Regenerative peripheral nerve interface

• US 9,808,616 B2
• Filed: 01/13/2012
• Issued: 11/07/2017
• Est. Priority Date: 01/14/2011
• Status: Active Grant

• Current Assignee: University of Delaware, Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: University of Delaware, Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Cederna, Paul S., Urbanchek, Melanie G., Martin, David C.
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US13/979,507
• Publication Number:
  US 20140005763A1
• Time in Patent Office: 2,125 Days
• Field of Search: 607 2, 607116, 607118
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/72 Bioelectric control, e.g. myoelectric
• CPC Class Codes: A61L 2430/32 for nerve reconstruction
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00

Abstract

The present disclosure provides a regenerative peripheral nerve interface (RPNI) for a subject comprising an insulating substrate, at least one metallic electrode deposited onto the insulating substrate forming a thin-film array; a portion of the at least one metallic electrode surface having a layer of a first conductive polymer and a layer of decellularized small intestinal submucosa (SIS) coating a portion of the electrode, wherein a second conductive polymer is electrochemically polymerized through the SIS to form the regenerative peripheral nerve interface. The present disclosure also provides that a layer of muscle tissue contacts the regenerative peripheral nerve interface.

Claims

1. A regenerative peripheral nerve interface (RPNI) for a subject comprising:

an insulating substrate and at least one metallic electrode disposed on or in the insulating substrate, so that the insulating substrate and the at least one metallic electrode define a thin-film array;

a layer of decellularized biotic material comprising decellularized small intestinal submucosa (SIS); and

at least one conductive polymer.

2. The regenerative peripheral nerve interface of claim 1, wherein the at least one conductive polymer is electrically polymerized through the layer of decellularized biotic material to form a soft, mechanically compliant interface with the thin-film array.

3. The regenerative peripheral nerve interface of claim 1, wherein the layer of decellularized biotic material is a coating disposed on a portion of a surface of the at least one metallic electrode.

4. The regenerative peripheral nerve interface of claim 1, wherein the at least one conductive polymer is disposed on a portion of a surface of the at least one metallic electrode.

5. The regenerative peripheral nerve interface of claim 1, wherein the insulating substrate is selected from a group consisting of:

poly-paraxylylene (parylene), polyimide, silicon dioxide, and combinations thereof.

6. The regenerative peripheral nerve interface of claim 1, wherein the at least one metallic electrode comprises a metallic material or a non-metallic material, wherein the metallic material is selected from a group consisting of Gold (Au), Platinum (Pt), Iridium (Ir), Palladium (Pd), Tungsten (W), Stainless Steel (SS), Indium-Tin-Oxide (ITO), Zinc, Titanium (Ti), alloys, oxides, and combinations thereof, and the non-metallic material is selected from a group consisting of:

poly(3,4-ethylenedioxythiophene) (PEDOT), poly(pyrrole), polyaniline, polyacetylene, polythiophene, ester derivative 3,4-propylenedioxythiophene (ProDOT), natural or synthetic melanin, derivatives, and combinations thereof.

7. The regenerative peripheral nerve interface of claim 1, wherein the thin-film array comprises 1 to 32 electrodes and has a diameter of less than or equal to about 1.5 mm, a length of less than or equal to about 3.6 mm, a width of less than or equal to about 3.6 mm, and a thickness of less than or equal to 15 μ

m.

8. The regenerative peripheral nerve interface of claim 1, wherein the thin-film array has a length of less than or equal to about 1.5 mm.

9. The regenerative peripheral nerve interface of claim 1, wherein the at least one conductive polymer comprises a first conductive polymer and a second conductive polymer.

10. The regenerative peripheral nerve interface of claim 9, wherein the first conductive polymer and the second conductive polymer are independently selected from a group consisting of:

poly(3,4-ethylenedioxythiophene) (PEDOT), poly(pyrrole), polyaniline, polyacetylene, polythiophene, ester derivative 3,4-propylenedioxythiophene (ProDOT), natural or synthetic melanin, derivatives, and combinations thereof.

11. The regenerative peripheral nerve interface of claim 9, wherein the first conductive polymer or the second conductive polymer comprises poly(3,4-ethylenedioxythiophene) (PEDOT).

12. The regenerative peripheral nerve interface of claim 1, further comprising a layer of muscle tissue contacting the regenerative peripheral nerve interface.

13. The regenerative peripheral nerve interface of claim 12, wherein the regenerative peripheral nerve interface is implanted on at least one nerve stump of a peripheral nerve of the subject.

14. The regenerative peripheral nerve interface of claim 12, wherein the regenerative peripheral nerve interface is connected to at least one sensor configured to control a prosthetic device.

15. A method of forming a regenerative peripheral nerve interface, the method comprising:

forming at least one metallic electrode in or on an insulating substrate, wherein the at least one metallic electrode and the insulating substrate define a thin-film array;

depositing a first layer of a conductive polymer onto a first portion of a surface of the at least one metallic electrode; and

coating a second portion of the surface of the at least one metallic electrode with a layer of decellularized biotic material comprising decellularized small intestinal submucosa (SIS) to form the regenerative peripheral nerve interface.

16. The method of claim 15, further comprising electrically polymerizing a second conductive polymer through the layer of decellularized biotic material.

17. The method of claim 15, further comprising implanting the regenerative peripheral nerve interface on at least one nerve ending of a peripheral nerve of a subject.

18. The method of claim 17, wherein the implanted regenerative peripheral nerve interface is biologically stable for about a year to the lifetime of the subject.

19. The method of claim 15, wherein the regenerative peripheral nerve interface is capable of connecting with at least one sensor of a prosthetic device.

20. The method of claim 15, wherein the regenerative peripheral nerve interface is connected to at least one sensor of a prosthetic device in a subject, and the regenerative peripheral nerve interface is capable of controlling the prosthetic device.

21. A regenerative peripheral nerve interface device for interfacing between a peripheral nerve of a subject and a prosthetic device, the regenerative peripheral nerve interface device comprising:

an insulating substrate;

at least one metallic electrode disposed in or on the insulating substrate defining a thin-film array, a portion of a surface of the at least one metallic electrode having a layer of a first conductive polymer;

a layer of decellularized small intestinal submucosa (SIS) coating a portion of the surface of the at least one metallic electrode, wherein a second conductive polymer is electrochemically polymerized through the SIS to form a regenerative peripheral nerve interface; and

a layer of muscle tissue contacting the regenerative peripheral nerve interface.

22. The regenerative peripheral nerve interface device of claim 21, wherein the regenerative peripheral nerve interface device is implanted on at least one nerve stump of the peripheral nerve of the subject.

23. The regenerative peripheral nerve interface device of claim 21, wherein the regenerative peripheral nerve interface device is connected to at least one sensor configured to control the prosthetic device.