IP Library Granted Patent US 12,161,861
Granted Patent B2
US 12,161,861 · App. 17/991,045 · Granted Dec 10, 2024

Therapy delivery devices and methods for non-damaging neural tissue conduction block

Inventors: Niloy Bhadra (Cleveland Heights, OH); Kevin L. Kilgore (Avon Lake, OH); Narendra Bhadra (Chesterland, OH); Jesse Wainright (Willoughby Hills, OH); Tina Vrabec (Willoughby Hills, OH); Manfred Franke (South Euclid, OH)
Assignee: CASE WESTERN RESERVE UNIVERSITY
A61N1/0556A61N1/06A61N1/20A61N1/36064A61N1/36067A61N1/36071
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Quick Facts
Patent No.
US 12,161,861
App. No.
17/991,045
Granted
Dec 10, 2024
Kind
B2
Abstract

Devices and methods for blocking signal transmission through neural tissue. One step of a method includes placing a therapy delivery device into electrical communication with the neural tissue. The therapy delivery device includes an electrode contact having a high charge capacity material. A multi-phase direct current (DC) can be applied to the neural tissue without damaging the neural tissue. The multi-phase DC includes a cathodic DC phase and anodic DC phase that collectively produce a neural block and reduce the charge delivered by the therapy delivery device. The DC delivery can be combined with high frequency alternating current (HFAC) block to produce a system that provides effective, safe, long term block without inducing an onset response.

Claims (38)

1. A system comprising:

at least two electrode contacts configured to be in electrical communication with a nerve; and

a waveform generator coupled to the at least two electrode contacts,

wherein the waveform generator is configured to generate:

a first instance of a DC waveform to one of the at least two electrode contacts for a first time period, and

at least another instance of the DC waveform, shifted in time, to at least another of the at least two electrode contacts for at least another time period,

wherein the one of the at least two electrode contacts is configured to apply the first instance of the DC waveform to the nerve for the first time period and the at least the other of the at least two electrode contacts is configured to apply the at least the other instance of the DC waveform to the nerve for the at least the other time period,

wherein application of the first instance and at least the other instance establishes a predefined pattern that at least partially blocks conduction in the nerve continuously.

2. The system of claim 1 , wherein the DC waveform is a multiphase DC waveform comprising at least one cathodic phase and at least one anodic phase.

3. The system of claim 2 , wherein at least one of the at least one cathodic phase or the at least one anodic phase begins and ends with a current ramp to prevent at least a portion of axonal firing of the nerve.

4. The system of claim 2 , wherein one of the at least one cathodic phase or the at least one anodic phase establishes a conduction block in the nerve while another of the at least one cathodic phase or the at least one anodic phase is a recharge phase.

5. The system of claim 2 , wherein the multiphase DC waveform is charge balanced.

6. The system of claim 2 , wherein the DC waveform is charge imbalanced.

7. The system of claim 2 , wherein the system continuously blocks conduction in the nerve by cycling through the predefined pattern, wherein the time shift enables the other of the at least two electrode contacts to apply the cathodic phase of the second instance of the DC waveform as the one of the at least two electrode contacts applies the anodic phase of the second instance of the DC waveform.

8. The system of claim 2 , wherein the system non-continuously blocks conduction in the nerve by cycling through the predefined pattern, wherein the time shift enables the block to be stopped for a time before being restarted by applying the cathodic phase of the second instance of the DC waveform.

9. The system of claim 2 , wherein the multiphase DC waveform is asymmetric, wherein a plateau of the at least one cathodic phase and a plateau of the at least one anodic phase have different absolute amplitudes and/or durations.

10. The system of claim 1 , wherein the first time period overlaps with the other time period and the cathodic phase of the first instance of the DC waveform applied to the one of the plurality of electrode contacts for the first time period overlaps with a portion of the cathodic phase of the at least the other instance of the DC waveform applied to the other of the plurality of electrode contacts.

11. The system of claim 1 , wherein one or more of the at least two electrode contacts has a high charge capacity material.

