IP Library Granted Patent US 12,016,773
Granted Patent B2
US 12,016,773 · App. 17/468,325 · Granted Jun 25, 2024

Heart replacement valve with leaflet inversion and replacement procedure of a heart valve

Inventors: Michael B. McDonald (Cordova, TN); Vinayak Bapat (Minneapolis, MN)
A61F2/2433A61B17/32A61F2/2418A61B2017/320052A61F2220/0041
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Quick Facts
Patent No.
US 12,016,773
App. No.
17/468,325
Granted
Jun 25, 2024
Kind
B2
Abstract

A procedure for placing a cardiac valve includes cutting leaflets of another cardiac valve, expanding the cardiac valve, applying a downward pushing force to the expanded cardiac valve, and inverting the cut leaflets of the other cardiac valve toward a ventricle. The cardiac valve includes a self-expanding frame, vertical posts coupled to the self-expanding frame, and valve leaflets coupled to the self-expanding frame or to the vertical posts. Each of the vertical posts includes a connection to a corresponding control wire.

Claims (60)

1. A system for placing a cardiac valve, comprising:

the cardiac valve including:

a self-expanding frame including a plurality of open cells delineated by arms, the self-expanding frame having a lower portion extending upward from an inferior edge of the self-expanding frame, the self-expanding frame having an upper portion extending downward from a top edge of the self-expanding frame, wherein the upper portion includes arms that are the longest in the self-expanding frame, the arms delineating open cells that are the largest in the self-expanding frame;

a plurality of vertical posts coupled to the self-expanding frame, each of the plurality of vertical posts having a lower end located along the lower portion of the self-expanding frame, each of the plurality of vertical posts including a connection to a corresponding one of a plurality of control wires; and

valve leaflets coupled to the self-expanding frame or to one or more of the plurality of vertical posts,

wherein the plurality of vertical posts are configured to have, collectively, a strength sufficient for supporting, when the cardiac valve is expanded, a downward pushing force necessary for inverting cut leaflets of another cardiac valve toward a ventricle, and

wherein the open cells in the lower portion are configured to have a stiffness sufficient to compress cut leaflets of another cardiac valve radially against the other cardiac valve.

2. The system of claim 1 further comprising the plurality of control wires.

3. The system of claim 2 wherein at least one connection to one of the plurality of control wires includes a screw connection or a self-releasing connection.

4. The system of claim 2 wherein a diameter of each of the plurality of vertical posts is larger at the top end.

5. A system for placing a cardiac valve, comprising:

the cardiac valve including:

a frame including a plurality of open cells delineated by arms, the frame having a lower portion extending upward from an inferior edge of the frame, the frame having an upper portion extending downward from a top edge of the frame;

a plurality of vertical posts coupled to the frame, each of the plurality of vertical posts having a lower end located along the lower portion of the frame, each of the plurality of vertical posts including a connection to a corresponding one of a plurality of control wires; and

valve leaflets coupled to the frame or to one or more of the plurality of vertical posts wherein the plurality of vertical posts are configured to have, collectively, a strength sufficient for supporting, when the cardiac valve is expanded, a downward pushing force necessary for inverting cut leaflets of another cardiac valve toward a ventricle,

wherein the lowermost row of open cells includes a first plurality of arms forming the inferior edge of the frame and a second plurality of arms distinct from the first plurality, and

wherein the first plurality of arms includes arms that are shorter than each arm of the second plurality of arms,

whereby the inferior edge of the frame is sufficiently flat when the cardiac valve is expanded to avoid catching a cut leaflet of another cardiac valve.

6. The system of claim 5 wherein the upper portion includes arms that are the longest in the frame, the arms delineating open cells that are the largest in the frame.

7. The system of claim 5 wherein the frame includes notches,

wherein the notches are configured to fracture when the cardiac valve is expanded with a balloon, and

wherein the notches are configured to split the frame when the notches are fractured.

