Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
2000-09-22
2003-08-26
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Means for inserting or removing conduit within body
C604S096010
Reexamination Certificate
active
06610068
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to medical devices used in combination with guide members. More specifically, the present invention relates to intravascular balloon dilatation catheters for use in combination with guide wires, and in particular, to those intravascular balloon dilatation catheters referred to as single-operator-exchange, rapid exchange or “monorail” catheters used in combination with guide wires. The inner surface of the catheter shaft which receives the guide member is filled with a lubricious material to eliminate the need for flushing the catheter device before surgical procedures. Those skilled in the art will recognize the benefits of applying the present invention to similar fields not discussed herein.
BACKGROUND OF THE INVENTION
Intravascular diseases are commonly treated by relatively non-invasive techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). These therapeutic techniques are well-known in the art and typically involve the use of a balloon catheter with a guide wire, possibly in combination with other intravascular devices such as a stent. A catheter may also be used with a self-expanding stent alone. A typical catheter system has an elongate shaft with a device such as a balloon and/or stent attached to the distal end and a manifold attached to the proximal end. In use, the catheter is advanced over the guide wire such that the device positioned adjacent a restriction in a diseased vessel. The balloon is then inflated or the stent released and the restriction in the vessel is opened.
In particular, a typical angioplasty procedure requires inserting at least a guide catheter and a dilatation catheter into the vascular system of a patient to open a stenosis within that vascular system. There are two basic types of catheters used in combination with a guide wire. One type is an over-the-wire catheter. The second type is a modification of the basic over-the-wire catheter and is referred to as a single-operator-exchange (SOE) catheter or rapid exchange catheter. The construction and use of both OTW catheters and SOE catheters are well-known in the art.
The standard over-the-wire catheter has an inner or guide wire lumen that extends from the distal end of the catheter to the proximal end of the catheter. A manifold is attached at the proximal end of the catheter to provide an attachment for fluid communication with the guide wire lumen.
A single operator exchange catheter (SOE catheter), is a variation of the over-the-wire catheter. SOE catheters are commonly referred to in the art as rapid exchange catheters or “monorail” catheters. SOE catheters have a guide wire lumen that only extends through a portion of the catheter. The guide wire lumen extends from the distal end of the catheter to a distal porthole on the catheter tube.
An example of an OTW catheter may be found in U.S. Pat. No. 5,047,045 assigned to SCIMED Life Systems, Inc. Examples of SOE balloon catheters are disclosed U.S. Pat. No. 5,156,594 and U.S. Pat. No. 5,549,552 both also assigned to SCIMED Life Systems, Inc.
The guide wire lumen is provided for standard over-the-wire catheters and for SOE catheters so that a guide wire can be used to establish a path through the vascular system to the stenosis of the patient. The use of the guide wire enables the catheter to be advanced through the blood vessel relatively quickly, thereby reducing the time required for the procedure.
A concern that arises during an angioplasty procedure occurs when the operator attempts to load the guide wire into the catheter while the guide wire is in the vascular system of the patient. Generally, the relative diameters of the guide wire and the guide wire lumen make it difficult for the operator to load the guide wire into the inner or guide wire lumen. Once again, this problem is magnified by the fact that the angioplasty procedure is generally performed in a darkened room.
Typically therefore, before placing the catheter over the guidewire, it is desirable to flush the guidewire lumen with a flushing solution, generally a saline solution, to eliminate contaminants and air in the guidewire receiving lumen, as well as to lubricate the inner surface so that the catheter can be slid over the guidewire more easily.
The flushing procedure for a standard over-the-wire catheter is relatively simple because a luer-fitting is attached to the manifold on the proximal end of the guide wire lumen. The operator can simply attach a standard syringe to the proximal end of the guide wire lumen and force flushing fluid through the lumen. The flushing procedure for an SOE catheter is more difficult to perform because there is no fitting on either end of the guide wire lumen to connect a syringe to the guide wire lumen.
The procedure used for flushing a “rapid exchange” or “monorail” catheter typically involves the use of a blunt needle connected to a syringe. An operator, such as a nurse, inserts the blunt needle into the distal opening of the guidewire receiving lumen and then forces flushing fluid from the syringe, through the needle, into the distal opening of the guidewire receiving lumen and then forces flushing fluid from the syringe, through the needle, and into and through the inner or guidewire receiving lumen of the catheter.
The guide wire lumen of an angioplasty catheter is generally very small in size. For example, an angioplasty dilatation catheter having a guide wire lumen with a diameter as small as 0.016 inches is common in the medical industry. Therefore, it is very difficult to insert a lumen flushing needle (which commonly has an outside diameter of 0.012 inches) within the guide wire lumen of such a catheter. This problem is magnified by the fact that an angioplasty procedure is generally performed in a darkened room, making it very difficult to see the guide wire lumen of the catheter and the needle.
This procedure also creates a situation that is inherently dangerous to the operator. It is extremely easy for the operator to accidently stick a finger while attempting to insert the needle into the lumen (“needle stick”). Such an accident exposes the operator to a potential inadvertent transfer of dangerous or fatal diseases.
Using a needle and syringe can therefore be quite cumbersome, potentially dangerous and costly because the needle can puncture the balloon or the catheter, rendering the balloon catheter inoperable and increasing the risk to the patient.
Additionally, for some angioplasty procedures, more than one dilatating catheter having different balloon sizes or configurations may be used in a single procedure, or multiple stents may be inserted if the blockage is at a branch in a vessel, for instance. Therefore, it is common for the operator to remove a catheter from the vascular system and set that catheter aside to be reinserted at a later time in the procedure.
Another concern arises when the operator attempts to reinsert the catheter into the vascular system. This relates to the fact that the inner or guide wire lumen of the catheter has now been in fluid communication with the vascular system of the patient. Therefore, blood and other tissues from the patient may have collected within the guide wire lumen of the catheter. Such blood and tissue may coagulate and block the guide wire lumen of the catheter when the catheter is removed from the vascular system. The coagulated tissue then makes the catheter inoperable, since it prevents the operator from effectively guiding the catheter over the guide wire. Accordingly, the operator must flush the inner lumen of the catheter after removing it from the patient if the operator wants to reinsert the catheter later during the procedure.
There are numerous other medical procedures in addition to angioplasty that require an operator to use a lumen flushing technique similar to that described above. For example, some tissue collection procedures present the need for removing tissues from a collection chamber to perform further pathological studies on the tissue.
Nguyen Victor
Sci-Med Life Systems, Inc.
Vidas Arrett & Steinkraus
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