EP0051451A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Low profile prosthetic xenograft heart valve
Assignee: Livanova Holding USA Inc
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Filing: 1981-10-29
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Granted: —
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Expires: 2001-10-29
Abstract
Abstract Prosthetic heart valves having a low profile are disclosed which comprise an annular, right cylindrical, metal stent covered with fabric around which a glutaraldehyde-stabilized pericardial valving element is attached. The valving element is formed of three leaflets, each having a plateau on a truncated triangle extending higher at the center than at the edges, and formed as a cylinder having a diameter substantially equal to the diameter of the stent. In a preferred embodiment of the invention, the stent has upright legs which have radiused upper tips which are approximately one-half the width of prior art stent legs. These narrow tipped stent legs reduce stress induced in the leaflets by curvature of the leaflets around the tips of the stent legs in the closed position, extending the service life of the valve. Tabs are added to the tips of the stent legs to add structural strength. These tabs can be tapered or straight but their bottom portions must be narrower than the stent legs. The tabs have a plurality of holes in them through which coaptation stitches are passed. The coaptation stitch can be two separate stitches, one in a first plane and one in a second plane at 90° to the first plane, or, in the preferred embodi- . ment, a single figure eight stitch passing through the holes in the tab in a plane coincident with the long axis of the stent leg.
Inventors
- 👤 Marian Ian Ionescu
- 👤 Jay Alan Lenker
- 👤 Robert Frank Rosenbluth
- 👤 Louis Seiler, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-22 20:55
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2418; A61F2/2409; A61F2220/00; A61F2220/0025; A61F2220/0075; Y; Y10; Y10S; Y10S623/00; Y10S623/90
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
318 words
- A prosthetic heart valve comprising: a stent comprising an annular base integrally formed with three upwardly extending legs, the space between the legs configured to form generally elliptically shaped scallops having a depth U measured from the top of the legs to the bottom of the scallop, the stent circumferentially forming a substantially right cylinder having an interior diameter D with the legs extending parallel to the axis of the cylinder, the lower edge of the base forming scallops corresponding generally to the arc of the scallops between the legs, the scallops of the lower edge of the base and the scallops between the legs vertically defining three generally elliptically shaped one-third portions of the base between the respective upright legs; a fabric covering encompassing and following the configuration of the stent; an annular sewing ring attached to the fabric covering and extending outwardly from the base; a tissue valve element formed of three tissue leaflets joined to form a generally cylindrical three-cusp valving element, each leaflet having a top edge forming a raised truncated triangular form with a central plateau and two sides diverging from each side of the plateau to corners at their junctures with the sides of the leaflet; means attaching the tissue valve element around the fabric covered-stent; and a plurality of coaptation stitches through the tissue leaflets adjacent the upper edges thereof disposed directly above the tops of the fabric covered stent legs fixing the leaflets to form three cusps, with said plateaus extending upwardly midway between the legs in the open position of the valve, the upper edges of the cusps meeting in the closed position of the valve with the plateaus adjacent each other, and in the open position of the valve the tissue valve element forming a cylinder having an inside diameter at the top of the valve substantially equal to the inside diameter of the fabric covered stent.
Claim 2
Dependent Claim
318 words
- A prosthetic heart valve comprising: a stent comprising an annular base integrally formed with three upwardly extending legs, the space between the legs configured to form generally elliptically shaped scallops having a depth U measured from the top of the legs to the bottom of the scallop, the stent circumferentially forming a substantially right cylinder having an interior diameter D with the legs extending parallel to the axis of the cylinder, the lower edge of the base forming scallops corresponding generally to the arc of the scallops between the legs, the scallops of the lower edge of the base and the scallops between the legs vertically defining three generally elliptically shaped one-third portions of the base between the respective upright legs; a fabric covering encompassing and following the configuration of the stent; an annular sewing ring attached to the fabric covering and extending outwardly from the base; a tissue valve element formed of three tissue leaflets joined to form a generally cylindrical three-cusp valving element, each leaflet having a top edge forming a raised truncated triangular form with a central plateau and two sides diverging from each side of the plateau to corners at their junctures with the sides of the leaflet; means attaching the tissue valve element around the fabric covered-stent; and a plurality of coaptation stitches through the tissue leaflets adjacent the upper edges thereof disposed directly above the tops of the fabric covered stent legs fixing the leaflets to form three cusps, with said plateaus extending upwardly midway between the legs in the open position of the valve, the upper edges of the cusps meeting in the closed position of the valve with the plateaus adjacent each other, and in the open position of the valve the tissue valve element forming a cylinder having an inside diameter at the top of the valve substantially equal to the inside diameter of the fabric covered stent.
