Systems and methods for sizing and implanting prosthetic heart valves

Abstract

A method of implanting a prosthetic heart valve includes determining from a set of expandable prosthetic heart valves a first prosthetic heart valve. The first prosthetic heart valve has a first nominal diameter less than a native annulus diameter. The method further includes determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter, wherein the first suggested expanded diameter is greater than the first nominal diameter, and determining a pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve. The method further includes selecting the prosthetic heart valve from the set of expandable prosthetic heart valves with the suggested expanded diameter resulting in the lowest pressure gradient for implantation from the set of prosthetic heart valves.

1 . A method of implanting a prosthetic heart valve, comprising:
 determining a native annulus diameter and a native annulus area of a native annulus;   determining from a set of expandable prosthetic heart valves a first prosthetic heart valve configured to cover the native annulus diameter and the native annulus area, the first prosthetic heart valve having a first nominal diameter less than the native annulus diameter;   determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter, wherein the first suggested expanded diameter is greater than the first nominal diameter;   determining a pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve;   selecting the prosthetic heart valve from the set of expandable prosthetic heart valves with the suggested expanded diameter resulting in the lowest pressure gradient for implantation;   compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the suggested expanded diameter for the selected prosthetic heart valve;   positioning the selected prosthetic heart valve within the native annulus; and   expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration, wherein the prosthetic heart valve is expanded to a suggested expanded diameter of the selected prosthetic heart valve.   
     
     
         2 . The method of  claim 1 , wherein first suggested expanded diameter is greater than the first nominal diameter by up to four percent. 
     
     
         3 . The method of  claim 1 , wherein first suggested expanded diameter is less than the native annulus diameter by up to ten percent. 
     
     
         4 . The method of  claim 1 , wherein prior to selecting the prosthetic heart valve, the method further comprises:
 determining a native annulus area and the native annulus diameter of the native annulus by taking an image of the native annulus;   obtaining measurements of the native annulus from the image; and   calculating the native annulus area and the native annulus diameter based on the measurements.   
     
     
         5 . The method of  claim 1 , wherein prior to selecting the prosthetic heart valve, the method further comprises:
 inserting a measuring device into the native annulus;   obtaining measurements of the native annulus using the measuring device; and   calculating the native annulus area and the native annulus diameter based on the measurements.   
     
     
         6 . A method of implanting a prosthetic heart valve comprising:
 determining a native annulus diameter and a native annulus area of a native annulus;   determining from a set of expandable prosthetic heart valves a first prosthetic heart valve configured to cover the native annulus diameter and the native annulus area, the first prosthetic heart valve having a first nominal diameter less than the native annulus diameter;   determining from the set of expandable prosthetic heart valves a second prosthetic heart valve configured to cover the native annulus diameter and the native annulus area, the second prosthetic heart valve having a second nominal diameter greater than the native annulus diameter;   determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter;   determining a first pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve;   determining a second suggested expanded diameter for the second prosthetic heart valve based on the native annulus diameter;   determining a second pressure gradient across the second prosthetic heart valve at the second suggested expanded diameter based at least in part on pressure values from hemodynamic data of the second prosthetic heart valve;   selecting the prosthetic heart valve from the first and second prosthetic heart valves with the suggested expanded diameter resulting in the lowest pressure gradient for implantation;   compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the suggested expanded diameter for the selected prosthetic heart valve;   positioning the selected prosthetic heart valve within the native annulus; and   expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration, wherein the prosthetic heart valve is expanded to the suggested expanded diameter of the selected prosthetic heart valve.   
     
     
         7 . The method of  claim 6 , wherein the nominal diameter of the second prosthetic heart valve is greater than the native annulus diameter by up to forty percent. 
     
     
         8 . The method of  claim 7 , wherein the nominal diameter of the second prosthetic heart valve is greater than the native annulus diameter by up to thirty percent. 
     
     
         9 . The method of  claim 8 , wherein the nominal diameter of the second prosthetic heart valve is greater than the native annulus diameter by up to twenty percent. 
     
     
         10 . The method of  claim 9 , wherein the nominal diameter of the second prosthetic heart valve is greater than the native annulus diameter by up to ten percent. 
     
     
         11 . The method of  claim 6 , wherein the first suggested expanded diameter is greater than the first nominal diameter. 
     
     
         12 . The method of  claim 6 , wherein the second suggested expanded diameter is less than the second nominal diameter. 
     
     
         13 . A method of implanting a prosthetic heart valve, comprising:
 determining a native annulus diameter and a native annulus area of a native heart valve annulus;   determining from a plurality of different prosthetic heart valves a first prosthetic heart valve configured to cover the native annulus diameter and the native annulus area, the first prosthetic heart valve having a first nominal diameter less than the native annulus diameter;   determining a first suggested expanded diameter for the first prosthetic heart valve based on the native annulus diameter, wherein the first suggested expanded diameter is greater than the first nominal diameter;   determining a pressure gradient across the first prosthetic heart valve at the first suggested expanded diameter based at least in part on pressure values from hemodynamic data of the first prosthetic heart valve;   selecting the prosthetic heart valve resulting in the lowest pressure gradient at the suggested expanded diameter for implantation from the plurality of different prosthetic heart valves;   advancing the selected prosthetic heart valve through a patient's vasculature to the native heart valve annulus, wherein the selected prosthetic heart valve is in a radially collapsed configuration, and wherein the selected prosthetic heart valve comprises:
 a frame comprising an inflow end and an outflow end and being expandable from the radially collapsed configuration and a radially expanded configuration; and 
 a valvular structure mounted within the frame and comprising a plurality of leaflets that regulate flow of blood through the frame, wherein each of the leaflets comprises opposing upper tabs on opposite sides of the leaflet, a cusp edge portion extending between the upper tabs, the cusp edge portion being fixed relative to the frame, wherein each of the upper tabs is paired with an adjacent upper tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame; and 
   expanding the selected prosthetic heart valve from the radially collapsed configuration to the radially expanded configuration, wherein the selected prosthetic heart valve is expanded to the suggested expanded diameter, wherein in the radially expanded configuration.   
     
     
         14 . The method of  claim 13 , wherein first suggested expanded diameter is greater than the first nominal diameter by up to four percent. 
     
     
         15 . The method of  claim 13 , wherein prior to selecting the prosthetic heart valve resulting in the lowest pressure gradient at the suggested expanded diameter for implantation from the plurality of different prosthetic heart valves, the method comprises:
 determining from a plurality of different prosthetic heart valves a second prosthetic heart valve configured to cover the native annulus diameter and the native annulus area, the second prosthetic heart valve having a second nominal diameter greater than the native annulus diameter;   determining a second suggested expanded diameter for the second prosthetic heart valve based on the native annulus diameter, wherein the second suggested expanded diameter is less than the second nominal diameter; and   determining a pressure gradient across the second prosthetic heart valve at the second suggested expanded diameter based at least in part on pressure values from hemodynamic data of the second prosthetic heart valve.   
     
     
         16 . The method of  claim 13 , wherein each one of the upper tabs is folded along a horizontal fold line to form first and second tab layers. 
     
     
         17 . The method of  claim 16 , wherein the selected prosthetic heart valve further comprises a first reinforcing member placed against the first tab layer and a second reinforcing member placed against the second tab layer. 
     
     
         18 . The method of  claim 17 , wherein the first and second reinforcing members are secured together with stitching that extends through the first and second tab layers. 
     
     
         19 . The method of  claim 13 , wherein the selected prosthetic heart valve further comprises a sealing member mounted inside of the frame. 
     
     
         20 . The method of  claim 19 , wherein the sealing member comprises a plurality of triangular-shaped portions.