Prosthetic heart valve having leaflet inflow below frame

Patent metadata

Field	Value
Publication number	US-2018133003-A1
Application number	US-201715808599-A
Country	US
Kind code	A1
Filing date	Nov 9, 2017
Priority date	Nov 17, 2016
Publication date	May 17, 2018
Grant date	—

Abstract

Embodiments of a prosthetic heart valve are disclosed. An implantable prosthetic valve can include an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end. The valve can include a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame.

First claim

We claim:

1 . An implantable prosthetic valve comprising:
an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end; and a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges is unsupported by the frame.

2 . The valve of claim 1 , further comprising an inner skirt, wherein a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame.

3 . The valve of claim 2 , wherein the portions of the leaflet inflow edges unsupported by the frame are connected to the second portion of the inner skirt.

4 . The valve of claim 2 , wherein the inner skirt includes a first set of fibers that are sufficiently stiff to impede inward bending of the second portion due to systolic pressure gradient and blood flowing from the left ventricle to the aorta.

5 . The valve of claim 4 , wherein the first set of fibers run parallel to the central longitudinal axis.

6 . The valve of claim 4 , wherein the inner skirt includes a second set of fibers that run perpendicular to the first set of fibers, wherein the first set of fibers are stiffer than the second set of fibers.

7 . The valve of claim 4 , wherein the first set of fibers include monofilaments.

8 . The valve of claim 1 , wherein the portions of the leaflet inflow edges unsupported by the frame each include an apex portion of each leaflet.

9 . The valve of claim 1 , wherein the frame includes at least two rows of cells extending circumferentially around the central longitudinal axis and the at least two rows of cells define openings having a length in an axial direction and a length of the portion of the inflow edges unsupported by the frame is equal to or greater than the length of the openings.

10 . The valve of claim 1 , further comprising an outer sealing member mounted on the outside of the frame.

11 . The valve of claim 1 , further comprising an outer support layer mounted on the outside of the frame having an inflow end portion that extends axially beyond the inflow end of the frame, and the portions of the leaflet inflow edges unsupported by the frame are connected to the inflow end portion of the outer support layer.

12 . An implantable prosthetic valve, the prosthetic valve comprising:
an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end; an inner skirt, wherein a first portion of the inner skirt extends circumferentially around the central longitudinal axis along an inner surface of the frame and a second portion of the inner skirt extends circumferentially around the central longitudinal axis outside of the frame; and a valvular structure including two or more leaflets, each of the two or more leaflets having a leaflet inflow edge positioned at least partially outside of the frame and a leaflet outflow edge positioned within the frame, wherein at least a portion of each of the leaflet inflow edges are connected to the second portion of the inner skirt.

13 . The valve of claim 12 , wherein the inner skirt includes a first set of fibers and a second set of fibers that runs perpendicular to the first set of fibers, wherein the first set of fibers is stiffer than the second set of fibers.

14 . The valve of claim 12 , wherein the frame includes a row of cells defining openings having a length in an axial direction and further wherein a length of the second portion is equal to or greater than the length of the openings.

15 . The valve of claim 12 , further comprising an outer skirt connected to the second portion of the inner skirt.

16 . The valve of claim 12 , wherein the portions of the leaflet inflow edges unsupported by the frame include an apex portion of each leaflet.

17 . An implantable prosthetic valve comprising:
an annular frame having an inflow end, an outflow end and a central longitudinal axis extending from the inflow end to the outflow end; a support layer, wherein a first portion of the support layer extends circumferentially around the central longitudinal axis along an outer surface of the frame and a second portion of the support layer extends circumferentially around the central longitudinal axis axially beyond the inflow end of the frame; and a valvular structure, wherein at least a portion of the valvular structure is connected to the second portion of the support layer and is unsupported by the frame.

18 . The valve of claim 17 , further comprising an outer skirt positioned radially outside of the support layer and connected to the second portion of the support layer at an inflow end of the outer skirt.

19 . The valve claim 17 , wherein the support layer includes a first set of fibers and a second set of fibers that runs perpendicular to the first set of fibers, wherein the first set of fibers is stiffer than the second set of fibers.

20 . The valve of claim 19 , wherein the first set of fibers includes monofilaments.

21 . The valve of claim 17 , wherein the valvular structure comprises a plurality of leaflets and the at least a portion of the valvular structure unsupported by the frame includes an apex portion of each leaflet.

Assignees

• Edwards Lifesciences Corp

Inventors

• Levi Tamir S

Classifications

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2250/0003

  having an inflatable pocket filled with fluid, e.g. liquid or gas · CPC title

• A61F2/915

  with bands having a meander structure, adjacent bands being connected to each other · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title