Transapical method of delivering prosthetic heart valve

• US 9,662,207 B2
• Filed: 06/26/2014
• Issued: 05/30/2017
• Est. Priority Date: 11/16/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dehdashtian, Mark, Olin, Jane M.
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US14/316,390
• Publication Number:
  US 20140309728A1
• Time in Patent Office: 1,069 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. 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 native aortic valve. An introducer sheath is passed over the guidewire and into the left ventricle. A prosthetic heart valve is advanced over the guidewire and through the introducer sheath using a delivery catheter. After positioning the prosthetic heart valve in the native aortic valve, the prosthetic heart valve is radially expanded in 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 in the left ventricle;

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

advancing the guidewire through a native aortic valve;

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 prosthetic heart valve mounted thereon a deflecting segment located just proximal to the prosthetic heart valve and a pusher having a distal sleeve mounted over the deflecting segment;

advancing the valve delivery device over the guidewire until the prosthetic heart valve is located in the aortic valve annulus;

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

proximally displacing the pusher and sleeve with respect to the deflecting segment and then bending the deflecting segment from a proximal handle to facilitate positioning the prosthetic heart valve in the aortic valve annulus; and

then expanding the prosthetic heart valve in the aortic valve annulus, wherein the step of expanding the prosthetic heart valve in the aortic valve annulus comprises expanding the prosthetic heart valve in a prosthetic heart valve previously implanted within the native aortic valve annulus.

2. The method of claim 1, further comprising placing a purse-string suture generally in a circle defining a perimeter through the tissue of the left ventricle, and forming the puncture within the perimeter of the purse-string suture.

3. The method of claim 1, further comprising the steps of:

passing a balloon 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 in the native aortic valve; and

radially expanding the dilatation balloon, thereby compressing leaflets of the native aortic valve against the previously implanted prosthetic heart valve.

4. 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.

5. The method of claim 1, wherein the valve delivery device includes a steering mechanism for bending the deflecting segment controlled from the proximal handle thereof, and further comprising:

steering the valve delivery device from the proximal handle with the steering mechanism within the left ventricle to facilitate positioning the prosthetic heart valve in the aortic valve annulus.

6. 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 for holding the valve assembly open while the valve delivery device is inserted through the introducer sheath.

7. 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:

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 an aortic valve annulus;

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;

while maintaining tension on the one or more purse-string sutures, passing an introducer sheath over the dilator, 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, through the valve assembly of an introducer housing and through the lumen of the introducer sheath, the valve delivery device having a prosthetic heart valve mounted thereon a deflecting segment located just proximal to the prosthetic heart valve and a pusher having a distal sleeve mounted over the deflecting segment;

advancing the valve delivery device and prosthetic heart valve over the guidewire until the prosthetic heart valve is positioned in the aortic valve annulus;

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

proximally displacing the pusher and sleeve with respect to the deflecting segment and then bending the deflecting segment from a proximal handle to facilitate positioning the prosthetic heart valve in the aortic valve annulus; and

then expanding the prosthetic heart valve in the aortic valve annulus, wherein the step of expanding the prosthetic heart valve in the aortic valve annulus comprises expanding the heart valve in a prosthetic heart valve previously implanted in the aortic valve annulus.

8. The method of claim 7, 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 first circular pattern but in an opposite direction.

9. The method of claim 7, further comprising the steps of:

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

advancing the dilatation balloon to a position in the native aortic valve; and

radially expanding the dilatation balloon, thereby compressing leaflets of the native aortic valve against the previously implanted prosthetic heart valve.

10. The method of claim 7, 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.

11. The method of claim 7, wherein the valve delivery device includes a steering mechanism for bending the deflecting segment controlled from the proximal handle thereof, and further comprising:

steering the valve delivery device from the proximal handle with the steering mechanism within the left ventricle to facilitate positioning the prosthetic heart valve in the aortic valve annulus.

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

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

13. 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:

providing a delivery catheter having a distal end portion and an expandable prosthetic heart valve mounted on the distal end portion, the delivery catheter also having a deflecting segment located just proximal to the prosthetic heart valve and a pusher having a distal sleeve mounted over the deflecting segment;

creating an intercostal access opening and exposing an apex of a left ventricle;

creating a puncture at or near the apex of the left ventricle;

inserting an introducer sheath through the puncture;

passing the delivery catheter through the introducer sheath and into the left ventricle;

using the pusher and sleeve to advance the delivery catheter such that the prosthetic heart valve is positioned in the aortic valve annulus;

proximally displacing the pusher and sleeve with respect to the deflecting segment and then bending the deflecting segment from a proximal handle to facilitate positioning the prosthetic heart valve in the aortic valve annulus; and

then expanding the prosthetic heart valve in the aortic valve annulus for replacing the function of a native aortic valve, wherein the step of expanding the prosthetic heart valve in the aortic valve annulus comprises expanding the prosthetic heart valve within a previously implanted prosthetic heart valve.

14. The method of claim 13, wherein the delivery catheter includes a balloon on its distal end, and the prosthetic heart valve comprises a balloon-expandable stent, the step of expanding including:

injecting fluid into the balloon to expand the prosthetic heart valve into contact with the previously implanted prosthetic heart valve.

15. The method of claim 13, wherein the prosthetic heart valve is expanded into contact with leaflets of the previously implanted prosthetic heart valve.

16. The method of claim 13, wherein the delivery catheter comprises a steering mechanism for bending the deflecting segment controlled from the proximal handle thereof, and further comprising:

steering the valve delivery device from the proximal handle with the steering mechanism within the left ventricle to facilitate positioning the prosthetic heart valve in the aortic valve annulus.

17. The method of claim 13, further comprising placing a purse-string suture generally in a first circle defining a perimeter through the tissue of the left ventricle, and creating the puncture within the perimeter of the purse-string suture.