Systems and methods for restoring muscle function to the lumbar spine

• US 9,474,906 B2
• Filed: 07/06/2015
• Issued: 10/25/2016
• 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:
  US14/792,430
• Publication Number:
  US 20150306405A1
• Time in Patent Office: 477 Days
• Field of Search: 607/2, 607/43, 607/46, 607/48, 607/59, 607/60, 607/117
• 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 method for restoring muscle function to the lumbar spine, the method comprising:

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

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

transmitting a stimulation command from an activator to the implantable pulse generator;

electrically stimulating the tissue via at least one electrode of the one or more electrodes responsive to the stimulation command;

improving lumbar spine stability by rehabilitating function of one or more of a multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles responsive to the electrically stimulating.

2. The method of claim 1, wherein the implanting the one or more electrodes comprises implanting the one or more electrodes in or adjacent to a dorsal ramus nerve that innervates the multifidus muscle, and

wherein the electrically stimulating comprises electrically stimulating the dorsal ramus nerve that innervates the multifidus muscle.

3. The method of claim 1, 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 implantable pulse generator;

or a request to conduct an impedance assessment, and

wherein the rehabilitating takes place over time.

4. The method of claim 1, further comprising transmitting programming data to the implantable pulse generator, wherein electrically stimulating the tissue comprises electrically stimulating the tissue via the at least one electrode of the one or more electrodes consistent with the programming data and responsive to the stimulation command.

5. The method 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.

6. A method for restoring muscle function to the lumbar spine, the method comprising:

electrically stimulating tissue associated with control of the lumbar spine via one or more electrodes implanted in or adjacent to the tissue;

improving lumbar spine stability by rehabilitating function of one or more of a multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles responsive to the electrically stimulating.

7. The method of claim 6, wherein the one or more electrodes are implanted in or adjacent to a dorsal ramus nerve that innervates the multifidus muscle, and

wherein the electrically stimulating comprises electrically stimulating the dorsal ramus nerve that innervates the multifidus muscle.

8. The method of claim 6, wherein electrically stimulating the tissue comprises electrically stimulating 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.

9. The method of claim 6, wherein the one or more electrodes are disposed on a lead electrically coupled to an implantable pulse generator,

wherein electrically stimulating the tissue comprises electrically stimulating the tissue via at least one electrode of the one or more electrodes responsive to programming data stored within the implantable pulse generator, and

wherein the rehabilitating takes place over time.

10. The method of claim 6, wherein the one or more electrodes are disposed on a lead,

wherein the method further comprises anchoring first and second anchors coupled to the lead to an anchor site, and

wherein the first anchor is angled distally relative to the lead and the second anchor is angled proximally relative to the lead.

11. The method of claim 6, wherein the electrically stimulating the tissue comprises electrically stimulating the tissue at a stimulation rate between 10-30 Hz.

12. The method of claim 6, wherein the electrically stimulating the tissue comprises electrically stimulating the tissue at a pulse width between 20-500 μ

s.

13. The method of claim 6, wherein the rehabilitating takes place over time.

14. The method of claim 6, wherein the electrically stimulating and the rehabilitating restores muscle function to at least one of the one or more muscles.

15. The method of claim 14, wherein the muscle function is restored within 30 to 60 days of initiation of treatment.

16. The method of claim 6, wherein the electrically stimulating and the rehabilitating restores neural control to at least one of the one or more muscles.

17. The method of claim 6, wherein the electrically stimulating causes contraction of at least one of the one or more muscles.

18. The method of claim 6, wherein the electrically stimulating causes contraction of the multifidus muscle, and

wherein the rehabilitating is rehabilitating the multifidus muscle responsive to the electrically stimulating.

19. The method of claim 18, wherein the electrically stimulating that causes contraction of the multifidus muscle causes contraction of fascicles of the multifidus muscle.

20. The method of claim 6, wherein the rehabilitating and the improving reduces back pain.

21. The method of claim 6, wherein the tissue comprises a dorsal ramus nerve, and

wherein the electrically stimulating comprises electrically stimulating the dorsal ramus nerve to cause contraction of the multifidus muscle.

22. The method of claim 21, wherein the electrically stimulating the dorsal ramus nerve comprises electrically stimulating a branch of the dorsal ramus nerve.

23. The method of claim 22, wherein the electrically stimulating the branch of the dorsal ramus nerve comprises electrically stimulating a medial branch of the dorsal ramus nerve.

24. The method of claim 21, wherein the rehabilitating is rehabilitating the multifidus muscle over time.

25. The method of claim 6, wherein the tissue comprises a peripheral nerve that innervates at least one of the one or more muscles.

26. The method of claim 6, further comprising implanting an implantable pulse generator in communication with the one or more electrodes, and

wherein the electrically stimulating comprises electrically stimulating the tissue via at least one of the one or more electrodes responsive to electrical signals from the implantable pulse generator.

27. The method of claim 6, wherein the one or more electrodes are disposed on a lead,

wherein the method further comprises anchoring the lead to an anchor site.

28. The method of claim 27, wherein the anchoring comprises anchoring the lead to the anchor site with an anchor coupled to the lead and angled distally relative to the lead.

29. The method of claim 27, wherein the anchoring further comprises anchoring the lead to the anchor site with an additional anchor coupled to the lead and angled proximally relative to the lead.

30. The method of claim 27, wherein the anchor site comprises a muscle.

31. The method of claim 6, wherein the one or more electrodes are disposed on a lead, and

wherein the method further comprises implanting the lead using an introducer.

32. The method of claim 6, wherein the electrically stimulating comprises electrically stimulating the tissue via at least one of the one or more electrodes responsive to electrical signals from a stimulator disposed external to a body of a patient on a temporary or permanent basis.

