Artificial heart valve, implantation instrument and method therefor

Claim 2

An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising: a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region and a central portion located along a centerline extending between the plurality of peripheral anchors and between the upstream region and the downstream region when said frame is inserted in the position between the upstream region and the downstream region; a flexible valve element attached to the central portion of the frame having an upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region; and an opening extending through at least one of said frame and said flexible valve element for receiving an implement.

Claim 3

An artificial valve as set forth in claim 1 wherein said opening extends through the central portion of the frame and the flexible valve element.

Claim 4

An artificial valve as set forth in claim 2 further comprising a releasable fastener mounted on the frame for selectively connecting the valve to an instrument.

Claim 5

An artificial valve as set forth in claim 3 wherein the fastener comprises a hollow post mounted on the central portion of the frame coaxial with the opening.

Claim 6

An artificial valve as set forth in claim 4 wherein said fastener comprises a threaded fastener.

Claim 7

An artificial valve as set forth in claim 5 wherein said post is externally threaded.

Claim 8

An artificial valve as set forth in claim 4 wherein said fastener comprises a bayonet fastener.

Claim 9

An artificial valve as set forth in claim 1 wherein said flexibly resilient frame includes frame elements extending outward from the central portion, said frame elements being biased outward to engage the heart tissue and hold the frame in an expanded configuration in the position between the upstream region and the downstream region.

Claim 10

An artificial valve as set forth in claim 8 further comprising a band extending around the frame elements to limit outward movement of the frame elements to the expanded configuration and to sealingly engage adjacent heart tissue.

Claim 11

An artificial valve as set forth in claim 9 wherein said band includes an inner portion formed to limit outward movement of the frame elements, and an outer portion at least partially surrounding said inner portion and being biased inward, such that when the frame elements are forced inward to a collapsed configuration, the outer portion urges the inner portion inward to a position inside the frame elements.

Claim 12

An artificial valve as set forth in claim 10 wherein the frame elements are biased outward by a spring force sufficient to overcome the inward bias of the outer portion, so that the outward spring force maintains the frame in the expanded configuration.

Claim 13

An artificial valve as set forth in claim 11 wherein said outer portion comprises a braided mesh.

Claim 14

An artificial valve as set forth in claim 12 wherein said braided mesh comprises a woven fabric of filaments, each having a width of between about 0.05 mm and about 0.13 mm.

Claim 15

An artificial valve as set forth in claim 12 wherein said braided mesh comprises a material selected from the group consisting of Nitinol superelastic alloy, stainless steel alloy, Elgiloy® alloy, fiberglass, PTFE, polyester and Lycra®.

Claim 16

An artificial valve as set forth in claim 10 wherein said inner portion comprises a material selected from the group consisting of PTFE, Dacron® velour, Dacron® porous cloth, a synthetic polymer and biological source tissue.

Claim 17

A artificial valve as set forth in claim 8 further comprising a thin strand extending around the frame elements to limit outward movement of the frame elements to the expanded configuration.

Claim 18

An endothoracoscopic method of inserting an artificial valve as set forth in claim 1 between a plurality of cusps of a damaged heart valve, said method comprising the steps of: making an opening in a chest wall of a patient; making an incision in a heart of the patient; inserting an end of an elongate instrument through the opening made in the chest wall and the incision made in the heart; positioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve; ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart; retrieving the artificial valve into the end of the instrument; repositioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve; and ejecting the repositioned artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.

Claim 19

A transluminal method of inserting an artificial valve as set forth in claim 1 between a plurality of cusps of a damaged heart valve, said method comprising the steps of: making an incision in a vessel leading to the heart; inserting an end of an elongate flexible instrument through the incision made in the vessel; pushing the end of the instrument through the vessel; positioning the end adjacent the plurality of cusps of the damaged heart valve; ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart; retrieving the artificial valve into the end of the instrument; repositioning the inserted end of the instrument adjacent the plurality of cusps of the damaged heart valve; and ejecting the repositioned artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.

Claim 20

A transluminal method as set forth in claim 18 further comprising performing a septostomy between the atria of the heart and pushing the instrument through an atrial septal perforation created by the septostomy.

Claim 21

A transluminal method of inserting an artificial valve as set forth in claim 1 between a plurality of cusps of a damaged heart valve, said method comprising the steps of: making an incision in a vessel leading to the heart; inserting an end of a guide through the incision made in the vessel; pushing the guide through the vessel; threading an elongate flexible instrument having a hollow interior onto the guide; inserting an end of the elongate flexible instrument through the incision made in the vessel; pushing the end of the instrument through the vessel along the guide until the end is adjacent the plurality of cusps of the damaged heart valve; and ejecting an artificial valve from the end of the instrument positioned adjacent the plurality of cusps of the damaged heart valve into a position between said plurality of cusps of the damaged heart valve without removing the damaged heart valve from the heart.

Claim 22

A transluminal method as set forth in claim 20 further comprising performing a septostomy between the atria of the heart and pushing the instrument through an atrial septal perforation created by the septostomy.

Claim 23

An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising: a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region; a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to at least a portion of the frame, said element having a convex upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a concave downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region; and an opening extending through at least one of said frame and the flexible valve element.

Claim 24

An artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, said artificial valve comprising: a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region; a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to at least a portion of the frame, said element having a convex upstream side facing said upstream region when the frame is anchored in the position between the upstream region and the downstream region and a concave downstream side opposite the upstream side facing said downstream region when the frame is anchored in the position between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region; and an opening extending through at least one of said frame and the flexible valve element.

Claim 25

An artificial valve as set forth in claim 22 further comprising a releasable fastener mounted on the frame for selectively connecting the valve to an instrument.

Claim 26

An artificial valve as set forth in claim 23 wherein the fastener comprises a hollow post mounted on the frame coaxial with the opening.

