IP Library Granted Patent US 11,471,670
Granted Patent B2
US 11,471,670 · App. 17/647,341 · Granted Oct 18, 2022

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
A61N1/0551A61B18/1492A61N1/06A61N1/36071A61N1/37211A61B2017/00221A61B2018/00339A61B2018/00577A61B2018/124A61B2018/1467A61B2034/2048A61N1/36042
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Quick Facts
Patent No.
US 11,471,670
App. No.
17/647,341
Granted
Oct 18, 2022
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 (33)

1. A method to alleviate back pain, the method comprising:

placing at least one electrode within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human; and

applying electrical stimulation through the at least one electrode at a stimulation rate between 10-30 Hz to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction of the multifidus muscle to facilitate rehabilitation without targeting stimulation of afferent nerve fibers.

2. The method of claim 1 , further comprising:

implanting an implantable pulse generator operatively coupled with the at least one electrode within the human having back pain,

wherein the electrical stimulation is applied based on an electrical stimulation regime programmed in the implantable pulse generator.

3. The method of claim 2 , wherein the implantable pulse generator further is programmed to cause direct stimulation of the multifidus muscle.

4. The method of claim 2 , wherein the implantable pulse generator is programmed to cause direct stimulation of at least one nerve innervating the multifidus muscle.

5. The method of claim 2 , wherein the implantable pulse generator is programmed to ramp up and ramp down a strength and duration of the electrical stimulation.

6. The method of claim 2 , further comprising wirelessly communicating with the implantable pulse generator.

7. The method of claim 2 , wherein the at least one electrode is wired through a lead to the implantable pulse generator.

8. The method of claim 1 , wherein placing the at least one electrode comprises placing the at least one electrode within the multifidus muscle located at a lumbar level.

9. The method of claim 1 , wherein applying the electrical stimulation causes contraction of the multifidus muscle to enhance muscle tone.

10. The method of claim 1 , wherein the electrical stimulation causes contraction by reflex activation.

11. The method of claim 1 , wherein applying the electrical stimulation comprises applying the electrical stimulation to a medial branch of a dorsal ramus to cause contraction of the multifidus muscle.

12. The method of claim 1 , wherein placing the at least one electrode further comprises placing a lead having the at least one electrode.

13. The method of claim 12 , wherein placing the lead comprises percutaneously placing the lead.

14. The method of claim 12 , wherein placing the lead comprises implanting the lead in tissue of the human.

15. The method of claim 1 , wherein the electrical stimulation stimulating the efferent motor nerve fibers innervating the multifidus muscle is applied for a treatment period.

16. The method of claim 15 , wherein the treatment period is repeated over a period of a few weeks.

17. The method of claim 15 , wherein the treatment period is selected to provide extended back pain relief.

18. The method of claim 17 , wherein the treatment period is selected to provide extended back pain relief for no less than a period of time approximately a same length as the treatment period.

19. The method of claim 1 , wherein the electrical stimulation is applied for a prescribed period of time.

20. The method of claim 19 , wherein the prescribed period of time is approximately one hour per day over a period of a few weeks.

21. The method of claim 1 , further comprising evaluating the electrical stimulation by identifying a target muscle.

22. The method of claim 1 , further comprising positioning the at least one electrode at a location based on a target muscle location.

23. The method of claim 1 , further comprising:

placing at least one other electrode at a location different from the at least one electrode; and

applying electrical stimulation through the at least one other electrode positioned at the different location to cause contraction of the multifidus muscle to facilitate rehabilitation.

24. The method of claim 1 , wherein applying electrical stimulation through the at least one electrode comprises applying the electrical stimulation at the stimulation rate selected from 12-30 Hz.

25. The method of claim 24 , wherein the electrical stimulation is applied based on an electrical stimulation regime programmed in a pulse generator.

26. The method of claim 24 , wherein the pulse generator is configured to be implanted within the human.

27. The method of claim 24 , wherein the pulse generator is programmed to apply the electrical stimulation through the at least one electrode to a medial branch of a dorsal ramus to cause contraction of the multifidus muscle.

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 Jan 11, 2022
From: CROSBY, PETER A; SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON A; HEEMELS, JOHANNES P
To: MAINSTAY MEDICAL, INC.
Reel/Frame 058624/0493 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2022
From: MAINSTAY MEDICAL, INC.
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 058624/0538 →
Continuity (7)
Continuation 17173121 · Feb 10, 2021
Continuation 16817574 · Mar 12, 2020
Continuation 15853543 · Dec 22, 2017
Continuation 14849478 · Sep 9, 2015
Continuation 13045421 · Mar 10, 2011
Provisional Application 61339957 · Mar 11, 2010
Related Publication 20220126091A1 · Apr 28, 2022
Cited By (6)
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