Cochlear electrode implant assemblies with positioning system therefor

• US 5,545,219 A
• Filed: 03/30/1995
• Issued: 08/13/1996
• Est. Priority Date: 03/30/1995
• Status: Expired due to Fees

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Kuzma, Janusz A.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/414,656
• Time in Patent Office: 502 Days
• Field of Search: 623/10, 607/137, 607/56, 607/116
• US Class Current: 623/10
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An implantable cochlear electrode assembly includes an initially straight flexible rod-like electrode carrier and an initially straight flexible rod-like positioning member which extend in substantially parallel relation to and closely alongside each other. The assembly is inserted endwise into the scala tympani of the cochlea so as to adopt the spiral curvature of the cochlea, with the positioning member being disposed at that side region of the electrode carrier which faces the outer wall of the cochlea and is opposite to the side region of the electrode carrier at which the contact faces of the array of electrodes are exposed. The electrode carrier and the positioning member are connected to each other at their respective leading and trailing end regions but are separate from and unconnected to each other over their entire medial regions, so that the positioning member can assume an outwardly arched configuration relative to the electrode carrier for forcing the latter into a close hugging engagement with the modiolus and for disposing the contact faces of the electrodes in as close a juxtaposition to the cells of the spiral ganglion as possible. With the trailing end region of the positioning member locked to the trailing end region of the electrode carrier, a stable implantation of the assembly is achieved.

Claims

1. A self-positioning cochlear electrode implant assembly adapted to be implanted in the scala tympani of the spirally curved cochlea of a human ear for stimulating cells of the spiral ganglion, said assembly comprising:

a rod-shaped cochlear electrode carrier made of a biocompatible plastic material and sufficiently flexible to be able to assume the spiral curvature of the cochlea, said electrode carrier having leading and trailing end regions and tapering in cross-section from said trailing end region to said leading end region;

an array of cochlear electrode elements supported by said electrode carrier at respective longitudinally spaced locations thereon in a medial region of said electrode carrier between said leading and trailing end regions thereof, said electrode elements having respective contact faces exposed along a first longitudinal side region of said electrode carrier;

a rod-shaped electrode carrier-positioning member made of a biocompatible plastic material and sufficiently flexible to be able to assume the spiral curvature of the cochlea, said positioning member having leading and trailing end regions and being juxtaposed to and extending lengthwise of said electrode carrier along a second longitudinal side region of the latter opposite said first longitudinal side region thereof so as to have said leading and trailing end regions of said positioning member located adjacent said leading and trailing end regions, respectively, of said electrode carrier; and

means connecting said leading and trailing end regions of said positioning member to said leading and trailing end regions, respectively, of said electrode carrier so as to leave a medial region of said positioning member separated from said medial region of said electrode carrier and adapted to assume an arched configuration relative to said medial region of said electrode carrier upon insertion of the assembly into the cochlea;

whereby, upon insertion of said assembly into the scala tympani with said positioning member engaging and closely following the curvature of the radially outer wall of the cochlea and with said electrode carrier juxtaposed to and closely following the curvature of said positioning member, said positioning member when assuming said arched configuration against the constraint of the radially outer wall of the cochlea exerts a force on said electrode carrier at said leading and trailing end regions thereof to shift said electrode carrier into engagement of said first longitudinal side region thereof with the radially inner wall of the cochlea so as to position said contact faces of said array of electrode elements in close proximity to the spiral ganglion cells of the cochlea; and

said means connecting said trailing end region of said electrode carrier and said trailing end region of said positioning member further serves, when the insertion of said assembly into the cochlea has been completed and said positioning member is in said arched configuration thereof, to stabilize said assembly in and lock the same against inadvertent reverse movement out of the cochlea.

2. A cochlear electrode implant assembly according to claim 1, wherein said means for connecting said trailing end regions of said electrode carrier and said positioning member to each other comprises a fitting having a body which, when said electrode carrier and said positioning member are in side by side relation to each other, surrounds and accommodates said trailing end regions of said electrode carrier and said positioning member;

and said body of said fitting has a forward end at which a portion of said fitting constitutes means enabling said positioning member, after the same has been moved forwardly through said fitting and relative to said electrode carrier to assume said arched configuration, to be locked against a reverse movement relative to said electrode carrier that would permit said positioning member to return to its side by side relation with said electrode carrier.

