DEVICES AND METHODS FOR TRANSCATHETER RETRIEVAL OF MECHANICAL HEART VALVE LEAFLETS

• US 20160206426A1
• Filed: 09/02/2014
• Published: 07/21/2016
• Est. Priority Date: 08/30/2013
• Status: Abandoned Application

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Khoynezhad, Ali, Heinisch, Paul Philipp, Brecht, Ralf, Akra, Selena
• Application Number:
  US14/915,133
• Publication Number:
  US 20160206426A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

The present invention teaches apparatuses and methods for transcatheter removal of mechanical heart valve leaflets from a subject. The invention also teaches methods for subsequent transcatheter placement of a bioprosthesis within the annulus that remains after the leaflets are removed. Advantageously, the devices and methods of the present invention can be used without a heart-lung machine.

Claims

1. An apparatus for transcatheter removal of mechanical heart valve leaflets from a subject, comprising:

a catheter, comprising;

a first catheter end;

a second catheter end; and

an elongated catheter body;

a sheath, comprising;

a first sheath end;

a second sheath end; and

an elongated sheath body;

a leaflet capturing component, comprising;

an attaching end for attaching to a region near the first catheter end;

an elongated leaflet capturing body; and

a sliding end;

wherein (1) the catheter, sheath and leaflet capturing component are situated concentrically, such that the sheath is the outermost component and the catheter is the innermost component;

(2) the sliding end is configured to traverse the elongated catheter body; and

(3) when the sliding end is advanced in the direction of the attaching end, a section of the leaflet capturing component is extended beyond the first sheath end, thereby forming a basket.

2. The apparatus of claim 1, wherein the leaflet capturing component comprises mesh.

3. The apparatus of claim 2, wherein the mesh is made of a material selected from the group consisting of nitinol, semicompliant platinum, nickel-chromium, and combinations thereof.

4. The apparatus of claim 1, further comprising an inflatable balloon.

5. The apparatus of claim 4, wherein the inflatable balloon is located between the attaching end of the leaflet capturing component and the first catheter end.

6. The apparatus of claim 5, wherein the inflatable balloon is asymmetrical when inflated.

7. The apparatus of claim 6, wherein the inflatable balloon has an asymmetrical half dumbbell shape when inflated

8. The apparatus of claim 5, further comprising a means for inflating the balloon.

9. The apparatus of claim 5, further comprising a means for causing the leaflet capturing component to form a basket.

10. The apparatus of claim 5, wherein the catheter is telescoping, such that its overall length can be adjusted.

12. A method, comprising:

introducing the apparatus of claim 1 into the heart of a subject having a mechanical heart valve, wherein the mechanical heart valve comprises mechanical heart valve leaflets attached to a mechanical heart valve annulus;

introducing a balloon of a balloon catheter between the mechanical heart valve leaflets of the mechanical heart valve;

inflating the balloon until the mechanical heart valve leaflets are separated from the annulus of the mechanical heart valve;

forming a basket with the leaflet capturing component of the apparatus of claim 1 by advancing the sliding end of the leaflet capturing component in the direction of the attaching end of the leaflet capturing component;

enveloping the separated mechanical heart valve leaflets with the basket;

withdrawing the basket in the direction of the second end of the catheter, thereby substantially containing the mechanical heart valve leaflets within the basket; and

removing the apparatus of claim 1 and the mechanical heart valve leaflets from the subject.

13. The method of claim 12, wherein the apparatus of claim 1 is introduced into the subject'"'"'s heart through a blood vessel.

14. The method of claim 12, wherein the apparatus of claim 1 is introduced into the subject'"'"'s heart transapically.

15. The method of claim 12, further comprising placing a replacement heart valve in the mechanical heart valve annulus by using a balloon catheter, after the mechanical heart valve leaflets have been removed.

