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WO2010143693A1 - Medical device for forming liquid communication path - Google Patents

Medical device for forming liquid communication path Download PDF

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Publication number
WO2010143693A1
WO2010143693A1 PCT/JP2010/059860 JP2010059860W WO2010143693A1 WO 2010143693 A1 WO2010143693 A1 WO 2010143693A1 JP 2010059860 W JP2010059860 W JP 2010059860W WO 2010143693 A1 WO2010143693 A1 WO 2010143693A1
Authority
WO
WIPO (PCT)
Prior art keywords
protective cap
connector
male connector
tip
fluid communication
Prior art date
Application number
PCT/JP2010/059860
Other languages
French (fr)
Japanese (ja)
Inventor
石田美希
宮原英靖
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 KR1020117027451A priority Critical patent/KR101292899B1/en
Priority to MX2011013361A priority patent/MX2011013361A/en
Priority to CN201080025872.3A priority patent/CN102802692B/en
Priority to JP2011518576A priority patent/JP5278548B2/en
Publication of WO2010143693A1 publication Critical patent/WO2010143693A1/en
Priority to HK13105560.4A priority patent/HK1178471A1/en

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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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20Closure caps or plugs for connectors or open ends of tubes
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/162Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165Shrouds or protectors for aseptically enclosing the connector

