Post-implant expandable surgical heart valve configurations

• US 9,364,322 B2
• Filed: 12/20/2013
• Issued: 06/14/2016
• Est. Priority Date: 12/31/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S., Campbell, Louis A., Bobo, Donald E. Jr., Ford, Steven M., Johnson, Derrick
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/137,501
• Publication Number:
  US 20140188219A1
• Time in Patent Office: 907 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

Disclosed herein is a prosthetic heart valve, and associated methods therefore, 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. The prosthetic heart valve is configured to have an 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 having an inflow end and an outflow end, the prosthetic heart valve having a first unexpanded configuration and a second expanded configuration, the prosthetic heart valve comprising:

an inner support structure defined around a valve orifice, the support structure having a first inner diameter when the prosthetic heart valve is in the first unexpanded configuration and a second inner diameter when the prosthetic heart valve is in the second expanded configuration, the support structure configured when in the first unexpanded configuration to resist inward compression of the support structure and to permit radial expansion of the support structure to the second inner diameter when subjected to a dilation force, the support structure comprising a radially thin outer metallic support ring having an undulating shape with three downward cusps alternating with three upward truncated commissures around its circumference and including a single expansion segment that will plastically expand when subjected to the dilation force, the support structure further including a radially thin stent ring disposed in concentric abutment with and radially inside the support ring and being continuous and integrally formed of a polymeric material, the stent ring defining commissure posts aligned with and extending above the truncated commissures of the support ring and cusp portions aligned with the support ring cusps, wherein the support ring and the stent ring are secured together with a suture passing radially through both at a point around their common circumference, the stent ring having weakened areas below each of the commissure posts configured to break before other portions of the stent ring when the support ring expands; and

a valve portion supported by the support structure that allows for one-way blood flow through the valve when the valve is in the first unexpanded configuration.

2. The prosthetic heart valve of claim 1, wherein the expansion 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.

3. The prosthetic heart valve of claim 1, wherein the valve portion has flexible leaflets and further including a cloth covering surrounding the support structure and facilitating attachment of peripheral edges of the flexible leaflets along an outflow edge of the support structure.

4. The prosthetic heart valve of claim 1, wherein the expansion segment comprises a serpentine structure formed by metallic struts.

5. The prosthetic heart valve of claim 4, wherein the struts are compressed closely together, with minimal distances between adjacent struts in the unexpanded configuration to prevent inward compression of the structure to a smaller diameter.

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

6. A prosthetic heart valve having a first unexpanded configuration and a second expanded configuration, the prosthetic heart valve comprising:

a support structure defining a circumference, the support structure having a first inner diameter when the prosthetic heart valve is in the first unexpanded configuration and a second inner diameter when the prosthetic heart valve is in the second expanded configuration, wherein the second inner diameter is larger than the first inner diameter, wherein the support structure resists inward compression when the prosthetic heart valve is in the first unexpanded configuration, the support structure comprising a support band with circumferentially overlapping free ends with at least one hole each that register and are circumferentially aligned and a weakened section comprising a suture passing radially through the registered hole(s) and is secured by tying that maintains the free ends aligned but is configured to structurally fail when the support structure is subjected to a dilation force greater than forces associated with normal cardiac cycling, the support structure further including a stent band connected to the support band and having upstanding commissure posts;

a valve portion having flexible leaflets supported by the support structure that allows for one-way blood flow through the valve when the valve is in the first unexpanded configuration; and

an undulating wireform covered with fabric to which the valve 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 stent band.

7. The prosthetic heart valve of claim 6, wherein the support band has an undulating shape with alternating cusp and commissure portions, and the free ends overlap at one of the cusp portions.

8. The prosthetic heart valve of claim 6, wherein the support band has an undulating shape with alternating cusp and commissure portions, and the free ends overlap at one of the commissure portions.

9. The prosthetic heart valve of claim 6, wherein the stent band is arranged concentrically within the support band.

10. The prosthetic heart valve of claim 9, wherein the support band and the stent band are secured together at at least one point around the circumference of the support structure.

11. The prosthetic heart valve of claim 9, wherein the stent band comprises a polymeric material and the support band comprises a metal.

12. The prosthetic heart valve of claim 9, wherein the stent band comprises a weakened section configured to stretch or structurally fail when the support structure is subjected to the dilation force.

13. The prosthetic heart valve of claim 6, wherein the stent band commissure posts are aligned with and extend above the commissure portions of the support band and the stent band has cusps aligned with the support band cusp portions, and there are a plurality of weakened sections in the stent band located at each of the commissure posts.

14. The prosthetic heart valve of claim 6, wherein the support band comprises a metal and each overlapping free end has a series of holes that circumferentially align with the same number of holes in the other overlapping free end.

15. The prosthetic heart valve of claim 14, wherein the support band has an undulating shape with alternating cusp and commissure portions, and the free ends overlap at one of the cusp portions.

16. The prosthetic heart valve of claim 6, further including a cloth covering surrounding the support structure and facilitating attachment of peripheral edges of the flexible leaflets along an outflow edge of the support structure.

17. The prosthetic heart valve of claim 12, wherein the stent band includes a plurality of structurally weakened areas at an inflow edge below each of the commissure posts.

18. The prosthetic heart valve of claim 17, wherein the structurally weakened areas comprise notches at the inflow edge of the stent band.

19. The prosthetic heart valve of claim 6, further including a unique identifier on the support structure visible from outside the body after implant that identifies the support structure as being expandable.