WO2014196937A1

WO2014196937A1 - A fully automatic drug preparation device with a synchronized triple verification system (stvs)

Info

Publication number: WO2014196937A1
Application number: PCT/TR2013/000361
Authority: WO
Inventors: Erhan CULHAN; Erol CELIK
Original assignee: Oncosem Onkolojik Sistemler Sanayi Ticaret Limited Sirketi
Priority date: 2013-06-07
Filing date: 2013-12-06
Publication date: 2014-12-11

Abstract

The present invention is related to a fully automatic drug preparation device comprising modular units having a synchronized triple verification system-STVS which can be used for drugs that need to be prepared with precise measuring. The present invention aims to develop a fully automatic drug preparation device which can be used to prepare drugs by carrying out precise measurements, without the direct intervention of an operator. Another aim of the invention is to provide a modular fully automatic drug preparation device which prepared several numbers of drugs at the same time by placing side by side modules that can be attached to each other in order to prepare a plurality of drugs. The invention also aims to develop a drug preparation device which carries out verification by means of a synchronized triple verification system (STVS) that measures the amount of the drug that has been used from the bottle in which the drug was placed into, that measures the weight of the drug, and the volume of the drug drawn into the injector and the weight of the drug injected into the IV bag.

Description

DESCRIPTION

A FULLY AUTOMATIC DRUG PREPARATION DEVICE WITH A SYNCHRONIZED TRIPLE

VERIFICATION SYSTEM (STVS)

Technical Field The present invention is related to a fully automatic drug preparation device comprising modular units having a synchronized triple verification system-STVS which can be used for drugs that need to be prepared with precise measuring.

Prior Art

The drug forms that are being used nowadays are produced as tablets, capsules, syrups, or liquid or powder form which have been bottled and said drugs are kept ready in such form to be given at a certain dose to patients. However in some diseases it is not possible to use fixed dosed drugs which have been prepared beforehand. Drugs prepared for premature babies, patient who are old, and intensive care and cancer patients can be given as an example to this situation. In order to carry out the medical treatments of said patients, a very precise dose needs to be prepared from a single drug or a mixture of drugs in specifically determined doses according to the gender, weight, height, age of the patients and the progress of the disease.

One of the devices used to prepare precise drug mixtures has been described in the United States patent numbered US5037390A. In said patent application, the drugs found in the bottles are connected to the injector line both in the main line and via a vane which has 2 inlets and 2 outlets by means of the single direction valves. By this means the drugs drawn out of the bottles and measured with an injector can be collected into an IV bag after being injected from the injectors. A dilution solution found at one side of the main line, ensures that the drug inside the IV bag is diluted.

One of the other examples known in the state of the art is a system comprising an injector wherein the drug is drawn inside by means of again single direction valves which has been described in the United States patent application numbered US4433974A. The injector can manually carry our injection and drawing by means of the pump said system comprises.

Another example for the preparation of drugs used currently has been described in the PCT application numbered W09515142A1. In said application the drug is drawn into the injector by means of a motor and following this, the drug is delivered to a collection point. Said system is suitable to be automated as it can operate inside a housing which accommodates all drugs inside a completely closed apparatus.

Brief description of the invention

The present invention aims to develop a fully automatic drug preparation device which can be used to prepare drugs by carrying out precise measurements, without the direct intervention of an operator. Another aim of the invention is to provide a modular fully automatic drug preparation device which prepared several numbers of drugs at the same time by placing side by side modules that can be attached to each other in order to prepare a plurality of drugs. The invention also aims to develop a drug preparation device which carries out verification by means of a synchronized triple verification system (STVS) that measures the amount of the drug that has been used from the bottle in which the drug was placed into, that measures the weight of the drug, and the volume of the drug drawn into the injector and the weight of the drug injected into the IV bag. Besides these, the invention also aims to develop a drug recognition system in order to determine the correctness of the drug used. Detailed description of the invention

The drug preparation device developed in order to reach the aims of the invention has been shown in the attached figures wherein said figures illustrate the following;

Figure 1 - shows the perspective view of the fully automatic drug preparation device subject to the invention. Figure 2 - Shows the perspective view from the top of the 5 unit, modular fully automatic drug preparation device subject to the invention.

