Source: http://www.google.com/patents/US7974711?dq=1886562
Timestamp: 2016-02-11 04:34:19
Document Index: 266223805

Matched Legal Cases: ['Application No. 93501', 'Application No. 95246', 'Application No. 95286', 'Application No. 95286', 'Application No. 2', 'Application No. 2', 'Application No. 01973835', 'Application No. 01973835', 'Application No. 01973835', 'Application No. 01973835', 'Application No. 01973835', 'Application No. 01975835', 'Application No. 01975835', 'Application No. 01975875', 'Application No. 01973835', 'Application No. 01975875', 'Application No. 01973835', 'Application No. 01973835', 'Application No. 2002', 'Application No. 2002']

Patent US7974711 - Double stylet insertion tool for a cochlear implant electrode array - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA cochlear implant electrode assembly device (10) comprising an elongate electrode carrier member (11), a first stiffening element (15 a), and a second stiffening element (15 b). The carrier member (11) is made of a resiliently flexible first material and has a plurality of electrodes (12) mounted thereon....http://www.google.com/patents/US7974711?utm_source=gb-gplus-sharePatent US7974711 - Double stylet insertion tool for a cochlear implant electrode arrayAdvanced Patent SearchPublication numberUS7974711 B2Publication typeGrantApplication numberUS 11/853,641Publication dateJul 5, 2011Filing dateSep 11, 2007Priority dateOct 11, 2000Fee statusPaidAlso published asCA2382894A1, DE60113293D1, DE60113293T2, EP1341578A1, EP1341578A4, EP1341578B1, US7269461, US20030045921, US20080004684, WO2002030507A1Publication number11853641, 853641, US 7974711 B2, US 7974711B2, US-B2-7974711, US7974711 B2, US7974711B2InventorsFysh Dadd, Derek I. Darley, Peter Gibson, John Parker, Claudiu TreabaOriginal AssigneeCochlear LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (66), Non-Patent Citations (39), Classifications (10), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetDouble stylet insertion tool for a cochlear implant electrode array
US 7974711 B2Abstract
A cochlear implant electrode assembly device (10) comprising an elongate electrode carrier member (11), a first stiffening element (15 a), and a second stiffening element (15 b). The carrier member (11) is made of a resiliently flexible first material and has a plurality of electrodes (12) mounted thereon. The carrier member (11) has a first configuration selected to allow it to be inserted into an implantee's cochlea (30), a second configuration wherein it is curved in shape to match a surface of the cochlea (30), and at least one intermediate configuration between the first and second configurations. Both the first and second stiffening elements (15 a, 15 b) are made of a material relatively stiffer than said the material and in combination bias the elongate member into the first configuration. If either the first stiffening element (15 a) or the second stiffening element (15 b) are removed, the elongate member (11) adopts the at least one intermediate configuration.
an elongate carrier member including a plurality of electrodes and configured to adopt a substantially straight first configuration, a fully curved second configuration which substantially conforms to an inside surface of a cochlea, and at least one partially curved configuration that is more curved than the substantially straight configuration and less curved that the fully curved configuration;
a first stiffening element; and
at least a second stiffening element, wherein the first stiffening element and the second stiffening element in combination bias the carrier member into the substantially straight first configuration and further wherein the first stiffening element has insufficient stiffness to maintain the carrier member in the substantially straight configuration alone.
2. The device of claim 1, wherein the second configuration of the elongate member is curved.
3. The device of claim 2, wherein the elongate member adopts a spiral configuration when in the second configuration.
4. The device of claim 1, wherein the elongate member is preformed from a plastics material with memory and is preformed to the second configuration.
5. The device of claim 1, wherein the elongate member has a first end that is firstly inserted into the implantee.
6. The device of claim 1, wherein the first configuration is at least substantially straight.
7. The device of claim 1, wherein the elongate member is formed from a biocompatible material selected from the group comprising a silicone and a polyurethane.
8. The device of claim 1, wherein the first and second stiffening elements are formed of the same material.
9. The device of claim 1, wherein at least the first stiffening element is formed of a bioresorbable material which dissolves or softens on exposure to a fluid.
10. The device of claim 9, wherein the bioresorbable material of said at least first stiffening element is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).
