Methods for repairing damaged intervertebral discs

• US 7,318,823 B2
• Filed: 07/03/2003
• Issued: 01/15/2008
• Est. Priority Date: 04/13/1995
• Status: Expired due to Fees

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Woloszko, Jean, Eggers, Philip E., Sharps, Lewis, Hovda, David C., Thapliyal, Hira V.
• Primary Examiner(s): Cohen; Lee S.
• Application Number:
  US10/613,115
• Publication Number:
  US 20040024399A1
• Time in Patent Office: 1,657 Days
• Field of Search: 606/32, 606/34, 606/41, 606/49, 607/99, 607/105, 607/113, 604/35, 604/114, 128/898
• 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 18/1402 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 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• 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 an intervertebral disc by ablation of disc tissue. A method of the invention includes positioning at least one active electrode within the intervertebral disc, and applying at least a first high frequency voltage between the active electrode(s) and one or more return electrode(s), wherein the volume of the nucleus pulposus is decreased, pressure exerted by the nucleus pulposus on the annulus fibrosus is reduced, and discogenic pain of a patient is alleviated. In other embodiments, a curved or steerable probe is guided to a specific target site within a disc to be treated, and the disc tissue at the target site is ablated by application of at least a first high frequency voltage between the active electrode(s) and one or more return electrode(s). A method of making an electrosurgical probe is also disclosed.

Claims

1. A method of treating an inter-vertebral disc, comprising:

a) contacting at least a first region of a nucleus pulposus of the inter-vertebral disc with at least one heat delivery element of an electrosurgical system, the at least one heat delivery element disposed on a shaft of an electrosurgical probe; and

b) applying a first high frequency voltage to said heat delivery element sufficient to decompress said disc such that pressure on a nerve root is reduced wherein a portion of said nucleus pulposus is ablated thereby reducing the volume of the nucleus pulposus.

2. The method of claim 1, further comprising:

c) contacting at least a second region of the nucleus pulposus of the inter-vertebral disc with the at least one heat delivery element, and thereafter, repeating said step b).

3. The method of claim 1, wherein during said step b), the at least one heat delivery element is translated within the nucleus pulposus, wherein a channel is formed within the nucleus pulposus, and translation of the at least one heat delivery element within the nucleus pulposus is implemented via movement of the probe.

4. The method of claim 3, wherein movement of the probe is selected from the group consisting of axial movement, rotational movement, and concurrent axial and rotational movement.

5. The method of claim 1, wherein said steps a) and b) result in formation of a channel within the nucleus pulposus, the channel having a channel wall, and the method further comprises:

d) positioning the at least one heat delivery element adjacent to the channel wall; and

e) coagulating tissue of the nucleus pulposus by applying a second high frequency voltage to said at least one heat delivery element.

6. The method of claim 5, wherein tissue at the channel wall is coagulated, and the nucleus pulposus undergoes a physical change selected from the group consisting of stiffening, increased rigidity, increased strength, decrease in volume, and decrease in mass.

7. The method of claim 5, wherein the first high frequency voltage is in the range of from about 150 to about 700 volts rms, and the second high frequency voltage is in the range of from about 20 to about 150 volts rms.

8. The method of claim 5, wherein the first high frequency voltage is in the range of from about 150 to about 350 volts rms, and the second high frequency voltage is in the range of from about 20 to about 90 volts rms.

9. The method of claim 1, wherein said the at least one heat delivery element is disposed on a distal end of the shaft, and comprises a closed electrical circuit with said shaft.

10. The method of claim 1, further comprising the step of:

f) prior to said step b), providing an electrically conductive fluid at the at least a first region of the nucleus pulposus.

11. The method of claim 10, wherein said step f) comprises applying the electrically conductive fluid in the vicinity of the heat delivery element, or applying the electrically conductive fluid to the disc.

12. The method of claim 10, wherein the at least one heat delivery element is disposed on a distal end of the shaft, and the electrically conductive fluid provides an electrically conductive path between the at least one heat delivery element and the disc.

