Arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve
The present disclosure relates to an arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve. With the method or the arrangement, leakage or regurgitation between a prosthetic heart valve and the surrounding valve tissue is prevented. In one embodiment, an arrangement for replacement or repair of a native heart valve is provided, which comprises a loop-shaped support 41 and a prosthetic heart valve 70 and wherein an outer segment 32 of the loop-shaped support 41 is positionable towards surrounding valve tissue of a native heart valve and wherein an outer surface 74 of the prosthetic heart valve 70 is positionable towards an inner segment 34 of the loop-shaped support 41 so as to prevent paravalvular leakage or regurgitation between the prosthetic heart valve 70 and the surrounding valve tissue of the native heart valve.
1. A kit for replacement of a native mitral valve, said kit comprising:
a loop-shaped element having a core and an outer layer coating the core and
a prosthetic mitral valve wherein:
the loop-shaped element comprises a first section configured for placement on an atrial side of the native mitral valve and a second section configured for placement on a ventricular side of the native mitral valve
at least a part of the first section has an open arcuate shape,
the prosthetic mitral valve is sized and shaped for positioning through at least the second section of the loop-shaped element,
the prosthetic mitral valve comprises a stent frame that is balloon expandable to have a cylindrical shape when expanded,
at least one elongate extension is connected to the loop-shaped element and extends from said loop-shaped element in a direction that is substantially parallel with a center axis of the loop-shaped element, and
the at least one elongate extension is configured for supporting the prosthetic mitral valve inside the loop-shaped element.
2. The kit according to claim 1 , wherein at least part of the first section has a first pitch, an end of the second section has a second pitch, and the second pitch is greater than the first pitch.
3. The kit according to claim 1 , wherein the loop-shaped element has a coil structure or a helical structure and wherein said coil structure or helical structure comprises at least two and a half turns of said coil structure or said helical structure.
4. The kit according to claim 1 , wherein the loop-shaped element is curved along an entire length of the loop-shaped element.
5. The kit according to claim 1 , wherein the open arcuate shape is less than a full turn.
6. The kit according to claim 1 , wherein at least a part of the loop-shaped element overlaps itself to form a coil or helical structure.
7. The kit according to claim 1 , wherein the prosthetic mitral valve is configured to radially expand so as to tightly position an outer surface of the prosthetic mitral valve in a direction towards the second section of the loop-shaped element, so as to seal an area between the prosthetic mitral valve and the loop-shaped element.
8. The kit according to claim 7 , wherein the loop-shaped element and the prosthetic mitral valve are configured to pinch tissue of the native mitral valve when said area between the prosthetic heart valve and the loop-shaped element is sealed.
9. The kit according to claim 1 , wherein the loop-shaped element comprises a shape memory material.
10. The kit according to claim 1 , wherein the core comprises a metal.
11. The kit according to claim 10 , wherein the outer layer of the loop-shaped element is made of a material that is softer than the core.
12. The kit according to claim 11 , wherein the outer layer of the loop-shaped element is made of a textile.
13. The kit according to claim 1 , wherein the outer layer of the loop-shaped element comprises a flexible woven material.
14. The kit according to claim 13 , wherein the flexible woven material is polyethylene or polytetrafluoroethylene.
15. The kit according to claim 13 , wherein the flexible woven material has a rough, holed or porous surface.
16. The kit according to claim 13 , wherein the flexible woven material conforms to the prosthetic mitral valve.
17. The kit according to claim 1 , wherein the loop-shaped element has a cross-sectional shape that is round.
18. The kit according to claim 1 , wherein the loop-shaped element has a cross-sectional shape that is substantially flattened at an inner segment and substantially rounded at an outer segment.
19. The kit according to claim 1 , wherein said at least one elongate extension inhibits a tilting movement of the prosthetic mitral valve in relation to a plane parallel with a mitral plane when the prosthetic mitral valve is placed in an operational position of the prosthetic mitral valve.
20. A kit for replacement of a native mitral valve, said kit comprising:
a loop-shaped element having a core and an outer layer coating the core and
a prosthetic mitral valve wherein:
the loop-shaped element comprises a first section configured for placement on an atrial side of the native mitral valve and a second section configured for placement on a ventricular side of the native mitral valve;
the loop-shaped element has a coil structure or a helical structure and wherein said coil structure or helical structure comprises at least two and a half turns of said coil structure or said helical structure;
at least a part of the first section has an open arcuate shape;
the prosthetic mitral valve is sized and shaped for positioning through the loop-shaped element;
the prosthetic mitral valve comprises a stent frame that is balloon expandable to have a cylindrical shape when expanded;
at least one extension is connected to the loop-shaped element and extends from said loop-shaped element in a direction that is substantially parallel with a center axis of the loop-shaped element; and
the at least one extension is configured for supporting the prosthetic mitral valve inside the loop-shaped element and to prevent a tilting movement of the prosthetic mitral valve in the loop-shaped support relative to a plane of the native mitral valve when the prosthetic mitral valve is placed in an operational position.