Devices for Injecting a Curable Biomaterial into an Intervertebral Space

Abstract

A vented needle is provided for sealably injecting biomaterial into an intradiscal space interiorly of the annulus of a spinal disc and for providing an exhaust for the intradiscal space. The vented needle comprises a compressible seal body for pressing against an outer surface of the annulus, and a needle extending through the seal. The needle may be configured to connect to a syringe for pressure injection of the biomaterial. The seal includes a vent extending therethrough with an opening for communication with the intradiscal space and an opening for the discharge of excess biomaterial filling the intradiscal space. A kit of parts is also provided for use in the treatment of a spinal disc, the kit comprising the vented needle and an inflatable trial device. The trial device is removably introduced into the intradiscal space and inflated to determine the available size of said intradiscal space.

1 - 20 . (canceled)  
     
     
         21 . A kit of parts for use in the treatment of a damaged or diseased spinal disc between two opposing vertebral bodies, the disc having an inner nucleus pulposus and an outer annulus, the kit comprising: 
 a needle assembly including a seal body and a needle extending therethrough, said seal body having a compressible portion and adapted to be compressibly placed against the exterior surface of said annulus adjacent an opening formed through said annulus, said needle having a distal portion projecting from said seal body and adapted to be inserted into said annulus opening in communication with said intradiscal space, said needle having a proximal portion projecting from said seal body and adapted to receive biomaterial thereinto; and    an inflatable trial device adapted to be removably introduced into said intradiscal space and inflated therein with a medium capable of determining the size of said intradiscal space created by the removal of at least a portion of said nucleus pulposus.    
     
     
         22 . The kit of parts according to  claim 21 , wherein said inflatable trial device is a compliant trial balloon.  
     
     
         23 . The kit of parts according to  claim 22 , wherein said medium is a contrast medium capable of visualization under fluoroscopy.  
     
     
         24 . The kit of parts according to  claim 21 , wherein said needle assembly further includes a vent tube projecting through said seal body and adapted to communicate with and exhaust said intradiscal space and to allow biomaterial to seep out when said intradiscal space is substantially filled.  
     
     
         25 . The kit of parts according to  claim 24 , further including an inflatable distraction device adapted to be removably introduced into said intradiscal space and inflated therein to cause said opposed vertebral bodies to be separated further apart.  
     
     
         26 . The kit of parts according to  claim 25 , wherein said inflatable distraction device is a non-compliant balloon adapted to provide a limit to lateral expansion but to allow further expansion in the direction of said opposing vertebral bodies.  
     
     
         27 . The kit of parts according to  claim 21 , further including a quantity of curable biomaterial, said biomaterial adapted to be introduced into said needle in liquid form.  
     
     
         28 . The kit of parts according to  claim 27 , wherein said biomaterial comprises a polymer and a crosslinker adapted to be mixed together prior to being introduced into said needle.  
     
     
         29 . The kit of parts according to  claim 28 , further including a mixing device adapted to mix said polymer and said crosslinker.  
     
     
         30 . The kit of parts according to  claim 27 , further including an inflatable distraction device adapted to be removably introduced into said intradiscal space and inflated therein to cause said opposed vertebral bodies to be separated further apart.