Method and apparatus for use of a vacuum package for allograft material

Abstract

A method for reconstituting and delivering an allograft material is provided. A first container holds the allograft and maintains the allograft material at a vacuum and provides favorable negative pressure during reconstitution of the allograft. A reconstituting liquid is delivered to the allograft to reconstitute the allograft.

1 . A method of delivering an implantable substrate to a surgical area comprising: 
 providing a first container defining a chamber having a substrate therein and a sealing device;    maintaining a negative pressure within the chamber by housing the first container in a second container;    engaging the sealing device with a reconstituting delivery device; and    delivering a reconstituting liquid into the first container while preventing the introduction of significant amounts of gasses into the first container.    
     
     
         2 . The method of  claim 1 , further comprising: 
 removing the first container from the second container; and    opening the sealing device.    
     
     
         3 . The method of  claim 2 , wherein opening the sealing device includes removing a membrane from the first container.  
     
     
         4 . The method of  claim 1 , wherein the sealing device includes a valve for drawing the negative pressure on the chamber.  
     
     
         5 . The method of  claim 2 , wherein opening the sealing device includes opening a valve.  
     
     
         6 . The method of  claim 1 , wherein the sealing device is a gas permeable membrane.  
     
     
         7 . The method of  claim 1 , further comprising inserting a plunger into the first container.  
     
     
         8 . The method of  claim 1 , further comprising removing the substrate from the first container.  
     
     
         9 . The method of  claim 1 , wherein a plunger seal is interposed between the sealing device and the substrate within the first container.  
     
     
         10 . The method of  claim 9 , wherein the first container defines at least a part of a pressure boundary and the pressure boundary is adapted to maintain the negative pressure.  
     
     
         11 . The method of  claim 9 , wherein the sealing device defines at least a part of the pressure boundary.  
     
     
         12 . The method of  claim 1 , wherein engaging the sealing device with the reconstituting delivery device includes piercing the sealing device.  
     
     
         13 . The method of  claim 1 , wherein engaging the sealing device with the reconstituting delivery device includes coupling the sealing device with leur fitting.  
     
     
         14 . The method of  claim 1 , wherein delivering the reconstituting liquid includes injecting the reconstituting liquid into the first container through a leur fitting.  
     
     
         15 . The method of  claim 1 , wherein delivering the reconstituting liquid includes injecting the reconstituting liquid into the first container through a hypodermic needle.  
     
     
         16 . The method of  claim 1 , wherein the second container is a sealed bag.  
     
     
         17 . The method of  claim 1 , wherein the second container is a glass jar.  
     
     
         18 . A method of hydrating an implantable substrate for delivery to a surgical area comprising: 
 providing a first container defining a chamber having a substrate therein and a sealing device;    maintaining a negative pressure within the chamber by housing the first container in a second container;    engaging the sealing device with a reconstituting delivery device containing a reconstituting liquid; and    drawing the reconstituting liquid into the first container to cause a localized pressure increase across the substrate; and    instantaneously reconstituting the substrate by delivering the reconstituting liquid into the first container where there is a pressure differential across the substrate while preventing the introduction of significant amounts of gasses into the first container.    
     
     
         19 . The method of  claim 18 , wherein engaging the sealing device with the reconstituting delivery device includes coupling the sealing device with a leur fitting.  
     
     
         20 . The method of  claim 18 , wherein the sealing device includes a valve for drawing a negative pressure on the chamber to pressurize the substrate.  
     
     
         21 . The method of  claim 18 , wherein the sealing device defines at least part of the first container.  
     
     
         22 . The method of  claim 18 , wherein engaging the sealing device with the reconstituting delivery device includes piercing the sealing device.  
     
     
         23 . A method of hydrating an implantable substrate for delivery to a surgical area comprising: 
 providing a first container defining a chamber having an allograft therein and a sealing device defining at least part of the first container;    maintaining a negative pressure within the chamber by housing the first container in a second container;    engaging the sealing device with a reconstituting delivery device containing a reconstituting liquid comprising a platelet concentrate;    delivering the reconstituting liquid into the first container while preventing the introduction of significant amounts of gasses into the first container;    removing the first container from the second container and opening the sealing device;    removing the substrate from the first container; and    depositing the substrate at the surgical area.