 1080 extends through the conventional center for calculating the insertion depth, and the second insertion depth is A2B, which is about 350 degrees to about 355 degrees. Figure 10A and Figure 11A The temperature increased by about 90 to 95 degrees.

[0092] In an exemplary embodiment, the result of method 900 is an increase in the difference between A1 and A2 by approximately 30 degrees. Based on the reference frame used for A1 and A2, in an exemplary embodiment, the result of method 900 is an increase in the difference between the first angular insertion depth and the second angular insertion depth for the same insertion distance using the reference frame of A1 and A2 by at least 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, or more, or any value or range of values ​​therebetween in 1 degree increments.

[0093] In an exemplary embodiment, the result of method 900 is that the difference between A1B and A2B is approximately 90 degrees. In an exemplary embodiment, the result of method 900 is that the difference between the first angular insertion depth and the second angular insertion depth for the same insertion distance (linear insertion distance) using the reference system of A1B and A2B increases by 75 degrees. In an exemplary embodiment, the result of method 900 is that the difference between the first angular insertion depth and the second angular insertion depth for the same insertion distance, again using the reference system of A1B and A2B, increases by at least 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 degrees, or more, or any value or range of values ​​therebetween in 1 degree increments.

[0094] Figure 12 Depicts the same time for comparison purposes Figure 10A and Figure 11A The electrode array 190 is inserted at two different angles of depth.

[0095] Using the traditional reference system ( Figure 10B and Figure 11B The angular insertion depth measured in the reference frame of the round window is referred to in this article as the round window reference frame.

[0096] It can be seen that in exemplary embodiments, the bent electrode position of the electrode array can be achieved without external force release, external pressure release, reaction force, mass transfer and net energy transfer that cause the electrode array to achieve the transformation of the bent electrode position from the pre-perimodiolar position.

[0097] refer to Figure 10A and Figure 10B It should be noted that Figure 10A and Figure 10BThe geometry shown corresponds to the first geometry of method 600 noted above. Figure 11A and Figure 11B The illustrated geometry corresponds to the second geometry noted above for method 600. The third geometry noted above can be the electrode array in a substantially straightened configuration, wherein upon insertion of the electrode array into the cochlea, the sidewalls of the cochlea deform the electrode array from the third geometry to the first geometry.

[0098] In view of the above, in an exemplary embodiment, method 900 (or for that matter, any other method detailed herein) is performed wherein a first portion of the electrode array assembly (from the tip to the Figures 10A to 12 The act of inserting the first portion (the portion of the X in FIG. 1 ) into the cochlea requires inserting the first portion such that the first portion does not contact the modiolar portion of the cochlea until after the electrode array assembly has been inserted a first distance. That is, in an alternative embodiment, the electrode array has a configuration such that the exemplary method requires inserting the electrode array assembly a first distance into the cochlea without the electrode array contacting the lateral walls of the cochlea (except for portions of the lateral walls potentially proximal to the insertion location) and without the electrode array contacting the modiolar wall until at least after the first portion is fully inserted into the electrode array. In this regard, in the exemplary embodiment, method 900 is performed by "timing" the deformation of the electrode array relative to the deformation from the first geometry and / or the third geometry to the second geometry. By way of example only, and not limitation, in the exemplary method, when the constrained electrode array, which is, by way of example, constrained in a substantially straight configuration and / or a negatively curved configuration, is unconstrained, the electrode array begins to deform into (or more accurately, toward, as the geometry of the cochlea may prevent it from ultimately reaching its unconstrained state) its unconstrained state (e.g., curved). As the electrode array deforms into / towards an unconstrained state, the electrode array is gradually inserted into the cochlea such that the rate of deformation to its unconstrained state is sequenced by its rate of insertion so that the electrode array in general, or more specifically its intra-cochlear portion 188, avoids contact with the lateral wall.

[0099] In an exemplary embodiment, the electrode array is inserted in a configuration such that it achieves a mid-order insertion by relating a gradual deformation process due to the viscoelastic properties of the electrode array to the insertion depth.

[0100] A corollary to the above is that, in exemplary embodiments, the electrode array is configured such that more distal portions of the electrode array deform faster and / or at a different rate than more lateral portions of the electrode array to better conform to the internal geometry of the cochlea. Thus, in exemplary embodiments, the electrode array can be configured such that the rate of deformation from an unconstrained state is non-linear with respect to position along the electrode array.

