IP Library Granted Patent US 11,951,310
Granted Patent B2
US 11,951,310 · App. 17/092,073 · Granted Apr 9, 2024

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 (San Juan Capistrano, CA)
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 11,951,310
App. No.
17/092,073
Granted
Apr 9, 2024
Kind
B2
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 (32)

1. A method of rehabilitating a multifidus muscle to alleviate back pain of a patient, the method comprising:

electrically stimulating, via one or more electrodes positioned within the patient, tissue associated with the multifidus muscle which is associated with local segmental control of a lumbar spine, to cause the multifidus muscle to contract; and

further electrically stimulating the tissue over time via the one or more electrodes to cause the multifidus muscle to contract, thereby improving function of the multifidus muscle supporting lumbar spine stability to facilitate rehabilitation of the multifidus muscle.

2. The method of claim 1 , wherein the one or more electrodes are disposed on one or more leads.

3. The method of claim 2 , wherein the one or more leads are configured to be anchored such that the one or more electrodes are near or in contact with the tissue associated with the multifidus muscle.

4. The method of claim 1 , wherein the one or more electrodes are configured to be coupled to a pulse generator programmed to cause the one or more electrodes to deliver electrical stimulation.

5. The method of claim 4 , further comprising sensing muscle contraction via one or more sensors coupled to a programmable controller of the pulse generator and generating a sensor signal based on the muscle contraction, the sensor signal is indicative of patient compliance.

6. The method of claim 1 , wherein the one or more electrodes are positioned such that the electrical stimulation and the further electrical stimulation are delivered to a medial branch of a dorsal ramus nerve innervating the multifidus muscle.

7. The method of claim 6 , wherein the one or more electrodes are positioned such that the electrical stimulation and the further electrical stimulation are delivered to the medial branch of the dorsal ramus nerve that exits between L2 and L3 lumbar segments.

8. The method of claim 1 , wherein the one or more electrodes are positioned such that the electrical stimulation and the further electrical stimulation are delivered to nervous tissue innervating the multifidus muscle.

9. The method of claim 1 , wherein the one or more electrodes are positioned such that the electrical stimulation and the further electrical stimulation are delivered to efferent nervous tissue innervating the multifidus muscle.

10. The method of claim 1 , wherein the further electrical stimulation restores neural control.

11. The method of claim 1 , wherein the further electrical stimulation reduces back pain.

12. The method of claim 1 , wherein delivering the electrical stimulation and delivering the further electrical stimulation are each responsive to programming stored in a pulse generator configured to cause the one or more electrodes to deliver the electrical stimulation.

13. The method of claim 1 , wherein the one or more electrodes comprise a plurality of electrodes.

14. A method of rehabilitating a multifidus muscle to alleviate back pain of a patient, the method comprising:

causing one or more electrodes positioned within a patient near or in contact with tissue associated with a multifidus muscle which is associated with local segmental control of a lumbar spine to deliver electrical stimulation to the tissue to cause the multifidus muscle to contract; and

causing the one or more electrodes to deliver additional electrical stimulation to the tissue over time to cause the multifidus muscle to contract, thereby improving function of the multifidus muscle supporting lumbar spine stability to facilitate rehabilitation of the multifidus muscle.

15. The method of claim 14 , wherein the method reduces back pain for the patient.

16. The method of claim 14 , wherein positioning the one or more electrodes comprises positioning the one or more electrodes adjacent to a medial branch of a dorsal ramus nerve innervating the multifidus muscle such that the one or more electrodes deliver the electrical stimulation and the additional electrical stimulation to the medial branch of the dorsal ramus nerve.

17. A method of rehabilitating a multifidus muscle to alleviate back pain of a patient, the method comprising:

providing one or more electrodes configured to be positioned within a patient near or in contact with tissue associated with a multifidus muscle which is associated with local segmental control of a lumbar spine;

utilizing a pulse generator electrically coupled to the one or more electrodes to cause the one or more electrodes to:

deliver electrical stimulation to the tissue to cause the multifidus muscle to contract; and

deliver additional electrical stimulation to the tissue over time to cause the multifidus muscle to contract, thereby improving function of the multifidus muscle supporting lumbar spine stability to facilitate rehabilitation of the multifidus muscle.

18. The method of claim 17 , wherein the method reduces back pain for the patient.

19. The method of claim 17 , wherein the one or more electrodes are positioned such that the electrical stimulation and the additional electrical stimulation are delivered to a medial branch of a dorsal ramus nerve innervating the multifidus muscle.

20. The method of claim 1 , wherein the electrically stimulating and the further electrically stimulating are performed during a first treatment session.

21. The method of claim 1 , wherein the electrically stimulating is performed in a first treatment session and the further electrically stimulating is performed during subsequent treatment sessions.

22. The method of claim 20 , wherein the electrically stimulating and the further electrically stimulating are performed by a pulse generator programmed at the direction of a physician to cause the one or more electrodes to deliver the electrical stimulation to the multifidus muscle, and wherein the physician initiates the pulse generator to perform the electrically stimulating and the further electrically stimulating during the first treatment session.

23. The method of claim 1 , wherein the electrically stimulating and the further electrically stimulating are performed by a pulse generator programmed at the direction of a physician to cause the one or more electrodes to deliver the electrical stimulation to the multifidus muscle, and wherein at least one of a patient or a patient's caregiver initiates the pulse generator to perform the electrically stimulating and the further electrically stimulating during one or more treatment sessions.

24. The method of claim 1 , wherein the electrically stimulating and the further electrically stimulating are performed by a pulse generator programmed at the direction of a physician to cause the one or more electrodes to deliver the electrical stimulation to the multifidus muscle, and wherein the physician initiates the pulse generator to perform the electrically stimulating during a first treatment session and at least one of a patient or a patient's caregiver initiates the pulse generator to perform the further electrically stimulating during one or more treatment sessions.

Assignments (6)
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 Nov 6, 2020
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; CROSBY, PETER ANDREW
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 054305/0809 →
Continuity (14)
Continuation 15944730 · Apr 3, 2018
Continuation 15299399 · Oct 20, 2016
Continuation 14792430 · Jul 6, 2015
Continuation 14061614 · Oct 23, 2013
Continuation In Part 13858809 · Apr 8, 2013
Continuation 12075174 · Mar 10, 2008
Continuation 16817574 · Mar 12, 2020
Continuation In Part 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
Provisional Application 60905979 · Mar 9, 2007
Related Publication 20210069509A1 · Mar 11, 2021
Cited By (5)
US 12,285,612 US 12,458,802 US 12,582,816 US 12,594,096 US 12,702,824