Assembly of heart valves and intermediate adapter stent

Patent metadata

Field	Value
Publication number	US-11883282-B2
Application number	US-201916695008-A
Country	US
Kind code	B2
Filing date	Nov 25, 2019
Priority date	Dec 31, 2012
Publication date	Jan 30, 2024
Grant date	Jan 30, 2024

Abstract

A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

First claim

What is claimed is:

1. An assembly of a primary prosthetic heart valve with a secondary prosthetic heart valve expanded therein, comprising:
a surgical primary prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising a structural support stent defining an implant circumference that defines an orifice size of the primary prosthetic heart valve;
an adapter stent configured to be delivered in a contracted state to a position within an implanted primary prosthetic heart valve and expanded within the primary prosthetic heart valve so as to contact an inner orifice thereof, the adapter stent comprising a generally tubular configuration of interconnected struts defining an inflow end and an outflow end, wherein the adapter stent is formed by a series of generally axially-oriented serpentine segments defining circumferential rows of connection points at and between the inflow end and the outflow end, the adapter stent having a plurality of outward barbs extending from connection points and arrayed evenly around the outflow end that project radially outwardly to interface with the primary prosthetic heart valve which comprises a plurality of leaflets and commissure posts and a plurality of inward barbs extending from connection points and arrayed evenly around the inflow end that project radially inwardly to interface with frame struts of a secondary prosthetic heart valve expanded therein, wherein the outward barbs are arrayed just around two circumferential rows of connection points adjacent the outflow end, and the inward barbs are arrayed just around two circumferential rows of connection points adjacent the inflow end; and
the secondary prosthetic heart valve configured to be delivered in a contracted state to a position within the expanded adapter stent in contact with the primary prosthetic heart valve, the secondary prosthetic heart valve also being configured to expand outward into contact with the adapter stent.

2. The assembly of claim 1 , wherein the adapter stent is configured to be plastically expanded so as to contact an inner orifice thereof and expand the support stent of the primary prosthetic heart valve, and the secondary prosthetic heart valve is self-expandable.

3. The assembly of claim 1 , wherein the secondary prosthetic heart valve is configured to be plastically expanded so as to contact an inner orifice thereof and expand the support stent of the primary prosthetic heart valve.

4. The assembly of claim 1 , wherein the adapter stent is covered with a velour cloth.

5. The assembly of claim 1 , wherein the structural support stent of the primary prosthetic heart valve comprises an outer band surrounding and attached to an inner band that defines alternating cusps and the commissure posts, wherein the outer band has a single expandable segment around its periphery that permits expansion of the support stent from the first diameter to the second diameter.

6. The assembly of claim 1 , wherein the structural support stent of the primary prosthetic heart valve comprises a band that defines alternating cusps and the commissure posts, wherein the band has a single expandable segment formed by overlapping free ends located at one of the cusps that permits expansion of the support stent from the first diameter to the second diameter.

7. An assembly of a primary prosthetic heart valve with a secondary prosthetic heart valve expanded therein, comprising:
a surgical primary prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising a structural support stent defining an implant circumference that defines an orifice size of the primary prosthetic heart valve;
an adapter stent configured to be delivered in a contracted state to a position within an implanted primary prosthetic heart valve and expanded within the primary prosthetic heart valve so as to contact an inner orifice thereof, the adapter stent comprising a generally tubular configuration of interconnected struts joined at circumferential rows of connection points and defining an inflow end and an outflow end, the adapter stent having a plurality of barbs arrayed evenly around the outflow end each comprising a linear segment extending from a connection point toward the inflow end and having a small outwardly curved free end to interface with the primary prosthetic heart valve which comprises a plurality of leaflets and commissure posts and a plurality of inward barbs arrayed evenly around the inflow end each comprising a linear segment extending from a connection point toward the outflow end and having a small inwardly curved free end to interface with frame struts of a secondary prosthetic heart valve expanded therein; and
the secondary prosthetic heart valve configured to be delivered in a contracted state to a position within the expanded adapter stent in contact with the primary prosthetic heart valve, the secondary prosthetic heart valve also being configured to expand outward into contact with the adapter stent.

8. The assembly of claim 7 , wherein the adapter stent is formed by a series of generally axially-oriented serpentine segments with the circumferential rows of connection points located at and between the inflow end and the outflow end.

9. The assembly of claim 8 , wherein the outwardly projecting barbs are arrayed just around two circumferential rows of connection points adjacent the outflow end, and the inwardly projecting barbs are arrayed just around two circumferential rows of connection points adjacent the inflow end.

10. The assembly of claim 7 , wherein the adapter stent is configured to be plastically expanded so as to contact an inner orifice thereof and expand the support stent of the primary prosthetic heart valve, and the secondary prosthetic heart valve is self-expandable.

11. The assembly of claim 7 , wherein the secondary prosthetic heart valve is configured to be plastically expanded so as to contact an inner orifice thereof and expand the support stent of the primary prosthetic heart valve.

12. The assembly of claim 7 , wherein the adapter stent is covered with a velour cloth.

13. The assembly of claim 7 , wherein the structural support stent of the primary prosthetic heart valve comprises an outer band surrounding and attached to an inner band that defines alternating cusps and the commissure posts, wherein the outer band has a single expandable segment around its periphery that permits expansion of the support stent from the first diameter to the second diameter.

14. The assembly of claim 7 , wherein the structural support stent of the primary prosthetic heart valve comprises a band that defines alternating cusps and the commissure posts, wherein the band has a single expandable segment formed by overlapping free ends located at one of the cusps that permits expansion of the support stent from the first diameter to the second diameter.

Assignees

• Edwards Lifesciences Corp

Inventors

• Chung Visith
• Chang Da-Yu
• Conklin Brian S
• Kim Grace Myong
• Campbell Louis A
• Bobo Jr Donald E
• Howanec Jr Myron
• Lin David S
• Norasing Peng
• Tran Francis M
• Van Nest Mark
• Chien Thomas
• Chen Harvey H
• Guerrero Isidro L
• Johnson Derrick
• Schmidt Paul A
• Woo Cindy

Classifications

• A61F2/2418 Primary

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

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/2445

  Annuloplasty rings in direct contact with the valve annulus · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2210/0004

  bioabsorbable · CPC title