Transapical method of supplanting an implanted prosthetic heart valve

• US 10,314,702 B2
• Filed: 05/16/2017
• Issued: 06/11/2019
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark M., Olin, Jane M.
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US15/596,409
• Publication Number:
  US 20170245992A1
• Time in Patent Office: 756 Days
• Field of Search: 623 211, 623 111, 623900, 623902, 623904, 606108, 606191, 606192, 606194, 606198, 604 9503, 604 9601, 60410305, 604264, 604270, 604509
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method of delivering a prosthetic heart valve to the aortic valve annulus while a patient'"'"'s heart is beating is disclosed. The method includes accessing the left ventricle through an intercostal incision and forming a puncture in the left ventricle. A guidewire is advanced into the left ventricle and through the aortic valve. An introducer is passed over the guidewire and into the left ventricle. A valve delivery device is advanced over the guidewire and through the introducer until a prosthetic heart valve positioned thereon is located within the aortic valve. The prosthetic heart valve is then radially expanded within the aortic valve annulus for replacing the function of the native aortic valve.

Claims

1. A method of implanting a prosthetic heart valve in an aortic valve annulus of a patient while the patient'"'"'s heart remains beating, comprising:

accessing a left ventricle through an intercostal incision;

forming a puncture through tissue in the left ventricle;

introducing a guidewire through the puncture and into the left ventricle;

advancing the guidewire through a native aortic valve within which a prosthetic heart valve has been previously implanted;

passing a dilatation catheter having a dilatation balloon on a distal end over the guidewire and through the puncture in the left ventricle;

advancing the dilatation balloon to a position within the previously implanted prosthetic heart valve;

radially expanding the dilatation balloon against the previously implanted prosthetic heart valve;

removing the dilatation catheter from the patient while leaving the guidewire in place;

following removal of the dilation catheter passing an introducer sheath over the guidewire and through the puncture into the left ventricle, the introducer sheath having a lumen extending therethrough, the introducer sheath including a proximal housing containing a valve assembly for preventing bleeding from the lumen;

inserting a valve delivery device over the guidewire, through the valve assembly and through the lumen of the introducer sheath, the valve delivery device having a proximal handle and an expandable prosthetic heart valve mounted on a distal end in a contracted configuration;

advancing the valve delivery device over the guidewire until the expandable prosthetic heart valve is located within the previously implanted prosthetic heart valve; and

expanding the prosthetic heart valve against the previously implanted prosthetic heart valve.

2. The method of claim 1, further comprising placing a first line of purse-string suture generally in a first circle in one direction through the tissue of the left ventricle, and then placing a second line of purse-string suture generally in a circular pattern concentric to the first circle but in an opposite direction, and the apical puncture is formed within the first and second lines of purse-string sutures.

3. The method of claim 1, wherein the valve delivery device further has a deflecting segment located just proximal to the prosthetic heart valve, the method including bending the deflecting segment from the proximal handle to facilitate positioning the prosthetic heart valve in the aortic valve annulus.

4. The method of claim 3, wherein the deflecting segment comprises a coil spring and the valve delivery device includes a deflection wire fastened to a distal end of the deflecting segment and extending proximally to an actuator in the proximal handle for causing bending of the deflecting segment.

5. The method of claim 3, wherein the valve delivery device further has a pusher having a distal sleeve mounted over the deflecting segment, the method including:

using the pusher and sleeve to advance the prosthetic heart valve;

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to the step of bending the deflecting segment.

6. The method of claim 1, wherein the valve delivery device comprises a balloon catheter with a balloon on its distal end and wherein the balloon is inflated to expand the prosthetic heart valve in the aortic valve annulus.

7. The method of claim 1, further including the steps of:

prior to inserting the valve delivery device through the valve assembly, attaching a loader to the proximal housing having a distal nose for holding the valve assembly open while the valve delivery device is inserted through the introducer sheath.

8. An off-pump method of implanting a prosthetic heart valve in an aortic valve annulus of a patient while the patients heart is beating, comprising:

threading one or more purse-string sutures in a circular pattern through tissue of the left ventricle;

forming a puncture in the wall of the left ventricle within the circular pattern of the one or more purse-string sutures;

introducing a guidewire through the puncture and into the left ventricle;

advancing the guidewire through a native aortic valve within which a prosthetic heart valve has been previously implanted;

while maintaining tension on the one or more purse-string sutures, advancing a dilator over the guidewire and through the puncture into the left ventricle;

prior to the step of advancing the dilator over the guidewire, passing a dilatation catheter having a dilatation balloon on a distal end over the guidewire and through the puncture in the left ventricle;

advancing the dilatation balloon to a position within the previously implanted prosthetic heart valve;

