WO2012101982A1 - 医療用投与セット - Google Patents

医療用投与セット Download PDF

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Publication number
WO2012101982A1
WO2012101982A1 PCT/JP2012/000251 JP2012000251W WO2012101982A1 WO 2012101982 A1 WO2012101982 A1 WO 2012101982A1 JP 2012000251 W JP2012000251 W JP 2012000251W WO 2012101982 A1 WO2012101982 A1 WO 2012101982A1
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WO
WIPO (PCT)
Prior art keywords
connector
main body
sealing
port
boat
Prior art date
Application number
PCT/JP2012/000251
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
隆彦 国重
佳彦 小橋
Original Assignee
株式会社ジェイ・エム・エス
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 株式会社ジェイ・エム・エス filed Critical 株式会社ジェイ・エム・エス
Priority to JP2012522857A priority Critical patent/JP6016024B2/ja
Priority to KR1020137019670A priority patent/KR20130140129A/ko
Priority to CN2012800063086A priority patent/CN103327947A/zh
Priority to SG2013056965A priority patent/SG192151A1/en
Publication of WO2012101982A1 publication Critical patent/WO2012101982A1/ja

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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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • 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
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • 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
    • 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
    • A61J15/00—Feeding-tubes for therapeutic 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/1011—Locking means for securing connection; Additional tamper safeties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D33/00—Details of, or accessories for, sacks or bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/36—Closures with frangible parts adapted to be pierced, torn, or removed, to provide discharge openings
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08—Tubes; Storage means specially adapted therefor
    • A61M2039/085—Tubes; Storage means specially adapted therefor external enteral feeding tubes
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1044—Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources

Definitions

  • the present invention relates to a medical administration set in which a medical container is connected to an infusion tube or the like, and more particularly to a technique for accurately and liquid-tightly connecting a nutrient container and an infusion tube while preventing impurities from being mixed.
  • Enteral nutrition therapy is known as a method for infusion of nutrients and drugs to patients.
  • a predetermined medical administration set including a medical container and an infusion tube connected thereto is used. That is, a flexible tube (referred to as a nasal tube) is inserted from the patient's nasal cavity to the intestine, and liquid substances such as nutrients, drugs, and liquid food stored in a medical container through the nasal tube (hereinafter, Simply referred to as “nutrient”) directly into the patient's intestine.
  • a nasal tube a flexible tube
  • liquid substances such as nutrients, drugs, and liquid food stored in a medical container through the nasal tube (hereinafter, Simply referred to as “nutrient”) directly into the patient's intestine.
  • enteral nutrition therapy there is another method in which nutrition is administered to a patient through a PEG (percutaneous endoscopic gastrostomy) tube.
  • PEG percutaneous endoscopic gastrostomy
  • a medical container is provided with a port (drainage port), and the end of the port is usually sealed with a sealing cap before use.
  • the operator first removes the sealing cap of the medical container to release the port, and breaks the sealing inside the container.
  • a predetermined connection cap is connected to the port.
  • a predetermined nozzle-shaped connector is prepared and connected to the connection cap, and one end of a nasal tube or a PEG tube (or an infusion tube connected to the PEG tube) is connected to the connector. Connect the connection cap and connector to each other. At this time, the port and the connector may be locked to each other so that they are not easily disconnected.
  • the operator touches the outside air with the nutrient in the medical container to release the port immediately before connecting the connector to the connection cap.
  • impurities or other germs derived from outside air may be mixed in the nutrient and may cause contamination (contamination).
  • connection cap and the infusion tube side it is necessary to accurately connect the connection cap and the infusion tube side, but there is a risk of erroneous connection of the nutrient container side to a different infusion tube or the like arranged for other purposes. There is also a need to reliably prevent this problem.
  • the present invention has been made in view of the above-described problems, and while maintaining the liquid tightness of the medical container, the medical container is securely connected to the tube, and the nutrition stored in the medical container
  • the purpose of the present invention is to provide a medical administration set that can prevent the contamination (contamination) and leakage of liquids such as medicines, and can expect good nutrition therapy and enteral nutrition therapy.
  • the present invention provides a medical administration set comprising a medical bag, an infusion tube, and a connector for connecting the two, wherein the medical bag stores a liquid substance. And a port, and a body portion having a first engagement portion, a flow path for the liquid material, and a sealing portion for sealing the flow path are formed in the port, and the connector Has a second engagement portion that can be engaged with the first engagement portion, and moves the main body portion and the connector relative to each other while the main body portion and the connector are in liquid-tight contact with each other. The first engagement portion and the second engagement portion are engaged, and the flow path is released by breaking the sealing by the sealing portion.
  • the port may be a boat-shaped port
  • the storage portion may be a bag-shaped resin film
  • the boat-shaped port may be disposed so as to communicate with the inside thereof.
