WO2010038130A1

WO2010038130A1 - Mixer for preparing bags for administering antineoplastic drugs

Info

Publication number: WO2010038130A1
Application number: PCT/IB2009/006973
Authority: WO
Inventors: Alfredo Speranzi
Original assignee: Maspres Di Speranzi Alfredo
Priority date: 2008-09-30
Filing date: 2009-09-29
Publication date: 2010-04-08
Also published as: ITFI20080186A1

Abstract

A mixer for preparing bags for administering antineoplastic drugs comprises a housing unit (3) for bags containing a respective component to be mixed; at least two outfeed conduits (10) extending through a path controlled by two clamp-type solenoid valves (11); a peristaltic pump (14) controlled by a stepping motor; a load cell (17) for controlling the quantity of fluids introduced into a bag intended for a patient.

Description

"MIXER FOR PREPARING BAGS FOR ADMINISTERING ANTINEOPLASTIC

DRUGS" Technical Field of the Invention

The object of the present invention is a mixer for preparing bags for administering antineoplastic drugs, and a method for preparing bags for administering antineoplastic drugs.

Background of the Invention

As it is known, the preparation of bags containing antineoplastic drugs to be administered to patients, is carried out by mixing a predetermined amount of carrier inert fluid and a predetermined amount of active principle.

By way of example, the carrier fluid may be a normal saline . The operation of preparation consists in taking out the amount of physiological saline from a suitable bottle by means of a graduated syringe and pouring it into the bag intended for the patient. Afterwards, the amount of active principle is taken out and introduced into the bag intended for the patient.

The preparation of bags for the administration of antineoplastic drugs, as it is known at present, exhibits serious drawbacks.

Owing to the high toxicity of the active principle, the above described preparation operation must be carried out by highly specialized personnel, also in relation to the accuracy necessary for dosing the active principle above all.

On the other hand, the mixing of the above cited components cannot take place but in particularly protected environments provided also of ventilation systems, as necessary for the removal of toxic residues if any.

Detailed Description

In this context, the technical task on which the present invention is based is to propose a mixer for preparing bags for administering antineoplastic drugs and a method for preparing bags for administering antineoplastic drugs, said mixer and method being able to overcome the drawbacks of the prior art above indicated. In particular, the object of the present invention is to provide a mixer for preparing bags for administering antineoplastic drugs, and a method for preparing bags for administering antineoplastic drugs, being able to simplify and speed up the preparation of bags of antineoplastic drugs while maintaining high standards of accuracy and safety.

The indicated technical task and the specified objects are substantially achieved by a mixer for preparing bags for administering antineoplastic drugs and a method for preparing bags for administering antineoplastic drugs comprising the technical characteristics set forth in claim 11.

Further characteristics and advantages of the present invention will appear more clearly from the indicative, and thus non-limiting, preferred, but non-exclusive, embodiment of a mixer for preparing bags for administering antineoplastic drugs and a method for preparing bags for administering antineoplastic drugs, as illustrated in the accompanying figure 1 which is a schematic side view of a mixer for preparing bags for administering antineoplastic drugs according to the present invention.

With reference to the accompanying figure, numeral 1 indicates as a whole a mixer for preparing bags for administering antineoplastic drugs according to the present invention.

The mixer 1 comprises a holding body 2, box-shaped for example, and a housing unit 3 external to the holding body 2 on which the bags "Sl", "S2" containing the two components to be mixed are supported. With reference to the present embodiment, one of the components is a carrier and inert liquid substance, such as a physiological saline, for example. The other component is an antineoplastic active principle.

The housing unit 3 comprises a frame 4 rigidly associated with the holding body 2 and two supports 5 in which the two bags "Sl", "S2" containing the components to be mixed are placed.

