SELECTIVE HIGH FREQUENCY SPINAL CORD MODULATION FOR INHIBITING PAIN, INCLUDING CEPHALIC AND/OR TOTAL BODY PAIN WITH REDUCED SIDE EFFECTS, AND ASSOCIATED SYSTEMS AND METHODS

• US 20160287875A1
• Filed: 04/06/2016
• Published: 10/06/2016
• Est. Priority Date: 09/08/2011
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Thacker, James R., Alataris, Konstantinos, Gliner, Bradford Evan
• Granted Patent: US 10,493,277 B2
• Time in Patent Office: Days
• 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 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Selective high-frequency spinal cord modulation for inhibiting pain with reduced side effects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 kHz to about 100 kHz may be applied to the patient'"'"'s spinal cord region to address abdominal pain without creating paresthesia in the patient.

Claims

1-38. -38. (canceled)

39. A method for treating abdominal pain in a patient, exclusive of abdominal pain associated with total body pain, comprising:

configuring a signal generator to generate and deliver an abdominal pain therapy signal to a target vertebral location via at least one implantable signal delivery device coupled to the signal generator,

wherein at least a portion of the therapy signal has a frequency in a frequency range of from 1.5 kHz to 100 kHz, includes pulses with a pulse width in a pulse width range of 10 microseconds to 333 microseconds, and has an amplitude in an amplitude range of 0.1 mA to 20 mA, which at least partially alleviates the abdominal pain, exclusive of abdominal pain associated with total body pain, without generating paresthesia in the patient.

40. The method of claim 39 wherein the therapy signal has a frequency of from about 5 kHz to about 15 kHz.

41. The method of claim 39 wherein the therapy signal has a frequency of from about 3 kHz to about 15 kHz.

42. The method of claim 39 wherein the therapy signal has a frequency of from about 3 kHz to about 20 kHz.

43. The method of claim 39 wherein the therapy signal has a frequency of from about 3 kHz to about 10 kHz.

44. The method of claim 39 wherein the therapy signal has a frequency of about 10 kHz.

45. The method of claim 39 wherein the target vertebral location is at a vertebral level of from about T6 to about T12.

46. The method of claim 39 wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

47. The method of claim 39 wherein configuring the signal generator includes programming the signal generator.

48. The method of claim 39 wherein the pulse width range is between 25 microseconds and 166 microseconds.

49. The method of claim 39 wherein the portion of the electrical therapy signal is biphasic.

50. The method of claim 39 wherein the pulse width range is 30 microseconds to 35 microseconds.

51. The method of claim 39 wherein the amplitude range is 0.5 mA to 10 mA.

52. The method of claim 39 wherein the amplitude range is 3 mA to 10 mA.

53. The method of claim 39 wherein the amplitude range is less than 1 mA to 6 mA.

54. The method of claim 39 wherein the amplitude range is up to 6 mA.

55. The method of claim 39 wherein the frequency range is 5 kHz to 15 kHz, the pulse width range is 30 microseconds to 35 microseconds, and the amplitude range is 0.5 mA to 10 mA.

56. The method of claim 39 wherein the target vertebral location is an epidural location.

57. The method of claim 39 wherein the pain includes acute pancreatitis pain.

58. The method of claim 39 wherein the pain includes chronic pancreatitis pain.

59. The method of claim 39 wherein the pain includes cancer pain.

60. The method of claim 39 wherein the pain includes ilioinguinal neuralgia pain.

61. The method of claim 39 wherein the pain includes visceral pain.

62. The method of claim 39 wherein the pain includes post-vasectomy pain.

63. The method of claim 39 wherein the pain includes genitofemoral neuralgia pain.

64. A method of treating a non-total body pain abdominal pain indication, comprising:

applying an electrical therapy signal to a thoracic vertebral location of a patient'"'"'s spinal cord, wherein the thoracic vertebral location is between T6-T12, inclusive, wherein at least a portion of the electrical therapy signal (a) is at a frequency in a frequency range of 1.5 kHz to 100 kHz, (b) has electrical pulses with a pulse width in a pulse width range of 10 microseconds to 333 microseconds, and (c) is at an amplitude in an amplitude range of 0.1 mA to 20 mA, and wherein the electrical therapy signal treats the abdominal pain indication without generating paresthesia in the patient.

