Prosthetic heart valve system
First Claim
1. A prosthetic aortic heart valve system configured for implant at an aortic annulus and partially within sinus cavities downstream adjacent thereto, comprising:
- a plastically-expandable base stent adapted to anchor against an aortic valve annulus, the base stent being radially expandable from a compressed configuration to an expanded configuration, wherein the base stent in the expanded configuration has an outflow end defining a first diameter and an inflow end defining a second diameter smaller that the first diameter and an outflow end portion that tapers down to an inflow end portion, and wherein the outflow end portion of the base stent in the expanded configuration has a three-lobed cross-sectional profile in a plane perpendicular to a longitudinal axis of the base stent with three outwardly-projecting sinus-shaped lobes intermediate three regions of lesser radial dimension that mimics a shape of aortic sinuses at an aortic root, and the inflow end portion has a circular cross-sectional profile in a plane perpendicular to the longitudinal axis, such that the base stent is configured to expand in vivo with the outflow end portion conforming to the sinus cavities downstream from the aortic annulus and the inflow end portion fitting within the aortic valve annulus; and
a valve component comprising a prosthetic valve defining therein a non-expandable, non-collapsible support frame surrounding an orifice, the valve component also comprising an expandable coupling stent extending from an inflow end of the support frame, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the base stent, wherein the portion of the base stent with the three-lobed cross-sectional profile defines a seating area against which the support frame of the prosthetic valve is mounted, the first diameter at the outflow end of the base stent being sized to receive the support frame therethrough and the seating area having a diameter that is less than a diameter of the support frame to prevent axial movement of the prosthetic valve toward the inflow end of the base stent, and wherein the support frame defines a three-lobed shape adapted to seat within the portion of the base stent with the three-lobed cross-sectional profile and the coupling stent has a length sufficient to extend through the aortic valve annulus and within the inflow end portion of the base stent.
1 Assignment
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Accused Products
Abstract
An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent. In its expanded configuration, the outflow end portion base stent has tri-lobular shape that closely conforms to the shape of the aortic root and a support ring of the prosthetic valve that is mounted within the base stent.
374 Citations
13 Claims
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1. A prosthetic aortic heart valve system configured for implant at an aortic annulus and partially within sinus cavities downstream adjacent thereto, comprising:
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a plastically-expandable base stent adapted to anchor against an aortic valve annulus, the base stent being radially expandable from a compressed configuration to an expanded configuration, wherein the base stent in the expanded configuration has an outflow end defining a first diameter and an inflow end defining a second diameter smaller that the first diameter and an outflow end portion that tapers down to an inflow end portion, and wherein the outflow end portion of the base stent in the expanded configuration has a three-lobed cross-sectional profile in a plane perpendicular to a longitudinal axis of the base stent with three outwardly-projecting sinus-shaped lobes intermediate three regions of lesser radial dimension that mimics a shape of aortic sinuses at an aortic root, and the inflow end portion has a circular cross-sectional profile in a plane perpendicular to the longitudinal axis, such that the base stent is configured to expand in vivo with the outflow end portion conforming to the sinus cavities downstream from the aortic annulus and the inflow end portion fitting within the aortic valve annulus; and a valve component comprising a prosthetic valve defining therein a non-expandable, non-collapsible support frame surrounding an orifice, the valve component also comprising an expandable coupling stent extending from an inflow end of the support frame, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the base stent, wherein the portion of the base stent with the three-lobed cross-sectional profile defines a seating area against which the support frame of the prosthetic valve is mounted, the first diameter at the outflow end of the base stent being sized to receive the support frame therethrough and the seating area having a diameter that is less than a diameter of the support frame to prevent axial movement of the prosthetic valve toward the inflow end of the base stent, and wherein the support frame defines a three-lobed shape adapted to seat within the portion of the base stent with the three-lobed cross-sectional profile and the coupling stent has a length sufficient to extend through the aortic valve annulus and within the inflow end portion of the base stent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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Specification