Systems of heart valve delivery on a beating heart

• US 10,500,044 B2
• Filed: 07/27/2017
• Issued: 12/10/2019
• 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 M., Yee, Kristopher J.
• Primary Examiner(s): Lynch, Robert A
• Application Number:
  US15/662,021
• Publication Number:
  US 20170319341A1
• Time in Patent Office: 866 Days
• 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. The system includes a delivery catheter having a steering mechanism thereon for delivering a balloon-expandable prosthetic heart valve to the aortic valve 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. 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 system for delivery of a prosthetic heart valve to a beating heart, comprising;

a delivery catheter having a catheter tube and an expandable prosthetic heart valve disposed in a contracted state on the catheter tube just distal to a deflectable portion thereof, the delivery catheter also having a proximal control handle with a plurality of concentric tubes extending from within the control handle including the catheter tube, the proximal control handle having mounted on an exterior thereof both a deflection actuator for deflecting the deflectable portion of the catheter tube via a deflection pull wire and an actuator for moving one of the concentric tubes axially relative to the other concentric tubes, the deflection actuator and actuator being located so as to enable one handed operation of both;

an introducer that receives the delivery catheter therethrough and has an elongated tubular sheath extending distally from a proximal housing containing a plurality of introducer valves for fluidly sealing around devices passed therethrough, the tubular 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 less than the first stiffness, the introducer having a length sufficient to extend from outside a patient through an intercostal incision and into the left ventricle of the patient; 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 valves and facilitates passage therethrough 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 housing.

2. The system of claim 1, wherein the deflectable portion comprises a braided structure with a distal coil to which the deflection pull wire attaches.

3. The system of claim 1, wherein the introducer sheath is no more than 13 inches (33 cm) long.

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

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

6. The system 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.

7. The system of claim 1, wherein the proximal housing of the loader has a resilient vent member therein, and the single-handed vent comprises a vent button that projects through an aperture in the side of the proximal housing and is positioned such that inward depression of the vent button causes deformation of the vent member which in turn opens the loader throughbore to the atmosphere.

8. The system of claim 7, wherein there are two vent buttons on opposite sides of the proximal housing of the loader that each engage the resilient vent member.

9. The system of claim 1, wherein the deflection actuator is a trigger and the actuator is a slider.

10. The system of claim 1, wherein the prosthetic heart valve is crimped into its contracted state over a balloon on the delivery catheter, the balloon having a sufficient expanded diameter to expand the prosthetic heart valve to an expanded state.

11. The system of claim 1, wherein the structure on the tubular loader for engaging mating structure on the proximal end of the introducer housing comprises a pair of attached cantilevered fingers extending longitudinally with internally facing snap ridges for securing the tubular loader to a nipple on a proximal end cap of the introducer housing.

12. A system for delivery of a prosthetic heart valve to a beating heart, comprising;

a delivery catheter having a catheter tube and an expandable prosthetic heart valve disposed in a contracted state on a distal end of the catheter tube, the delivery catheter also having a proximal control handle with a plurality of concentric tubes extending from within the control handle including the catheter tube, the proximal control handle having mounted on an exterior thereof an actuator for moving one of the concentric tubes axially relative to the other concentric tubes and the control handle 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, the delivery catheter tube having a fluoroscopically-visible marker located proximal to the prosthetic heart valve;

an introducer that receives the delivery catheter therethrough and has an elongated tubular sheath extending distally from a proximal housing containing a plurality of introducer valves for fluidly sealing around devices passed therethrough, the introducer sheath having a fluoroscopically-visible marker on a distal tip distinguishable from the marker of the delivery catheter tube, the introducer having a length sufficient to extend from outside a patient through an intercostal incision and into the left ventricle of the patient; 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 valves and facilitates passage therethrough of the delivery catheter, the loader having a proximal housing with a loader seal for fluidly sealing around the delivery catheter.

13. The system of claim 12, wherein the passive seal includes a pair of O-rings on either side of a washer.

14. The system of claim 12, wherein the loader proximal housing has a single-handed vent for aspirating air from within the loader housing.

15. The system of claim 12, wherein the loader seal is a passive valve that does not prevent axial movement of the delivery catheter.

16. The system of claim 12, wherein the catheter tube has a deflectable portion located just proximal to the prosthetic heart valve and actuated by a deflection pull wire, and wherein the proximal control handle has a deflection actuator mounted on the exterior thereof for pulling the pull wire, the deflection actuator and actuator being located so as to enable one handed operation of both.

17. The system of claim 12, wherein the tubular sheath has 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 less than the first stiffness.

18. The system of claim 17, wherein the length L is at least 24 cm, and the length l ranges between about 6-9 cm.

19. The system of claim 12, wherein the prosthetic heart valve is crimped into its contracted state over a balloon on the delivery catheter, the balloon having a sufficient expanded diameter to expand the prosthetic heart valve to an expanded state.

20. The system of claim 19, 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 marker of the delivery catheter tube and the marker of the introducer sheath.

21. The system of claim 12, wherein the structure on the tubular loader for engaging mating structure on the proximal end of the introducer housing comprises a pair of attached cantilevered fingers extending longitudinally with internally facing snap ridges for securing the tubular loader to a nipple on a proximal end cap of the introducer housing.