UNITARY QUICK-CONNECT PROSTHETIC HEART VALVE DEPLOYMENT METHODS
First Claim
1. A method of delivery and implant of a prosthetic heart valve system to an aortic annulus, comprising:
- preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and flexible occluding leaflets, the heart valve further including an expandable coupling stent connected to and extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the aortic annulus, wherein a valve holder is mounted to the heart valve, the step of preparing including assembling to the valve holder a sleeve that extends within the flexible leaflets, the sleeve having a throughbore;
connecting a delivery handle having a lumen to the valve holder and sleeve assembly such that the lumen aligns with the sleeve throughbore;
advancing the heart valve with the coupling stent in its contracted state to an implant position adjacent the aortic annulus;
advancing a balloon of a balloon catheter through the lumen of the handle and through the sleeve throughbore to a position within the coupling stent; and
inflating the balloon to expand the coupling stent into contact with the aortic annulus.
1 Assignment
0 Petitions
Accused Products
Abstract
A quick-connect heart valve prosthesis that can be quickly and easily implanted is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable coupling stent, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the coupling stent attached thereto. The coupling stent may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes a hollow two-piece handle through which a balloon catheter passes. A valve holder is stored with the heart valve and the handle easily attaches thereto to improve valve preparation steps.
39 Citations
21 Claims
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1. A method of delivery and implant of a prosthetic heart valve system to an aortic annulus, comprising:
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preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and flexible occluding leaflets, the heart valve further including an expandable coupling stent connected to and extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the aortic annulus, wherein a valve holder is mounted to the heart valve, the step of preparing including assembling to the valve holder a sleeve that extends within the flexible leaflets, the sleeve having a throughbore; connecting a delivery handle having a lumen to the valve holder and sleeve assembly such that the lumen aligns with the sleeve throughbore; advancing the heart valve with the coupling stent in its contracted state to an implant position adjacent the aortic annulus; advancing a balloon of a balloon catheter through the lumen of the handle and through the sleeve throughbore to a position within the coupling stent; and inflating the balloon to expand the coupling stent into contact with the aortic annulus. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of delivery and implant of a prosthetic heart valve system to an aortic annulus, comprising:
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preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and surrounded on an inflow end by a suture-permeable ring, the heart valve further including a plastically-expandable coupling stent connected to and extending from an inflow end thereof, the coupling stent having a contracted state for delivery to an implant position and an expanded state configured for outward connection to the aortic annulus; attaching three guide sutures at three spaced locations around the aortic annulus and extending three pairs of free ends of the guide sutures out of the operating site; threading the three pairs of guide sutures through spaced locations around the suture-permeable ring; advancing the heart valve along the guide sutures with the coupling stent in its contracted state to an implant position adjacent the annulus; and applying outward force on the inside of the coupling stent to convert the coupling stent from the contracted state to the expanded state into contact with the aortic annulus. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method of delivery and implant of a prosthetic heart valve system to an aortic annulus, comprising:
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preparing for implant a heart valve including a prosthetic valve having a non-expandable, non-collapsible orifice and surrounded on an inflow end by a suture-permeable ring having an undulating contour on an underside thereof to match the undulating contour of the aortic annulus, the heart valve further including an expandable cloth-covered coupling stent sewn to the suture-permeable ring and extending away in the inflow direction therefrom, the coupling stent having a conical contracted state for delivery to an implant position and a conical expanded state configured for outward connection to the aortic annulus, the coupling stent further having a reinforcing ring on an outflow end continuously sewn to the sewing ring that follows an undulating path with peaks and troughs generally corresponding to the underside of the sewing ring, the coupling stent thus providing when expanded a substantially solid cloth-covered conical skirt extending from the suture-permeable ring to help seal against paravalvular leakage and promote tissue ingrowth; connecting a delivery handle to the heart valve; advancing the heart valve with the coupling stent in its contracted state to an implant position adjacent the aortic annulus; and expanding the coupling stent into contact with the aortic annulus. - View Dependent Claims (20, 21)
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Specification