Method for delivering a prosthetic heart valve

• US 10,500,045 B2
• Filed: 11/26/2018
• Issued: 12/10/2019
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M.
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US16/200,366
• Publication Number:
  US 20190091019A1
• Time in Patent Office: 379 Days
• 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 2230/0069 cylindrical
• 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 25/0147 with movable mechanical means, e.g. pull wires

Abstract

An assembly for delivering a prosthetic heart valve to a native heart valve is disclosed. The assembly includes a self-expanding prosthetic heart valve formed with an expandable metallic stent and a flexible valvular structure. The assembly also includes a delivery apparatus having a delivery sleeve. The delivery sleeve includes a selectively steerable section and a distal portion for retaining the prosthetic heart valve in a compressed state. A handle is coupled to a proximal end of the delivery sleeve and a pull wire extends from the handle to the steerable section of the delivery sleeve. The handle preferably includes a rotatable portion for actuating the pull wire and thereby selectively controlling a curvature of the steerable section during advancement through the patient'"'"'s vasculature. In preferred embodiments, the steerable section includes a flexible metallic tubular portion formed with a plurality of circumferentially extending openings.

Claims

1. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:

introducing a delivery system into a femoral artery of the patient, the delivery system comprising an outer sleeve comprising a selectively steerable distal end portion, the delivery system further comprising a balloon catheter extending through a central lumen in the outer sleeve, wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable distal end portion, and a prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter, wherein the distal end of the steerable distal end portion is a free end and the prosthetic valve is positioned distal to the free end as the delivery system is introduced into the femoral artery;

advancing the prosthetic valve through the femoral artery and an aorta of the patient until the prosthetic valve reaches an aortic arch of the patient, wherein the outer sleeve does not cover the prosthetic valve as the prosthetic valve is advanced through the aorta;

actuating a pull wire for selectively controlling a curvature of the steerable distal end portion so as to advance the prosthetic valve through the aortic arch, the pull wire having a distal end portion fixedly connected to the steerable distal end portion;

positioning the prosthetic valve at a target site within the native aortic valve; and

radially expanding the prosthetic valve by inflating the balloon.

2. The method of claim 1 further comprising pre-dilating leaflets of the native aortic valve for increasing a flow area through the native aortic valve.

3. The method of claim 1, wherein the pull wire is actuated by a steering mechanism located in a handle that is coupled to a proximal end of the outer sleeve.

4. The method of claim 3, wherein the steering mechanism is configured to pull the pull wire proximally to bend the steerable distal end portion when actuated by a user.

5. The method of claim 3, wherein the steering mechanism comprises a rotatable knob operably coupled to a longitudinally moveable core member disposed inside the handle, a proximal end portion of the pull wire being fixed to the core member, such that rotation of the knob in a first rotational direction produces longitudinal movement of the core member in a first longitudinal direction to increase tension in the pull wire and rotation of the knob in a second rotational direction produces longitudinal movement of the core member in a second longitudinal direction to decrease tension in the pull wire.

6. The method of claim 1, wherein the distal end portion of the pull wire is fixed to the steerable distal end portion at a location proximal to the prosthetic valve such that the prosthetic valve remains straight when the pull wire is actuated to change the curvature of the steerable distal end portion.

7. The method of claim 1, wherein the act of positioning the prosthetic valve comprises aligning the prosthetic valve with respect to the native aortic valve by controlling the curvature of the steerable distal end portion.

8. The method of claim 1, wherein the act of positioning the prosthetic valve comprises pushing the balloon catheter across the native aortic valve.

9. The method of claim 1, wherein the act of introducing the delivery system comprises advancing the prosthetic valve, the balloon catheter, and the outer sleeve as a single unit through an introducer that extends into the femoral artery.

10. The method of claim 1, wherein the acts of advancing and positioning the prosthetic valve comprise identifying a location of the prosthetic valve within the patient using fluoroscopy to locate one or more markers positioned along the balloon catheter.

11. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:

introducing a delivery system into a femoral artery of the patient, the delivery system comprising a tubular sleeve and a selectively steerable section fixedly attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a central lumen in the tubular sleeve and the steerable section, wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable section, and a prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter, wherein the distal end of the steerable section is a free end and the prosthetic valve is positioned distal to the free end as the delivery system is introduced into the femoral artery;

advancing the prosthetic valve, the balloon catheter, and the steerable section through the femoral artery and an aortic arch of the patient, wherein the tubular sleeve does not cover the prosthetic valve as the prosthetic valve is advanced through the aorta;

selectively controlling a curvature of the steerable section during advancement around the aortic arch;

positioning the prosthetic valve at a target site within the native aortic valve; and

inflating the balloon so as to radially expand the prosthetic valve.

12. The method of claim 11, wherein the act of selectively controlling the curvature of the steerable section comprises actuating a pull wire through a rotatable handle assembly located proximal to the tubular sleeve, and wherein the pull wire has a distal end portion fixedly connected to the steerable section at a location proximal to the prosthetic valve such that the prosthetic valve remains straight when the pull wire is actuated to change the curvature of the steerable section.

13. The method of claim 12, wherein the rotatable handle assembly comprises a rotatable knob operably coupled to a longitudinally moveable core member, a proximal end portion of the pull wire being fixed to the core member, such that rotation of the knob in a first rotational direction produces longitudinal movement of the core member in a first longitudinal direction to increase tension in the pull wire and rotation of the knob in a second rotational direction produces longitudinal movement of the core member in a second longitudinal direction to decrease tension in the pull wire.

14. The method of claim 11, wherein the act of positioning the prosthetic valve comprises aligning the prosthetic valve with respect to the native aortic valve by controlling the curvature of the steerable section and pushing the balloon catheter across the native aortic valve.

15. The method of claim 11 further comprising inserting an introducer into the femoral artery so that an inner passageway of the introducer is in fluid communication with the femoral artery and wherein the act of introducing the delivery system into the femoral artery comprises advancing the delivery system through the introducer and into the femoral artery after the introducer is inserted into the femoral artery.

16. The method of claim 15 wherein the act of advancing the delivery system through the introducer further comprises inserting the prosthetic valve and the distal end portion of the balloon catheter into a loader, inserting the loader through a proximal opening of the introducer, and advancing the prosthetic valve and the delivery system outwardly through a distal opening of the loader into the inner passageway of the introducer and then outwardly through a distal opening of the introducer into the femoral artery.

17. The method of claim 16 wherein inserting the loader through a proximal opening of the introducer further comprises inserting a tube of the loader through a seal of the introducer.

18. The method of claim 15, wherein the inner passageway of the introducer has a circumference that is smaller than an outer circumference of the prosthetic valve.

19. The method of claim 11 further comprising deflating the balloon and withdrawing the delivery system after the expanded prosthetic valve is securely deployed at the target site.

20. A method of implanting a balloon expandable prosthetic valve within a native aortic valve in a patient, the method comprising:

inserting an introducer into a femoral artery of the patient;

inserting a prosthetic valve and a distal end portion of a balloon catheter into a loader, wherein the prosthetic valve is crimped over a balloon disposed along the distal end portion of the balloon catheter, wherein the balloon catheter extends through a central lumen of an outer sleeve comprising a selectively steerable distal end portion, and wherein the distal end portion of the balloon catheter and the prosthetic valve are positioned distal to a distal end of the steerable distal end portion, the distal end being a free end;

inserting the loader through a proximal opening of the introducer;

pushing the prosthetic valve, the balloon catheter, and the outer sleeve as a single unit outwardly through a distal opening of the loader, into and through the introducer and into the femoral artery;

advancing the prosthetic valve through the femoral artery and an aorta of the patient until the prosthetic valve reaches an aortic arch of the patient, wherein the outer sleeve does not cover the prosthetic valve as the prosthetic valve is being advanced through the aorta;

actuating a pull wire for selectively controlling a curvature of the steerable distal end portion so as to advance the prosthetic valve through the aortic arch, the pull wire having a distal end portion fixedly connected to the steerable distal end portion at a location proximal to the prosthetic valve such that the prosthetic valve remains straight when the pull wire is actuated to change the curvature of the steerable distal end portion;

aligning the prosthetic valve with respect to the native aortic valve by controlling the curvature of the steerable section;

advancing the balloon catheter and the prosthetic valve across the native aortic valve; and

inflating the balloon so as to radially expand the prosthetic valve.