Method for treating intervertebral discs

• US 20040102824A1
• Filed: 11/14/2003
• Published: 05/27/2004
• 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 7,400,930 B2
• Time in Patent Office: Days
• US Class Current: 607/101
• 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
• CPC Class Codes: A61B 2017/0011 : piezoelectric
• CPC Class Codes: A61B 2017/00119 : alarm; indicating an abnormal situation
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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
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• 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
• CPC Class Codes: A61B 2017/22082 : after introduction of a substance
• CPC Class Codes: A61B 2017/22087 : photodynamic
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• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00011 : with fluids
• CPC Class Codes: A61B 2018/00267 : having a basket shaped structure
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• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00595 : Cauterization
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• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2218/002 : Irrigation
• 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
• CPC Class Codes: A61M 25/0144 : having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• 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
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia

Abstract

A device is described that may be positioned at a location in an intervertebral disc for diagnosis or treatment of the disc. Treatment may include, for example, applying energy or removing material, and may decrease intradiscal pressure. Radiofrequency energy may be applied. 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 manipulating a disc tissue of an intervertebral disc, the disc having a nucleus pulposus, an annulus fibrosus, and an inner wall of the annulus fibrosus, the method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter and a proximal region for externally guiding the distal region of the catheter within an intervertebral disc;

positioning the electrode at the inner wall of the annulus fibrosus by applying a sufficient force to advance the catheter through the nucleus pulposus to the inner wall of the annulus fibrosus, which force is insufficient to puncture the annulus fibrosus; and

delivering energy to the disc tissue using the electrode.

2. The method of claim 1, wherein the catheter defines a lumen.

3. The method of claim 1, wherein the step of providing a catheter is followed by the steps of:

providing an introducer with a proximal end and a distal end and having an introducer lumen with a distal opening at a terminus of the introducer;

inserting the introducer into the disc so that the proximal end of the introducer is external to the body and the distal opening of the introducer lumen is internal to the body; and

slidably inserting the catheter into the introducer.

4. The method of claim 3, wherein the distal end of the introducer is internal to the nucleus pulposus.

5. The method of claim 3, wherein the distal end of the introducer is adjacent to an opening in the annulus fibrosus communicating with the nucleus pulposus.

6. A method of manipulating a disc tissue at a selected location of the intervertebral disc, the disc having a nucleus pulposus, an annulus fibrosus, and an inner wall of the annulus fibrosus, the method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter and a proximal region for externally guiding the distal region of the catheter within an intervertebral disc;

positioning the electrode at the selected location of the disc by applying a sufficient force to advance at least a portion of the distal region of the catheter through the nucleus pulposus beyond a central region of the nucleus pulposus, which force is insufficient to puncture the annulus fibrosus; and

removing material at the selected location of the disc using the electrode.

7. A method of manipulating a disc tissue of an intervertebral disc, the disc having a nucleus pulposus, an annulus fibrosus, and an inner wall of the annulus fibrosus, the method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter and a proximal region for externally guiding the distal region of the catheter within an intervertebral disc;

positioning the electrode at a location selected from the group consisting of posterior medial inner, posterior lateral, anterior lateral and anterior medial wall of the annulus fibrosus or combinations thereof by applying a sufficient force to advance at least a portion of the distal region of the catheter through the nucleus pulposus beyond a central region of the nucleus pulposus, which force is insufficient to puncture the annulus fibrosus; and

delivering energy to the disc tissue using the electrode at the selected location.

8. A method of manipulating a disc tissue of an intervertebral disc, the disc having a nucleus pulposus, an annular fibrosus, and an inner wall of the annulus fibrosus, the method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter and a proximal region for externally guiding the distal region of the catheter within an intervertebral disc;

positioning the electrode at a first selected location of the disc by applying a sufficient force to advance at least a portion of the distal region of the catheter through the nucleus pulposus beyond a central region of the nucleus pulposus, which force is insufficient to puncture the annulus fibrosus;

delivering energy to the disc tissue at the first selected location of the disc using the electrode;

positioning the electrode at a second selected location; and

delivering energy to the disc tissue at the second selected location of the disc using the electrode.

9. A method of manipulating a disc tissue at a selected location of an intervertebral disc, the disc having a nucleus pulposus, an annulus fibrosus, and an inner wall of the annulus fibrosus, the method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter and a proximal region for externally guiding the distal region of the catheter within an intervertebral disc;

positioning the electrode at the selected location of the disc by twisting the proximal region of the catheter and applying a sufficient force to advance at least a portion of the distal region of the catheter through the nucleus pulposus beyond a central region of the nucleus pulposus, which force is insufficient to puncture the annulus fibrosus; and

delivering energy to the disc tissue at the selected location of the disc using the electrode.

