ITUD20070093A1 - EQUIPMENT FOR THE AUTOMATIC PREPARATION OF A DRUG AND ITS PROCEDURE FOR PREPARATION - Google Patents

Abstract

An apparatus (10) for the automatic preparation of a drug consisting of at least two components comprises a first container (12) for a first component, a second container (14) for a second component, a third container (16) to receive the prepared drug, an intermediate container (27) for the preparation of the drug, connected both to the third container (16) and also, by means of valve means (34, 36) selectively openable and closable, to the first container (12) and to the second container (14). The apparatus (10) also comprises an intake/injection device (20) able to be activated in intake mode to take in dosed quantities of the first and second component inside the intermediate container (27), and activated in injection mode to transfer the prepared drug from the intermediate container (27) to the third container (16), and an electronic control unit (40) suitable to manage automatically and in a coordinated manner the selective activation of the valve means (34, 36) and the intake/injection device (20).

Description

"EQUIPMENT FOR THE AUTOMATIC PREPARATION OF A DRUG AND RELATED PROCEDURE FOR THE PREPARATION"

FIELD OF APPLICATION

The present invention relates to an apparatus for the automatic preparation of a drug and to the related preparation process. In particular, the present invention can be used for the preparation and dosage of homogeneous liquid solutions or dispersions of chemical products, of synthetic or natural origin, to prepare solutions for clinical use in the human and veterinary field or for industrial use.

STATE OF THE TECHNIQUE

It is known that the preparation of a drug starting from two or more basic components contained in special containers, and the relative transfer into a container suitable for the intravenous administration of the drug itself are quite difficult, especially in the case of therapies in the oncological field which include the administration of chemotherapy drugs.

A first difficulty is linked to the fact that the prescription of a drug to the patient undergoing chemotherapy takes place following the evaluation of his clinical status and the prescribed dosages must be confirmed with a medical examination at each cycle. It follows that the unit used for the preparation of the drug with the particular dosage must quickly prepare, and often in large numbers, solutions that are always customized and different from time to time, of drug with the correct dosages, to allow, then, the nursing team to administer the therapies within the time of service, often in "day hospital".

A further difficulty is linked to the variety of molecules used and to the need to control the delivery of the preparations, depending on the use within the characteristic stability time of each preparation. The number of solutions prepared per year can be in the order of a few tens of thousands, with a few tens of different molecules, of which a good part of daily use. Another difficulty is the need to guarantee absolute sterility at every stage of the preparation cycle.

These drugs, or their components, are supplied in containers with dosages varying between about 50% and 150% of the average individual daily dose. The complexity of the therapeutic protocols may also involve the use of five different active ingredients, distributed over several days.

Typically, the drug preparation operation consists in withdrawing a solution containing the drug from a container placed in a suction hood, using a sterile syringe, visually checking, on the graduated scale of the syringe, the volume of the solution withdrawn.

The accuracy of the evaluation depends on the optical aberrations due to the parallax error in the alignment between the eye of the operator and the graduated scale of the syringe. This error can be accentuated by taking into account the interference of the glass of the extractor hood.

Subsequently, the solution withdrawn is further diluted and infused through an injection point into a bag or container made of deformable plastic material.

Since these are often toxic compounds, the dosage must be accurate, according to the measuring instruments used, such as sterile syringes and connection sets between syringe and containers, also taking care to maintain the sterility of the product using standard disinfection methods. For example, the work environment is protected by adequate techniques to prevent the production of sprays during the process of dilution, withdrawal and preparation of the drug.

The use of extractor hoods and personal protective equipment, such as gloves, work shirts and masks, allows the protection of the operator and the work areas but, at the same time, limits the space for maneuvering and makes the operations difficult. dosage, especially considering that these operations are repeated by the operator many times in a working day The repetitiveness of the operation and the practice acquired by the operator in handling the components of the drugs also leads to a decrease in attention operator itself, which increases the probability of errors. For example, the manual operation could be wrong due to the exchange of the solutions used or due to the dosage error. The solutions, in fact, are mostly colorless or with similar colors and packaging. If a mistake is made, it would be impossible to detect before administering the drug.

These errors, also considering the patient's often critical clinical picture, can have very serious consequences.

