Method and apparatus for treating annular fissures in intervertebral discs

• US 6,997,941 B2
• Filed: 03/17/2003
• Issued: 02/14/2006
• Est. Priority Date: 08/13/1996
• Status: Expired due to Fees

• 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., Le, Le Trong
• Primary Examiner(s): DAHBOUR, HENRY
• Application Number:
  US10/388,609
• Publication Number:
  US 20030181964A1
• Time in Patent Office: 1,065 Days
• Field of Search: 607/96, 607/113, 607/116, 607/98, 607/100, 607/101, 607/102, 607/117, 607/89, 607/99, 606/48, 606/50, 606/27, 606/28, 606/29, 606/30, 606/31, 606/32, 606/2, 606/13, 606/14, 606/41, 128/898, 600/373
• 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
• 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 2018/00577 : 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 device for treating an intervertebral disc, the device comprising:

an introducer including a needle, the introducer defining an introducer lumen, and the introducer having sufficient rigidity to penetrate an annulus fibrosus of an intervertebral disc; and

a catheter configured to be inserted through the introducer lumen and into the intervertebral disc, the catheter having a distal region including a bipolar radiofrequency electrode configuration, the distal region having sufficient column strength to be advanced by blunt dissection through a nucleus pulposus of the intervertebral disc to an inner wall of the annulus fibrosus and sufficient rigidity in a direction out of a disc plane of the intervertebral disc to substantially inhibit bending in the direction.

2. The device of claim 1 wherein the needle comprises a 17-gauge needle.

3. The device of claim 1 or 2 wherein the introducer comprises a trocar.

4. The device of claim 1 wherein the catheter has a proximal region and the catheter has sufficient torsional strength to transmit rotation applied at the proximal region to the distal region, with the distal region located in the nucleus pulposus of the intervertebral disc.

5. The device of claim 1 wherein the catheter has a total length between 5 and 24 inches.

6. The device of claim 1 or 5 wherein the catheter is configured to be extended from the introducer a maximum distance of no greater than one and one-half times the circumference of the nucleus pulposus.

7. The device of claim 1 or 5 wherein the distal region comprises a biased region that permits advancement of the catheter from the introducer into the intervertebral disc in substantially only one lateral direction relative to a longitudinal axis of the introducer.

8. The device of claim 7 wherein the catheter has a proximal region and the catheter has sufficient torsional strength to transmit rotation applied at the proximal region to the distal region, with the distal region located in the nucleus pulposus of the intervertebral disc.

9. The device of claim 1 wherein the direction out of the disc plane comprises a direction orthogonal to the disc plane.

10. The device of claim 1 wherein the direction out of the disc plane comprises a direction along an axis defined by a spinal column.

12. The device of claim 1 or 4 wherein the bipolar radiofrequency electrode configuration includes an active electrode and a return electrode, and the catheter further comprises a second active electrode.

13. The device of claim 1 wherein the catheter is further configured to conform sufficiently to the inner wall of the annulus fibrosus to contact multiple locations on the inner wall.

14. The device of claim 1 wherein the distal region of the catheter is configured to provide differential flexibility between the direction and at least one other direction.

15. The device of claim 14 wherein the catheter comprises a mandrel that provides the differential flexibility.

16. The device of claim 15 wherein at least a portion of the mandrel has a rectangular cross-section.

17. The device of claim 15 wherein at least a portion of the mandrel has a D-shaped cross-section.

18. The device of claim 15 wherein at least a portion of the mandrel has an oval cross-section.

19. The device of claim 2 wherein the catheter includes a sheath on at least a portion of an outer surface of the catheter.

20. The device of claim 19 wherein the sheath is formed of a polyimide material.

21. The device of claim 20 wherein the bipolar electrode configuration is disposed distal to a portion of the sheath.

22. The device of claim 21 wherein the catheter is configured to provide preferential localized heating so that water is removed from the nucleus pulposus.

23. The device of claim 21 further comprising a visible marker that is configured to show rotation of the catheter during use.

