Methods and apparatus for treating back pain

• US 20030158545A1
• Filed: 02/26/2003
• Published: 08/21/2003
• Est. Priority Date: 09/28/2000
• Status: Abandoned Application

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Woloszko, Jean, Martini, Brian E., Hovda, David C., Sanders, Norman R.
• Application Number:
  US10/374,411
• Publication Number:
  US 20030158545A1
• Time in Patent Office: Days
• US Class Current: 606/32
• CPC Class Codes: A01N 43/52 condensed with carbocyclic rings, e.g. benzimidazoles
• CPC Class Codes: A01N 43/80 five-membered rings with one nitrogen atom and either one oxygen atom or one sulfur atom in positions 1,2
• CPC Class Codes: A01N 43/90 having two or more relevant hetero rings, condensed among themselves or with a common carbocyclic ring system
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/149 bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00119 : with metal oxide nitride
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00178 : Electrical connectors
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/0044 : Spinal cord
• CPC Class Codes: A61B 2018/00505 : Urinary tract
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00583 : Coblation, i.e. ablation using a cold plasma
• CPC Class Codes: A61B 2018/00589 : Coagulation
• CPC Class Codes: A61B 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1213 : creating an arc
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2018/165 : Multiple indifferent electrodes
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: C07D 403/12 : linked by a chain containing hetero atoms as chain links
• CPC Class Codes: C07D 409/12 : linked by a chain containing hetero atoms as chain links
• CPC Class Codes: C07D 413/12 : linked by a chain containing hetero atoms as chain links
• CPC Class Codes: C07D 491/04 : Ortho-condensed systems

Abstract

Apparatus and methods for treating back pain of a patient by denervation of an intervertebral disc or a region of the posterior longitudinal ligament by the controlled application of heat to a target tissue. In one embodiment, the invention may include a procedure combining both decompression of a disc, and denervation of the annulus fibrosus. In one embodiment, a method of the invention includes positioning an active electrode of an electrosurgical instrument in at least close proximity to an intervertebral disc, and applying at least a first high frequency voltage between the active electrode and a return electrode, wherein nervous tissue within the annulus fibrosus is inactivated, and discogenic pain of the patient is alleviated. In one embodiment, the invention includes positioning a first electrode of a dual-shaft electrosurgical instrument at a first location in relation to a target disc, positioning a second electrode of the instrument at a second location, and applying a high frequency voltage between the first and second electrodes, wherein the first and second electrodes are disposed on separate shafts of the instrument.

Claims

1. A method for treating discogenic pain, comprising:

a) advancing an active electrode of an electrosurgical probe from a location outside an intervertebral disc towards an annulus fibrosus of the disc;

b) positioning the active electrode in at least close proximity to the annulus fibrosus; and

c) electrosurgically denervating at least a portion of the annulus fibrosus, whereby the pain is alleviated.

2. The method of claim 1, wherein the probe includes a shaft having a steerable shaft distal end, and said step a) comprises steering the shaft distal end towards the posterior of the annulus fibrosus.

3. The method of claim 1, wherein the active electrode is at a working end of the probe, and said step b) comprises positioning the active electrode within the posterior of the annulus fibrosus.

4. The method of claim 1, wherein said step b) comprises positioning the active electrode within or adjacent to the annulus fibrosus without contacting or passing through a nucleus pulposus of the disc.

5. The method of claim 1, wherein said step c) comprises applying a high frequency voltage between the active electrode and a return electrode.

6. The method of claim 5, further comprising:

d) after said step c), repositioning the active electrode with respect to the annulus fibrosus; and

e) reapplying the high frequency voltage between the active electrode and the return electrode.

7. The method of claim 1, wherein the probe includes a shaft and an electrode assembly disposed at the shaft distal end, the electrode assembly including the active electrode and a return electrode, and wherein said step c) comprises applying a high frequency voltage between the active electrode and the return electrode.

