Percutaneous heart valve devices

Abstract

The invention includes a medical device and more specifically relates to a valve found generally within a frame. In a preferred device, the frame preferably comprises a self-expanding stent frame, and the valve has at least one expandable and contractible pocket member within the stent frame for resisting and permitting fluid flow, respectively.

1 - 36 . (canceled)  
   
   
       37 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded configuration adapted for deployment at the vascular site;    said expanded configuration being generally cylindrical in shape and providing an inner lumen, said expanded configuration further providing a first frame end and a second frame end;    said expanded configuration of said frame providing a plurality of struts that reverse direction and thereby provide a plurality of bends with apexes occurring at said second frame end;    said first frame end providing an inlet end of the valve device, and said second frame end providing an outlet end of the valve device;    a flexible collagenous biomaterial;    said flexible collagenous biomaterial forming at least two flexible valve leaflets within said inner lumen;    said at least two flexible valve leaflets each extending substantially from said first frame end to said second frame end; and    said at least two flexible valve leaflets forming a valve orifice at the outlet end of said frame.    
   
   
       38 . The percutaneous heart valve device of  claim 37 , wherein said flexible collagenous material is attached to said frame at least at said outlet end.  
   
   
       39 . The percutaneous heart valve device of  claim 37 , wherein: 
 said apexes of said bends are substantially co-terminal.    
   
   
       40 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded configuration adapted for deployment at the vascular site;    said expanded configuration being generally cylindrical in shape and providing an inner lumen, said expanded configuration further providing a first frame end and a second frame end;    said first frame end providing an inlet end of the valve device, and said second frame end providing an outlet end of the valve device;    a flexible collagenous biomaterial;    said flexible collagenous biomaterial forming at least two flexible valve leaflets within said inner lumen;    said at least two flexible valve leaflets each extending substantially from said first frame end to said second frame end;    said at least two flexible valve leaflets forming a valve orifice at the outlet end of said frame; and    said flexible collagenous material attached to said frame at least at said outlet end.    
   
   
       41 . The percutaneous heart valve device of  claim 40 , wherein: 
 said expanded configuration of said frame provides a plurality of struts that reverse direction and thereby provide a plurality of bends.    
   
   
       42 . The percutaneous heart valve device of  claim 40 , wherein said frame is a self-expanding frame.  
   
   
       43 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded configuration adapted for deployment at the vascular site;    said expanded configuration being generally cylindrical in shape and providing an inner lumen, said expanded configuration further providing a first frame end and a second frame end;    said expanded configuration of said frame providing a plurality of struts that reverse direction and thereby provide a plurality of bends with apexes occurring at said second frame end;    said first frame end providing an inlet end of the valve device, and said second frame end providing an outlet end of the valve device;    a flexible material;    said flexible material forming at least two flexible valve leaflets within said inner lumen;    said at least two flexible valve leaflets each extending substantially from said first frame end to said second frame end;    said at least two flexible valve leaflets forming a valve orifice at the outlet end of said frame; and    said flexible material attached to said frame at least at said outlet end.    
   
   
       44 . The percutaneous heart valve device of  claim 43 , wherein: 
 said flexible material is a collagenous biomaterial.    
   
   
       45 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded configuration adapted for deployment at the vascular site;    said expanded configuration providing a first frame end and a second frame end;    said expanded configuration of said frame providing a plurality of struts that reverse direction and thereby provide a plurality of bends with apexes occurring at said second frame end and wherein each of said apexes is substantially co-terminal with the other apexes;    said flexible collagenous biomaterial formed to provide at least two flexible valve leaflets;    said at least two flexible valve leaflets having cooperating leaflet edge portions, said cooperating leaflet edge portions having outer ends connected to said frame and extending inwardly therefrom to form a valve orifice at said second end of said frame.    
   
   
       46 . The percutaneous heart valve device of  claim 45 , wherein: 
 said outer ends of said leaflet edge portions are connected to said frame by sutures.    
   
   
       47 . The percutaneous heart valve device of  claim 45 , wherein: 
 said frame is a self-expanding frame.    
   
   
       48 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded configuration for deployment at the vascular site;    said expanded configuration being generally cylindrical in shape and providing an inner lumen, said expanded configuration further providing a first frame end and a second frame end;    said first frame end providing an inlet end of the valve device, and said second frame end providing an outlet end of the valve device;    a flexible collagenous biomaterial;    said flexible collagenous biomaterial extending substantially from said first frame end to said second frame end;    said flexible collagenous biomaterial forming at least two flexible valve leaflets defining a valve orifice at the outlet end of said frame; and    said flexible collagenous material attached to said frame at least at said outlet end.    
   
   
       49 . The percutaneous heart valve device of  claim 48 , wherein: 
 said frame is a self-expanding frame.    
   
   
       50 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second configuration for deployment at the vascular site, said second configuration expanded relative to said first configuration;    said second, expanded configuration providing a first frame end and a second frame end;    a flexible collagenous biomaterial attached to said frame;    said flexible collagenous biomaterial formed to provide at least two flexible valve leaflets;    said at least two flexible valve leaflets forming a valve orifice at said second frame end;    said at least two flexible leaflets extending only partially between said second frame end and said first frame end;    said at least two flexible valve leaflets having cooperating leaflet edge portions, said cooperating leaflet edge portions forming a valve orifice at said second end of said frame.    
   
   
       51 . The percutaneous heart valve device of  claim 50 , wherein: 
 said cooperating leaflet edge portions have ends connected at said second frame end.    
   
   
       52 . The percutaneous heart valve device of  claim 50 , wherein: 
 said frame is a self-expanding frame.    
   
   
       53 . A percutaneous heart valve device, comprising: 
 a frame having a first configuration suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second configuration suitable for deployment at the vascular site, said second configuration expanded relative to said first configuration;    said second configuration providing a first frame end and a second frame end;    a flexible collagenous biomaterial;    said flexible collagenous biomaterial formed to provide at least two flexible valve leaflets;    said at least two flexible leaflets extending only partially between said second frame end and said first frame end;    said at least two flexible leaflets having portions attached to said frame between said first frame end and said second frame end; and    said at least two flexible valve leaflets having orifice-forming leaflet edge portions, said orifice-forming leaflet edge portions cooperating to form a valve orifice at said second end of said frame.    
   
   
       54 . The percutaneous heart valve device of  claim 53 , wherein: 
 said orifice-forming leaflet edge portions have ends attached to said frame.    
   
   
       55 . The percutaneous heart valve device of  claim 53 , wherein: 
 said frame is a self-expanding frame.