Surgery – Instruments
Reexamination Certificate
2000-04-07
2003-03-18
Milano, Michael J. (Department: 3731)
Surgery
Instruments
C600S585000, C279S042000, C128S126100, C081S487000
Reexamination Certificate
active
06533772
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to catheter guide wires, and particularly to a device for feeding, holding and controlling a catheter guide wire during a medical procedure.
There are many operations or procedures made possible by using catheter-based intravascular methods which are less invasive than traditional surgery or which were not possible previously. Typical percutaneous intravascular procedures include percutaneous transluninal coronary angioplasty (PTCA), directional coronary atherectomy (DCA), angiography, angioplasty, stenting, and embolization procedures. Catheter-based methods also have demonstrated utility in other procedures including gastrointestinal and genitourinary.
In an intravascular procedure of this kind, a guide wire followed by a catheter (a small diameter, thin wall flexible tube) is inserted through a small hole made in the femoral artery in the groin area, is slowly fed through the femoral artery hole and then is slowly and tediously maneuvered through the vascular system to an operating site. In moving toward the site, the guide wire is often steered around sharp corners and through small openings. The steering is most often done by using a guide wire with a bend at the tip and by rotating the wire (torqueing) and feeding the wire forward, as it is carefully maneuvered into position.
Steering a guide wire is made more difficult because visibility of the wire within the vascular system is achieved by viewing a fluoroscope on a video screen. Visualization of the vessels and the wire often happens only for a couple of seconds at a time and appears as a two dimensional image. The person manipulating the guide wire into position must pay careful attention to the video screen and must avoid distraction by shifting attention to their hands, which are maneuvering the wire.
A new development called “Glidewire” provides a guide wire with a very slippery hydrophilic coating allowing the wire to slide through a vessel without damage. This slippery coating requires the need for a torque device to grip the wire for precise feeding and torqueing.
The constant feeding, maneuvering, positioning and repositioning of the guide wire throughout the operation requires constant gripping and ungripping of the wire in a torque device while trying to maintain the wire's position within the vascular system. This is a difficult and tedious job often requiring the retracing of the wire around tight corners or into tiny vessels after it has slipped out of position when the wire is jerked by adjusting the torque device.
In addition, positioning and repositioning of the guide wire and catheter often requires quick removal and reinsertion of the guide wire into the catheter and torque device several times during an operation. Presently, this a tedious and time consuming job. Often, the bend at the end tip of the guide wire gets hung-up as it is being feed into present torque devices, as it is fed through such torque devices, and as the wire is being fed into a catheter.
Existing guide wire torque device technology is broken down into two commonly used guide wire torque devices: a traditional collet design, and a newer one-handed slide wedge lock design.
Traditional collet design devices comprise a small tube having an outside diameter of about ¼ inch and a length of 1 to 1¼ inches. One end of the tube has four fingers formed in the tube wall which flex radially and which are covered by a larger diameter screw cap having an inner angled cam surface for moving the fingers radially. In use, the guide wire is fed through the center of the tube and end fingers. By tightening the screw cap onto the tube, the cap cams the fingers inward to clamp the wire in the same manner as a collet of a machine tool. In order to grip and ungrip the guide wire, the screw cap must be tightened and loosened. Manipulation of the wire is a three hand task: one hand must hold the wire in place while a second hand holds the collet torque device in place, and a third hand loosens and tightens the screw cap. So, two people are needed to operate an awkward device which is wasteful.
A newer one-handed device on the market is made by Cook, Inc. The Cook device is a large bulky design (3½ inches long by almost 1 inch wide) that operates the gripping mechanism by means of linear slide of a button along the axis of the device. The linear slide travels along an interior track angled relative to the axis of the guide wire. In use, the slide is pushed along the angled track gradually closing the guide wire opening and wedging the guide wire against an opposite wall thereby gripping the wire and holding it in place. This wedging action often causes doctors to complain that the device is jammed or will not release the wire. Often, doctors believe they are ungripping or releasing the wire when in fact they are actually tightening the grip on the wire. Another complaint with the linear slide lock arises from the back and forth jerking motion which often causes the guide wire tip to be shifted or dislodged inside a vessel. Another problem with this device is the difficulty in feeding a guide wire through the device without being hung-up in openings or on sharp corners. In practice, the device which is claimed to be one-handed, actually requires two hands: one to hold the wire in position and another to operate the device.
A guide wire introducer tube is now commonly used to deal with the problem of introducing the curved tip of a guide wire into a catheter tube. The introducer tube is a separate device that is used many times in a single operation. Each time it is used, the tube must be strung onto the guide wire and after starting the wire into a catheter tube, the introducer tube must be worked backward over the guide wire and removed from the trailing or opposite end of the wire.
There has been tremendous growth in the number of catheter-based operating procedures creating a need for improved instrumentation to make each aspect of such operations faster, less tedious for the physician, and safer for the patient. There is common need for accurate feeding, holding and controlling a catheter guide wire. There is need for accurate control when a catheter guide wire is being carefully maneuvered through vessels using conventional wire gripping devices that are awkward and require three hands for operation. Gripping and ungripping a guide wire using the present technology is not a smooth action and the wire tends to be dislodged from a vessel or lose position. When this happens it is a great inconvenience, wastes time, and is a danger to the patient while the physician must tediously steer the wire back into position.
Hydrophilic coatings make guide wires very slippery requiring high gripping forces to hold a wire, and also requiring sufficient mechanical advantage to rotate a wire.
SUMMARY OF THE INVENTION
The present invention provides a simple, inexpensive and disposable guide wire torque device as a solution to the difficulties encountered in practice with conventional devices. A device according to the invention securely holds and controls a catheter guide wire with one hand and with smooth operation. The device is simpler, faster to load and adjust, faster to grip and ungrip, safer for the patient, and free of jerking wire movements during catheter-based operating procedures.
A preferred embodiment of the invention comprises an elongate tubular body with interior long axial channel and a rotary clamp wheel for gripping and ungripping a guide wire extending through the channel. The clamp wheel is accommodated within an integral enlargement of the tubular body with a segment of the wheel surface extending through the surface of the enlargement for rotation by a user's thumb in order to grip and ungrip a guide wire extending through the interior channel.
The clamp wheel is mounted for rotation on an axis normal to the long axial channel. The wheel is fitted with an eccentric cam in registry with the axial channel to grip and ungrip a guide wire as the wheel rotates.
McClellan Bruce
Sherts Charles R
Innex Corporation
Milano Michael J.
Roberts Paul A
Walsh Patrick J.
LandOfFree
Guide wire torque device does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Guide wire torque device, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Guide wire torque device will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3045950