Furthermore, this type of manual preparation requires maximum precision to minimize the waste of the drug which, typically, is very expensive.

An object of the present invention is to provide an apparatus and to develop a related process which allows to automatically prepare a drug starting from several components, in a precise and safe manner, both for the patient and for the operator, of the all sterile, fast and with accurately repeatable results.

In order to obviate the drawbacks of the known art and to obtain this and further objects and advantages, the Applicant has studied, tested and implemented the present invention.

EXPOSURE OF THE FOUND

The present invention is expressed and characterized in the independent claims.

The related dependent claims disclose other characteristics of the present invention, or variants of the main solution idea.

In accordance with the above purpose, an apparatus for the automatic preparation of a drug consisting of at least two components comprises a first container for a first component, a second container for a second component and a third container for receiving the drug thus prepared.

In accordance with a characteristic aspect of the present invention, the apparatus further comprises an intermediate container for the preparation of the drug, connected both to the third container and to the first and second container by means of a valve means which can be selectively opened and closed; an aspiration / injection device, which can be activated on aspiration to aspirate metered quantities of the first and second components inside the intermediate container and which can be activated by injection to transfer the prepared drug from the intermediate container to the third container; and an electronic control unit arranged to automatically and in a coordinated manner manage the selective activation of the valve means and of the suction / injection device.

An advantageous variant of the present invention provides that the electronic unit comprises, or is associated with, storage means suitable for storing data relating to predetermined drug preparation dosages. Advantageously, moreover, the apparatus according to the invention is provided with sensor means suitable for detecting the values of the aforesaid metered quantities and for transmitting them to the electronic control unit. In this way, by comparing the stored data and the detected values, it is possible to check the correctness of the quantities of components actually aspirated, avoiding toxic effects for the patient.

Advantageously, the entire preparation operation is automated and does not directly involve the operator, except in the preparation of the component feed containers and in the start-up and possible control of the preparation procedure managed by the electronic control unit. .

The present invention thus makes it possible to automatically prepare a drug starting from several components, in a precise and safe manner, both for the patient and for the operator, rapidly and with accurately repeatable results.

Advantageously, the exact quantity of suction is checked by setting the suction / injection device, the containers and the relative connection circuits. These calibration values are entered in the electronic control unit by the operator responsible for starting each drug preparation operation or, preferably, stored once in the control unit itself.

Any change in the suction / injection device, the containers and the relative connection circuits is detected by the aforementioned sensor means and signaled to the control unit which, by means of suitable alarm means, for example acoustic and / or visual, forces the operator to insert or recall the corresponding calibration values from the memory.

The accuracy of the aspiration and the dosage thus determined also allows to reduce the waste of the drug components, allowing a considerable cost saving.

An advantageous variant of the present invention provides for the use of a sterile-type dosing syringe as an aspiration and injection device.

By using sterile containers and syringes, as well as the relative connection circuits, the equipment is made sterile as a whole and prevents contamination of the prepared drug. Advantageously, the present invention can also be used as an injector - doser during parenteral therapy as per programming controlled by the electronic control unit, by connecting the sterile syringe to an infusion line of suitable length.

ILLUSTRATION OF DRAWINGS

These and other characteristics of the present invention will become clear from the following description of a preferential embodiment, given by way of non-limiting example, with reference to the attached drawings in which:

- fig. 1 is a schematic representation of an apparatus for the automatic preparation of a drug according to the present invention; And

- fig. 2 is a schematic representation of a method for the automatic preparation of a drug according to the present invention.

DESCRIPTION OF A PREFERENTIAL FORM OF

REALIZATION

With reference to fig. 1, an apparatus 10 according to the present invention can be used for the preparation of chemotherapeutic drugs formed by two or more components and used in oncological therapies.

The apparatus 10 comprises two containers 12 and 14, a first container 12 which contains a drug in solution, at a concentration such that it must be suitably diluted to be administered to the patient, and a second container 14 which contains a diluent for the drug in solution to be diluted.

The specially prepared drug is sent, as illustrated below, in a medical bag 16

The containers 12 and 14 are of the sterile closure type, of the standard type for medical applications, as well as the medical bag 16.

