Endoluminal cardiac and venous valve prostheses and methods of manufacture and delivery thereof

Abstract

This invention relates to prosthetic cardiac and venous valves and a single catheter device and minimally invasive techniques for percutaneous and transluminal valvuloplasty and prosthetic valve implantation.

What is claimed is: 
     
         1 . A method of endoluminally delivering a valvular prosthesis within an anatomic passageway to replace an anatomic valve using a catheter, the valvular prosthesis carried on a distal end of the catheter, the valvular prosthesis comprising an distal anchor section, a proximal anchor section and an intermediate section, the method comprising the step of:
 passing the catheter through an anatomic passageway so that the distal anchor section of the valvular prosthesis is positioned distal the anatomic valve;   positioning the intermediate section within the anatomic valve; and   releasing the valvular prosthesis from the catheter into a space occupied by the anatomic valve such that the distal anchor section is distal the anatomic valve, the proximal anchor section is proximal the anatomic valve and the intermediate section operates to exclude and replace the anatomic valve.   
     
     
         2 . The method of endoluminally delivering a valvular prosthesis according to  claim 1 , wherein the positioning step comprises withdrawing the catheter to allow the intermediate section to exclude the anatomic valve. 
     
     
         3 . The method of endoluminally delivering a valvular prosthesis according to  claim 1 , wherein the valvular prosthesis is self-expanding and has anchoring flanges projecting substantially radially outwardly from the valvular prosthesis and positioned at a distal end of the valvular prosthesis, and wherein the withdrawing step further comprises the steps of:
 withdrawing a sheath to deploy the anchoring flanges, and   engaging the anchoring flanges to a distal end of the anatomic valve, thereby positioning the valvular prosthesis within the anatomic valve.   
     
     
         4 . The method of  claim 1 , wherein the catheter has a delivery profile of  12  French size or smaller. 
     
     
         5 . The method of  claim 1 , wherein the catheter is further comprised of a guidewire shaft positioned co-axially within the central longitudinal lumen and an annular plug member concentrically coupled to the guidewire shaft, and wherein the withdrawing step further includes the step of maintaining a position of the guidewire shaft as the catheter is withdrawn in retrograde fashion so that the annular plug member maintains the position of the valvular prosthesis while deploying the valvular prosthesis within the anatomic valve. 
     
     
         6 . The method of  claim 1 , wherein the valvular prosthesis further comprises at least one valve flap member positions within a lumen defined within the intermediate section, wherein the at least one valve flap member is biased toward a position that occludes the lumen within the intermediate section. 
     
     
         7 . The method of  claim 6 , wherein further comprising at least one biasing member positioned at the intermediate section that acts on and biases the at least one valve flap member. 
     
     
         8 . The method of  claim 6 , wherein the valvular prosthesis further comprises a shape memory alloy. 
     
     
         9 . The method of  claim 6 , wherein the valvular prosthesis further comprises a balloon-expandable material. 
     
     
         10 . The method of  claim 6 , wherein the valvular prosthesis further comprises a generally tubular configuration and the proximal end and distal ends have a larger diameter than the intermediate section when in the valvular prosthesis is in a deployed deployed state. 
     
     
         11 . The method of  claim 10 , wherein the valvular prosthesis further comprises a plurality of struts forming walls of the generally tubular valvular prosthesis. 
     
     
         12 . The method of  claim 11 , wherein the valvular prosthesis further comprises a plurality of struts forming walls of the generally tubular valvular prosthesis and a biasing member positioned at the intermediate section that acts on and a biases the at least one valve flap member. 
     
     
         13 . The method of  claim 11 , further comprising a covering on at least one of a luminal or abluminal surfaces of the generally tubular valvular prosthesis, wherein the covering forms the at least one valve flap member. 
     
     
         14 . The method of  claims 13 , further comprising the step of balloon expanding the anatomic valve prior to positioning the intermediate section within the anatomic valve.