Apparatus and method for blocking activation of tissue or conduction of action potentials while other tissue is being therapeutically activated

• US 20040162594A1
• Filed: 05/17/2001
• Published: 08/19/2004
• Est. Priority Date: 05/17/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: King, Gary W.
• Granted Patent: US 6,928,320 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/39624 Pain reduction therapy

Abstract

A desired effect is produced by therapeutically activating tissue at a first site within a patient'"'"'s body and a corresponding undesired side effect is reduced by blocking activation of tissue or conduction of action potentials at a second site within the patient'"'"'s body by applying high frequency stimulation and/or direct current pulses at or near the second site. Time-varying DC pulses may be used before or after a high frequency blocking signal. The high frequency stimulation may begin before and continue during the therapeutic activation. The high frequency stimulation may begin with a relatively low amplitude, and the amplitude may be gradually increased. The desired effect may be promotion of micturition or defecation and the undesired side effect may be sphincter contraction. The desired effect may be defibrillation of the patient'"'"'s atria or defibrillation of the patient'"'"'s ventricles, and the undesired side effect may be pain.

Claims

1. A system for producing a desired effect by therapeutically activating tissue at a first predetermined site within a patient'"'"'s body and for reducing a corresponding undesired side effect by blocking activation of tissue or conduction of action potentials at a second predetermined site within the patient'"'"'s body, the system comprising:

a first signal generator for producing low frequency stimulation;

a second signal generator for producing high frequency and/or direct current pulse stimulation; and

at least one implantable lead including a first electrode coupled to the first signal generator, the first electrode being adapted to therapeutically activate tissue at the first predetermined site by applying low frequency stimulation, the at least one implantable lead including a second electrode coupled to the second signal generator, the second electrode being adapted to block activation of electrically excitable tissue at the second site by applying high frequency stimulation or one or more direct current pulses or both high frequency stimulation and one or more direct current pulses at or near the second site.

2. The system of claim 1, wherein:

the desired effect is promotion of micturition; and

the undesired side effect is sphincter contraction.

3. The system of claim 2, wherein:

the first site is selected from the group consisting of the patient'"'"'s bladder dome, sacral roots, and pelvic plexus.

4. The system of claim 3, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, hypogastric plexi, and perineal nerve.

5. The system of claim 1, wherein:

the desired effect is promotion of defecation; and

the undesired side effect is selected from the group consisting of;

sphincter contraction, elevated pelvic floor, and sharp ano-rectal angle.

6. The system of claim 5, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

hypogastric plexus, pelvic plexus, nerves to rectum, sacral roots, pelvic plexus, and rectal muscle.

7. The system of claim 5, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, and nerves to the patient'"'"'s pelvic floor muscles.

8. The system of claim 1, wherein:

the desired effect is peristalsis of the patient'"'"'s esophagus; and

the undesired side effect is contraction at the patient'"'"'s gastroesphageal sphincter.

9. The system of claim 8, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

esophagus, nerves to the patient'"'"'s esophagus, pharynx, and nerves to the patient'"'"'s pharynx.

10. The system of claim 8, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

hiatal esophagus area near the patient'"'"'s diaphragm and nerves to the patient'"'"'s esophagus.

11. The system of claim 1, wherein:

the desired effect is peristalsis of the patient'"'"'s ureter; and

the undesired side effect is closure of the patient'"'"'s anti-reflux valves near the patient'"'"'s bladder trigone.

12. The system of claim 10, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

renal pelvis and a portion of the patient'"'"'s ureter.

13. The system of claim 10, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

base of the bladder near an entrance of the ureter, hypogastric plexus, and pelvic plexus.

14. The system of claim 1, wherein:

the desired effect is peristalsis of the patient'"'"'s stomach; and

the undesired effect is closure of the patient'"'"'s pyloric sphincter.

15. The system of claim 14, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

stomach wall muscles and nerves leading to the patient'"'"'s stomach wall muscles.

16. The system of claim 14, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

muscle fibers of the patient'"'"'s pyloric sphincter and nerves to the patient'"'"'s pyloric sphincter.

17. A system for producing a desired effect by therapeutically activating tissue at a first predetermined site within a patient'"'"'s body and for reducing a corresponding undesired side effect by blocking activation or conduction of action potentials of tissue at a second predetermined site within the patient'"'"'s body, the system comprising:

at least one signal generator capable of simultaneously producing both low frequency stimulation and high frequency stimulation or direct current pulses; and

at least one implantable lead including a first electrode coupled to the at least one signal generator, the first electrode being adapted to therapeutically activate tissue at the first predetermined site by applying low frequency stimulation, the at least one implantable lead including a second electrode coupled to the at least one signal generator, the second electrode being adapted to block activation of electrically excitable tissue at the second site by applying high frequency stimulation or one or more direct current pulses or both high frequency stimulation and one or more direct current pulses at or near the second site.

18. The system of claim 17, wherein:

the desired effect is peristalsis of the patient'"'"'s intestine; and

the undesired effect is closure of the patient'"'"'s ileocecal valve to the patient'"'"'s colon.

19. The system of claim 18, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

intestinal wall smooth muscle, hypogastric plexus, and nerves to the patient'"'"'s hypogastric plexus.

20. The system of claim 18, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

ileocecal valve, mesenteric ganglia, dorsal root, spinal dorsal columns, and splanchnic nerves.

21. The system of claim 17, wherein:

the desired effect is selected from the group consisting of;

defibrillation of the patient'"'"'s atria or defibrillation of the patient'"'"'s ventricles; and

the undesired side effect is pain.

22. The system of claim 21, wherein:

the first site is selected from the group consisting of;

a heart pacing lead inside the patient'"'"'s heart chambers and a heart pacing lead outside the patient'"'"'s heart chambers.

23. The system of claim 21, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

vagus nerve, branches of the patient'"'"'s vagus nerve from the patient'"'"'s heart, thoracic sympathetic nerves, ansa subclavia, sympathetic trunk ganglia (T1-T4), stellate ganglia, cervical ganglia (C1-C

     8), celiac plexus, brachial plexi, dorsal roots (C1-T4), spinal dorsal columns, and dorsal roots.

24. The system of claim 17, wherein:

the desired effect is extension of the patient'"'"'s leg;

the first site is the patient'"'"'s femoral nerve to the patient'"'"'s quadriceps femoris;

the undesired side effect is co-contraction of the antagonist muscles; and

the second site is the patient'"'"'s tibial nerve to the patient'"'"'s gastrocnemius muscle.

25. The system of claim 17, wherein:

the desired effect is movement of one of the patient'"'"'s joints in a predetermined direction;

the first site is the patient'"'"'s peripheral nerve;

the undesired side effect is co-contraction of antagonist muscles; and

the second site is the patient'"'"'s nerve branch to an antagonist muscle.

26. The system of claim 17, wherein:

the desired effect is activation of peripheral nerve axons to cause muscle contraction or promote organ functionality;

the first site is the patient'"'"'s peripheral nerve or spinal ventral root;

the undesired side effect is unpleasant sensation or causation of undesired reflexes; and

the second site is selected from the group consisting of the patient'"'"'s spinal dorsal roots, dorsal columns, and ventrolateral spinal cord surface near the spinothalamic tract.

27. The system of claim 17, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin before and continue during the therapeutic activation.

28. The system of claim 17, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin with a relatively low amplitude and the amplitude is gradually increased.

29. The system of claim 17, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses are terminated by gradually reducing the amplitude of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses.

30. The system of claim 17, further comprising:

a sensor for sensing a state of the tissue at the second site or at a site that is remote from both the first site and the second site; and

means, responsive to the sensor, for adjusting at least one parameter of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses, the parameter being selected from the group consisting of;

pulse amplitude, pulse width, pulse frequency, pulse duty cycle, pulse polarity, and pulse waveform.

31. The system of claim 17, further comprising:

a sensor for sensing a state of the tissue at the second site or at a site that is remote from both the first site and the second site; and

means, responsive to an indication from the sensor that tissue at the second site or at the remote site is activated, for applying the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses to the second site.

