Percutaneous aortic valve

• US 20040225353A1
• Filed: 05/05/2003
• Published: 11/11/2004
• Est. Priority Date: 05/05/2003
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: Hinchliffe, Peter W.J., McGuckin, James F. Jr.
• Granted Patent: US 6,974,476 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: Y10S 623/904 Heart

Abstract

The present invention provides a valve configured for insertion on the proximal and distal sides of a heart valve annulus to replace the heart valve of a patient. The valve comprises a first substantially annular portion adapted to be positioned on a proximal side of the annulus of a patient and a second substantially annular portion adapted to be positioned on a distal side of the annulus of a patient, wherein at least one of the first and second substantially annular portions is movable towards the other portion to a clamped position to clamp around the annulus. The second portion has a flow restricting portion extending therefrom and is movable between a first position to permit the flow of blood and a second position to restrict the flow of blood. In one embodiment, the valve has a suture joining the first and second portions to draw the first and second portions into closer proximity and a cinch member to secure the suture to maintain the first and second portions in the clamped position. In another embodiment, the first and second portions are connected by a first segment which biases the first and second portions toward the clamped position.

Claims

1. A valve configured for insertion on the proximal and distal sides of a heart valve annulus to replace the heart valve of a patient, the valve comprising:

a first substantially annular portion adapted to be positioned on a first side of the annulus of a patient;

a second substantially annular portion adapted to be positioned on a second side of the annulus of a patient, at least one of the first and second substantially annular portions being movable towards the other portion to a clamped position to clamp around the annulus, the second substantially annular portion having a flow restricting portion extending therefrom and movable between a first position to permit the flow of blood and a second position to restrict the flow of blood.

2. The valve of claim 1, further comprising a suture joining the first and second portions wherein tensioning of the suture draws the first and second portions to the clamped position.

3. The valve of claim 2, further comprising a cinch member positioned on the suture and connected to the second portion to retain the suture and the first and second portions in the clamped position.

4. The valve of claim 1, wherein the flow restricting portion comprises a plurality of leaflets extending from the second portion in a direction away from the first portion, the leaflets extending circumferentially around the second portion and foldable inwardly towards a convergence region at the midpoint of the second portion so the convergence region is concentric with the second portion to restrict blood flow.

5. The valve of claim 1, wherein the flow restricting portion comprises a plurality of leaflets extending from the second portion in a direction away from the first portion, the leaflets extending circumferentially around the second portion and foldable inwardly towards a convergence region offset from a midpoint of the second portion so the convergence region is eccentric with the second portion to restrict blood flow.

6. The valve of claim 1, wherein the first and second portions are comprised of unitary wire.

7. The valve of claim 6, wherein the wire is composed of a shape memory alloy.

8. The valve of claim 6, wherein the first and second portions are connected by a first segment of the unitary wire.

9. The valve of claim 8, wherein the first segment is arcuate and biases the first and second portions toward the clamped position.

10. The valve of claim 8, wherein at least a portion of the first and second portions lie in parallel planes, and the first segment extends at an angle to the parallel planes.

11. The valve of claim 6, wherein the first substantially annular portion underlies a first arcuate portion and the second substantially annular portion overlies a second arcuate portion to form a coil wire of multiple overlapping segments.

12. The valve of claim 9, wherein the first substantially annular portion underlies a first arcuate portion and the second substantially annular portion overlies a second arcuate portion to form a coil wire of multiple overlapping segments.

13. The valve of claim 1 wherein the flow restricting portion includes a plurality of spaced apart leaflets extending from the second portion in a direction away from the first portion, the leaflets extending circumferentially around the second portion and foldable inwardly to restrict blood flow, the flow restricting portion further including a membrane joining adjacent leaflets to cooperate with the leaflets to restrict blood flow when the leaflets are in the closed position.

14. The valve of claim 1, wherein the leaflets have a thicker portion at a portion closer to the second portion and the membrane has a thinner portion at a portion further from the second portion.

15. The valve of claim 1, wherein the flow restricting portion includes a plurality of foldable leaflets, a portion of adjacent leaflets overlapping in the closed position to restrict blood flow.

16. The valve of claim 1, wherein the first and second portions are comprised of a unitary coiled wire, the wire being composed of shape memory material and being retained in an elongated position prior to positioning in the patient'"'"'s body.

17. A replacement cardiac valve implantation system comprising:

a valve comprising a wire element having a first ring-like portion and a second ring-like portion connected to the first ring like portion, at least the first ring like portion being movable towards and away from the second ring-like portion and being biased towards the second ring like portion;

a delivery member for introducing the wire element into a patient'"'"'s body such that the first ring like portion is placed on a first side of the annulus and the second ring like portion is placed on the a second side of the annulus, the bias forcing the first and second ring like portions in closer proximity to secure the valve in a clamped position around the annulus.

18. The valve of claim 17, wherein the first and second ring-like portions are joined by an arcuate wire segment extending therebetween, the arcuate wire segment biasing the first and second ring like portions to a clamped position.

19. The valve of claim 18, further comprising a first wire segment overlying portion of the first ring-like portion and a second wire segment underlying the second ring-like portion, the first and second wire segments being arcuate in configuration.

20. A method of installing a replacement valve to replace a cardiac valve of a patient comprising:

positioning a valve in a first configuration inside a first catheter;

inserting the first catheter through the femoral artery;

advancing the first catheter around the aortic arch so that a distal end portion of the catheter is adjacent an annulus of a patient;

ejecting a first portion of the valve from the catheter to position it on a first side of the annulus; and

ejecting a second portion of the valve on a second side of the annulus allowing the first and second portions to clamp around both sides of the annulus.

21. The method of claim 20, wherein upon ejection of the second portion, the first and second portions are biased towards each other so they automatically move toward each other upon ejection.

22. The method of claim 20, further comprising the step of tensioning a tightening member to place the first and second portions in closer proximity.

23. The method of claim 22, wherein the tightening step comprises tensioning a suture connected to at least one of the first and second portions.

24. The method of claim 20, further comprising the step of withdrawing the catheter through the femoral artery leaving the valve implanted in the patient.