Apparatus and methods for making leaflets and valve prostheses including such leaflets
First Claim
1. A method for making a bioprosthetic heart valve, comprising:
- creating a leaflet from a sheet of target material;
creating a plurality of alignment holes in the leaflet along at least one peripheral edge of the leaflet;
providing a crescent-shaped support structure having a concave edge, a convex edge, and a plurality of alignment holes corresponding to at least some of the alignment holes in the leaflet; and
directing one or more sutures through the corresponding alignment holes in the leaflet and the support structure to secure the leaflet to the support structure.
2 Assignments
0 Petitions
Accused Products
Abstract
A method for making a bioprosthetic heart valve includes providing a non-contact cutting apparatus and a layer of tissue. The non-contact cutting apparatus may include a laser cutting system or high pressure water jet system. A leaflet is cut from the layer of tissue using a predefined template, and a plurality of alignment holes in the leaflet are created in the leaflet, e.g., along a peripheral edge. A support structure is provided having a plurality of alignment holes corresponding to alignment holes in the leaflet. The leaflet is secured to the support structure by securing one or more sutures through corresponding alignment holes in the leaflet and the support structure to provide a leaflet subassembly. A bioprosthetic heart valve is made by securing a set of leaflet subassemblies to a frame.
275 Citations
28 Claims
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1. A method for making a bioprosthetic heart valve, comprising:
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creating a leaflet from a sheet of target material; creating a plurality of alignment holes in the leaflet along at least one peripheral edge of the leaflet; providing a crescent-shaped support structure having a concave edge, a convex edge, and a plurality of alignment holes corresponding to at least some of the alignment holes in the leaflet; and directing one or more sutures through the corresponding alignment holes in the leaflet and the support structure to secure the leaflet to the support structure. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method for making a bioprosthetic heart valve, comprising:
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creating a first leaflet from a sheet of target material, the first leaflet comprising a crescent-shaped edge; creating a plurality of alignment holes in the first leaflet along the crescent-shaped edge; providing a first crescent-shaped support structure having a concave edge, a convex edge, and a plurality of alignment holes corresponding to at least some of the alignment holes in the first leaflet; and directing one or more sutures through the corresponding alignment holes in the first leaflet and the first support structure to secure the first leaflet to the first support structure. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for making a bioprosthetic heart valve using a plurality of leaflets, each leaflet comprising a crescent-shaped edge, comprising:
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creating a plurality of alignment holes along the crescent-shaped edge of each leaflet; providing a plurality of crescent-shaped struts, each strut comprising a plurality of alignment holes arranged similar to the alignment holes in each leaflet; directing one or more sutures through the corresponding alignment holes in each leaflet and a respective strut to secure the leaflet to the respective strut; and attaching the struts to an annular frame at intermediate regions of the struts, thereby allowing free ends of the struts to bend or deflect independent of one another, the struts being offset from one another about a periphery of the frame. - View Dependent Claims (23, 24)
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25. A method for making a bioprosthetic heart valve, comprising:
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creating a plurality of leaflets from biological tissue; creating a plurality of alignment holes in each of the leaflets along at least one peripheral edge of the respective leaflets; providing a plurality of crescent-shaped support structures, each of the support structures having a curved intermediate region between opposite ends, and a plurality of alignment holes corresponding to at least some of the alignment holes in the leaflets; and directing one or more sutures through the corresponding alignment holes in the leaflets and the support structures to secure the leaflets to respective support structures, thereby providing a set of separate leaflet sub-assemblies. - View Dependent Claims (26, 27, 28)
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Specification