HEART VALVE PROSTHESIS

• US 20120165929A1
• Filed: 03/30/2010
• Published: 06/28/2012
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: Fondazione Ri.Med
• Original Assignee: ULC Business PLC
• Inventors: Burriesci, Gaetano, Seifalian, Alexander M., Zervides, Constantinos
• Granted Patent: US 10,357,358 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A heart valve prosthesis comprising: a support structure comprising a framework deformable between an expanded state and a compressed state and vice versa; and a flow-control structure, supported by the support structure, for permitting blood flow in a first direction, and for restricting blood flow in a direction opposite to the first direction. At least one end of the support structure comprises a plurality of apexes of the framework. The support structure is collapsible into the compressed state by pulling on the apexes, to enable it to be drawn into a sheath having an inner radial dimension smaller than the radial dimension of the support structure in the expanded state.

Claims

1. A heart valve prosthesis comprising:

a support structure comprising a framework deformable between an expanded state and a compressed state and vice versa; and

a flow-control structure, supported by the support structure, for permitting blood flow in a first direction, defining an axial direction of the prosthesis, and for restricting blood flow in a direction opposite to the first direction,

wherein the flow-control structure comprises at least one leaflet, and wherein the support structure comprises an integral rib, curved to match the profile of the radially outer edge of said leaflet, and to which the leaflet is attached,

wherein the support structure comprises a first set of petal-like portions that protrude beyond the flow-control structure axially in the direction opposite to the first direction, and protrude radially further than the flow-control structure, and

wherein at least one end of the support structure comprises a plurality of apexes of the framework, and wherein the support structure is collapsible from the fully expanded state into the compressed state by pulling on the apexes, to enable it to be drawn into a sheath in the compressed state, the sheath having an inner radial dimension smaller than the radial dimension of the support structure in the expanded state.

2. A prosthesis according to claim 1, wherein the support structure comprises smoothly curved ribs.

3. A prosthesis according to claim 2, wherein the ribs are formed from bent wire.

4. A prosthesis according to claim 1, wherein the support structure is formed from a single wire bent to form a framework.

5. A prosthesis according to claim 1, wherein the support structure comprises a second set of petal-like portions that protrude beyond the flow-control structure axially in the first direction, and protrude radically further than the flow-control structure.

6. A prosthesis according to claim 1, wherein loops are provided at the apexes for attaching members for pulling thereon for collapsing the heart valve.

7. A prosthesis according to claim 1, further comprising clefts in the support structure between apexes, wherein at least one of the clefts is a deep cleft having a length in the axial direction greater than the average radius of the support structure.

8. A prosthesis according to claim 7, wherein the length in the axial direction of the deep cleft is greater than the average diameter of the support structure.

9. A prosthesis according to claim 7, comprising at least three deep clefts.

10. A prosthesis according to claim 1, wherein the support structure is elastically deformable, and is self-expanding from the compressed state to the expanded state.

14. A method according to claim 11, performed on a prosthetic heart valve as defined in claim 1.

11. A method of collapsing a heart valve prosthesis, the prosthesis comprising:

a support structure comprising a framework deformable between an expanded state and a compressed state and vice versa; and

a flow-control structure, supported by the support structure, for permitting blood flow in a first direction, defining an axial direction of the prosthesis, and for restricting blood flow in a direction opposite to the first direction, wherein at least one end of the support structure comprises a plurality of apexes of the framework, the method comprising;

pulling on the apexes when in the expanded state, to commence collapse into the compressed state; and

drawing the prosthesis into a sheath having an inner radial dimension smaller than the radial dimension of the support structure in the expanded state.

12. A method according to claim 11, wherein the prosthesis comprises filiform members attached to the apexes and that pass through the sheath, and the pulling and drawing steps are performed by pulling on the filiform members.

13. A method according to claim 11, wherein at least one filiform member forms a loop attached to adjacent apexes, and the method comprises pulling the apexes radially and tangentially to commence the collapse by pulling on the or each filiform member.

15. A method according to claim 11, comprising commencing with the framework in a fully expanded state.

16. A method according to claim 11, performed on a heart valve prosthesis ex vivo.