[0101] In exemplary embodiments, upon release of the constraints on the electrode array and / or relaxation of the constraints on the electrode array, the aforementioned deformation from the first geometric shape and / or the third geometric shape to the second geometric shape occurs automatically. A corollary of this is that, in exemplary embodiments, the movement of the electrode array assembly to achieve the second angular insertion depth relative to the first angular insertion depth occurs automatically. In exemplary embodiments, the aforementioned automatic occurrence is generally a result of the viscoelastic properties of a portion of the first portion of the electrode array, particularly the intracochlear portion of the electrode array.

[0102] It should be noted that in some exemplary embodiments, the aforementioned change from the first angular insertion depth to the second angular insertion depth is initiated and / or performed without external force release, external pressure release, reaction force, mass transfer, and net energy transfer that causes the transformation from the first angular insertion depth to the second angular insertion depth.

[0103] In an exemplary embodiment, the first angular insertion depth corresponds to the geometry of the electrode array of the first geometry, and the second angular insertion depth corresponds to the geometry of the electrode array of the second geometry. Therefore, any of the above-described temporal characteristics associated with the first geometry and / or the second geometry, or any other characteristics associated therewith, may also apply to the first angular insertion depth and the second angular insertion depth.

[0104] It should be noted that while the embodiments detailed thus far have been directed to scenarios where the angular insertion depth and / or geometry changes due to, for example, the elastic properties of the electrode array, it should be noted that some other embodiments, instead of or in addition to this, also involve changes in the size / geometry of the electrode array relative to the radial direction. In this regard, in an exemplary embodiment, there is an implantable device comprising an electrode array, the electrode array comprising a body (e.g., electrode carrier 491) carrying the electrodes, wherein the body is configured to elastically expand in a radial direction relative to a longitudinal axis (e.g., the longitudinal axis of the electrode array) after insertion into a recipient without any mass transfer into the expanded portions of the body. In this exemplary embodiment, the body is configured such that, starting from the release of full compression, the body can expand from a compressed diameter perpendicular to the longitudinal axis to a diameter that is at least 1.5 times the compressed diameter within a period of no less than about 30 seconds from the release of full compression. In an exemplary embodiment, the body is configured such that the body can expand from a compressed diameter perpendicular to the longitudinal axis to a diameter of at least 1.5 times the compressed diameter within the following time period: not less than approximately 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 2 minutes, 2.5 minutes, 3 minutes, 3.5 minutes, 4 minutes, 4.5 minutes or 5 minutes or more, or any value or range of values ​​therebetween in one second increments, starting when the body is fully compressed and released.

[0105] Figure 13 A cross-sectional view of an exemplary intra-cochlear portion 188 of the electrode array is depicted in a fully relaxed state, with diameter D1 visible. Figure 14 An exemplary intracochlear portion is depicted in a compressed state, compressed such that D2 is approximately 66.67% of D1. This compression may be due to, for example, compression caused by the use of an inserted sheath, etc. (see below for details). In an exemplary embodiment, D2 requires the aforementioned time period to return to D1.

[0106] It should be pointed out that Figure 13 and Figure 14 The embodiments are presented for conceptual purposes. In this regard, although Figure 14 The embodiment is depicted with the body pulled away from the sides of the electrode 148 (it does not deform as the body deforms), but in alternative embodiments the electrode array is configured such that the body is attached to the sides of the electrode array.

[0107] In an exemplary embodiment, body 1388 (electrode carrier) is made of foam. In an exemplary embodiment, body 1388 is made of a viscoelastic material. Thus, in an exemplary embodiment, the body is a viscoelastic foam. In at least some exemplary embodiments, the foam can enhance viscoelastic properties relative to a condition without foaming.

[0108] It should be pointed out that compared to Figures 9 to 12 In certain embodiments, viscoelastic or otherwise, foams as previously described may be used. In certain exemplary embodiments, the foam is similar to foams used in earplugs and the like. In fact, in certain exemplary embodiments, the foam corresponds to foams used in commercial grade earplugs. In certain exemplary embodiments, as Figure 15 As can be seen, body 1388 is at least partially covered or otherwise enclosed in expandable skin 1389. In this regard, the skin can cover the foam or otherwise protect the foam from bodily fluids, etc. In an exemplary embodiment, the skin can be made of soft silicone that provides a smooth, continuous outer surface for the electrode array.

