Patent foramen ovale closure method
View Patent ↗The present invention relates to devices for closing a passageway in a body, for example a patent foramen ovale (PFO) in a heart, and related methods of using such closure devices for closing the passageway. The method includes introducing a mechanical closure device into an atrium of the heart and transeptally deploying the closure device across the interatrial septum to provide proximation of the septum secundum and septum primum.
1. A method to facilitate closure of a PFO in a heart, the heart having an interatrial septum comprised of a septum primum and a septum secundum between a first atrium and a second atrium, the method comprising:
introducing a mechanical closure device into the first atrium of the heart, the closure device having a proximal end portion and a distal end portion, and further comprising a flexible closure line coupled to a proximal expandable anchor and a distal expandable anchor, the proximal and distal expandable anchors each having a plurality of longitudinally oriented legs attached between proximal and distal end rings, the proximal and distal end rings being held in a longitudinally extended constrained position by a constraining force;
penetrating only the septum primum or the septum secundum from the first atrium to the second atrium in the heart at a first location along the interatrial septum so that at least the distal end portion of the closure device is located in the second atrium;
deploying the distal expandable anchor associated with the closure device into the second atrium by distally advancing a catheter to push against a back portion of the distal expandable anchor to distally advance the distal expandable anchor and releasing the constraining force, allowing the legs of the distal expandable anchor to expand radially outward, causing the proximal and distal end rings of the distal expandable anchor to move longitudinally inward towards one another;
partially withdrawing the closure device from the second atrium to the first atrium;
deploying the proximal expandable anchor associated with the closure device into the first atrium by distally advancing a plunger within the catheter to push and distally advance the proximal expandable anchor and releasing the constraining force, allowing the legs of the proximal expandable anchor to expand radially outward, causing the proximal and distal end rings of the proximal expandable anchor to move longitudinally inward towards one another; and
radially expanding the proximal and distal expandable anchors into a flat shape by tensioning the closure line.
2. The method of claim 1 wherein introducing the mechanical closure device into an atrium of the heart comprises a minimally invasive procedure.
3. The method of claim 2 wherein the minimally invasive procedure is a percutaneous procedure.
4. The method of claim 1 wherein penetrating the interatrial septum comprises piercing the interatrial septum.
5. The method of claim 1 wherein penetrating the interatrial septum comprises non-core cutting of the interatrial septum.
6. The method of claim 1 further comprising adjusting the proximal anchor relative to the distal anchor to enhance proximation.
7. The method of claim 6 wherein adjusting the proximal anchor comprises uni-axially adjusting the proximal anchor relative to the closure line associated with the closure device.
8. The method of claim 7 wherein uni-axially adjusting the proximal anchor comprises incrementally adjusting the proximal anchor relative to the closure line associated with the closure device.
9. The method of claim 1 further comprising assessing the degree of proximation between the septum secundum and septum primum.
10. The method of claim 1 further comprising releasing the closure device from a delivery device.