Devices and methods for spine repair

Abstract

Surgical methods of repairing defects and deficiencies in the spine are disclosed. The methods involve delivering a single part in-situ polymerizing fluid to (i) close a weakened segment or fissure in the annulus fibrosus, (ii) strengthen the annulus, (iii) replace or augment the disc nucleus, or (iv) localize a disc prosthesis. The methods may include placing a delivery conduit adjacent to the repair site and providing a liquid tissue adhesive to bond to and repair a disc defect or deficiency

1 - 13 . (canceled) 
   
   
       14 . A method of reinforcing a spinal annulus, the method comprising the steps of:
 accessing the disc containing the annulus to be reinforced;   advancing a catheter in the annulus fibrosus in an orientation substantially parallel to and within two or more layers of the annulus;   introducing a wire or ribbon through the catheter, or deploying a balloon on the tip of the catheter, to create at least one of a pocket, a cavity, and a delamination within the annulus;   extending the pocket, cavity or delamination to at least partially circumnavigate the annulus;   introducing, through the same or another catheter, a tube for delivering a tissue adhesive; and   gradually withdrawing the tube and catheter while filling said pocket, cavity, or delamination to bind the two or more layers of the annulus with the tissue adhesive.   
   
   
       15 . The method of  claim 14 , further comprising allowing the adhesive to cure to form a hydrophilic implant within two or more layers of the pocket, cavity, or delamination. 
   
   
       16 . The method of  claim 15 , wherein the curable adhesive is characterized in being hydrophilic; reactive with functional groups normally found on tissue surfaces so as to bond to tissue; and capable of self-curing in the presence of water and in the absence of added reactive materials or chain extenders, to form a solid material adherent to at least one tissue surface. 
   
   
       17 . The method of  claim 14 , wherein the step of filling said pocket, cavity, or delamination with the tissue adhesive comprises inserting an injector through the tube into one or both of the annulus and the nuclear space; and injecting a controlled amount of the tissue adhesive. 
   
   
       18 . The method of  claim 17  wherein the injector is bendable. 
   
   
       19 . The method of  claim 17  wherein a tip of the injector is selectable for penetration of tissue or for sliding on a fissure plane. 
   
   
       20 . The method of  claim 17  wherein multiple injections of adhesive polymer are performed. 
   
   
       21 . The method of  claim 20  wherein the injector is moved between injections. 
   
   
       22 . The method of  claim 14  wherein the tissue adhesive is naturally liquid at room or body temperature. 
   
   
       23 . The method of  claim 14  wherein the tissue adhesive contains water or an aqueous solution in the range of about 5% to about 95% by volume. 
   
   
       24 . The method of  claim 14  wherein the tissue adhesive swells in body fluids. 
   
   
       25 . The method of  claim 14  wherein the tissue adhesive comprises a water-soluble polyether polyol. 
   
   
       26 . The method of  claim 28  wherein the excess polyisocyanate has a molecular weight less than about 1000 Daltons. 
   
   
       27 . (canceled) 
   
   
       28 . The method of  claim 14  wherein the tissue adhesive comprises branched polyether polyols with polyisocyanate caps and excess polyisocyanate. 
   
   
       29 . The method of  claim 14  wherein the defect repair is reinforcing comprises one or more of closing a tear, window or fissure in an annulus; re-connection between layers of an annulus. 
   
   
       30 . The method of  claim 17  wherein the injector further comprises visualization means. 
   
   
       31 . The method of  claim 17  wherein the injector detects pressure. 
   
   
       32 . The method of  claim 14  wherein the tissue adhesive comprises one or more of contrast or visualization media, electrolytes, volume-control polymers, fillers or reinforcing materials, pharmaceutical or therapeutic agents including disinfectants, and nucleolytic agents including enzymes and chemicals. 
   
   
       33 . (canceled) 
   
   
       34 . The method of  claim 14 , further comprising the step of filling a nuclear space with the tissue adhesive.