Systems and methods to place one or more leads in tissue to electrically stimulate nerves of passage to treat pain

• US 9,895,530 B2
• Filed: 09/06/2012
• Issued: 02/20/2018
• Est. Priority Date: 12/05/2008
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: SPR Therapeutics, Inc.
• Inventors: Boggs, II, Joseph W., Zang, Rosemary H.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US13/605,653
• Publication Number:
  US 20130238066A1
• Time in Patent Office: 1,993 Days
• Field of Search: 607117, 607118
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Systems and methods are provided for applying electrical stimulation to a body by an electrode spaced from a target nerve of passage. It has been discovered that pain felt, or perceived to be felt, in a given region of the body can be treated by stimulating muscle close to a “nerve of passage” in a region that is superior (i.e., cranial or upstream toward the spinal column) to the region where pain is felt, such as in a case of post-amputation residual limb pain, or purportedly felt in the case of post-amputation phantom limb pain.

Claims

1. A method of reducing a perception of pain by a human body, the method comprising the steps of:

placing an electrode at a therapeutically effective distance spaced from a neural fiber bundle within said body, wherein said neural fiber bundle comprises at least one of a Type Ia and Ib afferent nerve fiber with at least one of Type III and Type IV nerve fibers; and

delivering electrical stimulation from said electrode to said neural fiber bundle to reduce a perception of pain by said human, wherein said

at least one Type Ia and Ib afferent nerve fiber of said neural fiber bundle are selectively activated while

minimizing recruitment of activation of said at least one of Type III and Type IV nerve fiber of said neural fiber bundle due to the electrode being at the therapeutically effective distance.

2. A method according to claim 1, wherein said placing step is performed without incising a skin surface of said human body.

3. A method according to claim 1, wherein said electrode is disposed on a lead comprising at least one conductive wire.

4. A method according to claim 3, wherein during said delivering step, said conductive wire extends through a skin surface of said body.

5. A method according to claim 4, wherein said delivering step is performed for a predetermined amount of time and said conductive wire remains extended through said skin surface throughout said predetermined amount of time.

6. A method according to claim 5, wherein said predetermined amount of time comprises about two weeks to about four weeks.

7. A method according to claim 5, wherein said electrode is removed from said body after said predetermined amount of time.

8. A method according to claim 5, wherein said reduction in perception of pain continues beyond said predetermined amount of time.

9. A method according to claim 8, wherein said reduction in perception of pain continues for at least as long as said predetermined amount of time beyond said predetermined amount of time.

10. A method according to claim 9, wherein said reduction in perception of pain continues for at least twice as long as said predetermined amount of time beyond said predetermined amount of time.

11. A method according to claim 1, wherein the reduction in perception of pain comprises an at least thirty percent reduction in pain.

12. A method according to claim 1, wherein said therapeutically effective distance is greater than one centimeter.

13. A method according to claim 1, wherein said therapeutically effective distance is about 0.2 centimeters to about 3.0 centimeters.

14. A method according to claim 13, wherein said therapeutically effective distance is about five millimeters to about twenty millimeters.

15. A method according to claim 1, wherein said neural fiber bundle comprises said Type Ia and Ib afferent nerve fibers and Type III and Type IV nerve fibers.

16. A method according to claim 1, wherein said neural fiber bundle comprises said Type Ia afferent nerve fiber.

17. A method according to claim 1, wherein said neural fiber bundle comprises said Type III nerve fiber.

18. A method according claim 1, wherein said nerve fiber bundle includes an efferent nerve fiber and further comprises minimizing recruitment of activation of said efferent nerve fiber of said neural fiber bundle.

19. A method of reducing a perception of pain by a human body, the method comprising the steps of:

placing an electrode at a therapeutically effective distance spaced from a neural fiber bundle within the body, wherein said neural fiber bundle comprises at least one of a Type Ia and Ib afferent nerve fiber plus an efferent nerve fiber; and

delivering electrical stimulation from said electrode to said neural fiber bundle to reduce a perception of pain by said human, wherein said

at least one of Type Ia and Ib afferent nerve fiber of said neural fiber bundle are selectively activated while

minimizing recruitment of activation of said efferent nerve fiber of said neural fiber bundle due to the electrode being at the therapeutically effective distance.

20. A method according to claim 19, wherein selectively activating at least one of said Type Ia and Ib afferent nerve fibers includes selectively activating both of said Type Ia and Ib afferent nerve fibers.

21. A method according to claim 19, wherein minimizing recruitment of activation includes minimizing recruitment of activation of at least one of a Type III and Type IV nerve fiber of said neural fiber bundle.

22. A method according to claim 21, wherein minimizing recruitment of activation includes minimizing recruitment of activation of both said Type III and Type IV nerve fibers of said neural fiber bundle.

23. A method according to claim 19, wherein said electrode is a monopolar electrode.

24. A method according to claim 19, wherein said electrode is operably coupled with a coiled fine wire lead.

25. A method according to claim 19, wherein said electrode is a multi-contact electrode whereby only a single electrode delivers electrical stimulation.

26. A method according to claim 19, wherein said electrode includes a distal end whereby said distal end encourages in-growth of connective tissue.

27. A method of reducing a perception of pain by a human body, the method comprising the steps of:

placing an electrode at a therapeutically effective distance spaced from a neural fiber bundle within said body, wherein said neural fiber bundle comprises more than one type of nerve fiber, wherein said therapeutically effective distance is about 0.2 centimeters to about 3.0 centimeters from said neural fiber bundle; and

delivering electrical stimulation from said electrode to said neural fiber bundle to reduce a perception of pain by said human, wherein

a first of said type of nerve fiber is selectively activated while

minimizing recruitment of activation of a second of said type of nerve fiber due to the electrode being at the therapeutically effective distance, wherein said second of said type of nerve fiber includes at least one of a Type III, Type IV and efferent nerve fiber.

28. A method according to claim 27, wherein said first of said type of nerve fiber includes at least one a Type Ia and Type IB afferent nerve fiber.

29. A method according to claim 28, wherein said second of said type of nerve fiber includes said Type III and Type IV nerve fibers.

30. A method according to claim 29, wherein said first of said type of nerve fiber includes Type Ia and Type IB afferent nerve fibers.

31. A method according to claim 27, wherein said therapeutically effective distance is about five millimeters to about twenty millimeters.

32. A method according claim 27, wherein said second of said type of nerve fiber includes said efferent nerve fiber.