Implantable valve device

Abstract

Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.

1 . A valve device for implantation in a recipient vessel, said valve device comprising:
 an expandable support frame; and   a bioprosthetic valve attached to the support frame, the bioprosthetic valve comprising a single leaflet and a contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve, the contiguous portion including the natural margins of attachment between the leaflet and the vessel wall.   
   
   
       2 . The valve device according to  claim 1 , wherein the contiguous portion of the vessel wall comprises at least a portion of a natural sinus formed in the vascular valve adjacent the leaflet. 
   
   
       3 . The valve device according to  claim 1 , wherein the contiguous portion of the vessel wall includes the entire natural sinus formed in the vascular valve adjacent the leaflet. 
   
   
       4 . The valve device according to  claim 1 , wherein the bioprosthetic valve comprises a leaflet and contiguous portion of a vessel wall harvested from a xenogeneic valve selected from porcine valves, ovine valves, and equine valves. 
   
   
       5 . The valve device according to  claim 1 , wherein the bioprosthetic valve comprises a leaflet and contiguous portion of a vessel wall harvested from a porcine valve. 
   
   
       6 . The valve device according to  claim 5 , wherein the bioprosthetic valve comprises a leaflet and contiguous portion of a vessel wall harvested from a non-aortic valve. 
   
   
       7 . The valve device according to  claim 5 , wherein the bioprosthetic valve comprises a leaflet and contiguous portion of a vessel wall harvested from an aortic valve. 
   
   
       8 . The valve device according to  claim 7 , wherein the leaflet comprises a noncoronary leaflet of the aortic valve. 
   
   
       9 . The valve device according to  claim 1 , wherein the support frame includes one or more struts and defines a window portion substantially free of the one or more struts and positioned to allow the leaflet to close against a portion of an inner wall of said recipient vessel. 
   
   
       10 . The valve device according to  claim 1 , wherein the support frame includes one or more struts that defines an outwardly projecting curvilinear portion configured to create a sinus region in said recipient vessel upon implantation therein. 
   
   
       11 . The valve device according to  claim 1 , wherein the bioprosthetic valve is attached to the support frame along an attachment pathway with at least one attachment element. 
   
   
       12 . The valve device according to  claim 11 , wherein the at least one attachment element passes through only a partial thickness of the contiguous wall portion at at least one point on the attachment pathway. 
   
   
       13 . The valve device according to  claim 11 , wherein the at least one attachment element passes through only a partial thickness of the contiguous wall portion at substantially all points along the attachment pathway. 
   
   
       14 . The valve device according to  claim 11 , wherein the at least one attachment element passes through only a partial thickness of the contiguous wall portion at all points along the attachment pathway. 
   
   
       15 . The valve device according to  claim 11 , wherein the at least one attachment element comprises a single suture extending along the entire attachment pathway. 
   
   
       16 . The valve device according to  claim 1 , wherein the contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve comprises a non-circumferential portion of a vessel wall harvested from a multi-leaflet vascular valve. 
   
   
       17 . The valve device according to  claim 1 , further comprising a second bioprosthetic valve attached to the support frame, the second bioprosthetic valve comprising a second single leaflet and a second contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve, the second contiguous portion including the natural margins of attachment between the second single leaflet and the vessel wall;
 wherein the first and second bioprosthetic valves are attached to the support frame such that the single leaflet and the second single leaflet are able to coapt with each other to close a valve opening formed between the single leaflet and the second single leaflet.   
   
   
       18 . A valve device for implantation in a recipient vessel, said valve device comprising:
 a bioprosthetic valve comprising a leaflet and a contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve, the leaflet having a base portion attached to the contiguous wall portion; and   an expandable support frame comprising one or more struts defining an outwardly projecting curvilinear portion configured to outwardly deflect a portion of the inner wall of the recipient vessel upon implantation therein;   wherein the bioprosthetic valve is attached to the support frame and the base portion of the leaflet is positioned substantially adjacent the outwardly projecting portion such that a valve sinus region is formed between the outwardly deflected portion of the inner wall of the recipient vessel and the leaflet.   
   
   
       19 . The valve device according to  claim 18 , wherein the contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve comprises at least a portion of a natural sinus formed in the vascular valve adjacent the leaflet. 
   
   
       20 . The valve device according to  claim 18 , wherein the contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve includes the entire natural sinus formed in the vascular valve adjacent the leaflet. 
   
   
       21 . The valve device according to  claim 18 , wherein the contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve comprises a non-circumferential portion of a vessel wall harvested from a multi-leaflet vascular valve. 
   
   
       22 . A delivery system for percutaneously delivering a valve device to a desired point of treatment in a recipient vessel, said delivery system comprising:
 an elongate member having a proximal end, a distal tip adapted for insertion into and navigation through said recipient vessel, and a length from the proximal end to the distal tip, the elongate member including a device chamber adapted to receive an expandable medical device therein;   a sheath disposed about the elongate member and over the device chamber, the sheath adapted to slidably move along the length of the elongate member; and   a valve device for implantation in said recipient vessel, the valve device disposed within the device chamber and comprising a support structure and a bioprosthetic valve attached to the support structure, the bioprosthetic valve comprising a single leaflet and a contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve, the contiguous portion including the natural margins of attachment between the leaflet and the vessel wall.