[0109] In view of the above, it can be seen that in exemplary embodiments, there is an electrode array in general, and in particular an intracochlear portion made of a viscoelastic material that has a relatively slow recovery time with respect to returning to its original form after deformation. By way of example only and not limitation, all other conditions are the same as for a curved electrode array made of non-viscoelastic silicone manufactured by Cochlear LTD in 2015. Under the trade name Contour Advance TM and Slim Modiolar TM In some embodiments, after complete release of the constraints on the electrode array, the recovery time of at least some embodiments made of viscoelastic material is at least 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, 11 times, 12 times, 13 times, 14 times, 15 times, 16 times, 17 times, 18 times, 19 times, 20 times, 21 times, 22 times, 23 times, 24 times, 25 times, 26 times, 27 times, 28 times, 29 times, 30 times or more slower than the recovery time of the above-mentioned non-viscoelastic electrode array, relative to recovering to at least 80%, 85%, 90%, 95% or in some embodiments 100% of the original form.

[0110] It should be noted that in exemplary embodiments, an insertion tool (such as an insertion sheath) is used to place the electrode array in the aforementioned third geometry, which geometry can be substantially straight (including straight), as detailed above, or the geometry can be negatively curved. In embodiments utilizing an insertion sheath, the insertion sheath can be utilized without the need to place the insertion sheath into the cochlea. In fact, in exemplary embodiments, with respect to the laterally extended electrode array, the insertion sheath compresses the electrode array to a diameter that is less than its relaxed state, and due to the viscoelastic properties of the electrode array, the electrode array will remain at a reduced diameter relative to its relaxed diameter for a sufficient period of time so that the electrode array is inserted into the cochlea after being unconstrained by the insertion sheath (e.g., after leaving / popping out of the end of the insertion sheath).

[0111] In at least some exemplary embodiments, the use of viscoelastic materials, foams, or other methods can enable the electrode array to conform to various sizes and / or shapes of the cochlea with minimal chronic contact pressure. In exemplary embodiments, the viscoelastic material of the electrode array can be configured to cause the outer circumference of the electrode array to expand outward, thereby pushing the outer circumference of the electrode array further in the lateral direction than the outer circumference of the electrode due to the expansion of the viscoelastic material from a compressed state. As the electrode array transforms from a first geometry to a second geometry, this provides a "cushion" between the surface electrodes of the cochlea and the modiolar wall before the electrode array reaches the modiolar wall. Because the outer diameter of the electrode array can be compressed, the diameter of the cochlear anastomosis or insertion port into the round window, etc., can be smaller than that required to accommodate the "full" diameter of the electrode array in an unconstrained state (or, more accurately, an electrode array having these features but which may expand to the unconstrained diameter more quickly than is the case according to some exemplary embodiments detailed herein).

[0112] Still further, in an exemplary embodiment, the electrode array can be configured as a space-filling array. In an exemplary embodiment, the body (carrier) can be squeezed inside a sheath or the like (or in the aforementioned compression tool or the like). Due to its relatively slow expansion (relative to what is possible via the use of non-viscoelastic materials), the electrode array can be inserted into the cochlea with a compressed diameter, after which the electrode array expands to fill (or at least partially fill) the space within the cochlea, or at least fill a portion of the cochlea in the basal region. In an exemplary embodiment, the electrode array can expand to contact the inner wall of the cochlea, thereby "pushing" the electrode toward the modiolar wall. In an exemplary embodiment, the electrode array can expand to contact the interior of the cochlea at one or more locations, thereby providing a "scaffold" that prevents movement.

[0113] In exemplary embodiments, this space-filling / supporting feature can reduce the amount of current loss relative to an electrode array having a smaller diameter in its most expanded state. Still further, in exemplary embodiments, this expansion feature can be used to provide mechanical fixation of the electrode array, thereby reducing the risk of migration relative to a situation in which this expansion is absent.

[0114] In an exemplary embodiment, the space-filling (including partial-filling) nature of the electrode array displaces at least some of the perilymph fluid within the cochlea, thereby reducing current losses relative to a situation where the fluid is not displaced.

[0115] In an exemplary embodiment, the viscoelastic material used to make the carrier is a viscoelastic silicone resin disclosed in U.S. Patent Application Publication No. 20120329896, entitled “Viscoelastic silicon rubber compositions,” published by the USPTO on December 27, 2012. In an exemplary embodiment, the viscoelastic material used to make the carrier has one or more or all of the characteristics of one or more or all of the embodiments disclosed in U.S. Patent Application Publication No. 20120329896.