8. The method of claim 1, wherein said step c) comprises electrosurgically heating a portion of the annulus fibrosus to a temperature sufficient to inactive unmyelinated nerve fibers within the annulus fibrosus.

9. The method of claim 8, wherein the temperature is insufficient to cause contraction of collagen fibers within the annulus fibrosus.

10. The method of claim 1, wherein said step c) comprises inactivating one or more branches of the sinuvertebral nerve within the annulus fibrosus.

11. The method of claim 1, wherein said step c) comprises electrosurgically heating a portion of the annulus fibrosus to a temperature in the range of from about 43°

C. to 53°

C.

12. The method of claim 1, wherein said step c) comprises electrosurgically heating a portion of the annulus fibrosus to a temperature in the range of from about 45°

C. to 50°

C.

13. The method of claim 1, wherein said step c) comprises coagulating nervous tissue within the annulus fibrosus.

14. The method of claim 1, wherein said step c) comprises inactivating nociceptors within the annulus fibrosus.

15. The method of claim 1, wherein said step c) comprises ablating nervous tissue within the annulus fibrosus.

16. The method of claim 5, wherein the probe includes a temperature sensor for monitoring a temperature of the annulus fibrosus, and the method further comprises adjusting the high frequency voltage applied between the active electrode and the return electrode in response to a sensed temperature.

17. The method of claim 1, wherein said step b) comprises positioning the active electrode within a posterior region of the annulus fibrosus, and the method further comprising positioning a return electrode adjacent to an external surface of the posterior region of the annulus fibrosus.

18. The method of claim 17, wherein said step g) comprises positioning the return electrode at a location external to the disc.

19. The method of claim 17, wherein said step b) comprises positioning the active electrode within the annulus fibrosus adjacent to the nucleus pulposus.

20. The method of claim 18, wherein the active electrode is disposed on a first shaft and the return electrode is disposed on a second shaft.

21. A method for denervating an intervertebral disc, comprising:

a) advancing an active electrode of an electrosurgical instrument from a location outside the disc towards a posterior region of an annulus fibrosus of the disc;

b) positioning the active electrode in at least close proximity to the posterior region of the annulus fibrosus; and

c) applying a high frequency voltage between the active electrode and a return electrode, wherein the posterior region of the annulus fibrosus is denervated.

22. The method of claim 21, wherein said step a) comprises accessing the disc in an open procedure.

23. The method of claim 22, wherein accessing the disc comprises:

d) forming an incision in the patient'"'"'s back;

e) dissecting the underlying tissue to the lamina; and

f) removing a portion of the lamina.

24. The method of claim 22, wherein the open procedure comprises stabilizing the spine.

25. The method of claim 24, wherein stabilizing the spine comprises fusing together two or more adjacent vertebrae.

26. The method of claim 21, wherein said step a) comprises accessing the disc percutaneously.

27. The method of claim 21, wherein said step a) comprises advancing the active electrode towards the disc via a posterolateral approach.

28. The method of claim 21, wherein said step c) comprises applying the high frequency voltage in the range of from about 20 volts RMS to about 90 volts RMS.

29. The method of claim 21, wherein said step c) effects heating of the annulus fibrosus in a region adjacent to the active electrode to a temperature in the range of from about 45°

C. to 50°

C.

30. The method of claim 21, wherein the active electrode is disposed on a distal end of a first shaft, and wherein said step b) comprises positioning the distal end of the first shaft within the annulus fibrosus at a location adjacent to the posterior of the nucleus pulposus of the disc.

31. The method of claim 30, wherein the return electrode is disposed on a distal end of a second shaft, and the method further comprises:

g) advancing the distal end of the second shaft to a location adjacent to an outer wall of the annulus fibrosus.

32. The method of claim 31, wherein the return electrode is positioned external to the disc.

33. A method for treating an intervertebral disc, comprising:

a) advancing an active electrode of an electrosurgical instrument from a location outside an intervertebral disc towards the annulus fibrosus; and

b) electrosurgically inactivating nervous tissue within the annulus fibrosus.

