Transapical delivery system for heart valves

• US 8,439,970 B2
• Filed: 07/13/2010
• Issued: 05/14/2013
• Est. Priority Date: 07/14/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Jimenez, Teodoro S., Lee, Walter, Dehdashtian, Mark, Yee, Kristopher
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Lynch, Robert A
• Application Number:
  US12/835,555
• Publication Number:
  US 20110015729A1
• Time in Patent Office: 1,036 Days
• Field of Search: 606/108, 606/167, 606/185, 606/200, 623/1.23, 623/2.11, 623/1.11, 623/1.12
• 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 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.

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 heart valve crimped 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 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, both actuators being integrated into the control handle to facilitate one-handed operation of the two; 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.

2. The combination of claim 1, wherein the delivery catheter includes a plurality of concentric tubes extending from within the control handle, and at least one passive seal within the control handle for sealing around one of the tubes, such that the passive seal does not prevent axial movement of the one tube.

3. The combination of claim 1, wherein the deflection actuator is a trigger and the pusher actuator is a slider.

4. The combination of claim 3, wherein the deflection wire includes a plug fixed on its proximal end acted on by a rail that slides longitudinally within the control handle and which moves with the trigger.

5. The combination of claim 1, wherein the deflectable portion comprises a braided structure and the deflection wire 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.

6. The combination of claim 1, further including a tubular loader defining a throughbore that receives a distal portion of the delivery catheter and including structure for engaging mating structure on a proximal end of the introducer, 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 loader seal for fluidly sealing around the delivery catheter, and the loader seal is a passive valve that does not prevent axial movement of the delivery catheter.

7. The combination of claim 6, wherein the proximal housing of the loader has a single-handed vent for aspirating air from within the loader.

8. The combination of claim 1, wherein the balloon in a deflated configuration is folded in a manner that leaves only longitudinal fold lines.

9. The combination of claim 1, further including a marker band at a proximal end of the balloon, 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.

10. The combination of claim 9, wherein the introducer sheath has a marker dot array around its distal tip to distinguish the distal tip from the marker band of the balloon and the longitudinal fold lines of the folded balloon.

11. 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, the delivery catheter further including a proximal control handle and a plurality of concentric tubes extending from within the control handle including at least a balloon deflection tube and a balloon inflation tube that extends through the lumen of the balloon deflection tube, and at least one passive seal within the handle for sealing around one of the tubes, such that the passive seal does not prevent axial movement of the one tube; 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.

12. The combination of claim 11, wherein the plurality of concentric tubes further includes a tubular valve pusher that slides over the balloon deflection tube and moves longitudinally with respect to the balloon deflection tube and the balloon, and a protective sleeve that extends from the control handle over a majority of the pusher body.

13. The combination of claim 11, wherein the passive seal forms a fluid seal around the balloon deflection tube that moves within the control handle.

14. The combination of claim 13, wherein the passive seal includes a pair of O-rings on either side of a washer.

15. The combination of claim 11, further including a tubular loader defining a throughbore that receives a distal portion of the delivery catheter and including structure for engaging mating structure on a proximal end of the introducer, 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.

16. The combination of claim 15, wherein the loader has a proximal housing with a passive loader seal that does not prevent axial movement of the delivery catheter.

17. The combination of claim 15, wherein the loader has a proximal housing with a single-handed vent for aspirating air from within the loader.

18. The combination of claim 11, wherein the plurality of concentric tubes includes a tubular valve pusher that slides over the balloon deflection tube and moves longitudinally with respect to the balloon deflection tube and the balloon, and further including a deflection actuator for deflecting a deflectable portion of the balloon deflection tube and a pusher actuator for longitudinally displacing the valve pusher with respect to the balloon, both actuators being integrated into the proximal control handle to facilitate one-handed operation of the two.

19. The combination of claim 11, further including a marker band at a proximal end of the balloon, wherein the plurality of concentric tubes includes a tubular valve pusher that slides over the balloon deflection tube and moves longitudinally with respect to the balloon deflection tube and the balloon and has a distal marker band, and wherein the sheath of the introducer has a marker dot array around its distal tip to distinguish the distal tip from the marker bands of the balloon and the pusher.

20. The combination of claim 11, wherein the balloon in a deflated configuration is folded in a manner that leaves only longitudinal fold lines.