Apparatus for treating intervertebral discs with resistive energy

• US 6,122,549 A
• Filed: 06/24/1997
• Issued: 09/19/2000
• Est. Priority Date: 08/13/1996
• Status: Expired due to Term

• Current Assignee: NeuroTherm, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Oratec Interventions Incorporated
• Inventors: Le, Le T, Saal, Jeff, Sharkey, Hugh J., Ashley, John, Saal, Joel
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): CARTER, RYAN CHRISTOPHER
• Application Number:
  US08/881,525
• Time in Patent Office: 1,183 Days
• Field of Search: 607/96-102, 607/113, 607/116-117, 607/149, 600/373, 606/27-32
• US Class Current: 607/99
• 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 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 2018/00625 : 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

An externally guidable intervertebral disc apparatus manipulates disc tissue at a selected location of an intervertebral disc. The apparatus comprises a catheter having a distal end, a proximal end and a longitudinal axis. The catheter has an intradiscal section at its distal end. The intradiscal section is extendible into the disc, has sufficient rigidity to be advanceable through the nucleus pulposus and around the annulus fibrosus of the disc under a force applied longitudinally to the proximal end, has sufficient flexibility in a direction of the disc plane to be compliant with the inner wall, and has insufficient penetration ability to be advanceable out through the annulus fibrosus under the applied force. A thermal energy delivery device is located in the intradiscal section for preferentially heating the selected location of the disc. The apparatus is used to locally and controllably heat but not char or burn tissue in a disc. Such heat shrinks the collagen component.

Claims

1. An externally guidable intervertebral disc apparatus for manipulation of tissue at a selected location of an intervertebral disc, the apparatus comprising:

a proximal end for externally guiding a distal end of the apparatus within an intervertebral disc;

a self-navigating intradiscal section adjacent a distal end of the apparatus which navigates itself adjacent an inner wall of an annulus of the disc when the apparatus is extended into an intervertebral disc, the intradiscal section having (a) sufficient rigidity to be advanceable through a nucleus pulposus and around the inner wall of an annulus fibrosus under a force applied longitudinally to the proximal end of the apparatus, (b) insufficient penetration ability to be advanceable out through the annulus fibrosus under the applied force, and (c) sufficient flexibility in a direction of a disc plane to be compliant with the inner wall; and

a resistive energy delivery device incorporated into the apparatus adjacent the intradiscal section for preferentially heating the selected location of the disc.

2. The apparatus of claim 1, wherein at least a portion of the intradiscal section further has differential bending ability in two orthogonal directions at right angles to the longitudinal axis.

3. The apparatus of claim 2, wherein the differential bending ability is controlled by a structural element with different thicknesses in the two orthogonal directions.

4. The apparatus of claim 2, wherein the differential bending ability is maintained in a fixed orientation relative to the apparatus by a control element at the proximal end of the apparatus.

5. The apparatus of claim 1, wherein the intradiscal section has a length at least one-half the diameter of the nucleus pulposus.

6. The apparatus of claim 1, wherein the intradiscal section has a distal portion with a blunt tip.

7. The apparatus of claim 1, wherein the intradiscal distal tip has lower rigidity than a majority of the intradiscal section.

8. The apparatus of claim 1, wherein the intradiscal section has a directionally biased distal tip portion.

9. The apparatus of claim 1, wherein an electrical power supply is operably attached to the resistive energy delivery device through the apparatus.

10. The apparatus of claim 1, wherein the apparatus includes a plurality of resistive energy delivery devices.

11. The apparatus of claim 1, wherein intradiscal section has at least one sensor capable of monitoring temperature, power, voltage, or a combination thereof, and thereby controlling heating.

12. The apparatus of claim 11, wherein information from the sensor controls power delivered to the resistive energy delivery device.

13. The apparatus of claim 1, wherein at least a portion of the apparatus is radiographically opaque.

14. The apparatus of claim 1, wherein the intradiscal section of the apparatus is configured to have at least two radii of curvature when advanced around the annulus.

15. The apparatus of claim 1, wherein the apparatus includes an irrigation lumen extending from a proximal end of the apparatus to the intradiscal section.

16. The apparatus of claim 1, wherein intradiscal section of the apparatus has one or more flat sides.

17. The apparatus of claim 1, wherein the resistive energy delivery device is located along one side of the intradiscal section.

18. The apparatus of claim 1, wherein the apparatus further comprises an introducer capable of entering the disc and through which the intradiscal section of the apparatus is capable of sliding.

19. The apparatus of claim 1, wherein the apparatus further comprises an active steering mechanism.

20. The apparatus of claim 1, wherein the intradiscal section comprises a helical support structure.

21. The apparatus 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.

22. The apparatus 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.

23. The apparatus 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.

24. The apparatus of claim 23, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

25. The apparatus of claim 23, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

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

27. The apparatus of claim 26, wherein the proximal end of the apparatus has a column strength between about 0.1-25 kg.

28. The apparatus of claim 26, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

29. The apparatus of claim 26, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

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

31. The apparatus of claim 30, wherein the proximal end of the apparatus has a column strength between about 0.1-25 kg.

32. The apparatus of claim 30, wherein the proximal end of the apparatus has a column strength between about 0.2-7 kg.

33. The apparatus of claim 30, wherein the proximal end of the apparatus has a column strength between about 0.7-4 kg.

34. The apparatus of claim 1, wherein the resistive energy delivery device is capable of delivering a controlled amount of energy such that no vaporization occurs when energy is delivered by the resistive energy delivery device.

35. The apparatus of claim 1, wherein the resistive energy delivery device is capable of delivering a controlled amount of energy at such that no material other than water is removed when energy is delivered by the resistive energy delivery device.

36. The apparatus of claim 1, wherein the resistive energy delivery device is capable of delivering a controlled amount of energy such that no destructive lesion is formed on a disc when energy is delivered by the resistive energy delivery device.

37. An intervertebral disc apparatus, comprising:

a catheter including a self-navigating intradiscal section with a resistive energy delivery device,

wherein the intradiscal section has sufficient column strength to be advanceable through a nucleus pulposus of an intervertebral disc and to be navigable along an inner wall of an annulus fibrosus, a low enough flexural strength in an axial plane of the intervertebral disc, and a sufficient flexural strength in oblique and cephalo-caudal planes to be constrained within the axial plane.