[0116] In an exemplary embodiment, there is an exemplary method comprising: obtaining a curved electrode array, accessing the interior of the cochlea, and inserting the electrode array into the cochlea in a deformed state deformed from a relaxed, unconstrained curved state, wherein at least a portion of the electrode array remains in substantially the same deformed state after entering the cochlea. The exemplary method further comprises: surgically closing a surgical opening in a recipient after entering the cochlea. The method is performed such that, after surgically closing the surgical opening, all components that entered the cochlea after entering the interior of the cochlea remain within the cochlea. In this regard, no stylet is entered into the cochlea (in fact, no stylet is used). It should be noted that if a portion of the array containing the stylet enters the cochlea, the stylet that is completely within the electrode array remains within the cochlea. Further, in this regard, no sheath is inserted into the cochlea. Further, in this regard, no soluble material dissolves into the fluid of the cochlea, which in turn dissolves into other parts of the body, thereby leaving the cochlea.

[0117] It should be noted that some and / or all of the teachings detailed herein may be used with hearing prostheses, such as cochlear implants. Although the embodiments detailed herein have been directed to cochlear implants, other embodiments may be directed to applications in other types of hearing prostheses, such as, by way of example, other types of electrode arrays used in medical devices (e.g., pacemakers, neurostimulators, deep brain stimulators, etc.). Indeed, the embodiments may be used with any type of medical device that utilizes an implantable electrode array or even a non-implantable array. Still further, the teachings detailed herein are not limited to electrode arrays, but may be used with any implant, so long as the teachings detailed herein and / or variations thereof have practical value.

[0118] It should be noted that any disclosure regarding one or more embodiments detailed herein may be practiced in combination with any other disclosure regarding one or more other embodiments detailed herein.

[0119] It should be noted that some embodiments include a method of utilizing a device and system having one or more or all of the teachings and / or variations thereof described herein. In this regard, it should be noted that any disclosure of the device and / or system herein also corresponds to a disclosure of utilizing the device and / or system described herein in detail in a manner that at least utilizes its functionality. Further, it should be noted that any disclosure of a manufacturing method corresponds to a disclosure of the device and / or system produced by the manufacturing method. It should also be noted that any disclosure of the device and / or system herein corresponds to a disclosure of manufacturing the device and / or system. Moreover, any disclosure of a method action herein also corresponds to a system and / or device for performing the method action. In addition, any disclosure of the device and / or system herein corresponds to a disclosure of a method of using the device and / or system, and a method of manipulating the device and / or system using the features disclosed herein.

[0120] Although various embodiments have been described above, it should be understood that they are presented by way of example only and not limitation. It will be apparent to those skilled in the relevant art that various changes in form and detail may be made therein without departing from the spirit and scope of the present invention. Therefore, the breadth and scope of the present invention should not be limited by any of the exemplary embodiments described above, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. An electrode array comprising: Multiple electrodes; as well as an electrode carrier carrying the plurality of electrodes, wherein The electrode carrier comprises a viscoelastic material; wherein the electrode carrier is configured to: return from a substantially flat first state to a curved, unconstrained and relaxed second state; wherein in the first state, a portion of the viscoelastic material is compressed; and in the second state, the portion of the viscoelastic material is relaxed to allow the electrode carrier to bend; and The electrode carrier is configured to return from the first state to the second state after an external force or constraint is removed.

2. The electrode array according to claim 1, wherein: The electrode carrier is made of viscoelastic material.

3. The electrode array according to claim 1, wherein: The electrode carrier is made of viscoelastic silicone resin.

4. The electrode array according to claim 3, wherein: The electrode carrier does not contain non-viscoelastic silicone resin.

5. The electrode array according to claim 2, wherein: The electrode carrier has a curved configuration in an unconstrained and relaxed state.

6. The electrode array according to claim 1, wherein: The electrode carrier is configured to recover from the first state to the second state in no less than 30 seconds.

7. The electrode array according to claim 2, wherein: The electrode carrier is configured to return from the first state to the second state in no less than one minute.

8. The electrode array according to claim 1, wherein: The electrode carrier is configured to return from the first state to the second state in no less than two minutes.

9. The electrode array according to claim 2, wherein: The electrode carrier is configured to recover from the first state to the second state in no less than three minutes.

