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 heart valve crimped thereon, wherein the delivery catheter has a proximal control handle including two molded halves with a plurality of concentric tubes extending from within the control handle and at least one actuator on the exterior of the control handle for moving one of the tubes axially, the control handle further enclosing a passive seal for sealing around the tube that is moved by the actuator such that the passive seal does not prevent axial movement thereof; and
an introducer that receives the delivery catheter therethrough and has an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough, the sheath including a proximal segment extending a length of at least one half a total length L of the sheath and having a first stiffness, and a distal section having a length l of one half or less of the total length L of the sheath that has a second stiffness different than the first stiffness.
1 Assignment
0 Petitions
Accused Products
Abstract
A delivery system 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. 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 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. A pre-dilation valvuloplasty procedure may also be utilized.
244 Citations
18 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 heart valve crimped thereon, wherein the delivery catheter has a proximal control handle including two molded halves with a plurality of concentric tubes extending from within the control handle and at least one actuator on the exterior of the control handle for moving one of the tubes axially, the control handle further enclosing a passive seal for sealing around the tube that is moved by the actuator such that the passive seal does not prevent axial movement thereof; and an introducer that receives the delivery catheter therethrough and has an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough, the sheath including a proximal segment extending a length of at least one half a total length L of the sheath and having a first stiffness, and a distal section having a length l of one half or less of the total length L of the sheath that has a second stiffness different than the first stiffness. - 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 heart valve crimped thereon, the delivery catheter including a marker band at a proximal end of the balloon, the delivery catheter also including a tubular valve pusher that slides over the catheter and moves longitudinally with respect to the balloon and has a distal marker band; and an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough, the sheath having a throughbore for passage of the delivery catheter and a marker dot array around its distal tip to distinguish the distal tip from the marker bands of the balloon and the pusher, wherein the delivery catheter has 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, and the delivery catheter also has 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. - 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 heart valve crimped thereon; an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough; and a tubular loader defining a throughbore that receives a distal portion of the delivery catheter, and includes structure for engaging mating structure on a proximal end of the introducer housing and a distal nose that extends through and opens the introducer valve and facilitates passage therethrough of the balloon of the delivery catheter, the loader having a proximal housing witha loader seal for fluidly sealing around the delivery catheter, and a single-handed vent for aspirating air from within the loader, wherein the delivery catheter has 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 further including a tubular valve pusher that slides over the catheter tube and moves longitudinally with respect to the balloon, and the delivery catheter also has 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 - View Dependent Claims (17, 18)
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15. 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 heart valve crimped thereon; an introducer having an elongated tubular sheath extending distally from a proximal housing containing at least one introducer valve for fluidly sealing around devices passed therethrough; and a tubular loader defining a throughbore that receives a distal portion of the delivery catheter, and includes structure for engaging mating structure on a proximal end of the introducer housing and a distal nose that extends through and opens the introducer valve and facilitates passage therethrough of the balloon of the delivery catheter, the loader having a proximal housing with a loader seal for fluidly sealing around the delivery catheter, and a single-handed vent for aspirating air from within the loader, wherein the delivery catheter has 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 further including a tubular valve pusher that slides over the catheter tube and moves longitudinally with respect to the balloon, and the delivery catheter also has 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. - View Dependent Claims (16)
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Specification