The mixer 1 further comprises a housing unit 7 which receives a bag intended for the patient ^""S3" and contains the components already mixed. Such housing unit 7 which receives the bag intended for the patient "S3" comprises a bearing body 8 which acts as a support, and a tray 9 onto which the bag intended for the patient "S3" is made to rest . The mixer 1 further comprises at least two outfeed conduits 10 which extend through a path controlled by respective solenoid valves 11. Preferably, the solenoid valves 11 are of clamp type. To this end, the outfeed conduits 10 are preferably made up of silicone material and are, therefore, flexible.

The mixer 1 further comprises an outlet conduit 12 connectable to the bag intended for the patient "S3" and disposed on the tray 9 of housing unit 7 which receives said bag for patient "S3". The outfeed conduits 10 join into the outlet conduit 12. The outlet conduit 12 is made from silicone material as well and is, therefore, flexible. In greater detail, each clamp-type solenoid valve 11 is associated with a respective outfeed conduit 10 to allow or not the transit of the physiological saline and of the active principle and, thus, the introduction or not of these components into the bag intended for the patient "S3".

The outfeed conduits 10 and the outlet conduit 12 as well are supported on the holding body 2. The mixer 1 further comprises a plurality of quick- disconnect leakproof joints 15, each being associated with the outfeed conduits 10 and outlet conduits 12. In greater detail, the quick-disconnect leakproof joints 15 are disposed in correspondence of respective ends 10a, 12a of the outfeed conduits 10 and outlet conduits 12. The quick- disconnect leakproof joints 15 (also known as dry quick- disconnect joints) make it possible to connect/disconnect the outfeed conduits to/from the bags "Sl", "S2" containing the components to be mixed and the outlet conduit 12 to/from the bag intended for the patient "S3" by preventing any leakage of liquid also when they are disconnected. The mixer 1 further comprises at least one "T"-joint 13 to which the two outfeed conduits 10 and the outlet conduit 12 are connected. Advantageously, the "T"-joint 13 is of leakproof type to prevent unwanted escapes of physiological saline and, above all, of antineoplastic active principle. The mixer 1 further comprises a peristaltic pump 14 acting on the outlet conduit 12 for pumping both the physiological saline and the antineoplastic active principle into the bag intended for the patient "S3".

Advantageously, the peristaltic pump 14 is controlled by a stepping motor (not shown in the figure) . In this way, it is possible to accurately adjust the activation and/or deactivation of the peristaltic pump 14, as well as its velocity and flowrate.

Advantageously, the outfeed conduits 10 and the outlet conduit 12 are of disposable type. In other words, after having prepared a bag for the patient "S3", the outfeed conduits 10 and the outlet conduit 12 are removed from the holding body 2. Accordingly, every time a bag intended for the patient "S3" is to be prepared, the fresh, cleaned and sterile outfeed conduits 10 and outlet conduit 12 are reconnected to the holding body 2. Moreover, it is advantageous to replace the outfeed conduits 10 and the outlet conduit 12 every time the type of drug to be mixed is replaced.

Also the above indicated "T"-joint is of disposable type and is replaced, along with the outfeed conduits 10 and the outlet conduit 12, every time it is required to prepare a new bag intended for the patient "S3".

To this end, the mixer 1 comprises a plurality of coupling members 16 to connect the outfeed conduits 10 and the outlet conduit 12 to the holding body 2. The coupling members 16 allow the outfeed conduits 10 and outlet conduit 12 to be easily and quickly removed and connected.

According to the present invention, a load cell 17 is associated with the housing unit 7 of the bag intended for the patient "S3". In greater detail, the load cell 17 is associated with the tray 9 of the housing unit 7 of the bag intended for the patient "S3" in order to measure the mass of same bag.

During the preparation of the bag intended for the patient "S3", the load cell 17 measures moment by moment the mass of the physiological saline and of the active principle which are introduced into the bag intended for the patient "S3" by means of the peristaltic pump 14.

To this end, the mixer 1 comprises an electronic processing unit 18 connected to the load cell 17 for acquiring a signal representative of the mass of the component introduced into the same mixer.

