TRANSAPICAL DELIVERY SYSTEM FOR HEART VALVES

• US 20110015728A1
• Filed: 07/13/2010
• Published: 01/20/2011
• Est. Priority Date: 07/14/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yee, Kristopher, Lee, Walter, Jimenez, Teodoro S., Dehdashtian, Mark
• Granted Patent: US 8,475,522 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

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.

Claims

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; and

an introducer that receives the delivery catheter therethrough has 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 including a proximal segment extending a length L of at least one half the length of the sheath and having a first stiffness, and a distal section having a length l that has a second stiffness different than the first stiffness.

2. The combination of claim 1, wherein the length l ranges between about 4-12 cm.

3. The combination of claim 1, wherein the length L is at least 24 cm, and the length l ranges between about 6-9 cm.

4. The combination of claim 1, wherein the tubular sheath has an inner liner and a reinforcing coil that both extend the entire length, and at least two sections of outer tubes in series having different durometers that create the differing stiffnesses of the sheath.

5. The combination of claim 1, wherein the second stiffness is less than the first stiffness.

6. The combination of claim 1, 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 displacing the valve pusher with respect to the balloon.

7. The combination of claim 1, wherein the delivery catheter has a proximal control handle and includes 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.

8. The combination of claim 1, wherein the delivery catheter includes a tubular valve pusher that slides over the catheter tube and moves longitudinally with respect to the balloon, and a protective sleeve that extends over a majority of the valve pusher, 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, the loader having 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 passive loader seal such that movement of the protective sleeve is never prevented by the loader seal.

9. 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 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 a proximal length of the delivery catheter, 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.

10. The combination of claim 9, 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.

11. The combination of claim 10, wherein the delivery catheter includes 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.

12. The combination of claim 10, wherein the deflectable portion comprises a braided structure and the deflection wire extends along its length up to a distal coil to which the deflection wire attaches, the deflectable portion having a dimension no greater than 8 French.

13. The combination of claim 9, wherein the delivery catheter includes a tubular valve pusher that slides over the catheter tube and moves longitudinally with respect to the balloon, and a protective sleeve that extends over a majority of the valve pusher, 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, the loader having 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 passive loader seal such that movement of the protective sleeve is never prevented by the loader seal.

14. The combination of claim 9, wherein the balloon in a deflated configuration is folded in a manner that leaves only longitudinal fold lines.

15. 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;

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; 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 introducer sheath, and a single-handed vent for aspirating air from within the loader.

16. The combination of claim 15, wherein the loader seal comprises a resilient vent member connected to at least one lateral button that projects through an aperture in the side of the proximal housing, wherein manipulation of the lateral button causes deformation of the vent member, which in turn opens a space within the proximal housing to the atmosphere.

17. The combination of claim 15, 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.

18. The combination of claim 15, wherein the delivery catheter has a proximal control handle and includes 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.

19. The combination of claim 15, wherein the delivery catheter includes a protective sleeve that extends over a majority of the valve pusher, and wherein the loader seal is a passive valve such that movement of the protective sleeve is never prevented by the loader seal.

20. The combination of claim 15, wherein the balloon in a deflated configuration is folded in a manner that leaves only longitudinal fold lines.