Method for treating annular fissures in intervertebral discs

• US 6,126,682 A
• Filed: 09/15/1998
• Issued: 10/03/2000
• Est. Priority Date: 08/13/1996
• Status: Expired due to Term

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories)
• Original Assignee: Oratec Interventions Incorporated (Smith & Nephew PLC)
• Inventors: Sharkey, Hugh J., Ashley, John, Saal, Joel, Saal, Jeffrey
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/153,552
• Time in Patent Office: 749 Days
• Field of Search: 606/13-15, 606/41, 606/49, 607/89, 607/96, 607/98, 607/99, 607/101, 607/102
• US Class Current: 607/96
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00022 : Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00084 : Temperature
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• CPC Class Codes: A61B 2017/00119 : alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00261 : Discectomy
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• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00336 : with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00455 : Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• CPC Class Codes: A61B 2017/22049 : Means for locking the guide wire in the catheter
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• CPC Class Codes: A61B 2018/00595 : Cauterization
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• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
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• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2007/0298 : with a section for heating and a section for cooling
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0133 : Tip steering devices
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• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: A61M 25/09 : Guide wires
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Abstract

A percutaneous method of repairing a fissure in the annulus pulposus includes 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 intervetebral disc comprising:

providing a catheter having an intradiscal section with at least one functional element adjacent a distal end of the catheter and a proximal end for externally guiding the distal end of the catheter within an intervertebral disc;

positioning the functional element adjacent the annular fissure by 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; 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 2, wherein the steps of positioning the functional element and adding energy are repeated at least once.

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

5. The method of claim 2, wherein heating the disc includes delivering a controlled amount of energy such that no vaporization occurs.

6. The method of claim 2, wherein heating the disc includes delivering a controlled amount of energy at such that no material other than water is removed.

7. The method of claim 2, wherein the heating the disc includes delivering a controlled amount of energy such that no destructive lesion is formed on a disc.

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

9. The method of claim 1, wherein the step of positioning the functional element includes positioning the functional element in a position selected from the group consisting of at a posterior medial, posterior lateral, anterior lateral, and anterior medial portion of the annulus fibrosus, and combinations thereof.

10. 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.

11. 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.

12. The method of claim 11 comprising the additional step of placing a material in the disc.

13. The method of claim 12 wherein any of the following are placed:

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

14. 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.

15. The method of claim 1, wherein the intradiscal section has a bending stiffness as measured in Taber stiffness units between about 2-400 units in a desired bending plane.

16. The method of claim 1, wherein the intradiscal section has a bending stiffness as measured in Taber stiffness units between about 3-150 units in a desired bending plane.

17. The method of claim 1, wherein the intradiscal section has a bending stiffness as measured in Taber stiffness units between about 4-30 units in a desired bending plane.

18. The method of claim 17, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

19. The method of claim 17, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

20. The method of claim 1, wherein the intradiscal section has a column strength between about 0.05-4 kg.

21. The method of claim 20, wherein the proximal end of the apparatus has a column strength between about 0.1-25 kg.

22. The method of claim 20, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

23. The method of claim 20, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

24. The method of claim 1, wherein the intradiscal section has a column strength between about 0.05-2 kg.

25. The method of claim 24, wherein the proximal end of the apparatus has a column strength between about 0.1-25 kg.

26. The method of claim 24, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

27. The method of claim 24, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

28. A method of treating of 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.

29. The method of claim 28 wherein the step of providing energy is performed to raise the temperature to at least 50°

C. for at least one minute.

30. The method of claim 28 wherein the step of providing energy is performed to raise the temperature to at least 50°

C. for at least two minutes.

31. The method of claim 28 wherein the step of providing energy is performed to raise the temperature to at least 50°

C. for at least three minutes.

32. The method of claim 28 further comprising the step of placing a sealant in or near the fissure to help seal the fissure.

33. The method of claim 32 further comprising the step of heating the sealant at a temperature and for a time sufficient to seal the fissure.