Methods and apparatus for treating back pain

• US 7,331,956 B2
• Filed: 08/02/2006
• Issued: 02/19/2008
• Est. Priority Date: 09/28/2000
• Status: Expired due to Term

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Sanders, Norman, Martini, Brian, Hovda, David, Woloszko, Jean
• Primary Examiner(s): Cohen; Lee S.
• Application Number:
  US11/498,846
• Publication Number:
  US 20070010809A1
• Time in Patent Office: 566 Days
• Field of Search: 606/32, 606/41, 606/49, 606/50, 607/99
• 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 electrosurgical probe comprising an energy-applying element from a location outside an intervertebral disc towards a nucleus pulposus of the disc;

b) positioning said energy-applying element within the nucleus pulposus of the disc;

c) electrosurgically treating the nucleus pulposus of the disc by applying a first high frequency voltage at the energy-applying element;

d) positioning said energy-applying element within the posterior of the annulus fibrosus; and

e) electrosurgically coagulating nerve tissue within the posterior of the annulus fibrosus by applying heat using said energy-applying element, 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 d) comprises steering the shaft distal end towards the posterior of the annulus fibrosus.

3. The method of claim 1, wherein said step d) comprises positioning the energy-applying element without contacting or passing through the nucleus pulposus of the disc.

4. The method of claim 1, wherein said step e) comprises applying a high frequency voltage between the energy-applying element and a return electrode.

5. The method of claim 4, 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 energy-applying element and the return electrode in response to a sensed temperature.

6. 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 energy-applying element and a return electrode, and wherein said step c) comprises applying a high frequency voltage between the energy-applying element and the return electrode.

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

8. The method of claim 7, wherein the temperature is insufficient to cause contraction of collagen fibers within the annulus fibrosus.

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

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

C. to about 53°

C.

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

C. to about 50°

C.

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

13. The method of claim 1 further comprising:

positioning said energy applying element within the annulus fibrosus and ablating nervous tissue within the annulus fibrosus.

14. The method of claim 1, wherein the energy-applying element comprises an active electrode.

15. A method for treating discogenic pain, comprising:

a) advancing an electrosurgical probe comprising an energy-applying element from a location outside an intervertebral disc towards an annulus fibrosus of the disc;

b) positioning said energy-applying element within the posterior of the annulus fibrosus and positioning a return electrode adjacent to an external surface of the posterior region of the annulus fibrosus; and

c) electrosurgically coagulating nerve tissue within the posterior of the annulus fibrosus by applying heat using said energy-applying element, whereby the pain is alleviated.

16. The method of claim 15, wherein said step b) comprises positioning the return electrode at a location external to the disc.

17. The method of claim 15, wherein said step b) comprises positioning the energy-applying element within the annulus fibrosus adjacent to the nucleus pulposus.

18. The method of claim 16, wherein the energy-applying element is disposed on a first shaft and the return electrode is disposed on a second shaft.

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

a) advancing an electrosurgical probe comprising an energy-applying element from a location outside an intervertebral disc towards a nucleus pulposus of the disc;

b) positioning said energy-applying element within the nucleus pulposus of the disc;

c) electrosurgically treating the nucleus pulposus of the disc by applying a first high frequency voltage at the energy-applying element;

d) advancing the energy-applying element of an electrosurgical instrument from a location outside the disc towards a posterior region of an annulus fibrosus of the disc;

e) positioning the energy-applying element within the annulus fibrosus; and

f) applying a high frequency voltage between the energy-applying element and a return electrode to coagulate tissue within the annulus fibrosus, wherein the posterior region of the annulus fibrosus is denervated.

20. The method of claim 19, wherein said step a) comprises accessing the disc in an open procedure.

21. The method of claim 20, wherein accessing the disc comprises:

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

dissecting the underlying tissue to the lamina; and

removing a portion of the lamina.

22. The method of claim 20, wherein the open procedure comprises stabilizing the spine.

23. The method of claim 22, wherein stabilizing the spine comprises fusing together two or more adjacent vertebrae.

24. The method of claim 19, wherein said step a) comprises accessing the disc percutaneously.

25. The method of claim 19, wherein said step a) comprises advancing the energy-applying element towards the disc via a posterolateral approach.

26. The method of claim 19, wherein said step f) comprises applying the high frequency voltage in the range of from about 20 volts RMS to about 90 volts RMS.

27. The method of claim 19, wherein said step f) effects heating of the annulus fibrosus in a region adjacent to the energy-applying element to a temperature in the range of from about 45°

C. to 50°

C.

28. The method of claim 19, wherein the energy-applying element is disposed on a distal end of a first shaft, and wherein said step e) 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.

29. The method of claim 19, wherein said energy-applying element comprises an active electrode.

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

a) advancing the energy-applying element of an electrosurgical instrument from a location outside the disc towards a posterior region of an annulus fibrosus of the disc, wherein the energy-applying element is disposed on a distal end of a first shaft;

b) positioning the energy-applying element within the annulus fibrosus at a location adjacent to the posterior of the nucleus pulposus of the disc;

c) applying a high frequency voltage between the energy-applying element and a return electrode to coagulate tissue within the annulus fibrosus, wherein the posterior region of the annulus fibrosus is denervated, and wherein the return electrode is disposed on a distal end of a second shaft; and

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

31. The method of claim 30, wherein the return electrode is positioned external to the disc.

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

a) advancing a first electrosurgical probe comprising a first energy-applying element from a location outside an intervertebral disc towards a nucleus pulposus of the disc;

b) positioning said first energy-applying element within the nucleus pulposus of the disc;

c) electrosurgically treating the nucleus pulposus of the disc by applying a first high frequency voltage at the first energy-applying element;

d) advancing an energy-applying element of a second electrosurgical instrument from a location outside the intervertebral disc into the annulus fibrosus; and

e) electrosurgically coagulating collagen within the posterior of the annulus fibrosus by applying heat with a second energy-applying element of said second electrosurgical instrument.

33. The method of claim 32, wherein said step e) comprises inactivating nociceptors within the posterior of the annulus fibrosus.

34. The method of claim 32, wherein said step e) comprises applying a high frequency voltage between the second energy-applying element and the second return electrode, wherein the second instrument is operating in a sub-ablation mode.

35. The method of claim 32, wherein said step e) comprises coagulating nerve fibers within the posterior of the annulus fibrosus.

36. The method of claim 35, wherein said step e) comprises electrosurgically heating a posterior region of the annulus fibrosus to a temperature in the range of from about 45°

C. to about 50°

C.

37. The method of claim 32, wherein said energy-applying element is adapted for delivering a controlled depth of thermal heating of the tissue surrounding said disc.

38. A method for treating back pain, comprising:

a) electrosurgically applying heat at a target tissue within a posterior region of an annulus fibrosus of an intervertebral disc via an electrosurgical probe;

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 by coagulating nerve tissue therein, whereby the pain is alleviated; and

wherein the probe includes an active electrode disposed on a working end of a first shaft of the probe and a return electrode disposed on a working end of a second shaft of the probe, and, prior to step a), the method further comprises;

d) advancing the working end of the first shaft through a portion of 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

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

39. 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.

40. The method of claim 39, wherein the second location is spaced from the first location by a distance in the range of from about 1 mm to 1 cm.

41. The method of claim 39, wherein the second electrode is positioned external to the posterior of the disc.