Surgical heart valves adapted for post implant expansion

Patent metadata

Field	Value
Publication number	US-2016296331-A1
Application number	US-201615190094-A
Country	US
Kind code	A1
Filing date	Jun 22, 2016
Priority date	Sep 19, 2008
Publication date	Oct 13, 2016
Grant date	—

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 . A surgical prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:
a continuous circular structural support stent surrounding a flow axis and having upstanding three commissure posts cantilevered toward the outflow end of the heart valve, wherein the support stent defines an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use and has at least one expandable segment around its periphery that permits expansion of the support stent from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use; a biodegradable band disposed concentrically and in close contact with the support stent, the biodegradable band configured to provide resistance to expansion of the support stent after implantation which resistance lessens over time as the band degrades in the body; and a plurality of flexible leaflets supported by the support stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve.

2 . The prosthetic heart valve of claim 1 , wherein the prosthetic heart valve further includes a radially-expandable inflow stent secured to and projecting from an inflow end of the support stent, wherein the radially-expandable inflow stent has a strength requiring a predetermined expansion force to convert to an expanded state, and wherein the biodegradable band is configured to provide resistance to expansion of the support stent when the predetermined expansion force is applied to the radially-expandable inflow stent.

3 . The prosthetic heart valve of claim 1 , wherein the support stent is a single polymer band.

4 . The prosthetic heart valve of claim 1 , wherein the support stent is a single metallic band.

5 . The prosthetic heart valve of claim 1 , wherein the expandable segment comprises a weak point that fails.

6 . The prosthetic heart valve of claim 1 , wherein the expandable segment comprises a structure that stretches.

7 . The prosthetic heart valves of claim 1 , wherein the prosthetic heart valve is a two-part valve with the plurality of flexible leaflets being mounted on a detachable frame that couples to the support stent at the commissure posts thereof.

8 . The prosthetic heart valve of claim 1 , further including a cloth covering surrounding the support stent and facilitating attachment of leaflet peripheral edges along an outflow edge of the support stent.

9 . The prosthetic heart valve of claim 1 , further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

10 . The prosthetic heart valve of claim 1 , wherein there is just one of the expandable segments located around the support stent intermediate two adjacent commissure posts.

11 . The prosthetic heart valve of claim 1 , wherein there are three of the expandable segments located around the support stent intermediate each two adjacent commissure posts.

12 . A surgical prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:
a continuous circular structural support stent surrounding a flow axis and having upstanding three commissure posts cantilevered toward the outflow end of the heart valve, wherein the support stent defines an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use and at least one biodegradable segment that is configured to provide resistance to expansion of the support stent after implantation which resistance lessens over time as the band degrades in the body so as to permit expansion of the support stent from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use; and a plurality of flexible leaflets supported by the support stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve.

13 . The prosthetic heart valve of claim 12 , the biodegradable segment is located intermediate two adjacent commissure posts.

14 . The prosthetic heart valve of claim 12 , wherein there are three of the biodegradable segments located around the support stent intermediate each two adjacent commissure posts.

15 . The prosthetic heart valve of claim 12 , wherein the support stent further includes at least one reinforcing filament embedded therein and extending around the implant circumference, the reinforcing filament providing resistance to expansion of the support stent until application of a predetermined outward dilatory force from within the support stent.

16 . The prosthetic heart valve of claim 15 , wherein the prosthetic heart valve further includes a radially-expandable inflow stent secured to and projecting from an inflow end of the support stent, wherein the radially-expandable inflow stent has a strength requiring a predetermined expansion force to convert to an expanded state, and wherein the reinforcing filament is configured to provide resistance to expansion of the support stent when the predetermined expansion force is applied to the radially-expandable inflow stent.

17 . The prosthetic heart valve of claim 12 , wherein the support stent defines arcuate cusp regions intermediate each two adjacent commissure posts, and wherein the biodegradable segment is a chordal segment located in one of the cusp regions that tapers larger from the commissure posts until a maximum axial dimension at mid-points of the cusp regions.

18 . The prosthetic heart valve of claim 12 , wherein the support stent is a single polymer band.

19 . The prosthetic heart valve of claim 12 , the prosthetic heart valve is a two-part valve with the plurality of flexible leaflets being mounted on a detachable frame that couples to the support stent at the commissure posts thereof.

20 . The prosthetic heart valve of claim 12 , further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

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 H
• Chen Harvey H
• Guerrero Isidro L
• Johnson Derrick
• Schmidt Paul A

Classifications

• A61F2250/0004

  adjustable · CPC title

• A61F2250/0063

  Nested prosthetic parts · CPC title

• A61F2210/0004

  bioabsorbable · CPC title

• A61F2220/0033

  made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit · CPC title

• A61F2310/00011

  Metals or alloys · CPC title