Distal tip element for a ventricular assist device

Patent metadata

Field	Value
Publication number	US-12453848-B2
Application number	US-202217722752-A
Country	US
Kind code	B2
Filing date	Apr 18, 2022
Priority date	Jan 24, 2019
Publication date	Oct 28, 2025
Grant date	Oct 28, 2025

Abstract

Apparatus and methods are described including delivering a left-ventricular assist device to a subject's aorta. The device including a distal-tip element that defines a straight proximal portion, and a curved distal portion, the curved distal portion defining first and second curves with an elongated straight portion between the first and second curves. The distal-tip element is centered with respect to the aortic valve using the curved distal portion of the distal-tip element, to thereby guide the device through the subject's aortic valve atraumatically. A pump pumps blood through from the subject's left ventricle to the subject's aorta. Other applications are also described.

First claim

The invention claimed is:

1. An apparatus comprising:
a left-ventricular assist device configured to assist left-ventricular functioning of a subject, the left-ventricular assist device comprising:
a tube configured to traverse an aortic valve of the subject, such that a proximal portion of the tube is disposed within an aorta of the subject and a distal portion of the tube is disposed within a left ventricle of the subject, the tube defining at least one blood inlet opening that is configured to be disposed within the subject's left ventricle, and at least one blood outlet opening that is configured to be disposed within the subject's aorta;
a pump disposed within the tube and configured to pump blood through the tube from the subject's left ventricle to the subject's aorta, by pumping the blood into the tube via the at least one blood inlet opening and by pumping blood out of the tube via the at least one blood outlet opening; and
a distal-tip element configured to define a straight proximal portion, and a curved distal portion shaped to define first and second curves with an elongated straight portion between the first and second curves, such that the curved distal portion is effective to center the distal-tip element with respect to the subject's aortic valve.

2. The apparatus according to claim 1 , wherein the distal-tip element is configured to separate the at least one blood inlet opening from a posterior wall of the subject's left ventricle when the distal-tip element is placed against an apex of the subject's left ventricle.

3. The apparatus according to claim 1 , wherein the distal-tip element has a question-mark shape.

4. The apparatus according to claim 1 , wherein the distal-tip element has a tennis-racket shape.

5. The apparatus according to claim 1 , wherein the blood pump comprises an impeller disposed on an axial shaft, and wherein the distal-tip element comprises an axial-shaft receiving tube configured to receive the axial shaft of the blood pump, and a distal-tip portion configured to define the curved distal portion of the distal-tip element.

6. The apparatus according to claim 1 , wherein the distal-tip element is configured to guide the left-ventricular assist device through the subject's aortic valve atraumatically.

7. The apparatus according to claim 1 , wherein the curved distal portion is shaped to define a bulge and wherein a radius of the bulge is sufficiently large as to center the distal-tip element with respect to the subject's aortic valve.

8. The apparatus according to claim 1 , wherein the first and second curves of the curved distal portion are curved respectively in first and second directions that are different from each other.

9. The apparatus according to claim 1 , wherein the curved distal portion is shaped that the elongated straight portion protrudes at an angle with respect to a longitudinal axis of the proximal straight portion of the distal-tip element.

10. The apparatus according to claim 1 , wherein the distal-tip element is configured to separate the at least one blood inlet opening from a septal wall of the subject's left ventricle as the distal-tip element contacts an apex of the subject's left ventricle.

11. The apparatus according to claim 10 , wherein the curved distal portion is shaped to define a bulge, and wherein the distal-tip element is configured such that, when distal-tip element is inserted into the left ventricle such that the bulge bulges toward the septal wall, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward a free wall of the subject's left ventricle.

12. The apparatus according to claim 11 , wherein the distal-tip element is configured such that, in response to the distal-tip element being pushed against the apex of the subject's left ventricle, the blood inlet opening gets pushed away from the septal wall and toward the free wall of the subject's left ventricle by the straight proximal portion of the distal-tip element pivoting about the curved distal portion of the distal-tip element.

13. The apparatus according to claim 1 , wherein a duckbill valve is disposed within a distal-most 10 mm of the distal-tip element.

14. The apparatus according to claim 13 , wherein the duckbill valve defines a wide inlet and a narrow tip that defines a slit therethrough, the duckbill valve being proximally facing, such that the wide inlet faces a distal end of the distal-tip element and such that the narrow tip faces away from the distal end of the distal-tip element.

15. A method comprising:
delivering a left-ventricular assist device to an aorta of a subject, the left-ventricular assist device including:
a tube;
a pump disposed within a distal portion of the tube; and
a distal-tip element that defines a straight proximal portion, and a curved distal portion that defines first and second curves with an elongated straight portion between the first and second curves;

centering the distal-tip element with respect to an aortic valve of the subject, using the curved distal portion of the distal-tip element;
thereby guiding the left-ventricular assist device through the subject's aortic valve atraumatically, such that the tube traverses the subject's aortic valve, with a proximal portion of the tube disposed within the subject's aorta, and the distal portion of the tube is disposed within a left ventricle of the subject; and
operating the pump to pump blood through the tube from the subject's left ventricle to the subject's aorta, by pumping the blood into the tube via at least one blood inlet opening that is defined by the tube and that is disposed within the subject's left ventricle, and by pumping blood out of the tube via at least one blood outlet opening that is defined by the tube and that is disposed within the subject's aorta.

16. The method according to claim 15 , further comprising using the distal-tip element to separate the at least one blood inlet opening from a posterior wall of the subject's left ventricle when the distal-tip element is placed against an apex of the subject's left ventricle.

17. The method according to claim 15 , wherein the distal-tip element has a question-mark shape.

18. The method according to claim 15 , wherein the distal-tip element has a tennis-racket shape.

19. The method according to claim 15 , wherein the curved distal portion is shaped to define a bulge and centering the distal-tip element with respect to the subject's aortic valve comprises using the bulge to center the distal-tip element with respect to the subject's aortic valve.

20. The method according to claim 15 , wherein the first and second curves of the curved distal portion are curved respectively in first and second directions that are different from each other.

21. The method according to claim 15 , wherein the curved distal portion is shaped that the elongated straight portion protrudes at an angle with respect to a longitudinal axis of the proximal straight portion of the distal-tip element.

22. The method according to claim 15 , further comprising using the distal-tip element to separate the at least one blood inlet opening from a septal wall of the subject's left ventricle as the distal-tip element contacts an apex of the subject's left ventricle.

23. The method according to claim 22 , wherein the curved distal portion is shaped to define a bulge, further comprising using the dis

Assignees

• Magenta Medical Ltd

Inventors

• Tuval Yosi
• Sohn Zev
• Schwammenthal Ehud
• Lubinsky Gad
• Troshin Victor
• Mustacchi Shaul Jacob Leisner
• Elisha Yinnon
• Sudin Yuri
• Harel Hagit Zemer
• Rozenfeld Avi

Classifications

• A61M60/804

  Impellers · CPC title

• A61M60/81

  Pump housings · CPC title

• A61M60/174

  discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system · CPC title

• A61M60/165

  implantable in, on, or around the heart · CPC title

• A61M60/139

  inside the aorta, e.g. intra-aortic balloon pumps · CPC title