Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-08-28
2001-02-06
Coggins, Wynn Wood (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S095030
Reexamination Certificate
active
06183463
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 U.S. Pat. No. 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 U.S. Pat. No. 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 is directed to a bidirectional steerable catheter. 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 a pair of off-axis lumens, preferably diametrically opposed off-axis lumens, 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. A distal piston is mounted in the distal end of the housing and fixedly attached to the proximal end of the catheter body. The distal piston is slidably movable relative to the housing. First and second proximal pistons are mounted in the housing proximal to the distal piston. Each of the proximal pistons is slidably movable relative to the housing. The control handle further comprises a movable member capable of selectively and releasably engaging one of the proximal pistons to prevent slidable movement of that engaged proximal piston relative to the housing while allowing slidable movement of the other non-engaged proximal piston relative to the housing so that proximal movement of the housing relative to the distal piston and catheter body results in proximal movement of the engaged proximal piston relative to the distal piston and catheter body.
The catheter further comprises a pair of puller wires having proximal and distal ends. Each puller wire extends from the control handle, through a lumen in the catheter body and into a separate off axis lumen 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 anchored to a separate associated proximal piston in the control handle.
In practice, proximal movement of the selectively engaged proximal piston 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 associated puller wire extends.
The moveable member can be any suitable member that can selectively engage one proximal piston to prevent movement of that piston while permitting longitudinal movement of the other piston. In one embodiment, the movable member comprises a manually moveable member extending transversely through the handle housing and moveable transversely between first and second positions. In its first position, the moveable member engages the first proximal piston to prevent longitudinal movement of that first proximal piston relative to the housing without preventing longitudinal movement of the second proximal piston relative to the housing. In its second position, the moveable member engages the second proximal piston to prevent longitudinal movement of that second proximal piston relative to the housing without preventing longitudinal movement of the first proximal piston relative to the housing.
In a particularly preferred embodiment, each proximal piston has a select diameter along its length and each comprises a circumferential notch section along its length having a reduced diameter less than the selected diameter. The moveable member comprises a generally dumbbell-shaped slot having a generally rectangular center section which has a width greater than the reduced diameter of the circumferential notch section, but less than the select diameter of the proximal pistons. The slot further comprising a generally circular section at each end of the center section, the diameter of each circular section being greater than the select diameter of the proximal pistons. When the moveable member is in its first position, the center section of the slot engages the circumferential notch section of the first proximal piston, preventing longitudinal movement of the first proximal piston relative to the handle housing, and the first of the generally circular sections is positioned to allow longitudinal movement of the second proximal piston therethrough. Similarly, when the moveable member is in its second position, the center section of the slot engages the circumferential notch section of the second proximal piston, preventing longitudinal movement of the second proximal piston relative to the handle housing, and the second of the generally circular sections is positioned to allow longitudinal movement of the first proximal piston therethrough.
In another embodiment, the movable member comprises a sleeve in surrounding relation to and rotatable around the distal piston between the housing and the distal piston whereby the proximal end of the sleeve can engage the distal ends of the first and second proximal pistons when they are in their proximal pistons to prevent distal movement of the proximal pistons. The sleeve comprises at least one, and preferably two, longitudinal slots at its proximal end. The sleeve can be rotated to align one of the slots to receive one proximal piston, thereby allowing longitudinal movement of that proximal piston while still engaging and prohibiting longitudinal movement of the other proximal piston. Distal movement of the distal piston results in distal movement of the catheter body relative to the handle body and the engaged proximal piston, causing deflection of the tip section in the direction of the puller wire anchored to the engaged proximal piston. The sleeve can be rotated so that a slot receives the previously engaged proximal piston thereby allowing longitudinal movement of that proximal piston while prohibiting longitudinal movement of the previously movable proximal piston. When the sleeve is rotated into this second position, distal movement of the distal piston results in distal movement of the catheter body relative to the handle body and newly engaged proximal piston, causing deflection of the tip section in the direction of the p
Christie Parker & Hale LLP
Coggins Wynn Wood
Cordis Webster, Inc.
Sadula Jennifer R.
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