Devices, systems, and methods employing a molded nerve cuff electrode

• US 20080172116A1
• Filed: 01/16/2007
• Published: 07/17/2008
• Est. Priority Date: 01/16/2007
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, Inc. (Medtronic Plc)
• Inventors: Rundle, Kenneth P., Mrva, Joseph J., Boggs, Joseph W.
• Granted Patent: US 7,996,092 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

Devices, systems, and methods for recording, and/or stimulation, and/or blocking of a nerve make use of a molded nerve cuff electrode. One or more electrodes are positioned in one or more frames within a casing. The exterior surface of the casing is wrapped in an insulating material, and the wrapped casing is positioned within a cover tube. One or more additional electrodes may be positioned anywhere outside of the casing. An applicator tool having a body to hold the molded nerve cuff in an expanded configuration is used to implant the cuff about a nerve.

Claims

1. An implantable cuff electrode for placement about a biological tissue comprising:

an inner elastic body, the inner elastic body having at least one aperture sized and configured to accept at least one electrically conductive surface,

the at least one electrically conductive surface positioned in the at least one aperture and configured to allow contact between the electrically conductive surface and the biological tissue to be surrounded,

an insulating material positioned over the inner elastic body and the at least one electrically conductive surface, and

a cover tube positioned over the insulating material.

2. The implantable cuff electrode of claim 1

wherein the insulating material is secured to at least a portion of the inner elastic body.

3. The implantable cuff electrode of claim 1

wherein the cover tube is secured to at least a portion of the insulating material.

4. The implantable cuff electrode of claim 1

wherein the inner elastic body includes a longitudinal split extending the length of the inner elastic body.

5. The implantable cuff electrode of claim 1

wherein the cover tube includes a longitudinal split extending the length of the cover tube.

6. The implantable cuff electrode of claim 1

wherein the inner elastic body comprises an expansion portion and a non-expansion portion.

7. The implantable cuff electrode of claim 1

wherein the cover tube comprises an expansion portion and a non-expansion portion.

8. The implantable cuff electrode of claim 1

wherein the cover tube extends in a range of about 350 degrees to about 540 degrees from end to end.

9. The implantable cuff electrode of claim 1

wherein the biological tissue comprises at least one nerve.

10. The implantable cuff electrode of claim 1

further including at least one additional electrically conductive surface that is positioned away from an inside surface of the cuff, the at least one additional electrically conductive surface being in electrical conductive contact with the at least one electrically conductive surface positioned in the inner elastic body.

11. The implantable cuff electrode of claim 1

wherein the inner elastic body includes a. longitudinal split extending the length of the inner elastic body and the cover tube includes a longitudinal split extending the length of the cover tube.

12. The implantable cuff electrode of claim 11

wherein the inner elastic body longitudinal split and the cover tube longitudinal split are out of phase and are sized and configured to provide an access point to open the cuff electrode for placement about the biological tissue.

13. The implantable cuff electrode of claim 1

wherein the cover tube includes at least one aperture sized and configured to accept at least one cover tube electrically conductive surface.

14. The implantable cuff electrode of claim 13

wherein the at least one cover tube electrically conductive surface is positioned in the at least one aperture in the cover tube and configured so there is no intimate contact between the cover tube electrically conductive surface and the biological tissue surrounded.

15. A method of manufacturing a cuff electrode comprising:

conductively coupling at least one wire to at least one electrically conductive surface,

positioning the at least one electrically conductive surface in an aperture within an inner elastic body,

placing an insulating material around at least a portion of the inner elastic body, and

positioning a cover tube over the assembled inner elastic body, at least one electrically conductive surface, and insulating material.

16. The method according to claim 15:

wherein the positioning the cover tube includes securing the cover tube to at least a portion of the insulating material using an implantable bonding technique.

17. The method according to claim 15:

wherein the positioning the at least one electrically conductive surface includes securing the electrically conductive surface in the aperture of the inner elastic body using an implantable bonding technique.

18. The method according to claim 15:

wherein the placing further includes securing the insulating material to at least a portion of the inner elastic body using an implantable bonding technique.

19. A system for neuronal recording and/or stimulating and/or blocking, the system comprising:

an implantable lead having a proximal end and a distal end,

a cuff electrode coupled to the distal end of the lead, the cuff electrode comprising

an inner elastic body, the inner elastic body having at least one aperture sized and configured to accept at least one electrically conductive surface,

the at least one electrically conductive surface positioned in the at least one aperture and configured to allow contact between the electrically conductive surface and a biological tissue to be surrounded,

an insulating material positioned over the inner elastic body and the at least one electrically conductive surface, and

a cover tube positioned over the insulating material,

the lead encapsulating a wire element extending from the at least one electrically conductive surface to the proximal end of the lead, and

the proximal end of the lead being coupled to a stimulation pulse generator.

20. The system according to claim 19:

wherein the proximal end of the lead comprises an implantable IS-1 connector.

21. The system according to claim 19:

further including means to anchor the distal portion of the lead to surrounding tissue.