16. The method of claim 15, wherein the replacement heart valve is a bioprosthetic valve.

17. The method of claim 12, wherein the apparatus of claim 1 and the balloon catheter are inserted into the subject'"'"'s body such that they approach the mechanical heart valve from opposite directions.

18. The method of claim 12, wherein the apparatus of claim 1 and the balloon catheter are inserted into the subject'"'"'s body such that they each approach the mechanical heart valve from the same direction.

19. The method of claim 12, wherein the mechanical heart valve is located in the position of a heart valve selected from the group consisting of an aortic valve, a mitral valve, a pulmonic valve and a tricuspid valve.

20. A method, comprising:

introducing the apparatus of claim 4 into the heart of a subject having a mechanical heart valve comprising mechanical heart valve leaflets attached to a mechanical heart valve annulus;

introducing the balloon of the apparatus of claim 4 between the mechanical heart valve leaflets of the mechanical heart valve;

inflating the balloon of the apparatus of claim 4 until the mechanical heart valve leaflets are separated from the annulus of the mechanical heart valve;

forming a basket with the leaflet capturing component of the apparatus of claim 4 by advancing the sliding end of the leaflet capturing component in the direction of the attaching end of the leaflet capturing component;

enveloping the mechanical heart valve leaflets with the basket;

withdrawing the basket in the direction of the second end of the catheter, thereby substantially containing the mechanical heart valve leaflets within the basket;

deflating the balloon; and

removing the apparatus of claim 4 and the mechanical heart valve leaflets from the subject.

21. The method of claim 20, wherein the mechanical heart valve is located in the position of a heart valve selected from the group consisting of an aortic valve, a mitral valve, a pulmonic valve and a tricuspid valve.

22. The method of claim 20, further comprising placing a replacement heart valve in the mechanical heart valve annulus by utilizing a balloon catheter, after the mechanical heart valve leaflets have been removed.

23. The method of claim 22, wherein the replacement heart valve is a bioprosthetic valve.

11. A system, comprising:

(a) an apparatus for transcatheter removal of mechanical heart valve leaflets from a subject, comprising;

a catheter, comprising;

a first catheter end;

a second catheter end; and

an elongated catheter body with an elongated lumen traversing the long axis of said elongated catheter body;

a sheath, comprising

a first sheath end;

a second sheath end; and

an elongated sheath body;

a leaflet capturing component, comprising;

an attaching end for attaching to a region near the first catheter end;

an elongated leaflet capturing body; and

a sliding end;

wherein (1) the catheter, sheath and leaflet capturing component are situated concentrically, such that the sheath is the outermost component and the catheter is the innermost component;

(2) the sliding end is configured to traverse the elongated catheter body; and

(3) when the sliding end is advanced in the direction of the attaching end, a section of the leaflet capturing component is extended beyond the first sheath end, thereby forming a basket; and

(b) a guidewire configured to traverse the elongated lumen of the catheter body.

24. A kit, comprising:

(a) an apparatus for transcatheter removal of mechanical heart valve leaflets from

a subject, comprising;

a catheter, comprising;

a first catheter end;

a second catheter end; and

an elongated catheter body with an elongated lumen traversing the long axis of said elongated catheter body;

a sheath, comprising

a first sheath end;

a second sheath end; and

an elongated sheath body;

a leaflet capturing component, comprising;

an attaching end for attaching to a region near the first catheter end;

an elongated leaflet capturing body; and

a sliding end;

wherein (1) the catheter, sheath and leaflet capturing component are situated concentrically, such that the sheath is the outermost component and the catheter is the innermost component;

(2) the sliding end is configured to traverse the elongated catheter body; and

(3) when the sliding end is advanced in the direction of the attaching end, a section of the leaflet capturing component is extended beyond the first sheath end, thereby forming a basket;

(b) a guidewire configured to traverse the elongated lumen of the catheter body; and

optionally

(c) instructions for the use of the apparatus for removing mechanical heart valve leaflets from a subject.