Heart valve sealing assemblies

Patent metadata

Field	Value
Publication number	US-2025057646-A1
Application number	US-202418934905-A
Country	US
Kind code	A1
Filing date	Nov 1, 2024
Priority date	Jan 30, 2019
Publication date	Feb 20, 2025
Grant date	—

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 narrow band of fabric circumscribing the stent outside of the thin fabric layer and forming a series of pockets around the stent open to an inflow direction, the narrow band being narrower than an axial height of the stent.

2 . The heart valve of claim 1 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the band of fabric is located approximately midway along the stent, spaced from both the plush fabric cuff and the inflow end of the annular support structure.

3 . The heart valve of claim 1 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the band of fabric extends between the plush fabric cuff and the compressible sealing ring and is attached at interrupted locations to the compressible sealing ring to form the pockets between the interrupted locations.

4 . The heart valve of claim 3 , wherein the band of fabric comprises a folded-over sheet of fabric with a rear portion separated from a crenellated front portion at a longitudinal fold line, and the pockets are formed in valleys between peaks of the crenellated front portion.

5 . The heart valve of claim 1 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the band of fabric is located immediately axially above the plush fabric cuff.

6 . The heart valve of claim 1 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the band of fabric is secured around the plush fabric cuff.

7 . The heart valve of claim 1 , wherein the band of fabric is secured around the inflow edge of the stent, and further including a plush fabric cuff secured on top of the band of fabric.

8 . The heart valve of claim 1 , wherein the band of fabric comprises a folded-over sheet of fabric with a rear portion separated from a crenellated front portion at a longitudinal fold line, and the pockets are formed in valleys between peaks of the crenellated front portion.

9 . The heart valve of claim 8 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the plush fabric cuff reaches and covers the longitudinal fold line of the folded-over sheet of fabric.

10 . The heart valve of claim 9 , wherein the band of fabric extends between the plush fabric cuff and the compressible sealing ring and the peaks of the crenellated front portion are attached to the compressible sealing ring.

11 . 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 band of fabric circumscribing the stent outside of the thin fabric layer and forming a series of pockets around the stent open to an inflow direction, a lower edge of the band being sutured to the thin fabric layer along a circumferential stitch line.

12 . The heart valve of claim 11 , wherein the band of fabric comprises a folded-over sheet of fabric with a rear portion separated from a crenellated front portion at a longitudinal fold line, and the pockets are formed in valleys between peaks of the crenellated front portion.

13 . The heart valve of claim 12 , wherein the peaks of the crenellated front portion are attached to the compressible sealing ring.

14 . The heart valve of claim 13 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent.

15 . The heart valve of claim 12 , wherein the peaks of the crenellated front portion are attached to the thin fabric layer.

16 . The heart valve of claim 15 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent.

17 . The heart valve of claim 11 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent.

18 . The heart valve of claim 17 , wherein the band of fabric is located immediately axially above the plush fabric cuff.

19 . The heart valve of claim 11 , wherein the band of fabric is secured around the inflow edge of the stent, and the plush fabric cuff is secured on top of the band of fabric.

20 . The heart valve of claim 11 , further including a plush fabric cuff surrounding the thin fabric layer around the inflow edge of the stent, wherein the plush fabric cuff reaches and covers the circumferential stitch line.

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