Cell encapsulation loading device

Abstract

The present invention provides a loading fixture for loading cells, cell clusters, and media to an immune-isolation device. The loading fixture permits the loading of cells into the immune-isolation device without manual manipulation of the immune-isolation device, until the loading device is opened at the point of use, thereby minimizing the risk of contamination of the immune-isolation device.

What is claimed is: 
     
         1 . A method of preparing immune-isolation devices, comprising:
 providing a loading system comprising:
 a base having a base bottom surface and a base wall extending from the base bottom surface to form a cavity, 
 an inlet conduit positioned on the base and extending there through into the cavity, and 
 a disk lid removably attachable to the base to seal the cavity; 
   coupling an immune-isolation device comprising an inlet tube attached to a pouch, to the inlet conduit positioned on the base within the cavity;   sealing the cavity with the disk lid;   filling the pouch of the immune-isolation device with cells via the inlet conduit;   filling the cavity with cell media; and   sealing the inlet tube.   
     
     
         2 . The method of  claim 1 , further comprising wetting the immune-isolation device prior to filling the pouch. 
     
     
         3 . The method of  claim 1 , further comprising sterilizing the loading system. 
     
     
         4 . The method of  claim 3 , wherein sterilizing comprises at least one of gamma sterilization, e-beam sterilization, and ethylene oxide sterilization. 
     
     
         5 . The method of  claim 2 , further comprising introducing saline through an opening in the disk lid. 
     
     
         6 . The method of  claim 5 , further comprising introducing saline without pumps or pressure. 
     
     
         7 . The method of  claim 5 , further comprising introducing an alcohol through the inlet conduit. 
     
     
         8 . The method of  claim 7 , further comprising allowing the alcohol and saline to equilibrate. 
     
     
         9 . The method of  claim 7 , further comprising removing a portion of the alcohol through the inlet conduit. 
     
     
         10 . The method of  claim 9 , further comprising coupling a saline source to the inlet conduit, and coupling a pump to a hole in the disk lid. 
     
     
         11 . The method of  claim 10 , further comprising drawing saline from the saline source by reducing pressure with the pump. 
     
     
         12 . The method of  claim 11 , further comprising sealing the loading system, and allowing the loading system to equilibrate. 
     
     
         13 . The method of  claim 11 , further comprising coupling a cell and media source to the inlet conduit. 
     
     
         14 . The method of  claim 11 , further comprising drawing cell and media from the cell and media source by reducing pressure with the pump. 
     
     
         15 . The method of  claim 14 , further comprising sealing the immune-isolation device. 
     
     
         16 . The method of  claim 15 , wherein sealing the immune-isolation device comprises inserting a barb into the inlet tube with a plunger pusher assembly. 
     
     
         17 . The method of  claim 16 , engaging a first feature on the base bottom surface outside the cavity with a second feature such that the loading system is stabilized during transportation. 
     
     
         18 . The method of  claim 16 , wherein the loading system further comprises a blade having an edge slidably disposed within the cavity of the base and configured to slide in front of the inlet conduit, and sliding the blade to cut the inlet tube of the immune-isolation device. 
     
     
         19 . The method of  claim 18 , wherein the blade is part of a blade assembly slidably located in the cavity of the base, and wherein the blade assembly is configured to interact ratchedly with the disk lid. 
     
     
         20 . The method of  claim 19 , wherein removing the disk lid exposes the immune-isolation device. 
     
     
         21 . The method of  claim 20 , wherein removing the disk lid facilitates the sliding of the blade to cut the inlet tube of the immune-isolation device.