Bioartificial pancreas

Abstract

A bioartificial device, such as a bioartificial pancreas, for implantation in a patient's vascular system. The bioartificial pancreas includes a scaffold adapted to engage an interior wall of a blood vessel, a cellular complex support by the scaffold and extending longitudinally within the interior cavity of the scaffold so as to be exposed to the blood flow when the scaffold is engaged with the blood vessel, the cellular complex support comprising one or more pockets bordered by thin film; and cellular complex comprising pancreatic islets disposed in the one or more pockets, the thin film being adapted to permit oxygen and glucose to diffuse from flowing blood into the one or more pockets at a rate sufficient to support the viability of the islets. The invention also includes methods of making and using a bioartificial pancreas.

What is claimed is: 
     
         1 . A bioartificial pancreas comprising:
 a scaffold adapted to engage an interior wall of a blood vessel, the scaffold comprising a blood flow lumen extending longitudinally through an interior cavity of the scaffold so as to permit blood flow therethrough when the scaffold is engaged with the blood vessel;   a cellular complex support by the scaffold and extending longitudinally within the interior cavity of the scaffold so as to be exposed to the blood flow when the scaffold is engaged with the blood vessel, the cellular complex support comprising one or more pockets bordered by thin film; and   cellular complex comprising pancreatic islets disposed in the one or more pockets, the thin film being adapted to permit oxygen and glucose to diffuse from flowing blood into the one or more pockets at a rate sufficient to support the viability of the islets.   
     
     
         2 . The bioartificial pancreas of  claim 1  wherein the cellular complex support has a thickness from 0.30 mm to 1.0 mm when loaded with the cellular complex. 
     
     
         3 . The bioartificial pancreas of  claim 1  wherein the cellular complex support further comprises an attachment region adjacent the one or more pockets, the cellular complex support being attached to the scaffold at the attachment region. 
     
     
         4 . The bioartificial pancreas of  claim 3  further comprising a thermal bond between the attachment region and the scaffold attaching the cellular complex support to the scaffold. 
     
     
         5 . The bioartificial pancreas of  claim 3  further comprising a suture attaching the cellular complex support to the scaffold. 
     
     
         6 . The bioartificial pancreas of  claim 3  further comprising a pressure bond between the attachment region and the scaffold attaching the cellular complex support to the scaffold. 
     
     
         7 . The bioartificial pancreas of  claim 3  wherein the cellular complex support further comprises a plurality of attachment regions adjacent a plurality of pockets, with cellular complex comprising islets being disposed in each pocket. 
     
     
         8 . The bioartificial pancreas of  claim 1  wherein the cellular complex support comprises two microporous thin film layers. 
     
     
         9 . The bioartificial pancreas of  claim 8  wherein each microporous layer comprises a plurality of pores each having a diameter less than 100 μm. 
     
     
         10 . The bioartificial pancreas of  claim 8  wherein each microporous layer has a thickness less than 0.1 mm. 
     
     
         11 . The bioartificial pancreas of  claim 1  wherein the cellular complex has an islet density of 2.5% to 100%. 
     
     
         12 . The bioartificial pancreas of  claim 11  wherein the cellular complex has an islet density of 12% to 30%. 
     
     
         13 . The bioartificial pancreas of  claim 1  wherein the cellular complex support extends substantially around the interior cavity. 
     
     
         14 . The bioartificial pancreas of  claim 1  wherein the cellular complex support extends only partially around the interior cavity. 
     
     
         15 . The bioartificial pancreas of  claim 1  wherein the scaffold is an expandable stent. 
     
     
         16 . The bioartificial pancreas of  claim 15  wherein the cellular complex support is attached to struts of the expandable stent. 
     
     
         17 . The bioartificial pancreas of  claim 1  wherein the scaffold and cellular complex support have a delivery configuration with a first diameter and a deployed configuration with a second diameter greater than the first diameter, the bioartificial pancreas being adapted to be delivered in the delivery configuration by a catheter to an implantation site within the blood vessel and to be expanded to the deployed configuration outside of the catheter at the implantation site. 
     
     
         18 . The bioartificial pancreas of  claim 1  wherein the scaffold is bio-absorbable. 
     
     
         19 . A bioartificial pancreas comprising:
 a scaffold adapted to engage an interior wall of a blood vessel, the scaffold comprising a blood flow lumen extending longitudinally through an interior cavity of the scaffold so as to permit blood flow therethrough when the scaffold is engaged with the blood vessel;   a cellular complex support supported by the scaffold and extending longitudinally within the interior cavity of the scaffold so as to be exposed to the blood flow when the scaffold is engaged with the blood vessel, the cellular complex support comprising one or more pockets; and   cellular complex comprising pancreatic islets disposed in the one or more pockets; wherein the cellular complex support has a thickness from 0.30 mm to 1.0 mm when loaded with the cellular complex.   
     
     
         20 . The bioartificial pancreas of  claim 19  wherein the cellular complex support further comprises an attachment region adjacent the one or more pockets, the cellular complex support being attached to the scaffold at the attachment region. 
     
     
         21 . The bioartificial pancreas of  claim 20  further comprising a thermal bond between the attachment region and the scaffold attaching the cellular complex support to the scaffold. 
     
     
         22 . The bioartificial pancreas of  claim 20  further comprising a suture attaching the cellular complex support to the scaffold. 
     
     
         23 . The bioartificial pancreas of  claim 20  further comprising a pressure bond between the attachment region and the scaffold attaching the cellular complex support to the scaffold. 
     
     
         24 . The bioartificial pancreas of  claim 20  wherein the cellular complex support further comprises a plurality of attachment regions adjacent a plurality of pockets, with cellular complex comprising islets being disposed in each pocket. 
     
     
         25 . The bioartificial pancreas of  claim 19  wherein the cellular complex support comprises two microporous thin film layers. 
     
     
         26 . The bioartificial pancreas of  claim 25  wherein each microporous layer comprises a plurality of pores each having a diameter less than 100 μm. 
     
     
         27 . The bioartificial pancreas of  claim 25  wherein each microporous layer has a thickness less than 0.1 mm. 
     
     
         28 . The bioartificial pancreas of  claim 19  wherein the cellular complex has an islet density of 2.5% to 100%. 
     
     
         29 . The bioartificial pancreas of  claim 28  wherein the cellular complex has an islet density of 12% to 30%. 
     
     
         30 . The bioartificial pancreas of  claim 19  wherein the cellular complex support extends substantially around the interior cavity. 
     
     
         31 . The bioartificial pancreas of  claim 19  wherein the cellular complex support extends only partially around the interior cavity. 
     
     
         32 . The bioartificial pancreas of  claim 19  wherein the scaffold is an expandable stent. 
     
     
         33 . The bioartificial pancreas of  claim 32  wherein the cellular complex support is attached to struts of the expandable stent. 
     
     
         34 . The bioartificial pancreas of  claim 19  wherein the scaffold and cellular complex support have a delivery configuration with a first diameter and a deployed configuration with a second diameter greater than the first diameter, the bioartificial pancreas being adapted to be delivered in the delivery configuration by a catheter to an implantation site within the blood vessel and to be expanded to the deployed configuration outside of the catheter at the implantation site.