Closure devices, related delivery methods and tools, and related methods of use
View Patent ↗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 delivering a closure device to a patent foramen ovale in a heart, comprising:
advancing a catheter into the right atrium of the heart;
advancing the catheter through the patent foramen ovale into the left atrium of the heart;
deploying a first anchor of the closure device in the left atrium;
withdrawing the catheter into the right atrium of the heart;
deploying a second anchor of the closure device in the right atrium, wherein deploying the second anchor includes deploying a flexible elongate member passing through the second anchor and having a first end connected to the first anchor; and
positioning the second anchor, wherein positioning the second anchor includes moving the second anchor along the flexible elongate member toward the septum secundum by advancing a positioning catheter connected to the second anchor, and wherein advancing the positioning catheter includes inflating a balloon in contact with a releasable fixation mechanism of the closure device.
2. The method of claim 1 , further comprising positioning the first anchor within the left atrium prior to deploying the second anchor.
3. The method of claim 2 , wherein positioning the first anchor includes pivoting the first anchor with respect to the flexible elongate member.
4. The method of claim 3 , wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum.
5. The method of claim 3 , wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum and the septum secundum.
6. The method of claim 3 , wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum and to bring the septum primum into sealing contact with the septum secundum.
7. The method of claim 3 , further including testing the effectiveness of the positioning of the first anchor prior to deploying the second anchor.
8. The method of claim 1 , wherein withdrawing the catheter into the right atrium of the heart includes deploying a flexible elongate member having a first end connected to the first anchor into the patent foramen ovale.
9. The method of claim 1 , wherein deploying the second anchor in the right atrium includes deploying the second anchor a substantial distance away from the septum secundum, such that the second anchor does not contact the septum secundum as it is deployed.
10. The method of claim 1 , wherein deploying the second anchor includes expanding the second anchor from a delivery configuration to a deployed configuration.
11. The method of claim 1 , further comprising positioning the second anchor.
12. The method of claim 1 , further comprising sealingly contacting the septum secundum with the second anchor.
13. The method of claim 12 , further comprising fixing the second anchor to the flexible elongate member subsequent to sealingly contacting the septum secundum.
14. The method of claim 13 , wherein fixing the second anchor includes deflating the balloon in contact with the releasable fixation mechanism of the closure device.
15. The method of claim 14 , wherein fixing the second anchor further includes piercing the flexible elongate member with at least one pin of the releasable fixation mechanism.
16. The method of claim 15 , further comprising severing the flexible elongate member adjacent the second anchor after fixing the second anchor to the flexible elongate member.