Systems and methods for restoring muscle function to the lumbar spine

• US 9,072,897 B2
• Filed: 10/23/2013
• Issued: 07/07/2015
• Est. Priority Date: 03/09/2007
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Sachs, Dan, Rawat, Prashant Brijmohansingh, Shiroff, Jason Alan, Crosby, Peter Andrew
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/061,614
• Publication Number:
  US 20140046398A1
• Time in Patent Office: 622 Days
• Field of Search: 607/48, 607/59, 607/60, 607/117, 607/2, 607/43, 607/46
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

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

1. A system for restoring muscle function to the lumbar spine, the system comprising:

one or more electrodes configured to be implanted in or adjacent to tissue associated with control of the lumbar spine;

an implantable pulse generator coupled to the one or more electrodes, the implantable pulse generator having a programmable controller and a first communications circuit;

a handheld activator having a second communications circuit, the activator configured to transfer a stimulation command to the implantable pulse generator via the first and second communications circuits; and

an external programmer having a third communications circuit, the external programmer configured to transfer programming data to the implantable pulse generator via the first and third communications circuits,

wherein the stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data to improve lumbar spine stability and to rehabilitate function of one or more of a multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles.

2. The system of claim 1, wherein the external programmer is coupled to a computer, the computer having software configured to select, adjust, and display the programming data based on user input.

3. The system of claim 1, 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.

4. The system of claim 1, wherein the stimulation commands 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 implantable pulse generator;

or a request to conduct an impedance assessment.

5. 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.

6. The system of claim 1, wherein the programmable controller directs the one or more electrodes to stimulate the dorsal ramus nerve, or fascicles thereof, that innervate the multifidus muscle.

7. The system of claim 1, wherein the first, second, and third communication circuits are inductive.

8. The system of claim 1, wherein the first, second, and third communication circuits employ RF transceivers.

9. The system of claim 1, wherein the handheld activator comprises a pad coupled to a handheld housing by a cable, the cable having a sufficient length to enable a user to place the pad in extracorporeal proximity to the implantable pulse generator while viewing the handheld housing.

10. The system of claim 1, wherein the programmable controller directs the one or more electrodes to stimulate the tissue at a pulse amplitude between about 0.1-7 mA, a pulse width between about 20-500 μ

s, and a stimulation rate between about 1-20 Hz.

11. The system of claim 1, further comprising a lead having the one or more electrodes disposed thereon, the lead configured to be coupled to the implantable pulse generator.

12. The system of claim 11, further comprising a first fixation element coupled to the lead, the first fixation element configured to anchor the lead to an anchor site.

13. The system of claim 12, further comprising a second fixation element coupled to the lead distal to the first fixation element, wherein the first fixation element is angled distally relative to the lead and the second fixation element is angled proximally relative to the lead, and wherein the first and second fixation elements are configured to sandwich the anchor site therebetween.

14. The system of claim 1, wherein the programmable controller directs the one or more electrodes to stimulate the tissue in a charge-balanced manner.

15. The system of claim 1, wherein the programmable controller directs the one or more electrodes to stimulate the tissue with increasing pulse amplitudes to a peak pulse amplitude and then stimulate with decreasing pulse amplitudes.

16. A method for restoring muscle function of the lumbar spine to reduce back pain, the method comprising:

providing one or more electrodes, an implantable pulse generator, an external programmer, and a handheld activator;

implanting the one or more electrodes in or adjacent to tissue associated with control of the lumbar spine;

implanting the implantable pulse generator in communication with the one or more electrodes;

transferring programming data to the implantable pulse generator from the external programmer; and

operating the handheld activator to command the implantable pulse generator to stimulate the tissue with the one or more electrodes responsive to the programming data to improve lumbar spine stability and to rehabilitate function of one or more of a multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles.

17. The method of claim 16, wherein implanting the one or more electrodes comprises implanting the one or more electrodes in or adjacent to at least one of:

nervous tissue, a muscle, a ligament, or a joint capsule.

18. The method of claim 16, wherein the handheld activator commands the implantable pulse generator to stimulate the dorsal ramus nerve, or fascicles thereof, that innervate the multifidus muscle.

19. The method of claim 16, 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.

20. The method of claim 16, wherein the handheld activator commands the implantable pulse generator to start or stop a treatment session, report a status of the implantable pulse generator, or to request an impedance assessment.