Heart valve prosthesis

Abstract

Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

1 - 25 . (canceled) 
     
     
         26 . A valve prosthesis for implantation into a native valve site, the valve prosthesis comprising:
 a frame including an hourglass-shaped central portion with a reduced waist region, the frame including a plurality of struts and a plurality of crowns, with a plurality of openings formed by the plurality of struts and the plurality of crowns; and   a skirt attached to the frame, the skirt extending over at least a portion of each opening of the plurality of openings, wherein endmost crowns of the plurality of crowns extend beyond an endmost edge of the skirt.   
     
     
         27 . The valve prosthesis of  claim 26 , wherein the frame further includes a first leaflet support arm being configured to engage a first native valve leaflet and a second leaflet support arm being configured to engage a second native valve leaflet, the second leaflet support arm being diametrically opposed to the first leaflet support arm. 
     
     
         28 . The valve prosthesis of  claim 27 , wherein the first and second leaflet support arms each has an acute configuration when initially implanted in situ and a chronic configuration after being implanted in situ for a predetermined amount of time, wherein the chronic configuration differs from the acute configuration. 
     
     
         29 . The valve prosthesis of  claim 26 , wherein the skirt is a portion of a valve body that is supported within the frame. 
     
     
         30 . The valve prosthesis of  claim 29 , wherein the valve body includes at least two valve leaflets. 
     
     
         31 . The valve prosthesis of  claim 26 , wherein the skirt is formed from a low-porosity woven fabric. 
     
     
         32 . The valve prosthesis of  claim 26 , wherein the skirt is formed from pericardium. 
     
     
         33 . The valve prosthesis of  claim 26 , wherein the frame includes an inflow end and an outflow end, and wherein the endmost crowns of the plurality of crowns form the outflow end of the valve prosthesis. 
     
     
         34 . The valve prosthesis of  claim 26 , wherein the frame includes an inflow end and an outflow end, and wherein first openings of the plurality of openings are disposed at the inflow end and second openings of the plurality of openings are disposed at the outflow end, and wherein the first openings are larger than the second openings. 
     
     
         35 . The valve prosthesis of  claim 26 , wherein the central region is configured to pinch a muscular ridge of a native annulus when implanted therein. 
     
     
         36 . A valve prosthesis for implantation into a native valve site, the valve prosthesis comprising:
 a frame having an hourglass shape with a reduced waist region, the frame including
 a central portion supporting the valve body, the central portion configured to fit within an annulus of the native valve site, 
 an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site, 
 a first ventricular arm that outwardly extends from the reduced waist region of the frame, and 
 a second ventricular arm that outwardly extends from the reduced waist region of the frame, the second ventricular arm being diametrically opposed to the first ventricular arm, each of the first and second ventricular arms being positioned along a circumference of the central portion, 
   wherein the hourglass shape of the frame is formed by the inflow portion and the first and second ventricular arms such that the frame pinches the annulus from both the atrial and ventricular sides of the annulus; and   a valve body supported within the frame.   
     
     
         37 . The valve prosthesis of  claim 36 , wherein the frame further includes a first leaflet support arm being configured to engage a first native valve leaflet and a second leaflet support arm being configured to engage a second native valve leaflet, the second leaflet support arm being diametrically opposed to the first leaflet support arm, wherein each of the first and second ventricular arms is positioned along a circumference of the central portion between the first and second leaflet support arms. 
     
     
         38 . The valve prosthesis of  claim 36 , wherein the inflow portion of the frame and the first and second ventricular arms originate from a same node location of the central portion. 
     
     
         39 . The valve prosthesis of  claim 36 , wherein the inflow portion of the frame and the first and second ventricular arms originate from different node locations of the central portion such that a gap is present between the inflow portion of the frame and the first and second ventricular arms within the reduced waist region. 
     
     
         40 . A valve prosthesis for implantation into a native valve site, the valve prosthesis comprising:
 a valve body; and   a frame comprising,
 a central portion supporting the valve body, the central portion configured to fit within an annulus of the native valve site, 
 an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site, 
 a first leaflet support arm being configured to engage a native valve leaflet and restrict movement of the valve prosthesis in an upstream direction of blood flow at the native valve site, 
 a second leaflet support arm being configured to engage a native valve leaflet and restrict movement of the valve prosthesis in an upstream direction of blood flow at the native valve site, the second leaflet support arm being diametrically opposed to the first leaflet support arm, 
 a first commissural engagement support arm extending from a distal end of the frame to provide ventricular fixation of the valve prosthesis within the native valve site, and 
 a second commissural engagement support arm extending from the distal end of the frame to provide ventricular fixation of the valve prosthesis within the native valve site, the first and second commissural engagement support arms being disposed side-by-side and positioned along a circumference of the central portion between the first and second leaflet support arms. 
   
     
     
         41 . The valve prosthesis of  claim 40 , wherein each of the first and second commissural engagement support arms has a U-shape. 
     
     
         42 . The valve prosthesis of  claim 40 , wherein the first and second commissural engagement support arms are configured to be deployed sequentially after deployment of the first and second leaflet support arms.