Figure 3 - Is another perspective view from the top of the 5 unit modular fully automatic drug preparation device subject to the invention.

Figure 4 - Is the side view of the 5 unit modular fully automatic drug preparation device subject to the invention

Figure 5 - Is the plan view of the 5 unit modular fully automatic drug preparation device subject to the invention.

Figure 6 - Is the front view of the 5 unit modular fully automatic drug preparation device subject to the invention. Figure 7 - Is the front view where the lids of the 5 unit modular fully automatic drug preparation device subject to the invention are open.

Figure 8 - Is the side view of the fully automatic drug preparation device subject to the invention where the lids are open. Figure 9 - Is the detailed view of the single fully automatic drug preparation device subject to the invention.

Figure 10 - Is the single perspective view of the fully automatic drug preparation device subject to the invention, where the injector gripping lid of the injector group is closed.

Figure 11 - Is the single perspective view of the fully automatic drug preparation device subject to the invention, where the injector gripping lid of the injector group is open.

Figure 12 - Is the top view of the fully automatic drug preparation device subject to the invention, where the injector gripping lid of the injector group is closed.

Figure 13 - Is the detailed perspective view of the motor unit of the injector group of the fully automatic drug preparation device subject to the invention. Figure 14 - Is the detailed side view of the motor unit of the injector group of the fully automatic drug preparation device subject to the invention.

Figure 15 - Is the schematic view of the drug recognition device which is used together with the fully automatic drug preparation device subject to the invention.

The parts in the figures have each been numbered and the references of said numbers have been listed below.

1. Drug preparation device

2. Body

3. Lid

4. Injector group 5. Serum (drug) carrier

6. Drug holder 7. Solution pump

8. Injector slot

9. Injector cap

10. Piston motion channel 11. Piston holder

12. Motor

13. Helical gear

14. Drive shaft

15. Carrier 16. Drug recognition unit

17. Light

18. Camera

The fully automatic drug preparation device (1) subject to the invention basically comprises a body (2), an injector group (4) mounted on said body, a drug carrier (5) a drug holder (6) and a solution pump (7). The drug preparation device (1) which is to be used in order to fill a drug into an IV bag after diluting a certain drug with a kind of solution, carries out said procedures automatically. In order to reach this aim, the injector group (4) which injects the drug into the IV bag and the solution pump (7) which injects the solution again into the IV bag can perform a drawing and an injection and pumping action by means of their mechanical drive means and drive circuits.

When drug compounds are being prepared, the amount of the drug that is necessary to be diluted as it is in high content, and the amount of the solution (concentration) corresponding to the amount of drug used that is to be transferred into the IV bag needs to be monitored. This is the only way that drug concentration can be prepared correctly. As each of the drugs has high efficiency and could be harmful in the case of an overdose, the amount of the drug needs to be precisely measured before the drug is transferred. For this reason instead of directly transferring the drug into an IV bag, the drug is drawn into an injector and then transferred into the IV bag.

The fully automatic drug preparation device (1), comprises a drug holder (6) which can accommodate drug bottles, an injector group (4) which can accommodate injectors and a drug carrier (5) which carries the IV bag on it so that it is compatible with currently used components such as drug bottles, injectors and IV bags in terms of structure. The drug holder (6) which carries the concentrated amount of the drug to be prepared, is connected to the injector group (4) via a tube which has single direction valves. Said valves have been placed in the tubes such that the drug can be drawn out of the bottle into the injector during the drawing (suction) motion created by the injector. At the same time, as the injector to carries out the injection action, the drug does not flow back into the bottle but instead it is injected into the IV bag, again with the aid of the single direction valves.

