Spinal Diagnostic Methods and Apparatus

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 embodiment, 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 source 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.

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;   introducing at least one substance into the disc nucleus through the catheter device while the distal portion remains anchored in the disc nucleus; 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 , wherein positioning the distal portion comprises passing the catheter device through a lumen of an introducer device. 
   
   
       3 . A method as in  claim 2 , 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.   
   
   
       4 . A method as in  claim 2 , wherein positioning the distal portion further comprises piercing through an annulus fibrosis of the disc with a tapered distal end of the catheter device. 
   
   
       5 . A method as in  claim 4 , wherein positioning the distal portion further comprises passing the catheter device over a guidewire. 
   
   
       6 . A method as in  claim 2 , wherein a distal end of the introducer device is advanced to a position in the disc before the catheter device is passed through the introducer device. 
   
   
       7 . A method as in  claim 6 , wherein positioning the distal portion further comprises passing the catheter device over a guidewire. 
   
   
       8 . A method as in  claim 7 , wherein the catheter device is passed through the introducer device over a guidewire. 
   
   
       9 . A method as in  claim 7 , wherein the introducer device is removed over the guidewire before the catheter device is passed over the guidewire. 
   
   
       10 . A method as in  claim 1 , 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. 
   
   
       11 . A method as in  claim 1 , wherein anchoring comprises deploying at least one anchoring member of the catheter device. 
   
   
       12 . A method as in  claim 11 , wherein the at least one anchoring member is deployed on or near the distal portion of the catheter device. 
   
   
       13 . A method as in  claim 12 , wherein anchoring comprises inflating at least a first expandable member in the disc. 
   
   
       14 . A method as in  claim 13 , further comprising inflating at least a second expandable member adjacent an outer surface of the disc. 
   
   
       15 . A method as in  claim 1 , wherein anchoring comprises deploying at least one mechanism on or near the distal portion of the catheter device to increase the effective cross-sectional diameter of the catheter at one or more locations. 
   
   
       16 . A method as in  claim 15 , wherein increasing the cross-sectional diameter comprises releasing one or more shape memory or spring loaded members from constraint. 
   
   
       17 . A method as in  claim 15 , wherein increasing the cross-sectional diameter comprises actuating one or more mechanical members of the catheter. 
   
   
       18 . A method as in  claim 15 , wherein increasing the cross-sectional diameter comprises moving an inner catheter shaft of the catheter device relative to an outer catheter shaft of the catheter device to cause one or more anchoring members to buckle outwards. 
   
   
       19 . A method as in  claim 1 , wherein anchoring comprises deforming at least part of the distal portion to change from a substantially straight shape to a substantially curved or geometric shape. 
   
   
       20 . A method as in  claim 1 , wherein anchoring comprises attaching part of the distal portion to an annulus fibrosis of the disc. 
   
   
       21 . A method as in  claim 20 , wherein attaching part of the distal portion to the annulus fibrosis comprises at least one of screwing, twisting and piercing the part of the attachment member into the annulus fibrosis. 
   
   
       22 . A method as in  claim 1 , wherein introducing the at least one substance comprises introducing at least one of an anesthetic; an analgesic; an antibiotic; a hydrating agent such as hypotonic saline, isotonic saline or hypertonic saline; a supportive agent such as a hydrogel, ethylene-vinyl alcohol copolymer, Dimethyl Sulfoxide or Tantalum; a prolotherapy agent such as sodium morrhuate, cod oil, phenol, minerals or ethyl alcohol; and other agents such as collagen, stem cells, Osteogenic Protein-1, ethanol, alcohol, steroids, radio-opaque contrast agents, ultrasound contrast agent, Bone Morphogenetic Protein (BMP), BMP-2, BMP-4, BMP-6, BMP-7, BMP-12, Serotonin 5-HT2A receptor inhibitors, LMP-1, TIMP-1, TGF-1, TGF-2, Rofecoxib, Ketorolac, Glucosamine, Chondroitin Sulfate, Dextrose, DMSO, non-steroidal anti-inflammatory drugs, ibuprofen, naprosyn, Bestra, Vioxx, Celebrex, indomethacin, botulinum toxin, capsaicin, vanilloid agonists, vanilloid antagonists, VR1, VRL-1, steroids, methylprednisolone or chymopapain. 
   
   
       23 . A method as in  claim 22 , wherein at least two different substances are introduced into the disc. 
   
   
       24 . A method as in  claim 1 , wherein introducing the at least one substance comprises introducing a placebo substance into the disc. 
   
   
       25 - 130 . (canceled)