Closure devices, related delivery methods and tools, and related methods of use
A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.
1. A method of sealing a passageway in the heart, the passageway having a first opening at a first end thereof and a second opening at a second end thereof, the passageway defining a path from the first end to the second end, a flap of body tissue being located proximate the first end of the passageway, the method comprising:
passing a first anchor through the passageway from the second end to the first end;
positioning the first anchor proximate the first end of the passageway, the first anchor having an elongate member connected thereto, the elongate member extending within the passageway from the first end to the second end such that a longitudinal axis of the elongate member extends along the path; and
manipulating the first anchor to secure the flap of body tissue in a position such that the flap of body tissue covers the first opening.
2. The method of claim 1 , wherein the passageway is a patent foramen ovale, the flap of body tissue being a septum primum, and the passageway being defined through a septum secundum.
3. The method of claim 1 , wherein the path is non-linear, the elongate member being sufficiently flexible to conform to the non-linear path of the passageway.
4. The method of claim 1 , wherein manipulating the first anchor comprises pulling proximally on the elongate member to seat the first anchor against the flap of body tissue and to bring the flap of body tissue into sealing contact with heart tissue surrounding the first opening.
5. The method of claim 4 , wherein, when the flap of body tissue is in sealing contact with the heart tissue surrounding the first opening, the first anchor is positioned in substantial apposition to a distal surface of the flap of body tissue and to a distal surface of the heart tissue surrounding the first opening.
6. The method of claim 1 , wherein positioning the first anchor proximate the first end of the passageway comprises advancing the first anchor out of a distal end of a catheter.
7. The method of claim 6 , further comprising expanding the first anchor from a collapsed state to a deployed state.
8. The method of claim 6 , wherein the catheter extends through the passageway when the first anchor is advanced out of the distal end.
9. The method of claim 8 , further comprising withdrawing the catheter through the passageway.
10. The method of claim 1 , wherein the first anchor includes a plurality of arms extending outwardly from a central hub.
11. The method of claim 10 , wherein the first anchor does not include a cover structure spanning between the plurality of arms.
12. The method of claim 1 , further comprising advancing a second anchor along the elongate member to a position proximate the second end of the passageway.
13. The method of claim 12 , wherein the elongate member passes through the second anchor.
14. The method of claim 12 , wherein advancing the second anchor along the elongate member comprises advancing the second anchor out of a distal end of a catheter.
15. The method of claim 14 , further comprising expanding the second anchor from a collapsed state to a deployed state.
16. The method of claim 12 , further comprising sealingly covering the second opening with the second anchor.
17. The method of claim 16 , wherein the second anchor includes a plurality of arms extending outwardly from a central hub.
18. The method of claim 17 , wherein the second anchor includes a covering that spans between the plurality of arms of the second anchor.
19. The method of claim 12 , further comprising severing the elongate member adjacent the second anchor.
20. The method of claim 12 , further comprising securing the position of the second anchor along the elongate member with a locking element.
21. A method of closing a patent foramen ovale, the method comprising:
positioning a first anchor in a left atrium of a heart, the first anchor being connected to a tether extending coaxially within the foramen ovale from the left atrium to a right atrium of the heart; and
applying tension to the tether such that the first anchor brings a septum primum into sealing contact with a septum secundum.
22. The method of claim 21 , wherein, when the septum primum is in sealing contact with the septum secundum, the first anchor is positioned in substantial apposition to a left atrial surface of the septum primum and to a left atrial surface of the septum secundum.
23. The method of claim 21 , wherein the first anchor includes a plurality of arms extending outwardly from a central hub.
24. The method of claim 21 , further comprising advancing a second anchor along the tether within the right atrium to a position in contact with the septum secundum.
25. The method of claim 24 , wherein the second anchor seals an opening of the foramen ovale through the septum secundum.
26. The method of claim 25 , wherein the second anchor includes a plurality of arms extending outwardly from a central hub, the second anchor including a covering that spans between the plurality of arms of the second anchor.
27. The method of claim 24 , further comprising securing the position of the second anchor along the tether with a locking element.
28. The method of claim 27 , further comprising severing the tether adjacent the second anchor.