11. The device of claim 1, wherein at least the first stiffening element is formed from a non-bioresorbable material.
12. The device of claim 11, wherein at least the first stiffening element is a metallic or plastic stylet.
13. The device of claim 12, wherein the second stiffening element is a metallic or plastic stylet.
14. The device of claim 13, wherein the respective stylets extend through a single lumen in the elongate member.
15. A device of claim 13, wherein the first stiffening element includes a lumen and the second stiffening element is configured to extend through the lumen of the first stylet.
16. A cochlear implant electrode assembly device comprising:
an elongate carrier member including a plurality of electrodes and configured to adopt a first configuration that facilitates insertion of the carrier member into an implantee's cochlea, a second configuration which substantially conforms to a surface of the cochlea, and at least one intermediate configuration that is more curved than the first configuration and less curved than the second configuration;
at least a second stiffening element, wherein the first stiffening element and the second stiffening element in combination bias the carrier member into the first configuration and further wherein if either the first stiffening element or the second stiffening element is removed wholly or partially from the carrier member, the carrier member adopts the at least one intermediate configuration.
17. The device of claim 16, wherein the carrier member is made of a resiliently flexible first material, and the first stiffening element is made of a second material that is stiffer than the first material.
18. The device of claim 17, wherein the second stiffening element is relatively stiffer than said first stiffening element.
19. The device of claim 18, wherein the second stiffening element has a greater diameter than the first stiffening element.
20. A cochlear implant electrode assembly device comprising:
an elongate carrier member including a plurality of electrodes and configured to adopt a first configuration that facilitates insertion of the carrier member into an implantee's cochlea, a second configuration which substantially conforms to a surface of the cochlea, and at least one intermediate configuration that is more curved than the first configuration and less curved than the second configuration, said elongate member being made of a resiliently flexible first material;
a first stiffening element comprising a second material that is stiffer than the first material; and
a second stiffening element that is stiffer than the first stiffening element, wherein the first stiffening element and the second stiffening element in combination bias the carrier member into the first configuration and further wherein if either the first stiffening element or the second stiffening element is removed wholly or partially from the carrier member, the carrier member adopts the at least one intermediate configuration.
This application is a continuation of U.S. patent application 10/070,102 filed on Jul. 8, 2002, now U.S. Pat. No. 7,269,461, entitled, “Double Stylet Insertion Tool For A Cochlear Implant Electrode Array,” which is a national stage application of PCT/AU01/01230 entitled, “Double Stylet Insertion Tool For A Cochlear Implant Electrode Array” and filed on Sep. 28, 2001, and which claims priority to Australian Patent Application PR 0684, filed Oct. 11, 2000, Australian Patent Application PR 0807, filed Oct. 17, 2000, Australian Patent Application PR 1005, filed Oct. 25, 2000, and Australian Patent Application PR 1778, filed Nov. 29, 2000, all of which is hereby incorporated by reference herein.
The implanted stimulator/receiver unit typically included the antenna receiver coil that receives the coded signal and power from the external processor component, and a stimulator that processes the coded signal and outputs a stimulation signal to an intracochlear electrode assembly which applies the electrical stimulation directly to the auditory nerve producing a hearing sensation corresponding to the original detected sound.
In another development, a bimetallic filament (such as nickel/titanium) or a shape memory alloy (eg. an alloy of nickel and titanium) is positioned in the electrode assembly and used to again hold a pre-curved electrode array in a generally straight configuration while the array is at about room temperature. On insertion into the body and exposure to body temperature, the filament or alloy bends into a pre-selected curved configuration.