34. The method of claim 33, wherein said step b) comprises inactivating nociceptors within the annulus fibrosus.

35. The method of claim 33, wherein said step b) comprises applying a high frequency voltage between the active electrode and a return electrode, wherein the instrument is operating in a sub-ablation mode.

36. The method of claim 33, wherein said step b) comprises coagulating nerve fibers within the annulus fibrosus.

37. The method of claim 36, wherein said step b) comprises electrosurgically heating a posterior region of the annulus fibrosus to a temperature in the range of from about 45°

C. to 50°

C.

38. A method for treating an intervertebral disc, comprising:

a) electrosurgically decompressing the disc; and

b) denervating the annulus fibrosus of the disc.

39. The method of claim 38, wherein said step a) comprises electrosurgically ablating or shrinking a portion of the nucleus pulposus.

40. The method of claim 38, wherein said step b) comprises electrosurgically heating a portion of the annulus fibrosus to a temperature sufficient to inactivate unmyelinated nerve fibers.

41. The method of claim 38, wherein said step a) comprises introducing a first electrosurgical instrument within a nucleus pulposus of the disc, and said step b) comprises positioning a second electrosurgical instrument in at least close proximity to a posterior region of the annulus fibrosus.

42. The method of claim 38, wherein said step b) comprises heating at least a portion of the annulus fibrosus to a temperature in the range of from about 45°

C. to 50°

C.

43. A method for treating an intervertebral disc, comprising:

a) providing an electrosurgical instrument, the instrument including a shaft having a shaft distal end and an electrode assembly disposed at the shaft distal end, the electrode assembly including an active electrode and a return electrode;

b) positioning the active electrode within a nucleus pulposus of the disc;

c) electrosurgically decompressing the disc;

d) positioning the active electrode in at least close proximity to a posterior region of an annulus fibrosus of the disc; and

thereafter

e) electrosurgically denervating the posterior region of the annulus fibrosus.

44. The method of claim 43, wherein said step c) comprises applying a first high frequency voltage between the active electrode and the return electrode.

45. The method of claim 44, wherein the first high frequency voltage effects ablation of at least a portion of the nucleus pulposus.

46. The method of claim 44, wherein the first high frequency voltage effects shrinkage of at least a portion of the nucleus pulposus.

47. The method of claim 46, wherein the first high frequency voltage effects heating of at least a portion of the nucleus pulposus to a temperature in the range of from about 60°

C. to 70°

C.

48. The method of claim 44, further comprising the step of:

f) providing an electrically conductive fluid to the electrode assembly, wherein the electrically conductive fluid provides a current flow path between the active electrode and the return electrode.

49. The method of claim 48, wherein the electrically conductive fluid comprises a gel.

50. The method of claim 43, wherein said step e) comprises applying a second high frequency voltage between the active electrode and the return electrode.

51. The method of claim 50, wherein the second high frequency voltage effects coagulation of unmyelinated nervous tissue within the annulus fibrosus.

52. The method of claim 50, wherein the second high frequency voltage effects heating of the posterior region of the annulus fibrosus to a temperature in the range of from about 45°

C. to 50°

C., whereby nociceptors within the annulus fibrosus are inactivated.

53. The method of claim 52, further comprising g) during said step e), monitoring a temperature of the annulus fibrosus in the vicinity of the shaft distal end.

54. The method of claim 50, further comprising:

h) adjusting the second high frequency voltage in response to the temperature monitored in said step g).

55. A method for treating back pain, comprising:

a) positioning an active electrode of an electrosurgical probe in at least close proximity to a target tissue of a patient'"'"'s spine, wherein the target tissue comprises a region of a posterior longitudinal ligament; and

b) electrosurgically denervating the region of the posterior longitudinal ligament, whereby the back pain is alleviated.

