Method for treating intervertebral discs

• US 7,267,683 B2
• Filed: 11/14/2003
• Issued: 09/11/2007
• Est. Priority Date: 08/13/1996
• Status: Expired due to Term

• 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 T.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/712,063
• Publication Number:
  US 20040111136A1
• Time in Patent Office: 1,397 Days
• Field of Search: 607/96, 607 98-102, 607/117, 606/41, 606 47- 50, 128/898
• 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
• CPC Class Codes: A61B 2017/0011 : piezoelectric
• CPC Class Codes: A61B 2017/00119 : alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00261 : Discectomy
• CPC Class Codes: A61B 2017/00274 : Prostate operation, e.g. prostatectomy, turp, bhp treatment
• 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 for prostheses A61F2210/0014
• 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
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320008 : Scrapers
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• 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
• CPC Class Codes: A61B 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/0044 : Spinal cord
• CPC Class Codes: A61B 2018/00547 : Prostate
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00595 : Cauterization
• CPC Class Codes: A61B 2018/00625 : Vaporization
• CPC Class Codes: A61B 2018/00654 : with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/1266 : with DC current output
• CPC Class Codes: A61B 2018/1405 : Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1407 : Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2018/1472 : for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2090/0454 : by reflection
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3937 : Visible markers
• 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 treating an intervertebral disc, the method comprising:

inserting an introducer into an intervertebral disc having a contained disc herniation;

inserting a catheter through the introducer and into the intervertebral disc;

advancing a distal region of the catheter through a nucleus pulposus of the intervertebral disc to an inner wall of an annulus fibrosus by blunt dissection;

delivering radiofrequency (“

RF”

) energy to material of the intervertebral disc using an electrode disposed at the distal region of the catheter; and

removing the material with the delivered RF energy,

wherein removing material with the delivered RF energy reduces pressure in the intervertebral disc to treat the disc herniation.

2. The method of claims 1 wherein removing the material comprises removing water.

3. The method of claim 1 wherein removing the material with the delivered RF energy comprises ablating the material.

4. The method of claim 1 or 3 wherein removing the material comprises removing disc tissue.

5. The method of claim 1, 2, or 3 wherein advancing the distal region of the catheter through the nucleus pulposus comprises advancing the distal region along a curved path.

6. The method of claim 1, 2, or 3 wherein the introducer comprises a needle and inserting the introducer comprises inserting the needle.

7. The method of claim 6 further comprising inserting the needle and a trocar.

8. The method of claim 6 wherein inserting a needle comprises inserting a 17-gauge needle.

9. The method of claim 8 further comprising inserting the needle and a trocar.

10. The method of claim 1, 2, or 3 further comprising providing the catheter with a total length between 5 and 24 inches.

11. The method of claim 1, 2, or 3 wherein advancing the distal region of the catheter comprises advancing the catheter so that a maximum distance the catheter extends from the introducer is no greater than one and one-half times the circumference of the nucleus pulposus.

12. The method of claim 1, 2, or 3 wherein delivering RF energy comprises delivering RF energy from a bipolar electrode configuration.

13. The method of claim 1, 2, or 3 further comprising twisting the catheter after inserting the catheter into the intervertebral disc.

14. The method of claim 13 wherein advancing the distal region of the catheter through the nucleus pulposus comprises advancing the distal region along a curved path.

15. The method of claim 1, 2, or 3 further comprising heating the material to a temperature in a range of 45-70 degrees C. with the delivered RF energy.

16. The method of claims 1, 2, or 3 further comprising heating the material to a temperature of 55 degrees C. with the delivered RF energy.

17. The method of claims 1, 2, or 3 further comprising heating the material to a temperature of 65 degrees C. with the delivered RF energy.

18. The method of claim 1, 2, or 3 further comprising denervating at least a portion of the intervertebral disc with the delivered RF energy.

19. The method of claim 1, 2, or 3 wherein advancing the distal region comprises advancing the electrode beyond the introducer.

20. The method of claim 1, 2, or 3 wherein delivering RF energy comprises delivering RF energy to the inner wall of the annulus fibrosus.

21. The method of claim 1, 2, or 3 wherein delivering RF energy comprises delivering RF energy while the catheter is positioned at a location adjacent the inner wall of the annulus fibrosus.

22. The method of claim 1, 2, or 3 wherein delivering RF energy comprises delivering RF energy to multiple locations in the intervertebral disc using at least the electrode.

23. The method of claim 22 wherein delivering RF energy to multiple locations comprises delivering RF energy to the multiple locations simultaneously.

24. The method of claim 22 wherein delivering RF energy to multiple locations comprises:

delivering RF energy to at least a first of the multiple locations using the electrode; and

delivering RF energy to at least a second of the multiple locations using a second electrode.

25. The method of claim 22 wherein delivering RF energy to multiple locations comprises delivering RF energy to the multiple locations serially.

26. The method of claim 22 wherein delivering RF energy to multiple locations comprises delivering RF energy to the multiple locations using the electrode.

27. The method of claim 1, 2, or 3 further comprising advancing the catheter along the inner wall of the annulus fibrosus.

28. The method of claim 1 wherein advancing the distal region of the catheter comprises conforming the catheter sufficiently to the inner wall of the annulus fibrosus to contact multiple locations on the inner wall.