Abstract: Bilumen catheters and methods of using same for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrode positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber, and more particularly to a method and apparatus for introducing such a cardiac lead having low torqueability and pushability through a tortuous pathway to enable attachment of the cardiac lead at the implantation site employing a bilumen guide catheter are disclosed. The bilumen catheter body includes a relatively large diameter delivery lumen to introduce a small diameter cardiac lead and a small diameter guide lumen to receive a stylet or guidewire to locate the guide catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen.

Abstract: Bilumen catheters and methods of using same for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrode positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber, and more particularly to a method and apparatus for introducing such a cardiac lead having low torqueability and pushability through a tortuous pathway to enable attachment of the cardiac lead at the implantation site employing a bilumen guide catheter are disclosed. The bilumen catheter body includes a relatively large diameter delivery lumen to introduce a small diameter cardiac lead and a small diameter guide lumen to receive a stylet or guidewire to locate the guide catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen.

Abstract: An introducer is structured with an elongated tube having first and second lumens. A molded handle is coupled to the proximal end of the tube with an opening aligned with the first lumen. Further, a wall adjacent the opening of the handle defines a slot and is located diametrically opposite the second lumen. A tubular reinforcement member is located within the second lumen and the handle is provided with a second opening, thereby having a communication with the second lumen. In another embodiment a lead/catheter introducer includes an implantable lead or catheter having an elongated first lumen through which the lead or catheter passes and a second lumen extends parallel to the first lumen along at least a distal portion thereof. A tubular reinforcement member is disposed within the second lumen. The tubular reinforcement member further includes an internal lumen and a curvable stylet disposed in the lumen.

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: A medical electrical lead having a fixation helix which is surface treated along at least a portion to have a relatively high microscopic area along with a relatively low macroscopic area. In the preferred embodiment, such a surface treated portion is accomplished with a porous platinized construction. The surface treated portion further has a bioabsorbable coating in order to permit the helix to be inserted into the heart tissue without causing damage to the heart tissue through the engagement of the surface treated portion with heart tissue during insertion. In the preferred embodiment the bioabsorbable material is mannitol, although other bioabsorbable materials may also be used, such as a material which is no more than sparingly soluble in water, for example, the steroid beclomethasone dipropionate anhydrous. Through such a construction the helix may be inserted into tissue while the coating of absorbable materials provides a smooth surface between the surface treated portion of the helix and the tissue.

Abstract: A transvenous lead introducer having a mechanical valve assembly disposed thereon. In a preferred embodiment, a longitudinally splittable introducer sheath is provided with a sliding valve at or near one end. The sliding valve may be spring-biased to a normally closed position. A semicircular notch may be provided in the forward end of the sliding valve, so that the sheath may be effectively sealed even when a guide wire runs through the sheath. In an alternative embodiment, the sliding valve is adapted to have its forward end inserted into a notch in the cylindrical sheath body. The mechanical valve assembly is further configured to permit use with a splittable lead introducer sheath.