AUSTRALIA Patents Act 1990 HEARWORKS PTY LTD COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Cochlear electrode with precurved and straight sections The following statement is a full description of this invention including the best method of performing it known to us:- 2 Field of the Invention The present application relates to an implantable device and, in one embodiment, to an implantable cochlear electrode assembly. 5 Background of the Invention In many people who are profoundly deaf, the reason for their deafness is sensorineural hearing loss. This type of hearing loss is due to the at least partial 10 absence of, or destruction of, the hair cells in the cochlea which transduce acoustic signals into nerve impulses. Cochlear implants bypass the hair cells and deliver electrical stimulations to the auditory nerve fibres thereby allowing the brain to perceive a hearing sensation resembling the natural hearing sensation normally delivered to the auditory nerve. 15 The implantable component of the cochlear implant typically comprises a receiver antenna coil and a stimulator unit that processes coded signals delivered from an external component and outputs a stimulation signal to an intracochlear electrode assembly which applies the electrical stimulation to the auditory nerve. 20 Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the 25 field relevant to the present invention as it existed before the priority date of each claim of this application. Summary of the Invention 30 Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. 35 According to one aspect, the present invention is an implantable electrode array for insertion into an implantee's body, the array comprising: 3 an elongate carrier having a proximal end and a distal end; and a plurality of electrodes supported by the carrier at respective longitudinally spaced locations thereon between the proximal end and the distal end; wherein the carrier is comprised of a first portion that preferentially adopts a 5 first at least partially curved configuration and at least a second portion that preferentially adopts a second different configuration to that of the first portion, said second portion being closer to said distal end than said first portion; and further wherein both the first and second portions each have at least one electrode supported thereon. 10 Brief Description of the Drawings By way of example only, the invention is described with reference to the accompanying drawings: 15 Figs. 1 A-IC are pictorial representations of a cochlear implant electrode array; Figs. 2a-2c are diagrammatic, not to scale, representations of the electrode carrier; 20 Figs. 3A-3C are pictorial representations of another cochlear implant electrode array; Figs. 4A-4c depict diagrammatically insertion of the array into a cochlea using 25 an insertion tool; Figs. 5A-5N depict some of the steps for manufacturing an electrode array; and Figs. 6a-6e depict some of the steps in the use of a mold to form one 30 embodiment of the array. Detailed Description of an Exemplary Embodiment of the Invention While the depicted embodiment is directed to an implantable electrode array for 35 implantation in the cochlea, it will be appreciated that the present invention has broader application and could be implantable in other suitable locations within an implantee.
4 One embodiment of an implantable electrode array for insertion into the cochlea of an implantee is depicted generally as 10 in Figs. IA-IC. The array 10 comprises an elongate carrier 11 having a proximal end 12 and a distal tip or end 13. It will be 5 understood that the carrier 11 supports a plurality of electrodes at respective longitudinally spaced locations thereon between the proximal end 12 and the distal end 13. The electrodes are not visible in Figs. lA-IC for reasons of drawing clarity. Electrical signals are delivered from an implanted stimulator unit (not visible) through a cable or lead 14 to the electrodes. It will be understood that the electrodes can be 10 equally spaced along the carrier I1, non-equally spaced or be equally spaced for a length of the carrier 11 and also non-equally spaced for a length of the carrier 11. The depicted carrier 11 is comprised of a first portion 15, which in turn has at least a portion thereof that preferentially adopts a first at least partially curved 15 configuration. Said portion of the first portion 15 or the entire first portion 15 can be partially, substantially or fully straightened but is formed such that it prefers to adopt a curved configuration, with one example of a curved configuration depicted in Fig. IA. The carrier 11 also comprises a second portion 16 that preferentially adopts a second different configuration to that of the first portion. In this embodiment, this second 20 different configuration is a substantially straight configuration. It will be appreciated that the second different configuration could have a degree of curvature that would typically be less than the degree of curvature of the first portion 15 or be straight. While depicted as substantially straight, the second portion 16 is sufficiently flexible such that it is able to conform to the shape of the implant location (eg cochlea 5) 25 following its implantation therein (see Fig. IC). As depicted, the second portion 16 is closer to the distal end 13 than the first portion 15. In the depicted embodiment, the carrier 11 is comprised of the first portion 15 and the second portion 16 between its proximal end 12 and distal end 13. As 30 depicted, the first portion 15 itself is comprised of a portion that is substantially straight for a length away from the cochleostomy marker 17 and then a curved portion. It will be appreciated that in other embodiments, the carrier 11 could be comprised of additional portions than that depicted. Still further, the entire length of the first portion 15 could have a degree of curvature. 