Muscle stimulator

• US 8,428,728 B2
• Filed: 03/10/2008
• Issued: 04/23/2013
• 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
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US12/075,174
• Publication Number:
  US 20080228241A1
• Time in Patent Office: 1,870 Days
• Field of Search: 607/2, 607/46, 607/48, 607/117, 607/43
• US Class Current: 607/43
• 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 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

Abstract

An implantable medical device for treating the back of a patient. Stimulation energy is delivered to muscles or joint capsules or ligaments or nerve fibers to improve the heath of the back.

Claims

1. A method of treating a patient'"'"'s back comprising:

implanting within the patient'"'"'s back a lead having one or more electrodes and a fixation anchor;

anchoring the lead in or adjacent to tissue associated with local segmental control of the lumbar spine, consisting of at least one of nervous tissue, a ligament or a joint capsule;

implanting an internally powered pulse generator;

programming the pulse generator to rehabilitate function of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles;

delivering, according to the programming, electrical stimulation from the pulse generator to nervous tissue associated with segmental control of the lumbar spine via the one or more electrodes, thereby improving lumbar spine stability.

2. The method of claim 1, wherein anchoring the lead comprises anchoring the lead such that the one or more electrodes are adjacent to muscle.

3. The method of claim 1, wherein anchoring the lead comprises anchoring the lead such that the one or more electrodes are in or adjacent to nervous tissue.

4. The method of claim 1, wherein anchoring the lead comprises anchoring the lead such that the one or more electrodes are in or adjacent to a ligament.

5. The method of claim 1, anchoring the lead comprises anchoring the lead such that the one or more electrodes are in or adjacent to a joint capsule.

6. The method of claim 1, wherein delivering electrical stimulation causes contraction of the multifidus.

7. The method of claim 1, wherein anchoring the lead comprises anchoring the fixation anchor to or alongside a boney structure.

8. The method of claim 1, wherein anchoring the lead comprises anchoring the lead to or alongside a boney structure of the spine selected from the group consisting of a spinous process, transverse process, lamina or vertebral body.

9. A method of treating a patient'"'"'s back comprising:

implanting a plurality of electrodes in or adjacent to tissue associated with local segmental control of the lumbar spine consisting of at least one of nervous tissue, a ligament or a joint capsule;

implanting an internally powered pulse generator;

programming the pulse generator to rehabilitate function of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles; and

delivering, according to the programming, electrical stimulation from the pulse generator to nervous tissue associated with segmental control of the lumbar spine via the plurality of electrodes, thereby improving lumbar spine stability.

10. The method of claim 9, wherein delivering electrical stimulation causes contraction of the multifidus.

11. The method of claim 9, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes adjacent to muscle.

12. The method of claim 9, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to nervous tissue.

13. The method of claim 9, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to a ligament.

14. The method of claim 9, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to a joint capsule.

15. The method of claim 9 wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to a disc annulus, facet capsule, interspinous ligament, supraspinous ligament, or sacro-iliac joint.

16. The method of claim 9, wherein delivering electrical stimulation further comprises delivering electrical stimulation to muscles of a diaphragm or pelvic floor.

17. The method of claim 9, wherein delivering electrical stimulation comprises delivering electrical stimulation episodically.

18. The method of claim 9, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes adjacent to tissue that includes antagonist muscles that inhibit agonist muscle contraction.

19. A method of treating a patient'"'"'s back comprising:

implanting a plurality of electrodes at a stimulation site in or adjacent to a medial branch of a dorsal ramus of a spinal nerve;

implanting an internally powered pulse generator;

programming the pulse generator to rehabilitate motor control of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles; and

delivering, according to the programming, electrical stimulation from the pulse generator to the medial branch of the dorsal ramus of the spinal nerve via the plurality of electrodes, thereby improving lumbar spine.

20. The method of claim 19, wherein delivering electrical stimulation causes contraction of the multifidus.

21. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes adjacent to muscle.

22. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to nervous tissue.

23. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to a ligament.

24. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to a joint capsule.

25. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to bone.

26. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes in or adjacent to the disc annulus, facet capsule, interspinous ligament, supraspinous ligament, or sacro-iliac joint.

27. The method of claim 19, wherein implanting the plurality of electrodes comprises implanting the plurality of electrodes adjacent to tissue that includes antagonist muscles that inhibit agonist muscle contraction.

28. The method of claim 19, further comprising sensing displacement of the patient'"'"'s lumbar vertebrae.

29. A neuromuscular electrical stimulation system for improving stability of a patient'"'"'s lumbar spine, the system comprising:

a lead having one or more electrodes and a fixation anchor configured to be implanted in or adjacent to tissue associated with local segmental control of the lumbar spin;

consisting of at least one of nervous tissue, a ligament or a joint capsule; and

a pulse generator that is subcutaneously implantable, programmable and internally powered, the pulse generator configured to be operatively coupled to the one or more electrodes, the pulse generator programmed to electrically stimulate nervous tissue associated with segmental control of the lumbar spine to rehabilitate function of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles, wherein the pulse generator is programmed to stimulate the nervous tissue with a patient-specific frequency, magnitude and duration.

30. The system of claim 29, wherein the one or more electrodes are configured to be implanted adjacent to muscle.

31. The system of claim 30, wherein the electrical stimulator further is programmed to stimulate nervous tissue associated muscles of the diaphragm or pelvic floor.

32. The system of claim 29, wherein the one or more electrodes are configured to be implanted in or adjacent to nervous tissue.

33. The system of claim 29, wherein the one or more electrodes are configured to be implanted in or adjacent to a ligament.

