Abstract: An introducer or guide catheter for directing an implantable medical device such as a lead or catheter to a desired location within a patient's body. In one embodiment of the invention, the introducer comprises a two-lumen tube. A first lumen is configured to receive the implantable medical device that is to be introduced. A second lumen is provided to receive an insertable, elongated guiding member such as a stylet, which may be shapable in various orientations, and which may be used to alter the configuration of the introducer. The second lumen may be provided with an internal coil or other tubular reinforcement member to prevent perforation of this lumen by the guiding member when the introducer is in the patient's body. In order to facilitate removal of the introducer over an implantable medical device having a connector or fitting that is larger than the internal diameter of the first lumen, the introducer may be adapted to be slit or split along its length.

Abstract: An introducer system for introducing a lead or catheter and a method of use. The introducer system includes an elongated introducer sheath which has a luer hub mounted to its proximal end through which a lead or catheter is introduced and a slitter for slitting the luer hub and the introducer sheath. The slittable luer hub takes the form of a conical or cylindrical member carrying a laterally extending tab adapted to engage internal threading on a female luer lock fitting and has a slittable portion angularly displaced from the tab. The slitter includes a blade, a handle carrying the blade, a mechanism for engaging the lead or catheter in the vicinity of the blade and a mechanism for engaging the lead or catheter proximal to the blade, configured such that the lead or catheter body when engaged by the slitter is angled proximal to the blade of the slitter.

Abstract: A deflectable stylet or guidewire formed of an elongated tube having a coil mounted to its distal end and a movable tension or push wire mounted within the coil and the tube, mechanically coupled to the distal end of the coil. A backbone is located within the coil, mechanically coupled to the proximal and distal ends of the coil and extending along one side of the coil. The backbone may be provided with projections extending laterally between adjacent turns of the coil and may have a generally arcuate cross section having a width greater than its arc height. In some embodiments the backbone may be formed from a tube having a slot extending longitudinally along one side thereof. In some embodiments the backbone may be attached to the coil at points between the proximal and distal ends of the coil.

Abstract: An apparatus for deflecting a catheter or lead, for example a deflectable stylet or guidewire. The device includes an outer tubular member, a tension member mounted within the outer tubular member and coupled to the outer member and a handle mounted at the proximal end of the tubular member. The handle includes a major handle portion which has a rotatable knob located at its distal end, surrounding a proximal portion of the outer tubular member and provided with inwardly directed threading and an inner slider member provided with outwardly directed threading engaging the inwardly directed threading of the knob. The slider is advanced or retracted longitudinally within the handle by rotation of the knob but is rotationally fixed with regard to the major handle portion.