Systems and methods for treating spinal pain

• US 6,468,274 B1
• Filed: 10/11/2000
• Issued: 10/22/2002
• 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: Eggers, Philip E., Hovda, David C., Thapliyal, Hira V., Alleyne, Neville
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/689,264
• Time in Patent Office: 741 Days
• Field of Search: 606/32, 606/34, 606/41, 606/46, 606/49, 607/99, 607/105, 607/113, 128/898, 604/35, 604/114
• US Class Current: 606/41
• 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 18/148 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 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• 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 2018/00267 having a basket shaped structure
• 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 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00666 : using a threshold value
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/0072 : Current
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00779 : Power or energy
• 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 2018/00988 : Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• 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 2018/1467 : 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: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices

Abstract

The present invention provides systems and methods for selectively applying electrical energy to a fissure or tear location within an invertebral disc. The present invention applies high frequency (RF) electrical energy to one or more active electrodes in the presence of electrically conductive fluid to heat and seal a fissure on an annulus fibrosus. In one aspect of the invention, a method is provided for treating the fissure by applying sufficient electrical energy to the disc tissue to seal the fissure. In one embodiment, the RF energy is directed through the conductive fluid to heat the tissue immediately surrounding the fissure. The RF energy is sufficient to vaporize at least a portion of the fluid in contact with the active electrode. In another embodiment, the electrical current is directed through the tissue to directly heat the annulus tissue. This causes the annulus tissue to contract and seal the fissure. In a specific configuration, a sealant is added to the fissure to enhance the seal.

Claims

1. A method of treating a fissure in an intervertebral disc comprising:

positioning an active electrode adjacent an outer surface of an annulus surrounding an intervertebral disc;

delivering a sealant to a fissure within the annulus; and

applying a high frequency voltage difference between the active electrode and a return electrode, the voltage difference being sufficient to substantially seal the fissure within the annulus.

2. The method of claim 1 further comprising positioning the active electrode in an electrically conductive fluid.

3. The method of claim 2 wherein the electrically conductive fluid is isotonic saline.

4. The method of claim 2 wherein the active electrode and the return electrode are submersed within the electrically conductive fluid.

5. The method of claim 2 wherein the electrically conductive fluid is a viscous gel.

6. The method of claim 5 comprising heating the electrically conductive gel to heat the tissue surrounding the fissure.

7. The method of claim 2 comprising generating electric field intensities between the active electrode and the return electrode such that the electric field intensities are sufficient to vaporize at least a portion of the fluid in contact with the active electrode.

8. The method of claim 7 further comprising accelerating charged particles from the vaporized fluid to the tissue immediately surrounding the fissure to cause heating.

9. The method of claim 2 wherein the applying step is carried out by directing an electrical current through the electrically conductive fluid and into a tissue surrounding the fissure.

10. The method of claim 9 wherein the electrical current passes only through the electrically conductive fluid to heat the fissure.

11. The method of claim 2 comprising positioning the return electrode within the electrically conductive fluid to complete a current flow path between the active electrode and the return electrode.

12. The method of claim 2 comprising directing the electrically conductive fluid along a fluid path past the return electrode and active electrode to the fissure.

13. The method of claim 2 further comprising aspirating at least a portion of the electrically conductive fluid.

14. The method of claim 1 wherein the positioning step is carried out by placing the active electrode closer to the fissure than the return electrode.

15. The method of claim 1 comprising limiting a depth of penetration of an electrical current by drawing the electrical current from the active electrode toward the return electrode.

16. The method of claim 1 wherein the applying step elevates the temperature of the tissue adjacent to the fissure to a temperature between approximately 45°

C. and 90°

C.

17. The method of claim 1 wherein the applying step elevates the temperature of the tissue adjacent the fissure to a temperature between approximately 60°

C. and 70°

C.

18. The method of claim 1 wherein the act of applying a high frequency voltage difference between the active and return electrode comprises heating the collagen fibers within the annulus by passing an electric current into the collagen fibers.

19. The method of claim 1 wherein the applying step is carried out with RF electrical energy.

20. The method of claim 1 wherein the sealant is chosen from a group comprising fibrogen glue and collagen.

21. The method of claim 1 further comprising positioning the return electrode on the outer surface of the patient'"'"'s body, and conducting electrical current from the active electrode, through the patient'"'"'s body, to the return electrode.

22. The method of claim 1 wherein the active electrode comprises a single, active electrode at the distal end of a shaft.