3. A cochlear electrode implant assembly according to claim 1, wherein said means for connecting said trailing end regions of said electrode carrier and said positioning member to each other comprises a fitting having a body with at least partly arcuate exterior peripheral portions, forward and rearward ends, and an interior partition extending from one end of said body to the other to provide said fitting with first and second substantially parallel passageways extending therethrough for accommodating said electrode carrier and said positioning member, respectively;

the portion of said body of said fitting which in conjunction with said partition defines one of said first and second passageways is permanently affixed to the respective one of said electrode carrier and said positioning member extending through said one passageway;

the portion of said body of said fitting which in conjunction with said partition defines the other of said first and second passageways is dimensioned for permitting sliding relative movement between said fitting and the respective other of said electrode carrier and said positioning member extending through said other passageway; and

said portion of said body of said fitting in which said other passageway is located is provided with means enabling said other of said electrode carrier and said positioning member to be locked against movement through said other passageway.

4. A cochlear electrode implant assembly according to claim 3, wherein said second passageway is dimensioned to permit sliding relative movement between said fitting and said positioning member, and the portion of said body of said fitting in which said second passageway is located is provided with said means enabling said positioning member to be locked against movement through said second passageway.

5. A cochlear electrode implant assembly according to claim 3 or 4, wherein the portion of said body of said fitting in which said first passageway is located is permanently fixed to said electrode carrier.

6. A cochlear electrode implant assembly according to claim 3 or 4, wherein said portion of said body of said fitting in which said second passageway is located is provided with unidirectionally acting means permitting forward movement but preventing reverse movement of said positioning member through said second passageway.

7. A cochlear electrode implant assembly according to claim 6, wherein said unidirectionally acting means comprises a strip member supported by and extending forwardly from said portion of said body of said fitting in which said second passageway is located, said strip member being inclined toward the axis of said second passageway and having a forward end edge which is in sliding engagement with a first surface region of said positioning member when the latter moves forwardly through said second passageway, said forward end edge of said strip member being sufficiently sharp to bite into said first surface region of said positioning member and thereby wedge said positioning member against reverse movement through said second passageway substantially immediately upon start of such reverse movement.

8. A cochlear electrode implant assembly according to claim 7, wherein said strip member is supported by and extends forwardly from said partition at an inclination toward the axis of said second passageway.

9. A cochlear electrode implant assembly according to claim 8, wherein strip member is supported by said partition adjacent the rearwardmost end of said partition and extends forwardly therefrom within the confines of said second passageway.

10. A cochlear electrode implant assembly according to claim 9, wherein said strip member is welded to said partition.

11. A cochlear electrode implant assembly according to claim 9, wherein said strip member is an integral extension of said partition at said rearwardmost end of said partition and is bent over therefrom into said second passageway.

12. A cochlear electrode implant assembly according to claim 9, wherein said portion of said body of said fitting in which said second passageway is located has a forward end edge which is spaced from said forward end edge of said strip member and in sliding engagement with a second surface region of said positioning member, and which is sufficiently sharp to bite into said second surface region of said positioning member and thereby assist in wedging said positioning member against reverse movement through said second passageway substantially immediately upon start of such reverse movement.

13. A cochlear electrode implant assembly according to claim 1, wherein each of said electrode carrier and said positioning member has the form of a solid rod;

and said means connecting said leading end regions of said electrode carrier and said positioning member to each other comprises a ball-and-socket joint including a ball component and a correspondingly configured socket component each provided on a respective one of said electrode carrier and said positioning member.

14. A cochlear electrode implant assembly according to claim 13, wherein said ball component of said joint is located on said electrode carrier, and said socket component of said joint is located on said positioning member.

15. A cochlear electrode implant assembly according to claim 14, wherein said ball component of said joint comprises a plurality of bundled wires of a biocompatible metallic material which at a first end region thereof are embedded in said electrode carrier and which project from said leading end region of said electrode carrier generally longitudinally thereof, and said bundled wires exteriorly of said electrode carrier terminate in a second end region and thereat support a ball member;

said socket component of said joint comprises an axial rearwardly extending slit provided in said leading end region of said positioning member in a common axial plane of both said positioning member and said electrode carrier, and a ball member-receiving surface recess or depression provided on said positioning member on a side region of the latter which is directed away from said electrode carrier and at a location straddling said slit, said slit being dimensioned to accommodate the portion of said bundled wires between said first and second end regions of the latter; and

said joint is established by said portion of said bundled wires being received in said slit and said ball member being received and seated in said recess or depression.

16. A cochlear electrode implant assembly according to claim 1, wherein each of said electrode carrier and said positioning member has the form of a solid rod;

said means connecting said trailing end regions of said electrode carrier and said positioning member to each other comprises a tubular fitting having a body provided with an internal generally axial partition and defining on opposite sides of said partition first and second substantially parallel passageways extending through and generally axially of said tubular fitting for accommodating said electrode carrier and said positioning member, respectively;

the portion of said body of said tubular fitting which defines said first passageway is permanently fixed to said electrode carrier for joint movement of said tubular fitting with said electrode carrier;

the portion of said body of said tubular fitting which defines said second passageway is dimensioned to permit sliding movement of said positioning member relative thereto; and

said tubular fitting is provided with means adapted to be activated upon completion of the insertion of said assembly into the cochlea for immobilizing said positioning member in said arched configuration thereof against reverse movement of said positioning member relative to said tubular fitting and for thereby stabilizing said assembly in the cochlea.

