Device for the implantation and fixation of prosthetic valves

Abstract

A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent ( 10 ) with a prosthetic heart valve ( 11 ) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve ( 11 ) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis ( 11 ) in the patient's ventricle, the device includes a self-expanding positioning stent ( 20 ) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent ( 10 ) so that the two stents respectively interact in their expanded states such that the heart valve stent ( 10 ) is held by the positioning stent ( 20 ) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent ( 20 ).

The invention claimed is: 
     
       1. A method of treating a native aortic valve, comprising:
 positioning an expandable first stent adjacent the native aortic valve, the first stent having a first attachment element disposed adjacent a distal end of the first stent and at least one positioning element disposed adjacent a proximal end of the first stent, wherein the proximal end of the first stent is positioned closer to a patient's heart than the distal end of the first stent; 
 positioning the at least one positioning element behind a portion of a leaflet of the native valve, radially outward from the leaflet and radially inward from a portion of a vessel wall; 
 anchoring the first stent relative to the native aortic valve by expanding the first stent; 
 after expanding the first stent, positioning an expandable second stent radially within the first stent to connect the second stent to the first stent, the second stent having a second attachment element disposed adjacent a distal end of the second stent, wherein the proximal end of the second stent is positioned closer to the patient's heart than the distal end of the second stent; and 
 compressing at least a portion of a leaflet of the native valve against a vessel wall such that the compressed portion of the leaflet is positioned radially inward from the at least one positioning element of the first stent and radially outward from a portion of the second stent component; 
 wherein the first and second attachment elements are complimentary to one another. 
 
     
     
       2. The method of  claim 1 , wherein the second stent includes a plurality of engagement elements configured to be selectively attached to a catheter. 
     
     
       3. The method of  claim 1 , further including:
 disconnecting the second stent from the first stent; and 
 positioning an expandable third stent radially within the first stent to connect the third stent to the first stent, the third stent having a third attachment element adjacent a distal end of the third stent; 
 wherein the first and third attachment elements are complimentary to one another. 
 
     
     
       4. The method of  claim 1 , further including:
 positioning the at least one positioning element behind the portion of the leaflet before compressing a portion of the leaflet against the vessel wall.