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 . A percutaneous heart valve device, comprising:
 a self-expandable frame having a first condition suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded condition adapted for deployment at the vascular site,   said expanded condition providing an inner lumen and including a first frame end and a second frame end, said first frame end having a perimeter of a different length than the perimeter of said second frame end; and   a plurality of flexible valve leaflets located within the inner lumen of said frame, said plurality of flexible valve leaflets comprised of pericardium and each having a proximal end and a distal end, said leaflet proximal ends having cooperating leaflet edge portions having outer ends connected to said frame at a first intermediate location along the length of said frame, said leaflet edge portions extending inwardly from said frame and associating to provide a valve orifice within the lumen of said frame,   said plurality of flexible valve leaflets extending only partially along the length of said frame, wherein said leaflet distal ends are spaced proximally from an inlet end of said heart valve device, and each include a leaflet apex attached to said frame with a plurality of sutures extending in a generally lateral direction around a portion of the circumference of said frame, said leaflet apexes attached to said frame at a second intermediate location along the length of said frame, said second intermediate location spaced distally from said first intermediate location along said frame.   
   
   
       2 . A percutaneous heart valve device, comprising:
 a self-expandable frame having a first condition suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded condition adapted for deployment at the vascular site,   said expanded condition providing an inner lumen and including a longitudinal frame segment having a generally cylindrical shape, said longitudinal frame segment providing a first end and a second end, said first end providing an inlet end of the heart valve device; and   a valve arrangement residing within the inner lumen of said frame, said valve arrangement comprising a material in sheet-form and including a plurality of flexible valve leaflets each having a proximal end and a distal end, said leaflet proximal ends having cooperating leaflet edge portions having outer ends connected to said frame at a first intermediate location along the length of said frame, said leaflet edge portions extending inwardly from said frame and associating to provide a valve orifice within the lumen of said frame,   said plurality of flexible valve leaflets extending only partially along the length of said frame, wherein said leaflet distal ends are spaced proximally from said first end of said longitudinal frame segment, and each include a leaflet apex attached to said frame with a plurality of sutures extending in a generally lateral direction around a portion of the circumference of said longitudinal frame segment, said leaflet apexes attached to said frame at a second intermediate location along the length of said frame, said second intermediate location spaced distally from said first intermediate location along said frame.   
   
   
       3 . The percutaneous heart valve device of  claim 2 , wherein said material in sheet form includes a flexible collagenous biomaterial. 
   
   
       4 . The percutaneous heart valve device of  claim 3 , wherein said flexible collagenous biomaterial comprises a tissue material selected from the group consisting of pericardium, small intestine submucosa, stomach submucosa, urinary bladder submucosa, and dura mater. 
   
   
       5 . The percutaneous heart valve device of  claim 3 , wherein said flexible collagenous biomaterial comprises pericardium. 
   
   
       6 . The percutaneous heart valve device of  claim 2 , wherein said material in sheet form comprises a synthetic polymeric material. 
   
   
       7 . The percutaneous heart valve device of  claim 2 , wherein said material in sheet form includes material portions connected to said frame at the inlet end of the heart valve device. 
   
   
       8 . A percutaneous heart valve device, comprising:
 a self-expandable frame having a first condition suitable for percutaneous vascular delivery to a vascular site for providing a heart valve, and a second, expanded condition adapted for deployment at the vascular site,   said expanded condition providing an inner lumen and including a longitudinal frame segment having a generally cylindrical shape, said longitudinal frame segment providing a first end and a second end, said first end providing an inlet end of the heart valve device; and   a plurality of flexible valve leaflets located within the inner lumen of said frame, said plurality of flexible valve leaflets comprised of pericardium and each having a proximal end and a distal end, said leaflet proximal ends having cooperating leaflet edge portions having outer ends connected to said frame at a first intermediate location along the length of said frame, said leaflet edge portions extending inwardly from said frame and associating to provide a valve orifice within the lumen of said frame,   said plurality of flexible valve leaflets extending only partially along the length of said frame, wherein said leaflet distal ends are spaced proximally from said first end of said longitudinal frame segment, and each include a leaflet apex attached to said frame with a plurality of sutures extending in a generally lateral direction around a portion of the circumference of said longitudinal frame segment, said leaflet apexes attached to said frame at a second intermediate location along the length of said frame, said second intermediate location spaced distally from said first intermediate location along said frame.   
   
   
       9 . The percutaneous heart valve device of  claim 8  having two flexible valve leaflets. 
   
   
       10 . The percutaneous heart valve device of  claim 8  having three flexible valve leaflets. 
   
   
       11 . The percutaneous heart valve device of  claim 8 , wherein said outer ends of said cooperating leaflet edge portions are connected to said frame with sutures. 
   
   
       12 . The percutaneous heart valve device of  claim 8 , wherein said frame provides an inner frame surface, said cooperating leaflet edge portions sutured together in regions bounding said valve orifice and said valve orifice terminating before reaching said inner frame surface. 
   
   
       13 . The percutaneous heart valve device of  claim 8 , further comprising a covering material covering an outer surface of said frame. 
   
   
       14 . The percutaneous heart valve device of  claim 13 , wherein said covering material includes a portion extending circumferentially around said frame. 
   
   
       15 . The percutaneous heart valve device of  claim 14 , wherein said covering material includes a portion extending partially along the length of said frame. 
   
   
       16 . The percutaneous heart valve device of  claim 13 , wherein said covering material comprises a synthetic polymeric material.