radially expanding the dilatation balloon against the previously implanted prosthetic heart valve;

removing the dilatation catheter from the patient while leaving the guidewire in place;

while maintaining tension on the one or more purse-string sutures, passing an introducer sheath over the dilator and through the puncture and into the left ventricle, the introducer sheath having a lumen extending therethrough;

removing the dilator from within the introducer sheath;

advancing a valve delivery device over the guidewire and through the lumen of the introducer sheath, the valve delivery device having an expandable prosthetic heart valve mounted on a distal end in a contracted configuration and a deflecting segment located just proximal to the prosthetic heart valve;

advancing the valve delivery device over the guidewire until the expandable prosthetic heart valve is located within the previously implanted prosthetic heart valve;

bending the deflecting segment from the proximal handle to facilitate positioning the expandable prosthetic heart valve in the aortic valve annulus; and

then

expanding the prosthetic heart valve against the previously implanted prosthetic heart valve.

9. The method of claim 8, wherein the deflecting segment comprises a coil spring and the valve delivery device includes a deflection wire fastened to a distal end of the deflecting segment and extending proximally to an actuator in the proximal handle for causing bending of the deflecting segment.

10. The method of claim 8, wherein the valve delivery device further has a pusher having a distal sleeve mounted over the deflecting segment, the method including:

using the pusher and sleeve to advance the prosthetic heart valve;

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to the step of bending the deflecting segment.

11. The method of claim 8, wherein the step of threading one or more purse-string sutures comprises placing a first line of purse-string sutures generally in a first circle in one direction defining the circular pattern through the tissue of the left ventricle, and then placing a second line of purse-string sutures generally in a circular pattern concentric to the circular pattern of the first line of purse-string sutures but in an opposite direction.

12. The method of claim 8, wherein the valve delivery device comprises a balloon catheter having a balloon positioned along a distal end portion and wherein the balloon is inflated to expand the prosthetic heart valve in the aortic valve annulus.

13. The method of claim 8, further including the steps of:

prior to inserting the valve delivery device through the valve assembly, attaching a loader to the proximal housing having a distal nose for holding the valve assembly open while the valve delivery device is inserted through the introducer sheath.

14. An off-pump method of implanting a prosthetic heart valve in an aortic valve annulus of a patient while the patient'"'"'s heart is beating, comprising:

forming a puncture in the wall of the left ventricle;

introducing a guidewire through the puncture and into the left ventricle;

advancing the guidewire through a native aortic valve within which a prosthetic heart valve has been previously implanted;

advancing a dilator over the guidewire and through the puncture into the left ventricle;

prior to the step of advancing the dilator over the guidewire, passing a dilatation catheter having a dilatation balloon on a distal end over the guidewire and through the puncture in the left ventricle;

advancing the dilatation balloon to a position within the previously implanted prosthetic heart valve;

radially expanding the dilatation balloon against the previously implanted prosthetic heart valve;

removing the dilatation catheter from the patient while leaving the guidewire in place;

passing an introducer sheath over the dilator and through the puncture and into the left ventricle, the introducer sheath having a lumen extending therethrough, the introducer sheath including a proximal housing containing a valve assembly for preventing bleeding from the lumen;

removing the dilator from within the introducer sheath;

attaching a loader to the proximal housing having a distal nose for holding the valve assembly open while the valve delivery device is inserted through the introducer sheath, the loader passed over the guidewire;

advancing a valve delivery device over the guidewire, through the loader and through the lumen of the introducer sheath, the valve delivery device having an expandable prosthetic heart valve mounted on a distal end in a contracted configuration;

advancing the valve delivery device over the guidewire until the expandable prosthetic heart valve is located within the previously implanted prosthetic heart valve; and

expanding the prosthetic heart valve against the previously implanted prosthetic heart valve.

15. The method of claim 14, wherein the valve delivery device comprises a balloon catheter having a balloon positioned along a distal end portion and wherein the balloon is inflated to expand the prosthetic heart valve in the aortic valve annulus.

16. The method of claim 14, wherein the valve delivery device further has a deflecting segment located just proximal to the prosthetic heart valve, the method including bending the deflecting segment from the proximal handle to facilitate positioning the prosthetic heart valve in the aortic valve annulus.

17. The method of claim 16, wherein the deflecting segment comprises a coil spring and the valve delivery device includes a deflection wire fastened to a distal end of the deflecting segment and extending proximally to an actuator in the proximal handle for causing bending of the deflecting segment.

18. The method of claim 16, wherein the valve delivery device further has a pusher having a distal sleeve mounted over the deflecting segment, the method including:

using the pusher and sleeve to advance the prosthetic heart valve;

proximally displacing the pusher and sleeve with respect to the deflecting segment prior to the step of bending the deflecting segment.