IP Library › Granted Patent US 11,065,114
Granted Patent B2
US 11,065,114 · App. 16/374,240 · Granted Jul 20, 2021

Frame for prosthetic valve

Inventors: Ehud Raanani (Hod-HaSharon, IL); Boris Orlov (Haifa, IL); Boaz Harari (Haifa, IL); Oded Meiri (Moshav Ram-On, IL); Lichen Rozitsky (Haifa, IL)
Assignee: TEL HASHOMER MEDICAL RESEARCH INFRASTRUCTURE AND SERVICES LTD.
A61F2/2418A61F2/243A61F2/2436A61F2/2457A61F2220/0016A61F2220/0058A61F2220/0075A61F2230/005A61F2230/0013A61F2230/0078A61F2250/006
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Quick Facts
Patent No.
US 11,065,114
App. No.
16/374,240
Granted
Jul 20, 2021
Kind
B2
Abstract

Apparatus and methods are described including a valve frame configured to support a prosthetic valve within a native atrio-ventricular valve. The valve frame includes a frame body that includes an atrial portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the atrial portion is disposed on an atrial side of the native atrio-ventricular valve, and a ventricular portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the ventricular portion is disposed within a ventricle of the subject. At least one arm is configured to extend from the ventricular portion of the frame body. Other applications are also described.

Claims (57)

1. A method for use with a prosthetic valve that is configured to be deployed within a native atrio-ventricular valve of a heart of a mammalian subject, the native atrio-ventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles, the method comprising:

placing a valve frame within the subject's heart, the valve frame including:

a valve frame body that is configured to support the prosthetic valve within the native atrio-ventricular valve, and that includes an atrial portion and a ventricular portion, and

at least one arm that is configured to extend from the ventricular portion of the valve frame;

deploying the at least one arm among the chords of the native atrio-ventricular valve;

subsequently, rotating at least a portion of the valve frame, such as to cause the arm to twist the leaflets of the native valve, such that the leaflets of the native valve are placed in overlapping configurations with respect to each other; and

subsequently, causing the frame body of the valve frame to radially expand, such as to trap the leaflets of the native valve in the overlapping configurations with respect to each other.

2. The method according to claim 1 , wherein placing the valve frame within the subject's heart comprises placing two or more parts of the valve frame into the subject's heart and coupling the two or more parts to each other.

3. The method according to claim 1 , wherein rotating at least the portion of the valve frame comprises rotating at least the portion of the valve frame, such as to cause the arm to twist the leaflets of the native valve, such that the leaflets form a seal against each other, such that there is no clinically significant regurgitation from a ventricle of the subject to an atrium of the subject during systole of the subject.

4. The method according to claim 1 , wherein rotating at least the portion of the valve frame comprises rotating at least the portion of the valve frame, such as to cause the arm to twist the leaflets of the native valve, such that at least one commissure between the leaflets of the native atrio-ventricular valve is sealed by the leaflets of the native valve being placed in the overlapping configurations with respect to each other.

5. The method according to claim 1 , wherein deploying the at least one arm among the chords of the native atrio-ventricular valve comprises deploying the at least one arm among the chords of the native atrio-ventricular valve, even when the portion of the valve frame from which the at least one arm extends is in a radially-compressed state.

6. The method according to claim 1 , further comprising preventing chords from exiting the arm, using a protruding member shaped to protrude from the arm.

7. The method according to claim 1 , wherein causing the frame body of the valve frame to radially expand such as to trap the leaflets of the native valve in the overlapping configurations with respect to each other comprises using the at least one arm to trap the native valve leaflets in the overlapping configurations with respect to each other.

8. The method according to claim 1 , wherein causing the frame body of the valve frame to radially expand, such as to trap the leaflets of the native valve in the overlapping configurations with respect to each other comprises trapping the native valve leaflets between the atrial portion of the valve frame and the at least one arm.

9. The method according to claim 1 , wherein the native atrio-ventricular valve includes a native mitral valve, and placing the valve frame within the patient's heart comprises placing within a left heart of the patient a valve frame that is configured to support the prosthetic valve within the native mitral valve.

10. The method according to claim 9 , wherein causing the frame body of the valve frame to radially expand comprises avoiding interfering with left ventricular functioning of the subject by avoiding causing even partial occlusion in a vicinity of an aortic valve of the subject.

11. The method according to claim 9 , wherein causing the frame body of the valve frame to radially expand comprises avoiding interfering with left ventricular functioning of the subject by avoiding causing turbulence in a vicinity of an aortic valve of the subject.

12. A method for use with a prosthetic valve that is configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve including a valve annulus, valve leaflets, chords, and papillary muscles, the method comprising:

placing a valve frame within the subject's heart, the valve frame including:

a valve frame body that is configured to support the prosthetic valve within the native mitral valve, and that includes an atrial portion and a ventricular portion, and

at least one arm that is configured to extend from the ventricular portion of the valve frame;

deploying the at least one arm among the chords of the native mitral valve;

subsequently, rotating at least a portion of the valve frame, such as to cause the arm to twist the leaflets of the native mitral valve; and

subsequently, causing the frame body of the valve frame to radially expand, such as to trap the leaflets of the native mitral valve in the twisted configuration, and such as to avoid interfering with left ventricular functioning of the subject by avoiding causing even partial occlusion in a vicinity of an aortic valve of the subject.