32. A system for producing a desired effect by therapeutically activating tissue at a first predetermined site within a patient'"'"'s body and for reducing a corresponding undesired side effect by blocking activation of tissue or conduction of action potentials at a second predetermined site within the patient'"'"'s body, the system comprising:

a first signal generator for producing low frequency stimulation;

a second signal generator for producing high frequency and/or direct current pulse stimulation;

a first implantable lead including a first electrode coupled to the first signal generator, the first electrode being adapted to therapeutically activate tissue at the first predetermined site by applying low frequency stimulation; and

a second implantable lead including a second electrode coupled to the second signal generator, the second electrode being adapted to block activation of electrically excitable tissue or conduction of action potentials at the second site by applying high frequency stimulation or one or more direct current pulses or both high frequency stimulation and one or more direct current pulses at or near the second site.

33. The system of claim 32, wherein:

the desired effect is promotion of micturition; and

the undesired side effect is sphincter contraction.

34. The system of claim 33, wherein:

the first site is selected from the group consisting of the patient'"'"'s bladder dome, sacral roots, and pelvic plexus.

35. The system of claim 34, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, hypogastric plexi, and perineal nerve.

36. The system of claim 32, wherein:

the desired effect is promotion of defecation; and

the undesired side effect is selected from the group consisting of;

sphincter contraction, elevated pelvic floor, and sharp ano-rectal angle.

37. The system of claim 36, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

hypogastric plexus, pelvic plexus, nerves to rectum, sacral roots, pelvic plexus, and rectal muscle.

38. The system of claim 36, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, and nerves to the patient'"'"'s pelvic floor muscles.

39. The system of claim 32, wherein:

the desired effect is peristalsis of the patient'"'"'s esophagus; and

the undesired side effect is contraction at the patient'"'"'s gastroesphageal sphincter.

40. The system of claim 39, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

esophagus, nerves to the patient'"'"'s esophagus, pharynx, and nerves to the patient'"'"'s pharynx.

41. The system of claim 39, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

hiatal esophagus area near the patient'"'"'s diaphragm and nerves to the patient'"'"'s esophagus.

42. The system of claim 32, wherein:

the desired effect is peristalsis of the patient'"'"'s ureter; and

the undesired side effect is closure of the patient'"'"'s anti-reflux valves near the patient'"'"'s bladder trigone.

43. The system of claim 41, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

renal pelvis and a portion of the patient'"'"'s ureter.

44. The system of claim 41, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

base of the bladder near an entrance of the ureter, hypogastric plexus, and pelvic plexus.

45. The system of claim 32, wherein:

the desired effect is peristalsis of the patient'"'"'s stomach; and

the undesired effect is closure of the patient'"'"'s pyloric sphincter.

46. The system of claim 45, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

stomach wall muscles and nerves leading to the patient'"'"'s stomach wall muscles.

47. The system of claim 45, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

muscle fibers of the patient'"'"'s pyloric sphincter and nerves to the patient'"'"'s pyloric sphincter.

48. A system for producing a desired effect by therapeutically activating tissue at a first predetermined site within a patient'"'"'s body and for reducing a corresponding undesired side effect by blocking activation of tissue or conduction of action potentials at a second predetermined site within the patient'"'"'s body, the system comprising:

at least one signal generator capable of simultaneously producing both high frequency stimulation and low frequency stimulation; and

a first implantable lead including a first electrode coupled to the signal generator, the first electrode being adapted to therapeutically activate tissue at the first predetermined site by applying low frequency stimulation; and

a second implantable lead including a second electrode coupled to the signal generator, the second electrode being adapted to block activation of electrically excitable tissue or conduction of action potentials at the second site by applying high frequency stimulation or one or more direct current pulses or both high frequency stimulation and one or more direct current pulses at or near the second site.

49. The system of claim 48, wherein:

the desired effect is peristalsis of the patient'"'"'s intestine; and

the undesired effect is closure of the patient'"'"'s ileocecal valve to the patient'"'"'s colon.

50. The system of claim 49, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

intestinal wall smooth muscle, hypogastric plexus, and nerves to the patient'"'"'s hypogastric plexus.

51. The system of claim 49, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

ileocecal valve, mesenteric ganglia, dorsal root, spinal dorsal columns, and splanchnic nerves.

52. The system of claim 48, wherein:

the desired effect is selected from the group consisting of;

defibrillation of the patient'"'"'s atria or defibrillation of the patient'"'"'s ventricles; and

the undesired side effect is pain.

