Patent foramen ovale closure method
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 between a first atrium and a second atrium, the interatrial septum having a septum primum and septum secundum, the method comprising:
introducing an elongated delivery member into the first atrium of the heart, the elongated delivery member having a proximal end and a distal end, and including a distal catheter having a proximal end portion and a distal end portion;
positioning the distal end of the elongated delivery member against the interatrial septum;
penetrating through the interatrial septum from the first atrium to the second atrium in the heart at a first location along the interatrial septum by extending a needle from the distal catheter and advancing the distal catheter so that at least the distal end portion of the distal catheter is located in the second atrium;
advancing a first elongated tubular member into the second atrium through the distal catheter, the first elongated tubular member defining a first lumen and being slideably engaged within the distal catheter, the first elongated tubular member having a mechanical closure device at least partially disposed within the distal portion of the first lumen, the mechanical closure device having a proximal end portion and a distal end portion and further comprising a flexible closure line coupled to proximal and distal expandable anchors each having a radially expandable portion comprising 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;
deploying the distal expandable anchor associated with the closure device into the second atrium by advancing the first elongated tubular member within the distal catheter, the first elongated tubular member pushing against a back portion of the radially expandable anchor portion of the distal expandable anchor until the distal expandable anchor is advanced from the distal end of the distal catheter, releasing the constraining force and allowing the legs of the distal expandable anchor to expand radially outward;
partially withdrawing the distal catheter and first elongated tubular member from the second atrium to the first atrium;
deploying the proximal expandable anchor associated with the closure device into the first atrium by advancing a second elongated tubular member within the delivery member, wherein the second elongated tubular member defines a second lumen and is positioned coaxially within the first elongated tubular member such that at least a portion of the closure device is disposed within the second lumen, releasing the constraining force and allowing the legs of the proximal expandable anchor to expand radially outward; 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 1 , wherein penetrating the interatrial septum comprises drilling through the interatrial septum.
4. The method of claim 1 , further comprising adjusting the proximal expandable anchor relative to the distal anchor to enhance proximation.
5. The method of claim 4 wherein adjusting the proximal expandable anchor comprises uni-axially adjusting the proximal expandable anchor relative to the closure line associated with the closure device.