Everting transcatheter valve and methods
First Claim
Patent Images
1. A transcatheter valve having a multi-part frame, the transcatheter valve comprising:
- a multi-part frame including,a body frame defining a generally tubular shape;
a leaflet frame defining a generally annular shape and coaxially disposed relative to, extending away and spaced apart from the body frame defining a fold region therebetween, the leaflet frame defining a plurality of U-shaped portions each defining a base and a plurality of posts, the base of each U-shaped portion being located proximate to but not in contact with a body frame first end of the body frame with the U-shaped portions of the leaflet frame extending away from the body frame and the posts extending away from body frame, the posts being distal from the body frame first end; and
a film extending across and between the body frame and leaflet frame bridging the fold region and coupling the body frame to the leaflet frame, the leaflet frame and film defining a plurality of leaflets disposed within each U-shaped portion, each leaflet having a leaflet free edge, wherein the leaflet frame is operable to evert along the fold region so as to dispose the leaflet frame at least partially within the body frame and defining a valve wherein the leaflet free edges abut adjacent leaflet free edges and are moveable between an open and closed position.
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Abstract
Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve includes a collapsed configuration and an expanded configuration. The transcatheter valve can further include an everted configuration and a non-everted configuration.
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Citations
40 Claims
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1. A transcatheter valve having a multi-part frame, the transcatheter valve comprising:
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a multi-part frame including, a body frame defining a generally tubular shape; a leaflet frame defining a generally annular shape and coaxially disposed relative to, extending away and spaced apart from the body frame defining a fold region therebetween, the leaflet frame defining a plurality of U-shaped portions each defining a base and a plurality of posts, the base of each U-shaped portion being located proximate to but not in contact with a body frame first end of the body frame with the U-shaped portions of the leaflet frame extending away from the body frame and the posts extending away from body frame, the posts being distal from the body frame first end; and a film extending across and between the body frame and leaflet frame bridging the fold region and coupling the body frame to the leaflet frame, the leaflet frame and film defining a plurality of leaflets disposed within each U-shaped portion, each leaflet having a leaflet free edge, wherein the leaflet frame is operable to evert along the fold region so as to dispose the leaflet frame at least partially within the body frame and defining a valve wherein the leaflet free edges abut adjacent leaflet free edges and are moveable between an open and closed position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A transcatheter valve having a multi-part frame, the transcatheter valve comprising:
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a body frame defining a body frame lumen; a leaflet frame, the leaflet frame defining a first position in which the body frame extends coaxially, adjacent to and spaced apart from the leaflet frame; and a film assembly including a first portion defining a plurality of leaflets connected to the leaflet frame and a second portion extending between the leaflet frame and the body frame and defining a fold region, the leaflet frame being evertible about the fold region from the first position to a second position in which the leaflet frame is at least partially coaxially disposed within the body frame lumen. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30)
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31. A transcatheter valve having a multi-part frame, the transcatheter valve comprising:
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a first frame having an annular shape and being expandable from a first, compact diameter when the first frame is in a compacted state to a second, enlarged diameter when the first frame is in an expanded state; a second frame having an annular shape and being expandable from a first, compact diameter when the second frame is in a compacted state to a second, enlarged diameter when the second frame is in an expanded state, wherein the second, enlarged diameter of the second frame is larger than the second, enlarged diameter of the first frame; and a bridge region coupling the first frame to the second frame; the transcatheter valve having a first delivery state in which the first frame is coaxial with, but longitudinally spaced from the second frame with the bridge region extending longitudinally between the first frame and the second frame and an everted state in which the bridge region is folded over into the second frame and the first frame is coaxial with the second frame with at least a portion of the first frame disposed within the second frame. - View Dependent Claims (32)
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33. A transcatheter valve comprising:
a multi-part frame defining a flow lumen through which fluid is able to selectively flow, the multi-part frame including, an outer support portion having a generally tubular shape defining a first lumen, an evertible support portion having a generally tubular shape, and a flexible bridge material coupling the evertible support portion to the outer support portion, such that the evertible support portion is transitionable from a first, laterally adjacent position relative to the outer support portion and a second, everted position in which the evertible support portion is at least partially located within the first lumen of the outer support portion; and a plurality of leaflets coupled to the multi-part frame, each leaflet being moveable between an open position and closed position to selectively block and unblock the flow lumen of the multi-part frame. - View Dependent Claims (34, 35, 36, 37)
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38. A transcatheter valve comprising:
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a multi-part frame, including; a body frame having a generally tubular shape defining a body frame lumen, and a leaflet frame having a generally annular shape defining a plurality of bases and a plurality of posts, the body frame extending coaxially, adjacent to and spaced apart from the leaflet frame; and a plurality of leaflets coupled to the plurality of bases between the plurality of posts, wherein the multi-part frame is configured to be everted into itself from an axially extended, non-everted configuration in which the leaflet frame is spaced axially apart from the body frame to an everted configuration in which the leaflet frame is received at least partially within the lumen of the body frame. - View Dependent Claims (39, 40)
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Specification