53. The system of claim 52, wherein:

the first site is selected from the group consisting of;

a heart pacing lead inside the patient'"'"'s heart chambers and a heart pacing lead outside the patient'"'"'s heart chambers.

54. The system of claim 52, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

vagus nerve, branches of the patient'"'"'s vagus nerve from the patient'"'"'s heart, thoracic sympathetic nerves, ansa subclavia, sympathetic trunk ganglia (T1-T4), stellate ganglia, cervical ganglia (C1-C8), celiac plexus, brachial plexi, dorsal roots (C1-T4), spinal dorsal columns, and dorsal roots.

55. The system of claim 48, wherein:

the desired effect is extension of the patient'"'"'s leg;

the first site is the patient'"'"'s femoral nerve to the patient'"'"'s quadriceps femoris;

the undesired side effect is co-contraction of the antagonist muscles; and

the second site is the patient'"'"'s tibial nerve to the patient'"'"'s gastrocnemius muscle.

56. The system of claim 48, wherein:

the desired effect is movement of one of the patient'"'"'s joints in a predetermined direction;

the first site is the patient'"'"'s peripheral nerve;

the undesired side effect is co-contraction of antagonist muscles; and

the second site is the patient'"'"'s nerve branch to an antagonist muscle.

57. The system of claim 48, wherein:

the desired effect is activation of peripheral nerve axons to cause muscle contraction or promote organ functionality;

the first site is the patient'"'"'s peripheral nerve or spinal ventral root;

the undesired side effect is unpleasant sensation or causation of undesired reflexes; and

the second site is selected from the group consisting of the patient'"'"'s spinal dorsal roots, dorsal columns, and ventrolateral spinal cord surface near the spinothalamic tract.

58. The system of claim 48, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin before and continue during the therapeutic activation.

59. The system of claim 48, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin with a relatively low amplitude and the amplitude is gradually increased.

60. The system of claim 48, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses are terminated by gradually reducing the amplitude of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses.

61. The system of claim 48, further comprising:

a sensor for sensing a state of the tissue at the second site or at a site that is remote from both the first site and the second site; and

means, responsive to the sensor, for adjusting at least one parameter of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses, the parameter being selected from the group consisting of;

pulse amplitude, pulse width, pulse frequency, pulse duty cycle, pulse polarity, and pulse waveform.

62. The system of claim 48, further comprising:

a sensor for sensing a state of the tissue at the second site or at a site that is remote from both the first site and the second site; and

means, responsive to an indication from the sensor that tissue at the second site is activated, for applying the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses to the second site.

63. A method of blocking undesirable side effect activation of electrically excitable tissue, the method comprising the steps of:

therapeutically activating tissue at a first predetermined site within a patient'"'"'s body; and

blocking activation of tissue or conduction of action potentials at a second predetermined site within the patient'"'"'s body by applying high frequency stimulation or one or more direct current pulses or both high frequency stimulation and one or more direct current pulses at or near the second site.

64. The method of claim 63, wherein:

the desired effect is promotion of micturition; and

the undesired side effect is sphincter contraction.

65. The method of claim 64, wherein:

the first site is selected from the group consisting of the patient'"'"'s bladder dome, sacral roots, and pelvic plexus.

66. The method of claim 64, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, hypogastric plexi, and perineal nerve.

67. The method of claim 63, wherein:

the desired effect is promotion of defecation; and

the undesired side effect is selected from the group consisting of;

sphincter contraction, elevated pelvic floor, and sharp ano-rectal angle.

68. The method of claim 67, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

hypogastric plexus, pelvic plexus, nerves to rectum, sacral roots, pelvic plexus, and rectal muscle.

69. The method of claim 67, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

sacral dorsal roots, spinal dorsal columns, conus medullaris, pudendal nerve, and nerves to the patient'"'"'s pelvic floor muscles.

70. The method of claim 63, wherein:

the desired effect is peristalsis of the patient'"'"'s esophagus; and

the undesired side effect is contraction at the patient'"'"'s gastroesphageal sphincter.

