Method for delivering a prosthetic heart valve

• US 10,478,294 B2
• Filed: 11/26/2018
• Issued: 11/19/2019
• 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:
  US16/200,458
• Publication Number:
  US 20190091020A1
• Time in Patent Office: 358 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 comprising:

inserting an introducer into a blood vessel of a patient, the introducer having a proximal opening, a distal opening, and an inner passageway between the proximal opening and the distal opening;

inserting a delivery system and a prosthetic valve into a loader, the prosthetic valve being crimped over an inflatable balloon along a distal portion of the delivery system;

inserting the loader through the proximal opening of the introducer after inserting the delivery system and the prosthetic valve into the loader; 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 the distal opening of the introducer into the blood vessel;

wherein the act of inserting the delivery system and the prosthetic valve into the loader comprises inserting a distal end portion of the delivery system and the crimped prosthetic valve into a tube portion of the loader;

inserting the delivery system and the prosthetic valve through a cap opening of a cap portion of the loader; and

inserting the delivery system and the prosthetic valve through a seal opening of a seal member, wherein the seal opening is configured to align with the cap opening and is sized such that when the delivery system is inserted through the cap opening and the seal opening, an outer surface of the delivery system engages the seal opening so as to block blood flow through the seal member.

2. The method of claim 1, wherein the inner passageway of the introducer has a circumference that is smaller than an outer circumference of the prosthetic valve in the radially compressed state prior to being inserted into the introducer.

3. The method of claim 1, further comprising inserting a guidewire into the blood vessel.

4. The method of claim 3, further comprising inserting a dilator over the guidewire into the blood vessel and expanding an inner diameter of the blood vessel to allow insertion of the introducer.

5. The method of claim 3, wherein the act of inserting the introducer into the blood vessel comprises advancing the introducer over the guidewire into the blood vessel.

6. The method of claim 1, wherein the act of inserting the loader through the proximal opening of the introducer comprises inserting the tube portion of the loader through one or more valves located inside the introducer, the one or more valves being configured to control blood flow inside the inner passageway.

7. The method of claim 1, further comprising coupling the tube portion of the loader to the introducer.

8. The method of claim 1, further comprising expanding the prosthetic valve by inflating the inflatable balloon after the prosthetic valve is delivered through the blood vessel and deployed within a native aortic valve.

9. A method comprising:

inserting an introducer into a blood vessel of a patient, the introducer having a proximal opening, a distal opening, and an inner passageway between the proximal opening and the distal opening;

inserting a delivery system and a prosthetic valve into a loader, the prosthetic valve being crimped over an inflatable balloon along a distal portion of the delivery system;

inserting the loader through the proximal opening of the introducer after inserting the delivery system and the prosthetic valve into the loader; 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 the distal opening of the introducer into the blood vessel;

wherein the act of inserting the delivery system and the prosthetic valve into the loader comprises inserting a distal end portion of the delivery system and the crimped prosthetic valve into a tube portion of the loader;

inserting the delivery system and the prosthetic valve through a cap opening of a cap portion of the loader and through a seal member; and

coupling the cap portion to the tube portion.

10. A method comprising:

inserting a sleeve of an introducer into a blood vessel of a patient so that an inner passageway of the sleeve is in fluid communication with the blood vessel, a housing of the introducer attached to a proximal end of the sleeve being located outside the blood vessel;

inserting a delivery system and a prosthetic valve through a cap portion and a seal member of a loader, the prosthetic valve being crimped over an inflatable balloon of the delivery system, and the seal member being configured to engage an outer surface of the delivery system so as to block blood flow through the seal member;

inserting a tube portion of the loader through a proximal opening of the housing and one or more valves located inside the housing, the one or more valves being configured to block blood flow from the inner passageway of the sleeve to the proximal opening of the housing, wherein an inner lumen of the tube portion contains a distal end portion of the delivery system and the prosthetic valve retained thereon; and

advancing the prosthetic valve and the delivery system outwardly through a distal opening of the tube portion of the loader into the inner passageway of the sleeve and then outwardly through a distal opening of the sleeve into the blood vessel without contacting the one or more valves.

11. The method of claim 10, further comprising coupling the tube portion of the loader to the housing of the introducer.

12. The method of claim 10, further comprising inserting the distal end portion of the delivery system and the prosthetic valve retained thereon in the radially compressed state into the tube portion of the loader.

13. The method of claim 10, wherein the vessel is a femoral artery of the patient and the method further comprises advancing the distal end portion of the delivery system and the prosthetic valve through an aorta toward a native aortic valve.

14. The method of claim 13, further comprising advancing the distal end portion of the delivery system and the prosthetic valve through an aortic arch and actuating a steering mechanism of the delivery system to increase a curvature of the distal end portion of the delivery system.

15. The method of claim 14, further comprising positioning the prosthetic valve within the native aortic valve and radially expanding the prosthetic valve into engagement with surrounding tissue.

16. The method of claim 15, wherein radially expanding the prosthetic valve comprises inflating the inflatable balloon.

17. A method comprising:

inserting a guidewire into a blood vessel of a patient;

inserting a sleeve of an introducer over the guidewire into the blood vessel so that an inner passageway of the sleeve is in fluid communication with the blood vessel, a housing of the introducer attached to a proximal end of the sleeve being located outside the blood vessel;

inserting a delivery system and a prosthetic valve through a cap opening of a cap portion of a loader and a seal opening of a seal member, the prosthetic valve being crimped over an inflatable balloon of the delivery system, the seal opening being configured to align with the cap opening and is sized such that when the delivery system is inserted through the cap opening and the seal opening, an outer surface of the delivery system engages the seal opening so as to block blood flow through the seal member;

inserting the distal end portion of the delivery system and the prosthetic valve into a tube portion of the loader;

coupling the cap portion to the tube portion;

inserting the tube portion of the loader through a proximal opening of the housing and one or more valves located inside the housing, the one or more valves being configured to block blood flow from the inner passageway of the sleeve to the proximal opening of the housing;

coupling the tube portion of the loader to the introducer;

advancing the prosthetic valve and the delivery system outwardly as a single unit over the guidewire through a distal opening of the tube portion of the loader into the inner passageway of the sleeve and then outwardly through a distal opening of the sleeve into the blood vessel without contacting the one or more valves; and

expanding the prosthetic valve by inflating the inflatable balloon after the prosthetic valve is delivered through the blood vessel and deployed within a native aortic valve.