  • the main body portion is shaft-shaped
  • the connector has a cylindrical portion into which the shaft-shaped main body portion can be inserted, and the main body portion is inserted into the cylindrical portion of the connector to By relatively rotating the main body portion and the connector around the axis in a liquid-tight contact state, the engagement of the first engagement portion and the second engagement portion, and the flow path It is good also as a structure which performs release.
  • the sealing part is connected to the main body part by a connection part thinner than the main body part, and the main body part and the sealing part, and the connection part are integrally formed of the same material, As the sealing portion moves relative to the main body portion with rotation, the connecting portion is broken, the sealing by the sealing portion is broken, and the flow path can be released. .
  • the sealing portion includes one or more ribs, and the ribs are connected to the main body portion and the connecting portion, and the connector and the main body portion are liquidated inside the cylindrical portion of the connector.
  • a fitting groove that can be fitted to the rib when in close contact is formed, and the rib can be broken together with the connector during the rotation.
  • the main body may have a protrusion that can be inserted into the cylindrical part of the connector, and the sealing part may be connected to the upper surface of the protrusion by the connecting part. .
  • the present invention also relates to a medical bag for storing a liquid material and connected to an infusion tube for infusion of the liquid material, the storage bag storing the liquid material, and a port, the port Are formed with a main body having a first engagement portion, a flow passage for the liquid material, and a sealing portion for sealing the flow passage, and the port engages the first engagement with the infusion tube.
  • a connector having a second engaging portion engageable with a portion Connected using a connector having a second engaging portion engageable with a portion, and in a state where the main body portion and the connector are in liquid-tight contact, the main body portion and the connector are relatively moved, While engaging a 1st engaging part and a said 2nd engaging part, it is set as the structure which breaks the sealing by the said sealing part and releases the said flow path.
  • the port may be a boat-shaped port
  • the storage portion may be a bag-shaped resin film
  • the boat-shaped port may be arranged so as to communicate with the inside thereof.
  • the main body portion is shaft-shaped
  • the connector has a cylindrical portion into which the shaft-shaped main body portion can be inserted, and the main body portion is inserted into the cylindrical portion of the connector to By relatively rotating the main body portion and the connector around the axis in a liquid-tight contact state, the engagement of the first engagement portion and the second engagement portion, and the flow path It is also possible to adopt a configuration for performing release.
  • the sealing part is connected to the main body part by a connection part thinner than the main body part, and the main body part and the sealing part, and the connection part are integrally formed of the same material, As the sealing portion moves relative to the main body portion with rotation, the connecting portion is broken, the sealing by the sealing portion is broken, and the flow path can be released. .
  • the sealing portion includes one or more ribs, and the ribs are connected to the main body portion and the connecting portion, and the connector and the main body portion are liquidated inside the cylindrical portion of the connector.
  • a fitting groove that can be fitted with the rib when in close contact is formed, and the rib may be broken together with the connector during the rotation.
  • the rib may be connected to the main body portion at the connecting portion so as to radially extend over the main body portion.
  • the main body may have a protrusion that can be inserted into the cylindrical portion of the connector, and the sealing portion may be connected to the upper surface of the protrusion by the connecting portion. .
  • a sealing part for sealing the liquid material flow path is formed in the main body part of the port arranged in the medical bag.
  • a connector that can be engaged with the first engagement portion is disposed on the main body portion and on the infusion port side.
  • the operator When using this medical administration set, the operator first brings the main body of the port and the connector into liquid-tight contact. Then, while maintaining the liquid-tight contact state, the engagement portions (first and second engagement portions) are engaged with each other by relatively moving the port and the connector in a predetermined direction. By performing such engagement (locking) operation, the sealing of the flow path of the sealing portion is released in a state of being blocked from the outside, and the liquid material in the medical bag passes through the port to the connector side (infusion tube side) ) Can be distributed.
  • the liquid in the medical bag does not come into contact with the outside air until at least the port and the connector are engaged. Further, when the flow path through which the liquid material flows is released to the infusion tube side, the port and the connector are always engaged, and the flow path is shut off from the outside air and kept in a liquid-tight state. .
  • the medical administration set according to the present invention it is possible to reduce the problem that the liquid material comes into contact with the outside air and the impurities are mixed to generate contamination (contamination), and the liquid material leaks when the flow path is released and the outside is contaminated. Can be controlled, and nutrition administration therapy with high hygiene management can be implemented.
  • the present invention eliminates the need for operations such as removing the sealing seal disposed at the end of the port or opening the port prior to use, as in the prior art. The fear of being done can be avoided.
  • the medical bag of the present invention can directly fix the port to the connector without using a special cap or the like, so that the number of parts can be reduced and the production cost can be suppressed. Furthermore, since the medical administration set according to the present invention has a relatively small number of parts, the contact area with a liquid substance such as a medical bag or a connector is small, and also in this respect, the effect of preventing the occurrence of contamination (contamination). Can also be expected.
  • the port and the connector can be connected (locked) for the first time by using the first and second engaging portions, which are exclusive combinations with each other.
