Radiant energy – Radiation controlling means – Shielded receptacles for radioactive sources
Reexamination Certificate
2000-08-09
2003-06-10
Berman, Jack (Department: 2881)
Radiant energy
Radiation controlling means
Shielded receptacles for radioactive sources
C250S506100, C206S364000, C206S524100, C053S449000, C053S485000, C220S023870
Reexamination Certificate
active
06576918
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to shielded containers for the transportation of radioactive materials and, more particularly, to shielded containers for the transportation of syringes containing radioactive drugs, or radiopharmaceuticals.
In the nuclear medicine industry, it is well known for pharmacies to deliver syringes containing radioactive drugs to hospitals for injection into a patient. One use for these types of drugs is for the x-ray or other imaging of internal human organs. Pharmacies receive prescription orders and deliver the corresponding radioactive drugs to nearby hospitals for use. Each prescription is individually filled, and each dose of radioactive drug is packaged in a syringe intended for a specific patient.
Radioactive drugs must be carefully handled. Therefore syringes containing such drugs are delivered inside containers offering some degree of radiation shielding. Furthermore, government regulations require syringes to be disposed of in a disposal container that shields others from the risk of injury posed by their sharp, biologically-contaminated hypodermic needles. Such a container, generally referred to herein as a “sharps” container, typically has an inner cavity or chamber that can hold one or more syringes.
One type of conventional delivery container currently used for the delivery of syringes containing radioactive drugs is known as a radiopharmaceutical pig. The radiopharmaceutical pig has a shielded inner chamber suitable for enclosing a syringe that is itself held inside of a sharps container. In particular, the chamber is lined with elemental lead to shield people from the radioactive drug in the syringe. The exterior of the radiopharmaceutical pig is a plastic polystyrene shell. The sharps container has an insert and a cap that can be engaged by two snaps that fit into two aligned slots formed on the insert.
One conventional method for delivering the radioactive syringe uses the devices described above. In particular, at the pharmacy, a sharps container insert is placed in the radiopharmaceutical pig. The syringe is loaded with the required dose of a radioactive drug is placed in the insert, which is nested in the chamber of the radiopharmaceutical pig. The radiopharmaceutical pig is then closed and delivered to the hospital, whereupon the pig is disassembled and the syringe is used according to other, well known, safety standards.
After the dose is injected into the patient, the syringe is referred to as “spent,” but generally contains a small amount of residual radioactive drug. In addition to the radioactive contamination, the hypodermic needle of the spent syringe is biologically contaminated from contact with the patient. The spent syringe may then be placed back into the sharps insert and the cap may then be placed on the housing to hold the spent syringe within the sharps container. The radiopharmaceutical pig is reassembled and taken to a disposal area, which may or may not be at the pharmacy.
While the previously discussed radiopharmaceutical pig and sharps container are generally effective, under certain conditions there may be drawbacks associated with such devices. One such drawback is that the snaps on the sharps container cap must be aligned with the slots on the insert in order to attach the cap to the insert. Thus, it may be difficult or more time consuming for a healthcare worker to align the snaps with the slots to attach the cap to the insert.
The conventional cap also is difficult to remove from the insert after it has been attached to the insert. Thus, the cap typically is not installed on the insert at the pharmacy, prior to its delivery to the hospital. Because the insert is not capped, there is a risk that the loaded syringe could leak and that the leaked radioactive drug could escape from the insert if the pig is tilted or inverted. If such contamination occurs, cleaning and disinfecting of the pig will require additional manpower and expense. Such a process is expensive and, therefore, undesirable.
Yet another drawback is related to the difficulty of determining if the syringe in the sharps container is spent or not. If the insert is transparent, the sharps container must be removed from the radiopharmaceutical pig in order for a worker to look through the insert at the syringe. If the insert is not transparent, the sharps container may have to be disassembled to view the syringe. Therefore, a worker may expend excess time in determining whether or not the syringe in the sharps container is spent.
Still another drawback is associated with lead shielding of the radiopharmaceutical pig. The soft nature of lead is not well suited to form threaded engagements, so the pig has two plastic outer shells that threadedly engage each other. The outer shells could crack or break upon impact, thereby rendering the pig unusable. In addition, a cracked pig shell could cause a worker to be exposed to sharp edges formed by the cracked plastic. The lead shielding also is bulky, resulting in a large-sized radiopharmaceutical pig.
Accordingly, there exists a need for an improved radiopharmaceutical pig and/or sharps container that alleviates one or more of the drawbacks identified above.
SUMMARY OF THE INVENTION
The present invention resides in an improved method and apparatus for transporting a syringe containing radioactive material that provides manly advantages, including the safe enclosure of the syringe both before and after use, reduces the possibility of contamination of the radiopharmaceutical pig. The present invention also provides a radiopharmaceutical pig that eliminates the need for a protective plastic outer shell. Finally, the present invention allows the user to readily determine if a syringe within a closed sharps container is full or spent without handling the container.
Particularly, and by way of example only, one embodiment of the invention is a transportation container for a syringe containing a radioactive material. The transportation container includes a body and a grip. The body has an upper end, a lower end, and an interior surface defining an internal chamber sized to enclose the syringe. The internal chamber is surrounded by radiation resistant material. The grip is located on the upper end of the body and has an exterior surface defining an enlarged area to be grasped by the worker.
The container may have a grip that extends around the upper end of the body and the grip may be a separate piece attached by frictional engagement with the upper end of the body. In further details, an enlarged base may be provided on the lower end of the body. The base may have an enlarged bottom end to stabilize the container as it sits on a surface. The transportation container may also include a sharps container sized to enclose the syringe. The internal chamber of the body is sized to enclose the sharps container. The grip may be a separate piece or can be integrally formed into the body. The body of the container may be made of tungsten.
In yet another independent and separate embodiment, a transportation container for a syringe containing a radioactive material is provided. The transportation container includes a body having an upper end, a lower end, and an interior surface defining an internal chamber sized to enclose the syringe. The internal chamber is surrounded by radiation resistant material. Also included is a sharps container having a cap and a housing sized to cooperatively enclose the syringe and fit into the chamber of the body. The cap has a closed end and a mating end and the housing has a closed end and a mating end configured to releasably engage the mating end of the cap without requiring precise alignment of the cap with the housing. In this manner, healthcare workers can easily and conveniently attach and remove the cap without bothering to precisely align any clips or snaps. Further detailed features Stay include providing the cap of the sharps container with a circumferential ridge located around in its mating end and/or providing the housing of the sharps container with
Chen Fu Monty Mong
Zhu Bing Bing
Berman Jack
Sheppard Mullin Richter & Hampton LLP
Syncor International Corp.
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