Source: http://www.google.com/patents/US7822487?dq=7125605
Timestamp: 2016-12-08 18:48:51
Document Index: 455799754

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. 2002']

Patent US7822487 - Combination stylet and sheath for an 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 stiffening element (15), and a stiffening sheath (16) that at least partially envelops the elongate member (11). The member (11) is made of a resiliently flexible first material and has a plurality...http://www.google.com/patents/US7822487?utm_source=gb-gplus-sharePatent US7822487 - Combination stylet and sheath for an electrode arrayAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS7822487 B2Publication typeGrantApplication numberUS 11/604,338Publication dateOct 26, 2010Filing dateNov 27, 2006Priority dateOct 4, 2000Fee statusPaidAlso published asCA2392996A1, DE60142156D1, EP1255584A1, EP1255584A4, EP1255584B1, US7146227, US8265773, US20030181967, US20070073371, US20110040364, WO2002028474A1Publication number11604338, 604338, US 7822487 B2, US 7822487B2, US-B2-7822487, US7822487 B2, US7822487B2InventorsFysh Dadd, Ian Darley, Peter Gibson, John L. Parker, Claudiu TreabaOriginal AssigneeCochlear LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (62), Non-Patent Citations (36), Referenced by (1), Classifications (9), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetCombination stylet and sheath for an electrode array
US 7822487 B2Abstract
A cochlear implant electrode assembly device (10) comprising an elongate electrode carrier member (11), a stiffening element (15), and a stiffening sheath (16) that at least partially envelops the elongate member (11). The member (11) is made of a resiliently flexible first material and has a plurality of electrodes (12) mounted thereon. The member (11) has a first configuration that allows it to be inserted into an implantee's cochlea (30). The member (11) also has a second configuration wherein the member is curved to match an inside surface of the cochlea (30), and at least one intermediate configuration between the first and second configurations. Both the stiffening element (15) and sheath (16) are made of a material that is relatively stiffer than the member (11). The stiffening element (15) and the stiffening sheath (16) in combination bias the elongate member (11) into the first configuration. If either the stiffening element (15) or the stiffening sheath (16) is removed or deactivated, the elongate member (11) adopts an intermediate configuration.
1. A method for inserting an electrode array into a cochlea comprising the steps of:
stiffening an elongate member in a first configuration using first and second biasing means, wherein the first biasing means at least partially envelops the elongate member, and wherein the elongate member has a plurality of electrodes mounted thereon and the elongate member is made from a memory material capable of a second configuration;
modifying the first biasing means while inserting the elongate member into the cochlea; and
removing the second biasing means from the elongate member such that the elongate member assumes the second configuration when insertion into the cochlea is completed.
positioning the elongate member during insertion to apply preselected tissue stimulation with the plurality of electrodes.
3. The method of claim 1, wherein the first configuration is substantially straight.
4. The method of claim 1, wherein the second configuration is curved.
5. The method of claim 1, wherein the first biasing means is a sheath.
6. The method of claim 1, wherein modifying the first biasing means comprises:
dissolving the first biasing means.
7. The method of claim 1, wherein modifying the first biasing means comprises:
deactivating the first biasing means.
8. The method of claim 1, wherein modifying the first biasing means comprises:
bending the first biasing means using heat.
9. The method of claim 8, wherein the first biasing means is made from a heat sensitive material.
10. The method of claim 1, wherein the second biasing means is a stylet at least partially inserted in a lumen of the elongate member.
modifying the first biasing means before removing the second biasing means.
inserting the elongate member into the cochlea when the elongate member is in the first configuration.
13. The method of claim 1, wherein the elongated member may be partially outside the cochlea when insertion into the cochlea is completed.
14. An electrode array for an implantable hearing prosthesis comprising:
an elongate member having a plurality of electrodes mounted thereon and having a first configuration that allows the elongate member to be inserted into an implantee's body, a second configuration wherein the elongate member is adapted to apply preselected tissue stimulation with the electrodes, and at least one intermediate configuration between the first and second configurations;
a stiffening element at least partially inserted in a lumen of the elongate member; and
a stiffening sheath at least partially enveloping the elongate member;
wherein the stiffening element and the stiffening sheath in combination bias the elongate member into the first configuration and further wherein either the stiffening element or the stiffening sheath is configured to alone bias the elongate member into the at least one intermediate configuration.
15. The electrode array of claim 14, wherein the second configuration is curved.
16. The electrode array of claim 14, wherein the first configuration is substantially straight.
17. The electrode array of claim 14, wherein the stiffening element is removed from the lumen thereby allowing the stiffening sheath to bias the elongate member into the at least one intermediate configuration.