17. A cochlear electrode implant assembly according to claim 16, wherein the portion of said body of said tubular fitting which defines said second passageway is deformable to permit crimping thereof onto said positioning member, and said deformable portion of said body of said tubular fitting constitutes said means activatable for immobilizing said positioning member.

18. A cochlear electrode implant assembly according to claim 17, wherein said tubular fitting comprises a length of wire spirally wound to define both an outer wall of said body of said tubular fitting and said internal partition thereof between said first and second passageways.

19. A cochlear electrode implant assembly according to claim 16, wherein the portion of said body of said tubular fitting which defines said internal partition thereof is provided with a unidirectionally acting structure extending from said partition toward the axis of said second passageway for engagement with said positioning member when the latter is accommodated in said second passageway, said unidirectionally acting structure is arranged to permit forward movement and to block reverse movement of said positioning member through said second passageway, and said unidirectionally acting structure constitutes said means activatable for immobilizing said positioning member.

20. A cochlear electrode implant assembly according to claim 19, wherein said unidirectionally acting structure comprises a strip member projecting forwardly from said partition and inclined at an angle toward said axis of said second passageway, said strip member having a forward edge which does not interfere with forward movement of said positioning member through said second passageway but which is able to bite into said positioning member for blocking any reverse movement of the latter.

21. A cochlear electrode implant assembly according to claim 20, wherein said tubular fitting comprises a strip of metal wound to define both an outer wall of said body of said tubular fitting and said internal partition thereof between said first and second passageways, and the portion of said strip which constitutes said partition has a lateral angularly inclined extension which constitutes said strip member.

22. A cochlear electrode implant assembly according to claim 1, wherein said electrode carrier has the form of a solid rod;

said positioning member comprises an elastic axially compressed tube the length of which between its leading and trailing end regions in its compressed state is somewhat greater than the length of said array of electrode elements on said electrode carrier, and a flexible tension member extending slidably through said tube and having first and second end regions projecting from said tube at said leading and said trailing end regions, respectively, of said tube;

said means for connecting said leading end regions of said electrode carrier and said positioning member to each other comprises a fixed connection between said first end region of said tension member and said leading end region of said electrode carrier; and

said means connecting said trailing end regions of said electrode carrier and said positioning member to each other comprises a fixed connection between said trailing end region of said tube and said trailing end region of said electrode carrier, and means for releasably attaching said second end region of said tension member to said electrode carrier outside and somewhat rearwardly of said fixed trailing end region of said tube;

whereby said attaching means, when activated with said tension member straight prior to the insertion of said assembly into the cochlea, serves to maintain said positioning member in close juxtaposition to said electrode carrier while permitting both said electrode carrier and said positioning member jointly to assume the curvature of the cochlea;

when deactivated after insertion of said assembly into the cochlea, serves to release said tension member so as to permit said tube, while stiffened by said tension member, to expand and assume said arched configuration and to shift said electrode carrier within the cochlea so as to juxtapose said contact faces of said array of electrode elements to the spiral ganglion cells; and

when reactivated with said positioning member in said arched configuration thereof, serves to immobilize said tension member so as to maintain said positioning member in said arched configuration for thereby to stabilizing said assembly in the cochlea.

23. A cochlear electrode implant assembly according to claim 22, wherein said tension member is a wire of a biocompatible metal.

24. A cochlear electrode implant assembly according to claim 1, wherein each of said electrode carrier and said positioning member has the form of a solid rod, said electrode carrier being made of a biocompatible plastic material which is resistant to swelling or expanding when exposed to water, and said positioning member being made of a biocompatible plastic material which has the property of swelling or expanding when exposed to water;

and said means connecting said leading and trailing end regions of said electrode carrier to said leading and trailing end regions, respectively, of said positioning member comprise a pair of fixed connections therebetween;

whereby during the insertion of said assembly into the cochlea, said electrode carrier and said positioning member remain in close juxtaposition to each other and jointly assume the curvature of the cochlea;

after the insertion, upon said assembly being exposed over a period of time to the action of the water in the person'"'"'s body fluid present in the cochlea, said positioning member expands and assumes said arched configuration and shifts said electrode carrier within the cochlea so as to juxtapose said contact faces of said array of electrode elements to the spiral ganglion cells; and

said positioning member in said arched configuration serves to immobilize said assembly for stabilizing the same in the cochlea.

25. A cochlear electrode implant assembly according to claim 24, wherein said fixed connections between said electrode carrier and said positioning member are molded or bonded joints.