The containers 12 and 14 and the medical bag 16 are placed in communication with corresponding circuits 15, 17 and 19, of the sterile type, also of the standard type for medical applications, which in turn converge to a hydraulic connection element 18, for example formed by a two-way Luer-Lock ramp.

Downstream of the connection element 18 there is a container 27, selectively in connection with the containers 12, 14 and 16, in which, as illustrated below, the mixing and preparation of the drug takes place.

Connected to the connection element 18 there are two taps 34 and 36, for example of the two or three-way type, which are associated respectively with the circuits 15 and 17, to regulate the flow quantity of drug in solution and of diluent in inlet to the connection element 18. The circuits 15 and 17 can be constituted by needles or ventilated needles which pierce the containers 12 and 14 and which are hooked, screwed or inserted in the respective taps 34 and 36. The perforation of the containers 12 and 14 it is guided by a chute or cradle or hopper on the bottom of which there are gaskets, rigid or elastic, in such a number as to regulate the emergence of the tips of the needles on the inner side of the containers 12 and 14, allowing maximum recovery of the contents of the same.

The taps 34 and 36 are operated by relative independent motors 35 and 37 to operate in coordination with each other to determine all the possible combinations of quantity of drug in solution and of diluent. These motors 35 and 37 move shaped guides, not shown in the drawings, for housing the external wings of the taps 34 and 36

The exact dosage quantities of drug in solution and diluent are selectively aspirated by a dosing syringe 20, the hollow cylinder 26 of which defines the aforementioned container 27 inside. The drug in solution and the diluent are mixed inside the cylinder 26. and from here the prepared drug is injected, through the element 18, into the medical bag 16.

In particular, the hollow cylinder 26 of the dosing syringe 20 has a Luer-Lock tip 21, inserted in the connection element 18, and a plunger 22 slidably inserted inside it.

The plunger 22 and the cylinder 26 are able to slide relative to each other, along the common longitudinal axis X, for the known suction and injection operation of the syringe 20 itself. The piston 22 is provided with a piston-pushing portion 24, which is constrained to suitable retaining fins 32.

A suitable electric motor 28, schematically represented in fig. 1, is adapted to act, by means of a transmission mechanism 29, on these fins 32, to actuate the piston-pusher 24 and thus move the piston 22 alternately, along its longitudinal axis X. If the piston 22 is moved in the direction of the arrow F in fig. 1, the syringe 20 operates in suction, while if the plunger 22 is moved in the direction of the arrow G of fig. 1, the syringe 20 operates in injection.

The transmission mechanism 29 can be constituted by a worm screw, by a screwing pin, by metallic or polymeric telescopic extensions, according to need.

The base 23 of the cylinder 26 is constrained to further fins 30, mounted on the motor 28.

The connection between the fins 30 and 32 and the base 23 and the plunger 24 can take place by means of a screw, an elastic element, a coupling tooth or by means of a vacuum.

The preparation of the drug according to the present invention is carried out on the basis of updated dosages of the drugs to be administered to each patient. In a first phase of the drug preparation process, indicated by block 51 of fig. 2, these dosages are stored in a database 42 as drug preparation data, together with the chemical-physical characteristics of the components and any other necessary data.

In a second step of the method according to the invention, the containers 12 and 14, block 52 of fig. 2.

Furthermore, in this second phase, block 53 of fig.

2, provision is made for the medical bag 16 into which the drug prepared and ready to be administered is introduced.

According to the present invention, there is then an opening phase of at least one of the two cocks 34 and 36, block 54 of fig. 2 to allow the passage of a determined metered quantity of drug in solution and / or diluent. The case in which both taps 34 and 36 are open, simultaneously or according to a predetermined sequence, to allow the passage of a determined quantity of drug in solution and diluent corresponds to the typical drug preparation phase. The case in which only the tap 36 is open corresponds to the step of washing the circuits and the syringe by means of the diluent, preparatory to the preparation of a new drug.

Subsequently, the method according to the invention provides for an aspiration step by the syringe 20, block 55 of fig. 2, which is contextual to a step of mixing the drug in solution and the diluent in the cylinder 26 of the syringe 20, to prepare the final drug.