  • each connector strictly selects the connection target, so that it is possible to prevent the operator from erroneously connecting the boat-shaped port to another infusion tube side.
  • the medical administration set according to the present invention exhibits high safety also in this respect.
  • the medical administration set according to the present invention exhibits the above-described high effect when the combination of the port and the connector is used as described above, the port is formed by arranging the sealing portion in the boat-shaped port. Even when used alone, it is useful in that the liquid material stored in the medical bag can be kept liquid-tight by blocking it from the outside air.
  • FIG. 3 is a schematic diagram showing a configuration of a nutrient solution administration set 1 according to the first embodiment. It is a figure which shows each structure and connection method of the boat-shaped port 15 (with a male connector) and the connector 20 (female connector).
  • FIG. 6 is an external view and a cross-sectional view showing the configuration of the boat-shaped port 15.
  • FIG. 6 is an external view and a cross-sectional view showing the configuration of the connector 20.
  • 4 is a diagram for explaining an engagement process between a boat-shaped port 15 and a connector 20.
  • FIG. 3 is a partial cross-sectional view showing a positional relationship between a connector 20 and a boat-shaped port 15 before and after locking.
  • FIG. It is a top view which shows the positional relationship of the connector 20 and the boat-shaped port 15 before and behind locking.
  • It is a figure which shows the structure of connector 20A and boat-shaped port 15A of Embodiment 2.
  • FIG. 1 is a schematic diagram showing a configuration
  • FIG. 1 is a diagram illustrating a configuration of a medical administration set (nutrient administration set 1) according to the first embodiment.
  • FIG. 2 is a diagram illustrating each configuration and connection method of the boat-shaped port 15 and the connector 20 in the nutrient solution administration set 1.
  • the nutrient is administered, but this is not limited to a strict nutrient alone, and is a concept including a solution such as a liquid meal or physiological saline.
  • a medical bag 10 which is an example of a medical container (nutrient container), a connector 20, and an infusion tube 30 as constituent elements.
  • the medical bag 10 includes a storage unit 100 and a boat-shaped port 15.
  • the storage unit 100 is composed of a bag-like flexible container in which two rectangular resin films are bonded together by thermocompression bonding at the periphery thereof, and a liquid enteral nutrient is stored therein.
  • the boat-shaped port 15 is integrally formed of a resin material and has a flow path 159 for flowing a liquid material therein as shown in FIG. 3B, but is normally sealed.
  • the boat-shaped port 15 is sandwiched at a bonding portion of a resin film corresponding to one side of the storage unit 100, and the flow path 159 is arranged to communicate with the inside of the storage unit 100.
  • the medical bag 10 before use is sealed inside, and the enteral nutrient is kept in a sterile state.
  • the infusion tube 30 is an infusion line made of a resin material such as silicone resin and polyvinyl chloride having moderate flexibility. As shown in FIG. 1, a connector 20 for connecting to the boat-shaped port 15 is disposed at the upstream end. In order to administer the nutrient to the patient side, an insertion portion 33 in which a predetermined port is formed is arranged at the downstream end. A known infusion tube 31 and a clamp 32 for adjusting the flow rate are disposed in the middle of the infusion tube 30.
  • the storage unit 100 When the nutrient solution administration set 1 is used, the storage unit 100 is suspended from a predetermined stand with the boat-shaped port 15 facing downward as shown in FIG. Then, as shown in FIG. 2, the connector 20 is connected to the boat-shaped port 15 connected to the boat-shaped port 15, and the connection state is locked. Thereafter, the nutrient in the reservoir 100 is infused to the patient via the infusion tube 30.
  • the boat-shaped port 15 also serves to connect the storage unit 100 side to the connector 20.
  • the nutrient solution administration set 1 shown in FIG. 2 constitutes a pair of connector sets in which the boat-shaped port 15 and the connector 20 are connected to each other.
  • the port 15 is combined with the connector 20, and the internal seal of the medical bag 10 is broken along with the locking operation. Infusion can be made to the infusion tube 30 side via the boat-shaped port 15.
  • the nutrient solution administration set 1 when the boat-shaped port 15 and the connector 20 are connected at the time of use, the nutrient solution in the reservoir 100 does not come into contact with the outside air. Therefore, the nutrient can be kept very hygienic both immediately before and during administration, and a highly safe nutrient can be administered to the patient.
  • FIG. 3A is a diagram showing the appearance of the boat-shaped port (port with a male connector) 15 and the protective cover 16.
  • FIG. 3B is a cross-sectional view showing the internal configuration of the boat-shaped port 15. In this figure, the boat-shaped port 15 shown in FIG. 2 is shown upside down for explanation.
  • the boat-shaped port 15 is integrally formed by injection molding various known resin materials such as polycarbonate (PC), polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP) and the like.
