Methods for repairing damaged intervertebral discs
First Claim
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 active electrode of an electrosurgical system, the at least one active electrode disposed on a shaft of an electrosurgical probe, and the at least one active electrode functionally coupled to a power supply unit; and
b) applying a first high frequency voltage between the at least one active electrode and at least one return electrode, wherein at least a portion of the nucleus pulposus is ablated and the volume of the nucleus pulposus is decreased.
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Accused Products
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.
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Citations
57 Claims
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1. A method of treating an inter-vertebral disc, comprising:
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a) contacting at least a first region of a nucleus pulposus of the inter-vertebral disc with at least one active electrode of an electrosurgical system, the at least one active electrode disposed on a shaft of an electrosurgical probe, and the at least one active electrode functionally coupled to a power supply unit; and
b) applying a first high frequency voltage between the at least one active electrode and at least one return electrode, wherein at least a portion of the nucleus pulposus is ablated and the volume of the nucleus pulposus is decreased. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
c) contacting at least a second region of the nucleus pulposus of the inter-vertebral disc with the at least one active electrode, and thereafter, repeating said step b).
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3. The method of claim 1, wherein during said step b), the at least one active electrode is translated within the nucleus pulposus, wherein a channel is formed within the nucleus pulposus, and translation of the at least one active electrode within the nucleus pulposus is implemented via movement of the probe.
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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.
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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:
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d) positioning the at least one active electrode adjacent to the channel wall; and
e) coagulating tissue of the nucleus pulposus by applying a second high frequency voltage between the at least one active electrode and the at least one return electrode.
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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.
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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.
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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.
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9. The method of claim 1, wherein the at least one active electrode and the at least one return electrode are disposed on a distal end of the shaft, and the at least one return electrode is spaced proximally from the at least one active electrode.
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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.
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11. The method of claim 10, wherein said step f) comprises applying the electrically conductive fluid to the at least one active electrode, or applying the electrically conductive fluid to the disc.
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12. The method of claim 10, wherein the at least one active electrode and the at least one return electrode are disposed on a distal end of the shaft, and the at least one return electrode is spaced proximally from the at least one active electrode, and the electrically conductive fluid provides an electrically conductive path between the at least one active electrode and the at least one return electrode.
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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.
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14. The method of claim 1, wherein the shaft is visualized fluoroscopically or endoscopically.
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15. The method of claim 1, wherein the at least one active electrode 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.
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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.
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17. The method of claim 1, 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, and a second insulating sleeve on the return electrode.
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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.
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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.
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20. The method of claim 1, wherein decreasing the volume of the nucleus pulposus relieves pressure exerted by the nucleus pulposus on an annulus fibrosus.
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21. The method of claim 1, wherein decreasing the volume of the nucleus pulposus decompresses at least one nerve or nerve root, and discogenic pain is alleviated.
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22. The method of claim 1, wherein during said step b), the at least one active electrode 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 mm3.
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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.
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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.
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25. The method of claim 22, wherein the channel has a length in the range of from about 2 mm to about 50 mm.
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26. The method of claim 1, wherein during said step b), the at least one active electrode is axially translated within the nucleus pulposus and concurrently therewith the shaft is rotated about its longitudinal axis, wherein the at least one active electrode forms a channel within the nucleus pulposus, the channel is formed by a single rotational pass of the shaft, wherein the at least one active electrode 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.
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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.
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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.
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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.
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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.
- C. to about 90°
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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.
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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.
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33. A method of treating an inter-vertebral disc, comprising:
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providing an electrosurgical system including a probe and a power supply unit, wherein the probe includes a shaft and a handle, the shaft including a distal end portion, at least one active electrode, and at least one return electrode, the at least one active electrode located on the distal end portion of the shaft, the distal end portion of the shaft having a pre-defined bias in the longitudinal direction thereof;
inserting the distal end portion of the shaft within the disc; and
ablating at least a portion of nucleus pulposus tissue from the disc, wherein at least one channel is formed within the nucleus pulposus. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42)
removing the shaft from the disc, wherein said removing step causes the low molecular weight gaseous materials to be exhausted from the disc.
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38. The method of claim 33, wherein said ablating step causes localized ablation of targeted disc tissue with minimal collateral damage to non-target tissue within the disc.
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39. The method of claim 33, wherein said ablating step comprises applying a first high frequency voltage between the at least one active electrode and the at least one return electrode, and the method further comprises:
after said ablating step, applying a second high frequency voltage between the at least one active electrode and the at least one return electrode, wherein the second high frequency voltage is sufficient to coagulate disc tissue adjacent to the distal end portion of the shaft.
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40. The method of claim 33, further comprising:
before said ablating step, contacting the at least one active electrode with a quantity of an electrically conductive fluid.
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41. The method of claim 33, wherein said inserting step comprises advancing the shaft distal end portion via an introducer needle having a lumen and a needle distal end, wherein the shaft distal end portion is advanced distally beyond the needle distal end, wherein the at least one active electrode does not make contact with the needle distal end;
- and the method further comprises retracting the shaft distal end portion proximally within the lumen of the introducer needle, wherein the at least one active electrode does not make contact with the needle distal end.
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42. The method of claim 33, wherein the shaft includes a shield, the shaft distal end portion includes a first curve, a second curve proximal to the first curve, and an insulating collar distal to the first curve, and the at least one active electrode comprises a filament and a head having an apical spike and an equatorial cusp.
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43. A method of treating an inter-vertebral disc with an electrosurgical system, the electrosurgical system including a probe having a shaft, the shaft including a shaft distal end portion, an active electrode disposed on the shaft distal end portion, and a return electrode disposed proximal to the active electrode, the method comprising:
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a) contacting a nucleus pulposus of the disc with the active electrode;
b) applying a high frequency voltage between the active electrode and the return electrode, wherein the high frequency voltage is sufficient to ablate disc tissue; and
c) during the applying step, translating the shaft distal end portion within the nucleus pulposus, wherein tissue of the nucleus pulposus is ablated and the volume of the nucleus pulposus is decreased. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
d) inserting an ancillary introducer needle into the disc; and
e) advancing, via the ancillary introducer needle, an ancillary device into the nucleus pulposus, wherein the ancillary device comprises an endoscope, an optical fiber, an aspiration device, a fluid delivery assembly, or a return electrode.
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51. The method of claim 43, wherein the shaft distal end portion includes a tracking device for indicating a location of the shaft distal end portion relative to the nucleus pulposus.
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52. The method of claim 43, wherein the shaft includes at least one depth marking for indicating a location of the shaft distal end portion relative to the nucleus pulposus.
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53. The method of claim 43, wherein said contacting step comprises:
f) advancing the shaft distally through the nucleus pulposus until the shaft distal end portion contacts an inner wall of an annulus fibrosus; and
thereafter, retracting the shaft a defined distance.
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54. The method of claim 43, further comprising the step of:
g) determining a depth of penetration of the shaft distal end portion within the disc.
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55. The method of claim 54, wherein the shaft distal end portion is introduced into the disc via an introducer needle having an introducer proximal end, and said step g) comprises monitoring the position of the introducer proximal end relative to a mechanical stop or at least one depth marking.
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56. The method of claim 54, wherein said step g) comprises:
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h) advancing the shaft distal end portion through the nucleus pulposus until the shaft distal end portion contacts the annulus fibrosus; and
thereafter,i) retracting the shaft distal end portion a defined distance.
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57. The method of claim 55, wherein said step g) comprises:
h) advancing the shaft distal end portion through the nucleus pulposus until the mechanical stop contacts a proximal end of the introducer needle.
Specification