10. A method comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a radiofrequency electrode incorporated into the apparatus at a distal region of the apparatus is advanced beyond a central region of a nucleus pulposus of the disc to a selected location; and

delivering energy from the electrode positioned at the selected location such that no vaporization of intervertebral disc tissue occurs when energy is delivered.

11. A method comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a radiofrequency electrode incorporated into the apparatus at a distal region of the apparatus is advanced beyond a central region of a nucleus pulposus of the disc to a selected location; and

delivering energy from the electrode positioned at the selected location such that no material other than water is removed at the selected location of the intervertebral disc when energy is delivered.

12. A method comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a radiofrequency electrode incorporated into the apparatus at a distal region of the apparatus is advanced beyond a central region of a nucleus pulposus of the disc to a selected location; and

delivering energy from the electrode positioned at the selected location such that no destructive lesion is formed on a disc at the selected location of the intervertebral disc when energy is delivered.

13. A method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter;

advancing the electrode beyond a central region of a nucleus pulposus of an intervertebral disc to a selected location; and

delivering energy from the electrode positioned at the selected location.

14. The method of claim 13, wherein the electrode is positioned adjacent a portion of an inner wall of the disc which forms a region of the disc selected from the group consisting of:

a posterior medial, posterior lateral, anterior medial and anterior lateral region of the inner wall of the annulus fibrosus.

15. The method of claim 13, wherein the electrode is positioned at a site of an annular fissure of the inner wall of the disc.

16. The method of claim 13, wherein delivering energy includes delivering thermal energy or electromagnetic energy.

17. The method of claim 13, wherein delivering energy includes delivering a controlled amount of energy such that no vaporization occurs in the disc.

18. The method of claim 13, wherein delivering energy includes delivering a controlled amount of energy such that no material other than water is removed from the disc.

19. The method of claim 13, wherein delivering energy includes delivering a controlled amount of energy such that no destructive lesion is formed in the disc.

20. A method comprising:

providing a catheter having a radiofrequency electrode at a distal region of the catheter;

positioning the electrode in the intervertebral disc;

advancing the electrode non-linearly within the intervertebral disc beyond a central region of a nucleus pulposus of the disc to a selected location; and

delivering energy to the selected location from the electrode positioned at the selected location.

21. The method of claim 20, wherein the electrode is positioned adjacent an inner wall of the disc.

22. The method of claim 20, wherein the electrode is advanced along a path with multiple degrees of curvature.

23. The method of claim 20, wherein the electrode is advanced to an inner wall of the disc.

24. The method of claim 20, wherein the selected location is selected from the group consisting of a posterior medial, posterior lateral, anterior medial, and anterior lateral region of an inner wall of an annulus fibrosus.

25. The method of claim 20, wherein the selected location is at a site of an annular fissure of an inner wall of the disc.

26. The method of claim 20, wherein delivering energy includes delivering thermal energy or electromagnetic energy.

27. The method of claim 20, wherein delivering energy includes delivering a controlled amount of energy such that no vaporization occurs in the disc.

28. The method of claim 20, wherein delivering energy includes delivering a controlled amount of energy such that no material other than water is removed from the disc.

29. The method of claim 20, wherein delivering energy includes delivering a controlled amount of energy such that no destructive lesion is formed in the disc.

30. The method of claim 20 wherein advancing the electrode non-linearly within the intervertebral disc comprises conforming the catheter sufficiently to an inner wall of an annulus fibrosus to contact multiple locations on the inner wall.

31. A method for delivering a controlled amount of energy adjacent an inner wall of an intervertebral disc comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a functional element incorporated into the apparatus adjacent a distal end of apparatus is positioned adjacent a wall of the intervertebral disc; and

delivering energy from the functional element to the wall of the invertebral disc such that no vaporization of intervertebral disc tissue occurs when energy is delivered.

32. A method for delivering a controlled amount of energy adjacent an inner wall of an intervertebral disc comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a functional element incorporated into the apparatus adjacent a distal end of apparatus is positioned adjacent a wall of the intervertebral disc; and

delivering energy from the functional element to the wall of the invertebral disc such that no material other than water is removed at or near the wall of the intervertebral when energy is delivered.

33. A method for delivering a controlled amount of energy adjacent an inner wall of an intervertebral disc comprising:

introducing an intervertebral disc apparatus within an intervertebral disc such that a functional element incorporated into the apparatus adjacent a distal end of apparatus is positioned adjacent a wall of the intervertebral disc; and

delivering energy from the functional element to the wall of the invertebral disc such that no destructive lesion is formed on a disc at or near the wall of the intervertebral disc when energy is delivered.