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 .- 67 . (canceled)  
     
     
         68 . A catheter device for introducing one or more substances into an intervertebral disc, the device comprising: 
 an elongate flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating penetration of an annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and    at least one anchoring member disposed along the catheter body for anchoring at least part of the distal portion of the catheter in the intervertebral disc.    
     
     
         69 . A device as in  claim 68 , wherein the at least one anchoring member is disposed along the catheter body at or near the distal portion.  
     
     
         70 . A device as in  claim 68 , wherein the at least one anchoring member comprises at least one expandable member coupled with an inflation lumen.  
     
     
         71 . A device as in  claim 68 , wherein the at least one anchoring member comprises at least one shape memory, spring loaded or mechanically activated member for increasing the effective cross-sectional diameter of the catheter body at or near the distal portion.  
     
     
         72 . A device as in  claim 68 , wherein the at least one anchoring member comprises at least one outwardly buckling member coupled with an inner catheter shaft and an outer catheter shaft of the catheter body so as to outwardly buckle when the inner shaft is moved axially relative to the outer shaft.  
     
     
         73 . A device as in  claim 68 , wherein the at least one anchoring member comprises at least one attachment member for attaching to an annulus fibrosis of the disc.  
     
     
         74 . A device as in  claim 73 , wherein the attachment member comprises at least one threaded surface.  
     
     
         75 . A device as in  claim 73 , wherein the attachment member comprises at least one spiral needle.  
     
     
         76 . A device as in  claim 68 , wherein the at least one anchoring member comprises at least one deformable member to change at least part of the distal portion from a substantially straight shape to a substantially curved or geometric shape.  
     
     
         77 . A device as in  claim 68 , wherein the self-introducing distal portion comprises at least one pushable portion, the pushable portion having a stiffness greater than adjacent portions of the catheter body.  
     
     
         78 . A device as in  claim 77 , wherein the self-introducing portion further comprises a tapered distal end of the catheter device.  
     
     
         79 . A device as in  claim 68 , further comprising a pointed stylet removably disposed within a lumen of the catheter device for piercing through the annulus fibrosis of the disc.  
     
     
         80 . A device as in  claim 68 , wherein the stylet and catheter have self-coupling distal end to limit differential deflection.  
     
     
         81 . A device as in  claim 68 , wherein the catheter body comprises a friction resistant outer surface.  
     
     
         82 . A device as in  claim 68 , wherein an outer diameter of the catheter body is less than 2 mm.  
     
     
         83 . A device as in  claim 68 , wherein a cross-sectional diameter of the catheter body decreases along its length from a proximal end to a distal end.  
     
     
         84 . A device as in  claim 68 , wherein the catheter body comprises an outer surface having one or more markings for indicating depth of insertion of the catheter device into a patient's body.  
     
     
         85 . A device as in  claim 68 , wherein the catheter body comprises an outer surface having two or more different colors for indicating depth of insertion of the catheter device into a patient's body.  
     
     
         86 . A device as in  claim 68 , wherein the catheter body comprises at least one radiopaque marker or material for facilitating visualization of the catheter device in a patient.  
     
     
         87 . A device as in  claim 68 , further comprising: 
 an injection tube extending through at least part of the lumen of the catheter body for introducing one or more substances into the disc; and    an inflation tube extending through at least part of the lumen for expanding the deployable anchoring member.    
     
     
         88 . A device as in  claim 87 , wherein the inflation tube comprises a proximal septum to permit inflation with a needle.  
     
     
         89 . A device as in  claim 87 , further comprising: 
 wherein the injection tube is formed from a material selected from the group consisting of stainless steel, tempered stainless steel, annealed stainless steel, polymers, and superelastic alloys.    
     
     
         90 . A device as in  claim 87 , further comprising: 
 wherein the injection and inflation tubes exit a proximal end of the catheter body and are removably coupled with at least one adapter to provide for injection and inflation.    
     
