Methods for electrosurgical spine surgery

• US 6,726,684 B1
• Filed: 11/08/2000
• Issued: 04/27/2004
• Est. Priority Date: 07/16/1996
• Status: Expired due to Term

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Woloszko, Jean, Hovda, David C., Eggers, Philip E., Thapliyal, Hira V.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/708,962
• Time in Patent Office: 1,266 Days
• Field of Search: 606/41, 606/46, 606/32, 607/99, 607/105, 607/113
• US Class Current: 606/32
• 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 18/1477 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 2017/00261 Discectomy
• 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 2018/00291 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 2018/00577 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 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00827 : Current
• 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 2018/1273 : including multiple generators in one device
• 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 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints

Abstract

Methods and apparatus for selectively applying electrical energy to a target location within a patient'"'"'s body, particularly including tissue in the spine. In a method of the invention high frequency (RF) electrical energy is applied to one or more active electrodes on an electrosurgical probe in the presence of an electrically conductive fluid to remove, contract or otherwise modify the structure of tissue targeted for treatment. In one aspect, a dura mater and spinal cord are insulated from the electrical energy by an insulator positioned on a non-active side of the probe. In another aspect, a plasma is aggressively formed in the electrically conductive fluid by delivering a conductive fluid to a distal end portion of the probe and aspirating the fluid from a location proximal of the return electrode. In another aspect, a distal end of an electrosurgical probe having at least one electrode on a biased, curved, bent, or steerable shaft is guided or steered to a target site within an intervertebral disc having a disc defect for treatment of tissue to be treated at the target site by the selective application of electrical energy thereto.

Claims

1. A method of using an electrosurgical system for alleviation of spinal pain by targeted electrosurgery of an intervertebral disc of a patient, the electrosurgical system including a power supply unit functionally coupled to at least one active electrode, the at least one active electrode disposed on a shaft distal end of an electrosurgical instrument, and the method comprising:

a) advancing an introducer needle towards the intervertebral disc, the introducer needle including a lumen and a needle distal end;

b) passing the shaft distal end through the lumen distally beyond the needle distal end, wherein the shaft distal end avoids contact with the needle distal end; and

c) applying a high frequency voltage between the at least one active electrode and at least one return electrode while the shaft distal end is in the vicinity said intervertebral disc.

2. The method of claim 1, further comprising:

c) guiding the shaft distal end within the intervertebral disc such that the at least one active electrode contacts at least a first region of disc tissue; and

d) where applying high frequency voltage between the at least one active electrode and at least one return electrode ablates tissue components of at least a portion of the first region of disc tissue.

3. The method of claim 2, further comprising:

e) retracting the shaft distal end into the lumen of the introducer needle, wherein the shaft distal end avoids contact with the needle distal end.

4. The method of claim 2, wherein during said step b) the at least one active electrode avoids contact with the needle distal end.

5. The method of claim 2, wherein said step d) results in molecular dissociation of tissue components of the first region, and the volume of the nucleus pulposus is decreased.

6. The method of claim 2, wherein the guiding step is performed after the shaft distal end has been extended distally beyond the needle distal end.

7. The method of claim 2, wherein the guiding step is performed before the shaft distal end has been extended distally beyond the needle distal end the guiding step comprises rotating the shaft about its longitudinal axis.

8. The method of claim 2, wherein the guiding step comprises:

axially translating the shaft within the lumen of the introducer needle; and

rotating the shaft about its longitudinal axis.

9. The method of claim 2, wherein the shaft has a pre-defined curvature both prior to and after said guiding step.

10. The method of claim 9, wherein the pre-defined curvature results from at least one curve in a distal portion of the shaft.

11. The method of claim 10, wherein the at least one curve comprises a first curve and a second curve proximal to the first curve, and the first curve and the second curve are in the same plane relative to the longitudinal axis of the shaft, and the first curve and the second curve are in opposite directions.

12. The method of claim 11, wherein the shaft distal end comprises a first curve and a second curve proximal to the first curve, the first curve is characterized by a first angle and the second curve is characterized by a second angle, wherein the first angle determines a transverse location of the shaft distal end within the lumen of the introducer needle, and the second angle determines an amount of deflection of the shaft distal end away from the longitudinal axis of the shaft proximal end.

13. The method of claim 2, wherein the shaft has a linear configuration prior to said guiding step, and said guiding step comprises conforming the shaft into a non-linear configuration.

14. The method of claim 13, wherein the guiding step comprises steering the shaft distal end by application of a lateral force to the shaft.

15. The method of claim 2, wherein the first region of disc tissue comprises a target site, said step c) is performed under fluoroscopy, and the position of the shaft distal end relative to the target site is visualized fluoroscopically.

16. The method of claim 15, wherein the shaft includes a radiopaque tracking device on the shaft distal end, or at least one radiopaque depth marking.