Then there is a phase of closing the taps 34 and 36 so as to prevent unwanted returns of liquid towards the containers 12 and 14, block 56 and a subsequent phase of injection by means of the syringe 20, block 59, of the prepared drug, formed by drug in solution and diluent, in the special bag 16.

To coordinate the opening and closing of the taps 34 and 36 with the movement of the plunger 22 during the aspiration and injection phases and to ensure the correct dosage of the drug, the apparatus 10 is provided with a control unit 40, which it is also electronically connected to the clinical database 42 which reports the dosages.

The control unit 40 controls the two motors 35 and 37 of the taps 34 and 36, to selectively control their opening and closing, simultaneously or in sequence, according to the dosage foreseen for the preparation of a given drug to be administered.

Furthermore, the control unit 40 is also adapted to control the activation of the electric motor which drives the pusher 24, to determine the relative suction and injection phases.

The extent of the stroke of the plunger 22 and the opening of the taps 34 and 36 determines the quantity of drug in solution and diluent aspirated and is controlled by special electro-mechanical and / or electronic sensors 39, 41 and 43, schematically represented in the drawings.

In particular, during the aspiration phase the sensors 39, 41 and 43 detect signals relating to the metered quantities and send them to the control unit 40, as well as the sequence in which the components are aspirated through the taps 34 and 36.

These signals are used for a safety check, block 57 of fig. 2, by the control unit 40 which calculates the exact composition of the various components in the drug, verifies whether the dosages are correct, comparing them with those preset in the database 42. If the dosages are not correct, expulsion occurs, blocking 58 of fig.

2, of the drug prepared in the container 16 and the elimination of the latter, with the restoration of a new container 16, block 53 of fig. 2. If, on the other hand, the dosages are correct, proceed with the injection of the prepared drug, block 59.

The quantity and speed of transfer of the drug in solution and of the diluent through the circuits 15, 17 and 19 depends on the speed of movement of the plunger 22, controlled by the electric motor 28 in turn controlled by the unit 40. This speed, in particular , can be adjusted according to the prescribed drug dosages and also according to the nature of the components to be aspirated, for example lyophilized drug or in solution, and to the viscosity of the prepared or injected solutions, to prevent the formation of instantaneous overpressures or backflows in the containers 12 , 14 and 16.

Advantageously, moreover, the force applied by the motor to move the piston 22 is such as to allow to operate in depression and to empty the containers 12 and 14 even in the absence of an air valve, with a considerable reduction in waste. Alternatively, it is possible to use a ventilated needle and perform the same emptying operation at ambient pressure. However, the vacuum operation makes it possible to reduce the possibility of leaks in the subsequent operation of the feed container.

A further measure of safety and precision is given by a spirit level device 38.

The advantage of the invention is that the operating parts of the apparatus 10 as a whole, i.e. the motor that drives the syringe 20, the syringe 20 itself, the taps 34 and 36 with the relative motors 35 and 37 and part of the circuits 15, 17 and 19, they have a reduced overall size, so that they can be easily housed on the worktop of chemical, microbiological or chemotherapeutic hoods and of isotechnical isolators.

Advantageously, the containers 12, 14 and 16 used are provided with optical or electromagnetic reading identification labels, for example bar codes, so that each data entry operation relating to the components used in the control unit 40 can be validated. by automatic reading, considerably reducing the possibility of errors encountered in the manual introduction of such data to the keyboard deck. In particular, at the end of the preparation of the drug, the control unit 40 commands the printing of a bar code which certifies the correct sequence and conformity of the preparation and which contains the references of final destination, of the sequence of operations carried out and of the operators. intervened. An RFID tag can be used as an alternative to the barcode, which also gives the advantage of traceability.

Advantageously, moreover, the apparatus 10 can be aligned with other identical apparatuses for battery operation on the work surface of the hoods or on a surface suspended by means of a lattice outside the hoods. The modularity of the apparatus 10 makes it possible to associate several drug preparation lines in a battery under the same hood or insulator. In this case the connections and the electrical supplies and the electrical panels for the operation of the appliances 10 themselves can be arranged towards the outside of the work surface of the hoods and flow independently, through an electrical circuit, to the single control unit 40. Thus , simultaneous operation of the individual lines is possible even in the event of an interruption or failure of an equipment.