13. The method of claim 1, wherein the shaft includes a shaft distal end, and the shaft distal end is introduced into the nucleus pulposus via an introducer needle, the introducer needle includes a lumen and a needle distal end, the shaft distal end includes at least one curve therein, and the shaft distal end is retractable into the lumen without contacting the needle distal end.

14. The method of claim 1, wherein the shaft is visualized fluoroscopically or endoscopically.

15. The method of claim 1, wherein the at least one heat delivery element comprises an electrode head having a substantially apical spike and a substantially equatorial cusp, and the shaft includes an insulating collar located proximal to the electrode head.

16. The method of claim 15, wherein the insulating collar comprises a material selected from the group consisting of:

a ceramic, a glass, and a silicone.

17. The method of claim 1, wherein the at least one heat delivery element includes a filament;

and the shaft includes a first insulating sleeve encasing the filament, a return electrode on the first insulating sleeve, and a second insulating sleeve on the return electrode.

18. The method of claim 1, wherein the shaft includes a shield encasing the shaft, wherein the shield decreases the amount of leakage current passing from the electrosurgical probe.

19. The method of claim 1, wherein the shaft includes a first curve and a second curve proximal to the first curve, 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 different directions relative to the longitudinal axis of the shaft, the first curve is characterized by a first angle and the second curve is characterized by a second angle, wherein the first angle is less than the second angle.

20. The method of claim 1, wherein the volume of the nucleus pulposus is decreased and relieves pressure exerted by the nucleus pulposus on an annulus fibrosus.

21. The method of claim 1, wherein the volume of the nucleus pulposus is decreased and decompresses at least one nerve or nerve root, and discogenic pain is alleviated.

22. The method of claim 1, wherein during said step b), the at least one heat delivery element is axially translated within the nucleus pulposus to form a channel within the nucleus pulposus, wherein the channel is formed by a single straight pass of the shaft in the nucleus pulposus, and the channel has a volume in the range of from about 1 mm³ to about 2,500 mm.

23. The method of claim 22, wherein the channel has a volume in the range of from about 10 mm³ to about 2,500 mm³.

24. The method of claim 22, wherein the channel has a diameter in the range of from about 0.5 mm to about 7.5 mm.

25. The method of claim 22, wherein the channel has a length in the range of from about 2 mm to about 50 mm.

26. The method of claim 1, wherein during said step b), the at least one heat delivery element is axially translated within the nucleus pulposus and concurrently therewith the shaft is rotated about its longitudinal axis, wherein the at least one heat delivery element forms a channel within the nucleus pulposus, the channel is formed by a single rotational pass of the shaft, wherein the at least one heat delivery element is disposed on a distal end of the shaft, the shaft includes at least one curve, and the channel has a volume in the range of from about 2 mm³ to about 38,000 mm³.

27. The method of claim 26, wherein the channel has a volume in the range of from about 50 mm³ to about 10,000 mm³.

28. The method of claim 1, wherein the shaft has a length in the range of from about 4 cm to about 30 cm, and the shaft has a diameter in the range of from about 0.5 mm to about 2.5 mm.

29. The method of claim 1, wherein the shaft includes a shaft distal end, and wherein the shaft distal end is introduced into the nucleus pulposus via an introducer needle, the introducer needle including a lumen, wherein the introducer needle has a length in the range of from about 3 cm to about 25 cm, and the lumen has a diameter in the range of from about 0.5 mm to about 2.5 mm.

30. The method of claim 1, wherein the method is performed percutaneously, and the at least a portion of the nucleus pulposus is ablated at a temperature in the range of from about 45°

C. to about 90°

C.

31. The method of claim 1, wherein the intervertebral disc is a lumbar disc, and the shaft has a length in the range of from about 10 cm to about 25 cm.

32. The method of claim 1, wherein the intervertebral disc is a cervical disc, and the shaft has a length in the range of from about 4 cm to about 15 cm.

33. The method of claim 1, wherein said portion of the nucleus pulosus is removed.

34. The method of claim 1, wherein the heat delivery element comprises an active electrode.