Biodegradable vascular grafts

Abstract

Disclosed herein are biodegradable scaffolds for in situ tissue engineering. In some examples, biodegradable vascular grafts and methods of fabricating and uses of such are disclosed. In some examples, a vascular graft includes a biodegradable scaffold including a biodegradable polyester tubular core, a biodegradable polyester electrospun outer sheath surrounding the biodegradable polyester tubular core and/or a thromboresistant agent, such as heparin, coating the biodegradable scaffold. The disclosed vascular grafts can be used for forming a blood vessel of less than 6 mm, including, but not limited to a coronary or peripheral arterial.

We claim: 
     
         1 . A vascular graft, comprising:
 a biodegradable scaffold comprising a biodegradable polyester tubular core comprising poly(glycerol sebacate) (PGS) and having small pores of about 1 μm to about 500 μm and comprising an inner lumen surface and an outer surface; and   a biodegradable polyester electrospun outer sheath surrounding the outer surface of the biodegradable polyester tubular core; and   wherein the vascular graft is cell-free.   
     
     
         2 . The vascular graft of  claim 1 , wherein the biodegradable polyester tubular core comprises a copolymer comprising the poly(glycerol sebacate) (PGS). 
     
     
         3 . The vascular graft of  claim 1 , wherein the biodegradable polyester tubular core consists essentially of the PGS. 
     
     
         4 . The vascular graft of  claim 1 , wherein the biodegradable polyester electrospun sheath comprises poly(caprolactone) (PCL). 
     
     
         5 . The vascular graft of  claim 1 , further comprising a thromboresistant agent coating the biodegradable scaffold. 
     
     
         6 . The vascular graft of  claim 1 , wherein the thromboresistant agent comprises heparin. 
     
     
         7 . The vascular graft of  claim 1 , wherein the thromboresistant agent coats the inner lumen surface of the biodegradable polyester tubular core. 
     
     
         8 . The vascular graft of  claim 1 , wherein at least 75% of the pores are interconnected. 
     
     
         9 . The vascular graft of  claim 1 , wherein at least 95% of the pores are interconnected. 
     
     
         10 . The vascular graft of  claim 1 , wherein at least 99% of the pores are interconnected. 
     
     
         11 . The vascular graft of  claim 1 , wherein the vascular graft has an inner diameter of between 700 μm to 5000. 
     
     
         12 . The vascular graft of  claim 1 , wherein the vascular graft has a wall thickness between 100 μm and 500 μm. 
     
     
         13 . The vascular graft of  claim 1 , wherein the biodegradable polyester electrospun outer sheath has a thickness between 5 μm and 30 μm. 
     
     
         14 . The vascular graft of  claim 1 , wherein at least 95% of the vascular graft degrades within 90 days of implantation. 
     
     
         15 . The vascular graft of  claim 1 , wherein the vascular graft is used for forming a blood vessel of less than 6 mm. 
     
     
         16 . The vascular graft of  claim 15 , wherein the vascular graft is used for forming a blood vessel of less than 4 mm. 
     
     
         17 . The vascular graft of  claim 1 , wherein the vascular graft is used as a coronary or a peripheral arterial graft. 
     
     
         18 . A method of forming a blood vessel in a subject, comprising:
 implanting the vascular graft of  claim 1  into a subject at a target location to form a conduit in which blood flows through the vascular graft.   
     
     
         19 . A method of fabricating a vascular graft, comprising:
 preparing a biodegradable polyester tubular core comprising poly(glycerol sebacate) (PGS) and having small pores of about 1 μm to about 500 μm and comprising an inner lumen surface and an outer surface;   surrounding the outer surface of the biodegradable polyester tubular core with a biodegradable polyester electrospun outer sheath; and   coating the inner luminal surface of the biodegradable polyester tubular core with a thromboresistant agent, thereby forming a biodegradable vascular graft, in which at least 75% of the vascular graft degrades within 90 days of implantation in a subject.   
     
     
         20 . A biodegradable scaffold that induces tissue regeneration without cell seeding of the scaffold prior to implantation into a subject's body, wherein the scaffold comprises a biodegradable polyester core comprising poly(glycerol sebacate) (PGS) and having small pores of about 1 μm to about 500 μm and a biodegradable polyester electrospun outer sheath surrounding the biodegradable polyester core; and a thromboresistant agent coating the biodegradable scaffold, thereby forming a composition that facilitates tissue regeneration.