Prosthetic heart valve
First Claim
1. A stentless prosthetic heart valve, comprising:
- a plurality of thin, flexible leaflets, each of the leaflets having an inner face, an outer face, an in-flow edge, an out-flow edge, and side edges, the plurality of leaflets being sewn directly together along at least a portion of their side edges so as to form a substantially tubular valve structure having an in-flow end and an out-flow end, adjacent leaflets being arranged so that their side edges are substantially aligned and the inner faces of the leaflets engage each other adjacent the side edges, wherein the valve structure is movable between a closed position in which the out-flow edges of adjacent leaflets engage each other, and an open position in which the out-flow edges of adjacent leaflets are separated from each other except along the side edges, the sewn portions of the side edges of the leaflets biasing the leaflets toward a partially closed position.
2 Assignments
0 Petitions
Accused Products
Abstract
A tubular prosthetic semilunar or atrioventricular heart valve is formed by cutting flat, flexible leaflets according to a pattern. The valve is constructed by aligning the side edges of adjacent leaflets so that the leaflet inner faces engage each other, and then suturing the leaflets together with successive stitches along a fold line adjacent the side edges. During operation, when the leaflets open and close, the leaflets fold along the fold line. Distal tabs extend beyond the distal end of each leaflet. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs. The commissural tabs provide commissural attachment points to accommodate sutures and the like in order to secure the tab to a vessel wall, if a semilunar valve, and papillary muscles and/or chordae tendineae, if an atrioventricular valve.
931 Citations
66 Claims
-
1. A stentless prosthetic heart valve, comprising:
-
a plurality of thin, flexible leaflets, each of the leaflets having an inner face, an outer face, an in-flow edge, an out-flow edge, and side edges, the plurality of leaflets being sewn directly together along at least a portion of their side edges so as to form a substantially tubular valve structure having an in-flow end and an out-flow end, adjacent leaflets being arranged so that their side edges are substantially aligned and the inner faces of the leaflets engage each other adjacent the side edges, wherein the valve structure is movable between a closed position in which the out-flow edges of adjacent leaflets engage each other, and an open position in which the out-flow edges of adjacent leaflets are separated from each other except along the side edges, the sewn portions of the side edges of the leaflets biasing the leaflets toward a partially closed position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
-
-
15. A heart valve as in claim a additionally comprising a cloth reinforcement member attached to the valve in-flow end.
-
16. A stentless semilunar heart valve, comprising:
-
three thin, flexible leaflets, each of the leaflets having an inner face, an outer face, an in-flow edge, an out-flow edge, side edges, and tab portions extending outwardly beyond the side edges and positioned adjacent the out-flow edge, the leaflets being sewn directly to each other along their side edges so as to form a substantially tubular valve structure having an in-flow and an out-flow end;
wherein the tab portions of adjacent leaflets engage each other to form commissural attachment tabs, at least a portion of each commissural attachment tab being adjacent the outer faces of the adjacent leaflets. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
-
-
26. A stentless heart valve, comprising:
-
a first leaflet comprising a leaflet main body having an inner face, an outer face, a proximal end, a distal end, a first side edge, and a first tab portion adjacent the distal end and extending outwardly from the first side edge, the first tab portion connected to the first leaflet main body through a first neck portion; and
a second leaflet comprising a leaflet main body having an inner face, an outer face, a proximal end, a distal end, a second side edge, and a second tab portion adjacent the distal end extending from the second side edge, the second tab portion having a longitudinal slot and connected to the second leaflet main body through a second neck portion;
the first side edge of the first leaflet and the second side edge of the second leaflet being substantially aligned with and attached to one another and the inner faces of the first leaflet and the second leaflet engaging each other adjacent the aligned side edges; and
wherein the second tab portion is folded so that the first and second neck portions extend through the longitudinal slot of the second tab portion. - View Dependent Claims (27, 28, 29, 30, 31, 32)
-
-
33. A method for making a stentless tubular prosthetic hear valve, comprising:
-
providing a section of substantially flat, flexible material;
cutting a plurality of leaflets out of the flat material, each of the leaflets having an inner face, an outer face, a proximal end, a distal end, side edges, and tab portions adjacent the distal end and tending from the side edges;
aligning the side edges of adjacent leaflets together so that the inner faces of adjacent leaflets engage each other adjacent the side edges; and
sewing aligned side edges together so as to form a substantially tubular valve structure having an in-flow and an out-flow end. - View Dependent Claims (34, 35, 36, 37, 38)
-
-
39. A method of manufacturing a stentless prosthetic heart valve comprising:
-
providing a first valve leaflet and a second valve leaflet, the leaflets being formed separately from each other;
placing a portion of an inward face of the first valve leaflet against a corresponding portion of an inward face of the second valve leaflet; and
attaching the inward face portions to each other wherein the inward face portions of the leaflets are attached at the side edges of the leaflets. - View Dependent Claims (40)
-
-
41. The method of manufacturing a stentless prosthetic valve comprising providing first and second valve leaflets each having an integral tab portion at an end thereof;
- and
folding the tab portions relative to each other to provide a commissural tab, the commissural tab being attached to the leaflets along a commissural tab line such that free ends of the tabs extend substantially radially outwardly from the line; and
additionally comprising attaching side edges of the valve leaflets to each other along an attachment line which is coextensive with the commissural tab line.
