Prosthetic heart valve
The present disclosure is directed to embodiments of catheter-based prosthetic heart valves. In one embodiment, a prosthetic heart valve includes a collapsible and expandable annular frame, a leaflet assembly mounted within the annular frame, a first skirt mounted on the frame, and a second skirt mounted on the frame. The frame includes a plurality of rows of cells. The leaflet assembly includes a plurality of leaflets. Adjacent leaflets are connected to each other to form commissures, each of which is connected to a cell of an outflow row of cells of the frame. Inflow end portions of the leaflets are sutured to an outflow end portion of the first skirt along undulating suture line.
1 . A prosthetic heart valve, comprising:
a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside a patient's body, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame comprising a plurality of rows of angled struts, including a first row of angled struts defining the inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, a third row of angled struts downstream of the second row of angled struts, and a fourth row of angled struts downstream of the third row of angled struts and defining the outflow end of the frame, wherein the first and second rows of angled struts define an inflow row of cells and the third and fourth rows of angled struts define an outflow row of cells;
a leaflet assembly mounted within the frame, wherein the leaflet assembly comprises a plurality of leaflets, wherein each leaflet comprises an inflow end portion and an outflow end portion, wherein adjacent leaflets are connected to each other at the outflow end portions to form commissures of the leaflet assembly, wherein each commissure is aligned with one of the cells of the outflow row of cells and secured to two angled struts of the third row of angled struts and two angled struts of the fourth row of angled struts with sutures, wherein the sutures form multiple stitches that extend around and are spaced along a length of each of the two angled struts of the third row and each of the two angled struts of the fourth row at each commissure;
a first skirt mounted on the frame, wherein the first skirt has an inflow end portion and an outflow end portion, wherein the inflow end portions of the leaflets are sutured to the outflow end portion of the first skirt along an undulating suture line, wherein the outflow end portion of the first skirt has an undulating shape that corresponds with the undulating suture line; and
a second skirt mounted on the frame radially outward from the first skirt, wherein the second skirt has an inflow end portion and an outflow end portion.
2 . The prosthetic heart valve of claim 1 , wherein the second skirt comprises a pile fabric.
3 . The prosthetic heart valve of claim 2 , wherein the pile fabric is made of loop yarn.
4 . The prosthetic heart valve of claim 3 , wherein the loop yarn comprises polyethylene terephthalate loop yarn.
5 . The prosthetic heart valve of claim 2 , wherein the pile fabric is made of textured yarn.
6 . The prosthetic heart valve of claim 1 , wherein the inflow row of cells defines a plurality of apices at the inflow end of the frame and the inflow end portion of the second skirt extends beyond the apices when the frame is in the radially expanded state.
7 . The prosthetic heart valve of claim 1 , wherein the outflow end portion of the second skirt comprises a straight upper edge that transects the cells of one of the rows of cells.
8 . The prosthetic heart valve of claim 1 , wherein the frame comprises exactly four rows of cells.
9 . The prosthetic heart valve of claim 1 , wherein the cells are diamond shaped.
10 . The prosthetic heart valve of claim 1 , wherein the first skirt comprises a woven fabric and the second skirt comprises a knitted fabric.
11 . A method of implanting the prosthetic heart valve of claim 1 , wherein the method comprises:
inserting an introducer sheath into a blood vessel of a patient, wherein the introducer sheath comprises a tubular layer, an inner liner covering an inner surface of the tubular layer, and an outer layer covering an outer surface of the tubular layer, wherein the tubular layer comprises a metal or metal alloy;
inserting a distal end portion of the delivery apparatus through the introducer sheath and into the blood vessel, wherein the prosthetic heart valve is in a radially compressed state on the distal end portion of the delivery apparatus;
deploying the prosthetic heart valve in a native annulus of the heart.
12 . A prosthetic heart valve, comprising:
a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside a patient's body, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame comprising a plurality of struts, including a first row of angled struts defining the inflow end of the frame, a second row of angled struts downstream of the first row of angled struts, a third row of angled struts downstream of the second row of angled struts, a fourth row of angled struts downstream of the third row of angled struts, and a fifth row of angled struts downstream of the fourth row of angled struts and defining the outflow end of the frame, wherein the first and second rows of angled struts define a first, inflow row of cells, the second and third row of angled struts define a second row of cells downstream of the first row of cells, the third and fourth row of angled struts define a third row of cells downstream of the second row of cells, and the fourth and fifth row of angled struts define a fourth, outflow row of cells;
a leaflet assembly mounted within the frame, wherein the leaflet assembly comprises a plurality of leaflets, wherein each leaflet comprises an inflow end portion and an outflow end portion, wherein adjacent leaflets are connected to each other at the outflow end portions to form commissures of the leaflet assembly, wherein each commissure is aligned with one of the cells of the fourth row of cells and secured to two angled struts of the fourth row of angled struts and two angled struts of the fifth row of angled struts with sutures, wherein the sutures form multiple stitches that extend around and are spaced along a length of each of the two angled struts of the fourth row and each of the two angled struts of the fifth row at each commissure;
a first skirt mounted on the frame, wherein the first skirt has an inflow end portion and an outflow end portion, wherein the inflow end portions of the leaflets are sutured to the outflow end portion of the first skirt along an undulating suture line, wherein the outflow end portion of the first skirt has an undulating shape that corresponds with the undulating suture line, wherein the first skirt covers cells of the first and second rows of cells; and
a second skirt mounted on the frame radially outward from the first skirt, wherein the second skirt has an inflow end portion and an outflow end portion;
wherein the first skirt extends from the inflow end of the frame and overlaps the second skirt along an inflow end portion of the frame and extends beyond the outflow end portion of the second skirt in a direction toward the outflow end of the frame.
13 . The prosthetic heart valve of claim 12 , wherein the frame comprises exactly four rows of cells.
14 . The prosthetic heart valve of claim 12 , wherein the cells are diamond shaped.
15 . The prosthetic heart valve of claim 12 , wherein the first skirt comprises a woven fabric and the second skirt comprises a knitted fabric.
16 . The prosthetic heart valve of claim 12 , wherein the outflow end portion of the second skirt comprises a straight upper edge.
17 . The prosthetic heart valve of claim 16 , wherein the inflow end portion of the second skirt comprises a straight lower edge.
18 . The prosthetic heart valve of claim 12 , wherein the suture line transects struts that form the first row of cells.
19 . The prosthetic heart valve of claim 12 , wherein the second skirt comprises a pile fabric.
20 . The prosthetic heart valve of claim 19 , wherein the pile fabric is made of textured yarn.
21 . The prosthetic heart valve of claim 12 , wherein the cells of the fourth row of cells have the same size and shape.