SURGICAL HEART VALVES ADAPTED FOR POST-IMPLANT EXPANSION

• US 20140188221A1
• Filed: 12/20/2013
• Published: 07/03/2014
• 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., Campbell, Louis A., Bobo, Donald E. Jr., Lin, David S., Norasing, Peng, Van Nest, Mark, Chen, Harvey H., Johnson, Derrick, Kim, Grace M., Howanec, Myron, Tran, Francis M., Chien, Thomas Y., Guerrero, Isidro L., Schmidt, Paul A.
• Granted Patent: US 9,375,310 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 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:

an inner structural support stent including a generally circular composite band having upstanding commissure posts, wherein the support stent comprises an outer band surrounding and attached to an inner band that defines the 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 outer band 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; 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 the outer band includes a single expandable segment formed by overlapping free ends and located at either one of the cusps or one of the commissures.

3. The prosthetic heart valve of claim 2, wherein the overlapping free ends of the outer band each includes at least one hole that register with one another and a suture passed through the registered holes maintain the free ends aligned but is configured to break when the support stent is subjected to the outward dilatory force.

4. The prosthetic heart valve of claim 2, wherein the overlapping free ends of the outer band includes interlaced tabs that engage one another to maintain alignment of the free ends and permit a limited expansion of the support stent.

5. The prosthetic heart valve of claim 4, wherein the tabs have bulbous heads connected to the free ends by slimmer stems.

6. The prosthetic heart valve of claim 2, wherein the overlapping free ends of the outer band overlap with one outside the other and a sleeve surrounds them to maintain alignment of the free ends.

7. The prosthetic heart valve of claim 6, further including circumferential slots formed along each free end that extend beyond the sleeve when the support stent is in the first unexpanded configuration and permit fluid flow within a cavity defined by the sleeve.

8. The prosthetic heart valve of claim 2, wherein overlapping free ends of the outer band are located below one of the commissure posts of the inner band and the inner band further includes a notch at an inflow edge of the one commissure post to facilitate radial expansion thereof.

9. The prosthetic heart valve of claim 2, wherein the expandable segment comprises at least one tab on one free end bent around the other free end.

10. The prosthetic heart valve of claim 2, wherein the expandable segment comprises at least one tab on one free end that projects through a slot in the other free end.

11. The prosthetic heart valve of claim 2, wherein the overlapping free ends of the outer band each includes at least one hole that register and a polymer element passed through the registered holes maintains the free ends aligned but is configured to break when the support stent is subjected to the outward dilatory force.

12. The prosthetic heart valve of claim 1, wherein the inner band is a single polymer band, and the outer band is a single metallic band.

13. The prosthetic heart valve of claim 1, wherein the expandable segment comprises a series of interconnected struts connected end-to-end by hinge-like connections which forms an accordion-like structure having substantially diamond-shaped cells.

14. The prosthetic heart valve of claim 1, wherein the expandable segment comprises a substantially serpentine structure formed by plastically-expandable struts.

15. 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.

16. 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.

17. 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.

18. The prosthetic heart valve of claim 1, further including a biodegradable band disposed concentrically and in close contact with the structural 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.

19. The prosthetic heart valve of claim 18, 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.

20. The prosthetic heart valve of claim 1, wherein the valve is configured to expand without substantial change to the circumferential spacing of the commissure posts.