Surgery – Instruments – Electrical application
Reexamination Certificate
1998-12-03
2001-04-03
Cohen, Lee (Department: 3739)
Surgery
Instruments
Electrical application
C600S374000, C600S393000, C604S095030, C607S122000
Reexamination Certificate
active
06210407
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a deflectable catheter, and particularly to an electrode catheter that is deflectable in two directions.
BACKGROUND OF THE INVENTION
Steerable or deflectable tip cardiovascular catheters are useful in many applications, being a marked improvement over catheters with fixed tips. They are especially useful in the field of electrophysiology for performing radio-frequency ablation of cardiac tissue to interrupt abnormal electrical pathways in the heart. Typically, ablation catheters carry one or more electrodes at their distal end. A steerable catheter assists the physician in guiding the distal end of the catheter so that the electrodes can be properly aligned with the tissue to be ablated.
There are presently several useful designs for steerable tip catheters. For example, U.S. Pat. No. RE 34,502, the disclosure of which is incorporated herein by reference, describes a catheter having a control handle comprising a housing having a piston chamber at its distal end. A piston is mounted in the piston chamber and is afforded lengthwise movement. The proximal end of the elongated, tubular catheter body is attached to the piston. A puller wire is attached to the housing and extends through the piston, through the catheter body and into an off-axis lumen in the catheter tip section. The distal end of the puller wire is anchored in the tip section of the catheter. In this arrangement, lengthwise movement of the piston relative to the housing results in deflection of the catheter tip section.
Bidirectional catheters have been designed to be deflectable in one direction by one puller wire and in the opposite direction within the same plane by a second puller wire. In such a construction, the puller wires extend into opposing off-axis lumens within the tip section of the catheter. So that the tip section can bend in both directions in the same plane, the puller wires and their associated lumens must be located along a diameter of the tip section. For ablation catheters, electrode lead wires must also be provided within the distal end. Typically, an additional lumen is used to contain the electrode lead wires. Difficulties have been encountered in designing a distal tip having a relatively small diameter, e.g., 6½ French or less, that contains three lumens where the two puller wire lumens are contained along a diameter. This is especially true where a stainless steel braided tip construction is used and where the braid circumscribes all the lumens.
SUMMARY OF THE INVENTION
The present invention provides a bidirectional electrode catheter which overcomes the drawbacks encountered with small diameter bidirectional catheters. The catheter comprises a pair of off-axis lumens along a diameter for receiving puller wires and wherein the electrode lead wires extend through one of the puller wire lumens. The lumen containing both the lead wire and the puller wire is diametrically opposed to the lumen containing the other puller wire, and preferably has a larger diameter than the other puller wire lumen.
In one embodiment, the invention is directed to a bi-directional catheter comprising an elongated catheter body, a tip section and a control handle. The body has proximal and distal ends and at least one lumen therethrough. The tip section, which is positioned at the distal end of the catheter body, has proximal and distal ends and at least two diametrically-opposed off-axis lumens. The first off-axis lumen is smaller than the second off-axis lumen.
The control handle, which is at the proximal end of the catheter body, comprises at least two moveable members longitudinally movable between first and second positions. First and second puller wires, each having proximal and distal ends, extend within the catheter body. The proximal end of each puller wire is connected to an associated movable member of the control handle. Each puller wire extends from the control handle through a lumen of the catheter body. The first puller wire extends into the first off-axis lumen in the tip section, and the second puller wire extends into the second off-axis lumen in the tip section. The distal end of each puller wire is anchored to the tip section. Proximal movement of one of the movable members relative to the catheter body results in proximal movement of the puller wire associated with that movable member relative to the catheter body, which results in deflection of the tip section in the direction of the lumen in which that puller wire extends.
An electrode is mounted on the tip section, which can be a tip electrode or a ring electrode. Preferably both a tip electrode and at least one ring electrode are mounted on the tip section. A lead wire is provided for each electrode, with the distal end of the lead wire being electrically connected to its associated electrode. Each lead wire extends through the second lumen in the tip section, through a lumen in the catheter body, into the control handle, and to a connector.
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Christie Parker & Hale LLP
Cohen Lee
Cordis Webster, Inc.
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