The electronic processing unit 18 is also connected to the clamp-type solenoid valves 11 for opening/closing them according to the mass - detected by the load cell 17 - of the components introduced into the bag intended for the patient "S3".

Moreover, the electronic processing unit 18 is connected to the peristaltic pump 14 for controlling the activation/deactivation thereof, as well as the operation speed and thus the flowrate thereof. The mixer 1 further comprises a plurality of optical sensors 19 associated with the outfeed conduits 10 to check the presence or absence of air within the same outfeed conduits 10. In particular, an optical sensor 19 is associated with each outfeed conduit 10. The optical sensor 19 are connected to the electronic processing unit 18 so that the latter can stop the operation of the peristaltic pump 14 and close the solenoid valves 11 for detecting a damage, if any, in the conduits or in the bags "Sl" or ^MS2", or more simply for checking the exhaustion of the drug inside the latter.

An interface module (not shown) is associated with the electronic processing unit 18 to allow a user to input data relating to the absolute or relative quantity of physiological saline or antineoplastic active principle. The invention also refers to a method for preparing bags for administering antineoplastic drugs which utilizes the above described mixer 1.

At first, the bags "Sl" and "S2" containing the components to be mixed are placed in the supports 5 of the holding body 2 and connected to the outfeed conduits 10 through the corresponding leakproof quick-disconnect joints 15. Once the user has made an input of data relating to the dosage of the physiological saline and antineoplastic active principle, the electronic processing unit 18 starts the peristaltic pump 14.

At the same time, the electronic processing unit 18 operates the opening of at least one of the solenoid valves

11.

Advantageously, the electronic processing unit 18 operates the opening of the solenoid valve 11 associated with the physiological saline while keeping closed the solenoid valve associated with the antineoplastic active principle. In this way, the bag intended for the patient ^λλS3" and placed on the tray 9 begins to fill up. The load cell 17 detects in real time the mass of the physiological saline held in the bag intended for the patient ^λΛS3" and communicates this data to the electronic processing unit 18.

When the electronic processing unit 18 verifies that the amount of physiological saline present in the bag intended for the patient "S3" is equal to half the whole amount of physiological saline which is to be introduced into the said bag, the same electronic processing unit 18 operates the closing of the solenoid valve 11 associated with the physiological saline.

When the solenoid valve 11 associated with the physiological saline is closed, the electronic processing unit 18 operates the opening of the solenoid valve 11 associated with the antineoplastic active principle. In the same way as above described, the load cell 17 detects in real time the mass of the antineoplastic active principle held in the bag intended for the patient "S3" and communicates this data to the electronic processing unit 18. When the electronic processing unit 18 verifies that the amount of antineoplastic active principle present in the bag intended for the patient "S3" is equal to the whole amount of the antineoplastic active principle which is to be introduced into said bag, the same electronic processing unit 18 operates the closing of the solenoid valve 11 associated with the antineoplastic active principle. Upon completion of this step, the electronic processing unit 18 operates again the opening of the solenoid valve 11 associated with the physiological saline while keeping closed the solenoid valve 11 associated with the antineoplastic active principle.

The load cell 17 detects in real time the mass of the physiological saline as it is introduced into the bag intended for the patient and communicates this data to the electronic processing unit 18. When the electronic processing unit 18 verifies that the amount of physiological saline present in the bag intended for the patient "S3" is equal to the whole amount of the physiological saline which is to be introduced into the said bag, the same electronic processing unit 18 operates the closing of the solenoid valve 11 associated with the physiological saline.

In this way, the preparation of the bag intended for the patient is completed and the peristaltic pump 14 is stopped by the electronic processing unit 18.

As above mentioned, should an optical sensor 19 detect the presence of air in the outfeed conduits 10, the electronic processing unit 18 would stop the peristaltic pump 14 and close the solenoid valves 11. The invention achieves the proposed object.

