Continuous heart valve support frame and method of manufacture
First Claim
1. A method of manufacturing a heart valve, comprising:
- providing a tube made of NITINOL;
providing a heart valve support frame blank by separating a continuous support frame blank from the tube;
forcing the support frame blank into substantially the final shape of a heart valve support frame, wherein the support frame has an undulating shape with three arcuate cusps on an inflow end separated by three upstanding and generally axially-oriented commissures on an outflow end;
maintaining the support frame blank in its substantially heart valve support frame shape;
altering the internal structure of the NITINOL while maintaining the support frame blank in its heart valve support frame shape so that it remains in that shape and forms the support frame; and
assembling the heart valve by coupling a bioprosthetic valve or flexible leaflets to the support frame.
1 Assignment
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Accused Products
Abstract
Methods for forming a support frame for flexible leaflet heart valves from a starting blank include converting a two-dimensional starting blank into the three-dimensional support frame. The material may be superelastic, such as NITINOL, and the method may include bending the 2-D blank into the 3-D form and shape setting it. A merely elastic material such as ELGILOY may be used and plastically deformed in stages, possibly accompanied by annealing, to obtain the 3-D shape. Alternatively, a tubular blank could be formed to define a non-tubular shape, typically conical. A method for calculating the precise 2-D blank shape is also disclosed. A mandrel assembly includes a mandrel and ring elements for pressing the blank against the external surface of the mandrel prior to shape setting.
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Citations
20 Claims
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1. A method of manufacturing a heart valve, comprising:
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providing a tube made of NITINOL; providing a heart valve support frame blank by separating a continuous support frame blank from the tube; forcing the support frame blank into substantially the final shape of a heart valve support frame, wherein the support frame has an undulating shape with three arcuate cusps on an inflow end separated by three upstanding and generally axially-oriented commissures on an outflow end; maintaining the support frame blank in its substantially heart valve support frame shape; altering the internal structure of the NITINOL while maintaining the support frame blank in its heart valve support frame shape so that it remains in that shape and forms the support frame; and assembling the heart valve by coupling a bioprosthetic valve or flexible leaflets to the support frame. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of manufacturing a heart valve, comprising:
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providing a tube made of NITINOL; providing a heart valve support frame blank by separating a continuous support frame blank from the tube; in multiple stages, forcing the support frame blank into substantially the final shape of a heart valve support frame; after each stage of forcing, annealing the support frame blank by applying heat for a particular amount of time to remove residual stresses while maintaining the support frame blank shape so that it remains in that shape and forms the support frame after the final stage; and assembling the heart valve by coupling a bioprosthetic valve or flexible leaflets to the support frame. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20)
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Specification