18. The electrode array of claim 17, wherein the stiffening sheath is removed to allow the elongate member to adopt the second configuration when inserted in the cochlea.
19. The electrode array of claim 17, wherein the stiffening sheath dissolves to allow the elongate member to adopt the second configuration when inserted in the cochlea.
20. The electrode array of claim 17, wherein the stiffening sheath bends to allow the elongate member to adopt the second configuration when inserted in the cochlea.
21. The electrode array of claim 14, wherein the stiffening element dissolves in the lumen thereby allowing the stiffening sheath to bias the elongate member into the at least one intermediate configuration.
22. The electrode array of claim 21, wherein the stiffening sheath is removed to allow the elongate member to adopt the second configuration when inserted in the cochlea.
23. The electrode array of claim 21, wherein the stiffening sheath dissolves to allow the elongate member to adopt the second configuration when inserted in the cochlea.
24. The electrode array of claim 21, wherein the stiffening sheath bends to allow the elongate member to adopt the second configuration when inserted in the cochlea.
25. The electrode array of claim 14, wherein the stiffening element bends in the lumen thereby allowing the stiffening sheath to bias the elongate member into the at least one intermediate configuration.
26. The electrode array of claim 25, wherein the stiffening sheath is removed to allow the elongate member to adopt the second configuration when inserted in the cochlea.
27. The electrode array of claim 25, wherein the stiffening sheath dissolves to allow the elongate member to adopt the second configuration when inserted in the cochlea.
28. The electrode array of claim 25, wherein the stiffening sheath bends to allow the elongate member to adopt the second configuration when inserted in the cochlea.
29. The electrode array of claim 14, wherein the stiffening sheath is removed from the elongate member thereby allowing the stiffening element to bias the elongate member into the at least one intermediate configuration.
30. The electrode array of claim 29, wherein the stiffening element is removed from the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
31. The electrode array of claim 29, wherein the stiffening element dissolves in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
32. The electrode array of claim 29, wherein the stiffening element bends in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
33. The electrode array of claim 14, wherein the stiffening sheath dissolves thereby allowing the stiffening sheath to bias the elongate member into the at least one intermediate configuration.
34. The electrode array of claim 33, wherein the stiffening element is removed from the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
35. The electrode array of claim 33, wherein the stiffening element dissolves in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
36. The electrode array of claim 33, wherein the stiffening element bends in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
37. The electrode array of claim 14, wherein the stiffening sheath bends thereby allowing the stiffening sheath to bias the elongate member into the at least one intermediate configuration.
38. The electrode array of claim 37, wherein the stiffening element is removed from the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
39. The electrode array of claim 37, wherein the stiffening element dissolves in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
40. The electrode array of claim 37, wherein the stiffening element bends in the lumen to allow the elongate member to adopt the second configuration when inserted in the cochlea.
41. The electrode array of claim 14, wherein the elongate member is made from a material having a memory shape of the second configuration.
42. A method for inserting an electrode array into a cochlea comprising the steps of:
stiffening an elongate member in a first configuration using a stiffening sheath and a stiffening stylet, wherein the elongate member has a plurality of electrodes mounted thereon and the elongate member is made from a memory material capable of a second configuration;
modifying the stiffening sheath while inserting the elongate member into the cochlea; and
removing the stylet from the elongate member such that the elongate member assumes the second configuration when insertion into the cochlea is completed.
44. The method of claim 42, wherein modifying the sheath comprises:
dissolving the sheath.
45. The method of claim 42, wherein modifying the sheath comprises:
deactivating the sheath.
46. The method of claim 42, wherein modifying the sheath comprises:
bending the sheath using heat.
modifying the sheath before removing the stylet.
This application is a continuation of U.S. patent application Ser. No. 10/149,643, filed on May 29, 2003, and entitled “Combination Stylet and Straightening Coating for a Cochlear Implant Electrode Array,” now U.S. Pat. No. 7,146,227, which is a national stage of International Application PCT/AU2001/001232, filed on Sep. 28, 2001, and entitled “Combination Stylet and Straightening Coating for a Cochlear Implant Electrode Array,” which claims priority to the following Australian Provisional Applications: PR 0541, filed on Oct. 4, 2000, PR 0807, filed Oct. 17, 2000, PR 1005, filed on Oct. 25, 2000, and PR 1778, filed on Nov. 29, 2000.
