There are a variety of imaging techniques that have been used to diagnose disease in humans. One of the first techniques employed was X-rays. In X-rays, the images of the patients' body reflect the different densities of body structures. To improve the diagnostic utility of this imaging technique, contrast agents are employed to increase the density difference between various structures, such as between the gastrointestinal tract and its surrounding tissues. Barium sulfate and iodinated contrast media are the two primary pharmaceutical oral contrast agents used for X-ray gastrointestinal studies to visualize the esophagus, stomach, small intestine, and large intestine. Likewise, these same contrast agents are used for X-ray-based CT images to improve visualization and distension of the gastrointestinal tract and to provide improved contrast between the gastrointestinal tract and the structures adjacent to it, such as the blood vessels and lymph nodes. Such gastrointestinal oral contrast agents increase the density inside the esophagus, stomach, small intestine, and large intestine, and allow differentiation of the gastrointestinal system from the surrounding structures. Such gastrointestinal oral contrast agents also distend the bowel lumen allowing better evaluation of bowel wall structures, including abnormalities such as wall thickening or luminal obstruction.
Magnetic resonance imaging is another imaging technique; however, unlike X-rays and CT, MR does not utilize ionizing radiation. MR employs a magnetic field, radiofrequency energy and magnetic field gradients to make images of the body. The contrast or signal intensity differences between tissues mainly reflect the T1 and T2 relaxation values and the proton density of the tissues. Like CT, MR can make cross-sectional images of the body and it is desirable for many MR scans that a gastrointestinal contrast agent be administered to allow differentiation of the gastrointestinal system from the surrounding structures. Such gastrointestinal oral contrast agents also distend the bowel lumen allowing better evaluation of bowel wall structures, including abnormalities such as wall thickening or luminal obstruction.
Opacification of the gastrointestinal tract is a routine part of patient preparation prior to CT examination of the abdomen and pelvis because proper filling and distention of the bowel lumen with contrast medium facilitates identification of the normal and abnormal anatomy. For this reason, oral contrast agents are administered to the vast majority of patients undergoing CT scans of the abdomen and pelvis. Less commonly, oral contrast agents are administered to patients undergoing MR scans of the abdomen and pelvis.
In the early 1980s, when CT scan imaging was first gaining widespread use, the first oral agents used were the ionic iodinated contrast agents, comprised of the iodine-containing salts sodium diatrizoate, meglumine diatrizoate, or mixtures thereof. One example of the ionic iodinated oral contrast agents is Gastrografin® (Bracco Diagnostics, Princeton, N.J.), which is composed of the iodine-containing salts meglumine diatrizoate and sodium diatrizoate. Pharmaceutical agents like Gastrografin® were already approved for oral use and were widely used in full strength concentration for diagnostic gastrointestinal radiology imaging. These products, as well as the newer non-ionic iodinated agent approved for oral administration in the United States (e.g., iohexol, trade name Omnipaque®, GE Healthcare, Princeton, N.J.), were too concentrated in the form supplied by the manufacturers to be used for gastrointestinal opacification during CT imaging. These products were, therefore, diluted with water or other beverages in order to be of the proper concentration for optimal CT scan imaging.
Similarly, the gadolinium-based oral contrast agents, such as gadopentetate dimeglumine, are too concentrated in the form supplied by the manufacturers to be used for gastrointestinal opacification during MR imaging. These products must be diluted with water or other beverage in order to be of the proper concentration for optimal gastrointestinal opacification during MR imaging.
In addition to dilution for imaging, oral contrast agents are mixed with beverages to improve palatability and taste. Due to the bitter and unpleasant taste of oral contrast agents, and the relatively large volume of liquid that must be consumed, many patients have difficulty drinking an oral contrast agent unless it is mixed with a beverage that masks the unpleasant taste. Soda, fruit juices, flavored water or powdered drink mixes such as Kool-Aid™ or Crystal Light™ have been mixed with oral contrast agents to improve palatability and taste. In some cases, the beverage is poured, or in the case of powdered drink mixes combined with water, in a pitcher or similar container. The oral contrast agent is then added to the beverage in the pitcher and dispensed in a cup to the patient. The pitcher may contain the diluted oral contrast for a single patient or for multiple patients.
Using a pitcher and dispensing the oral contrast agent in a cup results in difficulty in monitoring and ensuring that the patient consumes the desired quantity of oral contrast agent over the time period established, particularly if the pitcher is used for oral contrast agent for more than one patient. It is also difficult to provide labeling or means to write on the pitcher the dose or type of oral contrast used, the patient name and medical identification number, and other data that may be of medical or regulatory significance.
In other cases, the dilute oral contrast agent is mixed and dispensed in a series of cups Because typically 32 ounces or more of the dilute oral contrast agent must be consumed by the patient, multiple cups are required. The use of multiple cups of oral contrast agent results in difficulty in monitoring the rate of consumption. In addition, labeling of the cups is typically minimal, and in some cases no labeling is used at all.
Accordingly, it would be advantageous to have a container or other device for administration of oral contrast agent that allowed the user to obtain the proper concentration and dilution of the oral contrast agent, monitor consumption of the oral contrast agent to ensure that proper quantities are consumed within the time period established, and/or provide easy labeling to track information such as the patient name, oral contrast agent used, concentration of oral contrast agent in the container, date and time of preparation, and quantities to be consumed for specific time periods.