33. The method of claim 32, wherein the one or more electrodes are disposed on a lead.

34. The method of claim 6, wherein the tissue comprises a medial branch of a dorsal ramus nerve and the electrically stimulating comprises electrically stimulating the medial branch of the dorsal ramus that exits between L2 and L3 lumbar segments and passes over a transverse process of an L3 vertebra.

35. The method of claim 34, wherein the electrically stimulating elicits contraction of fascicles of the multifidus muscle at the L3, L4, L5 and S1 segments.

36. The method of claim 6, wherein a session of electrical stimulation is between 1 and 60 minutes.

37. The method of claim 6, wherein the electrically stimulating comprises electrically stimulating the tissue via at least one electrode of the one or more electrodes responsive to programming data.

38. The method of claim 37, further comprising displaying the programming data on a computer.

39. The method of claim 38, further comprising adjusting the programming data based on user input received at the computer.

40. The method of claim 39, further comprising transmitting the adjusted programming data via an external programmer coupled to the computer.

41. The method of claim 38, further comprising displaying on the computer a number of sessions of electrical stimulation started for a selected day.

42. The method of claim 41, further comprising displaying on the computer a total number of minutes of sessions for the selected day.

43. The method of claim 37, 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.

44. The method of claim 37, wherein the programming data comprises pulse amplitude, pulse width, stimulation rate, stimulation frequency, and session timing.

45. The method of claim 6, wherein the tissue comprises at least one of nervous tissue, a muscle, a ligament, or a joint capsule.

46. The method of claim 6, wherein the electrically stimulating comprises electrically stimulating the tissue in a charge-balanced manner.

47. The method of claim 6, wherein the electrically stimulating comprises electrically stimulating the tissue with increasing pulse amplitudes to a peak pulse amplitude and then electrically stimulating with decreasing pulse amplitudes.

48. The method of claim 6, wherein the rehabilitating the one or more muscles causes the improving lumbar spine stability.

49. The method of claim 6, wherein the electrically stimulating comprises electrically stimulating the tissue responsive to a stimulation command transmitted by an activator.

50. The method of claim 49, wherein the stimulation command comprises a command to start a treatment session.

51. An activator for use in a system for restoring muscle function to the lumbar spine, the activator comprising:

a user interface configured to interact with a user;

an activator communications circuit configured to communicate with an implantable pulse generator (IPG) communications circuit; and

a programmable controller configured to cause the activator communications circuit to transmit a stimulation command to the IPG communications circuit to cause one or more electrodes in communication with an IPG housing the IPG communications circuit to electrically stimulate tissue associated with control of the lumbar spine to improve lumbar spine stability and rehabilitate function of one or more of a multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles responsive to electrical stimulation.

52. The activator of claim 51, wherein the one or more electrodes are caused 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.

53. The activator of claim 51, wherein the user interface comprises one or more buttons, and

wherein the programmable controller transmits the stimulation command responsive to user input received at the one or more buttons.

54. The activator of claim 51, wherein the user interface comprises one or more light emitting diodes configured to alert the user when a suitable connection between the activator communications circuit and the IPG communications circuit is achieved.

55. The activator of claim 51, wherein the activator communications circuit is configured to communicate with a computer storing a computer readable medium with instructions that, when executed by a processor of the computer, cause the computer to display programming data.

56. The activator of claim 55, wherein the activator communications circuit is configured to communicate with the computer via an external programmer.

57. The activator of claim 55, 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.

58. The activator of claim 51, 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 IPG;

or a request to conduct an impedance assessment.

59. The activator of claim 51, further comprising a pad coupled to a handheld housing by a cable, the cable having a sufficient length to enable the user to place the pad in extracorporeal proximity to the IPG while viewing the handheld housing.

60. The activator of claim 59, wherein the activator communications circuit comprises an inductive coil disposed within the pad.

61. The activator of claim 51, wherein the activator communications circuit employs an RF transceiver or is inductive or both.

62. The activator of claim 51, wherein the activator communications circuit is further configured to transmit power to the IPG communications circuit.

63. The activator of claim 51, wherein the one or more electrodes are caused to stimulate the tissue at a pulse amplitude between 3-4 mA, a pulse width between 100-400 μ

s, and a stimulation rate between 15-20 Hz.

64. The activator of claim 51, wherein the programmable controller is configured to cause the activator communications circuit to transmit the stimulation command to the IPG communications circuit to cause the one or more electrodes in communication with the IPG housing the IPG communications circuit to electrically stimulate the tissue associated with control of the lumbar spine to improve lumbar spine stability and rehabilitate function of the multifidus muscle responsive to the electrical stimulation.

65. The activator of claim 51, wherein the activator communications circuit comprises an inductive coil configured to transmit power to the IPG communications circuit and an RF transmitter configured to establish bidirectional or unidirectional data communication with the IPG communications circuit.

66. The activator of claim 51, wherein the user interface is configured to interact with the user by receiving user input and displaying information to the user.

67. The activator of claim 51, wherein the activator is configured to employ a low power mode of operation to periodically awaken to listen for incoming messages and to respond only to messages including a unique device identifier assigned to the activator.

68. The activator of claim 51, wherein the activator is configured to employ an encryption routine to ensure that messages sent from, or received by, the activator cannot be intercepted or forged.

69. The activator of claim 51, wherein the programmable controller is configured to cause the activator communications circuit to transmit the stimulation command to the IPG communications circuit to cause the one or more electrodes in communication with the IPG housing the IPG communications circuit to electrically stimulate the tissue associated with control of the lumbar spine to cause the one or more muscles to contract responsive to the electrical stimulation to rehabilitate function of the one or more muscles.

70. The activator of claim 69, wherein the muscle contraction restores neural control of the one or more muscles.