10. An implantable component comprising a viscoelastic material, such that the implantable component can be inserted into a recipient and, after being fully inserted into the recipient, transform from a first geometric shape to a second geometric shape; wherein the implantable component is configured to transform from the first geometry to the second geometry upon removal of an external force or constraint; wherein in the first geometric shape, a portion of the viscoelastic material is compressed; and in the second geometric shape, the portion of the viscoelastic material relaxes to transform the implantable component.

11. The implantable component according to claim 10, wherein: The action of transforming from the first geometry to the second geometry is entirely a result of the elastic material being free of metal.

12. The implantable component according to claim 10, wherein: The act of transforming from the first geometric shape to the second geometric shape is performed without moving any component relative to the implantable component initiating or generating the transformation.

13. The implantable component according to claim 10, wherein: The implantable component is a cochlear electrode array; Insertion of the implantable component into the recipient includes: insertion of the electrode array into the cochlea; The first geometry is a curved geometry resulting at least in part from the curvature of the cochlea; and The second geometric shape is a curved geometric shape having an average curvature radius smaller than an average curvature radius of the first geometric shape.

14. The implantable component according to claim 10, wherein: The implantable component is a cochlear electrode array; Inserting the implantable component into the recipient includes: inserting the electrode array into the cochlea of ​​the recipient in a third geometry; The first geometry is a curved geometry resulting at least in part from the curvature of the cochlea; and The third geometry is one of a substantially straight geometry or a negatively curved geometry relative to the curved geometry of the first geometry.

15. The implantable component of claim 10, wherein: The implantable component is a cochlear electrode array; Inserting the implantable component into the recipient includes: inserting the electrode array in the first geometry into the cochlea of ​​the recipient; as well as The transformation from the first geometry to the second geometry takes at least one minute.

16. The implantable component of claim 10, wherein: The implantable component is a curved cochlear electrode array; Inserting the implantable component into the recipient includes: inserting the electrode array into the cochlea of ​​the recipient in a third geometry; The second geometry is a curved geometry; The third geometry is one of a substantially straight geometry or a negatively curved geometry relative to the curved geometry of the second geometry; and The second geometry is closer to a relaxed state of the electrode array than the third geometry.

17. A curved electrode array assembly, wherein a first portion of the electrode array assembly comprises a viscoelastic material such that: The first portion of the electrode array assembly is insertable into a human cochlea in a deformed state, the deformed state being deformed from a relaxed, unconstrained state of the electrode array assembly such that: The first portion corresponds to a portion of the electrode array assembly that extends a first distance from the tip of the electrode array to a location in the cochlea proximate to the tip, and The portion of the electrode array constituting the first distance is inserted into the cochlea at a first angular insertion depth, wherein The first portion of the electrode array assembly achieves a second angular insertion depth greater than the first angular insertion depth after the first portion constituting the first distance is positioned in the cochlea; wherein at the first angular insertion depth, a portion of the viscoelastic material is compressed; and at the second angular insertion depth, the portion of the viscoelastic material relaxes to deform the first portion; and Wherein the change from the first angular insertion depth to the second angular insertion depth is performed after removing an external force or constraint.

18. The curved electrode array assembly of claim 17, wherein: A difference between the first angle insertion depth and the second angle insertion depth based on a round window reference system is at least 30 degrees.

19. The curved electrode array assembly of claim 17, wherein: The difference between the first angle insertion depth and the second angle insertion depth based on the round window reference system is at least 45 degrees.

20. The curved electrode array assembly of claim 17, wherein: A difference between the first angle insertion depth and the second angle insertion depth based on a round window reference system is at least 60 degrees.

21. The curved electrode array assembly of claim 17, wherein: The first portion of the electrode array assembly is further configured to be insertable into the cochlea such that the first portion does not contact the modiolus portion of the cochlea until after the electrode array assembly is inserted the first distance.

22. The curved electrode array assembly of claim 17, wherein: Achieving the second angular insertion depth of the electrode array assembly occurs automatically.

23. The curved electrode array assembly of claim 17, wherein: Achieving the second angular insertion depth of the electrode array assembly occurs due to the viscoelastic properties of the first portion.

24. The curved electrode array assembly of claim 17, wherein: The first portion of the electrode array assembly is further configured to be insertable into the cochlea such that the first portion does not contact a lateral wall of the cochlea and does not contact a modiolus portion of the cochlea until after the electrode array assembly is inserted the first distance.

25. The curved electrode array assembly of claim 17, wherein: The first distance is at least 16 mm.

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