Radiant energy – Fluent material containment – support or transfer means – With irradiating source or radiating fluent material
Reexamination Certificate
1999-11-24
2002-04-16
Anderson, Bruce (Department: 2881)
Radiant energy
Fluent material containment, support or transfer means
With irradiating source or radiating fluent material
C250S43200R, C250S496100, C250S497100, C250S436000, C250S505100, C600S003000, C600S008000, C424S001110
Reexamination Certificate
active
06373068
ABSTRACT:
The invention relates to a method for preparing radioactive or like medicines for administration. Such method is known from practice.
In the known method, an amount of medicine is introduced into a first container and irradiated therein with neutrons, after which the medicine is introduced into a second container to be sent to an end user. By the end user, for instance a doctor, analyst, laboratory technician or assistant, a dose of the medicine is subsequently transferred into an apparatus whereby it can be administered to a patient.
Separate vessels for irradiating and administering the (radio)active medicine are already used in a standard way.
It has been found that such vessels require many additional operations, in particular for transferring high radioactive material from one vessel to the other. This involves a substantial risk of a dose of radiation to the user in the widest sense (producer of the radioactive medicine, analyst, laboratory technician, etc.), at least of an undesired extra dose of radiation. Moreover, these operations take up extra time and entail a greater risk of contamination of the medicine and radioactive contamination of the environment.
The object of the invention is to provide a method for preparing radioactive or like medicines for administration, wherein the above drawbacks are avoided. To that end, a method according to the invention is characterized by the features of claim 1.
In the most general sense, the invention provides a method for preparing for administration a medicine which is to be shielded from the environment, wherein a vessel is employed which can be used both for irradiation and for administration thereof to a patient, so that the medicine need not be intermediately transferred to another vessel. In this regard, ‘medicine’ should be understood to comprise at least any means that can be administered to a patient for medicinal or diagnostic purposes. In this context, ‘not active’, or ‘disintegrating sufficiently quickly’ should be understood to mean that the material of the vessel preferably disintegrates more quickly than the irradiated medicine, and/or the vessel exhibits an activity-lower than 500 Bq/g preferably within 48 hours.
A method according to the invention offers the advantage that from the vessel in which it is irradiated the medicine can directly be administered to a patient by known means suitable therefor, such as a drip, pump means and the like. Moreover, such method has the advantage that, if desired, for each individual patient a suitable dose with a suitable irradiation can in a separate vessel be prepared for administration, which has advantages in terms of logistics and safety.
The invention further relates to an apparatus for preparing radioactive or like medicines for administration, characterized by the features of claim 6.
The vessel in an apparatus according to the invention is made from such material and in such form that it can also be used as administering vessel of a medicine contained therein, which medicine is first irradiated with neutrons in a nuclear reactor and can subsequently be administered to a patient as radioactive medicine without the medicine having to be taken out of the vessel intermediately.
The vessel preferably comprises at least one coupling connection (for instance Luer Lock) and the vessel is manufactured from a material which at least through neutron irradiation does not become active or disintegrates sufficiently quickly after activation, while, moreover, the vessel can preferably be autoclaved.
In a further embodiment, a vessel according to the invention is further characterized by the features of claim 7.
The separate compartment, separated from the vessel or communicating with the inner space of the vessel via an opening, offers the advantage that a small amount of medicine can be irradiated therein in the same manner as the medicine contained in the inner space of the vessel proper, or that after irradiation, a small amount of irradiated medicine can be received in this compartment. After irradiation, this small amount of medicine can at least partly be removed and checked without the other amount of medicine being affected thereby.
An irradiation/administration vessel according to the invention provides that the medicine can both be irradiated and administered to the patient in an easy and radiation load-reducing manner. For administration, the vessel can entirely be transferred within a shield, so that the radiation coming from the vessel is shielded. Preferably, the vessel is designed so that the radioactive medicine can be fed into a patient by means of an external carrier fluid. In this regard, the vessel is made from material which can hardly be activated, if at all, such as polyethylene, polypropylene, polycarbonate or another synthetic material suitable therefor or quartz glass. The vessel may also be made from a material which, after activation, disintegrates quickly, such as for instance a synthetic material having a fluorine compound such as Teflon.
An apparatus according to the invention can for instance be used as follows.
The vessel is closed during irradiation and before administration. The vessel can be autoclaved or sterilely filled with the medicine to be irradiated. After irradiation, the vessel is sent to the user. Here, a unit with carrier liquid is connected to the vessel and the radioactive medicine is suspended or dissolved in this liquid. After that, the vessel is connected to an administering apparatus which is connected to the patient. The medicine in the vessel is subsequently fed into the patient by the carrier liquid.
The invention further relates to the use of an apparatus according to the invention for preparing a radioactive or like medicine for administration, characterized by the features of claim 20.
Further advantageous embodiments of a method and apparatus according to the invention are given in the subclaims.
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patent: 0587106 (1994-04-01), None
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Mumper, Russell J. et al, “Poly (L-Lactic Acid) Microspheres Containing Neutron-Activatable Holmium—165: A study of the physical characteristics of microspheres before and after irradiation in a nuclear reactor”, Pharm. Res., (1992) 9(1), 145-154.
Mumper, Russell J. et al. “Formation and Stability of Lanthanide Complexes and Their Encapsulation into Polymeric Microspheres”, J. Phys. Chem. (1992), 96(21), 8626-8631.
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Mumper, Russell J. et al., “Polymeric Microspheres for Radionuclide Synovectomy Containing Neutron-Activated Holmium-166”J. Nucl. Med. (1992), 33(3), 398-402.
Mumper R J et al., “Biodegradable Radiotherapeutic Polyester Microspheres: Optimization and In-Vitro/In Vivo Evaluation”, Journal of Controlled Release, vol. 18, No. 3, Apr. 1, 1992, pp. 193-203, see p. 193, col. 1, line 1—col. 2, line 14.
Ma D. et al., Development of the Dysprosium-166 Holmium In-Vivo Generator for Radionuclide Radiotherapy, Journal of Nuclear Medicine, vol. 34, No. sup.5, 1993, p. 231p.
Nijsen Johannes Franciscus Wilhelmus
van het Schip Alfred Dirk
Zonnenberg Bernard Antoni
Academisch Ziekenhuis Utrecht
Anderson Bruce
Kinney & Lange , P.A.
Wells Nikita
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