Patent EA-004902-B1 (EA)
Title: Process and device for preparing radiopharmaceutical products for injection
Inventor: PHILIPPART GAUTHIER
IPC: A61J1/06
Filed: 2002-04-05
Abstract: 1. Device to be used in the automated preparation, packaging and further handling of a radiopharmaceutical compound individual dose, comprising the following set of elements: a cartridge intended to contain said individual dose, provided at a first end with a closing element (2) and at a second end by means of a component serving as a piston (3); a radiation-shielding container (10) comprising an inner cylinder-like part (4) capable to enclose said cartridge (1), and an outer cylinder-like part (5), serving as an additional shielding for transportation, said outer part being capable to enclose said inner part, said outer part being provided with a shielding lid (6); a plunger (7) to be fitted to the cartridge (1) at the time of an injection, while said cartridge is still inside said inner cylinder-like part (4) of the radiation shielding container (10), provided with a sliding rod (22) capable to contact said piston (3) of the cartridge (1), with a push button (23) and with support wings (25) for the fingers; an injection means (30) to be fitted to the first end of the cartridge (1) at the time of an injection, while said cartridge is still inside said inner cylinder-like part (4) of the radiation shielding container (4), wherein: the plunger is provided with fixing means (24) to said inner cylinder-like part (4) of the radiation shielding container (10); the closing element (2) is a septum, preferably an elastomeric stopper and the injection means (30) is capable to pierce the closing element (2) of the cartridge, (1) in a sterile manner and to enter in contact with said radiopharmaceutical compound. 2. Device according to claim 1, wherein the fixing means (24) of the plunger comprise a rapid attachment device such as screwing or clipping means. 3. Device according to claim 1, wherein said injection means (30) comprises inwardly a spike (31) and outwardly a needle (33) or a luer fitting (34) in connection to the spike (31), preferably of the VACUTAINER(RTM) type. 4. Device according to claim 1, wherein said spike (31) is protected in a sterile manner by an elastomeric sleeve (32) until said closing element (2) of cartridge (1) has been pierced. 5. Device according to claim 3 or 4, wherein the injection means elements (30) are covered by a protective cap (41,42) before use. 6. Device according to claim 1, wherein the injection means (30) are designed for rapid attachment to the cartridge such as screwing or clipping. 7. Device according to claim 1, wherein said cartridge is a standard cartridge of the type used for the packaging of insulin. 8. Device according to claim 1, wherein it is suitable for using a short-lived Positron Emission Tomography (PET) compound. 9. Device according to claim 1, wherein said inner cylinder-like part (4) is made of high density metal such as tungsten or a tungsten-based alloy. 10. Device according to claim 1, wherein said outer cylinder-like part (5) and said shielding lid (6) are made of a high density metal such as lead, tungsten, a high lead content alloy or a high tungsten content alloy. 11. Device according to claim 1, wherein a see-through window (20) is provided in the shielding (4). 12. Use of the device, according to anyone of claim 1 to 11, for automatically preparing, packaging and handling an individual dose of a radiopharmaceutical compound, comprising the following steps: filling the cartridge (1) with said dose of radiopharmaceutical compound via its first end, its second end remaining closed by means of the piston (3); closing said cartridge (1) at said first end by means of the closure device (2); placing said cartridge (1) in the radiation shielding device (10), comprising an inner part (4) and an outer part (5), said inner part serving as radiation shielding for an operator and said outer part serving as a transportation shielding container; closing said shielding container (5) by means of the shielding lid (6); transporting said container up to the place at which an injection of said radiopharmaceutical compound will be carried out; removing the shielding lid (6) of the container; fixing the plunger (7) to the inner part (4) of the shielding device (10); extracting the inner part (4) of the radiation shielding device (10), enclosing the cartridge, from the outer part (5), and placing injection means (30) on the cartridge end which is provided with the closing element, (2), said cartridge (1) being still enclosed in the inner part (4) of the shielding device (10).