Claim 3
Dependent Claim
18 words
The prosthetic heart valve of Claim 1 wherein the ratio U/D is from about 0.50 to about 0.65.
Claim 4
Dependent Claim
58 words
The prosthetic heart valve of Claim 1 wherein the width of the area of contact of the cusps in the closed position of the valve is about 0 to 2 mm in the center of the valve and from about 3 to about 7 mm halfway between the center of the valve and the legs of the stent.
Claim 5
Dependent Claim
28 words
The prosthetic heart valve of Claim 1 wherein the sewing ring extends outwardly circumferentially forming an annulus vertically following the scalloped curvature of the base of the stent.
Claim 6
Dependent Claim
56 words
A prosthetic heart valve of Claim 1 wherein said stent is dimensioned such that the quotient of the radius of curvature of mobile tissue measured at the point of greatest curvature divided by the thickness of said tissue is greater than or equal to five at all points of contact between said tissue and said stent.
Claim 7
Dependent Claim
134 words
A prosthetic heart valve comprising: a) a stent comprising: 1) a ring with scallops formed therein defining an aperture with inflow and outflow ends; and 2) a plurality of legs coupled to said ring extending upwardly toward said outflow end, said stent being dimensioned such that the quotient of the radius of curvature of mobile tissue measured at the point of greatest curvature divided by the thickness of said tissue is greater than or equal to five at all points of contact between said tissue and said stent; b) a plurality of tissue leaflets attached to said stent and to each other to form a valving element; and c) a plurality of coaptation means in the vicinity of the tips of said stent legs for causing joining of the edges of said tissue leaflets.
Claim 8
Dependent Claim
134 words
A prosthetic heart valve comprising: a) a stent comprising: 1) a ring with scallops formed therein defining an aperture with inflow and outflow ends; and 2) a plurality of legs coupled to said ring extending upwardly toward said outflow end, said stent being dimensioned such that the quotient of the radius of curvature of mobile tissue measured at the point of greatest curvature divided by the thickness of said tissue is greater than or equal to five at all points of contact between said tissue and said stent; b) a plurality of tissue leaflets attached to said stent and to each other to form a valving element; and c) a plurality of coaptation means in the vicinity of the tips of said stent legs for causing joining of the edges of said tissue leaflets.
Claim 9
Dependent Claim
64 words
The prosthetic heart valve of Claim 6 further including inwardly projecting tab means at the outflow end of each stent leg for adding structural strength to said legs, with the distance that said tab means project inwardly toward the center of said aperture being restricted to a distance which substantially eliminates touching between the tissue leaflets and the bottom surfaces of said tab means.
Claim 10
Dependent Claim
47 words
The prosthetic heart valve of Claim 7 further including means on said tab means coupled to said coaptation means for fixing the position of said coaptation means, with said means for fixing the position of said coaptation means comprising a plurality of holes through said tab means.
Claim 11
Dependent Claim
77 words
The valve of Claim 8 wherein each of said coaptation means comprises a coaptation stitch lying generally in a plane parallel to the long axis of the stent leg and passing through said plurality of holes and said tissue leaflets, and which stitch is tied off above the tip of said stent leg, with each of said tabs having two holes therein and each of said coaptation stitches defining a figure eight pattern through said two holes.
Claim 12
Dependent Claim
35 words
The valve of Claim 7 wherein the width of said tab means remains constant throughout its length while the width of said stent legs increases at points removed from the tips of said stent legs.
References Cited (Backward Citations)
No citation records indexed.
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