Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2000-10-05
2003-11-18
Casler, Brian L. (Department: 3763)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C604S030000, C604S246000
Reexamination Certificate
active
06650929
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a contrast media injection apparatus used in angiography or the like.
2. Description of the Prior Art
In recent years in the field of treatment of circulatory system diseases, radiography has come to be widely used for treatment under fluoroscopy as well as for simple diagnosis. The treatment under fluoroscopy includes, for example, (1) a treatment which comprises inserting a catheter into a patient with the disease part of the patient being confirmed by radiography, and injecting a thrombolytic substance to the thrombus-occluded site of vessel to reopen the vessel site and (2) a treatment which comprises inserting a catheter having a balloon at the front end, to the stricture site of vessel and allowing the balloon to expand to widen the stricture site.
In a treatment in which the thrombus generated in coronary artery is dissolved, a catheter is inserted as deep as the occluded site of coronary artery and a thrombolytic agent is spouted from the front end of the catheter, as shown in, for example, FIG.
5
. Even under fluoroscopy, an image of a target vessel is not obtained when no contrast media is used; therefore, a contrast media is used for confirmation of occluded vessel site or for insertion of catheter to coronary artery. Further, for safety of the patient, insertion of catheter is conducted while checking the blood pressure of patient.
A manually operated triple three-way cock valve, such as shown in
FIG. 5
has heretofore been used for checking of blood pressure and injection of contrast media. An enlarged illustration of this triple three-way cock valve is shown in FIG.
6
. First, a physiological saline solution is introduced into a syringe by the suction of a syringe while the cocks are operated to allow the suction. Then, the introduced physiological saline solution is pushed out of the syringe to fill the solution up to the front end of a catheter. The three cocks are operated to close a line of physiological saline solution; a line connecting to a pressure monitor is opened; and the catheter is inserted with the blood pressure of patient being monitored. When a contrast media is injected, the line connecting to a pressure monitor is closed (the line of physiological saline solution is also closed), the contrast media is filled in the syringe in a required amount by the suction of the syringe, and then the piston of the syringe is pushed to inject the contrast media from the front end of the catheter into the target site of vessel. Since the contrast media is a viscous liquid, a considerable pressure is needed for injection of the contrast media. An injection apparatus capable of conducting syringe operation mechanically has recently been developed, whereby use of a finer catheter has become possible. Nevertheless, the pressure required for injection has become as high as, for example, about 1,000 psi. Meanwhile, as the pressure monitor used for measurement of blood pressure, a small pressure transducer resistant to a pressure of about 400 mmHg is generally used; therefore, it ruptures easily when a high pressure is applied thereto. Hence, the above-mentioned switching of cocks has been requisite.
The switching of the triple three-way cock valve has been conducted manually, which has necessitated the presence of an operator and a patient in the same radiation room and has posed, to the operator, a problem of exposure to radiation.
Further, an error in timing of the switching of cocks has led to the breakage of the pressure transducer. Particularly in Coronary artery having many branches, imaging is conducted for each branch by moving the catheter and, therefore, injection of contrast media is generally repeated about 10 times. During this period, the catheter inside is flushed with a physiological saline solution to prevent the coagulation of blood inside the catheter or the like. To conduct the injection and cutoff of contrast media, the flushing with physiological saline solution, etc. a plurality of times in correct timings has needed care and labor.
SUMMARY OF THE INVENTION
The present invention has been made in view of the above-mentioned problems of the prior art and the objective thereof is to provide a contrast media injection apparatus capable of conducting the monitoring of blood pressure and the injection of contrast media under no radiation exposure. The present invention also aims at providing a contrast media injection apparatus capable of conducting the injection of contrast media simply without requiring the complex operation of cock switching.
The present invention is directed to a contrast media injection apparatus comprising:
a manifold having a port for connection of catheter, a port for connection of contrast media line, a port for connection of pressure-monitoring line and a port for connection of physiological saline solution line,
a pressure-monitoring line connected to the port for connection of pressure-monitoring line and having a cutoff mechanism in the middle,
a contrast media line connected to the port for connection of contrast media line, and
a contrast media injector connected to the back end of the contrast media line.
The contrast media injector is preferably an injector having a T-shaped one-way valve, a syringe and a syringe piston driving mechanism.
The cutoff means is preferably a two-way cock and preferably has a means for rotating the two-way cock.
In the present invention, it is preferred that the two-way cock is in an open state so as to enable monitoring of blood pressure, when no injection of contrast media is made and that the syringe piston driving mechanism and the means for rotating the two-way cock are driven synchronously so that the two-way cock is placed in a closed state before the piston of the syringe is moved forward and the injection of contrast media is started.
Another aspect of the present invention is further directed to a manifold having a port for connection of catheter, a port for connection of contrast media line, a port for connection of pressure-monitoring line and a port for connection of physiological saline solution line. This manifold is preferably used in the above-mentioned contrast media injection apparatus.
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Mizoguchi Kazuaki
Nemoto Shigeru
Saito Taro
Knobbe Martens Olson & Bear LLP
Nemoto Kyorindo Co., Ltd.
Sirmons Kevin C.
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