Multi-directional steerable catheters and control handles

Details Multi-directional steerable catheters and control handles Multi-directional steerable catheters and control handles

1999-03-22

2001-07-31

Kennedy, Sharon (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

Reexamination Certificate

active

06267746

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to multidirectional steerable catheters and to multidirectional control handles for use with the multidirectional steerable catheters.
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 elongated 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 a tip section at the distal end of 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 to form two different curves (e.g., deflect in more than one direction), 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 steerable catheters and novel control handles for use therewith. The catheter comprises a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough. A tip section comprising flexible tubing having proximal and distal ends and at least one lumen extending therethrough is fixedly attached at its proximal end to the distal end of the catheter body.
A 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 and a piston chamber and a piston having proximal and distal ends slidably mounted in the piston chamber of the housing. The distal end of the piston is fixedly attached to the proximal end of the catheter body. The piston is longitudinally movable between proximal and distal positions. A longitudinal groove having proximal and distal ends extends along a portion of the length of the piston. A puller wire anchor is slidably disposed within the longitudinal groove. A puller wire having proximal and distal ends extends from the control handle, through a lumen in the catheter body and into a lumen in the tip section. The proximal end of the puller wire is fixedly attached to the puller wire anchor in the control handle.
Means are provided for selectively causing deflection of the tip section in a select direction in response to proximal movement of the puller wire anchor relative to the catheter body. In one embodiment, the deflecting means comprises an off-axis lumen through which the puller wire extends and an anchor that anchors the puller wire to the side or distal end of the tip section or means for anchoring the puller wire to a tip electrode mounted at the distal end of the tip section. Another deflecting means is described in U.S. Pat. Nos. 5,336,182 and 5,364,351, the disclosures of which are incorporated herein by reference.
Means are also provided for blocking, preferably releasably blocking, distal movement of the puller wire anchor within the groove when the piston is moved distally. Preferably the prevention means comprises a set screw fixedly attached to the handle housing that extends radially inwardly into the longitudinal groove in the piston. When the piston is slid distally relative to the handle housing, the set screw prevents the puller wire anchor from moving distally with the piston.
In another embodiment, there is provided a multidirectional steerable catheter. The catheter comprises a catheter body having a tubular wall, proximal and distal ends, and at least one lumen extending therethrough. A tip section comprising flexible tubing having proximal and distal ends and at least one lumen extending therethrough it fixedly attached at its proximal end to the distal end of the catheter body.
A 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 and a piston chamber. A piston is slidably and rotatably mounted in the piston chamber of the housing. The distal end of the piston is fixedly attached to the proximal end of the catheter body. The piston is longitudinally movable between proximal and distal positions and rotatably movable between first and second positions.
Two longitudinal grooves having proximal and distal ends extends along a portion of the length of the piston. First and second puller wire anchors are each slidably disposed within a corresponding longitudinal groove. A circumferential groove preferably connects the distal ends of the longitudinal grooves. First and second puller wires having proximal and distal ends each extend from the control handle, through a lumen in the catheter body and into a lumen in the tip section. The proximal end of each puller wire is fixedly attached to a separate the puller wire anchor in the control handle.
A first means for causing deflection of the tip section to form a first curve in response to proximal movement of the first puller wire relative to the catheter body is provided. A second means for causing deflection of the tip section to form a second curve different from the first curve in response to proximal movement of the second puller wire relative to the catheter body is also provided. The first and second deflecting means can be any suitable means, such as those described above. Also provided is a means for selectively preventing distal movement of one of the first and second puller wire anchors when the piston is moved distally. A preferred means for selectively preventing distal movement of one of the first and second puller wire anchors comprises a set screw that extends radially inwardly from the handle housing into the circumferential groove. The piston can be rotated between first and second positions relative to the housing, resulting in movement of the circumferential groove relative to the set screw. When the piston is in its first position, the set screw is aligned with the first longitudinal groove, and, as the piston is moved distally relative to the handle housing, the set screw prevents distal movement of the puller wire anchor in the first longitudinal groove. Similarly, when the piston is in its second position, the set screw is aligned with the second longitudinal groove, and, as the piston is moved distally relative to the handle housing, the set screw prevents distal movement of the puller wire anchor in the second longitudinal groove.
By this design, the tip section can be deflected to form two different curves, and preferably be deflected in two opposite directions. However, simultaneous movement of the puller wires may be prevented by the releasable preventing means.


REFERENCES:
patent: Re. 34502 (1994-01-01), Webster, Jr.
patent: 4976688 (1990-12-01), Rosenblum
patent: 5228441 (1993-07-01), Lundquist
patent: 5656030 (1997-08-01), Hunjan et al.
patent: 5865800 (1999-02-01

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