71. The method of claim 70, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

esophagus, nerves to the patient'"'"'s esophagus, pharynx, and nerves to the patient'"'"'s pharynx.

72. The method of claim 70, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

hiatal esophagus area near the patient'"'"'s diaphragm and nerves to the patient'"'"'s esophagus.

73. The method of claim 63, wherein:

the desired effect is peristalsis of the patient'"'"'s ureter; and

the undesired side effect is closure of the patient'"'"'s anti-reflux valves near the patient'"'"'s bladder trigone.

74. The method of claim 72, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

renal pelvis and a portion of the patient'"'"'s ureter.

75. The method of claim 72, wherein:

the second site is the base of the patient'"'"'s bladder near an entrance of the ureter, hypogastric plexus, and pelvic plexus.

76. The method of claim 63, wherein:

the desired effect is peristalsis of the patient'"'"'s stomach; and

the undesired effect is closure of the patient'"'"'s pyloric sphincter.

77. The method of claim 76, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

stomach wall muscles and the nerves leading to the patient'"'"'s stomach wall muscles.

78. The method of claim 76, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

muscle fibers of the patient'"'"'s pyloric sphincter and nerves to the patient'"'"'s pyloric sphincter.

79. The method of claim 63, wherein:

the desired effect is peristalsis of the patient'"'"'s intestine; and

the undesired effect is closure of the patient'"'"'s ileocecal valve to the patient'"'"'s colon.

80. The method of claim 79, wherein:

the first site is selected from the group consisting of the patient'"'"'s;

intestinal wall smooth muscle, hypogastric plexus, and nerves to the patient'"'"'s hypogastric plexus.

81. The method of claim 79, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

ileocecal valve, mesenteric ganglia, dorsal root, spinal dorsal columns, and splanchnic nerves.

82. The method of claim 63, wherein:

the desired effect is selected from the group consisting of;

defibrillation of the patient'"'"'s atria or defibrillation of the patient'"'"'s ventricles; and

the undesired side effect is pain.

83. The method of claim 82, wherein:

the first site is selected from the group consisting of;

a heart pacing lead inside the patient'"'"'s heart chambers and a heart pacing lead outside the patient'"'"'s heart chambers.

84. The method of claim 82, wherein:

the second site is selected from the group consisting of the patient'"'"'s;

vagus nerve, branches of the patient'"'"'s vagus nerve from the patient'"'"'s heart, thoracic sympathetic nerves, ansa subclavia, sympathetic trunk ganglia (T1-T4), stellate ganglia, cervical ganglia (C1-C8), celiac plexus, brachial plexi, dorsal roots (C1-T4), spinal dorsal columns, and dorsal roots.

85. The method of claim 63, wherein:

the desired effect is extension of the patient'"'"'s leg;

the first site is the patient'"'"'s femoral nerve to the patient'"'"'s quadriceps femoris;

the undesired side effect is co-contraction of the antagonist muscles; and

the second site is the patient'"'"'s tibial nerve to the patient'"'"'s gastrocnemius muscle.

86. The method of claim 63, wherein:

the desired effect is movement of one of the patient'"'"'s joints in a predetermined direction;

the first site is the patient'"'"'s peripheral nerve;

the undesired side effect is co-contraction of antagonist muscles; and

the second site is the patient'"'"'s nerve branch to an antagonist muscle.

87. The method of claim 63, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin before and continue during the therapeutic activation.

88. The method of claim 63, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses begin with a relatively low amplitude and the amplitude is gradually increased.

89. The method of claim 63, wherein the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses are terminated by gradually reducing the amplitude of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses.

90. The method of claim 63, further comprising the steps of:

sensing a state of the tissue at the second site or at a site that is remote from both the first site and the second site; and

in response to the sensing step, adjusting at least one parameter of the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses, the parameter being selected from the group consisting of;

pulse amplitude, pulse width, pulse frequency, pulse duty cycle, pulse polarity, and pulse waveform.

91. The method of claim 63, further comprising:

sensing a state of the tissue at the second site or at a site remote from both the first site and the second site; and

in response to an indication from the sensor that tissue at the second site is activated, applying the high frequency stimulation or the direct current pulses or both the high frequency stimulation and the direct current pulses to the second site.