Peripheral nerve interface devices for treatment and prevention of neuromas

• US 9,352,146 B2
• Filed: 07/17/2013
• Issued: 05/31/2016
• Est. Priority Date: 01/14/2011
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Langhals, Nicholas B., Cederna, Paul S., Urbanchek, Melanie G.
• Primary Examiner(s): Lavert, Nicole F
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US13/944,167
• Publication Number:
  US 20130304174A1
• Time in Patent Office: 1,049 Days
• Field of Search: 600/373, 600/393, 623/23.51, 623/23.75, 623/23.76, 607/2, 607/116, 607/118
• US Class Current: 1/1
• 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 nerve interface devices, such as passive or active nerve caps or regenerative peripheral nerve interface devices (RPNI), for a subject in need thereof. The nerve interface devices include nerve interface cap devices capable of treating, minimizing, or preventing formation of neuromas in severed or damaged nerve endings. Such a nerve interface device includes a housing that may be formed of a scaffold, such as a biotic material or hydrogel, an autograft, and optionally an electrode and/or conducting polymer. The autograft may be free muscle or free skin tissue, which is attached to the nerve ending to permit reinnervation. The present disclosure also provides methods for treating, minimizing, or preventing neuroma formation in a subject having a severed or damaged nerve, especially a peripheral nerve.

Claims

1. An implantable nerve interface cap device to treat, minimize, or prevent neuroma formation in a nerve of a subject, the device comprising:

a housing comprising a scaffold material, the housing defining an enclosed cylindrical capped structure having a single opening capable of receiving a nerve ending therein; and

an interior region within the housing for receiving an autograft of muscle tissue or dermis tissue from the subject, wherein the interior region facilitates contact of the autograft with a portion of the nerve ending after implantation, so that the nerve ending grows within and innervates the autograft in the interior region of the housing to treat, minimize, or prevent neuroma formation.

2. The implantable nerve interface cap device of claim 1, wherein the device is passive and free of any electrodes.

3. The implantable nerve interface cap device of claim 1, wherein the housing further comprises a second scaffold material disposed therein.

4. The implantable nerve interface cap device of claim 1, wherein the housing has a length of less than or equal to about 10 cm and a diameter of less than or equal to about 10 cm.

5. The implantable nerve interface cap device of claim 1, wherein the scaffold material is selected from a group consisting of:

a decellularized biotic material, a hydrogel, a biological scaffold material, a polymeric material, a cellularized biotic or abiotic material, and combinations thereof.

6. The implantable nerve interface cap device of claim 5, wherein the scaffold material comprises a decellularized small intestinal submucosa (SIS).

7. An implantable nerve interface cap device to treat, minimize, or prevent neuroma formation in a nerve of a subject, the device comprising:

a housing formed of a scaffold material selected from a group consisting of;

a decellularized biotic material, a biological scaffold material, a cellularized biotic or abiotic material, and combinations thereof, wherein the housing defines an enclosed cylindrical capped structure having a single opening capable of receiving a portion of a nerve ending therein;

an interior region within the housing for receiving an autograft of muscle tissue or dermis tissue from the subject, wherein the interior region facilitates contact of the autograft with the portion of the nerve ending after implantation, so that the nerve ending grows within and innervates the autograft in the interior region of the housing; and

one or more electrodes disposed within at least a portion of the housing in electrical communication with the nerve ending, muscle tissue or dermis tissue, or both the nerve ending and muscle tissue or dermis tissue, wherein the one or more electrodes are used to apply electrical stimulation for pain modulation and/or desensitizing of the nerve ending so that the implantable nerve interface cap device treats, minimizes, or prevents neuroma formation.

8. The implantable nerve interface cap device of claim 7, wherein the housing further comprises at least one electrically conductive polymer in electrical communication with the nerve ending, the one or more electrodes, or the nerve ending and the one or more electrodes.

9. The implantable nerve interface cap device of claim 8, wherein the electrically conductive polymer 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.

10. The implantable nerve interface cap device of claim 7, wherein the scaffold material comprises a decellularized small intestinal submucosa (SIS).

11. The implantable nerve interface cap device of claim 7, wherein the one or more electrodes comprise a metallic or semiconductor material selected from a group consisting of:

Gold (Au), Platinum (Pt), Iridium (Ir), Palladium (Pd), Tungsten (W), Stainless Steel (SS), Indium-Tin-Oxide (ITO), Zinc (Zn), Titanium (Ti), Carbon (C), Silicon (Si), alloys, oxides, nitrides, and combinations thereof.

12. The implantable nerve interface cap device of claim 7, wherein the housing has a length of less than or equal to about 10 cm and a diameter of less than or equal to about 10 cm and the one or more electrodes have a maximum dimension of less than or equal to about 10 cm.

13. The implantable nerve interface cap device of claim 12, wherein the one or more electrodes have a maximum thickness of less than or equal to about 5 mm.

14. The implantable nerve interface cap device of claim 7, wherein the one or more electrodes comprise a thin-film array comprising a plurality of 1 to 64 individual electrodes, wherein the thin-film array 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, and a thickness of less than or equal to about 50 μ

m.

15. A method for treating, minimizing, or preventing neuroma formation in a subject having a severed or damaged nerve ending, the method comprising:

disposing an autograft having a predetermined size comprising muscle tissue or dermis tissue removed from the subject within a housing of an implantable nerve interface cap device, wherein the housing defines an enclosed cylindrical capped structure having a single opening and comprises a scaffold material; and

securing a portion of the nerve ending within the housing, wherein the nerve ending contacts the autograft after implanting the nerve interface cap device, so that the nerve ending grows within and innervates the autograft, thus treating, minimizing, or preventing neuroma formation in the nerve ending.

16. The method according to claim 15, wherein the implantable nerve interface cap device further comprises an electrode and the method further comprises applying electrical current to the electrode for desensitizing the nerve ending and modulating pain associated with the nerve ending in the subject.

17. The method according to claim 15, wherein the subject has a nerve that has been divided into a plurality of nerve endings, wherein the disposing and securing are repeated for each respective nerve ending with a plurality of distinct implantable nerve interface cap devices.

18. An implantable nerve interface cap device to treat, minimize, or prevent neuroma formation in a nerve of a subject, the device comprising:

a housing comprising a scaffold material, the housing defining an enclosed cylindrical capped structure having a single opening capable of receiving a nerve ending therein; and

an interior region within the housing having an autograft of muscle tissue or dermis tissue from the subject, wherein the interior region facilitates contact of the autograft with a portion of the nerve ending after implantation, so that the nerve ending grows within and innervates the autograft in the interior region of the housing to treat, minimize, or prevent neuroma formation.