WO2023287388A1 - Dispositif de perfusion - Google Patents

Dispositif de perfusion Download PDF

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Publication number
WO2023287388A1
WO2023287388A1 PCT/UA2022/000016 UA2022000016W WO2023287388A1 WO 2023287388 A1 WO2023287388 A1 WO 2023287388A1 UA 2022000016 W UA2022000016 W UA 2022000016W WO 2023287388 A1 WO2023287388 A1 WO 2023287388A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
solution
infusion device
filter
dropper
Prior art date
Application number
PCT/UA2022/000016
Other languages
English (en)
Inventor
Larysa Antonivna HRYNENKO
Original Assignee
Hrynenko Larysa Antonivna
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 Hrynenko Larysa Antonivna filed Critical Hrynenko Larysa Antonivna
Publication of WO2023287388A1 publication Critical patent/WO2023287388A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1411Drip chambers

Definitions

  • the invention relates to a field of medicine, namely, to a medical technology, and it is intended to infuse solutions to a human bloodstream in a medical practice, and it is for a disposable use.
  • Infusion is a slow infusion of a substance to a vein at a controlled or required rate; usually, this method is used to supplement for a lost body fluid and electrolytes, to administer blood products or to perform an extended administration of drug substances (e.g., antibiotics or pain medications etc.), as well as to feed a patient.
  • drug substances e.g., antibiotics or pain medications etc.
  • the infusion therapy means an intravenous administration of the infusion solutions to recover a deficiency of the blood circulation volume, to correct a water-electrolyte and an acid-base balance, and to administer drugs which could not be taken by the patient orally, or when only a parenteral administration route is possible.
  • Anti-bacterial, anti-viral, and anti-tumor chemotherapy when anti-bacterial, anti-viral or cytostatic drugs are administered, may serve as another example.
  • the infusion therapy utilizes an infusion device which is referred to as “an infusion system” in medical field, while its main purpose is to infuse blood substitutes and infusion solutions to the human blood stream.
  • the Applicant is aware of a large number of infusion devices, since the infusion therapy is known for a long time, and devices for the infusions have been continuously improving in the course of development and gaining knowledge by humanity.
  • the Applicant has revealed several technical solutions which are the closest ones to the proposed invention in terms of essential features.
  • a drawback of the proposed technical solution lies in that a needle to be introduced into a solution medium is made completely plastic, thereby leading to a formation of a large rapture in a bottle cap or in a package with the solution, and the drag may pour out of the bottle not through a dropper, but outside the dropper. Then, in order to fill the dropper with the solution from the bottle, it is required to move the dropper for several times, to tilt it, i.e., to adjust the filling of the dropper.
  • the device does not comprise a separate filter for the solution after an additional port for administration of the solution, where its main function could have lied in holding air droplets and all microparticles which could enter the device during an additional infusion of other solutions by means of syringes and other means and deices, and the air during an additional administration of medicines or in case of any incorrect filling of the dropper.
  • This filter protects the patient’s blood stream, during performing infusions, from entering of any types of contaminations, particles, air droplets, which are possible during such manipulation.
  • Patents Nos. UA62793 and UA62794 as of 12.09.2011 are known, which are taken as analogues, wherein a technical solution according to the patent UA62793 comprises a needle with two longitudinal openings, a plastic connector having an upper side to which the needle with the two longitudinal openings is secured, and a lower side with a vessel (namely, a dropper) for a drug is mounted with a special filter, wherein, an air intake valve is arranged on a lateral side of the plastic connector, the valve being equipped with an air cleaning filter, a drum flow controller, a plastic Luer Lock connector with a plug, a plastic tube that connects the drum flow controller to the vessel on one side, while connecting the drum flow controller to the Luer Lock controller with the plug on another side, and a solution according to the patent No.