In developing such electrode array designs, it is of great importance that the design be constructed to minimize potential damage to sensitive structures in the cochlea on insertion and placement. Each of the above constructions suffer from a number of disadvantages in this regard.
an elongate member having a plurality of electrodes mounted thereon and having a first configuration selected to allow said member to be inserted into an implantee's body, a second configuration wherein said elongate member is adapted to apply a preselected tissue stimulation with the electrodes, and at least one intermediate configuration between said first and second configurations, said elongate member being made of a resiliently flexible first material:
a second stiffening element;
wherein said first stiffening element and said second stiffening element in combination bias said elongate member into said first configuration and further wherein if either the first stiffening element or the second stiffening element is removed, the elongate member adopts said at least one intermediate configuration.
an elongate electrode carrier member having a plurality of electrodes mounted thereon and having a first configuration selected to allow said member to be inserted into an implantee's cochlea, a second configuration wherein said elongate member is curved to match a surface of said cochlea, and at least one intermediate configuration between said first and second configurations, said elongate member being made of a resiliently flexible first material;
In a preferred embodiment, the elongate member is formed from a suitable biocompatible material. In one embodiment, the material can be a silicone, such as a flexible silicone elastomer Silastic. Silastic MDX 4-4210 is an example of one suitable silicone for use in the formation of the elongate member. In another embodiment, the elongate member can be formed from a polyurethane or other similar materials.
In one embodiment, the first and second stiffening elements can be formed of the same material.
In one embodiment, the first stiffening element is made of a material that is relatively stiffer than the first material. In another embodiment, the second stiffening element can be relatively stiffer than said first stiffening element. In another embodiment, the second stiffening element can be relatively less stiff than the first stiffening element. In a still further embodiment, the first and second stiffening element can have the same stiffness.
Where the second stiffening element is relatively stiffer than the first stiffening element, the relatively greater stiffness of the second stiffening element can be provided by its structural parameters. For example, the second stiffening element can have a greater diameter than the first stiffening element.
The first stiffening element and/or the second stiffening element can be formed of a bioresorbable material which dissolves or softens on exposure to a fluid. The stiffening elements can dissolve or soften on exposure to a saline solution or a body fluid of the implantee such as cochlear fluid.
In a further embodiment, the bioresorbable material used for each stiffening element can be selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).
In another embodiment, the first and/or second stiffening element can be formed from a non-bioresorbable material. In this embodiment, the first and/or second stiffening element can comprise a metallic or plastic stylet. The stylets can extend through a single lumen in the elongate member or through respective lumens in the elongate member. The respective stylets can be positioned side-by-side in the elongate member. In another embodiment, one of said stylets can extend through a lumen of another tubular stylet. For example, the second stylet may extend through a lumen of the first tubular stylet. The first tubular stylet can be cylindrical or have another cross-sectional shape.
In one embodiment, each stylet can be formed from a biocompatible material, such as a metal or metallic alloy. In a preferred embodiment, each metal stylet can be formed from platinum.
In a still further embodiment, the first and/or second stiffening element can be formed from a shape memory alloy or a heat sensitive material. For example, each stiffening element can be formed from an alloy of nickel and titanium, or a bimetallic element formed from two layers of different metals, that is shaped to take a straight or substantially straight configuration at room temperature but bend into another shape once it is exposed to body temperature.
In yet another embodiment, the first and second stiffening elements can be of different lengths. For example, it may be desirable for the relatively stiffer stylet to have a shorter length and the relatively more flexible stylet to have a longer length, or vice versa. It is also envisaged that each stylet can have the same length.
In one embodiment, the lumen for the stylet can be cylindrical and also can have an opening formed therein. In the case where one or two metal stylets are used, the stylet or stylets can extend out of the opening allowing the stylet or stylets to be manipulated and removed from the lumen during or following insertion of the device.
In the case where the first and/or second stiffening elements are formed of a bioresorbable material, the opening can act as a fluid ingress means allowing body fluids to enter the lumen on insertion of the device into an implantee.
Where the first stiffening element is a metallic or metallic alloy stylet, the second stiffening element can be formed of a bioresorbable material which dissolves or softens on exposure to a fluid, or vice versa. The bioresorbable material can dissolve or soften on exposure to a saline solution or a body fluid of the implantee, such as cochlear fluid.
In a further embodiment, the bioresorbable material is selected from the group comprising polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA).
The device can include an additional layer surrounding the elongate member. The additional layer can have a first rate of fluid ingress therethrough and have at least one fluid ingress means formed therein, the rate of fluid ingress through the fluid ingress means being greater than the first rate of fluid ingress through the additional layer.
Where the first stiffening element is a metal or bioresorbable stylet, the second stiffening element can, in one embodiment, be formed from a shape memory or heat sensitive material, or vice versa. For example, the second stiffening element can be formed from a shape memory alloy or a bimetallic filament (such as nickel and titanium alloy or a bimetallic filament comprising respective layers of such metals) that is shaped to maintain the straight or substantially straight configuration of the elongate member at room temperature but will bend into another shape once exposed to body temperature.
Preferably, while both the first and second stiffening elements are in position within the device, it will retain the first configuration, which as discussed is preferably straight. If the first stiffening element is removed, whether it is by physical removal or otherwise, the remaining second stiffening element preferably has insufficient strength to retain the elongate member in its first configuration. It is preferred that the elongate member, on removal of the first stiffening element, will adopt an intermediate configuration in which the elongate member has at least some curvature. On subsequent removal of the second stiffening element, the elongate member is free to adopt the fully curved second configuration desired of an implant after insertion into the cochlea.
The present invention provides a surgeon with a means to at least partially control the rate of curvature formation in a cochlear electrode assembly during insertion into the cochlea. Such increased control is envisaged to reduce the potential for trauma to the cochlea caused by electrode assembly insertion.
According to a third aspect, the present invention is a cochlear implant electrode assembly device comprising:
a first stiffening element made of a material relatively stiffer than said first material: and
a second stiffening element that is relatively stiffer than said first stiffening element:
In a further embodiment, the device can have one or more of the preferred features of the first and second aspects.
By way of example only, preferred embodiments of the invention are now described with reference to the accompanying drawings, in which;
FIG. 1 is a simplified cross-sectional view of one embodiment of an electrode assembly according to the present invention depicted in its first configuration;
FIG. 2 is a simplified side elevational view of the electrode assembly of FIG. 1 depicted in an intermediate configuration;
FIG. 3 is a simplified side elevational view of the electrode assembly depicted in its second configuration; and
FIGS. 4 and 5 a-5 d depict alternative tip structures for the electrode assembly depicted in FIG. 1.
The depicted electrode assembly 10 has an electrical lead extending back to a stimulator/receiver housing. In considering this invention, it is to be understood that each electrode may have one or more wires (not depicted) electrically connected thereto and extending from each respective electrode back through the lead to the stimulator/receiver.
The assembly 10 comprises an elongate electrode carrier member 11 having a plurality of electrodes 12 mounted thereon. For the purposes of clarity, the electrodes 12 depicted in FIG. 1 are not necessarily shown to scale. The electrodes 12 are not depicted in FIGS. 2 and 3 for reasons of clarity.
The depicted elongate member 11 is preformed from a resiliently flexible silicone with memory and is preformed to a curved configuration suitable for insertion in the scala tympani of the cochlea. The elongate member 11 has a first end 13 that is firstly inserted into the implantee on insertion of the assembly 10.
As depicted in FIG. 4, the elongate member 11 can have a tip member 29 integrally formed with its first end 13. The tip 29 is formed from the same silicone used to fabricate the elongate member 11 and, in the depicted embodiment, the material of tip member 29 has a resilient flexibility equal to that of the material used for the carrier member 11.
As depicted in FIG. 5 d, the tip member 60 can comprise an elastomeric silicone material having a plurality of substantially spherical platinum particles 61 dispersed therethrough. The particles 61 have a diameter between about 50 μm and 100 μm. It will be appreciated that the particles 61 depicted in FIG. 5 d are not drawn to scale.
Disposed within a substantially cylindrical lumen 14 is a substantially straight first platinum stylet 15 a and a second platinum stylet 15 b. The stylet 15 a is relatively stiffer than the elongate carrier 11 but alone has a stiffness that is insufficient to retain the silicone elongate member 11 in the straight configuration depicted in FIG. 1. The second stylet 15 b has a greater diameter than stylet 15 a and is relatively stiffer than stylet 15 a. Stylet 15 b extends through opening 17 in lumen 14 to a handle 21 that can be gripped by the surgeon. Stylet 15 a also extends out of opening 17 to a separate handle 22 mounted around and movable relative to handle 21. It should be noted that the stylets do not have to be the same length. It may be desirable to have a short relatively stiffer stylet and a long relatively more flexible stylet.
While stylets 15 a,15 b are each depicted as a platinum stylet, one of both stiffening elements could be provided by a bioresorbable stylet formed from a bioresorbable polyacrylic acid (PAA) that is adapted to dissolve or soften on exposure to cochlear fluids. It will be appreciated that a bioresorbable stylet could be formed from other suitable bioresorbable materials. A stylet made from a shape memory or heat sensitive material could also be utilised as stylet 15 a and/or stylet 15 b. While the elongate member 11 is manufactured with a preformed curved configuration, the assembly 10 is typically delivered to a surgeon with the stylets 15 a,15 b in place. The placement of both of the stylets 15 a,15 b in the lumen 14 is sufficient to hold the elongate member 11 in the straight configuration depicted in FIG. 1.
On insertion of the device 10 into the scala tympani of the cochlea 30 and when the first end 13 reaches the back of the basal turn, the surgeon can grip handle 21 and withdraw the second relatively stiffer stylet 15 b from the lumen 14. As the stylet 15 b is withdrawn, the elongate member 11 commences to re-curl (see FIG. 2) as the stiffness of the stylet 15 a is insufficient to hold the elongate member 11 straight.
As the elongate member 11 curls, the surgeon can continue to further insert the curled assembly 10 into the scala tympani until the desired insertion is attained. Upon desired insertion, the platinum stylet 15 a can be fully withdrawn through the opening 17 of the lumen 14, using handle 22. On full withdrawal of the stylet 15 a, the elongate member 11 is free to adopt the spiral configuration depicted in FIG. 3 with the electrodes 12 facing the modiola within the cochlea 30 so that they are positioned as close as possible to the spiral ganglia thereof. It is also envisaged that during this final insertion, the platinum stylet 15 a can be simultaneously withdrawn using handle 22, through the opening 17 of the lumen 14 to further assist with the ease of insertion.
The combination of the first and second stiffening elements 15 a,15 b provides the surgeon with greater control of the implantation procedure for the cochlear implant electrode assembly 10. The provision of greater control minimises the potential for trauma to the sensitive tissues inside the cochlea and also enhances the likelihood of successful placement of the assembly 10 at the first attempt.
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Report: PCT/AU01/01230;-filed Sep. 28, 2001;-Applicant: Cochlear Limited.34PCT International Preliminary Examination Report: PCT/AU01/01230;—filed Sep. 28, 2001;—Applicant: Cochlear Limited.35PCT International Search Report: PCT/AU01/01230;-filed Sep. 28, 2001;-Applicant: Cochlear Limited.36PCT International Search Report: PCT/AU01/01230;—filed Sep. 28, 2001;—Applicant: Cochlear Limited.37Research Disclosure; Nov. 1997; No. 403-40342, 785pp; "Epicardial-Transvenous Left Atrial Lead with Wound 'Butterfly Tongue' Electrode"; by Disclosed Anonymously, K. Mason Publications, Ltd., England.38Research Disclosure; Nov. 1997; No. 403-40342, 785pp; "Epicardial-Transvenous Left Atrial Lead with Wound ‘Butterfly Tongue’ Electrode"; by Disclosed Anonymously, K. Mason Publications, Ltd., England.39Research Disclosure; Nov. 1997; No. 403-40349, 790-791pp; "Epicardial-Transvenous Left Ventricular Lead with Dual Ring Electrodes (Cathode Ring & Anode Ring) Design"; by Disclosed Anonymously, K. Mason Publications, Ltd., England.Classifications U.S. Classification607/137, 607/56, 607/55, 607/57International ClassificationA61N1/05, A61F11/04, A61F11/00Cooperative ClassificationA61N1/0541, A61F11/004European ClassificationA61N1/05K2Legal EventsDateCodeEventDescriptionJun 21, 2010ASAssignmentOwner name: COCHLEAR LIMITED,AUSTRALIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DADD, FYSH;DARLEY, DEREK I.;GIBSON, PETER;AND OTHERS;REEL/FRAME:024565/0153Effective date: 20020605Owner name: COCHLEAR LIMITED, AUSTRALIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DADD, FYSH;DARLEY, DEREK I.;GIBSON, PETER;AND OTHERS;REEL/FRAME:024565/0153Effective date: 20020605Dec 17, 2014FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services