IP Library Granted Patent US 11,033,734
Granted Patent B2
US 11,033,734 · App. 16/266,236 · Granted Jun 15, 2021

Treatment of pain using electrical nerve conduction block

Inventors: Niloy Bhadra (Cleveland Heights, OH); Narendra Bhadra (Chesterland, OH); Kevin L. Kilgore (Avon Lake, OH); Scott Lempka (Cleveland Heights, OH); Jesse Wainright (Willoughby Hills, OH); Tina Vrabec (Willoughby Hills, OH); Manfred Franke (Redwood City, CA)
Assignee: CASE WESTERN RESERVE UNIVERSITY
A61N1/0551A61N1/06A61N1/20A61N1/36021A61N1/36062A61N1/36071A61N1/36125A61N1/0456A61N1/0556A61N1/205A61N1/3615A61N1/36017A61N1/36171
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Quick Facts
Patent No.
US 11,033,734
App. No.
16/266,236
Granted
Jun 15, 2021
Kind
B2
Abstract

Described herein are systems and methods for the treatment of pain using electrical nerve conduction block (ENCB). Contrary to other methods of pain treatment, the ENCB can establish a direct block of neural activity, thereby eliminating the pain. Additionally, the ENCB can be administered without causing electrochemical damage. An example method can include: placing at least one electrode contact in electrical communication with a region of a subject's spinal cord; applying an electrical nerve conduction block (ENCB) to a nerve in the region through the at least one electrode contact; and blocking neural activity with the ENCB to reduce the pain or other unwanted sensation in the subject.

Claims (34)

1. A spinal cord neuromodulation system for delivery of a therapy signal to neural tissue, comprising:

a plurality of contacts configured to be in electrical communication with the neural tissue and further configured to deliver the therapy signal to the neural tissue, the plurality of contacts comprising a high charge capacity titanium nitride or tantalum material that limits formation of irreversible reaction products when the therapy signal delivers a charge of 100 μC or more to the neural tissue, and

a waveform generator configured to generate a multi-phase direct current waveform, wherein the multi-phase direct current waveform comprises an anodic phase and a cathodic phase, the anodic phase and the cathodic phase both comprising a ramp segment and a plateau segment,

wherein one or both of the anodic phase and the cathodic phase provides the therapy signal to the neural tissue, and the other of the subsequent cathodic phase or anodic phase is configured to reduce or balance a charge returned to the therapy delivery system.

2. The system of claim 1 , wherein a period of the anodic phase is about equal to a period of the cathodic phase.

3. The system of claim 1 , wherein the waveform generator is programmed to deliver a plurality of cycles of the waveform for about 10 seconds.

4. The system of claim 1 , wherein the multi-phase direct current waveform is sufficient to alter conduction through the neural tissue without causing damage to the neural tissue.

5. The system of claim 1 , wherein the waveform generator is also configured to generate a high frequency alternating current (HFAC) signal.

6. The system of claim 5 , wherein the high-frequency alternating current signal has a frequency of at least about 1 kHz.

7. The system of claim 5 , wherein the high-frequency alternating current signal has a frequency of between about 5 kHz and about 50 kHz.

8. The system of claim 1 , wherein the direct current waveform has a half-period of about 6 seconds.

9. The system of claim 1 , wherein the direct current waveform has a period of at least about 15 seconds.

10. The system of claim 1 , wherein the direct current waveform has an amplitude of at least about 0.5 mA.

11. The system of claim 1 , wherein the system is configured such that there is a charge imbalance between the anodic phase and the cathodic phase, wherein the charge imbalance is less than 10%.

12. A therapy delivery system for delivery of a therapy signal to neural tissue, comprising:

at least one contact configured to be in electrical communication with neural tissue and further configured to deliver a therapy signal to the neural tissue, the plurality of contacts comprising a high charge capacity material that limits formation of irreversible reaction products when the therapy signal delivers a charge of 100 μC or more to the neural tissue, and

a waveform generator configured to generate a multi-phase direct current waveform, wherein the multi-phase direct current waveform comprises an anodic phase and a cathodic phase, the anodic phase and the cathodic phase both comprising a first ramp segment, a second ramp segment, and a third ramp segment,

wherein the cathodic phase provides the therapy signal to the neural tissue, and the anodic phase is configured to reduce or balance a charge returned to the therapy delivery system.

