MATERIAL FOR TREATMENT OF A HEART VALVE, IN PARTICULAR A MITRAL VALVE

• US 20100145439A1
• Filed: 12/18/2007
• Published: 06/10/2010
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Seguin, Jacques R., Lecointe, Bruno
• Granted Patent: US 9,232,942 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

This material comprises an annuloplasty member (12) able to be introduced using a catheter (2) through minimally invasive vascular access, then to be delivered by said catheter and fixed to the valve annulus (104). According to the invention, it includes at least one catheter (2) comprising:—at least one guide member (10, 11) able to be deployed from said catheter (2) such that it extends along one portion of the valve annulus (104) of the valve (101), in the immediate proximity of said valve annulus, and—an implant (12) having a helical shape engaged on said guide member (10, 11), connected, with separation possibility, to actuation means (13, 20; 22, 23) making it possible to cause this implant (12) to move forward while driving it in rotation around its axis; the implant (12) can thus be deployed from the catheter (2) while being simultaneously moved forward and driven in rotation along its axis, said rotation enabling the implant (12) to penetrate the tissue of the valve annulus (104) while being guided along said annulus by said guide member (10, 11).

Claims

1. - Material for treating a heart valve, in particular a mitral valve (101), comprising an annuloplasty member (12) able to be introduced using a catheter (2) through minimally invasive vascular access, then to be delivered by said catheter and fixed to the valve annulus (104), characterized in that it includes at least one catheter (2) comprising:

at least one guide member (10, 11) able to be deployed from said catheter (2) such that it extends along one portion of the valve annulus (104) of the valve (101), in the immediate proximity of said valve annulus, and

an implant (12) having a helical shape engaged on said guide member (10, 11), connected, with separation possibility, to actuation means (13, 20;

22, 23) making it possible to cause this implant (12) to move forward while driving it in rotation around its axis;

the implant (12) can thus be deployed from the catheter (2) while being simultaneously moved forward and driven in rotation along its axis, said rotation enabling the implant (12) to;

penetrate the tissue of the valve annulus (104) while being guided along said annulus by said guide member (10, 11).

2. - Material according to claim 1, characterized in that the implant (12) varies in length and that it can adopt an extended shape for introduction and a shortened shape for implantation, the passage of the implant (12) to this shortened implantation shape making it possible to gather the valve annulus (104) portion in which said implant (12) is placed.

3. - Material according to claim 2, characterized in that the implant (12) is made of a shape memory material.

4. - Material according to claim 1, characterized in that the implant (12) has an invariable or slightly variable length.

5-Material. -Material according to claim 1, characterized in that the implant (12) comprises coils having a uniform pitch.

6. - Material according to claim 1, characterized in that the implant (12) comprises coils (12a, 12b) having a varied pitch, said pitch being greater at the distal part of the implant (12) and smaller at the proximal part of the implant.

7. - Material according to claim 4, characterized in that said actuation means comprises an abutment (23) integral with the implant (12) and an abutment (22) integral with the catheter (2);

once the implant (12) has been deployed, the abutment (23) integral with the implant (12) meets the abutment (22) integral with the catheter (2) and thus limiting the longitudinal progress of the implant (12) without limiting the rotation of said implant;

continuing rotation of the implant (12) around its axis after this longitudinal progress limitation causes gathering of the annulus portion (104) in which the implant (12) is placed.

8-Material. -Material according to any of claims 1 to 7, characterized in that each guide member (10, 11) is connected to means for its actuation making it possible to rotate the guide member (10, 11) in relation to the catheter (2).

9. - Material according to any of claims 1 to 8, characterized in that the catheter (2) contains two deployable guide members (10, 11) as previously mentioned, a first of which can be engaged on one side of the valve (101) and the second of which can be engaged on the other side of the valve (101), and in that the implant (12) is engaged around these two guide members (10, 11).

10. - Material according to claim 9, characterized in that the guide:

member (10), which is found, once deployed, on the other surface of the valve (101) relative to the catheter (2), comprises a bearing portion (10a) able to bear against the surface of the valve (101) opposite the catheter (2), making it possible to pinch this tissue between it and the end of the catheter (2).

