Method and apparatus for treating annular fissures in intervertebral discs

• US 20030181964A1
• Filed: 03/17/2003
• Published: 09/25/2003
• Est. Priority Date: 08/13/1996
• Status: Active Grant

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Oratec Interventions Incorporated
• Inventors: Ashley, John, Sharkey, Hugh R., Saal, Joel, Saal, Jeffrey A., Le, Le Trong
• Granted Patent: US 6,997,941 B2
• Time in Patent Office: Days
• US Class Current: 607/96
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Abstract

A percutaneous method of repairing a fissure in the annulus pulposus comprises placing an energy source adjacent to the fissure and providing sufficient energy to the fissure to raise the temperature to at least about 45-70° C. and for a sufficient time to cause the collagen to weld. An intervertebral fissure also can be treated by placing a catheter with a lumen adjacent to the fissure and injecting sealant into the fissure via the catheter, thereby sealing the fissure. An intervertebral fissure additionally can be treated by providing a catheter having a distal end, a proximal end, a longitudinal axis, and an intradiscal section at the catheter'"'"'s distal end on which there is at least one functional element. The next step is applying a force longitudinally to the proximal of the catheter which is sufficient to advance the intradiscal section through the nucleus pulposus and around an inner wall of an annulus fibrosus, but which force is insufficient to puncture the annulus fibrosus. Next the functional element is positioned at a selected location of the disc by advancing or retracting the catheter and optionally twisting the proximal end of the catheter. Then the functional unit treats the annular fissure. Optionally, there is an additional step of adding a substance to seal the fissure. An externally guidable intervertebral disc apparatus also is disclosed.

Claims

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

providing a catheter having a distal end, a proximal end and a longitudinal axis, the distal end having an intradiscal section with at least one functional element;

applying a force longitudinally to the proximal end of the catheter which is sufficient to advance the intradiscal section through the nucleus pulposus and around an inner wall of an annulus fibrosus, but which force is insufficient for the intradiscal section to puncture the annulus fibrosus;

positioning the functional element at the selected location of the disc by advancing or retracting the catheter and optionally twisting the proximal end of the catheter; and

using the functional element to treat the annular fissure.

2. The method of claim 1, wherein the step of using the functional element comprises heating the disc.

3. The method of claim 1, wherein the step of positioning the catheter is facilitated by a distal end which differentially bends in two orthogonal directions at right angles to the longitudinal axis.

4. The method of claim 1, wherein the step of positioning the functional element locates the functional element at a posterior medial, posterior lateral, anterior lateral, or anterior medial portion of the annulus fibrosus, or a combination thereof.

5. The method of claim 1, wherein the step of adding sufficient energy comprises adding energy sufficient to shrink the collagen component of the annulus fibrosus around the fissure.

6. The method of claim 2, wherein the steps of positioning the functional element and adding energy are repeated at least once.

7. The method of claim 2, wherein the step of adding sufficient energy comprises adding sufficient energy to cauterize granulation tissue in the fissure.

8. The method of claim 1, wherein the step of providing a catheter with at least one functional element further includes providing a catheter with a lumen capable of delivering or aspirating a material.

9. The method of claim 8 comprising the additional step of placing a material in the disc.

10. The method of claim 9 wherein any of the following are placed:

electrolyte solutions, contrast media, pharmaceutical agents, chemonucleolytic enzymes, hydrogel, osteoinductive substances, chondrocyte-inductive substances, sealants, collagen, fibrinogen and thrombin, and any combination thereof.

11. The method of claim 1 wherein the step of providing the catheter with at least one functional element includes providing a catheter with a heating element and a temperature sensor.

12. A method of treating an intervertebral fissure, said method comprising

placing an energy source adjacent to the fissure;

and

providing sufficient energy to the fissure to raise the temperature to at least about 45-70°

C. and for a sufficient time to cause the collagen to weld.

18. A method of treating an intervertebral fissure, said method comprising

placing a catheter with a lumen adjacent to the fissure;

and

injecting sealant into the fissure via the catheter lumen to seal the fissure.

19. The method of claim 18 wherein the injected sealant is selected from a mixture of thrombin and fibrin or from a gel which is liquid at room temperature and solidifies at body temperature.

