IP Library Granted Patent US 11,684,774
Granted Patent B2
US 11,684,774 · App. 17/812,981 · Granted Jun 27, 2023

Electrical stimulator for treatment of back pain and methods of use

Inventors: Peter Andrew Crosby (Blaine, MN); Dan Sachs (Minneapolis, MN); Prashant Brijmohansingh Rawat (Blaine, MN); Jason Alan Shiroff (Edina, MN); Johannes Petrus Heemels (Keerbergen, BE)
Assignee: Mainstay Medical Limited
A61N1/0551A61B18/1492A61N1/06A61N1/36071A61N1/37211A61B2034/2048
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Quick Facts
Patent No.
US 11,684,774
App. No.
17/812,981
Granted
Jun 27, 2023
Kind
B2
Abstract

Apparatus and methods for treating back pain are provided, in which an implantable stimulator is configured to communicate with an external control system, the implantable stimulator providing a neuromuscular electrical stimulation therapy designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability; the implantable stimulator further including one or more of a number of additional therapeutic modalities, including a module that provides analgesic stimulation; a module that monitors muscle performance and adjusts the muscle stimulation regime; and/or a module that provides longer term pain relief by selectively and repeatedly ablating nerve fibers. In an alternative embodiment, a standalone implantable RF ablation system is described.

Claims (43)

1. A method for treating low back pain, the method comprising:

providing at least one electrode configured to be placed within a lower back of a human such that the at least one electrode is implanted to stimulate nervous tissue associated with a multifidus muscle supporting stability of the human's lumbar spine;

electrically stimulating, via the at least one electrode, efferent nervous tissue associated with the multifidus muscle to cause contraction of the multifidus muscle to facilitate rehabilitation; and

electrically stimulating, via the at least one electrode, afferent nervous tissue associated with the multifidus muscle to reduce pain signals,

thereby reducing the human's low back pain.

2. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, the efferent nervous tissue comprises electrically stimulating a medial branch of a dorsal ramus nerve to cause contraction of the multifidus muscle to restore neural drive of the multifidus muscle to thereby reduce the human's low back pain.

3. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, the afferent nervous tissue comprises electrically stimulating a peripheral nerve to reduce the pain signals traveling towards the human's brain from the human's spinal cord.

4. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, the afferent nervous tissue comprises electrically stimulating the afferent nervous tissue to reduce pain signals resulting from electrically stimulating the efferent nervous tissue.

5. The method of claim 1 , wherein the at least one electrode comprises a plurality of electrodes.

6. The method of claim 5 , wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are done with different electrodes of the plurality of electrodes.

7. The method of claim 1 , wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are done at different locations within the human.

8. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, the efferent nervous tissue improves neural drive.

9. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, the efferent nervous tissue causes muscle contractions in the multifidus muscle during a predetermined number of sessions.

10. The method of claim 9 , wherein the predetermined number of sessions is over a period of weeks.

11. The method of claim 1 , wherein electrically stimulating, via the at least one electrode, comprises electrically stimulating at a stimulation rate selected from a range of 12-30 Hz.

12. The method of claim 1 , wherein electrically stimulating the afferent nervous tissue is at a higher stimulation frequency than electrically stimulating the efferent nervous tissue.

13. The method of claim 1 , wherein electrically stimulating the efferent nervous tissue is performed simultaneously with electrically stimulating the afferent nervous tissue.

14. The method of claim 1 , wherein electrically stimulating the efferent nervous tissue is performed in a time-wise interleaved manner as electrically stimulating the afferent nervous tissue.

15. The method of claim 1 , wherein the at least one electrode is disposed on at least one lead.

16. The method of claim 1 , wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are performed automatically responsive to an electrical stimulation regime programmed in a pulse generator coupled to the at least one electrode.

17. The method of claim 16 , wherein electrically stimulating, via the at least one electrode, the efferent nervous tissue comprises electrically stimulating based on programming associated with a first circuitry module programmed in the pulse generator, and

wherein electrically stimulating, via the at least one electrode, the afferent nervous tissue comprises electrically stimulating based on programming associated with a second circuitry module programmed in the pulse generator.