8. The system of claim 5 wherein each of the plurality of vertical posts has an upper end located above the top edge of the frame.

9. A method of placing a cardiac valve, comprising:

cutting leaflets of another cardiac valve;

expanding the cardiac valve;

applying a downward pushing force to the expanded cardiac valve;

inverting the cut leaflets of the other cardiac valve toward a ventricle; and compressing the cut leaflets radially against the other cardiac valve,

wherein the cardiac valve includes:

a self-expanding frame including a plurality of open cells delineated by arms, the self-expanding frame having a lower portion extending upward from an inferior edge of the self-expanding frame, the self-expanding frame having an upper portion extending downward from a top edge of the self-expanding frame, wherein the upper portion includes arms that are the longest in the self-expanding frame, the arms delineating open cells that are the largest in the self-expanding frame;

a plurality of vertical posts coupled to the self-expanding frame, each of the plurality of vertical posts having a lower end located along the lower portion of the self-expanding frame, each of the plurality of vertical posts including a connection to a corresponding one of a plurality of control wires; and

valve leaflets coupled to the self-expanding frame or to one or more of the plurality of vertical posts,

wherein the plurality of vertical posts are configured to have, collectively, a strength sufficient for supporting, when the cardiac valve is expanded, a downward pushing force necessary for inverting cut leaflets of another cardiac valve toward a ventricle, and

wherein the open cells in the lower portion are configured to have a stiffness sufficient to compress cut leaflets of another cardiac valve radially against the other cardiac valve.

10. The method of claim 9 further comprising releasing each connection to each of the plurality of control wires,

wherein at least one connection to one of the plurality of control wires includes a screw connection or a self-releasing connection.

11. The method of claim 9 wherein a diameter of each of the plurality of vertical posts is larger at the top end.

12. A method of placing a cardiac valve, comprising:

wherein the cardiac valve includes:

a frame including a plurality of open cells delineated by arms, the frame having a lower portion extending upward from an inferior edge of the frame, the frame having an upper portion extending downward from a top edge of the frame;

a plurality of vertical posts coupled to the frame, each of the plurality of vertical posts having a lower end located along the lower portion of the frame, each of the plurality of vertical posts including a connection to a corresponding one of a plurality of control wires; and

valve leaflets coupled to the frame or to the vertical posts,

wherein the plurality of vertical posts are configured to have, collectively, a strength sufficient for supporting, when the cardiac valve is expanded, a downward pushing force necessary for inverting cut leaflets of another cardiac valve toward a ventricle,

wherein the lowermost row of open cells includes a first plurality of arms forming the inferior edge of the frame and a second plurality of arms distinct from the first plurality, and

wherein the first plurality of arms includes arms that are shorter than each arm of the second plurality of arms,

whereby the inferior edge of the frame is sufficiently flat when the cardiac valve is expanded to avoid catching a cut leaflet of another cardiac valve;

the method comprising:

cutting leaflets of another cardiac valve;

expanding the cardiac valve, wherein expanding the cardiac valve causes the inferior edge of the frame to be sufficiently flat to avoid catching one of the cut leaflets of the other cardiac valve;

applying a downward pushing force to the expanded cardiac valve; and

inverting the cut leaflets of the other cardiac valve toward a ventricle.

13. The method of claim 12 further comprising aligning open cells that are the largest in the frame with a coronary artery ostium,

wherein the upper portion includes arms that are the longest in the frame, the arms delineating the open cells that are the largest in the frame.

14. The method of claim 12 further comprising:

expanding the cardiac valve with a balloon;

fracturing notches included in the frame;

splitting the frame; and

placing a larger-sized cardiac valve within the cardiac valve.

15. The method of claim 12 wherein the other cardiac valve is a surgical biologic valve, a balloon deployed transcatheter valve, or a self-expanding valve.

16. The method of claim 15 wherein a height of the other cardiac valve is less than a height of the cardiac valve.

Continuity (2)
Provisional Application 63074860 · Sep 4, 2020
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