  • PC polycarbonate
  • PET polyethylene terephthalate
  • PE polyethylene
  • PP polypropylene
  • the boat-shaped port 15 has an axial port main body 150 as a basic structure in appearance, and the port main body 150 and the sealing portion 155 are connected by connecting portions 1550a to 1550c.
  • the interior of the shaft-shaped port body 150 is hollow as shown in FIG. 3B, and a flow path 159 is formed.
  • the flow path 159 functions to infuse the nutrient in the storage unit 100 to the outside during administration of the nutrient, but the flow path 159 is sealed by the sealing portion 155 before the nutrient administration (use).
  • the port body 150 has a boat-shaped port base 151 having a certain height. On the ceiling surface 152 of the port base 151, a stepped portion 162 and a protruding portion 160 are continuously formed in the same order.
  • the stepped portion 162 is a cylindrical body having a diameter smaller than that of the port base portion 151.
  • a pair of engaging claws 153 and 154 project from the side surface near the upper edge of the stepped portion 162.
  • Each of the engagement claws 153 and 154 is a plate-like body provided with a main surface parallel to the ceiling surface 152, and the main surface facing each of the ceiling surfaces 152 protrudes toward the ceiling surface 152. Portions 1531 and 1541 (1541 not shown) are projected.
  • the ceiling surface of the stepped portion 162 functions as a contact surface 161 for contacting the contact surface 200 of the connector 20.
  • the protruding portion 160 is formed to protrude in the shape of a truncated cone at the center of the contact surface 161.
  • the peripheral surface shape of the projecting portion 160 is formed so as to be insertable according to the inner surface shape of the connector main body portion 21, and when the boat-shaped port 15 is inserted into the connector 20, the boat-shaped port 15 and the connector 20 project. It is adjusted so that they can be in liquid-tight contact with each other at the contact portion of the portion 160.
  • the sealing portion 155 On the upper surface of the port main body 150 (the upper surface of the protruding portion 160), the sealing portion 155 has one or more (three in this case) ribs 155a to 155c abutting each end on the axis of the protruding portion 160, It has a configuration in which the main surfaces are erected so as to form an angle of 120 [deg.] Between the main surfaces. Specifically, as shown in FIG. 3 (b), the sealing portion 155 is a connecting portion (thickness smaller than the member thickness of the port main body 150) in the root region of each of the ribs 155a to 155c. The thin wall portions 1550a to 1550c are connected to the upper surface of the protrusion 160 on the port main body 150 side.
  • slits 156a to 156c having a strip-like cross-sectional shape communicating with the flow path 159 are provided immediately below the ribs 155a to 155c (see FIG. 6B).
  • an opening 158 communicating with the flow path 159 is provided inside the boat-shaped port 15.
  • the protective cover 16 is for protecting the boat-shaped port 15 in the medical bag 10 before use, and includes a cover main body 165 that covers the projecting portion 160, the step portion 162, and the sealing portion 155. Engagement flanges 166 and 167 that can engage with the claws 153 and 154 are provided.
  • the protective cover 16 is integrally formed by injection molding of a resin material. As shown in FIG. 3A, the protective cover 16 can be separated from the boat-shaped port 15 by rotating around the step portion 162 in the direction of the arrow (the direction opposite to the second direction in FIG. 2). . (Connector 20) Returning to FIG.
  • the connector 20 is integrally formed by injection molding of the same material (here, a resin material) in the same manner as the boat-shaped port 15. It has a connector main body portion 21 that has a tapered appearance toward the tip and is a hollow cylindrical portion inside. On the outer peripheral surface, a pair of plate-like operation portions 205 and 206 that are operated by an operator with fingers are disposed. The inside of the connector main body 21 is formed in accordance with the shape of the port main body 150 of the connector 20 that is inserted in a liquid-tight manner. An infusion tube 30 extends from the tip 2033 (the lower end in FIG. 2) of the connector body 21.
  • a plate-like connector base portion 22 is disposed on the upper end portion of the connector main body portion 21 on the upstream side in the infusion direction, with each main surface orthogonal to the axis of the connector 20.
  • One main surface (the upper main surface in FIG. 2) of the connector base 22 functions as an abutment surface 200 that abuts against the abutment surface 161 of the boat-shaped port 15.
  • FIG. 4A is an external view showing the configuration of the connector 20 as viewed from the contact surface 200 side.
  • FIG. 4B is a cross-sectional view showing the internal configuration of the connector 20 (a cross-sectional view passing through the fitting groove 2030b and setting the angle around the axis of the connector main body 21 to 180 °).
  • FIGS. 5A, 5B, and 5C are views showing the engagement process between the engagement claw 153 and the engagement flange 202 as viewed from the shaft core side of the boat-shaped port 15 (for the sake of explanation, the engagement claw). 153 indicates a continuous portion with the step portion 160 in cross section).
  • the connector base 22 has a disc body with an opening 2031 provided at the center for communication with the connector main body 21 as a basic structure, and the axis of the connector main body 21 as a symmetrical axis.
  • the peripheral portion has a configuration protruding to the outside.
