Systems and methods to place one or more leads in tissue for providing functional and/or therapeutic stimulation

• US 9,884,189 B2
• Filed: 04/19/2016
• Issued: 02/06/2018
• Est. Priority Date: 12/05/2008
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: SPR Therapeutics, Inc.
• Inventors: Boggs, II, Joseph W.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/132,832
• Publication Number:
  US 20160228707A1
• Time in Patent Office: 658 Days
• Field of Search: None
• 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 make possible the placement of one or more electrode leads in a tissue region for providing functional and/or therapeutic stimulation to tissue. The systems and methods are adapted to provide the relief of pain.

Claims

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

activating a peripheral nerve innervating the painful region with an electrode near the peripheral nerve and outside of the painful region; and

evoking a tingling sensation over at least a portion of the painful region without damaging the peripheral nerve.

2. The method of claim 1, wherein the activation step is conducted a therapeutic time.

3. The method of claim 2, wherein at a conclusion of the therapeutic time the electrode is removed.

4. The method of claim 2, wherein the therapeutic time ranges from approximately one week to twelve weeks.

5. The method of claim 3, wherein pain relief is sustained after removal of the electrode.

6. The method of claim 1, wherein the peripheral nerve includes a peripheral nerve passing through at least one of a brachial plexus, lumbar plexus, sacral plexus, and cervical plexus.

7. The method of claim 1, wherein the peripheral nerve includes at least one of a femoral nerve, sciatic nerve, radial nerve, median nerve, ulnar nerve, and an intercostal nerve.

8. A system to reduce and/or relieve pain in a painful region, the system comprising:

an electrode placed near a peripheral nerve innervating the painful region and outside of the painful region; and

an electrical stimulator operatively coupled with the electrode, the electrical stimulator evoking a tingling sensation over at least a portion of the painful region without damaging the peripheral nerve.

9. The system of claim 8, wherein the electrode is inserted without surgery.

10. The system of claim 8 further comprising a lead operatively coupled with the electrode.

11. The system of claim 10, wherein the lead is no greater than about 0.75 mm diameter.

12. The system of claim 10, wherein the lead is configured to withstand mechanical forces and resists migration during the evoking of the tingling sensation.

13. The system of claim 10, wherein the lead includes a coiled fine wire electrode lead.

14. The system of claim 13, wherein the coiled fine-wire lead is configured to withstand mechanical forces and resists migration during long-term use.

15. The system of claim 10, wherein the lead includes one or more coiled metal wires within an open or flexible elastomer core.

16. The system of claim 15, wherein the wire is insulated.

17. The system of claim 16, wherein the wire is insulated with a biocompatible polymer film.

18. The system of claim 17, wherein the biocompatible polymer film includes at least one of polyfluorocarbon, polyimide, or parylene.

19. The system of claim 10, wherein the lead is coated with a textured, bacteriostatic material.

20. A method to alleviate pain comprising:

placing at least one electrode near a peripheral nerve innervating a painful region, the at least one electrode positioned outside of the painful region;

applying stimulation through the at least one electrode; and

activating the peripheral nerve to alleviate pain in the painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

21. The method of claim 20 further comprising evoking a tingling sensation over at least a portion of the painful region.

22. The method of claim 21, wherein evoking the tingling sensation includes applying an electrical stimulation to the peripheral nerve during or after placing of the at least one electrode 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.

23. The method of claim 20, 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 20, wherein the placing of the at least one electrode is upstream of a joint of a patient and free of interference with the joint.

26. The method of claim 20, wherein the painful region includes an incision from surgery and the at least one electrode is placed remote from the incision.

27. The method according to claim 20, wherein patient feedback is not required to position the at least one electrode.

28. A method to alleviate pain comprising:

placing at least one electrode within at least one of a range of distances from a peripheral nerve innervating a painful region,

applying simulation through the at least one electrode; and

activating the peripheral nerve to alleviate pain in the painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

29. A method to alleviate pain comprising:

inserting a coiled lead into a patient;

placing an electrode coupled with the lead within a distance from a peripheral nerve innervating a painful region,

applying simulation through the at least one electrode, wherein intensity of the stimulation is related to the distance;

activating the peripheral nerve to alleviate pain in the painful region without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

30. The method of claim 29, wherein the peripheral nerve includes a nerve trunk.

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

32. The method according to claim 29, wherein the lead is inserted into tissue upstream of the targeted pain area.

33. The method according to claim 29, wherein the electrode is placed remote from and upstream of the painful region.