35 5 In looking at the depicted carrier 11, it is to be understood that both the first portion 15 and the second portion 16 each have at least one electrode supported thereon. The second portion 16 could support one or more electrodes. 5 The carrier 11 has an extracochlear part and an intracochlear part. The extracochlear part extends from the proximal end 12 to the cochleostomy marker 17. The portion that is adapted to enter the cochlea extends from the marker 17 to the distal end 13. 10 While Figs. lA-IC depict a straight substantially second portion 16, Fig. 3A depicts an alternative array 20 having a carrier 21 in which the second portion 26 is non-straight and has instead a degree of curvature. In the depicted embodiment, the second portion 26 preferentially adopts a curved configuration having a degree of curvature less than the curved portion of the first portion 25. 15 As depicted in Fig. 2, the carrier I1 can have a constant diameter for some or all of its length (Fig. 2a), can taper in diameter for at least a portion of its length between the proximal end 12 and the distal end 13 (Fig. 2b), and even be comprised of a mixture of constant diameter and tapering diameter portions (Fig. 2c). 20 In the depicted embodiments, the intracochlear part of the carrier 11 can have a length between about 8mm and about 40mm. The first portion can have a length between about 8mm and about 34mm, for example about 18mm while the second portion can have a length between about 1mm and 10mm, more preferably about 3mm. 25 The carrier 11 can be formed in various cross-sectional shapes and even comprise a number of different cross-sectional shapes. For example, the shape may be circular, oval, hexagonal, octagonal, or a mixture of these and/or others. 30 The distal end 13 is preferably at least substantially hemispherical in form so that it presents a relatively soft and blunt shape to the inside of the cochlea during implantation. In the depicted embodiments, the carriers 10,20, following implantation, are 35 preferably positioned such that first portion 15,25 subtends an angle upto 6500, more preferably about 3600 within the basal section of the cochlea 5, while the second 6 portion 16,26 subtends an angle upto 3600, more preferably about 2700 within the apical section of the cochlea 5. The carrier of the implantable electrode array can be formed of a relatively soft 5 and resiliently flexible biocompatible material. The material can be an elastomeric material and/or a polymeric material. In one embodiment, the carrier 11,21 can be formed from a liquid silicone rubber, such as LSR30, LSR60 and the like, or an elastomer, such as HCRP 50, or a combination thereof. 10 In one embodiment, the first portion 15 can be formed from a different material to that of the second portion 16. For example, the first portion 15 can be formed of a relatively hard durometer silicone so as to ensure it recoils to its desired shape whereas the second portion 16 is formed of a relatively soft and resiliently flexible durometer material since it should not have to recoil, in use. 15 As depicted in Figs. I B and 3B, the carriers can be at least substantially straightenable by a removable straightening element extending through the carrier. The element can be formed of a biocompatible material. In the depicted embodiment, the element comprises a platinum stylet 18. An embodiment that does not rely on a stylet 20 is described below. In other embodiments, the element could be formed of other suitable materials, including titanium, a plastics material, or a combination of metals, alloys and plastics materials. The stylet can be circular in cross-section or can be molded or stamped in a 25 variety of profiles to create the desired properties required of the stylet. A platinum stylet can be left hardened as drawn or at least a portion thereof can be annealed. For example, a distal portion at and/or adjacent the distal end can be annealed. As depicted by Fig. 38, the stylet 18 can extend to the distal end 13 of the 30 carrier 21 or, as depicted in Fig. 3C, can instead only extend to the end of the first portion 25. It will be appreciated that the distal end of the stylet 18 could extend to a still different location including between the two depicted locations. The stylet 18 is not necessarily needed to straighten the second portion 26 but 35 can be used to create the desired mechanical properties required of the second portion 26 during the implantation procedure. For example, it would be expected that the 7 second portion 26 will be more flexible with the stylet 18 not present than the case when it is. In an arrangement where the stylet does not extend into the second portion 26, the second portion can be formed of a relatively harder durometer silicone than the first portion 25 than maybe needs to be case in the arrangement where the stylet 18 5 does extend to the distal end of the carrier 21. In one embodiment, the stylet 18 is positioned within a lumen extending through the carrier 20. The stylet can come in different lengths or the lumen does or does not extend into the second portion 26 depending on the arrangement being sought. 10 The depicted electrode arrays can be inserted into the cochlea using a variety of insertion methods and tools. For example, the carrier 11 can be inserted fully or partially into the cochlea prior to withdrawal of the stylet 18. Alternatively, an Advance Off-Stylet (AOS) mode can be employed in which the insertion of the carrier 15 and withdrawal of the stylet happens simultaneously. It will also be appreciated that the carrier could be implanted using a variety of insertion tools that are used with or without a stylet. In one embodiment, as depicted in Figs. 4A-4C, insertion can be undertaken using an insertion tool having a tubular tip 20 cartridge 30. In one embodiment, the tool having a tubular tip cartridge can be used in conjunction with a carrier having a stylet, such as that depicted in Figs. lB and 3B. In another embodiment, the tool could be used in conjunction with a carrier that does not have a stylet or lumen. 