IP Library › Granted Patent US 12,285,612
Granted Patent B1
US 12,285,612 · App. 18/980,413 · Granted Apr 29, 2025

Systems and methods for restoring muscle function to the lumbar spine

Inventors: Dan Sachs (Minneapolis, MN); Prashant Brijmohansingh Rawat (Blaine, MN); Jason Shiroff (Edina, MN); Peter Crosby (Blaine, MN)
Assignee: Mainstay Medical Limited
A61N1/36071A61N1/0551A61N1/0558A61N1/36003A61N1/36067A61N1/36125A61N1/36146A61N1/36167A61N1/36175A61N1/36185A61N1/37229A61N1/37247A61N2/008A61N2/06A61N1/36157
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Quick Facts
Patent No.
US 12,285,612
App. No.
18/980,413
Granted
Apr 29, 2025
Kind
B1
Abstract

A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Claims (39)

1. A method for alleviating or reducing back pain in a patient, the method comprising:

implanting a first electrode and a second electrode bilaterally on either side of a spine of a patient experiencing back pain to deliver electrical stimulation to tissue associated with one or more spine stabilizing muscles associated with local segmental control of the spine; and

electrically stimulating the tissue associated with the one or more spine stabilizing muscles via the first electrode to cause contraction of the one or more spine stabilizing muscles to improve neuromuscular control system performance of the one or more spine stabilizing muscles and via the second electrode to reduce back pain, thereby alleviating or reducing the patient's back pain,

wherein the first electrode is electrically coupled to a pulse generator via a first electrode lead and the second electrode is electrically coupled to the pulse generator via a second electrode lead.

2. The method of claim 1 , wherein implanting the first and second electrodes comprises implanting the first and second electrodes to deliver the electrical stimulation to a dorsal ramus nerve that innervates a multifidus muscle.

3. The method of claim 1 , wherein implanting the first and second electrodes comprises implanting the first and second electrodes to deliver the electrical stimulation to a medial branch of the dorsal ramus nerve that innervates a multifidus muscle.

4. The method of claim 1 , wherein the electrically stimulating alleviates or reduces the patient's back pain by improving neural control function of the one or more spine stabilizing muscles.

5. The method of claim 1 , wherein the electrically stimulating comprises electrically stimulating at a stimulation rate selected in a range of 12-30 Hz.

6. The method of claim 1 , further comprising implanting the pulse generator.

7. The method of claim 1 , wherein the electrically stimulating comprises electrically stimulating at stimulation parameters titrated for the patient.

8. The method of claim 7 , wherein the stimulation parameters comprise timing, magnitude, and/or duration of treatment.

9. The method of claim 1 , wherein the first electrode lead and the second electrode lead each comprise a plurality of electrodes.

10. The method of claim 1 , wherein the implanting comprises anchoring each of the first and second electrode leads via an anchor angled relative to the respective electrode lead.

11. The method of claim 1 , wherein the electrically stimulating alleviates or reduces the patient's lumbar back pain.

12. The method of claim 11 , wherein the electrically stimulating alleviates or reduces the patient's lumbar back pain following a treatment time period.

13. The method of claim 1 , wherein the one or more spine stabilizing muscles comprises a multifidus, transverse abdominis, quadratus lumborum, psoas major, internus abdominis, obliquus externus abdominis, and/or erector spinae muscle.

14. A method for alleviating or reducing back pain in a patient, the method comprising:

implanting first and second electrodes bilaterally on either side of a spine within a back of a patient experiencing back pain to deliver electrical stimulation to tissue associated with a multifidus muscle associated with local segmental control of the spine; and

electrically stimulating the tissue associated with the multifidus muscle via the first electrode to improve neuromuscular control system performance of the multifidus muscle and via the second electrode to reduce back pain, thereby alleviating or reducing the patient's back pain,

wherein the first electrode is electrically coupled to a pulse generator via a first electrode lead and the second electrode is electrically coupled to the pulse generator via a second electrode lead.

15. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue associated with the multifidus muscle to cause contraction of the multifidus muscle.

16. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue at a stimulation rate selected in a range of 12-30 Hz.

17. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue at a pulse width selected in a range of 20-500 μs.

18. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue at a pulse amplitude selected in a range of 0.1-7 mA.

19. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue at a stimulation rate selected in a range of 1-30 Hz, at a pulse width selected in a range of 20-500 μs, and at a pulse amplitude selected in a range of 0.1-7 mA.

20. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating the tissue adjunctive to a spine surgery intervention.

21. The method of claim 14 , wherein the electrically stimulating comprises electrically stimulating at stimulation parameters titrated for the patient.

22. The method of claim 21 , wherein the stimulation parameters comprise timing, magnitude, and/or duration of treatment.

23. The method of claim 14 , further comprising implanting the pulse generator.

24. The method of claim 14 , wherein the first electrode lead and the second electrode lead each comprise a plurality of electrodes.

25. The method of claim 14 , wherein the implanting comprises anchoring each of the first and second electrode leads via an anchor angled relative to the respective electrode lead.

26. The method of claim 14 , wherein the electrically stimulating alleviates or reduces the patient's lumbar back pain.

27. The method of claim 26 , wherein the electrically stimulating alleviates or reduces the patient's lumbar back pain following a treatment time period.

28. A method for alleviating or reducing back pain in a patient, the method comprising:

providing first and second electrodes for implantation bilaterally on either side of a spine of a patient experiencing back pain to deliver electrical stimulation to a dorsal ramus nerve that innervates a multifidus muscle which is associated with local segmental control of the spine;

causing, responsive to programming in a pulse generator, electrical stimulation to the dorsal ramus nerve via the first electrode to cause the multifidus muscle to contract improve neuromuscular control system performance and via the second electrode to reduce back pain, thereby alleviating or reducing the patient's back pain,

wherein the first electrode is electrically coupled to the pulse generator via a first electrode lead and the second electrode is electrically coupled to the pulse generator via a second electrode lead.

29. The method of claim 28 , wherein the pulse generator is programmed to deliver the electrical stimulation to the tissue to alleviate or reduce the patient's back pain by improving neural control function of the multifidus muscle.

30. The method of claim 28 , wherein the pulse generator is programmed to deliver the electrical stimulation at a stimulation rate selected in a range of 12-30 Hz.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 13, 2024
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; CROSBY, PETER ANDREW
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 069579/0459 →
Continuity (15)
Continuation 18333474 · Jun 12, 2023
Continuation In Part 17812989 · Jul 15, 2022
Continuation 17092073 · Nov 6, 2020
Continuation In Part 16817574 · Mar 12, 2020
Continuation In Part 15944730 · Apr 3, 2018
Continuation 15853543 · Dec 22, 2017
Continuation 15299399 · Oct 20, 2016
Continuation 14849478 · Sep 9, 2015
Continuation 14792430 · Jul 6, 2015
Continuation 14061614 · Oct 23, 2013
Continuation In Part 13858809 · Apr 8, 2013
Continuation 13045421 · Mar 10, 2011
Continuation 12075174 · Mar 10, 2008
Provisional Application 61339957 · Mar 11, 2010
Provisional Application 60905979 · Mar 9, 2007
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