Method and apparatus for treating intervertebral discs

• US 6,517,568 B1
• Filed: 11/03/2000
• Issued: 02/11/2003
• Est. Priority Date: 08/13/1996
• Status: Expired due to Fees

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Oratec Interventions Incorporated
• Inventors: Sharkey, Hugh J., Saal, Jeffrey, Ashley, John, Saal, Joel
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/706,244
• Time in Patent Office: 830 Days
• Field of Search: 607/96, 607/98-102, 607/113, 607/154, 604/95, 606/7, 606/15, 606/16
• 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 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 comprising:

delivering energy from an energy delivery device to the intervertebral disc to treat the intervertebral disc, the energy being delivered such that a greater amount of energy is delivered to an annulus fibrosus of the intervetebral disc than to a center of the intervertebral disc.

2. A method according to claim 1 wherein the energy delivery device does not pass through a central region of a nucleus pulposus of the intertebral disc prior to delivering energy.

3. A method according to claim 1 wherein delivering energy includes delivering thermal energy or electromagnetic energy.

4. A method according to claim 1 wherein delivering energy includes delivering a controlled amount of energy adjacent such that no vaporization occurs adjacent an inner wall of the intervertebral disc.

5. A method according to claim 1 wherein delivering energy includes delivering a controlled amount of energy such that no material other than water is removed adjacent an inner wall of the intervertebral disc.

6. A method according to claim 1 wherein delivering energy includes delivering a controlled amount of energy such that no destructive lesion is formed adjacent an inner wall of the intertebral disc.

7. A method according to claim 1 wherein the energy delivery device is positioned adjacent an inner wall of the intervertebral disc when the energy is delivered.

8. A method according to claim 1 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 45-70°

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

9. A method according to claim 1 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 50°

C. for at least one minute.

10. A method according to claim 1 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 50°

C. for at least two minutes.

11. A method according to claim 1 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 55°

C. for at least three minutes.

12. A method of treating an intervertebral disc comprising:

providing a catheter having an energy delivery device adjacent a distal end of the catheter;

positioning the energy delivery device relative to the intervertebral disc; and

delivering energy from an energy delivery device to the intervertebral disc to treat the intervertebral disc, the energy being delivered such that a greater amount of energy is delivered to an annulus fibrosus of the intervertebral disc than to a center of the intervertebral disc.

13. A method according to claim 12 wherein positioning the energy delivery device relative to the intervertebral disc is performed such that the energy delivery device does not pass through a central region of a nucleus pulposus of the intervertebral disc prior to delivering energy.

14. A method according to claim 12 wherein positioning the energy delivery device relative to the intervertebral disc comprises positioning the energy delivery device such that the energy treats a member of the group consisting of:

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

15. A method according to claim 12 wherein positioning the energy delivery device relative to the intervertebral disc comprises positioning the energy delivery device adjacent a site of an annular fissure.

16. A method according to claim 12 wherein delivering energy includes delivering thermal energy or electromagnetic energy.

17. A method according to claim 12 wherein delivering energy includes delivering a controlled amount of energy adjacent such that no vaporization occurs adjacent an inner wall of the intervertebral disc.

18. A method according to claim 12 wherein delivering energy includes delivering a controlled amount of energy such that no material other than water is removed adjacent an inner wall of the intervertebral disc.

19. A method according to claim 12 wherein delivering energy includes delivering a controlled amount of energy such that no destructive lesion is formed adjacent an inner wall of the intervertebral disc.

20. A method according to claim 12 wherein the energy delivery device is positioned adjacent an inner wall of the intervertebral disc when the energy is delivered.

21. A method according to claim 12 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 45-70°

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

22. A method according to claim 12 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 50°

C. for at least one minute.

23. A method according to claim 12 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 50°

C. for at least two minutes.

24. A method according to claim 12 wherein the energy delivery device is sufficient to raise the temperature of a portion of the intervertebral disc to be treated to at least about 55°

C. for at least three minutes.