Stents modified with material comprising amnion tissue and corresponding processes

Abstract

A stent scaffold combined with amniotic tissue provides for a biocompatible stent that has improved biocompatibility and hemocompatibility. The amnion tissue can be variously modified or unmodified form of amnion tissue such as non-cryo amnion tissue, solubilized amnion tissue, amnion tissue fabric, chemically modified amnion tissue, amnion tissue treated with radiation, amnion tissue treated with heat, or a combination thereof. Materials such as polymer, placental tissue, pericardium tissue, small intestine submucosa can be used in combination with the amnion tissue. The amnion tissue can be attached to the inside, the outside, both inside and outside, or complete encapsulation of the stent scaffold. In some embodiments, at least part of the covering or lining comprises a plurality of layers of amnion tissue. The method of making the biocompatible stent and its delivery and deployment are also discussed.

We claim: 
     
         1 . A biocompatible stent for placement in a vessel of a living subject comprising:
 a stent scaffold, and   a biocompatible material associated with the stent scaffold, wherein the biocompatible material comprises non-denuded amnion tissue that has not been cryo-preserved at a temperature of −60 to −100° C. and has not been dehydrated.   
     
     
         2 . The biocompatible stent of  claim 1  wherein the biocompatible material further comprises stem cells. 
     
     
         3 . The biocompatible stent of  claim 1  wherein the stent scaffold is bioabsorbable. 
     
     
         4 . The biocompatible stent of  claim 1  wherein the stent scaffold is self-expanding. 
     
     
         5 . The biocompatible stent of  claim 1  wherein the stent scaffold is balloon expandable. 
     
     
         6 . The biocompatible stent of  claim 1  wherein the stent scaffold is laser cut, wire based, braided, or cut from a sheet. 
     
     
         7 . The biocompatible stent of  claim 1  further comprising a thrombolytic agent, an anti-restenosis agent, cellular material, or a combination thereof. 
     
     
         8 . The biocompatible stent of  claim 1  wherein the stent scaffold has a first undeployed configuration and second deployed configuration wherein the first undeployed configuration of the stent scaffold has a first diameter and the second deployed configuration has a second diameter, and the first diameter is smaller than the second diameter. 
     
     
         9 . The biocompatible stent of  claim 1  wherein the stent scaffold has a first undeployed configuration and second deployed configuration wherein the first undeployed configuration of the stent scaffold has a first diameter and the second deployed configuration has a second diameter, and the first diameter is larger than the second diameter. 
     
     
         10 . A method for modifying a stent scaffold for placement in a vessel of a living subject, comprising:
 associating a processed biocompatible material with the stent scaffold,   wherein the processed biocompatible material is processed from a biocompatible material that comprises non-denuded amnion tissue that has not been cryo-preserved at a temperature of −60 to −100° C. and has not been dehydrated.   
     
     
         11 . The method of  claim 10  wherein the biocompatible material is processed by a method comprising chemically or enzymatically breaking up amnion tissue to form a solubilized amnion tissue and covering at least part of stent scaffold or the covering or lining of  claim 9  with the solubilized amnion tissue and allowing the solubilized amnion tissue to dry to form a coating on the covering or lining. 
     
     
         12 . The method of  claim 10  wherein processed biocompatible material is processed to form a covering or lining and the associating step comprises attaching the covering or lining to the stent scaffold. 
     
     
         13 . The method of  claim 12  wherein the covering or lining is attached to the inside, outside or both inside and outside of the stent scaffold. 
     
     
         14 . A biocompatible stent for placement in a vessel of a living subject comprising:
 a bioabsorbable stent scaffold, and   a biocompatible material associated with the stent scaffold, wherein the biocompatible material comprises non-denuded amnion tissue that has not been cryo-preserved at a temperature of −60 to −100° C. and has not been dehydrated.   
     
     
         15 . The biocompatible stent of  claim 14  wherein the stent scaffold is self-expanding. 
     
     
         16 . The biocompatible stent of  claim 14  wherein the stent scaffold is balloon expandable. 
     
     
         17 . The biocompatible stent of  claim 14  wherein the stent scaffold is laser cut, wire based, braided, or cut from a sheet. 
     
     
         18 . The biocompatible stent of  claim 14  further comprising a thrombolytic agent, an anti-restenosis agent, cellular material, or a combination thereof. 
     
     
         19 . The biocompatible stent of  claim 14  wherein the stent scaffold has a first undeployed configuration and second deployed configuration wherein the first undeployed configuration of the stent scaffold has a first diameter and the second deployed configuration has a second diameter, and the first diameter is smaller than the second diameter. 
     
     
         20 . The biocompatible stent of  claim 14  wherein the stent scaffold has a first undeployed configuration and second deployed configuration wherein the first undeployed configuration of the stent scaffold has a first diameter and the second deployed configuration has a second diameter, and the first diameter is larger than the second diameter.