Several procedures have been adopted to provide an electrode assembly that is relatively straightforward to insert while adopting a curved configuration following insertion in the cochlea. In one case, a platinum wire stylet is used to hold a pre-curved electrode array in a generally straight configuration up until insertion. Following insertion, the platinum stylet is withdrawn allowing the array to return to its pre-curved configuration. While such an arrangement has proved beneficial, penetration of the wall of the cochlea is possible if the surgeon does not insert the array using an appropriate rate and orientation, or withdraw the stylet at the appropriate end point during insertion of the assembly.
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 alloy or filament bends into a pre-selected curved configuration.
In developing such electrode array designs, it is of great importance that the design be constructed to minimise potential damage to sensitive structures in the cochlear on insertion and placement. For example, in the case of use of platinum stylets, some studies suggest that wall penetration is a problem in about 20% of cases. 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 that allows 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 stiffening element made of a material relatively stiffer than said first material; and
a stiffening sheath at least partially enveloping said elongate member and made of a material relatively stiffer than said first material;
wherein said stiffening element and said stiffening sheath in combination bias said elongate member into said first configuration and further wherein if either the stiffening element or the stiffening sheath is removed or deactivated, the elongate member adopts said at least one intermediate configuration.
According to a second aspect, the present invention is a cochlear implant electrode assembly including:
an elongate electrode carrier member having a plurality of electrodes mounted thereon and having a first configuration that allows said member to be inserted into an implantee's cochlea, a second configuration wherein said elongate member is curved to match an inside 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;
a stiffening sheath at least partially enveloping said elongate member and made of a third material relatively stiffer than said 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.
In a further embodiment, the bioresorbable material of the stiffening element is selected from the group consisting of polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA). It is envisaged that other similar materials could also be used.
In another embodiment, the stiffening element can be formed from a non-bioresorbable material. In this embodiment, the stiffening element can comprise a metallic stylet, or a stylet from any other suitable stiffening material, extending through a lumen in the elongate member. In one embodiment, the stylet can be formed from a biocompatible material, such as a metal, metallic alloy or a stiff plastic. In a preferred embodiment, a metal stylet can be formed from platinum.
In a still further embodiment, the stiffening element can be formed from a shape memory alloy or a heat sensitive material. For example, the stiffening element can be formed from a nickel/titanium alloy, or a bimetallic element formed of a laminate of two different metals, that is shaped to take a straight or substantially straight configuration at room temperature but bends into another shape once it is exposed to body temperature.
In one embodiment, the lumen for the stylet can be cylindrical and also can have an opening formed therein. In the case of a metal stylet, the stylet can extend out of the opening allowing the stylet to be manipulated and removed from the lumen during or following insertion of the device. In the case of a bibresorbable stiffening element, 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 stiffening element is a metallic or metallic alloy or plastic stylet, the stiffening sheath is preferably formed of a bioresorbable material which dissolves or softens on exposure to a fluid. The stiffening sheath 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 of the stiffening sheath is selected from the group consisting of polyacrylic acid (PAA), polyvinyl alcohol (PVA), polylactic acid (PLA) and polyglycolic acid (PGA). It is also envisaged that other suitable materials could also be used.
The device can include an additional layer surrounding the stiffening sheath. 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 stiffening element is a metal or bioresorbable stylet, the stiffening sheath can, in one embodiment, be formed from a shape memory alloy or a heat sensitive material. For example, the stiffening sheath can be formed from a nickel/titanium alloy, or a bimetallic element formed of a laminate of two different metals, that is shaped to take and maintain the straight or substantially straight configuration of the elongate member at room temperature but bends it into another shape once it is exposed to body temperature.
While both the stiffening element and the stiffening sheath are in position within the device, it will retain the first configuration, which as discussed is preferably straight. If the stiffening sheath is removed or softened, whether it is by dissolution or otherwise, the remaining stiffening element has insufficient strength to retain the elongate member in its first configuration. It is preferred that the elongate member, on removal or softening of the stiffening sheath, will adopt an intermediate configuration in which the elongate member has at least some curvature.
The purpose of allowing the elongate member to adopt this intermediate configuration is to enable the elongate member to be inserted into the cochlea in a way which minimises trauma to the walls of the cochlea. The preferred shape of this intermediate configuration is for the elongate member to assume a shape that is more curved than the straight configuration present upon insertion. By providing the previously straight array with a more curved shape, the elongate member is guided to adopt a mid-scala trajectory as it is inserted into the cochlea. This ensures that as the elongate member is carefully inserted deeper into the spiral shaped cochlea, the intermediate curved configuration assists in assuring that the elongate member can be inserted deep into the cochlea without causing excessive trauma to the walls of the cochlea.
