Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-08-07
2001-01-09
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S528000, C604S022000
Reexamination Certificate
active
06171277
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to improved bidirectional steerable catheters, and more particularly to catheters having bidirectional control handles.
BACKGROUND OF THE INVENTION
Electrode catheters have been in common use in medical practice for many years. They are used to stimulate and map electrical activity in the heart and to ablate sites of aberrant electrical activity.
In use, the electrode catheter is inserted into a major vein or artery, e.g., femoral artery, and then guided into the chamber of the heart which is of concern. Within the heart, the ability to control the exact position and orientation of the catheter tip is critical and largely determines how useful the catheter is.
Steerable catheters are generally well-known. For example, U.S. Pat. No. RE 34,502 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 catheter body is attached to the piston. A puller wire is attached to the housing and extends through the piston and through the catheter body. 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.
The design described in RE 34,502 is generally limited to a catheter having a single puller wire. If a bidirectional catheter is desired, i.e., a catheter that can be deflected in more than one direction without rotating the catheter body, more than one puller wire becomes necessary. When two puller wires are used, however, it is undesirable for both wires to be moved simultaneously. The handle design disclosed in RE 34,502 is not suitable for a two puller wire system. Accordingly, a need exists for a control handle capable of independently moving each of two puller wires but preventing simultaneous movement of the puller wires.
SUMMARY OF THE INVENTION
The present invention provides a bidirectional steerable catheter that is particularly useful in ablation procedures. The catheter comprises a catheter body, a tip section, and a control handle. The catheter body has a tubular wall, proximal and distal ends, and at least one lumen extending therethrough. The tip section comprises flexible tubing having proximal and distal ends and at least one lumen extending therethrough. The proximal end of the tip section is fixedly attached to the distal end of the catheter body.
The control handle is mounted at its distal end to the proximal end of the catheter body. The control handle comprises a housing having proximal and distal ends. Rotatably mounted within the housing is a generally-circular spur gear having gear teeth about its outer circumference. A pair of spaced apart rack gears are slidably mounted longitudinally on diametrically opposed sides of the spur gear within the housing. Each rack gear has an interior edge generally facing the interior edge of the other rack gear and comprises gear teeth along its interior edge, which engage the gear teeth of the spur gear. Each rack gear is longitudinally movable between first and second positions. In this arrangement, proximal movement of one rack gear results in rotational movement of the spur gear, and correspondingly distal movement of the other rack gear.
Two puller wires extend from the control handle, through a lumen in the catheter body and into separate, preferably diametrically opposed, off axis lumens in the tip section. The distal end of each puller wire is fixedly attached to the tip section, and the proximal end of each puller wire is fixedly attached to a separate associated rack gear in the control handle. Proximal movement of a rack gear and its associated puller wire relative to the catheter body results in deflection of the tip section in the direction of the off axis lumen into which that puller wire extends.
Preferably a manually movable member is fixedly attached to one of the rack gears so that the movable member is accessible, at least in part, on the exterior of the handle housing. The user can thus move one of the rack gears by longitudinally sliding the manually movable member.
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Christie Parker & Hale LLP
Cordis Webster, Inc.
Hayes Michael J.
Kennedy Sharon
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