IP Library › Granted Patent US 12,447,011
Granted Patent B2
US 12,447,011 · App. 17/553,566 · Granted Oct 21, 2025

Replacement heart valve prosthesis

Inventors: Matthew A. Peterson (Costa Mesa, CA); Seung-Beom Yi (Mission Viejo, CA); Siddharth Vad (Irvine, CA); Travis Zenyo Oba (Yorba Linda, CA); Lauren R. Freschauf (Mission Viejo, CA); Amanda French (San Francisco, CA); Yaron Keidar (Kiryat Ono, IL); Yuanlong Du (Irvine, CA); Gregory Bak-Boychuk (San Clemente, CA); Kevin M. Golemo (Mission Viejo, CA); Alexander H. Cooper (Costa Mesa, CA)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2412A61F2/2409A61F2/2418A61F2/2436A61F2/2427A61F2210/0014A61F2210/0076A61F2220/0008A61F2230/0013A61F2230/0054A61F2250/0003A61F2250/0014A61F2250/0018A61F2250/0036A61F2250/0039A61F2250/0063A61F2250/0069
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Quick Facts
Patent No.
US 12,447,011
App. No.
17/553,566
Granted
Oct 21, 2025
Kind
B2
Abstract

A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Claims (32)

1. A heart valve prosthesis for replacing a native heart valve, comprising:

a self-expanding frame having an upper region, an intermediate region and a lower region, the self-expanding frame comprising an inner frame and a supplemental outer frame, the self-expanding frame including a plurality of anchoring members extending outward from the lower region of the self-expanding frame and then upward toward the upper region of the self-expanding frame so as to facilitate capturing of the native heart valve by at least some of the plurality of anchoring members;

a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction; and

wherein each of the plurality of leaflets has an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures and wherein a connecting fabric connects the plurality of leaflets to the self-expanding frame such that, when the self-expanding frame is in an expanded configuration, the connecting fabric allows the commissures to be spaced radially inwardly from an inner surface of the self-expanding frame with a first end of the connecting fabric being coupled to the inner surface of the self-expanding frame and a second end of the connecting fabric being coupled to the commissures, and

wherein the inner frame and the supplemental outer frame are attached together at the upper region of the self-expanding frame.

2. The heart valve prosthesis of claim 1 , wherein the connecting fabric is formed from a material having a stiffness different from that of the plurality of leaflets and different from that of the self-expanding frame.

3. The heart valve prosthesis of claim 1 , wherein the leaflets are made from pericardium.

4. The heart valve prosthesis of claim 1 , wherein a diameter of the valve body is smaller than a diameter of the inner frame.

5. The heart valve prosthesis of claim 1 , wherein the plurality of leaflets comprises three leaflets.

6. The heart valve prosthesis of claim 1 , further comprising locking tabs adjacent the upper region of the self-expanding frame.

7. The heart valve prosthesis of claim 1 , wherein the self-expanding frame comprises a skirt configured to extend annularly around an outer surface of at least the lower region of the self-expanding frame.

8. The heart valve prosthesis of claim 1 , wherein the supplemental outer frame is formed separately from the inner frame, and wherein the inner frame and the supplemental outer frame are attached together via sutures.

9. The heart valve prosthesis of claim 7 , wherein the skirt further comprises wires formed from a resilient material for allowing the skirt to retain a particular shape.

10. A heart valve prosthesis for replacing a native heart valve, comprising:

a self-expanding frame having an upper region, an intermediate region and a lower region; a plurality of anchoring members extending radially outwardly from the lower region of the self-expanding frame and extending towards the upper region of the self-expanding frame so as to facilitate capturing of the native heart valve by at least some of the plurality of anchoring members; and

a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction,

wherein each of the plurality of leaflets has an arcuate proximal edge and a free distal edge, the plurality of leaflets being joined at commissures and wherein one or more intermediate components connect the plurality of leaflets to the self-expanding frame such that, when the frame is in an expanded configuration, the one or more intermediate components allow the commissures to be spaced radially inwardly from an inner surface of the self-expanding frame; and

a skirt surrounding and spaced apart from an outer surface of the self-expanding frame so as to form a clearance between the outer surface of the self-expanding frame and the skirt, the skirt configured to impede blood flow around the self-expanding frame.

11. The heart valve prosthesis of claim 10 , wherein the self-expanding frame comprises an inner frame and a supplemental outer frame that is formed separately from the inner frame.

12. The heart valve prosthesis of claim 11 , wherein the inner frame and the supplemental outer frame are attached together via sutures.

13. The heart valve prosthesis of claim 10 , wherein the one or more intermediate components are made from fabric.

14. The heart valve prosthesis of claim 10 , further comprising locking tabs adjacent the upper region of the self-expanding frame.

15. A heart valve prosthesis for replacing a native heart valve, comprising:

a self-expanding frame having an upper region, an intermediate region and a lower region;

a plurality of anchoring members extending radially outwardly from the lower region of the self-expanding frame and extending towards the upper region of the self-expanding frame so as to facilitate capturing of the native heart valve by at least some of the plurality of anchoring members;

a valve body positioned within the self-expanding frame, the valve body comprising a plurality of leaflets configured to allow blood flow through the self-expanding frame in a first direction and to prevent blood flow through the self-expanding frame in a second direction; and

a skirt surrounding an outer surface of at least the lower region of the self-expanding frame, the skirt configured to impede blood flow around the self-expanding frame, wherein the skirt further comprises wires formed from a resilient material for allowing the skirt to retain a particular shape.

16. The heart valve prosthesis of claim 15 , wherein the self-expanding frame comprises an inner frame and a supplemental outer frame that is formed separately from the inner frame.

17. The heart valve prosthesis of claim 16 , wherein the inner frame and the supplemental outer frame are attached together via sutures.

18. The heart valve prosthesis of claim 15 , further comprising locking tabs adjacent the upper region of the self-expanding frame.

19. The heart valve prosthesis of claim 15 , wherein the skirt is formed from multiple components.

20. The heart valve prosthesis of claim 15 , wherein the skirt is spaced radially apart from the outer surface of at least the lower region of the self-expanding frame.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2022
From: PETERSON, MATTHEW A.; YI, SEUNG-BEOM; VAD, SIDDHARTH; OBA, TRAVIS ZENYO; FRESCHAUF, LAUREN R.; FRENCH, AMANDA; KEIDAR, YARON; DU, YUANLONG; BAK-BOYCHUK, GREGORY; GOLEMO, KEVIN M.; COOPER, ALEXANDER H.
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 060128/0233 →
Continuity (5)
Continuation 16506886 · Jul 9, 2019
Continuation 15653390 · Jul 18, 2017
Provisional Application 62471213 · Mar 14, 2017
Provisional Application 62365070 · Jul 21, 2016
Related Publication 20220104940A1 · Apr 7, 2022
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