Rolled minimally-invasive heart valves and methods of manufacture
First Claim
1. A method of prosthetic heart valve implantation at an aortic annulus, comprising:
- delivering a rolled prosthetic heart valve to an aortic annulus, the prosthetic heart valve including a stent body having a spirally-wound contracted, first configuration with a first diameter configured for advancement to the aortic annulus and an unwound expanded, second configuration with a maximum second diameter, the prosthetic heart valve further including three flexible membranes attached to the stent body that form heart valve leaflets in the expanded configuration and portions of the stent body between the leaflets defining axially extending commissures;
unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration at the aortic annulus; and
positioning the prosthetic heart valve such that the stent body commissures align with native commissures of the aortic annulus.
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Accused Products
Abstract
Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery using a catheter, and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The stents may include an annulus section, a sinus section with the membranes attached over sinus apertures, and an outflow section. Lockout tabs and making slots secure the stents in their expanded shapes. Alignment structure ensures concentric unfurling of the stent. Anchoring elements at the stent edges or in the stent body secure the valve within the annulus. A method of manufacture includes shape setting the sheet-like stent to ensure an outward bias during deployment. The stent may also include dear tracks for engagement with a gear mechanism for deployment. The stent is desirably made of a superelastic material such as Nitinol and may have areas removed or thinned to reduce the bending stresses when rolled into its small spiral for catheter delivery.
812 Citations
33 Claims
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1. A method of prosthetic heart valve implantation at an aortic annulus, comprising:
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delivering a rolled prosthetic heart valve to an aortic annulus, the prosthetic heart valve including a stent body having a spirally-wound contracted, first configuration with a first diameter configured for advancement to the aortic annulus and an unwound expanded, second configuration with a maximum second diameter, the prosthetic heart valve further including three flexible membranes attached to the stent body that form heart valve leaflets in the expanded configuration and portions of the stent body between the leaflets defining axially extending commissures; unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration at the aortic annulus; and positioning the prosthetic heart valve such that the stent body commissures align with native commissures of the aortic annulus. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of prosthetic heart valve implantation, comprising:
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positioning a rolled prosthetic heart valve at a heart valve annulus, the prosthetic heart valve including a stent body having a spirally-wound contracted, first configuration with a first diameter configured for advancement to the heart valve annulus and an unwound expanded, second configuration with a maximum second diameter, the prosthetic heart valve further including a plurality of flexible, bioprosthetic tissue membranes attached to the stent body that form heart valve leaflets in the expanded configuration, wherein there are three flexible, bioprosthetic tissue membranes that form three heart valve leaflets in the expanded configuration of the stent body, and the stent body further defines axially extending commissures between the three leaflets; and unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration at the heart valve annulus. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17)
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18. A method of prosthetic heart valve implantation, comprising:
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providing a rolled prosthetic heart valve having a sheet-like stent body with lockout tabs and slots, the stent body having a spirally-wound contracted, first configuration with a first diameter for delivery to a heart valve annulus and an unwound expanded, second configuration wherein the tabs engage the slots to prevent contraction as well as further expansion, wherein the stent body has an annulus section on an inflow end, a sinus section, and an outflow section, the sinus section being between the annulus section and outflow section, and having a plurality of sinus apertures, and wherein the prosthetic heart valve comprises a plurality of flexible biocompatible membranes incorporated into the stent body that form heart valve leaflets in the expanded configuration, and wherein the flexible membranes each include an arcuate cusp edge and a free edge the arcuate cusp edges of the leaflets being attached around one of the sinus apertures; positioning the rolled prosthetic heart valve at a heart valve annulus; and unfurling the prosthetic heart valve in a controlled manner from the spirally-wound contracted, first configuration to the unwound expanded, second configuration within the heart valve annulus to ensure that the prosthetic heart valve retains a tubular shape rather than a frustoconical shape throughout the step of unfurling. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26)
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27. A method of prosthetic heart valve implantation, comprising:
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positioning a rolled prosthetic heart valve at a heart valve annulus, the prosthetic head valve including a stent body having a spirally-wound contracted, first configuration with a first diameter configured for advancement to the heart valve annulus and an unwound expanded, second configuration with a maximum second diameter, and wherein the stent body defines a pair of opposed side edges that generally mate in the expanded, second configuration, and a pair of opposed end edges that extend between the side edges, and at least one tab extending generally radially along each one of the end edges to ensure the stent body expands evenly along an axis when unfurling from the contracted, first configuration to the expanded, second configuration; and unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration at the heart valve annulus.
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28. A method of prosthetic heart valve implantation, comprising:
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providing a rolled prosthetic heart valve having a sheet-like stent body with lockout tabs and slots, the stent body having a spirally-wound contracted, first configuration with a first diameter for delivery to a heart valve annulus and an unwound expanded, second configuration wherein the tabs engage the slots to prevent contraction as well as further expansion, wherein the stent body defines a pair of opposed side edges that generally mate in the expanded, second configuration, and a pair of opposed end edges that extend between the side edges, and at least one guide tab extending generally radially along each one of the end edges to ensure the stent body expands evenly along an axis when unfurling from the contracted, first configuration to the expanded, second configuration; positioning the rolled prosthetic heart valve at a heart valve annulus; and unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration within the heart valve annulus.
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29. A method of prosthetic heart valve implantation, comprising:
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positioning a rolled prosthetic heart valve at a heart valve annulus, the prosthetic heart valve including a stent body having a spirally-wound contracted, first configuration with a first diameter configured for advancement to the heart valve annulus and an unwound expanded, second configuration with a maximum second diameter, the prosthetic heart valve further including a plurality of flexible, bioprosthetic tissue membranes attached to the stent body that form heart valve leaflets in the expanded configuration, wherein the stent body defines a pair of opposed side edges that generally mate in the expanded, second configuration, and a pair of opposed end edges that extend between the side edges, and further including at least one tab extending generally radially along each one of the end edges to ensure the stent body expands evenly along an axis when unfurling from the contracted, first configuration to the expanded, second configuration; and unfurling the prosthetic heart valve from the spirally-wound contracted, first configuration to the unwound expanded, second configuration at the heart valve annulus. - View Dependent Claims (30, 31, 32)
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33. A method of prosthetic heart valve implantation, comprising:
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providing a rolled prosthetic heart valve having a sheet-like stent body with lockout tabs and slots, the stent body having a spirally-wound contracted, first configuration with a first diameter for delivery to a heart valve annulus and an unwound expanded, second configuration wherein the tabs engage the slots to prevent contraction as well as further expansion, wherein the stent body defines a pair of opposed side edges that generally mate in the expanded, second configuration, and a pair of opposed end edges that extend between the side edges, and at least one guide tab extends generally radially along each one of the end edges to ensure the stent body retains its tubular shape throughout the step of unfurling; positioning the rolled prosthetic heart valve at a heart valve annulus; and unfurling the prosthetic heart valve in a controlled manner from the spirally-wound contracted, first configuration to the unwound expanded, second configuration within the heart valve annulus to ensure that the prosthetic heart valve retains a tubular shape rather than a frustoconical shape throughout the step of unfurling.
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Specification