Devices for disc herniation repair and methods of use

Abstract

Devices and methods for fixing defects in the anulus fibrosus (vertebral disc) of a patient are described. The devices a mesh patch; first, second, third, and fourth sutures; and first, second, third, and fourth anchors. Each anchor has a first portion adapted for insertion into a bone and a second portion having an opening. The sutures are disposed through the openings of the anchors. The first portions of the first and second anchors are inserted into a cranial vertebra. The first portions of the third and fourth anchors are inserted into a caudal vertebra. The mesh patch is positioned adjacent the defect. An end of first suture can be attached to an end of the third suture. An end of the second suture can be attached to an end of the fourth suture. The other ends of each of the first, second, third, and fourth sutures can then be anchored.

1 . A device for fixing a defect in the anulus fibrosus of a patient, comprising:
 a body adapted for insertion into the defect;   a mesh patch;   first and second sutures, each having a first end and a second end, wherein the first end is adapted for coupling to the mesh patch; and   first and second anchors, each having a first portion adapted for insertion into a bone and a second portion having an opening, wherein the opening of the first anchor is adapted to receive the first suture and the opening of the second anchor is adapted to receive the second suture.   
     
     
         2 . The device of  claim 1 , wherein the body is made from a material selected from the group consisting of cells, extracellular matrix, and cytokines. 
     
     
         3 . The device of  claim 2 , wherein the cells are selected from a group consisting of mesenchymal stems cells, fibroblasts, fibrocytes, cartilage cells, cells harvested from the annulus fibrosus, cells harvested from the nucleus pulposus, autograft cells, allograft cells, and xenograft cells. 
     
     
         4 . The device of  claim 3 , wherein the cells are prepared using tissue culture methods. 
     
     
         5 . The device of  claim 2 , wherein the extracellular matrix is selected from the group consisting of collagen scaffolds, autograft scaffolds, allograft scaffolds, and xenograft scaffolds. 
     
     
         6 . The device of  claim 2 , wherein the cytokines are selected from the group consisting of bone morphogenic proteins, recombinant growth hormone, vascular endothelial growth factor, platelet derived growth factor, transforming growth factor-beta, fibroblastic growth factor, insulin-like growth factor, granulocyte colony stimulating factor, macrophage colony stimulating factor, and epidermal growth factor. 
     
     
         7 . The device of  claim 6 , wherein the bone morphogenic protein is selected from the group consisting of BMP1, BMP2, BMP3, BMP4, BMP5, BMP6, BMP7, BMP8, BMP9, BMP10, BMP11, BMPI2, BMP13, BMP14, BMP15, BMP16, BMP17, BMP18, BMP19, and BMP20. 
     
     
         8 . The device of  claim 6 , wherein the Platelet derived growth factor is selected from the group consisting of rhPDGF-AA and rhPDGF-BB. 
     
     
         9 . The device of  claim 6 , wherein the fibroblastic growth factor is selected from the group consisting of rhaFGF and rhbFGF. 
     
     
         10 . The device of  claim 6 , wherein the granulocyte colony stimulating factor is selected from the group consisting of rhGM-CSF and rhG-CSF. 
     
     
         11 . The device of  claim 1 , wherein the body is soaked in a solution of BMP. 
     
     
         12 . The device of  claim 1 , wherein the body contains BMP in a dose of about 0.1 micrograms to about 30 mg. 
     
     
         13 . The device of  claim 1 , wherein the body contains BMP in a dose of at least about 0.1 micrograms. 
     
     
         14 . The device of  claim 1 , wherein the body is a collagen sponge. 
     
     
         15 . The device of  claim 1 , wherein the body is made from a natural polymer. 
     
     
         16 . The device of  claim 15 , wherein the natural polymer is selected from the group consisting of collagen, hyaluronans, chitosan, alignate, and other animal or plant-derived polysaccharides. 
     
     
         17 . The device of  claim 1 , wherein the body is made from a synthetic polymer. 
     
     
         18 . The device of  claim 17 , wherein the synthetic polymer is selected from the group consisting of poly(alpha-hydroxy acids), polyanhydrides, polyphosphazenes, polypropylene fumarate, polyethylene glycol-PLA, poloxamers, polyphosphate polymers, and their copolymers. 
     