13. The method according to claim 12 , wherein causing the frame body of the valve frame to radially expand further comprises avoiding interfering with left ventricular functioning of the subject by avoiding causing turbulence in a vicinity of the subject's aortic valve.

14. The method according to claim 12 , wherein placing the valve frame within the subject's heart comprises placing two or more parts of the valve frame into the subject's heart and coupling the two or more parts to each other.

15. The method according to claim 12 , wherein deploying the at least one arm among the chords of the native mitral valve comprises deploying the at least one arm among the chords of the native mitral valve, even when the portion of the valve frame from which the at least one arm extends is in a radially-compressed state.

16. The method according to claim 12 , further comprising preventing chords from exiting the arm, using a protruding member shaped to protrude from the arm.

17. The method according to claim 12 , wherein causing the frame body of the valve frame to radially expand, such as to trap the leaflets of the native mitral valve in the twisted configuration comprises using the at least one arm to trap the native valve leaflets in the twisted configuration.

18. The method according to claim 12 , wherein causing the frame body of the valve frame to radially expand, such as to trap the leaflets of the native mitral valve in the twisted configuration comprises trapping the native valve leaflets between the atrial portion of the valve frame and the at least one arm.

19. The method according to claim 12 , wherein:

rotating at least the portion of the valve frame comprises twisting the leaflets of the native valve, such that the leaflets of the native mitral valve are shaped into overlapping configurations with respect to each other, and

causing the frame body of the valve frame to radially expand, such as to trap the native valve leaflets in the twisted configuration comprises trapping the leaflets of the native valve in the overlapping configurations with respect to each other.

20. The method according to claim 19 , wherein twisting the leaflets of the native valve such that the leaflets of the native valve are shaped into overlapping configurations with respect to each other comprises sealing at least one commissure between the leaflets of the native mitral valve by twisting the leaflets of the native valve into the overlapping configurations with respect to each other.

21. The method according to claim 19 , wherein twisting the leaflets of the native valve, such that the leaflets of the native valve are shaped into overlapping configurations with respect to each other comprises causing the leaflets form a seal against each other, such that there is no clinically significant regurgitation from a ventricle of the subject to an atrium of the subject during systole of the subject.

22. An apparatus for use with a prosthetic valve that is configured to be deployed within a native atrio-ventricular valve of a heart of a mammalian subject, the native atrio-ventricular valve including a valve annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising:

a valve frame configured to support the prosthetic valve within the native atrio-ventricular valve, the valve frame comprising:

a frame body comprising:

an atrial portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the atrial portion is disposed on an atrial side of the native atrio-ventricular valve; and

a ventricular portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the ventricular portion is disposed within a ventricle of the subject; and

at least one arm configured to extend from the ventricular portion of the frame body; and

a delivery device configured to:

deliver the valve frame to the native atrio-ventricular valve;

subsequently, deploy the at least one arm among the chords of the native atrio-ventricular valve;

subsequently, rotate at least a portion of the valve frame, such as to cause the arm to twist the leaflets of the native valve, such that the leaflets of the native valve are placed in overlapping configurations with respect to each other; and

subsequently, cause the frame body of the valve frame to radially expand, such as to trap the native valve leaflets in in the overlapping configurations with respect to each other.

23. An apparatus for use with a prosthetic valve that is configured to be deployed within a native mitral valve of a heart of a mammalian subject, the native mitral valve including a valve annulus, valve leaflets, chords, and papillary muscles, the apparatus comprising:

a valve frame configured to support the prosthetic valve within the native mitral valve, the valve frame comprising:

a frame body comprising:

an atrial portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the atrial portion is disposed on an atrial side of the native mitral valve; and

a ventricular portion configured to be positioned such that, when the valve frame is deployed, at least a portion of the ventricular portion is disposed within a ventricle of the subject; and

at least one arm configured to extend from the ventricular portion of the frame body; and

a delivery device configured to:

deliver the valve frame to the native mitral valve;

subsequently, deploy the at least one arm among the chords of the native mitral valve;

subsequently, rotate at least a portion of the valve frame, such as to cause the arm to twist the leaflets of the native valve; and

subsequently, cause the frame body of the valve frame to radially expand, such as to trap the native valve leaflets in in the twisted configuration, and such as to avoid interfering with left ventricular functioning of the subject by avoiding causing even partial occlusion in a vicinity of an aortic valve of the subject.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 1, 2021
From: HARARI, BOAZ; MEIRI, ODED; ROZITSKY, LICHEN
To: MITRALHEAL LTD.
Reel/Frame 056731/0964 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 1, 2021
From: MITRALHEAL LTD.
To: TEL HASHOMER MEDICAL RESEARCH INFRASTRUCTURE AND SERVICES LTD.
Reel/Frame 056732/0086 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 1, 2021
From: RAANANI, EHUD; ORLOV, BORIS
To: TEL HASHOMER MEDICAL RESEARCH INFRASTRUCTURE AND SERVICES LTD.
Reel/Frame 056732/0609 →
Continuity (3)
Continuation 14402387
Provisional Application 61649319 · May 20, 2012
Related Publication 20190231522A1 · Aug 1, 2019
Cited By (15)
US 12,208,003 US 12,232,958 US 12,310,575 US 12,350,156 US 12,357,459 US 12,396,847 US 12,396,848 US 12,396,851 US 12,458,493 US 12,569,335 US 12,611,305 US 12,697,212 US 12,708,511 US 12,728,256 US 12,746,120