Systems and Methods for Applying Cross-Linked Mechanical Barriers

Abstract

A delivery device applies a biocompatible and biodegradable barrier material to a tissue region, e.g., to seal a vascular puncture site. The material comprises two liquid components, which are pre-packaged in individual dispensers. Upon mixing, the liquid components cross-link to create a barrier matrix. A holder attaches to the delivery device. The holder mutually supports the first and second dispensers while the protein solution and polymer solution are conveyed from the dispensers into a fluid delivery channel. The protein and polymer solutions mix as a result of flow through the channel.

1 . A biocompatible and biodegradable material applied to seal a vascular puncture comprising a mixture of protein solution and a polymer solution comprising poly(ethylene glycol)(PEG) with a functionality of at least three, wherein, upon mixing, the protein solution and the polymer solution cross link to form a solid matrix that seals the vascular puncture without use of a photo initiator and ultraviolet light energy. 
   
   
       2 . A material according to  claim 1 , wherein the protein solution has a pH value of between about 8 and about 10. 
   
   
       3 . A material according to  claim 1 , wherein the PEG has a molecular weight of between about 10,000 and 15,000 g/mole. 
   
   
       4 . A material according to  claim 1 , wherein the PEG comprises a multi armed polymer structure. 
   
   
       5 . A material according to  claim 1 , wherein PEG comprises a compound having the formula PEG (DCR CG)n, where PEG is poly(ethylene glycol), DCR is a degradation control region, CG is a cross linking group, and n is equal to or greater than three. 
   
   
       6 . A material according to  claim 5 , wherein the compound comprises a multi armed polymer structure. 
   
   
       7 . A material according to  claim 5 , wherein the PEG comprises a  4  arm PEG, the degradation control region comprises glutaric acid, and the cross linking group includes a N hydroxysuccinimide ester. 
   
   
       8 . A material according to  claim 1 , wherein the PEG has a functionality of four. 
   
   
       9 . A material according to  claim 1 , wherein the PEG has a concentration that ranges from about 5% to about 35% w/w.