WO2016155453A1 - Dispositif d'injection de médicament liquide emballé de manière flexible et procédé d'injection - Google Patents

Dispositif d'injection de médicament liquide emballé de manière flexible et procédé d'injection Download PDF

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Publication number
WO2016155453A1
WO2016155453A1 PCT/CN2016/075295 CN2016075295W WO2016155453A1 WO 2016155453 A1 WO2016155453 A1 WO 2016155453A1 CN 2016075295 W CN2016075295 W CN 2016075295W WO 2016155453 A1 WO2016155453 A1 WO 2016155453A1
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WO
WIPO (PCT)
Prior art keywords
liquid
liquid medicine
outlet
injection
fluid
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Application number
PCT/CN2016/075295
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English (en)
Chinese (zh)
Inventor
吴金韦
肖忠兵
牛丽萍
陈仕洪
Original Assignee
上海司太立制药有限公司
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Application filed by 上海司太立制药有限公司 filed Critical 上海司太立制药有限公司
Publication of WO2016155453A1 publication Critical patent/WO2016155453A1/fr

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    • 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

Definitions

  • the invention relates to an injection system, in particular to a soft packaging liquid injection device and an injection method.
  • the high-pressure injection system is a common auxiliary device in the medical imaging system, and its function is to ensure that a sufficient amount of high-concentration contrast agent is quickly injected into the examination site within a certain period of time.
  • High-pressure injection systems are now widely used in a variety of angiographic examinations, CT-enhanced contrast scans, and MRI-enhanced scans.
  • the contrast agent used in X-ray CT angiography and MRI angiography has a large viscosity characteristic, and a chemical solution having a large injection viscosity such as a contrast agent for X-ray ray CT contrast (such as iohexol, iodixanol, iopamidol, etc.) Iodine X-ray contrast agents) and contrast agents for MRI (such as bismuth glucosamine, guanidinium citrate, etc.) require high-pressure injection, which is difficult to handle by hand and has high work intensity.
  • a contrast agent for X-ray ray CT contrast such as iohexol, iodixanol, iopamidol, etc.
  • Iodine X-ray contrast agents such as bismuth glucosamine, guanidinium citrate, etc.
  • MRI such as bismuth glucosamine, guanidinium citrate, etc.
  • high-pressure injection systems there are two types of high-pressure injection systems that have been marketed.
  • One is a high-pressure injection system containing an injection syringe, which is characterized in that the contrast agent is first drawn into the syringe barrel and then injected into the contrast portion by high pressure (such as Empower CTA). High pressure syringe).
  • An injection device containing an injection syringe is disclosed in the patent document entitled "Potoscope High Pressure Syringe and Its Components" on June 25, 2014, the Chinese Patent Application No. 2014100587909.
  • the other is a contrast injection system that does not contain a syringe.
  • the peristaltic pump is used as a high-pressure power to inject contrast into the contrast through a pump hose (such as the Ulrich Missouri high-pressure syringe made in Germany).
  • a high-pressure injection system containing a syringe has the following drawbacks: after the end of one patient's injection, the next patient does not come, and the plunger of the syringe fails to retreat to the root of the syringe in time, causing the inner wall of the high-pressure syringe to be exposed to the air for too long. Contaminated; when the high-pressure syringe draws the drug, the drug stopper should be opened, the dust in the air, the debris in the hand may contaminate the drug; the high-pressure syringe syringe currently used is disposable, otherwise there will be a cross The risk of contamination, but this will increase the patient's medical costs.
  • bubbles are generated in the process of generating high-pressure power by the peristaltic pump squeeze pump hose.
  • a bubble detecting device is designed, once the bubble is generated, the bubble detector The detection of the bubble will automatically interrupt the injection, which will affect the injection of the contrast agent. If the detection device fails, the bubble may be injected into the human body, which may cause the risk of embolism.
  • the invention provides a reusable and injection-safe soft-packing liquid medicine injection device and a method for injecting the same, which solves the problem that the existing injection system cannot be reused and cross-contamination or generation occurs. Air bubbles cause the injection to be interrupted or the risk of embolism.
  • a flexible packaging liquid injection device comprising: a fluid delivery pump and a closable sealed container, the sealed container is provided with a medical liquid outlet and the same fluid The fluid inlet and outlet connected to the outlet end of the transfer pump.
  • the hermetic container comprises a first half and a second half that is sealingly and sealingly connected to the first half, and the medical liquid outlet is disposed in the first half and the second half between.
  • the convenience in sealing and the convenience in replacing the drug delivery tube can be achieved.
  • the chemical liquid outlet is provided with a sealing member
  • the sealing member comprises an elastic sealing tube located in the closed container and a connecting ring sealingly connected at one end of the elastic sealing tube, and the connecting ring is sealingly connected at the medicine liquid outlet
  • the inner surface of the elastic sealing tube is a conical surface, and an opening area of one end of the elastic sealing tube connected to the connecting ring is large, and an opening area away from one end of the connecting ring is small.
  • the outer diameter of the liquid medicine delivery tube When the outer diameter of the liquid medicine delivery tube is increased to the inner surface of the end of the elastic sealing tube having a large opening area, the inner diameter of the liquid medicine delivery tube is sealed and wrapped on the liquid medicine delivery tube, and the liquid medicine delivery tube of the largest outer diameter that can be installed in the present invention;
  • the outer diameter of the conveying pipe When the outer diameter of the conveying pipe is narrowed to the inner surface of only one end of the elastic sealing pipe having a small opening area, the inner surface of the conveying pipe is sealed and wrapped on the chemical liquid conveying pipe, and is the smallest outer diameter medical liquid conveying pipe which can be installed in the present invention. It can adapt to the sealing of the liquid medicine delivery tube with different outer diameters, and the sealing parts do not need to match the size of the liquid medicine delivery tube one by one.
