Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
KIT FOR DOSING AND DELIVERING OF RADIOACTIVE DRUGS
Document Type and Number:
WIPO Patent Application WO/2011/039626
Kind Code:
A1
Abstract:
A kit (1) for dosing and delivering radioactive drugs comprising a bulk (2) in which the radioactive drug to be dosed is totally transferred, an ionising chamber (3) in which the bulk (2) is housed and which is adapted to count the radioactivity contained in the bulk (2), weighing means (4) adapted to determine the weight of the bulk (2), a first syringe (5) adapted to perform the dosing operations, a second syringe (6) adapted to control the delivery of the radioactive drug to the patient, a bottle of physiological solution (7), a plurality of three-way valves (8) connected in series to one another and adapted to control the movements of the physiological solution and of the radioactive drug and a plurality of transport lines (9).

Inventors:
BEDESCHI PAOLO (IT)
Application Number:
PCT/IB2010/002497
Publication Date:
April 07, 2011
Filing Date:
October 01, 2010
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
COMECER SPA (IT)
BEDESCHI PAOLO (IT)
International Classes:
A61K51/12; G21G1/00
Domestic Patent References:
WO2006017946A12006-02-23
WO2007030249A22007-03-15
Foreign References:
US20050085682A12005-04-21
Other References:
None
Attorney, Agent or Firm:
JORIO, Paolo (Via Viotti 9, Torino, IT)
Download PDF:
Claims:
CLAIMS

1. A kit (1) for dosing and delivering radioactive drugs characterized by comprising a bulk (2) in which the radioactive drug to be dosed is totally transferred, an ionizing chamber (3) in which the bulk (2) is housed and which is adapted to count the radioactivity contained in the bulk (2) , weighing means (4) adapted to determine the weight of the bulk (2) , a first syringe (5) adapted to perform the dosing operations, a second syringe (6) adapted to control the delivery of the radioactive drug to the patient, a bottle of physiological solution (7) , a plurality of three-way valves (8) connected in series to one another and adapted to control the movements of the physiological solution and of the radioactive drug and a plurality of transport lines indicated generically by (9) .

2. The kit (1) for dosing and delivering radioactive drugs according to claim 1, characterized in that said weighing means comprise a load cell (4) .

3. The kit (1) for dosing and delivering radioactive drugs according to claim 1 or 2, characterized in that said first syringe (5) has a capacity of about 10 ml and said second syringe (6) has a capacity of about 1 ml .

4. The kit (i) for dosing and delivering radioactive drugs according to any of the preceding claims, characterized in that the plurality of transport lines (9) comprises a first line (10) , connected to a first three-way valve (8a) for withdrawing the radioactive drug from a multi-dose bottle (11) housed within an appropriate shielding structure (12) , a second line (13) also connected to the first three-way valve (8a) and arranged at the opposite end so as to be dipped within the bulk (2) , a third line (14) connected both to a third three-way valve (8c) and to the bottle of physiological solution (7) and a fourth line (15) connected, both to a fourth three-way valve (8d) and to an injection needle (16) provided with a filter (17) for delivering the radioactive drug to the patient.

5. The kit (1) for dosing and delivering radioactive drugs according to claim 4, characterized in that said first syringe (5) is connected to a second three-way valve (8b) , while said second syringe (6) is connected to the fourth three-way valve (8c) .

6. The kit (1) for dosing and delivering radioactive drugs according to any of the preceding claims, characterized in that said three-way valves (8) are moved by electrical movements.

7. A machine for dosing and delivering radioactive drugs characterized by comprising a kit according to any of the preceding claims.

Description:
KIT FOR DOSING AND DELIVERING RADIOACTIVE DRUGS

TECHNICAL FIELD

The present invention relates to a kit for dosing and delivering radioactive drugs. In particular, the kit of the present invention relates to the dosing and delivery of FDG, to which explicit reference will be made in the description without therefor loosing in generality.

BACKGROUND ART

Generally, after having been prepared, radioactive drugs must be accurately dosed in order to prepare the single doses to be delivered to patients.

Dosing a radioactive drug is a very delicate operation because it must satisfy the safety requirements needed for handling radioactive material and because doses must be prepared with the highest accuracy possible .

Dosing a radioactive drug substantially contemplates the procedure of determining the radioactivity of a given specimen of product and of calculating the amount to be taken from the specimen itself to obtain the required doses. Once the calculated amount has been taken, it is deposited in a sterile bottle or in a syringe to be subsequently delivered to the patient .

As apparent, neither the accuracy of the specific dose which must subsequently be delivered to the patient aor the necessary safety level may be compromised during the handling of the radioactive drug in the operations above. Furthermore, it must be considered that the decay time of radioactive drugs is rather short and that, as a consequence, the dosing and delivering operations must be carried out rapidly.

It was thus felt the need to have a machine the technical features of which were capable of rapidly ensuring both high accuracy of the prepared dose combined with a high safety level and direct delivery of the radioactive drug to the client.

DISCLOSURE OF INVENTION

It is the object of the present a kit for dosing and delivering radioactive drugs, the essential features of which are shown in claim 1, and the preferred and/or auxiliary features illustrated in claims 2-6.

BRIEF DESCRIPTION OF THE DRAWING

For a better understanding of the invention, an embodiment is described by way of non- limitative example only, with the aid of the appended drawing, which illustrates the kit object of the present invention as a whole .

BEST MODE FOR CARRYING OUT THE INVENTION

In the figure, numeral 1 indicates as a whole the kit for dosing and delivering radioactive drugs according to the present invention. The kit 1 comprises a bulk 2, in which the radioactive drug to be dosed is totally transferred, an ionizing chamber 3, in which the bulk 2 is housed, a load cell 4 adapted to determine the weight of the bulk 2, a first syringe 5 of capacity equal to 10 ml adapted to perform the dosing operations, a second syringe 6 of capacity equal to 1 ml adapted to control the delivery of the radioactive drug to the patient, a bottle of physiological solution 7, four three-way valves 8 connected in series to one another and adapted to control the movements of the physiological solution and of the radioactive drug and a plurality of transport lines indicated generically by numeral 9.

The plurality of transport lines 9 comprises a first line 10, connected to a first three-way valve 8a for withdrawing the radioactive drug from a multi-dose bottle 11 housed within an appropriate shielding structure 12, a second line 13, also connected to the first three-way valve 8a and arranged at the opposite end so as to be dipped within the bulk 2, a third line

14 connected both to a third three-way valve 8c and to the bottle of physiological solution 7 and a fourth line

15 connected both to a fourth three-way valve 8d and to an injection needle 16 provided with a filter 17 and responsible for delivering the radioactive drug to the patient. In particular, a check valve 18 adapted to ensure that the kit as a whole cannot be contaminated by contact with the client is provided on the fourth line 15.

The first syringe 5 is connected to the second three-way valve 8b, while the second syringe 6 is connected to the fourth three-way valve 8c .

The arrangement of the elements of the kit described above allows a series of operations adapted to guarantee a particularly rapid, accurate and safe dosing, as will be described below.

The kit is mounted on a machine in which the housings of the various components as the motors of the valves 8 and of the syringes 5 and 6 are provided. In particular, the valves 8 are actuated by electric motors provided with position control, and the kit working cycle is always controlled by valve control motor sensor feedback .

The transport lines 9 are filled with the physiological solution following a semi-automatic procedure .

By means of the action of the first syringe 5 and the correct configuration of the first and second three- way valve 8a and 8b, the FDG contained in the multi-dose bottle 11 is entirely transferred into the bulk 2. Subsequently, after having set the correct configuration of the valves 8, the multi-dose bottle 11 is washed with physiological solution and emptied again so as to have the certainty that the PDG has been all taken. Once the FDG has been transferred into the bulk 2, the ionizing chamber 3 measures total radioactivity, while the load cell 4 determines its weight with an accuracy of +0.05 g. The combination of these two measurements is used to determine the specific radioactivity of the PDG present in the bulk 2.

At this point, again by means of an appropriate configuration of the valves 8 and by moving the first syringe 5, the FDG contained in the bulk 2 can be diluted so as to reach the required concentration with an accuracy of +2%.

After having reached the required concentration and having appropriately configured the valves 8, the second syringe 6 aspirates from the bulk 2 the volume needed to obtain the necessary amount of PDG to be injected to the patient. The use of a 1 ml syringe guarantees an accuracy of +2%.

A second injection will be possible immediately after having replaced part of the line 15 downstream of the check valve 18 and having carried out a cleaning with the physiological solution.

At the end of the processing cycle, the product which possibly remains in the bulk is sent back to the multi-dose bottle, which thus performs a recovery function, while the lines are appropriately washed with physiological solution so as to be removed without assuming significant radiations .

As apparent from the description above, the kit of the present invention is capable of guaranteeing in fully automated manner a dosing with high features of accuracy and safety and, at the same time, a direct delivery of radioactive drug.