Surgical heart valves adapted for post-implant expansion

• US 9,375,310 B2
• Filed: 12/20/2013
• Issued: 06/28/2016
• 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 M., Campbell, Louis A., Bobo, Donald E. Jr., Howanec, Myron, Lin, David S., Norasing, Peng, Tran, Francis M., Van Nest, Mark, Chien, Thomas Y., Chen, Harvey H., Guerrero, Isidro L., Johnson, Derrick, Schmidt, Paul A.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/136,318
• Publication Number:
  US 20140188221A1
• Time in Patent Office: 921 Days
• US Class Current: 1/1
• 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 an annular composite band having upstanding commissure posts extending in the outflow direction alternating with arcuate inflow cusps, wherein the support stent comprises a radially thin outer band located concentrically around and attached to a radially thin inner band that defines the commissure posts, the stent defining an implant circumference that is non-compressible in normal physiological use and has a first diameter, and wherein the outer band has a single 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 larger than forces associated with normal physiological use, the single expandable segment being formed by overlapping free ends of the outer band located at one of the cusps of the stent, the free ends overlapping with one outside the other and wherein a flexible sleeve closely surrounds the overlapped free ends to maintain alignment thereof and provides an amount of friction to resist expansion thereof, the free ends otherwise being free to expand from the first diameter, and wherein the inner band is configured to expand below each of the commissure posts when the outer band expands; 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 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.

3. The prosthetic heart valve of claim 2, wherein the tabs have bulbous heads connected to the free ends by slimmer stems.

4. The prosthetic heart valve of claim 1, further including circumferential slots formed along each free end that extend circumferentially beyond the sleeve when the support stent is in the first unexpanded configuration and permit fluid flow within a cavity defined by the sleeve.

5. 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.

6. The prosthetic heart valve 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.

7. 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.

8. 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.

9. The prosthetic heart valve of claim 1, further including 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.

10. The prosthetic heart valve of claim 9, 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.

11. 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.

12. The prosthetic heart valve of claim 1, wherein the inner band includes structurally weakened areas at the inflow edge below each of the commissure posts.

13. The prosthetic heart valve of claim 12, wherein the structurally weakened areas comprise notches at the inflow edge of the inner band.

14. The prosthetic heart valve of claim 1, wherein the sleeve is biodegradable to maintain alignment of the overlapping free ends for a period after implant and then permit easy expansion of the outer band after degradation.

15. The prosthetic heart valve of claim 1, wherein the sleeve is an elastic material.

16. The prosthetic heart valve of claim 1, wherein the sleeve is formed of silicone rubber.

17. The prosthetic heart valve of claim 1, wherein the sleeve is formed of polyester.

18. The prosthetic heart valve of claim 17, wherein the sleeve is PET.

19. The prosthetic heart valve of claim 1, wherein the sleeve is a shrink wrap material.

20. The prosthetic heart valve of claim 1, further including an undulating wireform covered with fabric to which the leaflets are partially connected around their peripheral edges, and the leaflets include outwardly-projecting tabs that pass outside of the wireform and attach to the commissure posts of the inner band of the support stent.