METHODS OF IMPLANTING TWO-PART HEART VALVES
First Claim
1. A method of minimally-invasive heart valve replacement surgery on a patient using a two-part heart valve, comprising:
- providing an expandable heart valve subassembly having an undulating elastic wireform defining a plurality of alternating upstanding commissures and arcuate cusps, and a plurality of prosthetic leaflets attached to the wireform, each leaflet having an approximately semi-circular cusp edge terminating at each end in commissure portions, and a coapting edge extending between the commissure portions, each leaflet being attached to the wireform substantially entirely along the cusp edge and at both commissure portions, with a coapting edge remaining unattached;
storing the valve subassembly by itself in an expanded configuration;
compressing the valve subassembly just prior to implantation;
delivering the compressed valve subassembly to a heart valve annulus;
expanding the valve subassembly; and
coupling the valve subassembly to a separate annular tissue-engaging base to form the two-part heart valve wherein the leaflets permit one-way flow through the annulus.
1 Assignment
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Accused Products
Abstract
Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter. Preferably, the leaflets of the heart valves are secured to the commissure regions of the expandable stents using a clamping arrangement to reduce stress.
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Citations
20 Claims
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1. A method of minimally-invasive heart valve replacement surgery on a patient using a two-part heart valve, comprising:
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providing an expandable heart valve subassembly having an undulating elastic wireform defining a plurality of alternating upstanding commissures and arcuate cusps, and a plurality of prosthetic leaflets attached to the wireform, each leaflet having an approximately semi-circular cusp edge terminating at each end in commissure portions, and a coapting edge extending between the commissure portions, each leaflet being attached to the wireform substantially entirely along the cusp edge and at both commissure portions, with a coapting edge remaining unattached; storing the valve subassembly by itself in an expanded configuration; compressing the valve subassembly just prior to implantation; delivering the compressed valve subassembly to a heart valve annulus; expanding the valve subassembly; and coupling the valve subassembly to a separate annular tissue-engaging base to form the two-part heart valve wherein the leaflets permit one-way flow through the annulus. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of heart valve replacement surgery on a patient, comprising:
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providing a detachable two-part heart valve, each part being expandable from a collapsed state, comprising; a generally annular tissue-engaging base having a plurality of axial posts extending in an outflow direction each having a commissure connector on an outflow end thereof and a heart valve subassembly having an undulating elastic wireform defining a plurality of alternating upstanding commissures and arcuate cusps, each commissure having a connector thereon configured for mating with one of the commissure connectors on the tissue-engaging base to form a pair of mating connectors, the heart valve subassembly further having a plurality of prosthetic leaflets attached to the wireform; delivering the base in its collapsed state to an annulus of the patient'"'"'s heart valve being replaced; expanding the base into its expanded state in contact with the annulus; and connecting the mating connectors on the tissue-engaging base and heart valve subassembly to form the heart valve. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification