Multi-directional steerable catheters and control handles

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Reexamination Certificate

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06183435

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, 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 a 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 has proximal and distal ends and is mounted at its distal end to the proximal end of the catheter body. The control handle comprises a housing and a piston assembly. The housing has proximal and distal ends and a piston chamber extending therethrough, the piston chamber having proximal and distal ends. The piston assembly has proximal and distal portions and is slidably mounted in the piston chamber of the housing and longitudinally movable between proximal and distal positions. The distal portion of the piston assembly is fixedly attached to the proximal end of the catheter body. The proximal portion of the piston assembly comprises a distal section, a proximal section and a circumferential recess between the proximal section and distal section. The distal section has proximal and distal ends and comprises a plurality of notches at its proximal end. The proximal section comprises a plurality of longitudinal grooves about its entire circumference separated by dividing walls having angled distal ends.
The piston assembly further comprises a ring having proximal and distal ends rotatably mounted on the piston assembly. The ring comprises a plurality of projections that extend radially inwardly into the circumferential recess and that are capable of being received by the longitudinal grooves. The number of projections is less than the number of longitudinal grooves. The ring further comprises a plurality of teeth at its distal end capable of being received by the notches.
First and second puller wire anchors are slidably disposed within a corresponding longitudinal groove. First and second puller wires having proximal and distal ends 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 puller wire anchor in the control handle.
First means is provided 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. Second means is provided 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. In one embodiment, the deflecting means comprise off-axis lumens through which the puller wires extends and anchors that anchor the puller wires to the sides or distal end of the tip section or means for anchoring the puller wires 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.
Distal movement of the piston relative to the handle housing results in a projection on the ring extending in one of the longitudinal grooves to thereby prevent longitudinal movement of the puller wire anchor in the groove relative to the handle housing. This causes deflection of the tip section in the direction of the lumen into which the puller wire connected to that anchor extends. Proximal movement of the piston relative to the handle housing causes rotation of the ring, thereby aligning that same projection with a different longitudinal groove to thereby prevent longitudinal movement of the puller wire anchor in the groove relative to the handle housing. This movement causes deflection of the tip section in the direction of the lumen into which the puller wire connected to that anchor extends.


REFERENCES:
patent: 4960134 (1990-10-01), Webster, Jr.
patent: 5462527 (1995-10-01), Stevens-Wright et al.
patent: 5465716 (1995-11-01), Avitall
patent: 5656030 (1997-08-01), Hunjun et al.
patent: 5865800 (1999-02-01), Mirarchi et al.
patent: 5906590 (1999-05-01), Hunjan et al.

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