13. The therapy delivery system of claim 12 , further comprising a first plateau segment in between the first ramp segment and the second ramp segment.

14. The therapy delivery system of claim 13 , further comprising a second plateau segment in between the second ramp segment and the third ramp segment.

15. The therapy delivery system of claim 14 , wherein the beginning and end of the anodic phase and the cathodic phase are defined by at least two of said ramp segments.

16. The therapy delivery system of claim 15 , wherein the at least one contact comprises bipolar electrodes.

17. The therapy delivery system of claim 15 , wherein the at least one contact comprises a geometric surface area of at least about 1 mm 2 .

18. The therapy delivery system of claim 15 , wherein the at least one contact comprises a geometric surface area of between about 3 mm 2 and about 9 mm 2 .

19. The therapy delivery system of claim 15 , wherein the at least one contact is part of a cuff electrode.

20. The therapy delivery system of claim 15 , wherein the at least one contact is part of a paddle electrode.

21. The therapy delivery system of claim 15 , wherein the at least one contact is part of a mesh electrode.

22. A therapy delivery system for delivery of a therapy signal to neural tissue, comprising:

at least one contact configured to be in electrical communication with electrically excitable tissue and further configured to deliver a therapy signal to the electrically excitable tissue, the plurality of contacts comprising a high charge capacity material that limits formation of irreversible reaction products when the therapy signal delivers a charge of 10 μC or more to the neural tissue, and

a waveform generator configured to generate a multi-phase direct current waveform, wherein the multi-phase direct current waveform comprises an anodic phase and a cathodic phase, the anodic phase and the cathodic phase both comprising a first ramp segment, a second ramp segment, and a third ramp segment,

wherein at least one of the anodic phase or the cathodic phase provides the therapy signal to the neural tissue, and the subsequent of the anodic phase or the cathodic phase is configured to reduce or balance a charge returned to the therapy delivery system.

23. The system of claim 22 , wherein the high charge capacity material limits formation of irreversible reaction products when the therapy signal delivers a charge of at least 100 μC to the neural tissue.

24. The system of claim 22 , wherein the high charge capacity material has a charge injection capacity of at least about 5 mC/cm 2 .

25. The system of claim 22 , wherein the high charge capacity material comprises tantalum coated with titanium nitride.

Assignments (4)
CONFIRMATORY LICENSE Recorded Jul 26, 2023
From: CASE WESTERN RESERVE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 064620/0807 →
CONFIRMATORY LICENSE Recorded Jul 26, 2023
From: CASE WESTERN RESERVE UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 064620/0859 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2021
From: FRANKE, MANFRED; KILGORE, KEVIN L.; LEMPKA, SCOTT; BHADRA, NARENDA; BHADRA, NILOY; VRABEC, TINA; WAINRIGHT, JESSE
To: CASE WESTERN RESERVE UNIVERSITY
Reel/Frame 056452/0012 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 19, 2020
From: BHADRA, NILOY; BHADRA, NARENDA; KILGORE, KEVIN L.; LEMPKA, SCOTT; WAINRIGHT, JESSE; VRABEC, TINA; FRANKE, MANFRED
To: CASE WESTERN RESERVE UNIVERSITY
Reel/Frame 053536/0596 →
Continuity (6)
Continuation 15344959 · Nov 7, 2016
Continuation In Part 14969826 · Dec 15, 2015
Continuation In Part 14408017
Provisional Application 61660383 · Jun 15, 2012
Provisional Application 61821862 · May 10, 2013
Related Publication 20190167996A1 · Jun 6, 2019
Cited By (1)
US 12,465,776