     
         91 . A device as in  claim 87 , further comprising: 
 wherein the injection and inflation tubes extend through at least part of the catheter body lumen coaxially.    
     
     
         92 . A device as in  claim 87 , further comprising: 
 wherein the injection and inflation tubes extend through at least part of the catheter body lumen side-by-side.    
     
     
         93 . A device as in  claim 87 , further comprising: 
 wherein the injection and inflation tubes extend through part of the catheter body lumen coaxially and through another part of the lumen side-by-side.    
     
     
         94 . A device as in  claim 68 , wherein a proximal end of the proximal portion of the catheter body is bifurcated into two separate catheter body proximal ends.  
     
     
         95 . A device as in  claim 94 , wherein each of the two proximal ends is removably coupled with an adapter for facilitating injection or inflation via either end.  
     
     
         96 . A device as in  claim 68 , further comprising a guidewire having a distal end shaped to maintain the distal end within the disc.  
     
     
         97 . A device as in  claim 96 , wherein the distal end comprises at least one of a double-wire guidewire, a coil and a pigtail.  
     
     
         98 . A system for introducing one or more substances into an intervertebral disc, the system comprising: 
 an introducer device; and    a catheter device passable through the introducer device, the catheter device comprising: 
 an elongate flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating penetration of an annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and  
 at least one anchoring member disposed along the catheter body for anchoring at least part of the distal portion of the catheter in the disc.  
   
     
     
         99 . A system as in  claim 98 , further comprising a pointed stylet removably disposed within a lumen of the catheter device for piercing through the annulus fibrosis.  
     
     
         100 . A system as in  claim 98 , further comprising a guidewire over which the catheter device may be passed within the needle.  
     
     
         101 . A system as in  claim 98 , wherein the introducer device comprises an axially slit shaft covered with a frangible sheath.  
     
     
         102 . A system as in  claim 98 , wherein the at least one anchoring member is disposed along the catheter body at or near the distal end.  
     
     
         103 . A system as in  claim 98 , wherein the at least one anchoring member comprises at least one expandable member.  
     
     
         104 . A system as in  claim 98 , wherein the at least one anchoring member comprises at least one shape memory, spring loaded or mechanically activated member for increasing the effective cross-sectional diameter of the catheter body at or near the distal portion.  
     
     
         105 . A system as in  claim 98 , wherein the at least one anchoring member comprises at least one outwardly buckling member coupled with an inner catheter shaft and an outer catheter shaft of the catheter body so as to outwardly buckle when the inner shaft is moved axially relative to the outer shaft.  
     
     
         106 . A system as in  claim 98 , wherein the at least one anchoring member comprises at least one attachment member for attaching to an annulus fibrosis of the disc.  
     
     
         107 . A system as in  claim 106 , wherein the attachment member comprises at least one threaded surface.  
     
     
         108 . A system as in  claim 106 , wherein the attachment member comprises at least one spiral needle.  
     
     
         109 . A system as in  claim 98 , wherein the at least one anchoring member comprises at least one deformable member to change at least part of the distal portion from a substantially straight shape to a substantially curved or geometric shape.  
     
     
         110 . A device as in  claim 98 , wherein the self-introducing distal portion comprises at least one pushable portion, the pushable portion having a stiffness greater than adjacent portions of the catheter body.  
     
     
         111 . A device as in  claim 111 , wherein the self-introducing portion further comprises a tapered distal end of the catheter device.  
     
     
         112 . A system as in  claim 98 , wherein the catheter body comprises a friction resistant outer surface.  
     
     
         113 . A system as in  claim 98 , wherein an outer diameter of the catheter body is less than 2 mm.  
     
     
         114 . A system as in  claim 113 , wherein an inner diameter of the needle is between about 0.1 mm and about 0.01 mm larger than the outer diameter of the catheter body.  
     