25 In the arrangement depicted in Figs. 4A-4C, the cartridge 30 of the tool serves to hold the first portion 15 straight during implantation. The tip 31 of the insertion tool 30 is rested on the cochleostomy during the procedure and allows the carrier to be slid through the cochleostomy and into the cochlea 5. 30 It is anticipated that various manufacturing methods can be utilised to manufacture the electrode arrays as described herein. One embodiment of a manufacturing method for forming an electrode array is described herein with reference to Figs. 5A-5N. In this embodiment, the stylet 18 is 35 used in the array and is positioned so as to extend to the distal end of the carrier, such 8 as is depicted in Fig. 3B. It will be appreciated that the array could be formed without a stylet in place. In this embodiment, the second portion 26 is molded first and once formed is 5 then placed in a curved mold to allow completion of the moulding of the first precurved portion 25. One initial step is the formation of the rings 41 (in this embodiment, formed of platinum) that will constitute the electrodes of the array. In one embodiment, the 10 platinum rings 41 can be formed to a desired width by being cut from a platinum tube. The rings 41 are then placed in a jig for forming and welding. To achieve this, the rings 41 can be placed in a cavity 42 as depicted in Figs. 5C and 5D. Once positioned, the rings 41 can be squashed to form half rings 43 (see Figs. 5E and 5F). 15 Electrically conducting wires 44 can then be spot welded to each of the half rings 43 to form the array (Fig. 5G). A further step comprises preparing a stylet 18 for the array. As depicted in Fig. 5H, the stylet 18 can be positioned relative to the half rings 43 and held in place with a 20 few drops of a suitable silicone prior to the welded assembly being removed from the jig (See Fig. 51). It is to be appreciated that in considering Figs. 5H and 5I, the wires 44 are not shown for reasons of clarity. Figs. 5J and 5K depict steps of overmoulding the welded assembly with silicone 25 to form the second portion 26. This comprises placing the welded assembly in the bottom half 45 of a two part mold and then injecting liquid silicone rubber (LSR) into the mold through port 46. The precise type of LSR may be selected for hardness, elasticity and other properties to suit the required stiffness and flexibility of the array. 30 The steps depicted by Figs. 5A-5E can be repeated to form the welded assembly of the first portion 25. Once prepared, the welded assembly can be attached to the free end of the production stylet 18 by a few drops of silicone (see Fig. 5L). Note that for clarity, not all the rings that would be present in the first portion 25 are shown in Fig. 5L. 35 9 A further step comprises overmoulding the first portion 25 and the second portion 26 with an overmould. To achieve this, the welded assembly is placed in the bottom half of an overmould 47 as shown in Figure 5M. The mold can then be filled with an elastomer (e.g. HCRP50) or alternatively LSR can be injected into the mold 5 after the top half of the mold is put in place. When using elastomer, the top half of the mold is clamped in place and an appropriate temperature and pressure is applied as required to cure the chosen elastomer. Once cured, the overmoulded electrode array can be lifted out of the overmould 10 and the production stylet 18 can then be carefully withdrawn so leaving a lumen up to the distal end of the first portion 25. The result is the array depicted in Fig. 5N. In an alternative method where the stylet only extends to the distal end of the first portion 25, the process is identical to that of the previous process, except that after 15 fabricating the electrode described above the lumen of the second portion 26 is backfilled by injecting it with LSR from the tip. As depicted in Figs. 6a-6e, the electrode array can also be molded in a mold 60 (which is fully depicted in Fig. 6e). The mold 60 is made up of a number of 20 components (61, 62, 63, 64 and 65) that are put together to make up the mold 60. While the die of the mold extends in a third dimension (as depicted in Fig. 6a), the formed electrode array can be formed so as to adopt a planar configuration on removal from the mold 60. In an alternative embodiment, the parts of the array can be molded separately and then combined near the end of the manufacturing process to form the 25 entire array. The implantable electrode array as described herein is preferably adapted to cause relatively little, if any, trauma to the implant location (eg within the cochlea) during implantation. It is also preferably capable of being withdrawn from the cochlea, 30 if this is ever desired, without causing significant trauma to the cochlea. At least some of the array is also designed to be positionable in an optimal position within the cochlea despite the variety of shapes and dimensions of the human cochlea that do exist in practice. For example, the configuration of the first portion is preferably such that the array adopts a desired position in the basal turn following implantation. The 35 configuration of the second portion is preferably such that the size and shape of the 10 cochlea serves to at least partially assist in ensuring appropriate placement of the array in the second and apical turns of the cochlea. It will be appreciated by persons skilled in the art that numerous variations 5 and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.