Surgery – Diagnostic testing – Flexible catheter guide
Reexamination Certificate
2000-06-20
2002-12-17
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Flexible catheter guide
C604S523000
Reexamination Certificate
active
06494846
ABSTRACT:
TECHNICAL FIELD
The present invention pertains generally to medical equipment and, more particularly, to a dual mode catheter system and method for using same appropriate for use in percutaneous coronary intervention. The present invention pertains more specifically still to a dual mode catheter combining the abilities of an over-the-wire catheter with the abilities of a MONORAIL (trademark) catheter for use in percutaneous coronary intervention whereby a dual-lumen catheter can be used for delivery of drugs, contrast fluids, and other desired elements through a lumen adapted to further be used for over-the-wire use while simultaneously having a second lumen adapted for use by a shorter wire.
BACKGROUND ART
Percutaneous transluminal coronary angioplasty (PTCA) is a procedure which is well established for the treatment of blockages in the coronary arteries. For example, blockages may occur from cholesterol precipitation on the coronary wall which may be in any stage from initial deposit through aged lesions. PTCA is a technique performed through the skin (percutaneous) inside an artery (transluminal) of the heart (coronary), for example to reshape (angioplasty) that artery. Percutaneous transluminal angioplasty (PTA) is also a known treatment of other types of blocked body lumens.
In general, catheters are used to advance a medical device, such as a balloon or stent, or medical fluid, such as a drug or a contrast fluid, into an artery of a patient to accomplish a desired task inside the artery. For example, in many of today's surgical procedures, medical devices such as catheter mounted angioplasty balloons, incisors, stents and artherectomy cutters are routinely introduced into patients' cardiovascular systems in accordance with prescribed protocols.
One commonly used apparatus for introducing these medical devices is a guide wire. Typically, whenever a guide wire is used for the purpose of introducing a medical device into the cardiovascular system of a patient, the guide wire is pre-positioned in situ, usually through an introducer catheter which is used to establish an access site into the patient's cardiovascular system. In a typical operation, the guide wire is positioned within an artery or other vessel. As the catheter is advanced over the guide wire, a proximal end of the guide wire will remain outside or emerge from a side wall aperture such that the proximal portion of the guide wire remains outside of the catheter as the catheter is advanced to its desired operative site. If it becomes necessary or desirable to exchange a device such as with a balloon dilation catheter, the proximally exposed portion of the guide wire can be secured and stabilized manually by an operator while the first catheter is removed and a second catheter is slid over guide wire.
The most widely used form of percutaneous angioplasty makes use of a dilatation balloon catheter. In typical PTCA or PTA procedures, the cardiovascular system of a patient is accessed with an introducer, usually via the femoral artery, brachial artery, or radial artery. All other devices including a guiding catheter are percutaneously introduced into the cardiovascular system of a patient through the introducer and advanced through a vessel until the distal end thereof is at a desired location in the vasculature. A guide wire and a medical device are introduced through the guiding catheter with the guide wire sliding through the dilatation catheter. The guide wire is first advanced out of the guiding catheter into the patient's coronary vasculature and the requisite device such as a dilatation catheter is advanced over the previously advanced guide wire until the device is properly positioned and the desired procedure is then performed.
At present, two general types of catheters are utilized in clinical practice such as in percutaneous coronary intervention: so-called “over-the-wire” catheters using full length guide wires and “monorail” catheters using shorter guide wires than the over-the-wire catheters. MONORAIL is a trademark of SciMed Life Systems, Inc., One SciMed Place, Maple Grove, Minn., United States of America 55311. Each of these catheter systems has advantages as well as disadvantages. The dual mode catheter of the present invention combines an over-the-wire catheter with a monorail catheter to allow simultaneous use of and switching between the MONORAIL (trademark) and over-the-wire catheters in situ, for example to manipulate stents, balloons, other medical devices, or combinations thereof.
A wide variety of catheters have been developed in the prior art. For example, U.S. Pat. No. 5,776,111 issued to Tesio teaches a multiple catheter assembly having two single catheters each having multiple lumen. Tesio '111 also discusses other typical examples of a multiple lumen catheters such as a dual lumen catheter, commonly known as Tesio catheters, in which one lumen in the catheter tube introduces fluids and the other lumen in the tube removes fluids. Tesio '111 does not teach or suggest having over-the-wire and MONORAIL (trademark) capabilities simultaneously present in a single catheter. In the prior art, such a delivery tube is incapable of supporting a guide wire.
The present invention allows greater control of the medical devices and the catheter by a single physician while simultaneously allowing distal injection of individual components such as iodinated contrast fluids or drugs. Other advantages will be apparent to those of ordinary skill in the medical arts such as reducing necessary exposure to radiation for both doctor and patient.
Over-the-wire catheters incorporate a guide wire lumen extending substantially through the entire length of the catheter. The guide wire lumen is typically separate from catheter mounted devices such as balloons, stents, and the like.
After positioning the guide wire, the catheter mounted medical device is then subsequently advanced through a guiding catheter and over the guide wire. During the advancement of the catheter over the wire, however, it is extremely important for the physician to maintain positive control over both the stability of the guide wire and the advancement of the catheter. Further, it is important that the means for controlling the stability of the guide wire and the means for controlling the advancement of the catheter be relatively close to each other and relatively near the introductory access site into the patient.
An over-the-wire catheter may be used with numerous devices such as stents, balloons, and the like, and also allows distal injections of iodinated contrast fluids and drugs. Further, over-the-wire catheter may be advanced, the guide wire exchanged, and/or a wire tip reshaped without losing ground in situ such as within a coronary artery. However, the long guide wire used in over-the-wire catheters can be difficult to steer when attempting to accurately position the stents, balloons, and the like. Further, advancing such medical devices around, through, or across a coronary obstruction is not easily performable by a single operator.
One solution to the control problem for an over-the-wire catheter is to provide a guide wire of sufficient length so that any extracorporeal portion of the guide wire is longer than the catheter that is being introduced over the wire. Typically, over-the-wire systems incorporate a three hundred centimeter length guide wire. This, however, can be cumbersome and may require manipulation of the system at a substantial distance from introductory access site. A solution to this problem has been the use of so-called MONORAIL (trademark) catheters.
In a MONORAIL (trademark) style of angioplasty catheter, a guide wire lumen extends through only a distal portion of the catheter, typically from a distal tip orifice to a proximal aperture formed in the side wall of the catheter body. The MONORAIL (trademark) catheters in use today have a relatively short guide wire deployed near the distal tip of the catheter so that the guide wire can be separated from the catheter. Typically, MONORAIL (
Shaver Kevin
The Matthews Firm
Wayne Margolis Family Partnership, Ltd.
Wingood Pamela
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