     
         115 . A system as in  claim 98 , wherein the catheter body comprises an outer surface having one or more markings for indicating depth of insertion of the catheter device into a patient's body.  
     
     
         116 . A system as in  claim 98 , wherein the catheter body comprises an outer surface having two or more different colors for indicating depth of insertion of the catheter device into a patient's body.  
     
     
         117 . A system as in  claim 98 , wherein the catheter body comprises at least one radioopaque marker or material for facilitating visualization of the catheter device in a patient.  
     
     
         118 . A system as in  claim 98 , further comprising: 
 an injection tube extending through at least part of the lumen of the catheter body for introducing one or more substances into the disc; and    an inflation tube extending through at least part of the lumen for expanding the deployable anchoring member.    
     
     
         119 . A system as in  claim 118 , wherein the injection lumen comprises a material selected from the group consisting of stainless steel, tempered stainless steel, annealed stainless steel, polymers, and superelastic alloys.  
     
     
         120 . A system as in  claim 118 , wherein the injection and inflation tubes exit a proximal end of the catheter body and are removably coupled with two separate adapters for facilitating injection and inflation, respectively.  
     
     
         121 . A system as in  claim 118 , wherein the injection and inflation tubes extend through at least part of the catheter body lumen coaxially.  
     
     
         122 . A system as in  claim 118 , wherein the injection and inflation tubes extend through at least part of the catheter body lumen side-by-side.  
     
     
         123 . A system as in  claim 118 , wherein the injection and inflation tubes extend through part of the catheter body lumen coaxially and through another part of the lumen side-by-side.  
     
     
         124 . A system as in  claim 98 , wherein a proximal end of the proximal portion of the catheter body is bifurcated into two separate catheter body proximal ends.  
     
     
         125 . A system as in  claim 124 , wherein each of the two proximal ends is coupled with removably coupled with an adapter for facilitating injection or inflation via either end.  
     
     
         126 . A system as in  claim 98 , wherein the guidewire comprises a curved tip for maintaining a distal portion of the guidewire within the disc.  
     
     
         127 . A system as in  claim 98 , wherein the guidewire comprises at least one attachment member for attaching to an annulus fibrosis of the intervertebral disc to maintain a distal portion of the guidewire within the disc.  
     
     
         128 . A system as in  claim 98 , further comprising an implantable pump for coupling with the catheter device for introducing one or more substances into the disc over time.  
     
     
         129 . A system as in  claim 98 , further comprising an implantable injection port for coupling with the catheter device for introducing one or more substances into the disc over time.  
     
     
         130 . A system as in  claim 98 , further comprising an automatic injection device removably coupled with the catheter device for automatically introducing the at least one substance into the disc.  
     
     
         131 . A system as in  claim 130 , further comprising a recording device for recording patient inputs describing pain felt by a patient.  
     
     
         132 . A kit for introducing one or more substances into an intervertebral disc, the kit comprising: 
 a catheter device comprising: 
 an elongate flexible catheter body having a proximal portion, a self-introducing distal portion for facilitating penetration of an annulus fibrosis of the disc, and at least one lumen for introducing one or more substances into the intervertebral disc; and  
 at least one anchoring member disposed along the catheter body at or near the distal portion for anchoring at least part of the distal portion of the catheter in the disc;  
   at least one implantable device removably couplable with the catheter device for introducing the one or more substances into the disc over time; and    instructions for using the catheter device and implantable device.    
     
     
         133 . A kit as in  claim 132 , wherein the implantable device comprises a pump.  
     
     
         134 . A kit as in  claim 132 , wherein the implantable device comprises an injection port.  
     
     
         135 . A kit as in  claim 132 , further comprising an introducer device for facilitating positioning of the catheter device in the disc.  
     
     
         136 . A kit as in  claim 135 , further comprising a pointed stylet removably disposed within a lumen of the catheter device for piercing through the annulus fibrosis.  
     
     
         137 . A kit as in  claim 135 , further comprising a guidewire passable through the needle.