  • a pair of engaging flanges 201 and 202 that can be engaged with the pair of engaging claws 153 and 154 of the boat-shaped port 15 are formed on each of the protruding circumferential portions.
  • the engagement flanges 201 and 202 are configured by flange main bodies 2012 and 2022, flange portions 2013 and 2023, engagement claw contact portions 2011 and 2021, and the like.
  • the flange main bodies 2012 and 2022 are ribs erected along the edge of the contact surface 200.
  • the flanges 2013 and 2023 allow the engagement claws 153 and 154 to enter between the flange main bodies 2012 and 2022 and the contact surface 200, and therefore, the contact surfaces 200 along the side surfaces of the flange main bodies 2012 and 2022. Is a plate provided at a required height.
  • the engaging claw abutting portions 2011 and 2021 are prisms that are continuous with the flange portions 2013 and 2023 and that protrude from the flange main bodies 2012 and 2022 toward the axis of the connector 20.
  • the recess portions 2013 and 2023 are cut away in the thickness direction so that the recess portions 2014 and 2024 (2014 is an arrangement relationship). (Not shown) is formed.
  • the concave portions 2014 and 2024 are portions where the convex portions 1531 and 1541 of the engaging claws 153 and 154 are guided and fitted.
  • openings 2010 and 2020 are formed in the portion of the contact surface 200 immediately below the flanges 2013 and 2023 for the convenience of the mold used when the connector 20 is resin-molded.
  • the display surface 204 corresponding to the rear surface of the abutting surface 200, characters “stop” and an arrow indicating the rotation direction are displayed so that the operator can correctly recognize the direction in which the connector 20 is locked to the boat-shaped port 15. Yes.
  • the content displayed on the display surface 204 is not limited to this description, and the display may be omitted.
  • the inside of the connector main body 21 is formed in a shape into which the port main body 150 can be inserted. Further, as shown in FIGS. 4A and 4B, in the vicinity of the opening 2031, the inner wall is notched in the thickness direction so that the three fitting grooves 2030 a to 2030 c are arranged at equal intervals (to each other of the connector main body 21. The angles around the axis are formed at intervals of 120 °.
  • the fitting grooves 2030a to 2030c are means for fitting with the ribs 155a to 155c provided in the boat-shaped port 15.
  • a locking step 2032 is provided between the opening 2031 and the tip 2033 of the connector main body 21 by reducing the inner diameter in a step shape toward the tip 2033 side.
  • the locking step portion 2032 prevents the end portion of the infusion tube 30 from falling off, so that the connector 20 is integrally connected to the infusion tube 30.
  • an operator such as a doctor or nurse hangs one end of the medical bag 10 on a stand in the manner shown in FIG. 1, and directs the boat-shaped port 15 downward.
  • one end of the infusion tube 30 is passed through the connector 20, the end of the infusion tube 30 is locked to the locking step 2032 inside the connector main body 21, and the infusion tube 30 is extended from the distal end portion 2033.
  • the connector 20 and the infusion tube 30 may be connected in advance at the manufacturing stage or before shipment.
  • the insertion portion 33 provided on the other end side of the infusion tube 30 is connected to a predetermined tube tip disposed on the patient side.
  • the contact surface 200 of the connector 20 is made to contact the contact surface 161 of the boat-shaped port 15 while avoiding interference between the engagement flanges 201 and 202 and the engagement claws 153 and 154 and paying attention to the angle around the axis of the connector 20. (See the first direction indicated by the vertical arrow in FIG. 2). In this way, the operator brings the connector 20 and the boat-shaped port 15 into contact with each other and moves them relative to each other. At this time, the protruding portion 160 and the sealing portion 155 (ribs 155a to 155c) of the boat-shaped port 15 are inserted into the connector main body portion 21.
  • the outer peripheral surface of the protrusion 160 comes into liquid-tight contact with the inner surface of the connector main body 21, and the protrusion 160 and the sealing portion 155 of the connector main body 21, the boat-shaped port 15, The connection with the connector 20 and the boat-shaped port 15 is formed by being cut off from the outside air.
  • the operator fixes (locks) the connection state between the connector 20 and the boat-shaped port 15.
  • the operation parts 205 and 206 are sandwiched between fingers, and the connector 20 is rotated to an angle of 60 ° relative to the boat-shaped port 15 along the axis of the connector 20 (in FIG. (See the second direction indicated by the arrow).
  • the outer peripheral surface of the protruding portion 160 and the inner peripheral surface of the connector main body portion 21 slide relative to each other while maintaining a liquid-tight state, and relatively rotate around the axis of the connector 20.
  • the engaging claws 153 and 154 that are upstream of the flanges 2013 and 2023 in the rotation direction before the rotation operation (see FIG.
  • the connector 20 and the boat-shaped port 15 are firmly engaged with each other so that they do not easily come off.
