Nerve stimulation to promote neuroregeneration

• US 10,420,939 B2
• Filed: 03/09/2017
• Issued: 09/24/2019
• Est. Priority Date: 03/31/2016
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Gill, Bradley C., Nyame, Yaw A., Klein, Eric A.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/454,041
• Publication Number:
  US 20170281945A1
• Time in Patent Office: 929 Days
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36164 Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628

Abstract

Temporary or sub-threshold electrical stimulation to promote recovery of a damaged or injured nerve. Methods include promoting neuroregeneration of a nerve iatrogenically injured during a medical procedure performed on a target site of a patient'"'"'s body. Methods include placing an electrical lead in electrical communication with the injured or damaged nerve. Methods further include temporarily stimulating the nerve and/or applying sub-threshold stimulation to the nerve to promote neuroregeneration of the nerve. The nerve can be a peripheral nerve.

Claims

1. A method of promoting neuroregeneration of a damaged or injured nerve in a human'"'"'s body comprising:

placing an electrical lead in electrical communication with the nerve; and

delivering an electrical signal to the nerve for a period of time between at least a portion of one day to six weeks to promote neuroregeneration of the nerve wherein delivering an electrical signal to the nerve comprises delivering a sub-threshold electrical signal to the nerve, wherein the sub-threshold electrical signal promotes neuroregeneration of the nerve but does not stimulate the nerve to a level that triggers the nerve'"'"'s physiological effect, wherein the electrical signal has an amplitude of between about 10 to 40 mA, a frequency between about 10-60 Hz, and a pulse width of between about 0.22-2.0 ms.

2. The method of claim 1, wherein the electrical signal is charge-balanced.

3. The method of claim 1, wherein the electrical signal is delivered for a plurality of days, and the plurality of days are non-consecutive.

4. The method of claim 1, wherein the nerve is iatrogenically damaged or injured during a medical procedure performed on a target site of a patient'"'"'s body.

5. The method of claim 4, wherein the medical procedure involves surgical dissection or visualization of the nerve.

6. The method of claim 4, wherein the medical procedure is a prostatectomy, the target site is the prostate, and the nerve is a cavernous nerve.

7. The method of claim 4, wherein the medical procedure is a thyroidectomy, the target site is a thyroid gland, and the nerve is a laryngeal nerve.

8. The method of claim 4, wherein the medical procedure is a parotidectomy, the target site is a parotid gland, and the nerve is a facial nerve.

9. The method of claim 4, wherein the medical procedure is extremity surgery, the target site is an extremity of the patient'"'"'s body, and the nerve is a peripheral nerve.

10. The method of claim 4, wherein the medical procedure is childbirth, the target site is the birth canal, and the nerve is a pudendal nerve.

11. The method of claim 4, wherein promoting neuroregeneration comprises improving a complication associated with the medical procedure.

12. The method of claim 11, wherein the complication is erectile dysfunction.

13. The method of claim 1, wherein the nerve is iatrogenically damaged or injured during a medical procedure performed on a target site of a patient'"'"'s body and delivering an electrical signal comprises delivering the electrical signal to the nerve after the iatrogenic injury or damage.

14. The method of claim 1, wherein the nerve is iatrogenically damaged or injured during a medical procedure performed on a target site of a patient'"'"'s body and placing the electrical lead comprises placing the electrical lead in electrical communication with the nerve before the medical procedure is performed.

15. The method of claim 1, wherein the nerve is iatrogenically damaged or injured during a medical procedure performed on a target site of a patient'"'"'s body and placing the electrical lead comprises placing the electrical lead in electrical communication with the nerve while the medical procedure is performed.

16. The method of claim 1, wherein the electrode is a wire electrode.

17. The method of claim 1, further comprising chemically stimulating the nerve.

18. The method of claim 1, wherein the lead is percutaneously placed in direct electrical contact with the nerve.