In fact, the use of the mixer according to the invention allows preparing bags for the administration of antineoplastic drugs in a very rapid and simple manner while maintaining the best safety conditions. Actually, all the operating steps are carried out automatically and repeatedly by the same mixer without requiring any intervention from specialized personnel, the latter having to merely introduce the desired quantity of components therein. Moreover, the whole mixer is leakproof and allows handling the components (and, in particular, the antineoplastic active principle) without having to expose them to the outside.

Claims

1. Mixer for preparing bags for administering antineoplastic drugs comprising: a housing unit (3) for bags ("Sl", "S2") containing a respective component to be mixed; at least two outfeed conduits (10) extending through a path controlled by two clamp-type solenoid valves (11); a peristaltic pump (14) controlled by a stepping motor; a load cell (17) for controlling the quantity of fluids introduced into a bag intended for a patient (S3) .

2. Mixer according to claim 1, characterized in that each clamp-type solenoid valve (11) is associated with any of the outfeed conduits (10) for controlling the transit of the component contained in the relevant bag (Sl, S2) .

3. Mixer according to claim 1 or 2, characterized in that it further comprises an outlet conduit (12) able to be connected to said bag intended for a patient (S3) ; said outfeed conduits (10) joining into said outlet conduit (12) .

4. Mixer according to claim 3, characterized in that it further comprises at least one leakproof ^T"-joint (13) for connecting said outfeed conduits (10) to said outlet conduit (12) .

5. Mixer according to claim 3 or 4, characterized in that said outfeed conduits (10) and said outlet conduit (12) comprise at least one quick-disconnect leakproof joint (15) located in correspondence of respective ends (10a, 12a) .

6. Mixer according to any of claims 3 to 5, characterized in that it comprises a plurality of coupling members (16) for supporting said outfeed conduits (10) and said outlet conduit (12) .

7. Mixer according to any of claims 3 to 6, characterized in that said peristaltic pump (14) is active on said outlet conduit (12) .

8. Mixer according to any of the preceding claims, characterized in that it further comprises a housing unit (7) which receives a bag intended for the patient (S3); said load cell (17) being associated with said housing unit (7) of said bag intended for the patient (S3) .

9. Mixer according to any of the preceding claims, characterized in that it further comprises an electronic processing unit (18) operatively associated with said load cell (17) and with said clamp-type solenoid valves (11) for opening/closing them according to the quantity of relevant component put into the bag intended for the patient (S3) and detected by said load cell (17) .

10. Mixer according to claim 9, characterized in that it further comprises one optical sensor (19) associated with each of the outfeed conduits (10) for checking the presence of the respective component and connected to said electronic processing unit (18) .

11. Method for preparing bags for administering antineoplastic drugs by means of a mixer according to one or more g claims 1 to 10, wherein one component is a carrier substance and the other is an active principle, said method comprising the steps of: starting the peristaltic pump (14); opening the clamp-type solenoid valve (11) associated with the carrier substance for introducing said carrier substance into the bag intended for the patient (S3) ; detecting a mass of the carrier substance within the bag intended for the patient (S3) by the load cell (17) ; closing said clamp-type solenoid valve (11) associated with the carrier substance when said load cell (17) detects a mass within said bag which is equal to half the preset mass to be introduced therein; opening the clamp-type solenoid valve (11) associated with the active principle after closing said solenoid valve associated with the carrier substance; detecting a mass of the active principle, introduced into the bag intended for the patient (S3) , by means of the load cell (17) ; closing the clamp-type solenoid valve (11) associated with the active principle when the whole preset amount of active principle results introduced into the bag intended for the patient (S3) ; opening the clamp-type solenoid valve (11) associated with the carrier substance after closing the clamp-type solenoid valve (11) associated with the active principle; detecting a mass of the carrier substance, introduced into the bag intended for the patient (S3) , by means of the load cell (17) ; closing said clamp-type solenoid valve (11) associated with the carrier substance when said load cell (17) detects a mass of carrier substance in said bag which is equal to half the preset mass to be introduced therein.