  • the elastic sealing tube is located in the closed container, and the pressure of the fluid is sufficient to squeeze the elastic sealing tube to enhance the strong sealing effect.
  • the elastic sealing tube is a reversible structure.
  • the elastic sealing tube is turned over to the inner surface facing outward, then the liquid medicine delivery tube is inserted into the elastic sealing tube, and then the liquid medicine delivery tube is pulled to the elastic sealing tube to be turned into the inner surface inward.
  • the sealing tube is worn and the sealing effect is lowered.
  • the “elastic sealing tube is a reversible structure” can reduce the inner surface of the elastic sealing tube when the liquid medicine conveying tube is twitched in the elastic sealing tube. The wear of the sealing surface has little effect on the sealing performance of the sealing member during the process of installing the chemical liquid conveying pipe to the elastic sealing pipe.
  • the sealed container is provided with a support frame for storing the chemical liquid soft bag in a suspended state in a closed state.
  • the entire outer surface of the soft bag of the medical liquid can be squeezed by the fluid, so that the liquid medicine in the soft bag of the liquid medicine can be sufficiently discharged and the soft bag is less likely to be damaged.
  • the invention also includes a fluid storage tank coupled to the inlet end of the fluid transfer pump. By fluidly squeezing the soft bag of the drug solution, it is more convenient to directly control the injection speed and amount of the drug solution by controlling the flow rate and speed of the fluid delivery pump.
  • the fluid inlet and outlet are provided at the bottom of the closed container.
  • the fluid injected into the sealed container can be easily discharged completely.
  • the control of the injection volume is more accurate.
  • a heating device is provided in the sealed container. It can keep the liquid at the set temperature, usually about 37 °C. Since 37 °C is close to the human body temperature, it not only solves the problem of human tolerance, but also helps to reduce the viscosity of the contrast agent, which is beneficial to the injection.
  • a soft packaging liquid injection method comprising the following steps
  • the soft liquid bag containing the liquid medicine to be injected is placed in a closed container, so that the liquid medicine delivery tube connected with the soft bag of the medical liquid passes through the liquid medicine outlet;
  • the fluid is transported through the fluid inlet and outlet to the sealed container through the fluid transfer pump, and the fluid input into the closed container is discharged to the soft bag of the medical liquid to realize the injection of the liquid in the soft bag of the liquid medicine through the liquid medicine delivery tube.
  • the first step of the liquid medicine delivery tube is sealed and connected to the liquid medicine inlet; in the second step, the injection speed and the injection amount are controlled by controlling the output speed and output of the fluid delivery pump.
  • the liquid medicine delivery tube is sealed and connected to the liquid medicine inlet by the following method:
  • the elastic sealing tube is turned over to the inner surface of the elastic sealing tube facing outward and protrudes through the liquid medicine outlet to the closed container;
  • the liquid medicine delivery tube is passed through the sealing member from the inside of the sealed container to the outside of the closed container, and the outer surface of the elastic sealing tube is elastically clamped on the liquid medicine conveying tube under the elastic force of the elastic sealing tube;
  • the present invention has the advantage that the injection speed and the injection amount of the liquid medicine can be conveniently calculated by the conveying speed and the output amount of the conveying fluid, and the prior art is capable of the pumping amount and the output speed (such as a metering pump) of the pump. Accurate and convenient to obtain, so that the injection speed and amount of the liquid medicine can be easily and accurately known, the existing control injection speed is known by the sensory (such as the spotting), and the injection volume is obtained by manual observation.
  • the accuracy is inconvenient and inconvenient, and it is impossible to realize the injection of the liquid medicine in a half-bag manner (that is, one bag must be injected once); without the syringe, the liquid medicine can be completely avoided, and the cross infection can be completely avoided;
  • bubble generation which solves the defect of bubble generation by the peristaltic pump as the high-pressure power injection system, avoids the interruption of the injection operation due to the generation of the bubble, and improves the safety of the injection of the contrast agent; it is not necessary to use the disposable high-pressure injection syringe which is expensive to manufacture.
  • the medicine bag Directly through the extrusion of the medicine bag for injection, after the injection is completed, the medicine bag can be replaced, the cost of manufacture is relatively low, and the medical cost is reduced.
  • Embodiment 1 is a schematic structural view of Embodiment 1 of the present invention.
  • FIG. 2 is a schematic view showing the state of use of the first embodiment
  • FIG. 3 is a schematic view of a hermetic container in Embodiment 2 of the present invention.
  • FIG. 4 is a schematic view of a hermetic container according to Embodiment 3 of the present invention.
  • Figure 5 is a schematic view of the preparation of the liquid medicine delivery tube into the seal
  • Figure 6 is a schematic view of the liquid medicine delivery tube when it has been worn into the seal
  • Figure 7 is a schematic view of the seal when it is sealingly attached to the liquid delivery tube.
  • a closed container 1 a liquid medicine outlet 11, a fluid inlet and outlet 12, a first half 13, a second half 14, a hinge 15, a door buckle 16, a support frame 17, a liquid storage tank 2, a breathing hole 21,
  • a flexible packaging liquid injection device includes a hermetic container 1, a liquid storage tank 2, and a fluid transfer pump 3.
  • the sealed container 1 is provided with a chemical liquid outlet 11 and a fluid inlet and outlet port 12.
  • the fluid inlet and outlet 12 is provided at the bottom of the hermetic container 1.
  • the 1 closed container 1 includes a first half 13 and a second half 14. The first half 13 and the second half 14 are hinged together by a hinge 15.
  • a door buckle 16 is provided between the first half portion 13 and the second half portion 14. The first half 13 and the second half 14 are closed together and the buckle 16 is sealed together when buckled.
  • a support frame 17 is provided in the hermetic container 1.
  • a temperature-controlled heating device (not shown) is provided in the hermetic container 1.
  • the liquid storage tank 2 is provided with a breathing hole 21 and a liquid outlet 22.
  • the liquid outlet 22 is provided with a valve 23.
  • the outlet end of the fluid transfer pump 3 is docked with the fluid inlet and outlet 12.
  • the inlet end of the fluid transfer pump 3 is connected to the outlet port 22.
  • the method for injecting a soft-packed liquid medicine by the soft-pack liquid medicine injection device of the present invention is as follows:
  • the door buckle 16 is opened, and the first half 13 and the second half 14 are separated by the hinge 15 as a shaft, and the soft liquid bag 4 containing the liquid medicine to be injected is placed on the support frame 17, so that the same
  • the drug solution delivery tube 5 to which the chemical liquid soft bag is connected is passed through the drug solution outlet port 11.
  • the liquid medicine delivery tube 5 and the medical liquid supply port 11 are sealed and sealed together by a sealing ring.
  • the first half 13 and the second half 14 are closed, and the door buckle 16 is fastened to seal the first half 13 and the second half 14 together.
  • the valve 23 and the fluid transfer pump 3 are opened, and the fluid transfer pump 3 delivers the fluid (specifically water) in the liquid storage tank 2 to the closed container 1 through the fluid inlet and outlet 12, and inputs the fluid pair in the closed container 1.
  • the entire surface of the soft bag 4 is discharged, and the drug solution in the soft bag 4 of the drug solution is discharged from the drug delivery tube 5 to effect injection.
  • the injection speed and the amount of injection are controlled by controlling the output speed and output of the fluid delivery pump.
  • the appearance volume of the soft bag of liquid medicine In the middle of the injection to be injected The appearance volume of the soft bag of liquid medicine.
  • the method of determining whether the liquid medicine in the soft bag 4 of the drug solution is injected during the injection process is that by detecting the outlet pressure of the fluid transfer pump 3, when the outlet pressure of the fluid transfer pump 3 is detected to rise, the injection is completed. After the injection, the fluid transfer pump 3 is reversed, and the liquid, that is, the water in the sealed container 1, is again sucked back into the liquid storage tank 2 for the next repeated use. At this point, the injection of a bag of liquid medicine is completed, and the above process is repeated to carry out the injection of the next bag of the drug solution.
  • the heating device is turned on during the injection to keep the temperature of the liquid in the soft bag 4 of the drug solution at about 37°.
  • the drug solution outlet 11 is disposed between the first half 13 and the second half 14.
  • the seal 6 includes a resilient sealing tube 61 and a connecting ring 62.
  • the connecting ring 62 and the elastic sealing tube 61 are of unitary construction and are a sealed connection.
  • the elastic sealing tube 61 is of a reversible structure.
  • the elastic sealing tube 61 is located inside the hermetic container 1.
  • the inner surface 611 of the elastomeric sealing tube is a conical surface.
  • the outer surface 612 of the elastomeric sealing tube is a conical surface.
  • One end of the elastic sealing tube 61 connected to the connecting ring has a large outer radius and a small outer radius at the other end.
  • the one end of the elastic sealing tube 61 connected to the connecting ring has a large opening area and the opening area at the other end is small.
  • Between the connecting ring 62 and the elastic sealing tube 61 is a curved transition.
  • the liquid medicine delivery tube is sealed and connected with the liquid medicine inlet by the following method:
  • the elastic sealing tube 61 is turned over to the inner surface 611 of the elastic sealing tube facing outward and the elastic sealing tube 61 is extended out of the hermetic container 1 through the chemical liquid output port 11.
  • the liquid medicine delivery tube 5 is passed through the sealing member 6 from the inside of the hermetic container 1 to the outside of the hermetic container, and the outer surface 612 of the elastic sealing tube is elastically clamped under the elastic force of the elastic sealing tube 61. On the drug delivery tube 5.
  • the liquid medicine delivery tube 5 is pulled inside the sealed container 1, and the elastic sealing tube 61 is turned over to the inner surface 611 of the elastic sealing tube inward, and the inside of the tube is elastically sealed under the elastic force of the elastic sealing tube 61.
  • the surface is sealed on the liquid medicine delivery tube, and the liquid medicine delivery tube 4 is pulled toward the outside of the sealed container, so that the elastic sealing tube 61 is turned over to the inner surface 611 of the elastic sealing tube, and the elastic sealing tube is elastically acted upon by the elastic force of the elastic sealing tube 61.
  • the inner surface 611 is sealed on the liquid medicine delivery tube 5.
  • the liquid soft bag 4 is discharged by liquid.
  • a gas it is also possible to use a gas, but when the gas is used, the accuracy of the injection speed and the injection amount is not as good as the speed of the fluid transfer pump 3 and the output. Use liquid.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif d'injection de médicament liquide emballé de manière flexible comprend une pompe de distribution de fluide (3) et un contenant étanche (1) qui est capable d'être ouvert et fermé. Le récipient étanche (1) est pourvu d'une ouverture de sortie de médicament liquide (11) et d'une ouverture d'entrée et de sortie de fluide (12) connectée à une extrémité de sortie de la pompe de distribution de fluide (3). Le dispositif d'injection de médicament liquide emballé de manière flexible peut être réutilisé et est sans danger pour l'injection.
PCT/CN2016/075295 2015-04-01 2016-03-02 Dispositif d'injection de médicament liquide emballé de manière flexible et procédé d'injection WO2016155453A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510149717.7 2015-04-01
CN201510149717.7A CN104874048A (zh) 2015-04-01 2015-04-01 软包装药液注射装置及注射方法

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WO2016155453A1 true WO2016155453A1 (fr) 2016-10-06

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WO (1) WO2016155453A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104874048A (zh) * 2015-04-01 2015-09-02 上海司太立制药有限公司 软包装药液注射装置及注射方法
CN113456928B (zh) * 2021-07-08 2023-04-07 广州友沃医疗设备有限公司 一种按压式高压注射器

Citations (8)

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JPH10113385A (ja) * 1996-10-15 1998-05-06 Nissho Corp 薬液持続注入具
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CN104874048A (zh) * 2015-04-01 2015-09-02 上海司太立制药有限公司 软包装药液注射装置及注射方法

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Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH10113385A (ja) * 1996-10-15 1998-05-06 Nissho Corp 薬液持続注入具
CN2376926Y (zh) * 1999-05-28 2000-05-10 徐允中 软包装输液袋便携式加压输液器
JP2001269412A (ja) * 2000-03-23 2001-10-02 Top:Kk ガストロストミーチューブセット
CN2613269Y (zh) * 2003-04-18 2004-04-28 程定超 医用加压输注灌注器
CN201105054Y (zh) * 2007-12-03 2008-08-27 张月香 软包装液体快速输液加压装置
CN102958459A (zh) * 2010-05-27 2013-03-06 内斯特斯公司 医用和外科应用的中压和高压脉冲式液体射流发生器
CN204543104U (zh) * 2015-04-01 2015-08-12 上海司太立制药有限公司 软包装药液注射装置
CN104874048A (zh) * 2015-04-01 2015-09-02 上海司太立制药有限公司 软包装药液注射装置及注射方法

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