  • FIG. 6A illustrates the arrangement relationship of the connectors 20 and the boat-shaped port 15 and the infusion release mechanism using the ribs 155a to 155c (sealing portion 155) before locking and FIG. 6B illustrates the locking state.
  • the connector 20 is shown as a cross-sectional structure cut along a line passing through the fitting grooves 3020b and 3020c and passing through an angle of 120 ° around the axis of the connector main body 21.
  • FIGS. 7A and 7B are front views looking down from the connector tip 2033 along the axis of the connector 20 to show the positional relationship between the connector 20 and the boat-shaped port 15 before and after locking.
  • the outlines of the engagement flanges 201 and 202 are indicated by dotted lines.
  • the ribs 155a to 155c are simply fitted into the fitting grooves 2030a to 2030c inside the connector body 21. (See FIGS. 6A and 7A).
  • the operator operates the operation units 205 and 206 to perform the above-described locking operation.
  • the connector 20 is rotated with respect to the boat-shaped port 15 to the angle of 60 ° around the axis with the axis of the connector main body 21 as the rotation axis.
  • each of the ribs 155a to 155c is rotated together with the connector 20 while being fitted in the fitting grooves 2030a to 2030c, and rotates around the rotation shaft to a position shifted by 60 ° from the original position.
  • the connecting portions 1550a to 1550c at the bases of the ribs 155a to 155c are pushed and broken.
  • the slits 156a to 156c appear at positions facing the inside of the connector main body 21 (FIGS. 6B and 7B).
  • the ribs 155a to 155c rotate and the connecting portions 1550a to 1550c are broken, whereby the flow path 159 is broken by the sealing portion 155, and the slits 156a to 156c are interposed.
  • communication with the connector 20 side is established.
  • the liquid-tight state between the outer peripheral surface of the protrusion 160 and the inner peripheral surface of the connector main body 21 is maintained.
  • the medical bag 10 is suspended with the boat-shaped port 15 facing downward during use, the nutrient in the reservoir 100 flows through the boat-shaped port 15 and the connector main body 21 by its own weight. It is administered to the patient through the tube 30.
  • the nutrient administration set 1 since the administration of the nutrient can be started upon completion of the locking operation of the connector 20 and the boat-shaped port 15, the nutrient is also provided when the flow path 159 of the boat-shaped port 15 is released. Is always cut off from the outside air.
  • the boat-shaped port 15 can be directly connected and fixed to the connector 20 side only by performing the predetermined operation described above, and there is no need to use a special cap or the like. For this reason, the number of parts can be reduced and the production cost can be suppressed. Furthermore, since the number of parts is relatively small, the contact area of the medical bag 10, the connector 20 and the like that come into contact with the liquid can be suppressed. In this respect as well, contamination (contamination) is prevented and high reliability is achieved. It can be demonstrated.
  • the connector 20 and the boat-shaped port 15 are each engaged portions (here, the engagement claws 153 and 154 and the engagement flanges 201 and 202, the sealing portion 155 and the fitting groove 2030a) which are strictly configured by a dedicated combination. ⁇ 2030c) can be normally connected and locked for the first time. Since there is such a strict connection selectivity, even if the operator mistakenly tries to connect the boat-shaped port 15 to another infusion line arranged for the patient, it is possible to reliably prevent the occurrence of a connection error. Thus, the nutrient administration set 1 can exhibit high safety also from the viewpoint of preventing the occurrence of artificial medical errors.
  • connection portions 1550a to 1550c may be completely broken by the rotation of the connector 20, and the sealing portion 155 may be separated, but the ribs 155a to 155c remain fitted in the fitting grooves 2030a to 2030c. Therefore, the sealing portion 155 separated from the boat-shaped port 15 is not flowed to the infusion tube 30 side.
  • the engaging operation of the connector 20 and the boat-shaped port 15 and the releasing operation of the flow path 159 associated therewith may be performed by moving them relative to each other. Therefore, the operation may be performed either when the boat-shaped port 15 is moved with respect to the connector 20 or when the connector 20 is moved with respect to the boat-shaped port 15.
  • Embodiment 2 the respective configurations in which the connector 20A side is a male connector and the boat-shaped port 15A side is a female connector are shown in FIG. In FIG. 8, for the sake of explanation, the connector 20A is shown upward and the boat-shaped port 15A is shown downward. However, when used, as shown in FIGS.
  • a cylindrical portion 163 is erected so as to surround the periphery of the contact surface 152A that is the upper surface of the boat-shaped port base portion 151A.
  • the inner diameter of the cylindrical portion 163 is adjusted to match the outer diameter of the main body portion 21A of the connector 20A, and the main body portion 21A of the connector 20A is inserted (or press-fitted) into the cylindrical portion 163 when used.
  • a pair of engaging claws 153A and 154A having the same configuration as the above-described 153 and 154 are formed around the opening 164 of the cylindrical portion 163.
  • a sealing portion 155A similar to 155 is formed through a connection portion similar to 1550a to 1550c, and communicates with the flow path of the boat-shaped port 15A immediately below each rib 155a to 155c.
