Heart valve mimicry
The disclosure relates to a heart valve with improved functionality and durability.
1. A replacement heart valve prosthesis comprising a stent component and a valve component, wherein:
the valve component has a valve ratio of annulus to commissure distance (ACD) to annulus diameter (AD) of 1.01 to 1.14, the ACD being a distance between a proximal end of a commissure portion and a proximal end of an annulus portion; and
the stent component comprises an inflow end region and an outflow end region each comprising a plurality of cells, wherein in the inflow end region, a ratio of area of a given cell to a neighboring cell is 0.25 to 4, a ratio of height of the given cell to the neighboring cell is 0.5 to 2, or an aspect ratio of all cells of the inflow end region is 1 to 2, and wherein in the outflow end region, aspect ratios of a first cell and a second cell in a single circumferential row vary with respect to one another from 1 to 3, areas of the first cell and the second cell vary with respect to one another from 5 mm 2 to 250 mm 2 , or heights of the first cell and the second cell vary with respect to one another from 3 mm to 30 mm.
2. The prosthesis according to claim 1 , wherein the stent component includes at least one feeler for aligning the stent component relative to a native heart valve.
3. The prosthesis according to claim 2 , wherein the at least one feeler is configured to be introduced into a native cusp of the native heart valve.
4. The prosthesis according to claim 3 , wherein a distance from a proximal end of the at least one feeler to a distal end of the inflow end region of the stent component is 4 mm to 12 mm.
5. The prosthesis according to claim 4 , wherein the distance from the proximal end of the at least one feeler to the distal end of the inflow end region is 7.5 mm to 9 mm.
6. The prosthesis according to claim 2 , wherein the stent component includes three feelers for aligning the stent component relative to native cusps of the native heart valve.
7. The prosthesis according to claim 1 , wherein the valve component comprises tissue, and the stent component further comprises an arch for fixation of the valve tissue.
8. The prosthesis according to claim 7 , wherein the valve tissue comprises pericardial tissue.
9. The prosthesis according to claim 7 , wherein the arch comprises holes, rails, or notches.
10. The prosthesis according to claim 1 , wherein the valve ratio of ACD to AD is 1.03 to 1.04.
11. The prosthesis according to claim 1 , wherein a number of cells per cm 2 area of the stent component is 2 to 6 in the inflow end region, and 1 to 4 in the outflow end region.
12. The prosthesis according to claim 11 , wherein the number of cells per cm 2 area of the inflow end region is 3.7 to 5.1.
13. The prosthesis according to claim 11 , wherein the number of cells per cm 2 area of the outflow end region is 1.9 to 2.5.
14. The prosthesis according to claim 1 , wherein, in the inflow end region:
the ratio of area of the given cell to the neighboring cell is 1;
the ratio of height of the given cell to the neighboring cell is 1; and
the aspect ratio of all cells of the inflow end region is 1.5 to 1.6.
15. The prosthesis according to claim 1 , wherein, in the outflow end region:
the aspect ratios of the first cell and the second cell vary from 1.1 to 2.9;
the areas of the first cell and the second cell vary from 7 mm 2 to 198 mm 2 ; and
the heights of the first cell and the second cell vary from 6 mm to 25 mm.
16. The prosthesis according to claim 1 , wherein the prosthesis has a radial force, wherein 15 to 25% of the radial force is provided by an annulus region, and 75 to 85% of the radial force is provided by a supra-annulus region.
17. A replacement heart valve prosthesis comprising a stent component and a valve component, wherein:
the valve component has a valve ratio of annulus to commissure distance (ACD) to annulus diameter (AD) of 1.01 to 1.14, the ACD being a distance between a proximal end of a commissure portion and a proximal end of an annulus portion; and
the stent component comprises:
an inflow end region and an outflow end region each comprising a plurality of cells, a number of cells per cm 2 area being 2 to 6 in the inflow end region and 1 to 4 in the outflow end region; and
at least one feeler configured to engage with a native commissure of a native heart valve, the at least one feeler being part of, or fixed to, a proximal end of the prosthesis.
18. A method for treating heart valve stenosis or heart valve insufficiency comprising
introducing a catheter preloaded with the prosthesis according to claim 1 in a patient's vasculature,
positioning the catheter for deploying the prosthesis at a target site,
releasing and deploying the prosthesis at the target site, and
retracting the catheter from the patient's vasculature.
19. The method of claim 18 , further comprising loading the prosthesis into the catheter before the step of introducing the catheter in the patient's vasculature.