IP Library Granted Patent US 11,103,706
Granted Patent B2
US 11,103,706 · App. 16/264,632 · Granted Aug 31, 2021

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

Inventors: Dan Sachs (Minneapolis, MN); Prashant Brijmohansingh Rawat (Blaine, MN); Peter Andrew Crosby (Blaine, MN); Jason Hannon (Swords, IE)
Assignee: Mainstay Medical Limited
A61N1/36071A61N1/36067A61N1/36146A61N1/37229A61N2/008A61N2/02A61N1/0551A61N1/0558A61N1/36003A61N1/36125A61N1/36157A61N1/36167A61N1/36175A61N1/36185A61N1/37247A61N2/06
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Quick Facts
Patent No.
US 11,103,706
App. No.
16/264,632
Granted
Aug 31, 2021
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 (21)

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

selecting one or more electrodes and a pulse generator configured for electrical communication with the one or more electrodes;

implanting the one or more electrodes in or adjacent 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;

programming the pulse generator for enhancing function of the one or more spine stabilizing muscles; and

delivering, adjunctive to the spine surgery intervention, electrical stimulation from the pulse generator 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 in connection with the spine surgery intervention to facilitate rehabilitation and improve the function of the one or more spine stabilizing muscles after the spine surgery intervention.

2. The method of claim 1 , wherein implanting the one or more electrodes in or adjacent to tissue associated with one or more spine stabilizing muscles comprises implanting the one or more electrodes in or adjacent to a dorsal ramus nerve that innervates the multifidus muscle, and wherein delivering electrical stimulation comprises delivering electrical stimulation from the pulse generator to the dorsal ramus nerve that innervates the multifidus muscle.

3. The method 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.

4. The method of claim 1 , wherein the one or more electrodes are disposed on an electrode lead, the electrode lead having 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, and wherein implanting the one or more electrodes in or adjacent to tissue associated with one or more spine stabilizing muscles comprises anchoring the electrode lead in or adjacent to tissue associated with one or more spine stabilizing muscles via the first and second anchors.

5. The method of claim 1 , wherein programming the pulse generator further comprises transmitting programing data from an external programmer to the pulse generator, wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles comprises delivering electrical stimulation consistent with the programming data.

6. The method of claim 5 , 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.

7. The method of claim 1 , wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles causes contraction of the one or more spine stabilizing muscles.

8. The method of claim 1 , wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles comprises delivering electrical stimulation at a stimulation rate between 1-30 Hz.

9. The method of claim 1 , wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles comprises delivering electrical stimulation at a pulse width between 20-500 μs.

10. The method of claim 1 , wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles comprises delivering electrical stimulation at a pulse amplitude between 0.1-7 mA.

11. The method of claim 1 , wherein the pulse generator is configured to be percutaneously implanted, the method further comprising implanting the pulse generator prior to delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles via the one or more electrodes.

12. The method of claim 1 , further comprising transmitting a stimulation command from an activator to the pulse generator, wherein delivering electrical stimulation from the pulse generator to the tissue associated with the one or more spine stabilizing muscles comprises delivering electrical stimulation responsive to the stimulation command.

13. The method of claim 12 , 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.

14. The method of claim 1 , further comprising sensing muscle contraction via one or more sensors coupled to the pulse generator, and adjusting the electrical stimulation delivered by the pulse generator to maintain smooth and continuous muscle contraction.

15. The method of claim 1 , further comprising:

reprogramming the pulse generator for restoring muscle function of the one or more spine stabilizing muscles; and

delivering, according to the reprogramming and after the spine surgery intervention, electrical stimulation from the pulse generator 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.

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 Feb 19, 2020
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; CROSBY, PETER ANDREW; HANNON, JASON
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 051858/0498 →
Continuity (8)
Continuation In Part 15994730 · 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 20190167995A1 · Jun 6, 2019
Cited By (5)
US 12,285,612 US 12,458,802 US 12,582,816 US 12,594,096 US 12,702,824