IP Library Granted Patent US 10,828,490
Granted Patent B2
US 10,828,490 · App. 15/944,730 · Granted Nov 10, 2020

Systems and methods for restoring muscle function to the lumbar spine

Inventors: Dan Sachs (Minneapolis, MN); Prashant Brijmohansingh Rawat (Blaine, MN); Jason Alan Shiroff (Edina, MN); Peter Andrew 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 10,828,490
App. No.
15/944,730
Granted
Nov 10, 2020
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 (27)

1. A neuromuscular electrical stimulation system for rehabilitating skeletal muscles, the system comprising:

a lead having one or more electrodes configured to be implanted in or adjacent to nervous tissue associated with one or more skeletal muscles associated with local segmental control of a lumbar spine;

an implantable pulse generator coupled to the one or more electrodes, the implantable pulse generator having a programmable controller configured to be programmed to cause the one or more electrodes to electrically stimulate the nervous tissue to induce muscle contraction to restore neural control and rehabilitate the one or more skeletal muscles to thereby improve lumbar spine stability; and

an external transmitter coupled to the implantable pulse generator.

2. The system of claim 1 , wherein the lead comprises a first fixation element coupled to the lead, the first fixation element angled distally relative to the lead, and a second fixation element coupled to the lead distal to the first fixation element, the second fixation element angled proximally relative to the lead, wherein the first and second fixation elements are configured to sandwich an anchor site therebetween.

3. The system of claim 1 , wherein the one or more electrodes are configured to be implanted in or adjacent to at least one of nervous tissue, a muscle, a ligament, or a joint capsule.

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

5. The system of claim 1 , wherein the programmable controller is programmed to cause the one or more electrodes to electrically stimulate the nervous tissue at a pulse amplitude between 0.1-7 mA, a pulse width between 20-500 μs, and a stimulation rate between 1-20 Hz.

6. The system of claim 1 , wherein the programmable controller is configured to be programmed to cause the one or more electrodes to electrically stimulate the nervous tissue to induce muscle contraction to restore neural control and rehabilitate the one or more skeletal muscles selected from at least one of the following muscles: multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, or erector spinae.

7. The system of claim 1 , wherein the external transmitter is configured to control the implantable pulse generator by transferring a stimulation command to the implantable pulse generator, the stimulation command comprising at least one of: a command to start a treatment session or stop the treatment session; a command to provide a status of the implantable pulse generator; or a request to conduct an impedance assessment.

8. The system of claim 1 , wherein the implantable pulse generator comprises a first transceiver coupled to a first antenna, and wherein the external transmitter comprises a second transceiver coupled to a second antenna, such that the external transmitter is configured to control the implantable pulse generator via bi-directional communication between the first and second transceivers and the first and second antennas.

9. The system of claim 1 , wherein the external transmitter comprises a first telemetry system electrically coupled to a first coil, and wherein the implantable pulse generator comprises a second telemetry system electrically coupled to a second coil, such that the external transmitter is configured to charge the implantable pulse generator via energy transfer from the first telemetry system and coil to the second telemetry system and coil.

10. The system of claim 9 , wherein energy is transferred from the first telemetry system and coil to the second telemetry system and coil via inductive coupling.

11. The system of claim 1 , further comprising an external programmer configured to transfer programming data to the implantable pulse generator, the programming data comprising at least one of: pulse amplitude, pulse width, stimulation rate, stimulation frequency, ramp timing, cycle timing, session timing, or electrode configuration, wherein the external transmitter controls the implantable pulse generator to electrically stimulate the nervous tissue in accordance with the programming data.

12. The system of claim 11 , further comprising a computer-readable non-transitory medium having program instructions that, when executed by a processor of the external programmer, permit a user to select, adjust, and display the programming data based on user input.

13. The system of claim 1 , further comprising one or more sensors coupled to the programmable controller, the one or more sensors configured to sense muscle contraction and to generate a sensor signal based on the muscle contraction.

14. The system of claim 13 , wherein at least one of the one or more sensors comprises at least one of an accelerometer, a minute ventilation system, a pressure sensor, a movement sensor, or a strain gauge.

15. The system of claim 13 , wherein the sensor signal is indicative of patient compliance.

16. A method of rehabilitating skeletal muscles, the method comprising:

implanting a lead having one or more electrodes in or adjacent to nervous tissue associated with one or more skeletal muscles associated with local segmental control of a lumbar spine;

implanting an implantable pulse generator coupled to the one or more electrodes;

programming the implantable pulse generator to restore neural control and rehabilitate the one or more skeletal muscles; and

controlling the implantable pulse generator to cause the one or more electrodes to electrically stimulate the nervous tissue to induce muscle contraction via the one or more electrodes, thereby restoring neural control and rehabilitating the one or more skeletal muscles to thereby improve lumbar spine stability.

17. The method of claim 16 , further comprising transferring energy from an external transmitter to the implantable pulse generator via inductive coupling.

18. The method of claim 16 , further comprising one or more sensors coupled to a programmable controller of the implantable pulse generator, the method further comprising sensing muscle contraction via the one or more sensors and generating a sensor signal based on the muscle contraction.

19. The method of claim 18 , wherein at least one of the one or more sensors comprises at least one of an accelerometer, a minute ventilation system, a pressure sensor, a movement sensor, or a strain gauge.

20. The method of claim 18 , wherein the sensor signal is indicative of patient compliance.

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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED AT REEL: 045453 FRAME: 0523. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Apr 18, 2018
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; CROSBY, PETER ANDREW
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 045971/0843 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2018
From: SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; CROSBY, PETER ANDREW
To: MAINSTAY MEDICAL, INC.
Reel/Frame 045453/0523 →
Continuity (7)
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 20180353757A1 · Dec 13, 2018
Cited By (6)
US 12,285,612 US 12,397,156 US 12,458,802 US 12,582,816 US 12,594,096 US 12,702,824