20. An externally guidable intervertebral disc apparatus for treatment of fissures of the intervertebral disc, the apparatus comprising:

a catheter having a distal end, a proximal end, and a longitudinal axis, the catheter having an intradiscal section at the distal end of the catheter, the intradiscal section being extendible into the disc, having sufficient rigidity to be advanceable through a nucleus pulposus and around an inner wall of an annulus fibrosus under a force applied longitudinally to the proximal end, having insufficient penetration ability to be advanceable out through the annulus fibrosus under the applied force;

having sufficient flexibility in a direction of a disc Diane to be compliant with the inner wall; and

a functional element located at the intradiscal section for adding energy or material at or near the fissure.

13. The method of claim 20 wherein the step of providing energy is performed to raise the temperature to at least 50°

C. for at least one minute.

14. The method of claim 20 wherein the step of providing energy is performed to raise the temperature to at least 50°

C. for at least two minutes.

15. The method of claim 20 wherein the step of providing energy is performed to raise the temperature to at least 55°

C. for at least three minutes.

16. The method of claim 20 further comprising the step of placing a sealant in or near the fissure to help seal the fissure.

17. The method of claim 16 further comprising the step of heating the adhesive or cement at a temperature and for a time sufficient to seal the fissure.

21. The apparatus of claim 20, wherein at least a portion of the intradiscal section further has differential bending ability in two orthogonal directions at right angles to the longitudinal axis.

22. The apparatus of claim 21, wherein the differential bending ability is controlled by a structural element with different thicknesses in the two orthogonal directions.

23. The apparatus of claim 21, wherein the differential bending is maintained in a fixed orientation relative to the catheter by a control element located at the proximal end of the catheter.

24. The apparatus of claim 20, wherein the apparatus further comprises an introducer.

25. The apparatus of claim 20, wherein the intradiscal section has a length at least one-half of a diameter of the nucleus pulposus.

26. The apparatus of claim 20, wherein the intradiscal section has a distal portion configured to be non-piercing through an annulus fibrosus.

27. The apparatus of claim 20, wherein the intradiscal section has a distal portion with a blunt tip.

28. The apparatus of claim 20, wherein the intradiscal section has a distal portion with a rolling ball tip.

29. The apparatus of claim 20, wherein the intradiscal section has a tip less rigid than a more proximal portion of the intradiscal section.

30. The apparatus of claim 20, wherein the intradiscal section has a directionally biased tip portion.

31. The apparatus of claim 20, wherein the functional element comprises a thermal energy delivery device.

32. The apparatus of claim 31, wherein the thermal energy delivery device is a resistive heating electrode.

33. The apparatus of claim 31, wherein a thermal energy source is operably attached to the thermal energy delivery device through the catheter.

34. The apparatus of claim 31, wherein the thermal energy delivery device is a microwave probe, and the thermal energy source is a microwave source.

35. The apparatus of claim 31, wherein the thermal energy delivery device is an optical fiber, and the thermal energy source is a laser.

36. The apparatus of claim 31, wherein the thermal energy delivery device is an ultrasound emitter, and the thermal energy source is an ultrasound generator.

37. The apparatus of claim 31, wherein the thermal energy delivery device is a radiofrequency electrode, and the thermal energy source is an RF generator.

38. The apparatus of claim 20, wherein at least a portion of the intradiscal section of the catheter is actively steerable.

39. The apparatus of claim 20, wherein at least a portion of the catheter is radiographically opaque.

40. The apparatus of claim 20, wherein the intradiscal section further comprises at least one sensor capable of monitoring temperature, power, voltage or a combination thereof.

41. The apparatus of claim 40, wherein input from the sensor controls energy supplied to the thermal energy device.

42. The apparatus of claim 20, wherein the intradiscal section of the catheter includes a wound helical support structure.

43. The apparatus of claim 20, wherein the intradiscal section of the catheter is configured to have at least two radii of curvature.

44. The apparatus of claim 20, wherein the functional element comprises an irrigation lumen extending from a proximal end of the catheter to the intradiscal section.

45. The apparatus of claim 20, wherein the intradiscal section of the catheter has one or more flat sides.