In order to determine that the correct amount of drug is transferred the fully automatic drug preparation device (1) carries out 3 verifications one after the other and determines if the drug has been correctly transferred or not. These verification procedures respectfully are carried out by the following:

A weight measuring equipment (gravimetric control) of the drug holder (6) which measures the weight of the bottle which has been decreased as the drug is drawn out of it, - - A motor (12) (volumetric control) which calculates the volume of the drug drawn into the injector via the rotation the rotation amount during the motion of the injector piston and

A drug carrier (5) weight measuring equipment carries the IV bag and measures the changed weight of the IV bag; It will therefore be possible to determine by these means, the amount decreased in the drug bottle with procedures carried out successively, to determine if the specific weight of the increased volume in the injector has been filled by the drug or not and to determine if the amount decreased in the IV bag has been increased as much as the amount drawn from the bottle. Together with this, measuring the amount of the diluting solution inside the IV bag is also a necessity. However, as the error tolerance in the diluting solution is higher than the error tolerance of.the drug, a two step control shall be carried out only when measuring the solution amount. The first one of these controls, is the pumping amount of the solution pump (7). The dilution solution amount necessary to decrease the concentration of the drug, shall be drawn out from the main solution tank, bottle or bag by means of the solution pump (7) and then shall be injected into the IV bag.

The procedure carried out by the solution pump (7) shall be carried out via triggering notified by electronic drivers according to the characteristics of the tube which carries the pump and the diluting solution. However, in order to obtain a precise result, the change in the amount of the diluting solution inside the IV bag shall be determined via weight measurements and precise weighing integrated to the drug carrier (5) before the pumping action begins and after it ends. By this means, both the inspection of the operation of the solution pump (7) and the diluting solution amount via weight measuring can be monitored through two step controls.

The amount of the drug inside the IV bag can show great changes as it has been mentioned above. The injectors used in medical applications currently, work with certain error margins. When the injector volumes get higher, the precision of said injectors will decrease. The elasticity of the materials of the injectors or their volumes is important factors in the creation of said error margins. For this reason, the injector group (4) comprises injector slots (8) so that 3 different sizes of injectors can be used instead of a single sized injector. By this means, the drugs that need to be transferred with a low volume, can be transferred using a low volume injector without the need to make any changes on the device.

The injector slots (8), comprise cylinder shaped channels which can accommodate the plurality of injector bodies having 3 different sizes. After the injectors are accommodated inside said channels the injector holder cap (9) is closed and thus the injectors are fixed to their location. The injectors are also fixed with piston heads to the piston holders (11) which enable the motion of the pistons to be carried out.

After the piston holders (11) grip the piston heads, they are moved along the piston motion channel (10) and the drawing-injecting motion of the injector is created. The piston holders (11) move in order to create this motion when the injector group (4) is fixed and unmoving inside the drug preparation device (1). The motion of the piston holder (11) is performed by the moving of a carrier (15) connected to a helical gear (13) wherein the helical gear (13) is rotated with the aid of the mobile motor (12). As the carrier (15) is a part of the piston holder (11) it will ensure that the piston holder (11) moves towards the injector group (4). In order for the motion of the carrier (15) to be linear and in order for it to be moved without being twisted by the helical gear (13), the carrier (15) shall be moved on two drive shafts (14) parallel with each other.

The fully automatic drug preparation device (1) subject to the invention, is a device as mentioned in detail above, which draws the drug via an injector and transfers said drug into an IV bag or bottle by adjusting its concentration and at the same time measures all fluid actions. It can operate independently and moreover, modules can be added such that it can prepare several drugs at the same time. Together with this, the measurements that will be carried out in order to calculate if the drug has been used in the correct amount, depend actually on the correct selection of the drug. If the drug has been chosen incorrectly in the beginning it is obvious that the prepared composition will also be incorrect.

The fully automatic drug preparation device (1) can determine if the drug has been correctly selected, partially by measuring both the weight and the volume and then comparing these. However said determinations will be insufficient when drugs which have similar densities are concerned. For this reason, a RFID label reader shall be present on the drug holder (6) of the drug preparation device. This reader will determine if the correct drug has been placed into the device.

Together with this, another RFID labelling shall be provided for IV bags. The ID's of empty IV bags, shall be used during the process where the drug is monitored by matching together with the drug specifications following the preparation of the drug and during the process of applying the correct drug to a patient.

Moreover another necessity is for the users to choose the correct injector size. A key located inside the injector slots (8) shall be used to check if the correct injector has been inserted into its place and the motor (12) motion shall be provided in proportional to said injector sizes.

