PROSTHETIC HEART VALVE WITH RETENTION ELEMENTS
First Claim
Patent Images
1. A prosthetic valve, comprising:
- a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side, the leaflet frame having a leaflet frame central axis and a plurality of commissure posts extending parallel to the leaflet frame central axis that are spaced from one another, each commissure post defining a post slot therethrough that is aligned parallel to the leaflet frame central axis, between the commissure posts and contiguous therewith is a leaflet window;
a leaflet construct defining a contiguous cylinder comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend inward from the leaflet frame, each of the leaflets defining a fold-over portion that is folded over and lies against the leaflet frame outer side of the leaflet frame and coupled thereto, each of the bridge regions extending through one of the post slots and defining a bridge loop that is adjacent to the leaflet frame outer side; and
a retention element having a width that is larger than a width of the post slot, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the post slot.
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Abstract
Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct. The leaflet construct is at least partially coupled to a leaflet frame outer side of the leaflet frame and being coupled thereto by a retention element.
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Citations
39 Claims
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1. A prosthetic valve, comprising:
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a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side, the leaflet frame having a leaflet frame central axis and a plurality of commissure posts extending parallel to the leaflet frame central axis that are spaced from one another, each commissure post defining a post slot therethrough that is aligned parallel to the leaflet frame central axis, between the commissure posts and contiguous therewith is a leaflet window; a leaflet construct defining a contiguous cylinder comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend inward from the leaflet frame, each of the leaflets defining a fold-over portion that is folded over and lies against the leaflet frame outer side of the leaflet frame and coupled thereto, each of the bridge regions extending through one of the post slots and defining a bridge loop that is adjacent to the leaflet frame outer side; and a retention element having a width that is larger than a width of the post slot, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the post slot. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A prosthetic valve, comprising:
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a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side opposite the leaflet frame inner side, the leaflet frame further defining a plurality of commissure posts, each commissure post having a post outer side and a post inner side opposite the post outer side, the commissure posts are defined by a first post leg and a second post leg separated by a post slot therebetween; a leaflet construct defining a contiguous cylinder defining a plurality of leaflets and a bridge region between each of the leaflets, each bridge region defining a bridge first end adjacent a first leaflet and a bridge second end adjacent a second leaflet; and a plurality of retention elements, each retention element having a retention element inner side and a retention element outer side opposite the retention element inner side, the retention element inner side defining a dividing line bisecting the retention element, wherein each bridge region is wrapped around the retention element outer side to the retention element inner side of one of the retention elements with the bridge first end wrapped across the retention element inner side to adjacent the dividing line from a first direction and the bridge second end wrapped across the retention element inner side to adjacent the dividing line from an opposite direction, wherein the bridge first end and bridge second end are adjacent to each other to define a coaptation neck, wherein each of the coaptation necks passes through one of the post slots with the retention element adjacent the post outer side and wherein the leaflets extend from the leaflet frame inner side. - View Dependent Claims (31, 32, 33, 34, 35)
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36. A method of making a prosthetic valve, comprising:
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obtaining a tube comprising one or more layers of expanded PTFE composite; cutting a leaflet construct from the tube to include a plurality of leaflets each being separated by a bridge region from the tube; providing fold-over apertures in fold-over portions of each leaflet and providing bridge apertures in the bridge region; obtaining a plurality of retention elements, each retention element defining retention element apertures; folding each of the bridge regions into a bridge loop and defining a coaptation neck between each bridge loop and two adjacent leaflets, the bridge loops extending radially from a tube central axis; disposing a retention element into each of the bridge loops; suturing each retention element to the respective bridge loop passing suture through the bridge apertures and respective retention element apertures that are aligned therewith; providing a leaflet frame that is a tube defining leaflet frame windows and commissure posts therebetween where each commissure post defines a post slot dimensioned to receive a double thickness of the tube at the bridge region; providing leaflet window frame apertures in the leaflet window frame and providing post apertures in the commissure posts; disposing each coaptation neck in a respective post slot with the retention elements adjacent a post outer side and disposing the leaflets in the leaflet frame; aligning the retention element apertures with the post apertures; suturing each retention element to the respective commissure post passing suture through the retention element apertures and the post apertures that are aligned therewith; folding the fold-over portions of each leaflet along a leaflet frame inflow edge and against a leaflet frame outer side aligning the fold-over apertures with the leaflet window frame apertures; and suturing each fold-over portion to the respective leaflet window frame passing suture through the fold-over apertures and the leaflet window frame apertures that are aligned therewith. - View Dependent Claims (37, 38, 39)
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Specification