Methods for implanting a valve prothesis

• US 8,747,460 B2
• Filed: 12/23/2011
• Issued: 06/10/2014
• Est. Priority Date: 09/19/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi, Kilemnik, Ido, Benary, Raphael
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/336,767
• Publication Number:
  US 20120101570A1
• Time in Patent Office: 900 Days
• Field of Search: None
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A method for implanting a valve prosthesis at a native cardiac valve complex of a subject comprises implanting a distal fixation member of the valve prosthesis downstream of a native valve of the native valve complex such that two or more engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first axial force directed upstream. The method also comprises implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second axial force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve complex. The engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

Claims

1. A method for implanting a valve prosthesis at a native valve of a subject, the method comprising:

implanting a distal fixation member of the valve prosthesis downstream of a native valve such that engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first force directed upstream, wherein the number of engagement arms matches the number of leaflets of the native valve; and

implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve,

wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween.

2. The method according to claim 1, wherein the distal fixation member and the proximal fixation member are fabricated as one integrated structure.

3. The method according to claim 1, wherein the proximal fixation member comprises a bulging skirt that applies the second force.

4. The method according to claim 1, wherein implanting the distal fixation member comprises positioning the engagement arms such that the engagement arms limit an extent of opening of leaflets of the native valve.

5. The method according to claim 1, wherein implanting the proximal and distal fixation members comprises:

collapsing the proximal and distal fixation members;

advancing the proximal and distal fixation members, while collapsed, upstream and downstream of the native valve, respectively; and

expanding the proximal and distal fixation members upstream and downstream of the valve, respectively.

6. The method according to claim 5, wherein expanding the distal fixation member comprises contacting tissue adjacent and surrounding an annulus of the native valve with the engagement arms.

7. The method according to claim 6, wherein the engagement arms contact a floor of a sinus of the native valve.

8. The method according to claim 5, wherein

advancing the proximal and distal fixation members comprises storing at least one of the proximal and distal fixation members while collapsed in at least one tube selected from the group consisting of an overtube, a catheter tube, and a trocar;

and

expanding the proximal and distal fixation members comprises deploying the at least one of the proximal and distal fixation members from the selected tube.

9. The method according to claim 8, wherein advancing the proximal and distal fixation members comprises advancing the selected tube using a transaortic approach, a transapical approach, a transarterial approach, or a transseptal approach.

10. The method according to claim 1, wherein the application of the first and second forces couples the prosthesis to the native valve by sandwiching the native valve from a downstream side and the upstream side thereof.

11. The method according to claim 1, wherein any radial force applied by the valve prosthesis outwardly against the native valve annulus is insufficient by itself to chronically maintain the valve prosthesis in position with respect to the native valve annulus under conditions of normal cardiac motion.

12. The method according to claim 1, wherein the valve prosthesis embraces, without squeezing, leaflets of the native valve.

13. The method according to claim 1, wherein implanting the distal and proximal fixation members comprises determining a correct rotational disposition of the valve prosthesis with respect to the native valve based on tactile feedback.

14. The method according to claim 13, wherein determining the correct rotational disposition of the valve prosthesis does not include using any imaging techniques.

15. The method according to claim 1, wherein the native valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

16. The method according to claim 1, wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

17. A method for implanting a valve prosthesis at a native valve of a subject comprising:

implanting a distal fixation member of the valve prosthesis downstream of a native valve such that engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first force directed upstream; and

implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve,

wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve;

wherein implanting the proximal and distal fixation members further comprises;

collapsing the proximal and distal fixation members; and

advancing the proximal and distal fixation members, while collapsed, upstream and downstream of the native valve, respectively;

wherein advancing the proximal and distal fixation members comprises storing at least one of the proximal and distal fixation members while collapsed in at least one tube selected from the group consisting of an overtube, a catheter tube, and a trocar;

wherein implanting the proximal and distal fixation members comprises deploying the at least one of the proximal and distal fixation members from the selected tube; and

wherein advancing the proximal and distal fixation members comprises inserting the selected tube through tissue of a heart of the subject, and advancing the selected tube through a chamber of the heart until a distal end of the selected rube passes the native valve.

18. The method according to claim 17, wherein advancing the proximal and distal fixation members comprises advancing the selected tube using a transaortic approach, a transapical approach, or a transseptal approach.

19. The method according to claim 17, wherein the native valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

20. The method according to claim 17, wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

21. The method according to claim 17, wherein inserting the selected tube through tissue of the heart of the subject comprises inserting the selected tube through an apex of the heart of the subject.

22. The method according to claim 17, wherein the number of engagement arms matches the number of leaflets of the native valve.

23. A method for implanting a valve prosthesis at a native valve of a subject comprising:

implanting a distal fixation member of the valve prosthesis downstream of a native valve such that engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first force directed upstream, wherein the number of engagement arms matches the number of leaflets of the native valve; and

implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve,

wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween; and

wherein implanting the distal and proximal fixation members comprises aligning the valve prosthesis with respect to the native valve by rotating the valve prosthesis.

24. The method according to claim 23, wherein rotating the valve prosthesis comprises moving the valve prosthesis in a proximal direction such that the engagement arms contact tissue adjacent and surrounding an annulus of the native valve complex causing the valve prosthesis to rotate.

25. The method according to claim 24 further comprising verifying that the prosthesis is properly aligned with respect to the native valve by attempting to rotate the prosthesis with respect to the native valve.

26. The method according to claim 23, wherein the native valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

27. The method according to claim 23, wherein the engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.