Involuted cylinder valve

Abstract

A prosthetic tri-leaflet valve formed by involuting a portion of a tubular structure inside itself. The valve can be made by a method comprising providing a tubular segment in which three equidistant longitudinal incisions are made in one end of the tube creating three flaps which are involuted, i.e., folded, in toward the inside of the tube and the edges of the flaps secured to the inner wall of the tube to form leaflets. The tube can be formed of a single sheet of synthetic, organic or biological material and can be solid, woven, braided or the like. A braided configuration permits the valve to be annularly compressed and delivered to the site using a minimally invasive delivery mechanism, then expanded at the implantation site.

1 . A method of forming a prosthetic valve, comprising:
 a. providing a tube of material having an inner wall, an outer wall, a diameter “d”, a height “h” and a wall thickness “t”;   b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;   c. involuting each said flap within said tube; and,   d. attaching each said first edge and second edge of each involuted flap to said inner wall of said tube.   
   
   
       2 . The method of  claim 1 , wherein said three longitudinal incisions have a length “L”, such that L=½h−2t, where “h” is the cylinder height and “t” is the thickness of said tube. 
   
   
       3 . The method of  claim 1 , wherein said height “h” is approximately equal to the diameter of the recipient aortic annulus diameter “A”. 
   
   
       4 . The method of  claim 1 , wherein the edges of each flap are cut to be rounded off along their free edge to create concave shaped leaflets. 
   
   
       5 . The method of  claim 1 , wherein scallop shaped segments of said tube wall are removed between commissures. 
   
   
       6 . The method of  claim 1 , wherein said attaching is achieved by suturing. 
   
   
       7 . The method of  claim 1 , wherein said tube is comprises a generally rectangular sheet of material that has two opposing sides joined together. 
   
   
       8 . A method of constructing a support for development of an autologous valve, comprising: 
   
   
       9 . An autologous valve formed by a process, comprising:
 a. providing a tube of material having an inner wall, an outer wall, a diameter “a”, a height “b” and a wall thickness “t”;   b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;   c. involuting each said flap within said tube; and,   d. attaching each said first edge and second edge of each involuted flap to said inner wall of said tube.   
   
   
       10 . A method of converting a tube into a valve, comprising:
 a. providing a tube of material having an inner wall, an outer wall, a diameter “a”, a height “b” and a wall thickness “t”;   b. cutting three longitudinal incisions from one end in said material about 120 degrees apart to form three flaps, each said flap having a first edge, a second edge generally parallel to said first edge, and a bottom edge;   c. involuting each said flap within said tube; and,   d. attaching each said first edge and second edge of each involuted flap to said inner wall of said tube.   
   
   
       11 . A endovascular valve, comprising:
 a. a flexible tube having a first end and a second end, an inner wall and an outer wall;   b. a plurality of leaflets formed from a portion of said first end by making a plurality of longitudinal incisions in said downstream end to form a plurality of flaps, each flap having a first edge and second edge, involuting said flaps toward said inner wall and securing said first edge and second edge of each flap to said inner wall of said tube