Conduit for peripheral nerve replacement

Patent metadata

Field	Value
Publication number	US-9675358-B2
Application number	US-201314391346-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Apr 12, 2012
Publication date	Jun 13, 2017
Grant date	Jun 13, 2017

Abstract

A biphasic material and devices comprising the same are provided for the development of conductive conduits that may be used for the treatment of peripheral nerve injury. These devices or conduits are designed such that repeated electric field gradients can be initiated to promote neurite and axonal outgrowth. Conducting conduits using doped synthetic and/or natural polymers create specifically patterned high and low conducting segmented materials, which are mechanically used to produce the electrical properties needed for nerve conduits. These electrical properties stimulate neurite outgrowth and axonal repair following a peripheral nerve transection.

First claim

What is claimed is:

1. A biphasic material, comprising at least two first segments and at least two second segments, the first segments comprising a doped conductive polymer having a first polymer component doped with a non-metal component which increases the conductivity of the first polymer component, and the second segments comprising a second conductive polymer component, wherein the at least two first segments are disposed in contact with the at least two second segments, in alternating fashion, to provide the biphasic material with repeating alternating first and second polymer components.

2. The biphasic material of claim 1 , wherein the first polymer component comprises a bioabsorbable polymer.

3. The biphasic material of claim 1 , wherein the first polymer component comprises poly glycerol sebacate, an esterified polyglycerol sebacate, glycolic acid, polydiolcitrate, poly(ester-urethane)urea, polycaprolactone, hydroxyapatite, hyaluronic acid, alginate, collagen, elastin, vimentin, laminin, fibrin, melanin, gum arabic, polycaprolactonefumarate, poly(octane diol) citrate, lactic acid, or combinations thereof.

4. The biphasic material of claim 3 , wherein the esterified polyglycerol sebacate is acrylated polyglycerol sebacate.

5. The biphasic material of claim 1 , wherein the second polymer component comprises a bioabsorbable polymer.

6. The biphasic material of claim 1 , wherein the second polymer component comprises poly glycerol sebacate, an esterified polyglycerol sebacate, glycolic acid, polydiolcitrate, poly(ester-urethane)urea, polycaprolactone, hydroxyapatite, alginate, hyaluronic acid, collagen, elastin, vimentin, laminin, fibrin, melanin, gum arabic, polycaprolactonefumarate, poly(octane diol) citrate, lactic acid, or combinations thereof.

7. The biphasic material of claim 6 , wherein the esterified polyglycerol sebacate is acrylated polyglycerol sebacate.

8. The biphasic material of claim 1 , wherein the non-metal component comprises polypyrrole, polyaniline, poly(3,4-ethylenedioxythiophene), polyacetylene carbon nanotubes, a silicate, or combinations thereof.

9. The biphasic material of claim 1 , wherein the non-metal component has a conductivity in the range of 5-200 S/cm.

10. The biphasic material of claim 1 , wherein the first polymer component and second polymer component are configured to support differing electric field gradients, respectively, therein.

11. The biphasic material of claim 1 , wherein the doped conductive polymer has a conductivity of 10 −6 -10 −4 S/cm.

12. The biphasic material of claim 1 , wherein the second polymer component has a conductivity less than 1.25×10 −5 S/cm.

13. The biphasic material of claim 1 , wherein the first segments have the mechanical properties of native human nerve tissue.

14. The biphasic material of claim 13 , wherein the first polymer has one or more of an elastic modulus of 0.4-0.7 mPa and a tensile strength of 0.21-1.49 N.

15. The biphasic material of claim 13 , wherein the second segments have the mechanical properties of native human nerve tissue.

16. The biphasic material of claim 15 , wherein the second polymer has one or more of an elastic modulus of 0.4-0.7 mPa and a tensile strength of 0.21-1.49 N.

