Minimally-invasive prosthetic heart valve method
First Claim
1. A method for implanting a collapsible prosthetic heart valve, the method comprising:
- disposing a collapsed prosthetic heart valve into a distal end of a delivery tube, the prosthetic heart valve comprising a self-expanding tubular leaflet frame, three flexible leaflets, and three U-shaped cusp positioners, the leaflet frame and the cusp positioners being formed integrally as a single piece;
the leaflet frame comprising three cusp regions and three commissure regions at an outflow end thereof, the three cusp regions alternating with the three commissure regions, and the commissure regions are taller than the cusp positioners;
an outer edge of each leaflet attaches to the leaflet frame and when the heart valve expands the leaflets are arranged to coapt within the prosthetic heart valve to provide a one-way occlusion;
each cusp positioner rigidly fixed with respect to the leaflet frame, disposed intermediate two commissure regions, and extending radially farther outward than the commissure regions;
minimally invasively inserting the distal end of the delivery tube into a vasculature of a patient;
positioning the distal end of the delivery tube proximal of an aortic valve;
expelling the prosthetic heart valve from the delivery tube into an annulus of the aortic valve;
allowing the prosthetic heart valve to self-expand such that the cusp positioners come into contact with the sinus cavities of the aortic valve, rotationally orienting the prosthetic heart valve, the flexible leaflets expanding with the leaflet frame into a functional configuration; and
positioning the prosthetic valve with the cusp positioners located below the coronary artery ostia in the sinus cavities so as to stabilize and anchor the prosthetic valve in its implant position without occluding blood flow into coronary artery ostia.
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Accused Products
Abstract
A method of implanting a collapsible prosthetic heart valve is disclosed. The prosthetic heart valve includes three biological leaflets mounted within a self-expanding tubular leaflet frame formed of nitinol. The method comprises loading a collapsed prosthetic heart valve into a distal end of a delivery tube. The distal end of the delivery tube is inserted into a vasculature of a patient and positioned proximal to an aortic valve. The prosthetic heart valve is expelled into an annulus of the aortic valve and expanded. The prosthetic heart valve includes cusp positioners that engage sinus cavities above the valve annulus and rotationally orient the prosthetic valve. Preferred embodiments of the cusp positioners do not occlude the coronary arteries.
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Citations
20 Claims
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1. A method for implanting a collapsible prosthetic heart valve, the method comprising:
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disposing a collapsed prosthetic heart valve into a distal end of a delivery tube, the prosthetic heart valve comprising a self-expanding tubular leaflet frame, three flexible leaflets, and three U-shaped cusp positioners, the leaflet frame and the cusp positioners being formed integrally as a single piece;
the leaflet frame comprising three cusp regions and three commissure regions at an outflow end thereof, the three cusp regions alternating with the three commissure regions, and the commissure regions are taller than the cusp positioners;
an outer edge of each leaflet attaches to the leaflet frame and when the heart valve expands the leaflets are arranged to coapt within the prosthetic heart valve to provide a one-way occlusion;
each cusp positioner rigidly fixed with respect to the leaflet frame, disposed intermediate two commissure regions, and extending radially farther outward than the commissure regions;minimally invasively inserting the distal end of the delivery tube into a vasculature of a patient; positioning the distal end of the delivery tube proximal of an aortic valve; expelling the prosthetic heart valve from the delivery tube into an annulus of the aortic valve; allowing the prosthetic heart valve to self-expand such that the cusp positioners come into contact with the sinus cavities of the aortic valve, rotationally orienting the prosthetic heart valve, the flexible leaflets expanding with the leaflet frame into a functional configuration; and positioning the prosthetic valve with the cusp positioners located below the coronary artery ostia in the sinus cavities so as to stabilize and anchor the prosthetic valve in its implant position without occluding blood flow into coronary artery ostia. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for implanting a collapsible prosthetic heart valve, the method comprising:
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expanding a collapsed prosthetic heart valve in an annulus of a native aortic valve, the prosthetic heart valve having three outwardly flaring cusp positioners; seating the prosthetic heart valve at the annulus including permitting the outwardly flaring cusp positioners to engage surrounding tissue, and wherein in the case of any rotational misalignment with the three aortic valve sinus cavities above the aortic valve annulus the cusp positioners rotationally orient the prosthetic heart valve so that the cusp positioners are channeled by and aligned with the sinus cavities; and positioning the prosthetic valve with the cusp positioners in the sinus cavities of the aortic valve so as to stabilize and anchor the prosthetic valve in its implant position while permitting blood flow into coronary ostia. - View Dependent Claims (18, 19, 20)
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Specification