  • UA62793 comprises a metal needle with two longitudinal openings, a plastic connector having an upper side to which the needle with the two longitudinal openings is secured, and a lower side on which a vessel (namely, a dropper) for a blood, blood components or blood substitutes with a special filter for cleaning the blood, blood components or blood substitutes is mounted, wherein an air intake valve is arranged on a lateral side of the plastic connector, the valve being equipped with an air cleaning filter, an elastic connector (port), a blood, blood components or blood substitutes flow controller, a plastic tube with the blood, blood components or blood substitutes flow controller that is put on the tube so as to be capable of sliding along the tube, and the tube interconnects the blood, blood components or blood substitutes vessel and the elastic connector (port), a plastic Luer Lock connector having a one side that is connected to a proximal end of the elastic connector (port) and another side that is connected to an intravenous catheter or to a venous needle.
  • a vessel namely, a dropper
  • Drawbacks of said solutions lie in that the needle to be introduced into a solution medium is made completely plastic or completely metal. When the needle is made completely plastic, a large rupture will be formed in a bottle cap or in a package with the solution, and the drug may pour out of the bottle not through a dropper, but outside the dropper.
  • the needle is completely metal and it is long as provided in the mentioned analogues, then, until the bottle is completely filled with the solution, the needle will enter the bottle highly through the cover, however, when the solution is gradually reduced in the bottle, it will be necessary for a medical personnel to move downwardly (from the bottle), thereby enabling the solution to pour from the bottle outside the device or, if there is no movement, then a rather large amount of the solution from the bottle that remains within the bottles will not be infused to the patient. And the medical personnel must adjust the dropper additionally to provide functioning, thereby disturbing a sterility of the infusion of the solution to the human blood stream.
  • the needle is jointly made with the dropper, as made in the devices according to the mentioned patents, if the required moves of the dropper are made, then the needle will be loosened in the bottle cap and this may lead to a leakage of the solution outwardly, not through the dropper.
  • the additional port for infusion of the solution is a latex tube piece that must be pierced by the syringe needle to provide the additional infusion of the solution into the device, which may cause many complications, in particular, firstly, a possible case that the medical personnel may pierce the latex tube piece through and the solution will flow outwardly, rather than to the device, and injures (piercing) of the patient’s body may be possible; secondly, the latex may cause an allergy both in the patient and in the medical personnel; thirdly, when the latex tube is pierced by the sharp metal needle, microparticles of the latex tube will tear away and these particles will penetrate the human blood stream and may cause formation of thrombosis, phlebitis, and other complications.
  • said solutions do not comprise a separate filter for the solution after the additional port of various external shape (square-shaped, round-shaped, flat or rounded etc.) for the additional infusion of substances, where its main function could lie in retaining air droplets and all the microparticles which could penetrate into the device upon piercing the latex additional port, as well as the air upon the additional administration of drugs or upon any incorrect filling of the dropper.
  • This filter protects the patient’s blood stream, during performing additional infusions, from entering of any types of contaminations, particles, air droplets, which are possible during such manipulation.
  • the claimed invention is based on a task to improve the infusion device by altering a sequence of arrangement and by making the structural elements of the device with supplementation of new elements, and which could enable achievement of a technical effect that lies in: a maximum possible adjustment of the device before use, which is a mandatory main constituent in emergency care cases; ensuring a safe administration of a medical solution into the human blood stream (especially when the human is unconscious and is not able to call any one of the medical personnel for help or any one for help), and providing a reduction of allergies in the patients and the medical personnel.
  • an infusion device comprises a needle to be introduced into a solution medium, an air intake valve that is made as an opening having a cover and an air filter made of a glass fiber, a dropper having a filter, a rate controller to control a flow rate of the solution within the device, an additional solution introduction port, a device connector, a clamp, a connection tube, according to the invention
  • the needle to be introduced into the solution medium is made as a single assembly, namely, integrally with the air intake valve, and it is combined, i.e., it consists of two portions, wherein a first portion is made of metal with a side opening, and a second portion is made of a polymer, wherein a ratio between lengths of the metal and the polymer portions is 2:3 or 1:1;