17. A method of repairing a damaged nerve, comprising:
a. providing a tube having a hollow lumen with opposing proximal and distal open ends, the tube comprising the biphasic material of claim 1 , wherein the tube is configured to support a plurality of electric field gradients along its length and permit the ingrowth of nerve tissue within the lumen; and
b. securing a proximal stump of the damaged nerve within the proximal end of the tube and, securing a distal stump of the damaged nerve within the distal end of the tube such that proximal and distal stump of the damaged nerve are in electrical communication with the tube.

18. The method according to claim 17 , further comprising seeding the tube with one or more of Schwann cells, neuronal cells, stem cells, and fibroblasts.

19. The biphasic material according to claim 1 , comprising one or more of Schwann cells, neuronal cells, stem cells, and fibroblasts.

20. The biphasic material of claim 1 , wherein the first polymer component is acrylated polyglycerol sebacate, the second polymer component is acrylated polyglycerol sebacate, and the non-metal component is polypyrrole.

21. An open-ended, hollow tube configured to support a plurality of electric field gradients along its length and having a lumen extending therethrough to permit the growth of nerve tissue therein, the tube comprising a plurality of first conductive tubular segments and a plurality of second conductive tubular segments adjoined along a common axis of the tube to provide the lumen along the common axis, the first conductive tubular segments comprising a first polymer component doped with a non-metal component which increases the conductivity of the first polymer component, and the second tubular segments comprising a second conductive polymer component.

22. The tube according to claim 21 , wherein the tube is bioresorbable.

23. The tube according to claim 21 , wherein the first polymer component comprises a bioabsorbable polymer.

24. The tube according to claim 21 , wherein the first polymer component comprises poly glycerol sebacate, an esterified polyglycerol sebacate, glycolic acid, polydiolcitrate, poly(ester-urethane)urea, polycaprolactone, hydroxyapatite, alginate, collagen, elastin, vimentin, laminin, fibrin, melanin, hyaluronic acid, gum arabic, polycaprolactonefumarate, poly(octane diol) citrate, lactic acid, or combinations thereof.

25. The tube according to claim 24 , wherein the esterified polyglycerol sebacate is acrylated polyglycerol sebacate.

26. The tube according to claim 21 , wherein the second polymer component comprises a bioabsorbable polymer.

27. The tube according to claim 21 , wherein the second polymer component comprises poly glycerol sebacate, an esterified polyglycerol sebacate, glycolic acid, polydiolcitrate, poly(ester-urethane)urea, polycaprolactone, hydroxyapatite, alginate, collagen, elastin, vimentin, laminin, hyaluronic acid, fibrin, melanin, gum arabic, polycaprolactonefumarate, poly(octane diol) citrate, lactic acid, or combinations thereof.

28. The tube according to claim 27 , wherein the esterified polyglycerol sebacate is acrylated polyglycerol sebacate.

29. The tube according to claim 21 , wherein the non-metal component comprises polypyrrole, polyaniline, poly(3,4-ethylenedioxythiophene), polyacetylene carbon nanotubes, a silicate, or combinations thereof.

30. The tube according to claim 21 , wherein the non-metal component has a conductivity in the range of 5-200 S/cm.

31. The tube according to claim 21 , wherein the second polymer components has a relatively lower conductivity than the first polymer component.

32. The tube according to claim 21 , wherein the doped conductive polymer has a conductivity of 10 −6 -10 −4 S/cm.

33. The tube according to claim 21 , wherein the second polymer component has a conductivity less than 1.25×10 −5 S/cm.

34. The tube according to claim 21 , wherein the first tubular segments have the mechanical properties of native human nerve tissue.

35. The tube according to

Assignees

• Univ Wake Forest Health Sciences

Inventors

• Wagner William D
• Levi Nicole
• Rosenbalm Tabitha
• Argenta Louis C
• Morykwas Michael J

Classifications

• A61B17/1128 Primary

  of nerves · CPC title

• A61L2400/12

  Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces · CPC title

• A61L2430/32

  for nerve reconstruction · CPC title

• A61L27/26

  Mixtures of macromolecular compounds · CPC title

• A61F2/0077

  Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence) · CPC title