IP Library Granted Patent US 11,331,488
Granted Patent B2
US 11,331,488 · App. 17/411,713 · Granted May 17, 2022

Systems and methods for enhancing function of spine stabilization muscles associated with a spine surgery intervention

Inventors: Dan Sachs (Minneapolis, MN); Prashant Brijmohansing Rawat (Blaine, MN); Peter Andrew Crosby (Blaine, MN); Jason Hannon (Dublin, IE)
Assignee: Mainstay Medical Limited
A61N1/36067A61N1/0551A61N1/36071A61N1/36146A61N1/36167A61N1/37229A61N2/008A61N2/02A61N1/0558A61N1/36003A61N1/36125A61N1/36157A61N1/36175A61N1/36185A61N1/37247A61N2/06
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Quick Facts
Patent No.
US 11,331,488
App. No.
17/411,713
Granted
May 17, 2022
Kind
B2
Abstract

A method for enhancing muscle function of skeletal muscles in connection with a planned spine surgery intervention in a patient's back is provided. The method includes implanting one or more electrodes in or adjacent to tissue associated with one or more skeletal muscles within a back of a patient, the one or more electrodes in electrical communication with a pulse generator programmed for enhancing muscle function of the one or more skeletal muscles. Electrical stimulation is delivered, according to the programming during a time period associated with the planned spine surgery intervention, from the pulse generator to the tissue associated with the one or more skeletal muscles via the one or more electrodes, thereby improving neuromuscular control system performance of the one or more spine stabilizing muscles in connection with the planned spine surgery intervention to reduce the patient's recovery time associated with the planned spine surgery intervention.

Claims (30)

1. A system for enhancing function of spine stabilizing muscles in connection with a spine surgery intervention in a patient's back, the system comprising:

one or more electrodes configured to be implanted to deliver electrical stimulation to tissue associated with one or more spine stabilizing muscles associated with local segmental control of a lumbar spine within a back of a patient; and

a pulse generator in electrical communication with the one or more electrodes, the pulse generator programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles via the one or more electrodes to improve neuromuscular control system performance of the one or more spine stabilizing muscles to facilitate rehabilitation and improve the function of the one or more spine stabilizing muscles after the spine surgery intervention.

2. The system of claim 1 , wherein the one or more electrodes are configured to be implanted to deliver electrical stimulation to a dorsal ramus nerve that innervates the multifidus muscle.

3. The system of claim 1 , wherein the one or more electrodes are configured to be implanted to deliver electrical stimulation to a medial branch of the dorsal ramus nerve that innervates the multifidus muscle.

4. The system of claim 1 , wherein the one or more spine stabilizing muscles comprises at least one of a multifidus, transverse abdominis, quadratus lumborum, psoas major, internus abdominis, obliquus externus abdominis, or erector spinae muscles.

5. The system of claim 1 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles to cause contraction of the one or more spine stabilizing muscles.

6. The system of claim 1 , wherein the one or more electrodes are configured to be implanted to deliver electrical stimulation to tissue associated with a multifidus muscle, and

wherein the electrical stimulation is delivered to improve neuromuscular control system performance of the multifidus muscle to facilitate rehabilitation and improve the function of the multifidus muscle.

7. The system of claim 6 , wherein the pulse generator is programmed to deliver the electrical stimulation to the tissue associated with the multifidus muscle to cause contraction of the multifidus muscle.

8. The system of claim 1 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles at a stimulation rate between 1-30 Hz.

9. The system of claim 1 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles at a pulse width between 20-500 μs.

10. The system of claim 1 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles at a pulse amplitude between 0.1-7 mA.

11. The system of claim 1 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles at stimulation parameters titrated for the patient.

12. The system of claim 11 , wherein the stimulation parameters comprises at least one of timing, magnitude, or duration of treatment.

13. The system of claim 1 , wherein the pulse generator is configured to be implanted.

14. The system of claim 1 , wherein the pulse generator is configured to be reprogrammed for restoring muscle function of the one or more spine stabilizing muscles,

wherein the pulse generator is programmed to deliver, according to the reprogramming and after the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles via the one or more electrodes, thereby facilitating rehabilitation of the one or more spine stabilizing muscles after the spine surgery intervention.

15. The system of claim 1 , further comprising an electrode lead configured to electrically couple the pulse generator to the one or more electrodes.

16. The system of claim 15 , wherein the electrode lead comprises a first anchor angled distally relative to the electrode lead and a second anchor distal to the first anchor angled proximally relative to the electrode lead, the first and second anchors configured to anchor the electrode lead in or adjacent to the tissue associated with one or more spine stabilizing muscles.

17. The system of claim 1 , further comprising:

an external programmer configured to transmit programing data to the pulse generator,

wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles consistent with the programming data.

18. The system of claim 17 , wherein the programming data comprises at least one of: pulse amplitude, pulse width, stimulation rate, stimulation frequency, ramp timing, cycle timing, session timing, or electrode configuration.

19. The system of claim 1 , further comprising:

an activator configured to transmit a stimulation command to the pulse generator,

wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, electrical stimulation to the tissue associated with the one or more spine stabilizing muscles responsive to the stimulation command.

20. The system of claim 19 , wherein the stimulation command comprises at least one of: a command to start a treatment session or stop the treatment session; a command to provide a status of the pulse generator; or a request to conduct an impedance assessment.

21. The system of claim 1 , further comprising one or more sensors operatively coupled to the pulse generator, the one or more sensors configured to sense muscle contraction.

22. The system of claim 21 , wherein the pulse generator is programmed to deliver, adjunctive to the spine surgery intervention, an adjusted electrical stimulation based on sensed muscle contraction.

Assignments (4)
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 Aug 25, 2021
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; CROSBY, PETER ANDREW; HANNON, JASON
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 057287/0413 →
Continuity (9)
Continuation 16264632 · Jan 31, 2019
Continuation In Part 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
Provisional Application 60905979 · Mar 9, 2007
Related Publication 20210379380A1 · Dec 9, 2021
Cited By (5)
US 12,285,612 US 12,458,802 US 12,582,816 US 12,594,096 US 12,702,824