  • a slit is formed. The flow path and the slit have the same configuration as 159 and 156a to 156c, respectively.
  • the connector 20A has a main body portion 21A and a pair of engagement flanges 201A and 202A.
  • the main body 21A is a cylindrical body, and a contact surface 200A that contacts the contact surface 161A of the boat-shaped port 15A is disposed on the lower surface thereof, and a display surface 204A is disposed on the upper surface. .
  • the same letter and arrow as 204 are given to the surface of the display surface 204A, and the infusion tube 30 is connected to the center thereof.
  • the engaging flanges 201A and 202A can be engaged with the engaging claws 153 and 154 by the same mechanism as 201 and 202, and are formed at equal intervals on the side surface of the main body 21A.
  • the components of the engagement flanges 201A and 202A are covered with a box-shaped housing and cannot be seen from the outside.
  • circumferential ribs (tubular portions) surrounding the display surface 204A are erected, but this is not essential.
  • a radial (three arrow-shaped) fitting groove 2030A having a shape that can be fitted to the ribs 155a to 155c of the sealing portion 155 is formed.
  • a total of three connector holes L1, L2, and L3 are formed in the main body portion 21A so as to penetrate the contact surface 200A and the display surface 204A along the axial direction of the cylinder.
  • the connector holes L1, L2, and L3 communicate with the slit formed immediately below the sealing portion 155 after each opening on the contact surface 200A side locks the connector 20A to the boat-shaped port 15A.
  • Each opening on the 204 ⁇ / b> A side is formed so as to communicate with the inside of the infusion tube 30.
  • the connector holes L1, L2, and L3 have a circular cross section here, but may be adjusted to have a rectangular cross section or increase the number of holes in the connector.
  • the side surface of the connector main body portion 21A comes into liquid-tight contact with the inner surface of the cylindrical portion 163, and the connector 20A and the boat-shaped port 15A are connected.
  • the operator rotates the connector 20A around the axis of the connector 20A to an angle of 60 °, and the engagement claws 153A and 154A are respectively engaged with the engagement flanges 201A and 202A.
  • the locking operation is performed by engaging.
  • the sealing portion 155A fitted to the fitting portion 2030A rotates and the connection portion is broken, and the slit appears facing the connector holes L1 to L3.
  • the nutrient in the reservoir 100 can be distributed to the infusion tube 30 via the connector holes L1 to L3.
  • the seal of the boat-shaped port 15A can be released without the nutrient in the storage unit 100 touching the outside air during use. Therefore, it is possible to prevent contamination of the nutrient due to foreign matter contamination (contamination) and to administer the nutrient to the patient in a sanitary manner. Moreover, since the boat-shaped port 15A is released in a state where the boat-shaped port 15A is always connected to the connector 20A, the problem of nutrients leaking out from the boat-shaped port 15A can be prevented.
  • the boat-shaped port 15A and the connector 20A have strict connection selectivity with respect to each other, the effect of reliably connecting the boat-shaped port 15A to a different infusion tube can be reliably prevented. .
  • FIG. 8 illustrates the configuration in which the fitting groove 2030A and the connector holes L1 to L3 are formed in the connector 20A.
  • a cylindrical space (flow path) communicating with the infusion tube 30 is formed inside the connector main body 21A as in the connector 20 of the first embodiment, and ribs 155a to 155c are formed on the cylindrical inner wall. Fitting grooves 2030a to 2030c that can be fitted to each other may be formed.
  • the sealing portion 155 is shown in which the three ribs 155a to 155c are combined in a radial (three arrow shape), but the number of ribs is not limited to this and may be one or two. There may be four or more.
  • a rod (columnar body) is erected in parallel with the axial center of the connector, and a connecting part consisting of a thin part is formed around the base part of the rod.
  • a hole corresponding to the slit may be formed.
  • the connector is formed with a recess into which the rod can be inserted instead of the fitting groove, and each rod bends at the base with the locking operation, and a slit (hole) appears to release the port seal.
  • a combination of a sealing portion having a simple three-dimensional shape (a rectangular parallelepiped shape, a polygonal column shape, etc.) and a fitting groove that can be fitted thereto can be used. However, in either case, care should be taken so that the liquid-tight state is maintained even after the connector is connected to the boat-shaped port, and the inside of the connector main body part where the flow path is released is not exposed to the outside air.
  • a packing member or a sealing member made of a silicon material may be disposed on either the contact surface of the boat-shaped port or the surface of the protruding portion. It is also effective to perform a surface treatment for flattening the contact surface between the boat-shaped port and the connector.
  • the connector and the boat-shaped port are not limited to the configuration in which the connector is engaged with the engagement claw and the engagement flange, and other engagement means may be used.
  • the connector and the boat-shaped port may be engaged by screwing.
