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

• US 8,954,153 B2
• Filed: 12/07/2009
• Issued: 02/10/2015
• Est. Priority Date: 12/05/2008
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Boggs, Joseph W. II
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Dinga, Roland
• Application Number:
  US12/653,023
• Publication Number:
  US 20100152808A1
• Time in Patent Office: 1,891 Days
• Field of Search: 607 45- 46, 607/48, 607/61, 607/117, 607/118
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• 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

It has been discovered that pain felt in a given region of the body can be treated, not by motor point stimulation of muscle in the local region where pain is felt, but 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. Spinal nerves such as the intercostal nerves or nerves passing through a nerve plexus, which comprise trunks that divide by divisions and/or cords into branches, comprise “nerves of passage.”

Claims

1. A method to reduce and/or relieve pain in a targeted painful region comprising:

activating a peripheral nerve innervating the targeted painful region with an intramuscular lead inserted into muscle tissue near the peripheral nerve and outside of the targeted painful region and evoking a tingling sensation over at least a portion of the targeted painful region without damaging the peripheral nerve.

2. The method according to claim 1, wherein the intramuscular lead being inserted into muscle tissue near the peripheral nerve comprises the intramuscular lead being inserted into muscle tissue in electrical proximity to the nerve of passage.

3. The method according to claim 1, further comprising delivering a test stimulation through the intramuscular lead and observing a muscle response.

4. The method according to claim 1, wherein evoking the tingling sensation includes applying an electrical stimulation to the peripheral nerve during or after the insertion of the intramuscular lead and determining whether the electrical stimulation of the peripheral nerve generates the tingling sensation over the at least a portion of the targeted painful region.

5. The method according to claim 1, wherein the intramuscular lead is removable from the muscle tissue by pulling the intramuscular lead from the muscle tissue.

6. The method according to claim 1, wherein a duration of the evoking the tingling sensation ranges from approximately minutes to a plurality of years.

7. The method according to claim 6, wherein the duration ranges from approximately one week to twelve weeks.

8. The method according to claim 1, wherein patient feedback is not required to position the intramuscular lead to evoke the tingling sensation.

9. The method of claim 1, wherein the intramuscular lead is inserted without surgery.

10. The method of claim 1, wherein the intramuscular lead is spaced from the peripheral nerve while being in electrical proximity to the nerve of passage.

11. The method of claim 1, wherein the intramuscular lead is configured to withstand mechanical forces and resist migration during the evoking of the tingling sensation.

12. The method of claim 1, wherein the intramuscular lead enables movement of a joint during the evoking of the tingling sensation.

13. The method according to claim 1, wherein the lead is inserted into muscle tissue upstream of the targeted pain area.

14. A method to alleviate pain comprising:

identifying a tissue region including skeletal muscle innervated by a peripheral nerve innervating a targeted painful region,

placing at least one electrode within the tissue region near the peripheral nerve outside of the painful region, and

applying stimulation to the at least one electrode according to predefined therapeutic stimulation parameters to activate the peripheral nerve and provide therapeutic nerve stimulation that evokes a tingling sensation to alleviate pain in the targeted painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

15. A method according to claim 14

wherein the peripheral nerve includes a peripheral nerve passing through a nerve plexus.

16. A method according to claim 15

wherein the peripheral nerve includes a peripheral nerve passing through at least one of a brachial plexus, lumbar plexus, sacral plexus, and cervical plexus.

17. A method according to claim 14

wherein the peripheral nerve includes at least one of a femoral nerve, sciatic nerve, radial nerve, median nerve, ulnar nerve, and an intercostal nerve.

18. The method according to claim 14, wherein placing the at least one electrode is checked or guided by an imaging technique.

19. The method according to claim 18, wherein the imaging technique includes at least one of ultrasound, fluoroscopy, and X-ray.

20. The method according to claim 14, wherein placing the at least one electrode includes percutaneously inserting a lead in the muscle tissue or adipose tissue in electrical proximity to but spaced away from the peripheral nerve.

21. The method of claim 20, wherein the lead includes a coiled fine wire electrode lead.

22. The method of claim 21, wherein the coiled fine-wire electrode lead is configured to withstand mechanical forces and resist migration during long-term use.

23. The method of claim 14, wherein placing the at least one electrode is guided by a patient'"'"'s report of the tingling sensation.

24. The method of claim 23, wherein the patient'"'"'s report of the tingling sensation indicates confirmation of placement of the at least one electrode to alleviate the pain in the targeted painful region.

25. The method of claim 14, wherein a response of at least one muscle in the tissue region guides the placing of the at least one electrode.

26. The method of claim 14, wherein the placing of the at least one electrode is upstream of a joint of a patient and free of interference with the joint.

27. The method of claim 14, wherein the applying stimulation to the at least one electrode is accomplished for a therapeutic amount of time whereby the alleviation of pain in the targeted painful region lasts for a time longer than the therapeutic amount of time.

28. The method of claim 14, wherein the targeted painful region includes an incision from surgery and the at least one electrode is placed remote from the incision.

29. The method of claim 14, wherein the placing of the at least one electrode within the tissue region is accomplished in less than 10 minutes by a clinician.

30. The method of claim 14, wherein the peripheral nerve includes a nerve trunk.

31. The method of claim 30, wherein activating the nerve trunk alleviates the pain in the targeted painful region.

32. The method according to claim 14, wherein the electrode is placed remote from and upstream of the targeted pain area.