Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-11-10
2001-11-13
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S183000, C604S535000
Reexamination Certificate
active
06315762
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a device and a system for delivering contrast medium to a patient. The device and system are especially effective for delivering carbon dioxide gas to the vascular system of a patient. This invention also relates to an associated method for delivering contrast medium such as carbon dioxide gas to a patient.
Delivery systems for contrast media have been used for many years in the medical field. Keeping the system a “closed system” so that no room air will be introduced is critical to the features of these delivery systems. With the advent of carbon dioxide gas or CO
2
as a viable fluid for displacing blood in vessels for visualization under Digital Subtraction Angiography (DSA), the need to keep air out of the system is of even greater importance. Air and CO
2
are invisible so introduction of air into a CO
2
delivery system would pose a danger to a patient if it were inadvertently injected into the vasculature.
CO
2
has been shown to be an excellent fluid to be used for displacing blood in vessels. This void that is created in the vessel can be visualized with DSA. But since CO
2
is invisible introduction of room air into the system would pose a great danger to the patient. The air would go undetected and, once in the patient's vasculature, could cause a blockage or even an air embolism to the brain resulting in a stroke or death.
Because of this serious safety issue, it would make sense to use a closed system for the safe delivery of CO
2
. However, the conventional method used for delivering CO
2
is connecting a syringe to a CO
2
cylinder, filling the syringe with CO
2
, disconnecting the syringe from the cylinder and re-connecting to a catheter or tube set. If more CO
2
is needed, the syringe is disconnected from the catheter and refilled of the cylinder. This method allows for introduction of air into the system at every disconnection.
One method that was developed to reduce the number of disconnections was to attach the CO
2
cylinder directly to a stopcock with a syringe attached at on port and the catheter to the patient attached to the other port. When the syringe was to be filled, the stopcock would be opened to the syringe and the cylinder pressure would force CO
2
into the syringe. For injection into the patient, the stopcock would be closed to the cylinder and the syringe plunger would be advanced forward pushing the CO2 gas into the catheter and, subsequently, into the patient.
The problem with this method is that the CO
2
cylinder pressure is much higher than blood pressure (830 psi vs. 6 psi). If the stopcock is turned the wrong way, the cylinder is open to the catheter and liters of CO
2
will be delivered into the patient in less than a minute. Accordingly, the cylinder must be isolated from the patient and the delivery system used must be closed without providing a chance for the introduction of air.
BRIEF DESCRIPTION
It is an object of the invention to provide an improved device or system for delivering contrast medium to a patient's vascular system.
Another object of the present invention is to provide such a device or system wherein air can be effectively eliminated prior to the feeding of the contrast medium to the patient.
It is a further object of the present invention to provide such a device or system wherein highly pressurized sources of contrast medium are isolated from the patient to prevent chance introduction of excessive amounts of contrast medium into the patient.
An additional object of the present invention is to provide such a device or system wherein explosive introduction of gaseous contrast medium (carbon dioxide) into the patient can be minimized or eliminated.
Yet another object of the present invention is to provide such a device or system which is inexpensive and made of essentially off-the-shelf components.
A related object of the present invention is to provide an associated method for infusing contrast medium into a patient's vascular system.
These and other objects of the present invention are attained in a device cooperating with a pump for guiding a contrast medium from a source thereof to a catheter for delivery to a patient's vascular system. The device comprises a dual check valve, a tubular member, an in-line check valve and a three-port stopcock. The dual check valve has an inlet port connectable to the source of contrast medium, an inlet-outlet port connectable to the pump, and an outlet port coupled to the tubular member. The in-line check valve is connected to the tubular member at a point spaced from the dual check valve for preventing fluid flow towards the dual check valve. The stopcock connected at a first port to the in-line check valve, a second port of the stopcock being operatively connectable to the catheter.
Using this device, medical personnel may infuse contrast medium into the patient from the source without having to disconnect any element from the device during the infusion process. The entire system, including the source, the device, the pump and the catheter, is purged of air prior to beginning the infusion and air cannot be reintroduced back into the system during the infusion. The dual check valve permits continued connection of the pump to the system. Thus, where the pump takes the form of a syringe, the pump need not be disconnected from the system between an intake stroke and an ejection stroke of the syringe plunger. The in-line check valve prevents flow of blood from the catheter into the tubular member. It is contemplated that the dual check valve, the syringe and the tubular member are first purged of air by directing contrast medium through those parts of the system and out a third port of the stopcock, and subsequently the catheter, which is connected to the second port of the stopcock, is purged of air by allowing the patient's blood to flow through the catheter and out the third port of the stopcock.
According to another feature of the present invention, the in-line check valve is a dual check valve having an additional inlet port connected to the tubular member, an additional outlet port connected to the stopcock, and an additional inlet-outlet port operatively connectable to an ancillary pump such as a syringe. An additional stopcock may be disposed between the ancillary pump and the additional inlet-outlet port.
This additional structure facilitates a clearing of the catheter of blood prior to infusion of the contrast medium into the patient. The ancillary syringe has a limited volume not significantly greater than the volume in a path extending through the in-line check valve, the stopcock and the catheter. The ancillary syringe is operated to draw contrast medium from the source through the first dual check valve and then to drive the contrast medium through the catheter but not substantially into the patient. The system is now ready for the controlled infusion of contrast medium.
Preferably, the dual check valve, the tubular member, the in-line check valve and the stopcock are all permanently bonded to one another. This prevents the air leakage into the system.
In accordance with another feature of the present invention, the source of contrast medium is a flexible bag. A method for supplying a contrast medium to a patient's vascular system thus comprises operatively connecting the flexible bag to the patient's vascular system via a gas transfer system, purging the gas transfer system of air, and thereafter delivering contrast medium from the flexible bag through the gas transfer system to the patient's vascular system.
The flexible bag contains contrast medium at ambient atmospheric pressure, thus preventing accidental infusion of contrast medium and particularly excessive amounts of contrast medium into the patient. Prior to connecting the flexible bag to the contrast-medium transfer device, the bag is filled multiple times with contrast medium and squeezed empty to clear the bag of air.
In a device or system in accordance with the present invention for delivering contrast medium to
Hobbs Eamonn
Recinella Daniel K.
AngioDynamics, Inc.
Nguyen Anhtuan T.
Reed Smith LLP
Thompson Michael M
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