24. The device of claim 23 wherein the visible marker is disposed on a proximal end of the catheter.

25. The device of claim 2 further comprising a handle attached to a proximal end of the catheter, wherein the catheter includes a bend at the distal region and the handle includes a marker aligned with the bend.

26. The device of claim 25 wherein the catheter is adapted to be twisted at the handle to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration.

27. The device of claim 26 wherein the catheter is adapted to be advanced through the nucleus pulposus and is configured to remove nucleus tissue by application of RF energy.

28. The device of claim 2 further comprising a handle adapted to allow the device to be gripped during a procedure, and wherein (i) the device is configured so that the handle can be used to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration, and (ii) the device is configured to remove nucleus tissue by application of RF energy.

29. The device of claim 28 wherein the device is adapted to provide preferential local heating of the nucleus tissue.

30. The device of claim 29 wherein the preferential local heating of the nucleus tissue is adapted to remove at least water from the disc to decompress the disc.

31. The device of claim 2 wherein (i) the catheter includes a tube that provides stiffness to the catheter, (ii) the catheter includes a sheath disposed on at least a portion of the catheter, and (iii) a part of the radiofrequency electrode configuration is disposed distal to the sheath.

32. The device of claim 2 wherein an outer diameter of the catheter is between approximately 0.2 mm and approximately 5 mm.

33. The device of claim 32 wherein a total length of the catheter is between approximately 10 cm and approximately 60 cm.

34. The device of claim 33 wherein the total length of the catheter is between approximately 10 cm and approximately 30 cm.

35. The device of claim 34 wherein the catheter comprises a round metallic tube.

36. The device of claim 35 wherein one or more electrodes in the bipolar radiofrequency electrode configuration is disposed distal to the metallic tube.

37. The device of claim 36 wherein the catheter includes a polyimide sheath in addition to the metallic tube.

11. A kit for treating an intervertebral disc, the kit comprising:

a needle and a trocar; and

a catheter configured to be inserted through the needle and into the intervertebral disc, the catheter having a distal region including a bipolar radiofrequency electrode configuration, the distal region having sufficient column strength to be advanced by blunt dissection through a nucleus pulposus of the intervertebral disc to an inner wall of the annulus fibrosus and sufficient rigidity in a direction out of a disc plane of the intervertebral disc to substantially inhibit bending in the direction.

38. The kit of claim 11 wherein the catheter includes a sheath on at least a portion of an outer surface of the catheter.

39. The kit of claim 38 wherein the sheath is formed of a polyimide material.

40. The kit of claim 39 wherein the bipolar electrode configuration is disposed distal to a portion of the sheath.

41. The kit of claim 40 wherein the catheter is configured to provide preferential localized heating so that water is removed from the nucleus pulposus.

42. The kit of claim 41 wherein the catheter includes a visible marker that is configured to show rotation of the catheter during use.

43. The kit of claim 42 wherein the visible marker is disposed on a proximal end of the catheter.

44. The kit of claim 11 further comprising a handle attached to a proximal end of the catheter, wherein the catheter includes a bend at the distal region and the handle includes a marker aligned with the bend.

45. The kit of claim 44 wherein the catheter is adapted to be twisted at the handle to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration.

46. The kit of claim 44 wherein the catheter is adapted to be advanced through the nucleus pulposus and is configured to remove nucleus tissue by application of RF energy.

47. The kit of claim 11 further comprising a handle attached to the catheter that is adapted to allow the catheter to be gripped during a procedure, and wherein (i) the catheter is configured so that the handle can be used to adjust a position within the nucleus pulposus of one or more electrodes in the bipolar radiofrequency electrode configuration, and (ii) the device is configured to remove nucleus tissue by application of RF energy.

48. The kit of claim 47 wherein the catheter is adapted to provide preferential local heating of the nucleus tissue.

49. The kit of claim 48 wherein the preferential local heating of the nucleus tissue is adapted to remove at least water from the disc to decompress the disc.

50. The kit of claim 49 wherein (i) the catheter includes a tube that provides stiffness to the catheter, (ii) the catheter includes a sheath disposed on at least a portion of the catheter, and (iii) a part of the radiofrequency electrode configuration is disposed distal to the sheath.