RU236600U1 - Device based on sterile disposable cassettes for automated production of radiopharmaceuticals - Google Patents

Abstract

The utility model mainly relates to medical equipment, in particular, it is intended for the synthesis of preparations consisting of biologically active molecules and radionuclides used for therapy or SPECT, PET diagnostics. The technical result consists in minimizing the losses of reagents and product. The technical result is achieved due to the fact that in a device for the automated production of radiopharmaceuticals, containing valves connected to each other in a single housing for installing a disposable cassette, plates for attaching a disposable cassette to the housing, clamps for fixing cassette syringes, syringe pumps, pinch valves and heating units for installing cassette reactors equipped with reactor tubes made for interaction with the pinch valves, wherein the valves for installing a disposable cassette and the plates for attaching a disposable cassette are divided into two blocks, and the pinch valves, ports for supplying pressure and ports for vacuuming the elements of the disposable cassette are attached to the housing by means of fasteners.

Description

The utility model mainly relates to medical technology, in particular, it is intended for the synthesis of drugs consisting of biologically active molecules and radionuclides used for therapy or SPECT, PET diagnostics.

The closest analogue of the proposed utility model in technical essence is a device for the production of radiopharmaceuticals, according to the published international application WO2012141387A1. The described device operates using disposable cassettes and consists of six units, including cassette valves that set the direction of reagent flows, a vacuum pump and a syringe unit for transferring reagents, a reactor, and a heating element to maintain a specified temperature for a specified time to obtain the product. All stages of synthesis, purification and preparation of the drug can be performed using one described device. The device also provides for the synthesis of various types of radiopharmaceuticals, provided that the appropriate cassettes are used.

However, the main drawback of this prototype is the division of the cassette valves into six blocks, which requires additional connection of the valves with tubes and connectors, increasing the internal volume of the cassette. This leads to an increase in the synthesis time, the creation of excess dead volumes and, consequently, additional losses of reagents and product, which ultimately reduces the yield of the drug.

The objective of the utility model is to eliminate the disadvantage of the prototype, and the technical result is to minimize the loss of reagents and product.

The technical result is achieved due to the fact that in a device for the automated production of radiopharmaceuticals, containing valves connected to each other in a single housing for installing a disposable cassette, plates for fastening the disposable cassette to the housing, clamps for fixing cassette syringes, syringe pumps, pinch valves and heating blocks for installing cassette reactors equipped with reactor tubes designed to interact with the pinch valves, wherein the valves for installing the disposable cassette and the plates for fastening the disposable cassette are divided into two blocks, and the pinch valves, ports for supplying pressure and ports for vacuuming the elements of the disposable cassette are attached to the housing by means of fasteners.

The diagram of the device with the designation of external elements is shown in the drawing, where:

1 - block of cassette valves;

2 - plate for fixing the cassette;

3 - syringe clamps;

4 - heating blocks;

5 - pinch valves for sealing reactors;

6 - ports for supplying pressure to the cassette;

7 - ports for vacuuming cassette elements;

8 - plunger for receiving activity;

9 - pinch valve for sealing the activity line.

To manufacture any radiopharmaceutical, a disposable cassette assembled from components with a Luer connection type (three-way valves, tubes, columns with chemical sorbents, syringes, a reactor in the form of a vial with a conical bottom, sterilizing filters, connectors and holders for vials with reagents) is installed in the cassette valve blocks (1) of the device. The cassette is fixed using a plate (2). The cassette syringes are fixed using clamps (3) connected to syringe pumps located inside the housing. The cassette reactors are installed in heating blocks (4). The silicone tubes of the reactors are installed in pinch valves (5), which, when closed, seal the reactor. The cassette and reactor tubes are connected to the required pressure (6) and vacuum (7) ports using Luer connectors. The activity is fed into the plunger (8), connected to the syringe pump and installed in the empty cylinder of the cassette syringe, through a capillary installed in the pinch valve (9), which ensures the sealing of the plunger.

The device operates on the basis of disposable cassettes, which enable one module to operate with several isotopes and produce different radiopharmaceuticals.

To perform synthesis, the necessary reagents are installed in the cassette, and the synthesis algorithm for the corresponding preparation is launched in the device software. When the algorithm is executed, the reagents are transferred to the required place in the cassette using syringe pumps and three-way rotary valves that set the direction of reagent movement. For example, various reactions are carried out in reactors, and sorbent columns in the cassette can be used to trap the semi-finished product, purify the final product, etc. Evacuation and pressure supply to the cassette are used to purge the cassette elements, remove waste, and perform reactions.

Since the implementation of two cassette units in the present device provides for the use of a cassette from a single three-way valve line for each cassette unit and the connection of the valves with additional tubes and connectors is not required, the transfer of reagents is carried out mainly through the internal channels of these three-way valves. Thus, the reagents travel the minimum possible distance, which minimizes the loss of reagents in the volume of the cassette.

The elements of the device are structurally connected to each other as follows. Syringe pumps, heating and cassette units are attached to the frame of the device using fasteners, for example, with a screw connection. Ports for supplying pressure to the cassette and ports for vacuuming the cassette elements are attached to a durable opaque body using fasteners, for example, with a threaded connection. Pinch valves are attached to the body using fasteners, for example, with a screw connection.

Claims (1)

A device for the automated production of radiopharmaceuticals, comprising valves connected to each other in a single housing for installing a disposable cassette, plates for attaching a disposable cassette to the housing, clamps for fixing cassette syringes, syringe pumps, pinch valves and heating blocks for installing cassette reactors equipped with reactor tubes designed to interact with the pinch valves, wherein the valves for installing a disposable cassette and the plates for attaching a disposable cassette are divided into two blocks, and the pinch valves, ports for supplying pressure and ports for vacuuming the elements of the disposable cassette are attached to the housing by means of fasteners.