Prosthetic heart valve delivery methods

Patent metadata

Field	Value
Publication number	US-11116631-B2
Application number	US-202017002636-A
Country	US
Kind code	B2
Filing date	Aug 25, 2020
Priority date	Aug 22, 2008
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient can include introducing a prosthetic heart valve on a transvascular delivery apparatus into an artery of the patient, advancing the delivery apparatus through an aorta of the patient to the native aortic heart valve region, and releasing the prosthetic heart valve from the delivery apparatus. The delivery apparatus can have a shaft with a valve connection portion that is releasably coupled to posts of the prosthetic heart valve. The delivery apparatus can have a delivery sheath positioned around the prosthetic heart valve and the valve connection portion. The releasing the prosthetic valve can include moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve and the prosthetic heart valve can self-expand.

First claim

We claim:

1. A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient, the method comprising:
introducing a transvascular delivery apparatus into a femoral artery of the patient with the prosthetic heart valve positioned on the delivery apparatus in a radially compressed state;
wherein the prosthetic heart valve comprises an annular metal frame and a valve member disposed in an interior of the frame such that the valve member allows blood flow from an inlet end of the frame to an outlet end of the frame and restricts blood flow from the outlet end to the inlet end, the frame comprising a plurality of struts forming a plurality of apices defining the outlet end and a plurality of posts extending proximally beyond the apices of the outlet end of the frame, wherein each of the posts comprises an axial post portion coupled to the outlet end of the frame and a terminal post portion, wherein the terminal post portion has a circumferential dimension that is greater than a width of the axial post portion;
wherein the delivery apparatus comprises a shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a continuous cylindrical outer surface of fixed diameter and a plurality of radially facing recesses that receive the posts formed in the continuous cylindrical outer surface, wherein the recesses comprises axial recess portions that receives the axial post portions and enlarged recess portions that receive the terminal post portions, and wherein the circumferential dimension of the terminal post portions is greater than a circumferential width of the axial recess portions such that the posts cannot move axially out of the recesses;
wherein the terminal post portions have a rounded shape and the enlarged recess portions have a corresponding rounded shape to receive the terminal post portions; and
wherein the delivery apparatus further comprises a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft, wherein the delivery sheath maintains the prosthetic heart valve in the radially compressed state and maintains the posts within the recesses;

advancing the delivery apparatus from the femoral artery, through an aortic arch of the patient, and to the native aortic heart valve region; and
moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the prosthetic heart valve, including its posts, which allows the prosthetic heart valve to radially self-expand within the native aortic heart valve region and allows the posts to move radially out of the recesses of the valve connection portion to release the prosthetic heart valve from the delivery apparatus.

2. The method of claim 1 , wherein moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve comprises partially uncovering the prosthetic heart valve such that the posts are still covered by the delivery sheath and held in the recesses by the delivery sheath while a main body of the prosthetic heart valve including the valve member is uncovered and allowed to partially self-expand.

3. The method of claim 2 , further comprising adjusting an axial position of the partially self-expanded main body by moving the shaft axially and thereby applying axial force on the posts that are still held in the recesses.

4. The method of claim 3 , further comprising, after adjusting the axial position of the partially self-expanded main body, further moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the posts and allows the posts to move radially out of the recesses, releasing the prosthetic heart valve from the delivery apparatus.

5. The method of claim 2 , further comprising, after partially uncovering the prosthetic heart valve, moving the delivery sheath back distally relative to the shaft and the prosthetic heart valve to re-cover the main body with the delivery sheath and cause the prosthetic heart valve to return to the radially compressed state.

6. The method of claim 1 , further comprising, prior to introducing the delivery apparatus into the femoral artery of the patient:
positioning the prosthetic heart valve in a radially expanded state with the posts being radially outward of the recesses;
radially compressing the prosthetic heart valve such that the posts move radially inward into the recesses; and
covering the prosthetic heart valve with the delivery sheath such that the posts are retained in the recesses and the prosthetic heart valve is held in the radially compressed state.

7. The method of claim 1 , wherein the plurality of posts consists of two posts and the enlarged recess portions consist of two discrete enlarged recess portions that receive the two posts.

8. The method of claim 1 , wherein each of the terminal post portions has an oval shape and each of the enlarged recess portions is defined by a curved wall formed in the valve connection portion, the curved wall extending around the corresponding terminal post portion.

9. The method of claim 1 , wherein the terminal post portions are circumferentially curved and the enlarged recess portions are correspondingly circumferentially curved.

10. The method of claim 1 , wherein the terminal post portions each include a central opening.

11. A method of delivering a prosthetic heart valve to a native aortic heart valve region of a patient, the method comprising:
introducing a transvascular delivery apparatus into a femoral artery of the patient with the prosthetic heart valve positioned on the delivery apparatus in a radially compressed state;
wherein the prosthetic heart valve comprises a single annular metal frame and a valve member disposed in an interior of the frame such that the valve member allows blood flow from an inlet end of the frame to an outflow end of the frame and restricts blood flow from the outflow end to the inlet end, the frame comprising a plurality of posts extending proximally from the outflow end of the frame, wherein each of the posts comprises an axial post portion coupled to the outflow end of the frame and a terminal post portion, wherein the terminal post portion has a circumferential dimension that is greater than a width of the axial post portion;
wherein the delivery apparatus comprises a shaft comprising a valve connection portion that is releasably coupled to the posts of the prosthetic heart valve, wherein the valve connection portion comprises a plurality of radially facing recesses that receive the posts, wherein the recesses comprises axial recess portions that receives the axial post portions and enlarged recess portions that receive the terminal post portions, and wherein the circumferential dimension of the terminal post portions is greater than a circumferential width of the axial recess portions such that the posts cannot move axially out of the recesses; and
wherein the delivery apparatus further comprises a delivery sheath that is positioned around the prosthetic heart valve and the valve connection portion of the shaft, wherein the delivery sheath maintains the prosthetic heart valve in the radially compressed state and maintains the posts within the recesses;

advancing the delivery apparatus from the femoral artery, through an aortic arch of the patient, and to the native aortic heart valve region;
moving the delivery sheath proximally relative to the shaft and the prosthetic heart valve such that the delivery sheath uncovers the inlet end of the prosthetic heart valve while the

Assignees

• Edwards Lifesciences Corp

Inventors

• Alon David
• Benichou Netanel
• Meiri Oded

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title

• A61F2230/0076

  ellipsoidal or ovoid · CPC title