Systems and methods for preparing autologous fibrin glue

Abstract

The invention provides a system for preparing an autologous solid-fibrin web suitable for regenerating tissue in a living organism. The system includes a sealed primary container containing a separation medium and a low-density high-viscosity liquid. The separation medium is capable of separating red blood cells from plasma when the container contains blood and is centrifuged, and the primary container has a first pressure. The system further includes a sealed secondary container containing a calcium-coagulation activator. The secondary container has a second pressure that is less than the first pressure. The system also includes a transfer device having a cannula with a first end and a second end. The first and second ends are adapted to puncture the sealed primary and secondary containers in order to provide fluid communication between the first and second containers.

What is claimed is: 
     
         1 . A system for preparing an autologous solid-fibrin web, the system comprising
 a primary container containing plasma and a high-density, low-viscosity fluid;   a secondary container configured to receive the plasma from the primary container; and   a transfer device capable of providing fluid communication between the primary and secondary containers, and wherein a portion of the plasma moves to the secondary until the high-density, low viscosity fluid from the primary container enters the transfer device.   
     
     
         2 . The system of  claim 1 , wherein the secondary container is evacuated 
     
     
         3 . The system of  claim 2 , wherein the primary container has a first pressure, and wherein the secondary container has a second pressure that is less than the first pressure, and wherein the plasma in the primary container moves to the secondary container by pressure differentiation. 
     
     
         4 . The system of  claim 1 , wherein the secondary container includes an ionic coagulation activator. 
     
     
         5 . The system of  claim 4 , wherein the ionic coagulation activator is selected from calcium chloride, calcium fluoride, calcium carbonate, calcium gluconate, calcium fumarate, calcium pyruvate and combinations thereof. 
     
     
         6 . The system of  claim 1 , wherein the primary container further includes an anti-coagulant. 
     
     
         7 . The system of  claim 1 , wherein the secondary container includes one or more of an antibiotic, an analgesic, a cancer therapeutic, a platelet-growth factor and a bone morphogenic protein. 
     
     
         8 . The system of  claim 1 , wherein the primary container includes a separation medium for separating the plasma from other blood components in the primary container. 
     
     
         9 . The system of  claim 1 , wherein the transfer device includes a first needle assembly coupled to a second needle assembly, and wherein the first needle assembly extends in a first direction and the second needle assembly extends in a second direction opposite the first direction. 
     
     
         10 . The system of  claim 1 , wherein the primary container is in an inverted positioned when the plasma is transferred from the primary container to the secondary container. 
     
     
         11 . A system for preparing an autologous solid-fibrin web, the system comprising:
 a sealed primary container including a separation medium capable of separating red blood cells from plasma when the container is centrifuged;   a sealed secondary configured to receive the plasma from the primary container; and   a transfer device capable of providing fluid communication between the primary and secondary containers, the transfer device including
 a first needle assembly for puncturing the sealed primary container, and 
 a second needle assembly for puncturing the sealed secondary container. 
   
     
     
         12 . The system of  claim 11 , wherein the secondary container is evacuated. 
     
     
         13 . The system of  claim 12 , wherein the primary container has a first pressure, and wherein the secondary container has a second pressure that is less than the first pressure, and wherein the plasma in the primary container moves to the secondary container by pressure differentiation. 
     
     
         14 . The system of  claim 11 , wherein the secondary container includes an ionic coagulation activator. 
     
     
         15 . The system of  claim 14 , wherein the ionic coagulation activators selected from calcium chloride, calcium fluoride, calcium carbonate, calcium gluconate, calcium fumarate, calcium pyruvate and combinations thereof. 
     
     
         16 . The system of  claim 11 , wherein the primary container further contains an anti-coagulant. 
     
     
         17 . The system of  claim 11 , wherein the first needle assembly and the second needle assembly are each covered by an elastomeric sleeve being retractable when one of the first needle assembly and the second needle assembly punctures one of the primary container and the secondary container. 
     
     
         18 . The system of  claim 11 , wherein the secondary container includes one or more of an antibiotic, an analgesic, a cancer therapeutic, a platelet-growth factor and a bone morphogenic protein.