One-piece heart valve stents adapted for post-implant expansion

• US 10,543,085 B2
• Filed: 06/13/2018
• Issued: 01/28/2020
• Est. Priority Date: 12/31/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• 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.
• Primary Examiner(s): Prone, Christopher D.
• Assistant Examiner(s): Shipmon, Tiffany P
• Application Number:
  US16/007,879
• Publication Number:
  US 20180289475A1
• Time in Patent Office: 594 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2310/00011 Metals or alloys

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.

Claims

1. A prosthetic heart valve adapted for post-implant expansion and having an inflow end and an outflow end, comprising:

a one-piece inner structural support stent including a generally circular solid lower band having three upstanding commissure posts, the stent defining an implant circumference that is substantially non-compressible in normal physiological use and has a first diameter, and wherein the lower band is a continuous solid band except for a point of discontinuity around its periphery formed by adjacent abutting ends of the solid band which touch but are otherwise not connected located below at least one of the commissure posts 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 but prevents contraction of the lower band; and

a plurality of flexible leaflets supported by the stent and configured to ensure one-way blood flow therethrough.

2. The prosthetic heart valve of claim 1, wherein each commissure post has a gap between two sides and the lower band extends across the gaps in two wall segments, wherein the point of discontinuity is located where the wall segments come together.

3. The prosthetic heart valve of claim 1, wherein there is a point of discontinuity located below each of the commissure posts.

4. The prosthetic heart valve of claim 3, wherein the one-piece inner structural support stent further includes cusp supports located between each of the commissure posts, each cusp support extending away from the lower band and diverging toward but not touching the adjacent commissure posts.

5. 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.

6. The prosthetic heart valve of claim 5, wherein the unique identifier is a numerical valve size in odd 2-millimeter increments between 15-33mm.

7. The prosthetic heart valve of claim 5, wherein the unique identifier is laser cut in the lower band.

8. The prosthetic heart valve of claim 1, wherein the one-piece inner structural support stent is made of titanium.

9. The prosthetic heart valve of claim 8, wherein each commissure post has a gap between two sides and the lower band extends across the gaps in two wall segments, wherein the point of discontinuity is located where the wall segments come together.

10. The prosthetic heart valve of claim 9, wherein there is a single point of discontinuity located below one of the commissure posts.

11. The prosthetic heart valve of claim 9, wherein there is a point of discontinuity located below each of the commissure posts.

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

13. The prosthetic heart valve of claim 1, wherein the one-piece inner structural support stent is made of an acetal copolymer.

14. The prosthetic heart valve of claim 13, wherein each commissure post has a gap between two sides and the lower band extends across the gaps in two wall segments, wherein the point of discontinuity is located where the wall segments come together.

15. The prosthetic heart valve of claim 14, wherein there is a single point of discontinuity located below one of the commissure posts.

16. The prosthetic heart valve of claim 14, wherein there is a point of discontinuity located below each of the commissure posts.

17. The prosthetic heart valve of claim 14, further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.