Dural graft and method of preparing the same

Abstract

A dural graft is provided having improved stiffness characteristics relative to conventional dural substitutes. The dural graft can be formed from a collagen material having a stiffness between about 0.1 pounds per inch (lb./in.) and 0.25 lb./in. Relative to the collagen material forming conventional dural graft substitutes, the decreased stiffness of the collagen material of the present dural graft can provide the graft with a relatively improved or increased pliability. As a result of the increased pliability, the dural graft can sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The reduced stiffness of the collagen material can also provide for a relatively improved or increased flexibility or elasticity of the dural graft. The increased flexibility of the dural graft minimizes tearing of the graft when handled or manipulated during an implantation procedure.

1 . A dural graft, comprising:
 a bioimplantable dural graft having a size and shape suitable for placement to repair or replace a damaged meningeal membrane, the dural graft being formed of a collagen material having a stiffness in a range of about 0.01 pounds per inch to 0.25 pounds per inch.   
   
   
       2 . The dural graft of  claim 1 , wherein the collagen material has the stiffness in a range of about 0.04 pounds per inch to 0.12 pounds per inch. 
   
   
       3 . The dural graft of  claim 1 , wherein the collagen material comprises a substantially fluid impermeable material. 
   
   
       4 . The dural graft of  claim 1 , wherein the collagen material comprises a cross-linked collagen material having a plurality of pores, at least a portion of the pores having a diameter of less than about 10 micrometers. 
   
   
       5 . The dural graft of  claim 1 , further comprising at least one biological agent incorporated within the dural graft. 
   
   
       6 . The dural graft of  claim 5 , wherein the at least one biological agent is selected from the group consisting of an antibiotic, a growth factor, a hemostasis factor, an anti-adhesion agent, and an anti-cancer agent. 
   
   
       7 . The dural graft of  claim 1 , wherein the graft is configured to substantially conform to a curvature of a tissue at a site of implantation. 
   
   
       8 . A dural graft material, comprising:
 a first collagen layer having opposed surfaces; and   a second collagen layer disposed on at least a first surface of the first collagen layer, the second collagen layer having a stiffness in a range of about 0.01 pounds per inch to 0.25 pounds per inch.   
   
   
       9 . The dural graft material of  claim 8 , wherein the second collagen layer has the stiffness in a range of about 0.04 pounds per inch to 0.12 pounds per inch. 
   
   
       10 . The dural graft material of  claim 8 , wherein second collagen layer comprises a substantially fluid impermeable material. 
   
   
       11 . The dural graft material of  claim 8 , wherein the second collagen layer comprises a cross-linked collagen material having a plurality of pores, at least a portion of the pores having a diameter of less than about 10 micrometers. 
   
   
       12 . The dural graft material of  claim 8 , wherein the first collagen layer comprises a cross-linked collagen material having a plurality of pores, at least a portion of the pores having a diameter of less than about 10 micrometers. 
   
   
       13 . The dural graft material of  claim 8 , further comprising at least one biological agent incorporated within the dural graft material. 
   
   
       14 . The dural graft material of  claim 13 , wherein the at least one biological agent is selected from the group consisting of an antibiotic, a growth factor, a hemostasis factor, an anti-adhesion agent, and an anti-cancer agent. 
   
   
       15 . The dural graft material of  claim 8 , wherein the dural graft material is configured to substantially conform to a curvature of a tissue at a site of implantation.