18. The method of claim 16 , wherein the pulse generator is configured to be implanted.

19. The method of claim 18 , further comprising transmitting data associated with the pulse generator from the pulse generator to an external control system.

20. The method of claim 19 , further comprising receiving power at the pulse generator from the external control system to charge a battery of the pulse generator.

21. The method of claim 16 , further comprising transmitting data associated with the pulse generator from the pulse generator to a computer running monitoring and control software.

22. A method for treating low back pain of a human, the method comprising:

providing at least one electrode configured to be placed within a lower back of a human such that the at least one electrode is implanted to stimulate nervous tissue associated with a lumbar multifidus muscle supporting stability of the human's lumbar spine;

electrically stimulating, via the at least one electrode, efferent nervous tissue associated with the lumbar multifidus muscle to cause contraction of the lumbar multifidus muscle; and

electrically stimulating, via the at least one electrode, afferent nervous tissue associated with the lumbar multifidus muscle to reduce pain signals,

thereby reducing the human's low back pain.

23. A method for treating low back pain of a human, the method comprising:

electrically stimulating, via at least one electrode configured to be placed within a lower back of a human such that the at least one electrode is implanted to stimulate nervous tissue associated with a multifidus muscle supporting stability of the human's lumbar spine, efferent nervous tissue of a medial branch of a dorsal ramus nerve associated with the multifidus muscle; and

electrically stimulating, via the at least one electrode, afferent nervous tissue associated with the multifidus muscle to reduce pain signals,

thereby reducing the human's low back pain.

24. The method of claim 23 , wherein electrically stimulating, via the at least one electrode, the afferent nervous tissue comprises electrically stimulating the afferent nervous tissue to reduce pain signals resulting from electrically stimulating the efferent nervous tissue.

25. The method of claim 23 , wherein electrically stimulating, via the at least one electrode, the afferent nervous tissue comprises electrically stimulating a peripheral nerve associated with the multifidus muscle to reduce the pain signals traveling towards the human's brain from the human's spinal cord.

26. The method of claim 23 , wherein the at least one electrode comprises a plurality of electrodes, and

wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are done with different electrodes of the plurality of electrodes.

27. The method of claim 23 , wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are done at different locations within the human.

28. The method of claim 23 , wherein electrically stimulating, via the at least one electrode, comprises electrically stimulating at a stimulation rate selected from a range of 12-30 Hz.

29. The method of claim 23 , wherein electrically stimulating the efferent nervous tissue is performed simultaneously with electrically stimulating the afferent nervous tissue.

30. The method of claim 23 , wherein electrically stimulating the efferent nervous tissue and electrically stimulating the afferent nervous tissue are performed automatically responsive to an electrical stimulation regime programmed in a pulse generator coupled to the at least one electrode.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Mar 3, 2025
From: MADRYN FUND ADMINISTRATION, LLC
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 070388/0062 →
SECURITY INTEREST Recorded Jan 24, 2024
From: MADRYN HEALTH PARTNERS II (CAYMAN MASTER), LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 066367/0608 →
SECURITY INTEREST Recorded Sep 9, 2022
From: MAINSTAY MEDICAL LIMITED
To: MADRYN HEALTH PARTNERS II (CAYMAN MASTER), LP
Reel/Frame 061404/0708 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2022
From: CROSBY, PETER A; SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; HEEMELS, JOHANNES PETRUS
To: MAINSTAY MEDICAL, INC.
Reel/Frame 060537/0191 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 18, 2022
From: MAINSTAY MEDICAL, INC.
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 060537/0213 →
Continuity (9)
Continuation 17173121 · Feb 10, 2021
Continuation 16817574 · Mar 12, 2020
Continuation 15853543 · Dec 22, 2017
Continuation 14849478 · Sep 9, 2015
Continuation In Part 13045435 · Mar 10, 2011
Continuation 13045421 · Mar 10, 2011
Provisional Application 61339957 · Mar 11, 2010
Provisional Application 61339943 · Mar 11, 2010
Related Publication 20220347465A1 · Nov 3, 2022
Cited By (11)
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