65. The method of claim 64 wherein the thoracic vertebral location is between C2-C4, inclusive.

66. The method of claim 64 wherein the abdominal pain indication is selected from the group consisting of:

pancreatitis pain, chronic pancreatitis pain, cancer pain, ilioinguinal neuralgia pain, visceral pain, post-vasectomy pain, and genitofemoral neuralgia pain.

67. The method of claim 64 wherein the frequency range is 3 kHz to 20 kHz.

68. The method of claim 64 wherein the frequency range is 5 kHz to 15 kHz.

69. The method of claim 64 wherein the frequency range is 1.5 kHz to 50 kHz.

70. The method of claim 64 wherein the frequency range is 3 kHz to 10 kHz.

71. The method of claim 64 wherein the frequency is 10 kHz.

72. The method of claim 64, further comprising programming the signal generator to generate the electrical therapy signal.

73. The method of claim 64 wherein the electrical therapy signal is applied via one or more implanted signal delivery devices coupled to an implanted signal generator, wherein the signal generator is programmed with instructions that, when executed, treat the abdominal pain indication by generating the electrical therapy signal and delivering the electrical therapy signal to the thoracic vertebral location.

74. The method of claim 73 wherein the one or more signal delivery devices include a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

75. The method of claim 64 wherein the portion of the electrical therapy signal is biphasic.

76. The method of claim 64 wherein the pulse width range is 25 microseconds to 166 microseconds.

77. The method of claim 64 wherein the pulse width range is 30 microseconds to 35 microseconds.

78. The method of claim 64 wherein the amplitude range is 0.5 mA to 10 mA.

79. The method of claim 64 wherein the amplitude range is 3 mA to 10 mA.

80. The method of claim 64 wherein the amplitude range is less than 1 mA to 6 mA.

81. The method of claim 64 wherein the amplitude range is up to 6 mA.

82. The method of claim 64 wherein the frequency range is 5 kHz to 15 kHz, the pulse width range is 30 microseconds to 35 microseconds, and the amplitude range is 0.5 mA to 10 mA.

83. An abdominal pain treatment system for treating a non-total body pain abdominal pain indication, comprising:

a spinal cord modulation system having

at least one signal delivery device configured to be implanted proximate to a thoracic vertebral location of a patient'"'"'s spinal cord, wherein the thoracic vertebral location is between T6-T12, inclusive, and

a signal generator programmed with instructions that, when executed, treat the abdominal pain indication by generating and delivering a non-paresthesia-generating electrical therapy signal to the thoracic vertebral location, via the at least one signal delivery device,

wherein at least a portion of the electrical therapy signal (a) is at a frequency in a frequency range of 1.5 kHz to 100 kHz, (b) includes pulses having a pulse width in a pulse width range of 10 microseconds to 333 microseconds, and (c) is at an amplitude in an amplitude range of 0.1 mA to 20 mA.

84. The system of claim 83 wherein the abdominal pain indication is selected from the group consisting of:

pancreatitis pain, chronic pancreatitis pain, cancer pain, ilioinguinal neuralgia pain, visceral pain, post-vasectomy pain, and genitofemoral neuralgia pain.

85. The system of claim 83 wherein the frequency range is 3 kHz to 20 kHz.

86. The system of claim 83 wherein the frequency range is 5 kHz to 15 kHz.

87. The system of claim 83 wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

88. The system of claim 83 wherein the pulse width range is between 25 microseconds and 166 microseconds.

89. The method of claim 83 wherein the amplitude range is 0.5 mA to 10 mA.

90. The method of claim 83 wherein the amplitude range is 3 mA to 10 mA.

91. The method of claim 83 wherein the amplitude range is less than 1 mA to 6 mA.

92. The method of claim 83 wherein the amplitude range is up to 6 mA.