It is clear that modifications and / or additions of parts and / or phases can be made to the apparatus for the automatic preparation of a drug and to the relative preparation process described up to now, without thereby departing from the scope of the present invention.

For example, it falls within the scope of the present invention that the motor 28 which controls the movement of the piston 22 is of the pneumatic type and that this movement is transmitted directly or by mechanical transmission and that it is electro-mechanically controlled.

Furthermore, the motors 35 and 37, instead of shaped guides, can be provided with pliers or hooks or clamps, to operate the external wings of the taps 34 and 36.

Furthermore, the motor 28 can be shaped in such a way as to collect any leaks from the circuits 15 and 17 and be made of material resistant to corrosion by chemical substances used in the reclamation of the work areas and / or chemical neutralization.

Advantageously, moreover, a transparent shell that surrounds the syringe 20 and the taps 34 and 36 can be mounted on the motor 28 to detect and / or confine any sprays that develop.

It is also clear that, although the present invention has been described with reference to specific examples, a person skilled in the art will be able to realize other equivalent forms of apparatus for the preparation of a drug and of the related preparation process, having the characteristics expressed in the claims and therefore all falling within the scope of protection defined by them.

Claims (1)

CLAIMS 1. Apparatus for the automatic preparation of a drug consisting of at least two components comprising a first container (12) for a first of said components, a second container (14) for a second of said components, a third container (16) for receiving the drug prepared, characterized in that it additionally includes: - an intermediate container (27) for the preparation of said drug connected both to said third container (16) and to said first container (12) and to said second container, through valve means (34, 36) which can be selectively opened and closed (14); - an aspiration / injection device (20) which can be activated on aspiration to aspirate metered quantities of said first and second component inside said intermediate container (27) and which can be activated by injection to transfer the prepared drug from said intermediate container (27) to said third container (16); - an electronic control unit (40) arranged to manage automatically and in a coordinated manner the selective activation of said valve means (34, 36) and of said suction / injection device 2. Apparatus as in claim 1, characterized by the fact that the electronic control unit (40) is associated with, or comprises, storage means (42) suitable for storing data relating to predetermined drug preparation dosages. 3. Apparatus as in claim 1 or 2, characterized in that it also comprises sensor means (39, 41, 43) suitable for detecting the values of the metered quantities and for transmitting them to the electronic control unit (40). 4. Apparatus as in any one of the preceding claims, characterized in that it comprises motorization means (28), controlled by the electronic control unit (40), which are adapted to activate the suction / injection device (20). 5. Apparatus as in any one of the preceding claims, characterized in that the suction / injection device consists of a dosing syringe (20) comprising a tubular element (26), which defines the intermediate container (27), and a plunger (22) sliding inside the tubular element (26). 6.Procedure for the automatic preparation of a drug consisting of at least two components, characterized in that it includes: - a first step in which the data relating to predetermined preparation dosages of said drug are stored in storage means (42) associated with an electronic control unit (40); - a second step in which at least a first container (12) is provided for a first of said components, a second container (14) for a second of said components and a third container (16) for receiving the prepared drug; - a third step in which, by means of said electronic control unit (40), valve means (34, 36) associated with an intermediate container (27) for the preparation of said drug are selectively opened to put the first container (12) into communication ) and the second container (14) with said intermediate container (27); - a fourth phase in which, by means of the electronic control unit (40), an aspiration / injection device (20) is activated in the aspiration to aspirate, selectively, metered quantities of the first component and of the second component inside of the intermediate container (27), and in which, in correlation with the aspiration, the mixing of said components and the preparation of the drug is carried out; - a fifth step in which, by means of said electronic control unit (40), said valve means (34, 36) are closed; - a sixth step in which, by means of said electronic control unit (40), the suction / injection device (20) is activated by injection to transfer the prepared drug from the intermediate container (27) to the third container (16). 7. Process as in claim 6, characterized in that in the fourth phase there is a detection of values of the metered quantities by means of sensor means (39, 41, 43) and a transmission of the values to the electronic control unit (40) and that , before the sixth step, a step is provided for verifying the metered quantities on the basis of the data stored in the storage means (42). 8. Apparatus for the automatic preparation of a drug and related preparation process, substantially as described, with reference to the attached drawings.