Methods of valve delivery on a beating heart

• US 9,717,594 B2
• Filed: 01/30/2015
• Issued: 08/01/2017
• 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.
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/610,982
• Publication Number:
  US 20150150679A1
• Time in Patent Office: 914 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 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 and a more flexible distal section terminating in a distal end into the left side of the heart such that the distal section extends within and at least 4 cm beyond a heart wall and flexes with movement of the heart muscle to lessen damage to the heart wall from a stiff introducer, wherein the introducer has a free length L with the stiff proximal section having a length of at least one half the free length L, wherein the stiff proximal section extends substantially straight out of the body so as to provide a direct-access approach lumen;

advancing a balloon catheter having a prosthetic heart valve mounted on a distal balloon through and beyond the distal end of the introducer such that the prosthetic heart valve is positioned within the existing aortic valve, the balloon catheter having a proximal control handle; and

inflating the balloon to expand the prosthetic heart valve against the existing aortic valve.

2. The method of claim 1, wherein the incision is formed at the apex of the left ventricle and the balloon catheter is advanced to the existing aortic valve in an antegrade manner.

3. The method of claim 1, wherein the incision is formed in one of the carotid or subclavian arteries and the balloon catheter is advanced to the existing aortic valve through the ascending aorta.

4. 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 which is connected to a deflection actuator mounted on the proximal control handle, the method including deflecting the balloon and prosthetic heart valve relative to the existing aortic valve during the step of advancing.

5. The method of claim 4, 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.

6. The method of claim 1, further including a tubular loader defining a throughbore and structure for snapping onto 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.

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

8. The method of claim 1, wherein the introducer includes an inner tubular liner that extends the free length L, a reinforcing coil that extends the free length L, a distal exterior tube that extends along the distal section and a proximal exterior tube that extends along the stiff proximal section and abuts the distal exterior tube in series, and wherein the stiffness of the proximal exterior tube is greater than that of the distal exterior tube.

9. The method of claim 1, including advancing no more than about 24 inches (61 cm) in length of the balloon catheter through the introducer.

10. The method of claim 1, wherein the distal section has a length l of between about 4-12 cm.

11. The method of claim 10, wherein the free length L of the introducer is between about 20-24 cm.

12. The method of claim 10, wherein the distal section has a length l of between about 4 cm and one half the free length L.

13. The method of claim 12, wherein the length l is between about 6-9 cm.

14. 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 and a more flexible distal section terminating in a distal end into the left side of the heart, wherein the stiff proximal section extends substantially straight out of the body and the distal section is located within the heart so as to provide a direct-access approach lumen, and wherein 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 snapping onto mating structure on the introducer, the loader further having a proximal housing with a vent button and a distal nose that extends from the proximal housing and opens the hemostatic valve;

advancing a balloon catheter having a prosthetic heart valve mounted on a distal balloon through the loader throughbore and through and beyond the distal end of the introducer;

single-handedly aspirating air from within the loader throughbore using the vent button on the proximal housing 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 existing aortic valve; and

inflating the balloon to expand the prosthetic heart valve against the existing aortic valve.

15. The method of claim 14, wherein the incision is formed at the apex of the left ventricle and the balloon catheter is advanced to the existing aortic valve in an antegrade manner.

16. The method of claim 14, wherein the incision is formed in one of the carotid or subclavian arteries and the balloon catheter is advanced to the existing aortic valve through the ascending aorta.

17. The method of claim 14, wherein the proximal housing of the loader has a resilient vent member therein, and the vent button projects through an aperture in the side of the proximal housing and is positioned such that inward depression of the button causes deformation of the vent member which in turn opens the loader throughbore to the atmosphere.

18. The method of claim 14, wherein there are two vent buttons on opposite sides of the proximal housing of the loader.

19. The method of claim 14, 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 existing aortic valve.

20. The method of claim 19, 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.

21. 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 and a more flexible distal section terminating in a distal end into the left side of the heart, wherein the stiff proximal section extends substantially straight out of the body and the distal section is located within the heart so as to provide a direct-access approach lumen;

advancing a balloon catheter having a prosthetic heart valve mounted on a distal balloon through and beyond the distal end of the introducer such that the prosthetic heart valve is positioned within the existing aortic valve, the balloon catheter having a proximal control handle on which is mounted a deflection actuator for deflecting the balloon and the prosthetic heart valve relative to a proximal section of the catheter, further including a tubular loader defining a throughbore and structure for snapping onto 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;

moving the deflection actuator to deflect the balloon catheter and the prosthetic heart valve relative to the existing aortic valve; and

inflating the balloon to expand the prosthetic heart valve against the existing aortic valve.