  • the dropper is made so as to have a volume of at least 22 cm3 or 30 ml;
  • the additional solution introduction port is made latex- free and as a V-type connector
  • the device comprises an
  • the needle to be introduced into the solution medium may be connected to the air intake valve.
  • the needle may be made as a “pencil point”-type needle.
  • a diameter of the metal portion of the needle to be introduced into the solution medium may be 20G 1 1 ⁇ 2.
  • a length of the metal portion of the needle may be between 6 and 30 mm, and a length of the polymer portion is between 10 and 34 mm.
  • the filter of the dropper may be made of a polypropylene having a density of not more than 15 gm.
  • the additional solution filter may be made of a polypropylene having a density of not more than 15 gm.
  • the device connector may be made of a Luer type or a Luer Lock type with or without a cover in order to be connected to a peripheral catheter, butterfly or with a central venous catheter, or other connection assemblies, with or without the needle, with or without the needle cover.
  • the device may comprise a metal needle that is provided with the cover.
  • the diameter of the metal needle may be 18G 1 1 ⁇ 2.
  • the length of the metal needle may be 38. ..40 mm.
  • the needle to be introduced into the solution medium is made integrally with, as a single assembly, i.e., it is directly connected to the air intake valve that is made as the opening having the cover and the air filter made of the glass fiber that is intended to filter the air to remove microorganisms and enables the solution to pour out of the bottle/package (the solution medium) to the device and to move gravitationally within the device to the human blood stream.
  • the needle to be introduced into the solution medium is made in a combined fashion, i.e., it consists of two portions, wherein the first portion is made of the metal and of the “pencil point’ ’-type with the side opening, and the second portion is made of the polymer, wherein the ratio between the lengths of the metal and the polymer portions is 2:3 or 1:1.
  • This design of the needle enables to pierce the cap of the bottle of the package with the solution in a more accurate and precise fashion owing to the metal portion of the needle, and thereafter, the polymer portion of the needle enables a firm retention of the needle within the cap of the bottle or the package with the solution.
  • the inventor has revealed that the specific mentioned ratios are optimal for piercing the cap of the bottle or the package with the solution by the metal portion and to provide the firm retention of the needle within the syringe by the polymer portion.
  • the length of the metal portion of the needle is between 6 and 30 mm, and a length of the polymer portion is between 10 and 34 mm.
  • the needle is made of the “pencil point” type and the metal portion has the diameter of 20G 1 1 ⁇ 2, which enables, as it has been revealed by the inventor during the testing process, to make the smallest possible opening quickly (when looking at the needle pierce in more detail, it will look like a small piercing point) in the cap of the bottle with the solution or the plastic (polymer) package, while the side opening from the side of the needle for intake of the liquid from the bottle will not be filled upon piercing of the bottle cover by particles, i.e., thus, a possible formation of the particles upon piercing of the cap and penetration of the particles into the device are minimized.
  • the needle to be introduced into the solution medium is provided with the cap or a protective cap, or with a protective tube instead of the protective cap, in a non-operational state in order to provide sterility.
  • This design of the needle with the air intake valve connected directly enables to mount the needle in the bottle cover in a rational fashion in one hit without losing the solution from the bottle and without unnecessary disturbance of the medical personnel for checking the operation of the device, thereby providing that the sterility of the solution infusion is maintained longer.
  • the dropper is made so as to have the volume of at least 22 cm3 or 30 ml.
  • This design of the dropper enables to provide a minimum volume of arrangement of the medical solution within the device during the treatment without any unnecessary intrusion by the medical personnel.
  • the filter of the dropper is made of a polypropylene having the density of not more than 15 pm, the filter does not enable to filter the particles of more than 15 pm, i.e., the particles of up to 15 pm pass through a filtering surface, while if the particle is more than 15 pm, it will remain on the filtering surface of the filter, since the particles of more than 15 pm may cause the complication for the patient upon penetration into the human blood stream.
