Balloon-expandable pediatric surgical heart valve
AssigneeEdwards Lifesciences Corporation
InventorsRodolfo Rodriguez, Milton Deherrera, Van Huynh
Life of this patent
Estimating the term…
Abstract
A prosthetic surgical heart valve for smaller patients, in particular pediatric patients. The heart valves are smaller and more flexible, and may be incrementally expandable to accommodate growth in the patient. The heart valves are especially useful at the pulmonary valve position, where the opening and closing pressures are much lower than at the other native valve locations. The heart valves are formed of thinner and more flexible materials than aortic or mitral valves which enable them to open and close more effectively when subjected to the lower pulmonary blood flow pressures. Incremental expansion of the heart valves is enabled by a plastically-expandable stiffening band coupled to a valve member.
Claims21
A prosthetic surgical heart valve adapted for surgical delivery and implant at a native annulus, comprising:
- a valve member with a leaflet support structure defining a plurality of upstanding commissures alternating with the same number of arcuate cusps to define an undulating outflow edge, the valve member having a plurality of flexible leaflets extending along and attached to the undulating outflow edge that coapt against one another and form a one-way valve across an inner flow orifice defining a central axis, the support structure being formed of a plastically expandable material;
- a stiffening band comprising an alternating series of solid plate segments and expandable segments around a periphery thereof juxtaposed against an inflow end of the valve member, the stiffening band defining a generally annular shape with an initial diameter sufficient for valve functioning, the stiffening band being formed of a plastically expandable material and being incapable of compression smaller than the initial diameter, the stiffening band being capable of expansion of at least 2 mm in diameter;
- and
- fabric coverings around the valve member and stiffening band, wherein the fabric coverings and/or sutures connecting the fabric covering to the valve member and stiffening band supply the only coupling structure between the valve member and stiffening band and there are no other non-fabric components therebetween.
A prosthetic surgical heart valve adapted for surgical delivery and implant at a native annulus, comprising:
- a valve member with a leaflet support structure defining a plurality of upstanding commissures alternating with the same number of arcuate cusps to define an undulating outflow edge, the valve member having a plurality of flexible leaflets extending along and attached to the undulating outflow edge that coapt against one another and form a one-way valve across an inner flow orifice defining a central axis, the support structure being formed of a plastically expandable material, and the leaflets each having a thickness t of between about 0.004–0.013 inches (0.1–0.33 mm);
- a stiffening band comprising an alternating series of solid plate segments and expandable segments around a periphery thereof juxtaposed against and coupled to an inflow end of the valve member, the stiffening band defining a generally annular shape with an initial diameter sufficient for valve functioning, the stiffening band being formed of a plastically expandable material and being incapable of compression smaller than the initial diameter, the stiffening band being capable of expansion of at least 2 mm in diameter;
- and
- fabric coverings around the valve member and stiffening band.
A prosthetic heart valve surgical adapted for surgical delivery and implant at a native annulus, comprising:
- a valve member with a leaflet support wireform defining a plurality of upstanding commissures alternating with the same number of arcuate cusps to define an undulating outflow edge, the wireform having a wire diameter d of between about 0.009‒0.019 inches (about 0.23‒0.48 mm), the valve member having a plurality of flexible leaflets extending along and attached to the undulating outflow edge that coapt against one another and form a one-way valve across an inner flow orifice defining a central axis, the wireform being formed of an expandable material;
- a stiffening band comprising an alternating series of solid plate segments and expandable segments around a periphery thereof juxtaposed against and coupled to an inflow end of the valve member, the stiffening band defining a generally annular shape with an initial diameter sufficient for valve functioning, the stiffening band being formed of a plastically expandable material and being incapable of compression smaller than the initial diameter, the stiffening band being capable of expansion of at least 2 mm in diameter;
- and
- fabric coverings around the valve member and stiffening band.
Dependencies are inferred from the claim text.