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

• US 10,307,585 B2
• Filed: 02/19/2018
• Issued: 06/04/2019
• Est. Priority Date: 12/05/2008
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: SPR Therapeutics, Inc.
• Inventors: Boggs, Joseph W., Zang, Rosemary H.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/898,889
• Publication Number:
  US 20180236222A1
• Time in Patent Office: 470 Days
• 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, the method comprising the steps of:

placing or instructing placement of an electrode within tissue a distance spaced from (i) at least one of a Type Ia and Ib afferent nerve fibers and (ii) at least one of Type III and Type IV nerve fibers; and

instructing delivery or delivering electrical stimulation through the electrode to selectively activate at least one of the Type Ia and Ib afferent nerve fibers while minimizing recruitment of activation of the at least one of the Type III and Type IV nerve fibers because the electrode is spaced the distance from the at least one of a Type Ia and Ib afferent nerve fibers and the at least one of Type III and Type IV nerve fibers.

2. The method of claim 1, wherein the electrode is positioned on a lead comprising at least one conductive wire.

3. The method of claim 1, wherein the delivery of electrical stimulation does not produce a muscle contraction.

4. The method of claim 1, wherein the delivery of electrical stimulation evokes paresthesia.

5. The method of claim 1, wherein the tissue comprises muscle tissue.

6. The method of claim 1, wherein the tissue comprises adipose tissue.

7. The method of claim 1, wherein the tissue comprises connective tissue.

8. The method of claim 1, wherein the distance comprises 0.5 to 3 cm.

9. The method of claim 1, wherein the electrode is positioned on a distal end of a coiled fine wire lead.

10. A method of reducing a perception of pain, the method comprising the steps of:

placing or instructing placement of an electrode in tissue in electrical proximity to but spaced away from a neural fiber bundle within a body, wherein the neural fiber bundle comprises at least one of a Type Ia and Ib afferent nerve fiber and an efferent nerve fiber; and

delivering or instructing delivery of electrical stimulation from the electrode to the neural fiber bundle to reduce a perception of pain, wherein the at least one of Type Ia and Ib afferent nerve fiber of the neural fiber bundle are selectively activated while minimizing recruitment of activation of the efferent nerve fiber of the neural fiber bundle because the electrode is in electrical proximity but spaced away from the neural fiber bundle.

11. The method of claim 10, wherein selectively activating at least one of the Type Ia and Ib afferent nerve fibers includes selectively activating both of the Type Ia and Ib afferent nerve fibers.

12. The method of claim 11, wherein minimizing recruitment of activation includes minimizing recruitment of activation of at least one of a Type III and Type IV nerve fiber of the neural fiber bundle.

13. The method of claim 11, wherein minimizing recruitment of activation includes minimizing recruitment of activation of both the Type III and Type IV nerve fibers of the neural fiber bundle.

14. The method of claim 11, wherein the tissue comprises muscle tissue.

15. The method of claim 11, wherein the tissue comprises adipose tissue.

16. The method of claim 11, wherein the tissue comprises connective tissue.

17. The method of claim 10, wherein the electrode is a monopolar electrode.

18. The method of claim 10, wherein the electrical proximity to but spaced away from a neural fiber bundle comprises 0.5 to 3 cm from the neural fiber bundle.

19. the method of claim 10, wherein the electrode is percutaneously inserted.

20. The method of claim 19, wherein an introducer needle percutaneously inserts the electrode.

21. A method of reducing a perception of pain, the method comprising the steps of:

placing or instructing placement of an electrode at a therapeutically effective distance from a neural fiber bundle within tissue, wherein the neural fiber bundle comprises more than one type of nerve fiber;

delivering or instructing delivery of electrical stimulation from the electrode to the neural fiber bundle to reduce a perception of pain by said human, wherein a first of the type of nerve fiber is selectively activated while minimizing recruitment of activation of a second of the type of nerve fiber because the electrode is at the therapeutically effective distance; and

evoking or instructing evocation of paresthesia in a region of pain, wherein the region of pain is spaced from the electrode.

22. The method of claim 21, wherein the therapeutically effective distance is 0.2 centimeters to 3.0 centimeters from the neural fiber bundle.

23. The method of claim 21, wherein the first type of the type of nerve fiber comprises at least one of Type Ia and Ib afferent nerve fibers and the second of the type of nerve fiber comprises at least one of a Type III, Type IV and efferent nerve fibers.

24. The method of claim 21, wherein the electrode is placed using an introducer needle percutaneously inserted into the tissue.