Collapsible Heart Valve with Polymer Leaflets
First Claim
1. A human heart valve replacement comprising:
- a collapsible stent formed from at least one length of wire, the wire having a series of turns forming a spring-like stent wall; and
at least one leaflet attached to the stent;
wherein the stent wall is collapsible in a radial direction such that a contracted diameter of the heart valve is smaller than an expanded diameter of the heart valve,wherein the stent wall is spring biased to the expanded diameter, andwherein the heart valve is sufficiently collapsible to be disposed within a catheter for insertion into a human heart.
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Accused Products
Abstract
A Catheter Based Heart Valve (CBHV) is described herein which replaces a non functional, natural heart valve. The CBHV significantly reduces the invasiveness of the implantation procedure by being inserted with a catheter as opposed to open heart surgery. Additionally, the CBHV is coated with a biocompatible material to reduce the thrombogenic effects and to increase durability of the CBHV. The CBHV includes a stent and two or more polymer leaflets sewn to the stent. The stent is a wire assembly coated with Polystyrene-Polyisobutylene-Polystyrene (SIBS). The leaflets are made from a polyester weave as a core material and are coated with SIBS before being sewn to the stent. Other biocompatible materials may be used, such as stainless steel, Titanium, Nickel-Titanium alloys, etc.
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Citations
42 Claims
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1. A human heart valve replacement comprising:
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a collapsible stent formed from at least one length of wire, the wire having a series of turns forming a spring-like stent wall; and at least one leaflet attached to the stent; wherein the stent wall is collapsible in a radial direction such that a contracted diameter of the heart valve is smaller than an expanded diameter of the heart valve, wherein the stent wall is spring biased to the expanded diameter, and wherein the heart valve is sufficiently collapsible to be disposed within a catheter for insertion into a human heart. - 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)
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25. A human heart valve replacement comprising:
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a collapsible stent formed from at least one length of nitinol wire, the nitinol wire having a series of turns forming a spring-like stent wall; a forward migration retainer extending from one end of the stent wall, the forward migration retainer being formed from a loop of the nitinol wire and adapted to engage a vessel wall to prevent migration of the replacement human heart valve in a blood flow direction; a backflow migration retainer extending from another end of the stent wall, the backflow migration retainer being formed from a loop of the nitinol wire and adapted to engage a natural leaflet to prevent migration of the replacement human heart valve in a direction opposite to blood flow; three leaflets having a thickness of less than 280 microns attached to the stent, the three leaflets forming a central coaptation arrangement; wherein the stent wall is collapsible in a radial direction such that a contracted diameter of the replacement human heart valve is smaller than an expanded diameter of the replacement human heart valve, wherein the stent wall is spring biased to the expanded diameter, wherein the replacement human heart valve is sufficiently collapsible to be disposed within a catheter for insertion into a human heart, and wherein the heart valve is coated with a boicompatable material.
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26. A method of forming a stent for a replacement human heart valve, the method comprising:
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attaching an end of a wire to a stent plate and attaching the other end of the wire to a tensor; stretching the wire along a path determined by a plurality of pins on the stent plate; thermally treating the stretched wire; attaching the wire to a second plate; bending portions of the wire to form a forward migration retainer and a backflow migration retainer; thermally treating the stretched wire; bending the stent into a substantially cylindrical shape; and fixing the ends of the wire together within a hypodermic tube.
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27. A method of forming a leaflet for a replacement human heart valve, the method comprising;
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providing a sheet of material having a thickness of less than 280 microns; soaking the sheet of material in a 20 ml solution of SIBS; drying the sheet of material for approximately 12 hours at approximately 80 degrees C.; and folding the sheet of material into one of a double coaptation arrangement and a central coaptation arrangement.
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28. A method of inserting a human heart valve replacement into a human heart, the method comprising:
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providing a replacement human heart valve comprising; a collapsible stent formed from a length of wire, the wire having a series of turns forming a spring-like stent wall; and a leaflet attached to the stent; wherein the stent wall is collapsible in a radial direction such that a contracted diameter of the replacement human heart valve is smaller than an expanded diameter of the replacement human heart valve, the stent wall is spring biased to the expanded diameter, and the replacement human heart valve is sufficiently collapsible to be disposed within a catheter for insertion into a human heart; compressing the stent to a diameter less than that of a catheter; inserting the replacement human heart valve into the catheter; inserting the catheter into the human heart; and expanding the replacement human heart valve into an operational position in the human heart.
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29. A leaflet for an artificial human heart valve comprising:
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a sheet of woven fabric material; wherein the sheet of woven material is both peripherally and centrally coaptable. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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Specification