FOLDABLE PROSTHESES, MULTIPLE COMPONENT PROSTHETIC HEART VALVE ASSEMBLIES, AND APPARATUS AND METHODS FOR DELIVERING THEM
Multiple component heart valves and apparatus and methods for implanting them are provided. The heart valve generally includes a first annular prosthesis and a second valve prosthesis. The first prosthesis includes an annular member compressible from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition. The first prosthesis also includes guide rails extending therefrom. The second prosthesis includes an annular frame, valve elements, and receptacles for receiving respective guide rails therethrough when the second prosthesis is directed towards the first prosthesis. In addition, a valve holder may releasably carry the valve prosthesis that includes channels for receiving respective guide rails therethrough when the guide rails are received through the valve prosthesis. A delivery tool is also provided that includes an actuator for selectively compressing the annular member into the contracted condition.
1 . A heart valve assembly implantable within a biological annulus, comprising:
a first prosthesis comprising an annular member implantable within the biological annulus, the annular member being compressible radially inwardly from a relaxed condition to a contracted condition to facilitate delivery into a biological annulus, the annular member being resiliently expandable towards the relaxed condition;
a second valve prosthesis comprising an annular frame and at least one valve element; and
one or more connectors for securing the second prosthesis to the first prosthesis.
2 . The heart valve assembly of claim 1 , further comprising a plurality of leaders extending from the first prosthesis.
3 . The heart valve assembly of claim 2 , wherein the leaders comprise retention elements disposed a predetermined distance from the first prosthesis.
4 . The heart valve assembly of claim 3 , wherein the retention elements comprise a tapered arrow shape allowing unidirectional distal penetration through a portion of the second prosthesis.
5 . The heart valve assembly of claim 2 , wherein the annular member comprises a central longitudinal axis, the annular member being directable from the relaxed condition having a first cross-section to the contracted condition when the leaders are tensioned inwardly towards the central axis.
6 . The heart valve assembly of claim 1 , wherein the first prosthesis further comprises a sewing cuff extending outwardly from the annular member.
7 . The heart valve assembly of claim 1 , wherein the annular member changes shape between the relaxed and contracted conditions.
8 . The heart valve assembly of claim 1 , wherein the annular member has a generally circular cross-section in the relaxed condition and a multiple lobular cross-section in the contracted condition.
9 . The heart valve assembly of claim 1 , wherein the annular member has a generally circular cross-section in the enlarged condition and at least a portion of the annular member is folded in the contracted condition.
10 . The heart valve assembly of claim 1 , wherein the annular member comprises a shape memory material, wherein the material comprises a martensitic state at or below ambient temperature such that the annular member is compressible to the contracted condition to facilitate delivery into a biological annulus in the martensitic state, and wherein the material comprises an austenitic state at body temperature such that the annular member is biased to return towards the relaxed condition within the patient's body.
11 . A system for implanting a prosthesis into a biological annulus, comprising:
a first prosthesis comprising an annular member implantable within the biological annulus, and a sewing cuff extending outwardly from the annular member; and
a delivery tool comprising an elongate shaft including a proximal end with a handle, a distal end sized for introduction into the biological annulus, and an actuator for compressing the first prosthesis inwardly into a contracted condition comprising a multiple lobular shape.
12 . The system of claim 11 , wherein the annular member is compressible radially inwardly from an enlarged condition to a contracted condition to facilitate delivery into a biological annulus.
13 . The system of claim 12 , wherein the annular member is resiliently biased towards the enlarged condition.
14 . The system of claim 12 , wherein the annular member comprises a shape memory material that becomes biased towards the enlarged condition when exposed to a predetermined temperature.
15 . The system of claim 11 , wherein the first prosthesis comprises a plurality of elongate leaders extending from one of the annular member and the sewing cuff for guiding a valve prosthesis towards the sewing cuff, wherein the delivery tool comprises at least one of a channel and a lumen for receiving portions of the leaders therein, the actuator configured to engage the portions of the leaders received therein to at least one of secure, tension, and release the leaders to compress the first prosthesis into and release the first prosthesis from the contracted condition.
16 . The system of claim 15 , wherein the actuator comprises an actuating element movable relative to the elongate shaft for applying and releasing an axial tension on the leaders.
17 . The system of claim 15 , wherein the actuating element is movable proximally sufficient distance to compress the first prosthesis inwardly towards the contracted condition and movable distally sufficient distance to release the first prosthesis such that the annular member resiliently returns towards an enlarged condition.
18 . The system of claim 11 , wherein the delivery tool comprises a plurality of movable arms disposed around a central hub for selectively compressing the annular member between the arms and the hub to place the annular member in the contracted condition.
19 . The system of claim 18 , wherein the central hub comprises a plurality of supports offset radially from the arms such that the annular member is compressed into a multiple lobular shape between the arms and supports in the contracted condition.
20 . A system for implanting a prosthesis into a biological annulus, comprising:
a first prosthesis comprising an annular member implantable within the biological annulus, and a sewing cuff extending outwardly from the annular member; and
a delivery tool comprising an elongate shaft including a proximal end with a handle, a distal end including a plurality of supports and a plurality of movable arms, and an actuator for moving the arms towards and away from the supports for securing and releasing the first prosthesis between the supports and the arms, the first prosthesis being folded into a contracted condition when secured between the supports and the arms.
21 . A tool for implanting a prosthesis into a biological annulus, comprising:
an elongate shaft comprising a proximal end and a distal end;
a plurality of supports on the distal end;
a plurality of movable arms on the distal end adjacent the supports; and
an actuator on the proximal end for moving the arms towards and away from the supports for securing and releasing an annular prosthesis between the supports and the arms, the prosthesis being folded into a contracted condition when secured between the supports and the arms.
22 . The tool of claim 21 , wherein the supports are disposed about a longitudinal axis defined by the shaft, and the arms are offset radially about the longitudinal axis between adjacent supports.
23 . The tool of claim 21 , wherein the plurality of supports comprise three supports and the plurality of arms comprises three arms, thereby deforming the prosthesis into a generally shamrock shape when the prosthesis is secured between the supports and the arms.