On subsequent removal of the stiffening element, the elongate member is free to adopt the fully curved second configuration desired of an implant for final position in 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. The present invention also provides a means of assisting the insertion process of the electrode assembly into the cochlea by allowing the electrode assembly to alter its configuration during the insertion process to allow for deeper and more desirable cochlea penetration.
In one embodiment, the lead can extend from the elongate member to the stimulator means or at least the housing thereof. In one embodiment, the lead is continuous with no electrical connectors, at least external the housing. of the stimulator means, required to connect the wires extending from the electrodes to the stimulator means. One advantage of this arrangement is that there is no requirement for the surgeon implanting the device to make the necessary electrical connection between the wires extending from the electrodes and the stimulator means.
The stimulator means is preferably positioned within a housing that is implantable within the implanted. The housing for the stimulator means is preferably implantable within the bony well in the bone behind the ear posterior to the mastoid.
FIG. 3 is a simplified part-sectional, part side elevational view of the electrode assembly depicted in its second configuration following insertion in the cochlea;
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 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 cochlea upon insertion of the assembly 10.
Disposed within a lumen 14 is a substantially straight platinum stylet 15. The stylet 15 alone has a stiffness that is insufficient to retain the silicone elongate member 11 in a straight configuration.
While a platinum stylet is depicted, a bioresorbable stylet formed from a bioresorbable polyacrylic acid (PAA) that is adapted to dissolve or soften on exposure to cochlear fluids could be utilised with appropriate modification to the elongate carrier member 11. Equally, whilst a substantially cylindrical lumen is depicted, the lumen 14 could indeed be any shape necessary to perform the function. Again, the PAA stylet in this invention has a stiffness insufficient to retain the silicone elongate member 11 in a straight configuration as depicted in FIG. 1. It will be appreciated that a bioresorbable stylet could be formed from other suitable bioresorbable materials. A stylet made from a shape memory alloy or heat sensitive material could also be utilised as a stylet 15.
Overlaying the depicted elongate member 11 is a stiffening sheath 16 of bioresorbable material. The bioresorbable material of the depicted stiffening sheath 16 is PAA that is adapted to dissolve on exposure to cochlear fluids. Other suitable bioresorbable materials can be envisaged and such materials need not necessarily dissolve on exposure to fluids, the current invention could also function correctly if the sheath 16 is made of a material that softens upon exposure to fluids but does not get absorbed.
While the elongate member 11 is manufactured with a preformed curved configuration, the assembly 10 is typically delivered to a surgeon with the stylet 15 and sheath 16 in place. The combination of the stylet 15 and sheath 16 is sufficient to hold the elongate member 11 in the straight configuration depicted in FIG. 1.
On insertion into the scala tympani of the cochlea 30, the cochlear fluids commence to dissolve or soften the sheath 16. As the PAA softens and dissolves, the elongate member 11 commences to re-curl (see FIG. 2) as the stiffness of the stylet 15 is insufficient to hold the elongate member 11 straight. The provision of the stylet 15 within the elongate member 11 does, however, prevent the elongate member 11 from adopting its pre-formed spirally curved configuration.
As the elongate member 11 curls, the surgeon can continue to further insert the assembly 10 into the scala tympani 31 with a lessened risk of the member 11 puncturing fine tissues of the cochlea 30. It is possible that during the further insertion process the surgeon may simultaneously withdraw the platinum stylet 15 through the opening 17 of the lumen 14 at end 18. On withdrawal of the stylet 15, the elongate member 11 is free to adopt the spiral configuration depicted in FIG. 3 with the electrodes 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 in one arrangement the surgeon may withdraw the stylet 15 first and rely upon the sheath 16 to maintain the array in the intermediate position.
The combination of the stiffening element 15 and stiffening sheath 16 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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Applicant/Inventor: Anonymous (Kenneth Mason Publications Ltd., Emsworth, Hampshire, England); Comments on Relevance: Australian Search Report PR 1005.32Supplemental ESR for EP 01973835, dated Jan 22, 2004.33Supplementary European Search Report for EP 01975835 mailed May 15, 2009.34Supplementary European search Report for EP 01975875, dated May 8, 2009.35Supplementary European Search Report for European Patent Application No. 01973835, dated May 8, 2009.36Translation of a Notice of Reasons for rejection from the Japanese Patent Office for Japanese Patent Application No. 2002-535734.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS20120277544 *Apr 19, 2012Nov 1, 2012Medtronic, Inc.Biodegradable insertion guide for the insertion of a medical device* Cited by examinerClassifications U.S. Classification607/137, 600/585International ClassificationA61F11/00, A61N1/05, A61F11/04, A61F2/18Cooperative ClassificationA61F11/004, A61N1/0541European ClassificationA61N1/05K2Legal 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