Medtronic, Inc.

Michael E McIvor

Timothy G Laske

Kenneth C Gardeski

Pedro A Meregotte

Linda L Lach

Matthew David Bonner

Mary M Morris

Judith Betz

Mathew D Bonner

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.

Introducer system

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. In some embodiments of the invention, the introducer may be rendered splittable by provision of a weakened zone along its length. According to yet another aspect of the invention, the introducer may be provided with a luer lock at its proximal end to facilitate connection of the introducer to a hemostasis valve, t-fitting, or the like.

An introducer of the type employing an elongated introducer sleeve for receiving a catheter or lead body and an associated hemostasis clamp including a clamping member configured to engage the outer circumference of the introducer sleeve. The clamp is provided with a mechanism for maintaining the clamping member in engagement with said outer circumference of the sleeve to compress the outer circumference of the sleeve around a catheter or lead body inserted therethrough. In some embodiments the clamp takes the form of a hinged clamp provided with two jaws each having a recess adapted to engage a portion of the other circumference of the introducer sleeve. In other embodiments the clamp takes the form of interacting ramped members. The clamp is maintained in engagement with the sleeve either resiliently or by means of a latch.

Introducer with external hemostasis clip

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St. Petersburg, FL, United States of America

Michael E McIvor