Patent Number: 059441909
Section: summary

FIELD OF THE INVENTION The invention relates to containers for the transport and handling of radiopharmaceutical capsules, e.g., radioactive iodine capsules. BACKGROUND OF THE INVENTION Radiopharmaceutical capsules, e.g., radioactive iodine capsules, are used, for example, in oncology, e.g., in the treatment of thyroid cancer. Because of their radioactivity, such capsules typically are stored and transported in resealable lead canisters or "safes." Previously, such safes have been constructed so that they are either closed, i.e., the radiopharmaceutical capsules is environmentally sealed and the radiation is contained within the safe, or open, i.e., the capsule is environmentally exposed and the radiation is no longer contained. With such safe configurations, the radiopharmaceutical capsule is environmentally exposed even when the capsule is only being assayed, i.e., the radioactive strength of the capsule is being measured by means of a Geiger counter or in an ionization chamber. SUMMARY OF THE INVENTION The present invention provides a radiopharmaceutical capsule safe in which a radiopharmaceutical capsule can be packaged and transported. The radiopharmaceutical capsule is secured within a capsule vial, and the capsule vial, in turn, is secured in the middle of a radiopaque vessel or safe. The radiopharmaceutical capsule safe according to the invention is configured such that when it is only desired to assay the capsule, the upper portion or lid of the safe is turned in one direction and lifted away from the bottom portion of the safe, leaving the capsule vial sealed and secured within the safe bottom. When it is desired to dose the capsule, i.e., to deliver it to a patient, the safe lid is turned in the opposite direction (assuming it has been replaced after assaying) to unscrew the vial cap from the vial, thereby opening the vial and permitting access to the radiopharmaceutical capsule. Thus, according to a first aspect of the invention, the invention provides a radiopharmaceutical capsule safe. The radiopharmaceutical capsule safe includes a safe which, in turn, includes a safe bottom and a safe lid, each of which is formed from radiopaque material such as lead. The safe bottom has a vial bottom-receiving cavity formed therein, and the safe lid has a vial cap-receiving cavity formed therein. The radiopharmaceutical capsule safe also includes a capsule vial which, in turn, includes a vial bottom and a vial cap that is securable to the vial bottom. The vial cap is formed from radiotransmissive material such as plastic, and the vial bottom is configured to receive the radiopharmaceutical capsule therein. The configuration is such that the vial bottom fits within the vial bottom-receiving cavity in the safe bottom, and the vial cap fits within the vial cap-receiving cavity in the safe lid so that the capsule vial is completely encased within the safe when the safe lid is engaged with the safe bottom. By removing the safe lid but leaving the vial cap engaged with the vial bottom, the radiopharmaceutical capsule can be assayed while environmentally sealed within the vial capsule. Preferred embodiments of the invention may include one or more of the following features. The vial bottom can have two or more tabs extending outwardly therefrom, and the vial cap can similarly have two or more cap tabs extending outwardly therefrom. The tabs fit within slots in the vial bottom-receiving cavity and the vial cap-receiving cavity, respectively, and the vial cap can be disengaged from the vial bottom by rotating the safe lid relative to the safe bottom. The slots in the safe lid and/or the slots in the safe bottom can have circumferentially oriented tab-engaging slot extensions that permit limited rotation of the safe lid relative to the vial cap and/or limited rotation of the vial bottom relative to the safe bottom. The slot extensions retain the vial cap and the vial bottom in the respective safe lid or safe bottom. The slots and slot extensions may be provided by means of an upper and/or lower lock ring positioned in the opening of the vial cap-receiving cavity and/or the vial bottom-receiving cavity. The radiopharmaceutical capsule safe preferably includes a two-piece outer jar that consists of a jar bottom and a jar cap engageable with the jar bottom. The radiopaque safe is enclosed within the outer jar, preferably with the safe bottom retained within the jar bottom by means of a retaining member such as a retaining ring located at the open end of the jar bottom. In another aspect, the invention provides a method of packaging a radiopharmaceutical capsule. The method includes providing a safe, which safe includes a safe bottom and a safe lid, each being formed from radiopaque material. The safe bottom and the safe lid are engageable with each other. A capsule vial including a vial bottom and a vial cap is also provided, the vial cap being formed from radiotransmissive material. The vial bottom is disposed in a vial bottom-receiving cavity formed in the safe bottom, the vial cap is disposed in a vial cap-receiving cavity formed in the safe lid, and the radiopharmaceutical capsule is disposed in the vial bottom. The vial cap is engaged to the vial bottom, and the safe lid is engaged to the safe bottom. Preferably, the vial cap is disposed in the vial cap-receiving cavity before the vial cap is engaged with the vial bottom such that the vial cap is engaged with the vial bottom generally simultaneously with the safe lid being engaged with the safe bottom. Furthermore, activated charcoal is preferably disposed in the bottom of the vial bottom-receiving cavity before disposing the vial bottom in the bottom receiving cavity. The radiopaque safe is then preferably sealed within an outer jar that preferably is formed from plastic. In another aspect, the invention provides a method of assaying a radiopharmaceutical capsule. The method includes providing a radiopharmaceutical capsule that is disposed in a sealed capsule vial. The capsule vial is disposed in a sealed, radiopaque safe that has a safe bottom and a safe lid. The safe lid is removed from the safe bottom to expose the vial cap, which is radiotransmissive, while leaving the vial cap engaged with the vial bottom and the vial bottom disposed within the safe bottom. The radiopharmaceutical capsule is then assayed while still sealed within the capsule vial. In another aspect, the invention provides a method of dosing a radiopharmaceutical capsule. The method includes providing a radiopharmaceutical capsule that is disposed in a separate, sealed capsule vial. The capsule vial has a cap and a bottom and is disposed in a sealed, radiopaque safe having a radiopaque safe lid engaged with a radiopaque safe bottom. The vial cap is removed from the vial bottom, to expose the capsule for dosing, by disengaging the safe lid from the safe bottom. Finally, in another aspect, the invention provides a method of assaying and dosing a radiopharmaceutical capsule. A radiopharmaceutical capsule is provided in a sealed vial that is disposed in a sealed, radiopaque safe. The safe lid is removed from the safe bottom to expose the cap of the vial, which is radiotransmissive, while leaving the vial sealed with the vial bottom still disposed in the safe bottom. The radiopharmaceutical capsule is then assayed while still sealed within the capsule vial, and then the safe lid is re-engaged with the safe bottom to reseal the vial within the safe. Subsequently, the vial cap is removed from the vial bottom by disengaging the safe lid from the safe bottom and the radiopharmaceutical capsule is dispensed from the vial.