12. The system of claim 11 , wherein each of the at least two electrode contacts comprise a base body at least partially coated with the high charge capacity material.

13. The system of claim 1 , wherein the at least two electrode contacts comprise at least a first electrode contact, a second electrode contact, and a third electrode contact.

14. The system of claim 13 , wherein the second electrode is associated with a second instance of the DC waveform that is applied for a second time period, time shifted from the first time period, and the third electrode is associated with a third instance of the DC waveform that is applied for a third time period, time shifted from the first time period and the second time period.

15. The system of claim 1 , wherein the at least two electrode contacts comprise at least a first electrode contact, a second electrode contact, a third electrode contact and a fourth electrode contact.

16. The system of claim 15 , wherein the second electrode is associated with a second instance of the DC waveform that is applied for a second time period, time shifted from the first time period;

the third electrode is associated with a third instance of the DC waveform that is applied for a third time period, time shifted from the first and second time periods; and

the fourth electrode is associated with a fourth instance of the DC waveform that is applied for a fourth time period, time shifted from the first, second, and third time periods.

17. A method comprising:

generating a multiphase DC waveform by a waveform generator, wherein the multiphase DC waveform has at least a first phase, a second phase, and a third phase;

applying a first phase of the multiphase DC waveform by at least one electrode contact in electrical communication with a neural tissue, wherein the first phase of the multiphase DC waveform comprises a pre-charge pulse having a polarity;

after the pre-charge pulse, applying a second phase of the multiphase DC waveform, by the at least one electrode contact, wherein the second phase of the multiphase DC waveform comprises a blocking phase having an opposite polarity from the pre-charge pulse; and

after the blocking phase, applying a third phase of the multiphase DC waveform, by the at least one electrode contact, wherein the third phase of the multiphase DC waveform comprises a recharge phase having a same polarity as the pre-charge pulse, wherein the multiphase DC waveform blocks conduction in the nerve without damaging the nerve.

18. The method of claim 17 , wherein the multiphase DC waveform is delivered by at least one electrode contact having a high charge capacity material.

19. The method of claim 17 , wherein the multiphase DC waveform does not produce unwanted activity in the neural tissue.

20. The method of claim 17 , wherein the multiphase DC waveform comprises a slow ramp to a maximum absolute amplitude of each of the first, second, and third phases to reduce an onset response in the neural tissue.

21. The method of claim 17 , wherein the pre-charge pulse phase is applied for a first time period, the blocking phase is applied for a second time period at least as long as the first time period, and the recharge phase is applied for a third time period shorter than the blocking phase.

22. The method of claim 17 , wherein the pre-charge pulse is applied, by the at least one electrode contact in electrical communication with the neural tissue, at a charge for a length of time until a maximum charge capacity of the at least one electrode contact is reached.

23. The method of claim 17 , wherein a charge delivered by the second phase is at least twice as much as a charge that would be delivered if only the second phase were applied.

24. The method of claim 17 , wherein the third phase is applied to reduce the net charged delivered by the at least one electrode contact.

25. The method of claim 17 , further comprising providing a motor nerve block, a sensory nerve block, or an autonomic nerve block with the multiphase DC waveform.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jan 31, 2024
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 066386/0865 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2022
From: BHADRA, NILOY; KILGORE, KEVIN L.; BHADRA, NARENDRA; WAINRIGHT, JESSE; VRABEC, TINA; FRANKE, MANFRED
To: CASE WESTERN RESERVE UNIVERSITY
Reel/Frame 061839/0808 →
Continuity (8)
Continuation 16565841 · Sep 10, 2019
Continuation 16106092 · Aug 21, 2018
Continuation 15814817 · Nov 16, 2017
Continuation 15178633 · Jun 10, 2016
Division 14408017
Provisional Application 61821862 · May 10, 2013
Provisional Application 61660383 · Jun 15, 2012
Related Publication 20230086695A1 · Mar 23, 2023