Spinal diagnostic methods and apparatus

• US 7,452,351 B2
• Filed: 04/16/2004
• Issued: 11/18/2008
• Est. Priority Date: 04/16/2004
• Status: Active Grant

• Current Assignee: Globus Medical, Inc.
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Campbell, Peter F., Miller, David R., Alamin, Todd
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Bouchelle; Laura A
• Application Number:
  US10/825,961
• Publication Number:
  US 20050234425A1
• Time in Patent Office: 1,677 Days
• Field of Search: 604/500, 604506-510, 604/96.01, 604/164.01, 604/164.04, 604/164.05, 604/164.06, 60416409-16411, 604/164.13, 604/264, 604/523, 604/528, 606/167, 606/185
• US Class Current: 604/506
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

Methods, devices and systems facilitate diagnosis, and in some cases treatment, of back pain originating in intervertebral discs. Methods generally involve introducing one or more substances into one or more discs using a catheter device. In one embodiments, a patient assumes a position that causes back pain, and a substance such as an anesthetic or analgesic is introduced into the disc to determine whether the substance relieves the pain. Injections into multiple discs may optionally be performed, to help pinpoint a disc as a sources of the patient'"'"'s pain. In some embodiments, the catheter device is left in place, and possibly coupled with another implantable device, to provide treatment of one or more discs. A catheter device includes at least one anchoring member for maintaining a distal portion of the catheter within a disc.

Claims

1. A method for introducing one or more substances into an intervertebral disc having a nucleus, the method comprising:

positioning a distal portion of a catheter device in the disc nucleus;

anchoring the distal portion of the catheter device in the nucleus after it has been positioned to maintain the distal portion in the disc nucleus so that the catheter device will remain in the nucleus upon movement of the patient;

causing the patient to assume a position in which substantial spinal pain is experienced;

introducing at least one substance into the disc nucleus through the catheter device while the distal portion remains anchored in the disc nucleus, wherein the at least one substance includes at least one anesthetic or analgesic; and

allowing the patient to move so that the distal end of the catheter would be pulled from the nucleus if it weren'"'"'t anchored.

2. A method as in claim 1, further comprising:

positioning a distal portion of a second catheter device in a second intervertebral disc;

anchoring the distal portion of the second catheter device to maintain the distal portion in the second disc; and

introducing at least one substance into the second disc through the second catheter device.

3. A method as in claim 2, further comprising,

causing the patient to assume a position in which substantial spinal pain is experienced, wherein the at least one substance includes at least one anesthetic or analgesic.

4. A method as in claim 3, further comprising determining which of the discs into which the at least one substance was introduced is causing the patient'"'"'s spinal pain.

5. A method as in claim 1, further comprising performing a discography procedure on the intervertebral disc before positioning the distal portion of the catheter device in the disc.

6. A method as in claim 1, further comprising performing a discography procedure on the intervertebral disc after introducing the at least one anesthetic or analgesic.

7. A method for introducing one or more substances into an intervertebral disc having a nucleus, the method comprising:

positioning a distal portion of a catheter device in the disc nucleus;

anchoring the distal portion of the catheter device in the nucleus after it has been positioned to maintain the distal portion in the disc nucleus so that the catheter device will remain in the nucleus upon movement of the patient;

introducing at least one substance into the disc nucleus through the catheter device while the distal portion remains anchored in the disc nucleus, wherein the at least one substance is introduced automatically over a period of time; and

allowing the patient to move so that the distal end of the catheter would be pulled from the nucleus if it weren'"'"'t anchored.

8. A method as in claim 7, further comprising recording one or more patient inputs describing back pain experienced by the patient.

9. A method for introducing one or more substances into an intervertebral disc having a nucleus, the method comprising:

positioning a distal portion of a catheter device in the disc nucleus;

anchoring the distal portion of the catheter device in the nucleus after it has been positioned to maintain the distal portion in the disc nucleus so that the catheter device will remain in the nucleus upon movement of the patient;

introducing at least one substance into the disc nucleus through the catheter device while the distal portion remains anchored in the disc nucleus;

allowing the patient to move so that the distal end of the catheter would be pulled from the nucleus if it weren'"'"'t anchored;

leaving the catheter device in position with the distal portion in the disc; and

administering the at least one substance over time to provide treatment of spinal pain.