56. The method of claim 55, wherein said step b) comprises applying a high frequency voltage between the active electrode and a return electrode.

57. The method of claim 56, wherein said step b) comprises applying the high frequency voltage in the range of from about 20 volts RMS to 90 volts RMS.

58. The method of claim 55, wherein said step b) comprises electrosurgically heating the target tissue to a temperature sufficient to inactive unmyelinated nerve fibers within the target tissue.

59. The method of claim 58, wherein the temperature is insufficient to cause contraction of collagen fibers within the target tissue.

60. The method of claim 58, wherein the temperature is insufficient to cause shrinkage of the posterior longitudinal ligament.

61. The method of claim 55, wherein said step b) comprises electrosurgically heating the target tissue to a temperature in the range of from about 43°

C. to 53°

C.

62. The method of claim 55, wherein said step b) comprises electrosurgically heating the target tissue to a temperature in the range of from about 45°

C. to 50°

C.

63. The method of claim 55, wherein said step b) comprises coagulating nervous tissue within the posterior longitudinal ligament.

64. The method of claim 55, further comprising:

c) prior to said step a), introducing the probe into the patient endoscopically, percutaneously, or via an incision.

65. The method of claim 55, wherein said step a) involves a laminotomy.

66. A method for treating an intervertebral disc, comprising:

a) providing an apparatus adapted for the controlled heating of a target tissue;

b) via the apparatus, heating a posterior region of an annulus fibrosus of the disc; and

c) as a result of said step b), denervating at least a portion of the annulus fibrosus, whereby discogenic pain is alleviated, and wherein the apparatus does not contact or pass through a nucleus pulposus of the intervertebral disc.

67. The method of claim 66, wherein said step b) comprises heating a portion of the disc to a temperature sufficient to inactivate unmyelinated nerve fibers but insufficient to contract collagen fibers of the annulus fibrosus.

68. The method of claim 66, wherein said step b) comprises heating a portion of the disc to a temperature in the range of from about 43°

C. to 53°

C.

69. A method for treating back pain, comprising:

a) providing an apparatus adapted for the controlled heating of a target tissue;

b) via the apparatus, applying heat to a region of the posterior longitudinal ligament; and

c) as a result of said step b), at least partially denervating the region of the posterior longitudinal ligament, whereby the back pain is alleviated.

70. The method of claim 69, wherein said step b) effects heating of a portion of the posterior longitudinal ligament to a temperature in the range of from about 43°

C. to 53°

C.

71. A method for treating back pain, comprising:

a) applying heat to a target tissue of a patient'"'"'s spine;

b) controlling the temperature to which the target tissue is exposed, such that the target tissue is exposed to a temperature in the range of from about 43°

C. to 53°

C.; and

c) as a result of said steps a) and b), denervating at least a portion of the target tissue, whereby the pain is alleviated.

72. The method of claim 71, wherein the at least a portion of the target tissue is exposed to a temperature in the range of from about 45°

C. to 50°

C.

73. The method of claim 71, further comprising:

d) during said step a), sensing the temperature to which the target tissue is exposed;

e) comparing a sensed temperature value with a pre-set temperature value; and

f) adjusting the rate at which heat is supplied to the target tissue based on a comparison performed in said step e).

74. The method of claim 71, wherein the heat is applied electrosurgically via an electrosurgical probe.

75. The method of claim 74, wherein the probe does not contact, nor pass through, a nucleus pulpous of the disc.

76. The method of claim 74, wherein the probe includes an active electrode disposed on a first shaft of the probe and a return electrode disposed on a second shaft of the probe, and the method further comprises:

g) advancing a working end of the first shaft through the annulus fibrosus such that the active electrode is positioned within the annulus fibrosus at a first location adjacent to the posterior of the nucleus pulposus; and

h) advancing a working end of the second shaft towards the posterior of the annulus fibrosus such that the active electrode is positioned external to the annulus fibrosus at a second location adjacent to the posterior of the disc.

77. A method for electrosurgically treating a target tissue, comprising:

a) providing an electrosurgical instrument, the instrument having a first shaft and a second shaft, the first shaft having a first electrode disposed at the first shaft distal end, and the second shaft having a second electrode disposed at the second shaft distal end;

b) positioning the first electrode at a first location with respect to the target tissue;

c) positioning the second electrode at a second location with respect to the target tissue; and

d) applying a high frequency voltage between the first electrode and the second electrode, wherein at least a portion of the target tissue is modified or ablated.

78. The method of claim 77, wherein said step d) effects coagulation of the target tissue.

79. The method of claim 77, wherein said step d) effects contraction of the target tissue.

80. The method of claim 77, wherein said step d) effects denervation of the target tissue.

81. The method of claim 77, wherein the second location is spaced from the first location by a distance in the range of from about 1 mm to 1 cm.

82. The method of claim 77, wherein the first electrode is coupled to a first pole of a high frequency power supply, and the second electrode is coupled to a second pole of the high frequency power supply.

83. The method of claim 77, wherein the first electrode comprises an active electrode, and the second electrode comprises a return electrode.

84. The method of claim 77, wherein the target tissue comprises spinal tissue.

85. The method of claim 84, wherein the target tissue comprises the annulus fibrosus of an intervertebral disc or the posterior longitudinal ligament.

86. The method of claim 85, wherein said step d) effects heating of at least a portion of the target tissue to a temperature in the range of from about 45°

C. to 50°

C.

87. The method of claim 84, wherein said step c) comprises positioning the second electrode at a location external to a posterior region of the annulus fibrosus, and wherein the posterior of the annulus fibrosus is at least partially denervated.

88. An electrosurgical apparatus, comprising:

a first shaft having a first shaft distal end and a first shaft proximal end;

a first electrode disposed at the first shaft distal end;

a second shaft having a second shaft distal end and a second shaft proximal end;

a second electrode disposed at the second shaft distal end; and

a connection block for coupling the first electrode and the second electrode thereto.

89. The apparatus of claim 88, wherein the connection block is adapted for coupling the first and second electrodes to a high frequency power supply.

90. The apparatus of claim 89, further comprising a connection housing, wherein the first and second shafts are mechanically coupled to the connection housing.

91. The apparatus of claim 90, wherein the first shaft and the second shaft are mechanically coupled to the connection housing via the first shaft proximal end and the second shaft proximal end, respectively.

92. The apparatus of claim 91, wherein the connection block is housed within the connection housing.

93. The apparatus of claim 88, further comprising a high frequency power supply, wherein the first and second electrodes are coupled to the high frequency power supply via the connection block.

94. The apparatus of claim 90, wherein the first and second shafts extend in substantially the same direction from the connection housing.

95. The apparatus of claim 90, wherein the first and second shafts are independently detachable from the connection housing.

96. The apparatus of claim 88, wherein the first and second shafts are adapted for manipulation independently of each other.

97. A method for treating an intervertebral disc, comprising:

a) providing an electrosurgical instrument, the instrument having a first shaft and a second shaft, the first shaft having a first electrode disposed at the first shaft distal end, and the second shaft having a second electrode disposed at the second shaft distal end;

b) positioning the first electrode at a first location, the first location within the annulus fibrosus adjacent to a posterior region of a nucleus pulposus of the disc;

c) positioning the second electrode at a second location, the second location spaced from the first location in a direction towards the posterior of the disc; and

d) applying a high frequency voltage between the first electrode and the second electrode, wherein a portion of the annulus fibrosus is at least partially denervated.

98. The method of claim 97, wherein the second location is spaced from the first location by a distance in the range of from about 1 mm to 1 cm.

99. The method of claim 97, wherein the second electrode is positioned external to the posterior of the disc.