34. The system of claim 29, wherein the one or more electrodes are configured to be implanted in or adjacent to a joint capsule.

35. The system of claim 29, wherein the fixation anchor is configured to be coupled to or alongside a boney structure.

36. The system of claim 29, wherein the lead is configured to be anchored to or alongside a boney structure of the spine selected from the group consisting of a spinous process, transverse process, lamina or vertebral body.

37. The system of claim 29, further comprising a sensor.

38. The system of claim 37, wherein the sensor is configured to detect displacement of a patient'"'"'s vertebra.

39. The system of claim 29, wherein the pulse generator applies the electrical stimulation episodically.

40. The system of claim 29, wherein the system is configured to cause contraction of the multifidus.

41. The system of claim 29, wherein the one or more electrodes are configured to be placed in or adjacent to the disc annulus, facet capsule, interspinous ligament, supraspinous ligament, or sacro-iliac joint.

42. The system of claim 29, wherein the one or more electrodes are configured to be placed adjacent to tissue that includes antagonist muscles that inhibit agonist muscle contraction.

43. The system of claim 29, wherein the pulse generator applies low amplitude electrical stimulation.

44. An electrical stimulation system for improving stability of a patient'"'"'s lumbar spine to reduce low back pain, the system comprising:

a plurality of electrodes configured to be implanted in or adjacent to tissue associated with local segmental control of the lumbar spine consisting of at least one of nervous tissue, a ligament or a joint capsule; and

a fully implantable, internally powered and programmable pulse generator configured to be coupled to the plurality of implantable electrodes, the pulse generator programmed with a pulse frequency, magnitude and duration to deliver electrical stimulation to nervous tissue associated with segmental control of the lumbar spine to rehabilitate function of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles, thereby improving lumbar spine stability.

45. The system of claim 44, wherein the plurality of electrodes is configured to be implanted adjacent to muscle.

46. The system of claim 45, wherein the pulse generator further is programmed to deliver electrical stimulation to the muscles of the diaphragm or pelvic floor.

47. The system of claim 44, wherein the plurality of electrodes is configured to be implanted in or adjacent to nervous tissue.

48. The system of claim 44, wherein the plurality of electrodes is configured to be implanted in or adjacent to a ligament.

49. The system of claim 44, wherein the plurality of electrodes is configured to be implanted in or adjacent to a joint capsule.

50. The system of claim 44, further comprising a sensor associated with the pulse generator and configured to sense displacement of a patient'"'"'s lumbar vertebrae.

51. The system of claim 44, wherein the pulse generator applies the electrical stimulation episodically.

52. The system of claim 44, wherein the system is configured to cause contraction of the multifidus.

53. The system of claim 44, wherein the plurality of electrodes is configured to be placed in or adjacent to the disc annulus, facet capsule, interspinous ligament, supraspinous ligament, or sacro-iliac joint.

54. The system of claim 44, wherein the plurality of electrodes is configured to be placed adjacent to tissue that includes antagonist muscles that inhibit agonist muscle contraction.

55. The system of claim 44, wherein the pulse generator applies low amplitude electrical stimulation.

56. The system of claim 44, wherein the implantable lead comprises a fixation anchor.

57. The system of claim 56 wherein the fixation anchor is configured to be coupled to or alongside a boney structure.

58. An electrical stimulation system for reducing low back pain of a patient, the system comprising:

a plurality of implantable electrodes configured to be implanted at a stimulation site in or adjacent to a medial branch of a dorsal ramus of a spinal nerve; and

a fully implantable, internally powered and programmable pulse generator configured to be coupled to the plurality of implantable electrodes, the pulse generator programmed to deliver electrical stimulation via the electrodes to the medial branch of the dorsal ramus of the spinal nerve to rehabilitate motor control of one or more of the multifidus, transverse abdominus, quadratus lumborum, psoas major, internus abdominus, obliquus externus abdominus, and erector spinae muscles, thereby improving lumbar spine stability.

59. The system of claim 58, wherein the plurality of implantable electrodes is configured to be implanted adjacent to muscle.

60. The system of claim 59, wherein the plurality of implantable electrodes is configured to be implanted in or adjacent to nervous tissue.

61. The system of claim 58, wherein the plurality of implantable electrodes is configured to be implanted in or adjacent to a ligament.

62. The system of claim 58, wherein the plurality of implantable electrodes is configured to be implanted in or adjacent to a joint capsule.

63. The system of claim 58, wherein the plurality of implantable electrodes is configured to be implanted in or adjacent to bone.

64. The system of claim 58, wherein the pulse generator further is programmed to deliver electrical stimulation via the electrodes to rehabilitate motor control of the muscles of the diaphragm or pelvic floor.

65. The system of claim 58, further comprising a sensor associated with the pulse generator and configured to sense displacement of a patient'"'"'s lumbar vertebrae.

66. The system of claim 58, wherein the pulse generator applies the electrical stimulation episodically.

67. The system of claim 58, wherein the plurality of implantable electrodes is configured to be placed in or adjacent to the disc annulus, facet capsule, interspinous ligament, supraspinous ligament, or sacro-iliac joint.

68. The system of claim 58, wherein the plurality of implantable electrodes is configured to be placed adjacent to tissue that includes antagonist muscles that inhibit agonist muscle contraction.

69. The system of claim 58, wherein the pulse generator applies low amplitude electrical stimulation.

70. The system of claim 58, wherein the plurality of implantable electrodes comprises a fixation anchor.

71. The system of claim 69 wherein the fixation anchor is configured to be coupled to or alongside a boney structure.