     
         19 . The device of  claim 18 , wherein poly(alpha-hydroxy acids) is selected from the group consisting of polylactide, polyglycolide, and their copolymers. 
     
     
         20 . The device of  claim 1 , wherein the body is made from a composite of a natural and synthetic material. 
     
     
         21 . The device of  claim 1 , wherein the body is a tubular body having a proximal end, a distal end, and a lumen therethrough. 
     
     
         22 . The device of  claim 1 , wherein the body is a cylindrical body having a proximal end, a distal end, and a lumen therethrough. 
     
     
         23 . The device of  claim 1 , wherein the body comprises pores. 
     
     
         24 . The device of  claim 1 , further comprising an additional porous material adapted for insertion into the defect. 
     
     
         25 . The device of  claim 24 , wherein the additional porous material is a collagen sponge. 
     
     
         26 . The device of  claim 21 , wherein the tubular body further comprises a porous barrier disposed at any of the proximal opening, distal opening, or within the lumen of the tubular body. 
     
     
         27 . The device of  claim 21 , wherein the tubular body further comprises threads disposed on an outer surface of the tubular body. 
     
     
         28 . The device of  claim 1 , wherein the body is triangular in shape and has a proximal end, a distal end, and a lumen therethrough. 
     
     
         29 . The device of  claim 1 , wherein the body is elliptical in shape and has a proximal end, a distal end, and a lumen therethrough. 
     
     
         30 . The device of  claim 1 , wherein the body is coupled to the mesh patch. 
     
     
         31 . The device of  claim 27 , wherein the body is coupled to the mesh patch. 
     
     
         32 . The device of  claim 1 , further comprising:
 third and fourth sutures, each having a first end and a second end, wherein the first end is adapted for coupling to the mesh patch; and   third and fourth anchors, each having a first portion adapted for insertion into a bone and a second portion having an opening, wherein the opening of the third anchor is adapted to receive the third suture and the opening of the fourth anchor is adapted to receive the fourth suture.   
     
     
         33 . The device of  claim 1 , wherein the first and second sutures are attached to the mesh patch by welding the first ends of the first and second sutures to the mesh patch. 
     
     
         34 . The device of  claim 1 , wherein at least one of the first and second sutures further comprise a first end with an enlarged surface area adapted for coupling to the mesh patch. 
     
     
         35 . The device of  claim 34 , wherein a longest width of the enlarged surface area is longer than a diameter of the suture. 
     
     
         36 . The device of  claim 32 , wherein at least one of the third and fourth sutures further comprise a first end with an enlarged surface area adapted for coupling to the mesh patch. 
     
     
         37 . The device of claim.  1 , further comprising an anti-adhesion cover adapted to be connected to the mesh patch. 
     
     
         38 . The device of  claim 1 , further comprising a support structure having a body and first and second opening adapted to receive the first and second sutures, respectively. 
     
     
         39 . The device of  claim 1 , wherein the first and second sutures are slideably disposed within the openings of the first and second anchors, respectively. 
     
     
         40 . The device of  claim 1 , wherein the first and second sutures are fixedly attached to the first and second anchors, respectively. 
     
     
         41 . The device of  claim 1 , wherein the mesh patch is in the form of a shape selected from the group consisting of a rectangle, a square, a polygon, a circle, an ellipse, a oval, a planar disc, and a triangle. 
     
     
         42 . The device of  claim 37 , wherein the anti-adhesion patch is in the form of a shape selected from the group consisting of a rectangle, a square, a polygon, a circle, an ellipse, a oval, a planar disc, and a triangle. 
     
     
         43 . The device of  claim 1 , wherein the mesh patch comprises four corners and wherein the suture assembly is attached to each of the four corners of the mesh patch. 
     
     
         44 . The device of  claim 1 , wherein the first and second anchors are screws. 
     
     
         45 . The device of  claim 32 , wherein the third and fourth anchors are screws. 
     
     
         46 . The device of  claim 1 , wherein the first ends of the first and second sutures further comprise a transverse element adapted to anchor the first ends of the first and second sutures to the mesh patch. 
     
     
         47 .- 179 . (canceled)