Medical electrical lead and introducer system
摘要:
A medical electrical lead and introducer system. The lead is a single pass, dual chamber lead, which features in one embodiment an atrial tine. The introducer system is particularly designed for introduction of single pass, dual chamber lead which has an atrial tine. The introducer system facilitates the introduction of a such lead into a patient's heart while safeguarding the tine from damage due to kinking during lead positioning. The lead is a single pass lead which features an atrial tine while the introducer system is particularly designed for introduction of a such lead into a patient's heart so as to safeguard the tine from damage due to kinking during lead positioning. The lead is designed so as to electrically couple both the atrium and the ventricular chambers of the heart. The lead generally features several lengths each having differing stiffness as well as a pre-formed bend. The lead also features a atrial tine having an electrode at the tip. Due to the relatively fragile as well as difficult to maneuver lead, an introducer system is also disclosed. The introducer system is particularly designed to introduce such a lead. In use a removable tubing split element surrounds the atrial tine area of the lead while it is disposed through the introducer sheath, the split element both blocks the tine from lateral movement and fills up the space between the lead body and the introducer, thereby preventing blood leakage through the introducer. The element also has a longitudinal split for receiving the atrial tine while holding it against transverse movement when the lead is being repositioned. After optimal positioning of the lead, the tubing split element is withdrawn, and then the introducer is withdrawn. The tubing split element is a generally cylindrical piece of TEFLON, here called a tube split element, or just a “tube split”, is positioned around the lead body in the atrial tine area. The tube split element has a thickness which substantially fills the radial gap between the smaller diameter lead body and the introducer inner cylindrical wall, and has a longitudinal separation, or split, which accommodates the atrial tine, thereby permitting the tine to extend longitudinally but not transversely. The tubing split element is preferably mounted on the lead at the time of lead assembly. It has a length sufficient to extend proximally out of the introducer so that it can be withdrawn, and has a longitudinal tear line whereby the element can be separated and removed from the lead after final positioning of the lead.
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