IP Library Granted Patent US 9,861,811
Granted Patent B2
US 9,861,811 · App. 14/849,478 · Granted Jan 9, 2018

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 9,861,811
App. No.
14/849,478
Granted
Jan 9, 2018
Kind
B2
Abstract

Apparatus and methods for treating back pain are provided in which electrical stimulation therapy is designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability. In accordance with one aspect, electrical stimulation is applied through at least one electrode to stimulate efferent motor nerve fibers to cause muscle contraction to facilitate rehabilitation without targeting stimulation of afferent nerve fibers. In accordance with another aspect, a stimulator further includes 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.

Claims (33)

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

placing at least one electrode within a tissue of a human such that the at least one electrode is implanted adjacent to efferent motor nerve fibers of at least one 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 the efferent motor nerve fibers of the at least one muscle to cause contraction of the at least one muscle to facilitate rehabilitation without targeting stimulation of afferent nerve fibers.

2. The method of claim 1 , further comprising:

implanting at least one 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 at least one implantable pulse generator.

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

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

5. The method of claim 2 , wherein the at least one 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 at least one implantable pulse generator.

7. The method of claim 2 , wherein the at least one electrode is hardwired through at least one lead to the at least one 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 at least one muscle located at a level selected from a group consisting of: sacral, lumbar, thoracic and cervical levels.

9. The method of claim 1 , wherein applying the electrical stimulation causes contraction of the at least one muscle selected from a group consisting of: longissimus, iliocostalis, spinalis, and multifidus.

10. The method of claim 1 , wherein applying the electrical stimulation causes contraction of the at least one muscle to enhance muscle tone.

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

12. The method of claim 1 , wherein applying the electrical stimulation comprises applying the electrical stimulation to at least one nerve selected from a group consisting of: dorsal root of spinal nerve, ventral root of spinal nerve, and dorsal root ganglion.

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

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

15. The method of claim 13 , wherein placing the lead comprises implanting the lead in the tissue of the human.

16. The method of claim 1 , wherein the electrical stimulation stimulating the efferent motor nerve fibers of the at least one muscle is applied for a treatment period.

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

18. The method of claim 16 , wherein the treatment period is selected to provide extended back pain relief.

19. The method of claim 18 , 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.

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

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

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

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

24. The method of claim 23 , further comprising:

placing at least one other electrode at a location different from the at least one electrode,

applying electrical stimulation through the at least one other electrode positioned at the different location; and

modifying the electrical stimulation based on at least one muscle characteristic resulting from the electrical stimulation through the at least one other electrode positioned at the different location.

25. The method of claim 24 , wherein modifying the electrical stimulation comprises adjusting electrical stimulation parameters.

26. The method of claim 25 , wherein the electrical stimulation parameters are selected from a group consisting of:

frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, number of phases, and waveform shape.

Assignments (7)
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 →
RELEASE OF SECURITY INTEREST Recorded Sep 14, 2022
From: OXFORD FINANCE LLC
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 061433/0238 →
SECURITY INTEREST Recorded Sep 9, 2022
From: MAINSTAY MEDICAL LIMITED
To: MADRYN HEALTH PARTNERS II (CAYMAN MASTER), LP
Reel/Frame 061404/0708 →
SECURITY INTEREST Recorded Apr 6, 2021
From: MAINSTAY MEDICAL LIMITED
To: OXFORD FINANCE LLC
Reel/Frame 055832/0744 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2015
From: CROSBY, PETER ANDREW; SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; HEEMELS, JOHANNES PETRUS
To: MAINSTAY MEDICAL, INC.
Reel/Frame 036545/0498 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 11, 2015
From: MAINSTAY MEDICAL, INC.
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 036545/0581 →
Continuity (3)
Continuation 13045421 · Mar 10, 2011
Provisional Application 61339957 · Mar 11, 2010
Related Publication 20150374992A1 · Dec 31, 2015