Heart valve sealing assemblies

Patent metadata

Field	Value
Publication number	US-12138153-B2
Application number	US-202117389771-A
Country	US
Kind code	B2
Filing date	Jul 30, 2021
Priority date	Jan 30, 2019
Publication date	Nov 12, 2024
Grant date	Nov 12, 2024

Abstract

A hybrid heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The hybrid heart valve includes a substantially non-expandable, non-compressible prosthetic valve member having a peripheral sealing ring and an expandable stent frame projecting from an inflow end, thereby enabling attachment to the annulus without sutures. The stent frame may be plastically-expandable and may have a thin fabric layer covering its entirety as well as secondary sealing structures around its periphery to prevent paravalvular leaking. Other sealing solutions include interactive steps at the time of valve implant to establish seals around the stent and especially between the stent and the sealing ring of the valve member.

First claim

What is claimed is:

1. A hybrid prosthetic heart valve for implant at a heart valve annulus, comprising:
a valve member having a non-expandable, non-collapsible annular support structure defining a flow orifice and having an inflow end, the valve member having valve leaflets attached to the support structure and mounted to alternately open and close across the flow orifice and a compressible sealing ring encircling the inflow end of the annular support structure;
an expandable stent secured to the inflow end of the annular support structure and extending therefrom to an inflow edge, the stent comprising a generally tubular stent frame formed by struts, the stent frame being covered by a thin fabric layer; and
a flap of fabric having a circular inner edge secured between the stent and the valve member and an outer edge that extends outward adjacent and to an inflow side of the sealing ring and radially outward beyond the sealing ring.

2. The heart valve of claim 1 , wherein the flap of fabric has an undulating outer edge which forms a series of outwardly-protruding lobes around its circumference.

3. The heart valve of claim 2 , wherein the annular support structure of the valve member includes three evenly-spaced commissure posts alternating with three arcuate cusps, and there are three outwardly-protruding lobes each centered about one of the commissure posts.

4. The heart valve of claim 3 , wherein the outwardly-protruding lobes each extend outward beyond the sealing ring by between about 10-20% of the diameter of the valve member.

5. The heart valve of claim 2 , wherein the outer edge extends outward beyond the sealing ring by between about 10-20% of the diameter of the valve member.

6. The heart valve of claim 1 , wherein the outer edge extends outward beyond the sealing ring by between about 10-20% of the diameter of the valve member.

7. The heart valve of claim 1 , wherein the inner edge of the flap of fabric extends downward within the stent and is secured thereto with sutures.

8. The heart valve of claim 1 , wherein the outer edge is intermittently secured to the sealing ring with sutures so as to form pockets between the sutures.

9. The heart valve of claim 1 , wherein the flap of fabric is made of polyethylene terephthalate.

10. The heart valve of claim 9 , wherein the annular support structure of the valve member includes three evenly-spaced commissure posts alternating with three arcuate cusps, and the flap of fabric has an undulating outer edge which forms a series of outwardly-protruding lobes around its circumference each centered about one of the commissure posts.

11. The heart valve of claim 10 , wherein the inner edge of the flap of fabric extends downward within the stent and is secured thereto with sutures while the outer edge remains free.

Assignees

• Edwards Lifesciences Corp

Inventors

• Chen Harvey H
• Nguyen Son V
• Nguyen Devin D
• Edwards Diana Marie
• Yambao August R
• Rao Jyoti B
• Kornswiet Alyssa E
• Ai Lisong
• Tang Stephen W
• Romero Edward
• Dang Kevin K
• Francis Meena
• Campbell Louis A
• Kim Grace Myong

Classifications

• A61F2/2412 Primary

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

• A61F2250/006

  modular · CPC title

• A61F2250/0048

  differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title