Unitary quick-connect prosthetic heart valve deployment methods
First Claim
1. A method of delivery and implant of a prosthetic heart valve 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 between and parts 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
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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.
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Citations
19 Claims
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1. A method of delivery and implant of a prosthetic heart valve 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 between and parts 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, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification