Device for synthesis of radiopharmaceutical products

• US 20040028573A1
• Filed: 06/10/2003
• Published: 02/12/2004
• Est. Priority Date: 12/22/2000
• Status: Active Grant

• Current Assignee: Ion Beam Applications s.a.
• Original Assignee: Ion Beam Applications s.a.
• Inventors: Tadino, Vincent, Boeyen, Pierre-Emmanuel, Schmitz, Frederic
• Granted Patent: US 8,287,819 B2
• Time in Patent Office: Days
• US Class Current: 422/130
• CPC Class Codes: A61K 51/04 Organic compounds
• CPC Class Codes: A61K 51/0491 Sugars, nucleosides, nucleotides, oligonucleotides, nucleic acids, e.g. DNA, RNA, nucleic acid aptamers
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents

Abstract

The invention concerns a device for synthesis of radiopharmaceutical products based on chemical reagents contained in bottles, said device comprising several reaction compartments, transfer means between said bottles and said reaction compartments as well as mechanical means acting on said transfer means and enabling to monitor and control mechanically the transfer of chemical reagents. The invention is characterized in that it comprises: a fixed module including at least the mechanical means; a removable and disposable module, essentially in the shape of a support, whereon are arranged the transfer means between said bottles and said reaction compartments, said removable and disposable module not including any mechanical means; and means for securing said removable and disposable module to said fixed module.

Claims

1. Device for synthesis of radiopharmaceutical products from chemical reagents contained in bottles (3a,3b,3c,3d,3e), the said device comprising several reaction compartments (R₁,R₂), transfer means (4a,4b,4c,4d,4e, . . . ) between the said bottles (3a,3b,3c,3d,3e) and the said reaction compartments (R₁,R₂) as well as mechanical means (8a,8b,8c,8d,8e, . . . ) acting on the said transfer means (4a,4b,4c,4d,4e, . . . ) and enabling to monitor and control mechanically the transfer of the chemical reagents, characterised in that it comprises:

a fixed module (1) comprising at least the mechanical means (8a,8b,8c,8d,8e, . . . ),

a removable and disposable module (2), essentially in the shape of a support plate (5), on which the transfer means (4a,4b,4c,4d,4e, . . . ) between the said bottles (3a,3b,3c,3d,3e) and the said reaction compartments (R₁,R₂) are arranged, the said removable and disposable module (2) not including any mechanical means, and

means (10, 11, 12a-12d, 13a-13d) for securing the said removable and disposable module (2) to the said fixed module (1).

2. Device according to claim 1, characterised in that the said disposable module (2) furthermore comprises the said bottles (3a,3b,3c,3d,3e) and the said reaction compartments (R₁,R₂).

3. Device according to claim 1 or 2, characterised in that the bottles (3a,3b,3c,3d,3e) are pre-metered bottles.

4. Device according to any of the preceding claims, characterised in that the support plate (5) comprises means for the precise positioning of the transfer means (4a,4b,4c,4d,4e, . . . ).

5. Device according to claim 4, characterised in that the positioning means are constituted by grooves (6) in which the transfer means (4a,4b,4c,4d,4e, . . . ) are placed.

6. Device according to one of claims 1 to 5, characterised in that the transfer means are flexible tubes (4a,4b,4c,4d,4e, . . . ), the mechanical means (8a,8b,8c,8d,8e, . . . ) are pistons, the transfer means, the mechanical means and the positioning means (6) being capable of co-operating so as to form valves.

7. Device according to any of claims 1 to 6, characterised in that the securing means comprise at least one opening (10), shoulders (13a-13d) and fasteners (11, 12a-12d).

8. Device according to claim 7, characterised in that the said shoulders (13a-13d) are located on the support plate (5), preferably at the four corners of the support plate (5), and are capable of fitting into fasteners (12a-12d) located on the fixed module (1).

9. Device according to claim 8, characterised in that the said opening (10) is likewise located on the support plate (5), preferably at the centre of the said plate (5), and is capable of fitting into a fastener (11) located on the fixed module (1).

10. Device according to one of the preceding claims, characterised in that the nature of the support plate (5) and that of the transfer means (4a,4b,4c,4d,4e) are such that they allow washing of the said disposable module (2) by steam autoclaving and/or its sterilisation.

11. Device according to claim 10, characterised in that the support plate (5) is made of ABS.

12. Device according to claim 10 or 11, characterised in that the transfer means (4a,4b,4c,4d,4e, . . . ) are made of silicone.

13. Device according to any of the preceding claims, characterised in that it includes means of actuating mechanical means of the fixed module (1).

14. Device according to any of the preceding claims, characterised in that the actuating means are constituted by an automaton co-operating with a computer and forming part of the fixed module (1).

18. Process for synthesising radiopharmaceutical products using the device according to any of claims 1 to 14, characterised in that it comprises the following stages:

the transfer means (4a,4b,4c,4d,4e) are arranged on the support plate (5),

the bottles (3a-3e) containing the chemical reagents are fixed to one of the ends of the transfer tubes (4a,4b,4c,4d,4e),

the said support plate (5) with the transfer means is attached to the fixed module (1) with the aid of securing means (10, 11, 12a-12d, 13a-13d),

the transfer means (4a,4b,4c,4d,4e) are connected to the various elements of the fixed module (1),

the various operations required for synthesis of the pharmaceutical products, including the actuation of the mechanical means (8a-8e), are commanded via the automaton.

19. Process according to claim 18, characterised in that, before commanding the various operations required for synthesis of the pharmaceutical products, a test to verify the tightness of the device is carried out via the automaton.

20. Use of the device according to any of claims 1 to 14 or of the disposable module according to one of claims 15 to 17 for synthesising radiopharmaceutical compounds containing radio-elements with a short half-life, preferably ¹¹C, ¹³N, ¹⁵O or ¹⁸F.

15. Disposable and removable module (2) intended for association with a fixed module (1) by securing means (10, 11, 12a-12d, 13a-13d) and essentially in the form of a support plate (5) comprising means for positioning the means (4a,4b,4c,4d,4e, . . . ) for transferring chemical reagents.

16. Module (2) according to claim 15, characterised in that it furthermore comprises bottles (3a,3b,3c,3d,3e) and reaction compartments (R₁,R₂).

17. Plate according to claim 15 or 16, characterised in that the positioning means are constituted by grooves (6) capable of receiving transfer means (4a,4b,4c,4d,4e).