WO2014196937A1 - Dispositif entièrement automatique de préparation de médicament ayant un système de vérification triple synchronisé (stvs) - Google Patents

Dispositif entièrement automatique de préparation de médicament ayant un système de vérification triple synchronisé (stvs) Download PDF

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Publication number
WO2014196937A1
WO2014196937A1 PCT/TR2013/000361 TR2013000361W WO2014196937A1 WO 2014196937 A1 WO2014196937 A1 WO 2014196937A1 TR 2013000361 W TR2013000361 W TR 2013000361W WO 2014196937 A1 WO2014196937 A1 WO 2014196937A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
bag
preparation device
injector
bottle
Prior art date
Application number
PCT/TR2013/000361
Other languages
English (en)
Inventor
Erhan CULHAN
Erol CELIK
Original Assignee
Oncosem Onkolojik Sistemler Sanayi Ticaret Limited Sirketi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Oncosem Onkolojik Sistemler Sanayi Ticaret Limited Sirketi filed Critical Oncosem Onkolojik Sistemler Sanayi Ticaret Limited Sirketi
Publication of WO2014196937A1 publication Critical patent/WO2014196937A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/002—Compounding apparatus specially for enteral or parenteral nutritive solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14232—Roller pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6009—General characteristics of the apparatus with identification means for matching patient with his treatment, e.g. to improve transfusion security
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6054—Magnetic identification systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/04—Tools for specific apparatus
    • A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/1684—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion
    • A61M5/16845—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion by weight

Definitions

  • 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 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.
  • 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.
  • 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 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.
  • 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.
  • STVS synchronized triple verification system
  • 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.
  • Piston motion channel 11 Piston holder
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the injector group (4) comprises injector slots (8) so that 3 different sizes of injectors can be used instead of a single sized injector.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un dispositif de préparation de médicament entièrement automatique, ledit dispositif comportant des unités modulaires ayant un système de vérification triple synchronisé (STVS) qui peut être utilisé pour des médicaments qui doivent être préparés avec des mesures précises. La présente invention vise à développer un dispositif de préparation de médicament entièrement automatique qui peut être utilisé pour préparer des médicaments en exécutant des mesures précises, sans l'intervention directe d'un opérateur. L'invention concerne également un dispositif de préparation de médicament entièrement automatique, modulaire, qui permet de préparer plusieurs médicaments en même temps en plaçant côte-à-côte des modules qui peuvent être attachés l'un à l'autre de façon à préparer une pluralité de médicaments. L'invention concerne également un dispositif de préparation de médicament qui exécute une vérification au moyen d'un système de vérification triple synchronisé (STVS) qui mesure la quantité du médicament qui a été utilisée dans la bouteille dans laquelle le médicament était placé, qui mesure le poids du médicament et le volume du médicament aspiré dans l'injecteur et le poids du médicament injecté dans le sac pour perfusion intraveineuse.
PCT/TR2013/000361 2013-06-07 2013-12-06 Dispositif entièrement automatique de préparation de médicament ayant un système de vérification triple synchronisé (stvs) WO2014196937A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR201306903 2013-06-07
TR2013/06903 2013-06-07

Publications (1)

Publication Number Publication Date
WO2014196937A1 true WO2014196937A1 (fr) 2014-12-11

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PCT/TR2013/000361 WO2014196937A1 (fr) 2013-06-07 2013-12-06 Dispositif entièrement automatique de préparation de médicament ayant un système de vérification triple synchronisé (stvs)

Country Status (1)

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WO (1) WO2014196937A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106880886A (zh) * 2017-03-30 2017-06-23 青岛祥智电子技术有限公司 一种输液自动换瓶装置
CN113855562A (zh) * 2021-09-16 2021-12-31 武汉大学 一种药物抽吸设备及方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4433974A (en) 1981-06-17 1984-02-28 Baxter Travenol Laboratories, Inc. Mixing system for parenteral liquids
US5037390A (en) 1989-12-28 1991-08-06 Kenneth Raines System and method for mixing parenteral nutrition solutions
WO1995015142A1 (fr) 1993-12-03 1995-06-08 Technology 2000 Incorporated Systeme de melange robotise
EP1779830A1 (fr) * 2005-11-01 2007-05-02 Ingenium Universal ApS Dispositif et méthode de transfert de médicaments
US20100245056A1 (en) * 2009-03-30 2010-09-30 Mckesson Automation Inc. Methods, apparatuses, and computer program products for monitoring a transfer of fluid between a syringe and a fluid reservoir

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4433974A (en) 1981-06-17 1984-02-28 Baxter Travenol Laboratories, Inc. Mixing system for parenteral liquids
US5037390A (en) 1989-12-28 1991-08-06 Kenneth Raines System and method for mixing parenteral nutrition solutions
WO1995015142A1 (fr) 1993-12-03 1995-06-08 Technology 2000 Incorporated Systeme de melange robotise
EP1779830A1 (fr) * 2005-11-01 2007-05-02 Ingenium Universal ApS Dispositif et méthode de transfert de médicaments
US20100245056A1 (en) * 2009-03-30 2010-09-30 Mckesson Automation Inc. Methods, apparatuses, and computer program products for monitoring a transfer of fluid between a syringe and a fluid reservoir

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106880886A (zh) * 2017-03-30 2017-06-23 青岛祥智电子技术有限公司 一种输液自动换瓶装置
CN106880886B (zh) * 2017-03-30 2020-01-10 青岛大学附属医院 一种输液自动换瓶装置
CN113855562A (zh) * 2021-09-16 2021-12-31 武汉大学 一种药物抽吸设备及方法

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