  • the needle to be introduced into the solution medium and the dropper are separated between each other by a portion of the connection tube.
  • it is required to move the dropper for several times, to tilt it, to squeeze it, i.e., to adjust the filling of the dropper.
  • the needle is made jointly with the dropper, if the required moves of the dropper are made, then the needle will be loosened in the bottle cap and this may lead to a leakage of the solution outwardly, not through the dropper.
  • the needle and the dropper are separated by the connection tube in order to move the dropper without moving the needle, i.e., the tube acts to dampen mechanical movements made with the dropper in order to fill it.
  • the optimal length of this portion of the connection tube is up to 200 mm.
  • the additional solution introduction port is made of a latex-free material and in the form of a V-type connector.
  • the latex-free design of the additional introduction port enables to provide the hypoallergenicity of the device, and, thus, it may be used by all population groups, including highly allergic individuals. Furthermore, upon piercing by the metal needle, there will be no microparticles of the latex tube which could enter the human blood stream and cause a complication (formation of thrombosis, vasculitis, other complications).
  • Making the port as the V-type connector enables to additionally infuse, through/into the device (not from the bottle/package), the drug by means of the syringe with and without the needle, or another device for infusing solutions, e.g., another device for infusing solutions etc.
  • the device comprises the additional solution filter. Provision of the additional solution filter enables to retain the air droplets and all the microparticles which could enter the device upon piercing the cover of the bottle, and the air during the additional infusion of the drugs or during any incorrect filling of the dropper. This filter protects the patient’s blood stream, during performing infusions, from entering of any types of contaminations, particles, air droplets, which are possible during such manipulation.
  • the additional solution filter is made of a polypropylene having a various shape (square-shaped or round-shaped, flat or volumetric etc.) and having the density of not more than 15 pm, the filter does not enable to filter the particles of more than 15 pm, i.e., the particles of up to 15 pm pass through a filtering surface, while if the particle is more than 15 pm, it will remain on the filtering surface of the filter, since the particles of 15 pm may cause the complication for the patient upon penetration into the human blood stream.
  • the device connector is made as the Luer or Luer Lock type with or without the cover, with or without the needle, or for connection to the peripheral catheter, butterfly or to the central venous catheter, or other connection assemblies.
  • Such various variants of making the connector enable the device versatility for different types of the connection devices.
  • the clamp is arranged on the connection tube so as to be freely mountable on any section of the tube. Such making of the clamp enables to terminate the flow of the solution within the device quickly and conveniently in emergency situations.
  • connection tube that is made of the hypoallergic polymer and has a predefined length. Spacing all the elements apart allows to provide an autonomy and independence of each element (assembly) of the device structure, i.e., the tube acts to dampen mechanical movements made with any elements of the device.
  • the connection tube along which the solution flows is made of the hypoallergic polymer in order to avoid allergies in patients or medical personnel, and this polymer is more neutral for reacting with the drugs, it does not allow formation of compounds with the drugs and, thus, a loss of its properties of elasticity and transparency.
  • the range of the tube length as defined by the inventor allows a homogeneous arrangement of the above-mentioned elements of the structure, while providing the dampening of the mechanical movements made with any elements of the device.
  • this device is generally intended to protect the patient when performing the infusion of the solutions into the human blood stream, namely, due to the above-mentioned design of the needle for introducing into the solution medium, the loss of the solution is reduced, as well as the possibility of the quick adjustment of the dropper for infusing the solution into the human blood stream is provided.
  • the above-mentioned design of the additional solution introduction port enables to reduce risks of the unintentional additional piercing of the human body by the needle during the additional infusion of the solution into the device and of cases of the solution loss and penetration of the air into the device and into the human blood stream.
  • the lack of the latex enables to avoid the possible allergy in the patient and in the medical personnel.
