IP Library › Granted Patent US 12,419,741
Granted Patent B2
US 12,419,741 · App. 18/330,304 · Granted Sep 23, 2025

Limited expansion heart valves

Inventors: Brian S. Conklin (Orange, CA); Da-Yu Chang (Irvine, CA)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2418A61F2/2409A61F2220/0033A61F2220/0075
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Quick Facts
Patent No.
US 12,419,741
App. No.
18/330,304
Granted
Sep 23, 2025
Kind
B2
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. Interlocking members or flexible loops are included to limit expansion of the valve to one or two valve sizes, for example, with a 2-mm gap between each valve size. The valve may include an internal structural band with overlapped free ends having structure for limiting expansion, or external loops of suture may be added to the fabric covering which limits expansion.

Claims (26)

1. A prosthetic heart valve adapted for hosting a valve-in-valve procedure, comprising:

a non-collapsible surgical prosthetic heart valve adapted to be implanted at a native valve annulus, the surgical prosthetic heart valve having a non-collapsible inner structural support stent with three upstanding commissure posts extending in an outflow direction and three flexible leaflets supported by and within the commissure posts to ensure one-way blood flow through the heart valve, the support stent being configured to expand upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use such that the support stent periphery increases from a first diameter to a second diameter at least 2 mm larger in diameter than the first diameter, and wherein outward expansion of the support stent is limited by an internal structural band built-in to the surgical prosthetic heart valve.

2. The heart valve of claim 1 , wherein outward expansion of the support stent periphery is limited to 2 mm.

3. The heart valve of claim 1 , wherein outward expansion of the support stent periphery is limited to 4 mm.

4. The heart valve of claim 1 , wherein outward expansion of the support stent periphery is limited to a 20% increase in area within the periphery.

5. The heart valve of claim 1 , wherein the internal structural band extends around the periphery of the support stent and has overlapping free ends such that relative sliding of the overlapping free ends permits expansion of the support stent.

6. The heart valve of claim 5 , further including three arcuate inflow cusps midway between adjacent commissure posts, wherein the overlapping free ends are located at a single one of the inflow cusps of the support stent.

7. The heart valve of claim 5 , further including a flexible sleeve which surrounds the free ends and holds them radially together.

8. The heart valve of claim 7 , wherein the sleeve is made of a material selected from the group consisting of polyester shrink wrap tubing and silicone rubber.

9. The heart valve of claim 7 , wherein the sleeve is biodegradable to maintain alignment of the two free ends for a period after implant and then degrade to permit even easier expansion of the band.

10. The heart valve of claim 5 , further including an expansion limiting spacer interposed between the overlapping free ends that engages both free ends and prevents over-expansion of the stent past the second diameter.

11. The heart valve of claim 10 , wherein the expansion limiting spacer includes two fingers that are radially offset in opposite directions and extend through channels provided in respective structural band free ends and terminate in enlarged heads that are wider than the channels.

12. The heart valve of claim 10 , wherein the expansion limiting spacer is made of a lubricious material selected from the group consisting of polyester, polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene (UHMWPE) and polyether ether ketone (PEEK).

13. The heart valve of claim 5 , further including a loop of one or more filaments loosely threaded through holes in the structural band adjacent each free end such that slack in the loop permits the structural band to expand but prevents over-expansion of the stent past the second diameter.

14. The heart valve of claim 1 , wherein the internal structural band extends around the periphery of the support stent and has free ends such that relative movement of the free ends permits expansion of the support stent, and further including a loop of one or more filaments loosely threaded through holes in the structural band adjacent each free end such that slack in the loop permits the structural band to expand but prevents over-expansion of the stent past the second diameter.

15. The 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.

16. A prosthetic heart valve adapted for hosting a valve-in-valve procedure, comprising:

a non-collapsible surgical prosthetic heart valve adapted to be implanted at a native valve annulus, the surgical prosthetic heart valve having a non-collapsible inner structural support stent with three upstanding commissure posts extending in an outflow direction and three flexible leaflets supported by and within the commissure posts to ensure one-way blood flow through the heart valve, the support stent being configured to expand upon application of an outward dilatory force from within the support stent substantially larger than forces associated with normal physiological use such that the support stent periphery increases from a first diameter to a second diameter, and wherein outward expansion of the support stent is limited the support stent periphery is limited to a 20% increase in area within the periphery by a loop of flexible material built-in to the surgical prosthetic heart valve.

17. The heart valve of claim 16 , wherein outward expansion of the support stent periphery is limited to 2 mm.

18. The heart valve of claim 16 , wherein outward expansion of the support stent periphery is limited to 4 mm.

19. The heart valve of claim 16 , wherein the loop of flexible material has built-in relief or slack that permits expansion of the support stent from the first diameter to the second diameter but which defines a maximum circumference that limits expansion of the support stent to the second diameter.

20. The heart valve of claim 16 , wherein the support stent is covered with fabric and the loop of flexible material attaches either around an upper portion of the fabric-covered support stent or to the inside of the fabric-covered support stent.

21. The heart valve of claim 16 , further including a compressible suture-permeable sewing ring disposed circumferentially about an inflow end of the support stent, and the loop of flexible material attaches either to an outer edge of the sewing ring or to an underside of the sewing ring.

22. The heart valve of claim 21 , wherein the loop of flexible material is sewn in and out around the sewing ring and with ends of the loop of flexible material tied together or crimped to form the loop.

23. The heart valve of claim 16 , wherein the loop of flexible material is made of high tensile strength fiber.

24. The heart valve of claim 16 , further including a unique identifier on the support stent visible from outside the body after implant that identifies the support stent as being expandable.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 27, 2025
From: CONKLIN, BRIAN S.; CHANG, DA-YU
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 072588/0789 →
Continuity (5)
Continuation 17001528 · Aug 24, 2020
Continuation 16141604 · Sep 25, 2018
Continuation 15260053 · Sep 8, 2016
Provisional Application 62216936 · Sep 10, 2015
Related Publication 20230320849A1 · Oct 12, 2023
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