METHODS OF VALVE DELIVERY ON A BEATING HEART

• US 20130345798A1
• Filed: 06/19/2013
• Published: 12/26/2013
• 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 J.
• Granted Patent: US 8,945,208 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 method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:

while the heart is beating, forming an incision and passing an introducer having a stiff proximal section into the left side of the heart;

advancing a balloon catheter having a heart valve mounted on a distal balloon into and through the introducer such that the heart valve is positioned within the aortic annulus, the introducer being relatively short such that no more than about 24 inches (61 cm) in length of the balloon catheter extends into the introducer;

deflecting a distal end of the balloon catheter and orienting the heart valve substantially along the flow axis of aortic annulus; and

inflating the balloon to expand the heart valve against the aortic annulus.

2. The method of claim 1, wherein the incision is formed at the apex of the left ventricle.

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

4. The method of claim 1, wherein the introducer has a distal section that is more flexible than the stiff proximal section.

5. The method of claim 1, wherein the balloon catheter further comprises 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 balloon catheter further includes a proximal control handle on which is mounted a deflection actuator for deflecting the deflectable portion of the catheter tube, the method including displacing the deflection actuator to deflect the distal end of the balloon catheter.

6. The method of claim 5, wherein the balloon catheter further includes a tubular valve pusher that that slides over the catheter tube and moves longitudinally with respect to the balloon, and the proximal control handle has a pusher actuator for longitudinally displacing the valve pusher with respect to the balloon, the method including displacing the pusher actuator to proximally displace the valve pusher prior to actuating the deflection actuator.

7. The method of claim 1, further including a tubular loader defining a throughbore and structure for engaging mating structure on a proximal end of the introducer, the loader having a distal nose that extends through and opens an introducer valve and facilitates passage therethrough of the balloon of the balloon catheter, wherein the method includes single-handedly aspirating air from within the loader throughbore using a vent button on the loader after the heart valve has been inserted into the introducer through the loader.

8. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:

while the heart is beating, forming an incision and passing an introducer into the left side of the heart, the introducer including a proximal hemostatic valve to help prevent blood loss therethrough;

attaching a tubular loader to a proximal end of the introducer, the loader defining a throughbore and structure for engaging mating structure on the introducer, the loader having a distal nose that extends through and opens the introducer valve

advancing a balloon catheter having a heart valve mounted on a distal balloon into and through the loader throughbore and into the introducer;

single-handedly aspirating air from within the loader throughbore using a vent button on the loader after the heart valve has been inserted into the introducer through the loader;

further advancing the balloon catheter and positioning the heart valve within the aortic annulus; and

inflating the balloon to expand the heart valve against the aortic annulus.

9. The method of claim 8, wherein the incision is formed at the apex of the left ventricle.

10. The method of claim 8, wherein there the loader has a proximal housing with a resilient vent member therein, and the vent button project through apertures in the side of the proximal housing and are positioned such that inward depression of the button causes deformation of the vent member which in turn opens the loader throughbore to the atmosphere.

11. The method of claim 8, wherein there are two vent buttons on opposite sides of a proximal housing of the loader.

12. The method of claim 8, wherein the introducer is no more than 13 inches (33 cm) long.

13. The method of claim 8, wherein the introducer has a distal section that is more flexible than a stiff proximal section.

14. The method of claim 8, wherein the balloon catheter further comprises 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 balloon catheter further includes a proximal control handle on which is mounted a deflection actuator for deflecting the deflectable portion of the catheter tube, the method including displacing the deflection actuator to deflect the distal end of the balloon catheter during the step of positioning the heart valve within the aortic annulus.

15. A method of deploying and implanting a prosthetic heart valve into a beating heart, comprising:

while the heart is beating, forming an incision and passing an introducer of no more than 13 inches (33 cm) long into the left side of the heart, the introducer having a free length with a stiff proximal section and a flexible distal section, advancing the introducer so that at least 4 cm of the distal section enters the heart;

advancing no more than about 24 inches (61 cm) in length of a balloon catheter having a heart valve mounted on a distal balloon into and through the introducer such that the heart valve is positioned within the aortic annulus; and

inflating the balloon to expand the heart valve against the aortic annulus.

16. The method of claim 15, wherein the free length of the introducer is between about 20-24 cm.

17. The method of claim 15, wherein the distal section has a length l of between about 4 cm and one half the free length L.

18. The method of claim 17, wherein the length l is between about 6-9 cm.

19. The method of claim 15, wherein the incision is formed at the apex of the left ventricle.

20. The method of claim 15, wherein the balloon catheter further comprises 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 balloon catheter further includes a proximal control handle on which is mounted a deflection actuator for deflecting the deflectable portion of the catheter tube, the method including displacing the deflection actuator to deflect the distal end of the balloon catheter during the step of positioning the heart valve within the aortic annulus.