PATENT FORAMEN OVALE OCCLUDER WITH SUTURE BASED ANCHOR

摘要

Devices and methods are provided for closing a flap- or tunnel like anatomical aperture such as patent foramen ovale (PFO). The system 1 includes a sponge occluder 2 with integrated suture length distally 5 and proximally 8 which are used for guiding, advancement, and securing the occluder to the atrial septal tissue 17. According to an exemplary method, an integrated adapter 6 is used for docking the system device onto the wire track which was created from the venous access through the puncture site 171 of the tissue adjacent the PFO via the PFO 170, and traversed back through the same exit/entry site utilizing conventional transseptal catheter- and snare technique. Pulling back the tracking wire, the docked distal suture 5 follows the tracking pathway in reverse direction creating a suture looping via the PFO and puncture site and out of the body. The loop of the looped knot 9, which is integrated into the proximal suture length 8, is placed over the exteriorized distal suture length 5 and the system is advanced until the sponge occluder is positioned onto the right atrial side of the PFO. The loop knot is tightened providing an "adjustable" initial tying of the system to the tissue. Additional individual "stopper knots" are made externally and delivered by pusher catheter. Tying the knots is achieved by catheter- based tourniquet technique. Alternatively, the tying of the two ends of the suture looping is performed using an individually transportable "pledget loop knot unit". Free ends of the knotted sutures are cut off with a catheter- based cutter. Procedure is guided by ultrasound and fluoroscopy.