- and
-
42. A stentless prosthetic comprising:
-
a plurality of valve leaflets comprised of a flexible material, each leaflet having an inner surface and an outer surface, each leaflet sewn directly to another leaflet along an attachment line, a portion of an inner surface face of one leaflet being in facing relationship with a portion of an inner surface of another leaflet at the attachment line; and
a commissural tab at an end of each attachment line, said tab configured for attachment to tissue. - View Dependent Claims (43, 44, 45, 46)
-
-
47. A prosthetic valve comprising:
- a valve body comprising at least first and second leaflets joined along a leaflet attachment line, said valve body comprising an inlet and an outlet, said leaflet attachment line extending from the inlet towards said outlet and terminating at a location short of the outlet, said valve body including a commissural tab comprised of neck portions juxtaposed along a neck line that extends from the attachment line termination to said outlet, said neck portions being at least substantially unattached along said neck line.
- View Dependent Claims (48, 49, 50, 51, 52, 53, 54, 55, 56)
-
57. A prosthetic valve, comprising:
a valve body having an inlet portion comprising an annulus and an outlet portion, said annulus having a periphery comprised of edges which are scalloped. - View Dependent Claims (58, 59, 60, 61)
-
62. A stentless prosthetic heart valve, comprising:
-
a plurality of thin, flexible leaflets, each of the leaflets having an inner face, an outer face, an in-flow edge, an out-flow edge, and side edges, the plurality of leaflets being sewn together along at least a portion of their side edges so as to form a substantially tubular valve structure having an in-flow end and an out-flow end, adjacent leaflets being arranged so that their side edges are substantially aligned and the inner faces of the leaflets engage each other adjacent the side edges, wherein the valve structure is movable between a closed position in which the out-flow edges of adjacent leaflets engage each other, and an open position in which the out-flow edges of adjacent leaflets are separated from each other except along the side edges, the sewn portions of the side edges of the leaflets biasing the leaflets toward a partially closed position, wherein the leaflets comprises a tab portion adjacent the leaflet out-flow edge, the tab portions are disposed adjacent at least one of the leaflet side edges, the tab portion is formed adjacent each leaflet side edge, the tab portions of adjacent leaflets are connected to each other to form commissural attachment tabs;
wherein the connected tab portions are at least partially folded over each other.
-
-
63. A stentless semilunar heart valve, comprising:
-
three thin, flexible leaflets, each of the leaflets having an inner face, an outer face, an in-flow edge, an out-flow edge, side edges, and tab portions extending outwardly beyond the side edges and positioned adjacent the out-flow edge, the leaflets being attached to each other along their side edges so as to form a substantially tubular valve structure having an in-flow and an out-flow end;
wherein the tab portions of adjacent leaflets engage each other to form commissural attachment tabs, at least a portion of each commissural attachment tab being adjacent the outer faces of the adjacent leaflets;
wherein the in-flow edge and out-flow edge of each leaflet has a substantially scalloped shaped, a center portion of the in-flow edge of each leaflet extends a distance proximal of a position at which the side edge meets the in-flow edge;
wherein a center portion of the out-flow edge of each leaflet extends a proximal of a position which the side edge meets the out-flow edge.
-
-
64. A prosthetic valve comprising:
-
a valve body comprising at least first and second leaflets joined along a leaflet attachment line, said valve body comprising an inlet and an outlet, said leaflet attachment line extending from the inlet towards said outlet and terminating at a location short of the outlet, said valve body including a commissural tab comprised of neck portions juxtaposed along a neck line that extends from the attachment line termination to said outlet, said neck portions being at least substantially unattached along said neck line;
wherein the leaflets are joined along the attachment line by stitches.
-
-
65. A prosthetic valve comprising:
-
a valve body comprising at least first and second leaflets joined along a leaflet attachment line, said valve body comprising an inlet and an outlet, said leaflet attachment line extending from the inlet towards said outlet and terminating at a location short of the outlet, said valve body including a commissural tab comprised of neck portions juxtaposed along a neck line that extends from the attachment line termination to said outlet, said neck portions being at least substantially unattached along said neck line;
wherein said neck portions are disposed in a slot in said commissural tab, said slot retaining said neck portions in said juxtaposed relationship without attachment to each other;
wherein a distal end of the slot is rounded to avoid stress concentrations.
-
-
66. A prosthetic valve comprising:
-
a valve body comprising at least first and second leaflets joined along a leaflet attachment line, said valve body comprising an inlet and an outlet, said leaflet attachment line extending from the inlet towards said outlet and terminating at a location short of the outlet, said valve body including a commissural tab comprised of neck portions juxtaposed along a neck line that extends from the attachment line termination to said outlet, said neck portions being at least substantially unattached along said neck line;
wherein said neck portions are disposed in a slot in said commissural tab, said slot retaining said neck portions in said juxtaposed relationship without attachment to each other;
wherein said tab is stitched on opposite sides of said slot along respective lines that are spaced relative to said slot such that no stitches are in said neck portions.
-
Specification