  • the medical administration set of the present invention exhibits the highest effect when both a male connector and a female connector, which are produced as a combination exclusively for each other, such as the illustrated boat-shaped port 15 and the connector 20 are used together. .
  • the use of the sealing unit 155 is significant in that high sealing performance inside the back 100 can be exhibited until the connector 20 is locked. Has a merit.
  • a container made of a flexible resin film is illustrated as the storage unit 100, but this is only an example of a medical container, and the material is not limited.
  • Other known medical containers such as paper packs, glass bottles, metal containers, and syringes may be used.
  • liquid substance stored in the container is not limited to enteral nutrients, and may be various liquid substances such as various nutrients to be administered to patients other than those administered intravenously. Good.
  • the medical administration set of the present invention can be widely applied when, for example, a liquid substance stored in a medical container is administered to a patient using a tube in a medical field where enteral nutrition therapy is performed. It can be said that the range of is extremely wide.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Bag Frames (AREA)
PCT/JP2012/000251 2011-01-25 2012-01-18 医療用投与セット WO2012101982A1 (ja)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2012522857A JP6016024B2 (ja) 2011-01-25 2012-01-18 医療用投与セット
KR1020137019670A KR20130140129A (ko) 2011-01-25 2012-01-18 의료용 투여 세트
CN2012800063086A CN103327947A (zh) 2011-01-25 2012-01-18 医用给药套件
SG2013056965A SG192151A1 (en) 2011-01-25 2012-01-18 Medical administering set

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JP2011012476 2011-01-25
JP2011-012476 2011-01-25

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JP2014233593A (ja) * 2013-06-05 2014-12-15 株式会社トップ 雄コネクタ
WO2017030860A1 (en) * 2015-08-20 2017-02-23 Gambro Lundia Ab Fluid bag with controlled thickness to volume ratio and systems using same
JP2018052537A (ja) * 2016-09-28 2018-04-05 株式会社ジェイ・エム・エス メスコネクタ
JP2019508340A (ja) * 2016-03-14 2019-03-28 ゴリオ ソチエタ ペル アツィオニ 滅菌バッグクイック接続デバイス
JP2021036172A (ja) * 2013-11-06 2021-03-04 フレゼニウス メディカル ケア ドイッチェランド ゲゼルシャフト ミット ベシュレンクテル ハフツング コネクタ
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same
GB2620436A (en) * 2022-07-08 2024-01-10 Watson Marlow Ltd Aseptic connector

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KR102559338B1 (ko) 2014-12-18 2023-07-24 가부시키가이샤 오츠카 세이야쿠 고죠 포트, 및 약액 백
WO2017118109A1 (zh) * 2016-01-05 2017-07-13 胡绍勤 一种输液管路
CN109069037B (zh) * 2016-05-09 2021-11-16 株式会社村田制作所 阀、流体控制装置以及血压计
US11642281B2 (en) * 2018-10-02 2023-05-09 Boston Scientific Scimed, Inc. Endoscopic medical device for dispensing materials and method of use
DE102022110499A1 (de) * 2022-04-29 2023-11-02 Raumedic Ag Beutel zur Aufnahme eines medizinischen oder pharmazeutischen Mediums, Schlauch mit Konnektor zum Anschluss an einen solchen Beutel sowie Anordnung mit einem solchen Beutel und mit einem solchen Konnektor

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JP2014233593A (ja) * 2013-06-05 2014-12-15 株式会社トップ 雄コネクタ
JP2021036172A (ja) * 2013-11-06 2021-03-04 フレゼニウス メディカル ケア ドイッチェランド ゲゼルシャフト ミット ベシュレンクテル ハフツング コネクタ
JP7125459B2 (ja) 2013-11-06 2022-08-24 フレゼニウス メディカル ケア ドイッチェランド ゲゼルシャフト ミット ベシュレンクテル ハフツング コネクタ
WO2017030860A1 (en) * 2015-08-20 2017-02-23 Gambro Lundia Ab Fluid bag with controlled thickness to volume ratio and systems using same
JP2019508340A (ja) * 2016-03-14 2019-03-28 ゴリオ ソチエタ ペル アツィオニ 滅菌バッグクイック接続デバイス
JP2018052537A (ja) * 2016-09-28 2018-04-05 株式会社ジェイ・エム・エス メスコネクタ
WO2018062268A1 (ja) * 2016-09-28 2018-04-05 株式会社ジェイ・エム・エス メスコネクタ
US11674614B2 (en) 2020-10-09 2023-06-13 Icu Medical, Inc. Fluid transfer device and method of use for same
GB2620436A (en) * 2022-07-08 2024-01-10 Watson Marlow Ltd Aseptic connector

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TW201235032A (en) 2012-09-01
KR20130140129A (ko) 2013-12-23
JPWO2012101982A1 (ja) 2014-06-30
SG192151A1 (en) 2013-08-30
TWI566770B (zh) 2017-01-21
JP6016024B2 (ja) 2016-10-26
CN103327947A (zh) 2013-09-25

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