17. The method of claim 2, wherein the at least one return electrode is located on the shaft or on a dispersive pad.

18. The method of claim 2, wherein the at least one active electrode comprises an electrode head having a substantially apical spike and a substantially equatorial cusp, and the apical spike and the equatorial cusp provide a high current density in the vicinity of the electrode head upon application of the high frequency voltage between the at least one active electrode and the return electrode, the high current density promotes formation of a plasma in the vicinity of the electrode head, and the plasma causes localized ablation of disc tissue at a temperature in the range of from about 45°

C. to about 90°

C.

19. The method of claim 2, wherein the intervertebral disc includes a fragment of nucleus pulposus within an annulus fibrosus, and the shaft distal end portion is guided such that the at least one active electrode is in the vicinity of the fragment of the nucleus pulposus.

20. The method of claim 2, wherein the intervertebral disc includes an annulus fibrosus having at least one annular fissure therein, and the shaft distal end portion is guided such that the at least one active electrode is in the vicinity of the at least one annular fissure.

21. The method of claim 2, wherein the intervertebral disc includes a bulge in the nucleus pulposus, and the shaft distal end portion is guided such that the at least one active electrode is in the vicinity of the bulge.

22. The method of claim 2, wherein the method is performed in conjunction with epidural injection of a steroid.

23. The method of claim 2, further comprising the step of:

f) introducing an ancillary device into the disc, wherein the ancillary device is selected from the group consisting of an endoscope, an aspiration device, a return electrode, and a fluid delivery device.

24. The method of claim 1, wherein the method is performed percutaneously.

25. A method of ablating tissue at a target site of an intervertebral disc, comprising:

a) providing an electrosurgical system including a instrument, an introducer needle, and a power supply unit coupled to the instrument, the instrument having a shaft, the shaft including a distal end portion having at least one active electrode, the introducer needle having a lumen for accommodating axial movement of the shaft therein;

b) advancing the introducer needle towards the intervertebral disc;

c) passing the shaft distal end portion distally through the lumen of the introducer needle towards the disc, wherein the shaft distal end portion is inserted within the disc;

d) guiding the shaft distal end portion to the target site within the disc;

e) applying a high frequency voltage between the at least one active electrode and at least one return electrode, the high frequency voltage selected for ablating disc tissue at the target site; and

f) rotating the shaft about a longitudinal axis of the shaft.

26. The method of claim 25, wherein the shaft distal end portion has a pre-defined curvature, and where the act of rotating the shaft occurs during said step c).

27. The method of claim 25, wherein the method is performed percutaneously under fluoroscopy, and the position of the shaft distal end portion relative to the target site is visualized fluoroscopically.

28. The method of claim 25, wherein said step e) results in ablation of disc tissue, the volume or the mass of the disc tissue is decreased, and discogenic pain is alleviated.

29. The method of claim 25, wherein said step e) comprises applying a high frequency voltage in the range of from about 150 volts rms to about 350 volts rms between the at least one active electrode and the at least one return electrode, such that disc tissue at the target site is ablated at a temperature in the range of from about 45°

C. to about 90°

C.

30. The method of claim 25, further comprising:

g) after said step e), contacting tissue within the disc with the shaft distal end portion, and thereafter repeating said step e).

31. The method of claim 25, further comprising:

h) applying a quantity of an electrically conductive fluid in the vicinity of the at least one active electrode.

32. The method of claim 25, wherein the introducer needle includes a needle distal end, and said step b) comprises:

i) advancing the introducer needle through a first wall of the annulus fibrosus until said needle distal end of said introducer needle contacts the nucleus pulposus;

and said step d) comprises;

j) advancing the shaft distal end portion distally from the needle distal end until the at least one active electrode contacts an opposite wall of the annulus fibrosus; and

k) after said step j), retracting the shaft proximally a defined distance.

33. The method of claim 25, wherein the shaft includes a first curve and a second curve proximal to the first curve, and the first curve and the second curve are in the same plane relative to the longitudinal axis of the shaft, and the first curve and the second curve are in opposite directions.

34. The method of claim 25, wherein the at least one active electrode includes a filament, the shaft includes a first insulating sleeve encasing the filament, a return electrode on the first insulating sleeve, an insulating collar located at a distal end of the first insulating sleeve proximal to the return electrode, a second insulating sleeve on the return electrode, and a shield on the second insulating sleeve.

35. The method of claim 25, wherein the at least one active electrode comprises an electrode head having a substantially apical spike and a substantially equatorial cusp, and the apical spike and the equatorial cusp provide a high current density in the vicinity of the electrode head upon execution of said step e).

36. The method of claim 25, wherein the target site includes a disc defect selected from the group consisting of:

a fragmented nucleus pulposus, a bulge in the nucleus pulposus, and an annular fissure.

37. The method of claim 25, further comprising the step of:

l) injecting a steroid into an epidural space adjacent to the intervertebral disc.

38. The method of claim 25, further comprising the step of:

m) changing the location of a needle distal end relative to the intervertebral disc to define an appropriate position within the intervertebral disc from which the shaft distal end portion is guided in said step d).

39. The method of claim 25, wherein the electrosurgical system further includes an introducer extension tube having a distal end, and the method further comprises the step of:

n) advancing or retracting the introducer extension tube distal end to a selected location within the intervertebral disc.

40. The method of claim 39, wherein said step n) comprises advancing or retracting the introducer extension tube within the lumen of the introducer needle, and said step d) comprises guiding the shaft distal end portion from the introducer extension tube distal end.

41. A method of advancing and retracting a medical instrument through an introducer device, comprising the steps of:

a) advancing a distal end of the medical instrument distally beyond a distal end of the introducer device, wherein the distal end of the medical instrument does not contact the distal end of the introducer device, and wherein the distal end of the medical instrument includes a first curve and a second curve proximal to the first curve, the first curve is in a first direction and the second curve is in a second direction opposite to the first direction; and

b) retracting the distal end of the medical instrument into the distal end of the introducer device, wherein the distal end of the medical instrument does not contact the distal end of the introducer device.

42. The method of claim 41, wherein said step a) comprises passing the medical instrument within a lumen of the introducer device, and the distal end of the medical instrument occupies a substantially central transverse location within the lumen of the introducer device.

43. The method of claim 41, wherein the introducer device is selected from the group consisting of:

an introducer needle, an introducer extension tube, a catheter, a cannula, an endoscope, and a hypodermic needle.

44. The method of claim 41, wherein the medical instrument is selected from the group consisting of:

an electrosurgical probe, an endoscope, a trocar, and a fluid delivery device.

45. A method of ablating tissue at a target site of an intervertebral disc, comprising:

a) providing an electrosurgical system including a instrument, an introducer needle, and a power supply unit coupled to the instrument, the instrument having a shaft, the shaft including a distal end portion having at least one active electrode, the shaft also includes a first curve and a second curve proximal to the first curve, and the first curve and the second curve are in the same plane relative to the longitudinal axis of the shaft, and the first curve and the second curve are in opposite directions, the introducer needle having a lumen for accommodating axial movement of the shaft therein;

b) advancing the introducer needle towards the intervertebral disc;

c) passing the shaft distal end portion distally through the lumen of the introducer needle towards the disc, wherein the shaft distal end portion is inserted within the disc;

d) guiding the shaft distal end portion to the target site within the disc; and

e) applying a high frequency voltage between the at least one active electrode and at least one return electrode, the high frequency voltage selected for ablating disc tissue at the target site.

46. A method of ablating tissue at a target site of an intervertebral disc, comprising:

a) providing an electrosurgical system including a instrument, an introducer needle, and a power supply unit coupled to the instrument, the instrument having a shaft, the shaft including a distal end portion having at least one active electrode, wherein the at least one active electrode includes a filament, the shaft includes a first insulating sleeve encasing the filament, a return electrode on the first insulating sleeve, an insulating collar located at a distal end of the first insulating sleeve proximal to the return electrode, a second insulating sleeve on the return electrode, and a shield on the second insulating sleeve, the introducer needle having a lumen for accommodating axial movement of the shaft therein;

b) advancing the introducer needle towards the intervertebral disc;

c) passing the shaft distal end portion distally through the lumen of the introducer needle towards the disc, wherein the shaft distal end portion is inserted within the disc;

d) guiding the shaft distal end portion to the target site within the disc; and

e) applying a high frequency voltage between the at least one active electrode and at least one return electrode, the high frequency voltage selected for ablating disc tissue at the target site.

47. A method of ablating tissue at a target site of an intervertebral disc, comprising:

a) providing an electrosurgical system including a instrument, an introducer needle, and a power supply unit coupled to the instrument, the instrument having a shaft, the shaft including a distal end portion having at least one active electrode, wherein the at least one active electrode comprises an electrode head having a substantially apical spike and a substantially equatorial cusp, the introducer needle having a lumen for accommodating axial movement of the shaft therein;

b) advancing the introducer needle towards the intervertebral disc;

c) passing the shaft distal end portion distally through the lumen of the introducer needle towards the disc, wherein the shaft distal end portion is inserted within the disc;

d) guiding the shaft distal end portion to the target site within the disc; and

e) applying a high frequency voltage between the at least one active electrode and at least one return electrode, the high frequency voltage selected for ablating disc tissue at the target site and where the apical spike and the equatorial cusp of the electrode head provide a high current density in the vicinity of the electrode head.

48. A method of ablating tissue at a target site of an intervertebral disc, comprising:

providing an electrosurgical system including a instrument, an introducer needle, and a power supply unit coupled to the instrument, the instrument having a shaft, the shaft including a distal end portion having at least one active electrode, the introducer needle having a lumen for accommodating axial movement of the shaft therein, and having a distal end;

advancing the introducer needle towards the intervertebral disc through a first wall of the annulus fibrosus until the needle distal end contacts the nucleus pulposus;

passing the shaft distal end portion distally through the lumen of the introducer needle towards the disc, wherein the shaft distal end portion is inserted within the disc;

guiding the shaft distal end portion to the target site within the disc by advancing the shaft distal end portion distally from the needle distal end until the at least one active electrode contacts an opposite wall of the annulus fibrosus then retracting the shaft proximally a defined distance; and

applying a high frequency voltage between the at least one active electrode and at least one return electrode, the high frequency voltage selected for ablating disc tissue at the target site.