IP Library › Granted Patent US 12,440,328
Granted Patent B2
US 12,440,328 · App. 17/656,513 · Granted Oct 14, 2025

Modified prosthetic heart valve stent

Inventors: Rafael Pintor (Mission Viejo, CA); Sai Prasad Uppalapati (Plano, TX)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2418
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Quick Facts
Patent No.
US 12,440,328
App. No.
17/656,513
Granted
Oct 14, 2025
Kind
B2
Abstract

A prosthetic heart valve having an expandable stent modified to reduce the impact on the adjacent conduction system of the heart. A plurality of flexible leaflets arranged to close together along a flow axis through the valve prevent blood flow in one direction, and a support frame surrounds and supports the leaflets. The stent is defined by a plurality of connected struts arranged around a circumference. A pattern of the struts is consistent around the circumference except in a modified region on one side so that when converted to the expanded configuration the stent on the one side expands radially outward a smaller distance and/or has larger cells defined between the struts than around a remainder of the circumference. The stent may be connected to a non-collapsible valve member or the entire valve may be expandable. The valve may be for implant at the aortic annulus and the modified region may be centered at a commissure post of the support frame.

Claims (28)

1. A prosthetic heart valve configured for implant at an aortic annulus, comprising:

a valve member having a non-expandable, non-collapsible annular support frame surrounding and supporting three flexible leaflets arranged to close together along a flow axis through the valve member to prevent blood flow in one direction, the support frame defining three commissure posts at intersections between the leaflets, the valve member and its components having an inflow end and an outflow end with blood permitted to flow through the heart valve in an outflow direction;

a plastically-expandable stent connected to and extending axially away from the inflow end of the support frame such that an outflow end of the stent end is generally annular and non-expandable and non-collapsible at the connection as a consequence, the stent having an inflow end spaced axially from the inflow end of the support frame that is convertible from a radially contracted configuration to a radially expanded configuration, the stent being defined by a plurality of interconnected struts, wherein a pattern of the interconnected struts at the inflow end is consistent around a circumference of the stent except in a modified region on one circumferential side in alignment with one of the three commissure posts so that when converted to the expanded configuration the modified region has larger cells defined between the interconnected struts than around a remainder of the circumference and the modified region expands radially outward a smaller distance than outside of the modified region; and

a sealing ring circumscribing the valve at an axial location approximately at the connection between the valve member and the stent, the sealing ring being formed of suture-permeable material and presents an outward flange sized to contact an outflow side of the aortic annulus when implanted.

2. The heart valve of claim 1 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the row struts in the modified region of at least one row define shallower bends than the row struts outside of the modified region so that when converted to the expanded configuration the row struts in the modified region of the at least one row define final bend angles.

3. The heart valve of claim 2 , wherein final bend angles of the row struts in the modified region of the at least one row are between about 135-160°, while final bend angles of the row struts of the at least one row outside of the modified region are between about 45-90°.

4. The heart valve of claim 2 , wherein there are different final bend angles of the row struts in the modified region of the at least one row.

5. The heart valve of claim 1 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the larger cells are defined by at least one missing row strut in at least one row in the modified region.

6. The heart valve of claim 1 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the larger cells are defined by at least one missing row strut in the modified region in at least one row and at least one missing axial column strut in the modified region in at least one column.

7. The heart valve of claim 1 , wherein the modified region extends circumferentially between about 90-120°.

8. The heart valve of claim 1 , wherein the modified region extends circumferentially about 120°.

9. The heart valve of claim 1 , wherein the modified region is centered in alignment with the one of the three commissure posts.

10. The heart valve of claim 1 , wherein the sealing ring has a distinct elongated marking thereon aligned with the modified region of the stent.

11. The heart valve of claim 10 , wherein the elongated marking extends circumferentially about 120° and extends between two cusp markings on the sealing ring.

12. A prosthetic heart valve configured for implant at an aortic annulus, comprising:

a valve member having a non-expandable, non-collapsible annular support frame surrounding and supporting three flexible leaflets arranged to close together along a flow axis through the valve member to prevent blood flow in one direction, the support frame defining three commissure posts at intersections between the leaflets, the valve member and its components having an inflow end and an outflow end with blood permitted to flow through the heart valve in an outflow direction; and

a plastically-expandable stent connected to and extending axially away from the inflow end of the support frame such that an outflow end of the stent is generally annular and non-expandable and non-collapsible at the connection as a consequence, the stent having an inflow end spaced axially from the inflow end of the support frame that is convertible from a radially contracted configuration to a radially expanded configuration, the stent being evenly expandable around a circumference of the stent except in a modified region on one circumferential side in alignment with one of the three commissure posts so that when converted to the expanded configuration the modified region expands radially outward a smaller distance than outside of the modified region; and

a sealing ring circumscribing the valve at an axial location approximately at the connection between the valve member and the stent, the sealing ring being formed of suture-permeable material and presents an outward flange sized to contact an outflow side of the aortic annulus when implanted, wherein the sealing ring has a distinct elongated marking thereon aligned with the modified region of the stent.

13. The heart valve of claim 12 , wherein the elongated marking extends circumferentially about 120° and extends between two cusp markings on the sealing ring.

14. The heart valve of claim 12 , wherein the stent is defined by a plurality of interconnected struts and a pattern of the interconnected struts at the inflow end is consistent around a circumference of the stent except in the modified region so that when converted to the expanded configuration the modified region has larger cells defined between the interconnected struts than around a remainder of the circumference.

15. The heart valve of claim 14 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the row struts in the modified region of at least one row define shallower bends than the row struts outside of the modified region so that when converted to the expanded configuration the row struts in the modified region of the at least one row define final bend angles.

16. The heart valve of claim 15 , wherein final bend angles of the row struts in the modified region of the at least one row are between about 135-160°, while final bend angles of the row struts of the at least one row outside of the modified region are between about 45-90°.

17. The heart valve of claim 15 , wherein there are different final bend angles of the row struts in the modified region of the at least one row.

18. The heart valve of claim 14 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the larger cells are defined by at least one missing row strut in at least one row in the modified region.

19. The heart valve of claim 14 , wherein the plurality of interconnected struts includes a series of circumferential rows of row struts between axial columns of column struts, the row struts defining bends between the column struts, and wherein the larger cells are defined by at least one missing row strut in the modified region in at least one row and at least one missing axial column strut in the modified region in at least one column.

20. The heart valve of claim 12 , wherein the modified region extends circumferentially between about 90-120°.

21. The heart valve of claim 12 , wherein the modified region extends circumferentially about 120°.

22. The heart valve of claim 12 , wherein the modified region is centered in alignment with the one of the three commissure posts.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 18, 2025
From: PINTOR, RAFAEL; UPPALAPATI, SAI PRASAD
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 072300/0585 →
Continuity (3)
Continuation PCTUS2020052496 · Sep 24, 2020
Provisional Application 62907476 · Sep 27, 2019
Related Publication 20220211492A1 · Jul 7, 2022
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