Percutaneous aortic valve

• US 20060009841A1
• Filed: 09/09/2005
• Published: 01/12/2006
• 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 7,445,632 B2
• Time in Patent Office: Days
• US Class Current: 623/2.380
• 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

1-24. -24. (canceled)

25. 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, the first portion movable from an elongated reduced profile position for insertion to a substantially annular position for placement;

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, the second portion and flow restricting portion movable from an elongated reduced profile position for insertion to a substantially annular position for placement.

26. The valve of claim 25, 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.

27. The valve of claim 25, 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.

28. The valve of claim 25, wherein the first and second portions are comprised of unitary wire.

29. The valve of claim 28, wherein the unitary wire includes an arcuate wire segment extending between the first and second portions, the wire biasing the first and second portions toward each other in the substantially annular position.

30. The valve of claim 29, wherein the first and second annular portions circumscribe a segment greater than 360 degrees to form an overlapping segment.

31. The valve of claim 25, wherein the wire is composed of a shape memory alloy.

32. The valve of claim 28, wherein the wire is composed of a shape memory alloy.

33. The valve of claim 25, wherein the first and second portions are connected by a first segment of the unitary wire, the first segment being arcuate, 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.

34. The valve of claim 25, 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.

35. The valve of claim 25, 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.

36. The valve of claim 35, 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.

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

providing a valve having a first portion, a second portion and a movable flow restricting portion attached to the second portion;

positioning the valve in a first insertion configuration inside a first catheter such that the flow restricting portion and the first and second portions are positioned in an elongated reduced profile position;

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, the first portion moving to a second configuration for placement; and

ejecting a second portion of the valve on a second side of the annulus allowing the second portion to move to a second configuration, the flow restricting portion to move to a second placement configuration and the first and second portions to clamp around both respective sides of the annulus, the flow restricting portion being in the placement configuration to open and close to respectively permit and restrict blood flow.

38. The method of claim 37, wherein the first and second portions are biased towards each other so upon ejection of the second portion the first and second portions automatically move toward each other upon ejection to clamp respective sides of the annulus.

39. The method of claim 37, further comprising the step of moving at least one of the first and second portions toward the other to clamp the first and second portions on respective sides of the annulus.

40. The method of claim 37, further comprising the step of tensioning a tightening member to place the first and second portions in closer proximity.

41. The method of claim 37, wherein the tightening step comprises tensioning a suture connected to at least one of the first and second portions.

42. The method of claim 37, wherein the first and second portions are composed of shape memory material so that upon ejection from the catheter, the respective first and second portions move to a shape memorized position.

43. The method of claim 42, wherein the step of ejecting the first and second portions allows the first and second portions move to a substantially annular position.