Methods and systems for nerve regeneration

• US 20060194724A1
• Filed: 02/25/2005
• Published: 08/31/2006
• Est. Priority Date: 02/25/2005
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carbunaru, Rafael, Jaax, Kristen N., Whitehurst, Todd K., McGivern, James P., McClure, Kelly H.
• Application Number:
  US11/066,993
• Publication Number:
  US 20060194724A1
• Time in Patent Office: Days
• US Class Current: 514/423
• CPC Class Codes: A61K 38/185 Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
• CPC Class Codes: A61K 38/45 Transferases (2)
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells

Abstract

An exemplary method of regenerating a nerve within a patient includes implanting a system control unit within the patient and applying a stimulus to the nerve with the system control unit in accordance with one or more control parameters. The stimulus is configured to promote regeneration of the nerve. An exemplary system for regenerating a nerve within a patient includes a system control unit configured to apply a stimulus to the nerve in accordance with one or more control parameters. The system control unit is implanted within the patient and the stimulus promotes the regeneration of the nerve.

Claims

1. A method of regenerating a nerve within a patient, said method comprising:

implanting a system control unit within said patient; and

applying a stimulus to said nerve with said system control unit in accordance with one or more control parameters;

wherein said stimulus promotes said regeneration of said nerve.

2. The method of claim 1, wherein said system control unit is coupled to one or more electrodes, and wherein said stimulus comprises a stimulation current delivered via said electrodes.

3. The method of claim 2, wherein said control parameters control one or more of a frequency of said stimulation current, a pulse width of said stimulation current, and an amplitude of said stimulation current.

4. The method of claim 1, wherein said system control unit is connected to at least one catheter, and wherein said stimulus comprises stimulation via one or more drugs delivered through said at least one catheter.

5. The method of claim 4, wherein said control parameters control one or more of an amount of said one or more drugs delivered through said at least one catheter and a rate of delivery of said one or more drugs through said at least one catheter.

6. The method of claim 5, wherein said one or more drugs comprise at least one or more of a neurotrophic factor, a nerve growth factor, a brain-derived neurotropic factor, a Schwann cell product, a neurotrophic tyrosine kinase type two (TrkB), a protein kinase A (PKA), and a L2/HNK-1 carbohydrate.

7. The method of claim 1, wherein said system control unit is coupled to one or more electrodes and to at least one catheter, and wherein said stimulus comprises a stimulation current delivered via said electrodes and stimulation via one or more drugs delivered through said at least one catheter.

8. The method of claim 1, further comprising sensing at least one condition and using said at least one sensed condition to automatically adjust one or more of said control parameters.

9. The method of claim 8, wherein said at least one sensed condition is at least one or more of a neurotransmitter level, a nerve regeneration measurement, a hormone level, an electromyography signal level, a change in penile tumescence, a change in penile arteriole pressure, and a response of said patient to said stimulus.

10. The method of claim 1, further comprising manually adjusting said control parameters.

11. The method of claim 1, wherein said step of implanting said system control unit within said patient comprises coupling said system control unit to said nerve using one or more connectors.

12. The method of claim 1, wherein said system control unit comprises a microstimulator.

13. The method of claim 1, wherein said nerve comprises a nerve graft.

14. The method of claim 1, wherein said nerve is at least one or more of a cavernous nerve, a pudendal nerve, and a brachial plexus nerve.

15. The method of claim 1, wherein said stimulus is a treatment for erectile dysfunction.

16. The method of claim 1, further comprising communicating with or transferring power to said system control unit using an external device.

17. A system for regenerating a nerve within a patient, said system comprising:

a system control unit configured to apply a stimulus to said nerve in accordance with one or more control parameters;

wherein said system control unit is implanted within said patient and said stimulus promotes said regeneration of said nerve.

18. The system of claim 17, further comprising two or more electrodes coupled to said system control unit, wherein said stimulus comprises a stimulation current delivered by said system control unit via said electrodes.

19. The system of claim 18, wherein said control parameters control one or more of a frequency of said stimulation current, a pulse width of said stimulation current, and an amplitude of said stimulation current.

20. The system of claim 17, further comprising a pump for delivering one or more drugs, said pump coupled to a catheter, and wherein said stimulus comprises stimulation via said one or more drugs delivered through said catheter.

21. The system of claim 20, wherein said control parameters control one or more of an amount of said one or more drugs delivered through said catheter and a rate of delivery of said one or more drugs through said catheter.

22. The system of claim 20, wherein said one or more drugs comprise at least one of a neurotrophic factor, a nerve growth factor, a brain-derived neurotropic factor, a Schwann cell product, a neurotrophic tyrosine kinase type two (TrkB), a protein kinase A (PKA), and a L2/HNK-1 carbohydrate.

23. The system of claim 17, further comprising:

two or more electrodes coupled to said system control unit; and

a pump for delivering one or more drugs, said pump coupled to a catheter;

wherein said stimulus comprises a stimulation current delivered by said system control unit via said electrodes and stimulation via said one or more drugs delivered by said pump.

24. The system of claim 17, further comprising:

a sensor device for sensing at least one condition;

wherein said system control unit uses said at least one sensed condition to automatically adjust one or more of said control parameters.

25. The system of claim 24, wherein said at least one sensed condition is at least one or more of a neurotransmitter level, a nerve regeneration measurement, a hormone level, an electromyography signal level, a change in penile tumescence, a change in penile arteriole pressure, and a response of said patient to said stimulus.

26. The system of claim 17, wherein said control parameters are manually adjusted.

27. The system of claim 17, wherein said system control unit further comprises a programmable memory unit configured to store said control parameters.

28. The system of claim 17, wherein said system control unit comprises a micro stimulator.

29. The system of claim 28, wherein said microstimulator is coupled to said nerve with one or more connectors.

30. The system of claim 29, further comprising two or more moveable electrodes coupled to said microstimulator, wherein said stimulus comprises a stimulation current delivered to said nerve via said moveable electrodes.

31. The system of claim 30, wherein said nerve includes a nerve graft, and wherein said moveable electrodes are coupled to said nerve graft.

32. The system of claim 31, wherein said moveable electrodes are configured to move from an outer portion of said nerve graft towards a center portion of said nerve graft.

33. The system of claim 17, wherein said nerve comprises a nerve graft.

34. The system of claim 17, wherein said nerve is at least one or more of a cavernous nerve, a pudendal nerve, and a brachial plexus nerve.

35. The system of claim 17, wherein said system control unit is further configured to promote an erection of a penis.

36. The system of claim 17, further comprising an external device configured to communicate with or transfer power to said system control unit.

37. A system for regenerating a nerve within a patient, said system comprising:

means for generating a chemical or electrical stimulus; and

means for applying said stimulus to said nerve with said system control unit in accordance with one or more control parameters;

wherein said stimulus promotes said regeneration of said nerve.

38. The system of claim 37, wherein said system control unit is coupled to one or more electrodes, and wherein said stimulus comprises a stimulation current delivered via said electrodes.

39. The system of claim 37, wherein said system control unit is coupled to a means for delivering one or more drugs to said nerve, and wherein said stimulus comprises stimulation via delivery of said one or more drugs to said nerve.

40. The system of claim 37, further comprising means for sensing at least one condition and means for using said at least one sensed condition to automatically adjust one or more of said control parameters.

41. The system of claim 37, further comprising means for manually adjusting said control parameters.

42. The system of claim 37, wherein said means for implanting said system control unit within said patient comprises means for coupling said system control unit to said nerve.

43. The system of claim 37, further comprising means for communicating with or transferring power to said system control unit.