Heart valve sealing assemblies

Patent metadata

Field	Value
Publication number	US-2021353408-A1
Application number	US-202117389771-A
Country	US
Kind code	A1
Filing date	Jul 30, 2021
Priority date	Jan 30, 2019
Publication date	Nov 18, 2021
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 forming a series of pockets around the stent open to an inflow direction.

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 pockets between the interrupted locations.

4 . 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 above the plush fabric cuff.

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 secured around the plush fabric cuff.

6 . 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.

7 . 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.

8 . 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.

9 . The heart valve of claim 8 , wherein the flap of fabric has an undulating outer edge which forms a series of outwardly-protruding lobes around its circumference.

10 . The heart valve of claim 8 , 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.

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

12 . The heart valve of claim 8 , wherein the outer edge extends outward beyond the sealing ring by between about 10-20% of the diameter of the valve member.

13 . The heart valve of claim 8 , wherein the inner edge of the flap of fabric extends downward within the stent and is secured thereto with sutures.

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

15 . 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 strip of fabric circumscribing the stent outside of the thin fabric layer having a series of longitudinal pleats formed by folding the strip of fabric longitudinally upon itself at regular intervals to form longitudinal folds and securing the folds with suture to form the pleats.

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, wherein the strip of fabric is located immediately above the plush fabric cuff.

17 . The heart valve of claim 15 , wherein the strip of fabric extends the entire length of the stent.

18 . The heart valve of claim 15 , wherein the strip of fabric comprises a rectangular strip having a series of tabs spaced intermittently along an upper edge, wherein the rectangular strip is folded upon itself in a manner that places the tabs adjacent one another, wherein the tabs are sewn together and the strip sewn to the outside of the thin fabric layer to form the pleated skirt.

Assignees

• Edwards Lifesciences Corp

Inventors

• Chen Harvey H
• Nguyen Son V
• Nguyen Devin D
• George 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

• A61F2/2418

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

• A61F2220/0075

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