Four-leaflet stented mitral heart valve
First Claim
1. A prosthetic mitral heart valve for implant at a mitral valve annulus, comprising:
- a synthetic support frame having a rod-like wireform circumscribing a central orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis is substantially elliptical, with a longer major dimension and a shorter minor dimension perpendicular thereto, the support frame having an outflow edge that undulates in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion to an axial height from the cusps of at least 6 mm;
wherein the support frame comprises a cloth covering on the wireform and a dual-band stent surrounding the wireform; and
four (4) separate leaflets each mounted in cooperation with the four (4) arcuate cusps of support frame to provide a one-way valve in the orifice.
1 Assignment
0 Petitions
Accused Products
Abstract
A prosthetic mitral heart valve having four separate flexible leaflets. The heart valve includes a support frame that may be non-circular, for example elliptical or “D-shaped”. The support frame may have an undulating outflow edge defined by four inflow cusps and four outflow commissures to which each of the flexible leaflets attaches. The support frame may comprise an undulating wireform and a surrounding stent defining a structure having four cantilevered posts projecting in the outflow direction to support the four leaflets. The heart valve is designed to be secured in the annulus and function as a standalone unit without papillary muscle connections to the leaflets. The four leaflets may be arranged in two opposed pairs, one pair being smaller than the other pair. The larger pair of leaflets may be identical, or differently sized. Existing sizes of heart valve leaflets may be utilized with the smaller leaflets being at least two leaflet sizes smaller than the larger leaflets in odd millimeter increments.
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Citations
26 Claims
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1. A prosthetic mitral heart valve for implant at a mitral valve annulus, comprising:
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a synthetic support frame having a rod-like wireform circumscribing a central orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis is substantially elliptical, with a longer major dimension and a shorter minor dimension perpendicular thereto, the support frame having an outflow edge that undulates in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion to an axial height from the cusps of at least 6 mm;
wherein the support frame comprises a cloth covering on the wireform and a dual-band stent surrounding the wireform; andfour (4) separate leaflets each mounted in cooperation with the four (4) arcuate cusps of support frame to provide a one-way valve in the orifice. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A prosthetic heart valve for implant at a valve annulus, comprising:
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a support frame circumscribing a central orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis has no straight lines and is substantially elliptical, the support frame having an undulating shape in the inflow-outflow direction with four (4) arcuate cusps extending toward the inflow direction, wherein the ends of adjacent cusps converge to form four (4) upstanding commissures each extending generally in the outflow direction in a cantilevered fashion; and four (4) flexible leaflets each having a cusp region mounted around an arcuate support frame cusp and at least partway along adjacent commissures, and free edges that extend inward and provide a one-way valve in the orifice, wherein the four (4) flexible leaflets are arranged around the orifice in a diametrically opposed first pair and a diametrically opposed second pair of leaflets, and wherein the leaflets of the second pair are both larger than either of the leaflets of the first pair and the leaflets of the first pair are symmetric. - View Dependent Claims (12, 13, 14, 15)
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16. A prosthetic mitral heart valve for implant at a valve annulus, comprising:
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a support frame circumscribing an orifice about an axis along an inflow-outflow direction, wherein the orifice as viewed along the axis is substantially elliptical, wherein the orifice as viewed along the axis has a longer major dimension and a shorter minor dimension perpendicular thereto, the orifice on an anterior side configured to attach to an anterior aspect of the mitral annulus while the remainder of the orifice defines a posterior side configured to attach to a posterior aspect of the mitral annulus, and wherein the support frame is non-planar so as to have an axial height of at least 6 mm and is made of synthetic materials capable of maintaining its non-planar shape after implant, wherein the support frame comprises a cloth covering on the wireform and a dual-band stent surrounding the wireform; and four (4) separate flexible leaflets mounted around the support frame and having free edges that extend inward and provide a one-way valve in the orifice, wherein the four (4) flexible leaflets are arranged around the orifice with an anterior leaflet mounted along the anterior side of the support frame and three posterior leaflets mounted around the posterior side of the support frame, and wherein the posterior leaflet diametrically opposite the anterior leaflet is as large or larger than the anterior leaflet. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification