The pigtail catheter was embedded in a flexible 5.5F sheath (length 90 cm for the femoral version, 80 cm for the jugular version) with a radiopaque tip marker. A y-fitting proximal to the sheath allowed adjustable tightening and sheath flushing with the catheter inserted (Fig 1, bottom).
The catheter-sheath system was used either with a 0.035-inch teflon-coated guide wire with movable core and curved tip (tip radius 1.5 mm, Cook TCMT) or with a 0.035-inch hydrophilically coated guide wire with curved tip (Cook Roadrunner PC). Both wires allowed either to exit the end hole or the oval side hole of the pigtail catheter under fluoroscopic control. End hole exit of the wire straightened the pigtail for catheter introduction, probing, and removal. Side hole exit of the wire was essential for embolus fragmentation (Fig 1, top). Since the embolic occlusion of the pulmonary artery was passed with the wire, it worked as a fixed, central axis Source canadian pharmacy mall. The pigtail catheter was rotated bimanually within the fixed sheath and over the wire axis by twisting a rough shrink tube at the very proximal end of the catheter between thumb and index finger (Fig 1, bottom). The sheath reduced friction during rotation and stabilized the access route. The rotating pigtail may be advanced or withdrawn over the wire as a guide rail as often as necessary for fragmentation of the embolus.
Study Design and Selection of Patients
This study was conducted as an open, noncomparative, prospective trial in three German centers, according to the European Standard for Clinical Investigation of Medical Devices EN 54018 and under observation of the Declaration of Helsinki II (sponsor: William Cook Europe A/S, Denmark). Approval was obtained from the local university ethics committee for each center and from an EN540-certified European institutional review board. The local government (notified body) responsible for each center was informed.
Figure 1. Besides the two standard functions of a pigtail catheter (1, wire exiting the end hole and tip straightened for introduction and placement; 2, wire removed and pigtail recoiled for contrast injection), this special catheter is able to maintain a third tip configuration for embolus fragmentation: the wire is exiting the oval side hole proximal to the pigtail tip and serves as a directing axis crossing the embolic occlusion. The catheter shaft is rotated manually, and the embolus is fragmented by mechanical action of the recoiled pigtail. During rotation, the pigtail is slowly advanced and withdrawn over the stationary guide wire within the embolic occlusion. Top: pigtail rotation catheter (5F) with the wire leaving the oval side hole (long arrow). Tip of the 5.5F sheath (short arrow). Bottom: proximal end of the catheter system: a rough shrink tube allows bimanual rotation of the catheter shaft. Hemostasis valve of the sheath (arrow) with side port for flushing.