  • the infusion device comprises the needle 1 to be introduced into the solution medium, the needle is made integrally with the air intake valve 2 and consists of two portions, wherein the first portion is made of the metal with the side opening, and the second portion is made of the polymer.
  • the length of the metal portion of the needle is 16 mm, while the length of the polymer portion is 20 mm, wherein the diameter of the metal portion of the needle 1 to be introduced into the solution medium is 20G 1 1 ⁇ 2 that equals to 0.9 mm.
  • the shape of the needle 1 is made as the “pencil poinf’-type and has the side opening and the cap 3.
  • the air intake valve 2 is made as the opening with the cover 4 and the air filter of the glass fiber.
  • the infusion device comprises the dropper 5 having the filter.
  • the dropper 5 is made so as to have the volume of 22 cm3.
  • the filter of the dropper 5 is made of the polypropylene having the density of 15 pm.
  • the infusion device comprises the additional solution introduction port 7 that is made latex-free and as the V-type connector.
  • the device comprises the additional solution filter 8 that is made of the polypropylene having the density of 15 pm.
  • the device connector 9 is arranged which is made as the Luer Lock type in this example.
  • the device connector 9 may be made as the Luer or Luer Lock type with or without the cover, with or without the needle, or for connection to the peripheral catheter, butterfly or to the central venous catheter, or other connection assemblies.
  • the device comprises the clamp 10 that is made as a traditional one, but it may be shaped differently (e.g., square-shaped or round-shaped, or triangular shaped, or shaped in another way).
  • the clamp 10 is arranged on the connection tube 11 so as to be freely mountable on any section of the tube 11.
  • connection tube 11 that is made of the hypoallergic polymer and has the length of 1700 mm in this exemplary embodiment.
  • the present exemplary embodiment utilizes the metal needle with the cover 12 for injections, it has a diameter of 18G 1 1 ⁇ 2 that equals to 1.2 mm, and the length of 38 mm.
  • Various elements/means/devices may be connected to the connector 9 for performing various operations with the device.
  • the proposed infusion device operates as follows.
  • the vessel (the bottle) with the solution is arranged (secured) in a vertical position.
  • the bottle is connected to the device by means of the needle 1, the cover 4 of the air filter of the air intake valve 2 is opened, wherein the rate controller 6 for controlling the flow rate of the solution within the device must be closed.
  • the dropper 5 is squeezed for several times for 3-5 touches until it is filled with the solution approximately by half.
  • the rate controller 6 for controlling the flow rate of the solution within the device is opened in order to provide the flow of the solution within the device due to movement of a wheel in the controller 6 in order to allow flowing down of the solution along the tube 11 by forcing the air out until a first drop of the solution comes from the side of the connector 9.
  • the rate controller 6 for controlling the flow rate of the solution within the device is closed, then either the patient’s vein is punctured by the needle 12 or it is connected to the peripheral catheter or to the central venous catheter, or other connection assemblies located in the patient's vein.
  • the controller 6 is opened, a required flow rate is established (milliliters per second or a required number of drops per minute), and a manipulation is made (infusion of the solution into the human blood stream).
  • the flow of the liquid within the device is terminated by means of the wheel of the controller 6.
  • the syringe or another device is connected to the additional port 7 and the infusion of the additional solution or drug into the human blood stream is performed either slowly through the syringe or in doses through another device.
  • the syringe or another device is disconnected (taken out) from the port 7.
  • the wheel in the controller 6 is moved and the flow of the solution from the bottle is recovered again, if it is not required, the manipulation is ended without moving the wheel of the controller 6.
  • the connector 9 is disconnected from the peripheral catheter or from the central venous catheter, or from another connection assembly, or the needle 12 is taken out of the vein.
  • the proposed invention enables to improve the infusion device by altering the sequence of arrangement and making the structural elements of the device with addition of new elements, and it enables to achieve the technical effect that lies in the quick adjustment of the device for the use which is the mandatory main constituent in emergency care cases; ensuring the safe administration of the medical solution into the human blood stream, and providing the reduction of allergies in the patients and the medical personnel.

