TRANSAPICAL DELIVERY SYSTEM FOR HEART VALVES
First Claim
1. A medical introducer and heart valve delivery catheter combination, comprising;
- a delivery catheter having a distal balloon of sufficient diameter to expand a crimped heart valve thereon, the delivery catheter comprising a catheter tube and the balloon is disposed on the end of a deflectable portion of the catheter tube actuated by a deflection pull wire, the delivery catheter also including a tubular valve pusher that that slides over the catheter tube and moves longitudinally with respect to the balloon, and the delivery catheter further including a proximal control handle on which are mounted both a deflection actuator for deflecting the deflectable portion of the catheter tube and a pusher actuator for longitudinally displacing the valve pusher with respect to the balloon; and
an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around the delivery catheter.
1 Assignment
0 Petitions
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.
524 Citations
20 Claims
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1. A medical introducer and heart valve delivery catheter combination, comprising;
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a delivery catheter having a distal balloon of sufficient diameter to expand a crimped heart valve thereon, the delivery catheter comprising a catheter tube and the balloon is disposed on the end of a deflectable portion of the catheter tube actuated by a deflection pull wire, the delivery catheter also including a tubular valve pusher that that slides over the catheter tube and moves longitudinally with respect to the balloon, and the delivery catheter further including a proximal control handle on which are mounted both a deflection actuator for deflecting the deflectable portion of the catheter tube and a pusher actuator for longitudinally displacing the valve pusher with respect to the balloon; and an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around the delivery catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A medical introducer and heart valve delivery catheter combination, comprising;
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a delivery catheter having a distal balloon of sufficient diameter to expand a crimped heart valve thereon, the delivery catheter including a circumferential marker band at a proximal end of the balloon, and wherein the balloon in a deflated configuration is folded in a manner that leaves only longitudinal fold lines to provide good fluoroscopic contrast with the circumferential marker band of the balloon; and an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around a proximal length of the delivery catheter, the sheath having a throughbore for passage of the delivery catheter. - View Dependent Claims (10, 11, 12, 13)
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14. A medical introducer and heart valve delivery catheter combination, comprising;
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a delivery catheter having a distal balloon of sufficient diameter to expand a crimped heart valve thereon, the delivery catheter further including a proximal control handle and a plurality of concentric tubes extending from within the control handle, and at least one passive seal within the handle for sealing around one of the tubes, such that movement of the one tube is never prevented by the passive seal; and an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around the delivery catheter. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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Specification