Method for treating intervertebral disc degeneration

• US 6,095,149 A
• Filed: 06/24/1997
• Issued: 08/01/2000
• 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: Ashley, John, Sharkey, Hugh R., Saal, Joel, Saal, Jeffrey A.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/881,694
• Time in Patent Office: 1,134 Days
• Field of Search: 928/897, 928/898, 606/2, 606/15, 606/13-17, 607/89, 607/96
• US Class Current: 128/898
• 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 18/082 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
• 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
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments
• 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 2018/00625 : 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

Abstract

A percutaneous method treats degenerate disc disease characterized by a circumferential bulge. The method provides a catheter having a distal end, a proximal end, and a longitudinal axis, the distal end having an intradiscal section with at least one energy delivery device. The next step is applying a force longitudinally to the proximal end of the catheter which is sufficient to advance the intradiscal section through a nucleus pulposus and around an inner wall of an annulus, but which force is insufficient for the intradiscal section to puncture the annulus fibrosus. Next the energy delivery device is positioned at a selected location of the annulus by advancing or retracting the catheter and optionally twisting the proximal end of the catheter. The thermal energy delivery device is positioned adjacent the annulus and used to heat and stiffen the disc. Optionally, there is an additional step of adding a substance to reinforce the area. Optionally, access to the disc is provided by an introducer having an introducer lumen with an opening at a terminus of the introducer. An externally guidable intervertebral disc apparatus also is disclosed.

Claims

1. A method of treating an intervertebral disc comprising:

providing a catheter having an intradiscal section with at least one energy delivery device adjacent a distal end of the catheter and a proximal end for externally guiding the distal end of the catheter within an intevertebral disc;

positioning the energy delivery device at a selected location of the annulus by applying a force longitudinally to the proximal end of the catheter which is sufficient to advance the intradiscal section through a 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

causing the energy delivery device to supply sufficient energy to the selected location to stiffen the annulus.

2. The method of claim 1, wherein positioning the energy delivery device further comprises twisting the proximal end of the catheter.

3. The method of claim 1, advancing the catheter comprises advancing the catheter in a plane of the disc.

4. The method of claim 1, wherein positioning effectively locates the energy delivery device at a location selected from the group consisting of a posterior lateral, posterior medial, and anterior medial portion of the annulus fibrosus, or a combination thereof.

5. The method of claim 1, wherein positioning is preceded by

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 so that the distal end of the introducer is inside the annulus; and

slidably positioning the catheter in the introducer lumen.

6. The method of claim 1, wherein the step of causing the energy delivery device to supply sufficient energy comprises adding energy sufficient to shrink and stiffen the collagen component of the annulus fibrosus.

7. The method of claim 1, wherein positioning and causing the energy delivery device to supply sufficient energy are repeated at least once.

8. The method of claim 7, wherein positioning and causing the energy delivery device to supply sufficient energy are repeated until the entire disc circumference is treated.

9. The method of claim 1, wherein the step of providing a catheter further includes providing a catheter with a lumen capable of delivering or aspirating a material.

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

11. The method of claim 10 wherein the step of placing the material comprises placing a material selected from the group consisting of irrigation solutions, contrast media, pharmaceutical agents, chemonucleolytic enzymes, hydrogel, osteoinductive substances, chondrocyte-inductive substances, cements, adhesives, collagen, fibrinogen and thrombin, and combinations thereof.

12. The method of claim 11, wherein the step of placing a material is followed by the step of heating the material to seal it in place.

13. 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.

14. 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.

15. 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.

16. The method of claim 15, wherein the proximal end of the catheter has a column strength between about 0.2-7 kg.

17. The method of claim 15, wherein the proximal end of the catheter has a column strength between about 0.7-4 kg.

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

19. The method of claim 18, wherein the proximal end of the catheter has a column strength between about 0.1-25 kg.

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

21. The method of claim 18, wherein the proximal end of the catheter has a column strength between about 0.7-4 kg.

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

23. The method of claim 22, wherein the proximal end of the catheter has a column strength between about 0.1-25 kg.

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

25. The method of claim 22, wherein the proximal end of the catheter has a column strength between about 0.7-4 kg.

26. The method of claim 1, wherein the energy delivery device is capable of delivering a controlled amount of energy to the selected location such that no vaporization occurs at or near the selected location when energy is delivered by the energy delivery device.

27. The method of claim 1, wherein the energy delivery device is capable of delivering a controlled amount of energy to the selected location such that no material other than water is removed at or near the selected location when energy is delivered by the energy delivery device.

28. The method of claim 1, wherein the energy delivery device is capable of delivering a controlled amount of energy to the selected location such that no destructive lesion is formed on a disc at or near the selected location when energy is delivered by the energy delivery device.