Abstract

L'invention concerne un dispositif de perfusion comprenant une aiguille à introduire dans un milieu en solution, une soupape d'admission d'air qui se trouve sous forme d'une ouverture ayant un couvercle et un filtre d'air constitué d'une fibre de verre, un compte-gouttes comprenant un filtre, un dispositif de régulation de débit pour réguler un débit de la solution à l'intérieur du dispositif, un orifice d'introduction de solution supplémentaire, un raccord de dispositif, une pince, un tube de raccordement, un filtre de solution supplémentaire. Avec celui-ci, l'aiguille à introduire dans le milieu en solution est formée d'un seul tenant avec la soupape d'admission d'air et est fabriquée d'une manière combinée, c'est-à-dire qu'elle est constituée de deux pièces, une première pièce étant constituée du métal avec une ouverture latérale et une seconde pièce étant constituée du polymère, un rapport entre les longueurs des pièces métallique et polymère étant de 2:3 ou 1:1. Le compte-gouttes est formé de manière à avoir le volume d'au moins 22 cm3 ou 30 mL. L'orifice d'introduction de solution supplémentaire est exempt de latex et est de la forme d'un raccord de type V. La pince est disposée sur le tube de raccordement de manière à pouvoir être montée librement sur n'importe quelle section du tube. Ainsi, tous les éléments mentionnés du dispositif sont espacés et, en même temps, raccordés entre eux par le tube de raccordement qui est constitué d'un polymère hypoallergique et présente une longueur prédéfinie.
PCT/UA2022/000016 2021-07-15 2022-04-06 Dispositif de perfusion WO2023287388A1 (fr)

Applications Claiming Priority (2)

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UAU202104143 2021-07-15
UAU202104143 2021-07-15

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000002618A1 (fr) * 1998-07-07 2000-01-20 Pharmadule Ab Systeme d'administration pour liquides de perfusion et d'irrigation, et dispositif incorpore audit systeme
EP1225029A1 (fr) * 1999-10-14 2002-07-24 Kabushiki Kaisha Top Procede de raccord au moyen d'un element en resine synthetique
UA62794A (en) 2003-05-30 2003-12-15 Closed Joint Stock Res And Pro Assay system dia-amplisens sars for detecting rna of sars coronavirus by reverse transcription and polymerase chain reaction
UA62793A (en) 2003-05-30 2003-12-15 Kirovogr State Technical Unive System for fattening with mixed fodder
WO2011118411A1 (fr) * 2010-03-26 2011-09-29 テルモ株式会社 Ensemble d'amorçage et ensemble tubulure d'alimentation en liquide
EP2881138A1 (fr) * 2012-08-01 2015-06-10 JMS Co., Ltd. Ensemble de perfusion et procédé pour utiliser celui-ci
WO2019211808A1 (fr) * 2018-05-04 2019-11-07 Poly Medicure Limited Ensemble amélioré de perfusion intraveineuse

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000002618A1 (fr) * 1998-07-07 2000-01-20 Pharmadule Ab Systeme d'administration pour liquides de perfusion et d'irrigation, et dispositif incorpore audit systeme
EP1225029A1 (fr) * 1999-10-14 2002-07-24 Kabushiki Kaisha Top Procede de raccord au moyen d'un element en resine synthetique
UA62794A (en) 2003-05-30 2003-12-15 Closed Joint Stock Res And Pro Assay system dia-amplisens sars for detecting rna of sars coronavirus by reverse transcription and polymerase chain reaction
UA62793A (en) 2003-05-30 2003-12-15 Kirovogr State Technical Unive System for fattening with mixed fodder
WO2011118411A1 (fr) * 2010-03-26 2011-09-29 テルモ株式会社 Ensemble d'amorçage et ensemble tubulure d'alimentation en liquide
EP2881138A1 (fr) * 2012-08-01 2015-06-10 JMS Co., Ltd. Ensemble de perfusion et procédé pour utiliser celui-ci
WO2019211808A1 (fr) * 2018-05-04 2019-11-07 Poly Medicure Limited Ensemble amélioré de perfusion intraveineuse

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