10. A method as in claim 9, wherein at least one substance is administered over time via a subcutaneous injection port or implanted pump, the method further comprising coupling the catheter device to the subcutaneous injection port or implanted pump.

11. A method for identifying an intervertebral disc that is causing pain, the method comprising:

positioning a distal portion of a catheter device in a nucleus of a disc of a patient;

anchoring the distal portion of the catheter device in the disc nucleus after it has been positioned to maintain the distal portion in the disc nucleus;

instructing the patient to assume a position in which substantial spinal pain is experienced, wherein the patient assumes a position which would pull the distal end of the catheter from the disc nucleus if it weren'"'"'t anchored; and

introducing at least one analgesic or anesthetic into the disc through the catheter after the patient has assumed the position, wherein the patient observes whether the analgesic or anesthetic has reduced the pain experienced.

12. A method as in claim 11, wherein positioning the distal portion comprises passing the catheter device through a lumen of an introducer device.

13. A method as in claim 12, wherein positioning the catheter device comprises:

passing the catheter device through the lumen of the introducer device over a pointed stylet;

piercing through an annulus fibrosis of the disc using the stylet; and

withdrawing the stylet from the catheter device.

14. A method as in claim 12, wherein positioning the distal portion further comprises piercing through the annulus fibrosis into the disc with a tapered distal end of the catheter device.

15. A method as in claim 14, wherein positioning the distal portion further comprises passing the catheter device over a guidewire.

16. A method as in claim 12, wherein a distal end of the introducer device is advanced to a position within the disc before the catheter device is passed through the introducer device.

17. A method as in claim 16, wherein positioning the distal portion further comprises passing the catheter device over a guidewire.

18. A method as in claim 17, wherein the catheter device is passed through the introducer device over a guidewire.

19. A method as in claim 17, wherein the introducer device is removed over the guidewire before the catheter device is passed over the guidewire.

20. A method as in claim 11, wherein positioning the distal portion comprises visualizing at least one radiopaque marker or material at or near the distal portion to assess the location of the distal portion.

21. A method as in claim 11, wherein anchoring comprises deploying at least one anchoring member of the catheter device.

22. A method as in claim 21, wherein the at least one anchoring member is deployed on or near the distal portion of the catheter device.

23. A method as in claim 22, wherein anchoring comprises inflating at least a first expandable member in the disc.

24. A method as in claim 23, further comprising inflating at least a second expandable member adjacent an outer surface of the disc.

25. A method as in claim 11, wherein anchoring comprises deploying at least one mechanism along the distal portion of the catheter device to increase the effective cross-sectional diameter of the catheter at one or more locations.

26. A method as in claim 11, wherein anchoring comprises causing at least part of the distal portion to change from a substantially straight shape to a substantially curved or geometric shape.

27. A method as in claim 11, wherein anchoring comprises attaching part of the distal portion to an annulus fibrosis of the disc.

28. A method as in claim 11, further comprising introducing at least one substance comprises introducing a placebo substance into the disc.

29. A method as in claim 11, further comprising:

positioning a distal portion of a second catheter device in a second intervertebral disc;

anchoring the distal portion of the second catheter device to maintain the distal portion in the second disc; and

introducing at least one analgesic or anesthetic into the second disc through the second catheter device.

30. A method as in claim 29, further comprising, before or after introducing the at least one analgesic or anesthetic into the second disc, causing the patient to assume a position in which substantial spinal pain is experienced, wherein the patient observes where the position causes pain the second disc.

31. A method as in claim 30, further comprising determining which of the discs into which the at least one substance was introduced is causing the patient'"'"'s spinal pain.

32. A method as in claim 11, further comprising performing a discography procedure on the intervertebral disc.

33. A method as in claim 11, further comprising:

leaving the catheter device in position with the distal portion in the disc; and

administering at least one treatment substance over time to provide treatment of spinal pain.

34. A method as in claim 33, wherein at least one substance is administered over time via a subcutaneous injection port or implanted pump, the method further comprising coupling the catheter device to the subcutaneous injection port or implanted pump.

35. A method as in claim 11, wherein the at least one substance is introduced automatically over a period of time.

36. A method as in claim 11, further comprising recording one or more patient inputs describing back pain experienced by the patient.

37. A method as in claim 11, wherein the patient is instructed to perform a task.

38. A method as in claim 37, wherein the patient is instructed to bend over.