UNITARY QUICK-CONNECT PROSTHETIC HEART VALVEAND DEPLOYMENT SYSTEM AND METHODS
First Claim
1. A system for delivering a prosthetic heart valve, comprising:
- a heart valve including a prosthetic valve having a non-expandable, non-collapsible frame defining an orifice along a valve axis and leaflets that provide occluding surfaces across the orifice, the heart valve further including a plastically-expandable coupling stent having a first end connected to a sewing ring on an inflow end of the prosthetic valve, the coupling stent having a contracted state for delivery to an implant position and an expanded state;
a valve holder attached to the heart valve opposite the coupling stent and defining a central lumen coincident with the valve axis;
a catheter having a distal expander; and
a handle configured to attach to a proximal end of the valve holder and having a lumen for passage of the catheter, the distal expander in a contracted configuration being sized to extend distally through the handle lumen, through the holder lumen and through the heart valve to a position within the coupling stent for expansion of a second end thereof.
1 Assignment
0 Petitions
Accused Products
Abstract
A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure 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
25 Claims
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1. A system for delivering a prosthetic heart valve, comprising:
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a heart valve including a prosthetic valve having a non-expandable, non-collapsible frame defining an orifice along a valve axis and leaflets that provide occluding surfaces across the orifice, the heart valve further including a plastically-expandable coupling stent having a first end connected to a sewing ring on an inflow end of the prosthetic valve, the coupling stent having a contracted state for delivery to an implant position and an expanded state; a valve holder attached to the heart valve opposite the coupling stent and defining a central lumen coincident with the valve axis; a catheter having a distal expander; and a handle configured to attach to a proximal end of the valve holder and having a lumen for passage of the catheter, the distal expander in a contracted configuration being sized to extend distally through the handle lumen, through the holder lumen and through the heart valve to a position within the coupling stent for expansion of a second end thereof. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A system for delivering a prosthetic heart valve, comprising:
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a heart valve including a prosthetic valve defined by a support structure defining an orifice along a valve axis with an undulating shape of alternative cusps and commissures projecting in an outflow direction that supports flexible leaflets that come together in an outflow direction to occlude the orifice, the heart valve further including a balloon-expandable coupling stent having a first end attached to an inflow end thereof opposite the commissures and a second end projecting away therefrom, the coupling stent having a contracted state for delivery to an implant position and an expanded state; a handle system connected to an outflow side of the heart valve and having a throughbore that extends from an outflow side to an inflow side of the leaflets; and a balloon catheter having a balloon that, in a contracted configuration, is sized to pass distally through the throughbore of the handle system and distally past without contacting the heart valve leaflets such that the balloon is positioned to expand the coupling stent. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17)
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18. A system for delivering a prosthetic heart valve, comprising:
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a heart valve including a prosthetic valve having a support structure defining an orifice along a valve axis and flexible leaflets that provide occluding surfaces across the orifice, the heart valve further including a plastically-expandable coupling stent having a first end attached to an inflow end thereof and a second end projecting away therefrom, the coupling stent having a contracted state for delivery to an implant position and an expanded state; a valve holder connected to the heart valve on the side opposite to the coupling stent; a tubular sleeve having a throughbore connected to the valve holder and extending therefrom through the flexible leaflets; and a balloon catheter having a balloon that, in a contracted configuration, is sized to pass distally through the valve holder and sleeve and thus through the heart valve leaflets such that the balloon is positioned to expand the coupling stent. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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Specification