Each one of the precautions taken against the errors mentioned above, enables the synchronized triple verification system (STVS) to carry out correct calculations. Correct calculations can be carried out either when the calibration of all measurement devices in certain usage ranges during the drug preparation process is carried out or when it is determined that an incorrect measurement has been taken. It is sufficient for the device to give the necessary warnings and to continuously compare the measurements it has taken. However it is possible for the measurement devices to carry out incorrect measurements due to the pressure the clean air has created inside the inner volume of the system. In order to overcome this problem, calibrations shall be carried out in certain intervals according to the program which has been uploaded into the device.

After each operation of the fully automatic drug preparation device (1), certain components of the drug need to be changed so that the new drug does not get infused into the IV bag together with the residues of the previous drug if an active agent of the drug is to be changed. These components are the components of the device (1) which are not the main components such as the tubes, injectors and IV bags. By this means it shall be ensured that the drug preparation device (1) does not produce waste besides the components used and known as consumable materials. It has been mentioned above that determinations can be carried out after the drugs are inserted into the drug preparation device (1) by means of RFID tagging. However it is possible that not all drugs are tagged / labelled. The drugs are usually presented in similar colours and boxes. Moreover the same drug boxes/bottles can be used by changing only the rate of the active ingredient of the drug. In such cases, the users can make mistakes. In order to overcome these mistakes a drug preparation unit (16) shall be used.

The drug preparation unit (16) is comprised of a box which created a closed volume and ensures that the effect from the light of the environment is minimized and a light (17) and cameras (18) located inside said box. The light (17) shall continuously ensure that the light source is reflected on the drug bottle or the box, having similar characteristics. By this means, by decreasing changes, the comparison of the recorded images inside the system with the images captured by the camera (18) shall be carried out with fewer mistakes. Even if any kind of drug is placed onto the drug holder (6) without the approval of the drug recognition unit, the system will not work and as a result it shall be possible for the system to be used without mistakes.

Claims

1. A fully automatic drug preparation device (1) used for drugs that need to be prepared using precise measurements; said device comprises; o A body (2); wherein mounted on said body are the following;

■ A drug holder (6) which can accommodate drug bottles and which allows the drug inside the bottle to be drawn into the injector when the injector is drawing said drug,

■ A drug carrier (5) which carries the IV bag when the injector is carrying out the injection motion into the IV bag and not back to the drug bottle by means of the tubes attached to the single direction valves, and

■ Piston holders (11) which hold the piston of the injector that moves by means of the helical gear (13) driven by the motor (12) which can be used in order to ensure that the drug is drawn out of the drug bottle and transferred into the IV bag, by carrying out a drawing and injecting motion

Characterized in that it comprises,

■ A drug holder (6) weight measurement equipment which measures the weight of the bottle when the weight is decreased after the drug has been drawn out of the bottle,

■ A motor (12) which calculates the volume of the drug which has been drawn into the injector via the rotation amount during the motion of the injector piston and

■ An IV carrier weight measurement equipment which carries the IV bag and measures the changed weight of the IV bag;

In order to ensure that the drug is drawn out of the bottle and transferred into the IV bag following precise measurements.

2. A fully automatic drug preparation device (1) according to claim 1, characterized in that it comprises a drug carrier weight measurement equipment, or which measures the weight of the I bag to calculate the injected amount of the drug from the bottle or bag before the solution is pumped and after the solution is pumped into the bag from a solution tank, bottle or bag via the solution pump (7), in order to measure the diluting solution amount in the IV bag.

A drug preparation device (1) according to any of the preceding claims, characterized in that it comprises a RFID reader which is located on the drug holder (6) and which allows it to work by controlling the correctness of the drug placed into its place.

A drug preparation device (1) according to any of the preceding claims, characterized in that it comprises a RFID reader located on the drug carrier (5) which allows the IV bag prepared with the drug used to be tagged together with the drug.

A drug preparation device (1) characterized in that it comprises a drug recoghition unit which only allows the system to operate if the correct drugs are used which are determined by the images captured via the cameras (18) illuminated with the light (17) located inside a closed volume in order for the drug selection to be correct.