11. - Material according to claim 10, characterized in that said bearing portion is formed by a distal portion (10a) of the guide member (10), designed to be deployed, which is connected by a bent portion to a proximal portion of the guide member (10) intended to remain in the catheter (2), said bent portion allowing, after deployment, orientation of said distal portion (10a) substantially in the plane of the valve annulus (104).

12. - Material according to any of claims 1 to 11, characterized in that the catheter, or another catheter (1) comprised by the material, includes a piercing needle (5) for the valve annulus (104).

13. - Material according to claim 12, characterized in that it comprises:

a first catheter (1) containing said piercing needle (5), which is hollow;

a guidance wire (6) able to be slid through the needle (5);

a second catheter (2), containing the aforementioned guide member(s) (10, 11) and implant (12), the guide member (10) intended to extend on the surface of the valve (101) opposite the second catheter (2) being tubular and engaged on the guidance wire (6).

14. - Material according to claim 13, characterized in that, when it comprises two guide members (10, 11) each intended to be engaged on one of the surfaces of the valve (101), the guide member (10) intended to be engaged on the surface (101) opposite the catheter (2) is tubular and is engaged on this guidance wire (6).

15. - Material according to claim 13, characterized in that it comprises a guide member (25) positioned such that it can be deployed on one side of the catheter (2) diametrically opposite that on which another guide member (11) is deployed.

16. - Percutaneous operating method for treatment of a heart valve, characterized in that it comprises steps consisting of:

using at least one catheter, comprising;

at least one guide member able to be deployed from said catheter so as to extend along a portion of the valve annulus of the valve, in the immediate vicinity of said valve annulus, and

an implant having a helical shape engaged on said guide member, connected, with the possibility of being separated, to actuation means making it possible to move said implant forward while driving it in rotation along its axis;

deploying the implant from the catheter by causing said implant to move forward and driving it in rotation along its axis, said rotation allowing the implant to penetrate the tissue of the valve annulus while being guided along said annulus by said guide member.

17. - Percutaneous operating method according to claim 16, characterized in that it comprises the fact of using an implant that varies longitudinally in length and being able to adopt an extended introduction form and a shortened form making it possible to reduce the length of the annulus portion in which it is implanted.

18. - Percutaneous operating method according to claim 16, characterized in that it comprises the fact of using an implant having an invariable or slightly variable length.

19. - Percutaneous operating method according to claim 18, characterized in that it comprises a step consisting, after placement of the implant, of percutaneously implanting and anchoring a prosthetic valve.

20. - Percutaneous operating method according to claim 16, characterized in that it comprises the fact of using an implant comprising coils having an inconstant pitch, said pitch being larger at the distal part of the implant and smaller at the proximal part of said implant.

21. - Percutaneous operating method according to any of claims 16 to 20, characterized in that it comprises steps consisting of:

deploying a first guide member and a second guide member, on the surface of the valve facing the catheter and on the surface of the valve opposite the catheter, respectively;

positioning the two guide members in relation to each other so as to hold the valve tissue between the guide members.

22. - Percutaneous operating method according to any of claims 16 to 21, characterized in that it comprises steps consisting of:

introducing the catheter at the commissure formed by two leaflets adjacent to the valve, and

deploying a deployable member through said commissure.

23. - Percutaneous operating method according to any of claims 16 to 21, characterized in that it comprises steps consisting of:

introducing, outside the commissures formed by the leaflets of the valve, a catheter including a piercing needle for the valve annulus;

piercing the valve annulus using said needle;

removing the needle and deploying, through the hole made by said needle, a guide member designed to be placed on the side of the valve opposite the catheter.

24. - Percutaneous operating method according to claim 23, characterized in that it comprises steps consisting of:

piercing said hole using a first catheter containing said needle;

introducing, after piercing said hole, a guidance wire through this hole;

leaving this guidance wire in place and removing said first catheter as well as the needle;

introducing a second catheter, containing the aforementioned guidance wire(s) and implant, one of the guide members being tubular and engaged on the guidance wire.

25. - Percutaneous operating method according to claim 24, characterized in that it comprises steps consisting of:

using a tubular guide member,

engaging this guide member on the guidance wire, and

using the guidance wire to guide the second catheter during introduction of this second catheter.

26. - Percutaneous operating method according to any of claims 16 to 25, characterized in that it comprises steps consisting of:

using a catheter comprising a guide member positioned such that it can be deployed on one side of the catheter diametrically opposite that on which another guide member is deployed.