Methods of valve delivery on a beating heart
First Claim
1. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:
- while the heart is beating, forming an incision and passing an introducer having a stiff proximal section into the left side of the heart;
advancing a balloon catheter having a heart valve mounted on a distal balloon into and through the introducer such that the heart valve is positioned within the aortic annulus, the balloon catheter having a proximal control handle on which are mounted both a deflection actuator for deflecting the balloon and the heart valve relative to a proximal section of the catheter and a pusher actuator for longitudinally displacing a valve pusher with respect to the balloon, wherein the valve pusher in a distalmost position surrounds a proximal portion of the balloon;
using one hand on the control handle, moving the deflection actuator to deflect the balloon catheter and the heart valve relative to the aortic annulus and moving the pusher actuator to retract the valve pusher with respect to the balloon; and
inflating the balloon to expand the heart valve against the aortic annulus.
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Accused Products
Abstract
A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic annulus in an antegrade fashion through an introducer passing into the left ventricle through its apex. The introducer may have a more floppy distal section than a proximal section to reduce trauma to the heart wall while preserving good operating field stability. The delivery catheter includes a deflecting segment just proximal to a distal balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. A trigger in a catheter handle may be coupled to a deflection wire that actuates the deflecting segment, while a slider in the handle controls retraction of a valve pusher. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.
264 Citations
14 Claims
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1. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:
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while the heart is beating, forming an incision and passing an introducer having a stiff proximal section into the left side of the heart; advancing a balloon catheter having a heart valve mounted on a distal balloon into and through the introducer such that the heart valve is positioned within the aortic annulus, the balloon catheter having a proximal control handle on which are mounted both a deflection actuator for deflecting the balloon and the heart valve relative to a proximal section of the catheter and a pusher actuator for longitudinally displacing a valve pusher with respect to the balloon, wherein the valve pusher in a distalmost position surrounds a proximal portion of the balloon; using one hand on the control handle, moving the deflection actuator to deflect the balloon catheter and the heart valve relative to the aortic annulus and moving the pusher actuator to retract the valve pusher with respect to the balloon; and inflating the balloon to expand the heart valve against the aortic annulus. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:
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while the heart is beating, forming an incision and passing an introducer into the left side of the heart, the introducer including a proximal hemostatic valve to help prevent blood loss therethrough; attaching a tubular loader to a proximal end of the introducer, the loader defining a throughbore and structure for engaging mating structure on the introducer, the loader having a distal nose that extends through and opens the introducer valve; advancing a balloon catheter having a heart valve mounted on a distal balloon into and through the loader throughbore and into the introducer; single-handedly aspirating air from within the loader throughbore using a vent button on the loader after the heart valve has been inserted into the introducer through the loader; further advancing the balloon catheter and positioning the heart valve within the aortic annulus; and inflating the balloon to expand the heart valve against the aortic annulus. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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Specification