23. The method of claim 1 wherein the active electrode comprises a plurality of electrically isolated active electrodes at the distal end of a shaft.

24. The method of claim 23 wherein the active electrodes are linear.

25. The method of claim 1 further comprising independently controlling current flow from the active electrode based on impedance between the active electrode and the return electrode.

26. The method of claim 1 wherein the return electrode is axially spaced from the active electrode.

27. A method of treating an intervertebral disc comprising:

delivering a sealant to a fissure within an annulus fibrosus surrounding the intervertebral disc;

positioning an active electrode adjacent an outer surface of the annulus fibrosus;

directing a conducting fluid between the active electrode and the annulus; and

applying sufficient high frequency electrical energy to the active electrode to heat and seal a fissure in the annulus.

28. The method of claim 27 wherein the positioning step further comprises introducing at least a distal end of an electrosurgical instrument through a percutaneous penetration in a patient.

29. The method of claim 28 wherein the percutaneous penetration is located on the patient'"'"'s back, abdomen, or thorax.

30. The method of claim 29 further comprising advancing the active electrode through the annulus fibrosus and into a nucleus pulposus.

31. The method of claim 27 further comprising positioning the active electrode and a return electrode within an electrically conductive fluid to generate an electrically conductive path therebetween.

32. An electrosurgical system for treating a fissure within an annulus fibrosus comprising:

a shaft having a proximal end portion and a distal end portion, the distal end portion being configured for introduction to an outer surface of an annulus in close proximity to, or in contact with, a fissure in the annulus;

an active electrode disposed on the distal end portion of the shaft;

a return electrode;

a high frequency voltage source adapted to generate a voltage sufficient to seal the fissure, the high frequency voltage source in electrical communication with the active and return electrodes; and

a sealant delivery element for delivering a sealant to the fissure.

33. The system of claim 32 further comprising a fluid delivery element for supplying electrically conductive fluid to the fissure to substantially surround at least the active electrode with the fluid and to locate the fluid between the active electrode and the fissure.

34. The system of claim 33 wherein the fluid delivery element defines a fluid path in electrical contact with the return electrode and the active electrode to generate a current flow path between the return electrode and the active electrode.

35. The system of claim 33 wherein the fluid delivery element comprises a fluid tube extending along an outer surface of the shaft, the tube having an inlet positioned proximal to the return electrode, wherein the return electrode is spaced proximally from the active electrode.

36. The system of claim 33 wherein the fluid delivery element comprises a fluid supply instrument separate from the electrosurgical probe.

37. The system of claim 32 wherein the distal end portion of the shaft has a diameter less than about 2.0 mm.

38. The system of claim 32 wherein the return electrode is disposed proximal of the active electrode.

39. The system of claim 32 further including an insulating member positioned between the return electrode and the active electrode, the return electrode being sufficiently spaced from the active electrode to minimize direct contact between the return electrode and the annulus when the active electrode is positioned in close proximity or in partial contact with the fissure.

40. The system of claim 32 wherein the active electrode comprises an electrode array disposed near the distal end portion of the shaft, the array including a plurality of electrically isolated active electrodes disposed over a contact surface.

41. The system of claim 40 wherein the electrode array comprises an edge for promoting localized electric fields between the edge and the fissure.

42. The system of claim 32 wherein the active electrode comprises a single active electrode disposed near the distal end portion of the shaft.

43. The system of claim 32 further comprising a fluid aspiration element.

44. The system of claim 43 wherein the fluid aspiration element comprises a suction lumen extending through the shaft, the suction lumen having an inlet at a distal tip of the shaft adjacent the active electrode.

45. The system of claim 43, further comprising an aspiration electrode in fluid communication with the fluid aspiration element.

46. The system of claim 45, wherein the aspiration electrode comprises an electrode configuration selected from the group consisting of:

at least one coiled electrode, a wire mesh electrode, a cage electrode, and a screen electrode.

47. The system of claim 32 wherein the sealant delivery element extends down the shaft.

48. the system of claim 47 wherein the voltage is sufficient to heat the sealant within the fissure.

49. The system of claim 48 wherein the sealant delivery element comprise a tube extending along an outer surface of the shaft, the tube having an opening positioned adjacent the active electrode, wherein the return electrode is spaced proximally from the active electrode.

50. The system of claim 48 wherein the sealant is chosen from a group comprising an adhesive, collagen, and fibrogen glue.

51. The system of claim 48 wherein the sealant delivery element is separate from the shaft.