Claim 27

An artificial valve as set forth in claim 24 wherein said fastener comprises a threaded fastener.

Claim 28

An artificial valve as set forth in claim 25 wherein said post is externally threaded.

Claim 29

An artificial valve as set forth in claim 24 wherein said fastener comprises a bayonet fastener.

Claim 30

An artificial valve as set forth in claim 27 wherein said flexibly resilient frame includes frame elements extending outward from the central portion, said frame elements being biased outward to engage the heart tissue and hold the frame in an expanded configuration in the position between the upstream region and the downstream region.

Claim 31

An artificial valve as set forth in claim 28 further comprising a band extending around the frame elements to limit outward movement of the frame elements to the expanded configuration and to sealingly engage adjacent heart tissue and form a seal with the heart.

Claim 32

An artificial valve as set forth in claim 29 wherein said band includes a inner portion formed to limit outward movement of the frame elements, and an outer portion at least partially surrounding said inner portion and being biased inward, such that when the frame elements are forced inward to a collapsed configuration, the outer portion urges the inner portion inward to a position inside the frame elements.

Claim 33

In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and a guide for guiding the artificial valve between the upstream region and the downstream region, said combination comprising: said artificial valve including a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located along a centerline extending between the plurality of peripheral anchors, a flexible valve element fixedly attached to the central portion of the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side fading said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and an opening extending through at least one of said frame and the flexible valve element; and said flexible, elongate guide sized for receipt within the opening to guide the valve into position.

Claim 34

In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and a guide for guiding the artificial valve between the upstream region and the downstream region, said combination comprising: said artificial valve including a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located along a centerline extending between the plurality of peripheral anchors, a flexible valve element fixedly attached to the central portion of the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side fading said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and an opening extending through at least one of said frame and the flexible valve element; and said flexible, elongate guide sized for receipt within the opening to guide the valve into position.

Claim 35

A combination as set forth in claim 31 further comprising a holder having a hollow interior sized for holding the artificial valve when the frame is in the collapsed configuration.

Claim 36

A combination as set forth in claim 32 further comprising an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region.

Claim 37

A combination as set forth in claim 33 further comprising an installer received within the hollow interior of the holder and releasably attachable to the artificial heart valve for maneuvering the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region.

Claim 38

A combination as set forth in claim 32 wherein the holder comprises an outwardly flared end for receiving the artificial valve within the holder.

Claim 39

A combination as set forth in claim 32 wherein the holder comprises internal, longitudinal grooving for guiding the flexibly resilient frame.

Claim 40

A combination as set forth in claim 31 further comprising a vascular catheter.

Claim 41

In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and an instrument for inserting the artificial valve between the upstream region and the downstream region, said combination comprising: said artificial valve including a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located between the plurality of peripheral anchors, and a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side facing said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and an opening extending through at least one of said frame and the flexible valve element; and an instrument including a holder having a hollow interior sized for holding the artificial valve when the frame is in a collapsed configuration, an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region, and an installer received within the hollow interior of the holder and releasably attachable to the frame of the artificial heart valve for maneuvering the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region.

Claim 42

In combination, an artificial valve for repairing a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region, and an instrument for inserting the artificial valve between the upstream region and the downstream region, said combination comprising: said artificial valve including a flexibly resilient frame sized and shaped for insertion between the upstream region and the downstream region, the frame having a plurality of peripheral anchors for anchoring the frame between the upstream region and the downstream region and a central portion located between the plurality of peripheral anchors, and a flexible valve element fixedly attached to the frame so that at least a portion of the element is substantially immobile with respect to the central portion of the frame, said element having an upstream side facing said upstream region when the frame is anchored between the upstream region and the downstream region and a downstream side opposite the upstream side facing said downstream region when the frame is anchored between the upstream region and the downstream region, said flexible valve element moving in response to a difference between fluid pressure in said upstream region and fluid pressure in said downstream region between an open position in which the flexible valve element permits downstream flow between said upstream region and said downstream region and a closed position in which the flexible valve element blocks flow reversal from said downstream region to said upstream region, wherein the flexible valve element moves to the open position when fluid pressure in said upstream region is greater than fluid pressure in said downstream region to permit downstream flow from said upstream region to said downstream region and the flexible valve element moves to the closed position when fluid pressure in said downstream region is greater than fluid pressure in said upstream region to prevent flow reversal from said downstream region to said upstream region, and an opening extending through at least one of said frame and the flexible valve element; and an instrument including a holder having a hollow interior sized for holding the artificial valve when the frame is in a collapsed configuration, an elongate manipulator attached to the holder for manipulating the holder into position between the upstream region and the downstream region, and an installer received within the hollow interior of the holder and releasably attachable to the frame of the artificial heart valve for maneuvering the artificial heart valve from the hollow interior of the holder into position between the upstream region and the downstream region.

Claim 43

A combination as set forth in claim 38 wherein the frame includes a mount for selectively connecting the valve to the instrument.

Claim 44

A combination as set forth in claim 39 wherein the mount comprises a post mounted on the frame.

Claim 45

A combination as set forth in claim 40 wherein said post comprises a threaded fastener.

Claim 46

A combination as set forth in claim 41 wherein said post is externally threaded.

Claim 47

A combination as set forth in claim 42 wherein said installer includes an internally threaded portion for threadably receiving said externally threaded post.

Claim 48

A combination as set forth in claim 40 wherein said post comprises a bayonet fastener.

Claim 49

A combination as set forth in claim 38 wherein said holder has an outwardly flared end for receiving the peripheral anchors when the artificial valve is within the holder.

Claim 50

A combination as set forth in claim 38 wherein the holder comprises internal, longitudinal grooving for guiding the flexibly resilient frame.