Definitions

  • the present invention relates to a medical fluid communication device for forming a communication flow path by coupling together coupling members respectively attached to elements to be communicated, such as a connector device for connecting a medical tube, for example.
  • a medical fluid communication device for forming a communication flow path by coupling together coupling members respectively attached to elements to be communicated, such as a connector device for connecting a medical tube, for example.
  • the present invention relates to a liquid communication device including a protective cap that can be attached to at least one of the coupling members separated from each other and has a sterilizing function.
  • a connector for connecting a patient side transfer tube (extension tube) and a bag containing dialysate when exchanging dialysate for peritoneal dialysis is known. It has been.
  • Peritoneal dialysis (PD) therapy is a therapy in which dialysate is stored in the abdominal cavity through a peritoneal catheter that has been surgically implanted in the abdominal cavity of the patient in advance, and impurities accumulated in the body are filtered using peritoneal capillaries. It is.
  • a patient lives a daily life with a transfer tube (extension tube) used continuously connected to the outside of the peritoneal perfusion catheter. Then, the patient himself connects the dialysate bag to the tip of the transfer tube several times a day to exchange dialysate in the abdominal cavity.
  • the biggest problem in performing this peritoneal dialysis is that bacteria that accidentally adhere to the air or skin enter the peritoneal cavity together with the dialysate during the dialysate exchange performed several times a day. If bacteria enter the abdominal cavity, the peritoneum may become inflamed and peritonitis may occur.
  • the connector provided at the tip of the transfer tube is provided with a porous material such as a sponge impregnated with a bactericidal agent such as povidone iodine (hereinafter referred to as an impregnated member).
  • an impregnated member a bactericidal agent such as povidone iodine
  • FIGS. (A) of FIG. 13 shows the bag side connector 110 which is a female connector provided in a dialysate bag.
  • FIG. 14 (b) shows a patient-side connector 130 configured as a male connector.
  • 13B shows a bag-side connector cap 120
  • FIG. 14A shows a patient-side connector cap 140.
  • the bag-side connector 110 is composed of a double wall of a first annular luer part 111 and a first tip cylindrical part 112, and a first tube connecting part 116 is provided at the base end part 115 of the first annular luer part 111. Is provided.
  • the first tube connection part 116 is connected to a tube 119 connected to the dialysate bag.
  • a concave portion 117 is provided on the outer periphery of the base end portion 115, and a convex portion 118 is provided on the base end of the first tip cylindrical portion 112.
  • the first tip cylindrical portion 112 is fitted to the base end portion 115 and can be rotated independently of the first tube connecting portion 116 and the first annular luer portion 111 via the concave portion 117 and the convex portion 118. Are combined.
  • a female screw 113 is formed on the inner periphery of the first tip cylindrical portion 112.
  • a sealing member 114 made of an elastic material is embedded in the inner peripheral surface near the tip of the first annular luer portion 111.
  • the patient-side connector 130 includes a distal end cylindrical portion 132, a second annular luer portion 131 formed on the inside thereof, and a proximal end portion 134 having a second tube connection portion 135.
  • the second tube connection part 135 is connected to the tube 136.
  • the proximal end of the distal cylindrical portion 132 is coupled to the proximal end portion 134, and the distal cylindrical portion 132 extends long so as to cover the distal end of the second annular luer portion 131.
  • a male screw 133 is formed to be screwed with the female screw 113 provided on the inner periphery of the distal end cylindrical portion 112 of the bag side connector.
  • the outer periphery of the second annular luer part 131 can be in fluid-tight contact with a sealing member formed on the inner periphery of the tip end part of the first annular luer part 111 of the bag side connector.
  • the female screw 113 and the male screw 133 are screwed together without twisting the tubes 119 and 136. Can be connected.
  • the patient-side connector cap 140 includes a third inner cylinder 141, a third outer cylinder 142 formed concentrically around the third inner cylinder 141, and a plug 146 fitted to the tip of the third inner cylinder.
  • On the inner periphery of the third outer cylinder 142 an internal thread 143 is formed that engages with the external thread 133 formed on the outer periphery of the distal end cylindrical portion 132 of the patient-side connector.
  • a sealing member 145 made of an elastic material.
  • a sterilization pad 144 containing a sterilizing agent is attached to the base end of the third inner cylinder 141.
  • the stopper 146 is made of an elastic material, and is pressed against the second annular luer part 131 to seal liquid tightly.
  • the sterilization pad 144 sterilizes the distal end cylindrical portion 132 when the patient side connector 130 is screwed to the patient side connector cap 140.
  • the sealing member 145 seals the patient-side connector cap screwed with the patient-side connector so as to protect it from external contamination.
  • the bag-side connector cap 120 has a fourth tip cylindrical portion 121 and a fourth cap base end portion 123.
  • the fourth tip cylindrical portion 121 is formed with a male screw 122 that is screwed into a female screw 113 formed on the inner periphery of the first tip cylindrical portion 112.
  • JP 59-500801 A Japanese Patent Laid-Open No. 8-1555025 Japanese Patent Laid-Open No. 8-215311
  • the sterilizing agent that has exuded enters the internal flow path of the connector / conduit from the tip of the connector, or the sterilizing agent that leaks out leaks to the outside from the joint between the connector and the cap, contaminating the surroundings.
  • the disinfectant may enter the patient through the internal flow path of the transfer tube, which may adversely affect the health of the PD patient.
  • Such a problem is not limited to a connector for connecting a peritoneal dialysis tube, but is common to a connector used in a place where a liquid flow path needs to be connected, such as an infusion tube. More generally speaking, this is a problem common to medical fluid communication devices for forming a communication flow path by connecting members respectively attached to communication objects. More specifically, this is a problem common to configurations including a protective cap that can be attached to the coupling members separated from each other and has a sterilizing function.
  • the present invention can sufficiently sterilize the distal end portion of the coupling member by attaching a protective cap that holds the sterilizing agent impregnated member in the back, and the distal end portion of the coupling member becomes the sterilizing agent impregnated member.
  • An object of the present invention is to provide a medical fluid communication device capable of avoiding leakage of a bactericide due to contact.
  • the medical liquid communication device of the present invention has a connecting member that forms a communication flow path between the communication objects by being attached to each other and connected to each other, and a sterilizing agent having a cylindrical shape with one end closed And a protective cap that holds the impregnated member in the innermost portion and can be attached to at least one of the coupling members separated from each other.
  • an inner peripheral surface of the protective cap surrounds a distal end portion of the coupling member.
  • the dimensional relationship between the coupling member and the protective cap is set so that the disinfectant-impregnated member is opposed to the distal end portion of the coupling member while maintaining a gap, and the opening end portion of the protective cap is formed.
  • a sealing member mounted on an inner peripheral surface of the coupling member or an outer peripheral surface of a portion of the coupling member corresponding to an opening end of the protective cap, and the outer circumferential surface of the coupling member and the protection in a mounted state of the protective cap. The sealing member is pressed between the inner peripheral surfaces of the cap to form an airtight structure of the space.
  • FIG. 1A is a perspective view showing a male connector and a protective cap constituting the medical connector device in Embodiment 1 of the present invention in a separated state.
  • FIG. 1B is a perspective view showing a state in which a protective cap is attached to the male connector in the medical connector device.
  • FIG. 2A is a perspective view showing a female connector constituting the medical connector device.
  • 2B is a perspective view showing a state where the male connector of FIG. 1A and the female connector of FIG. 2A are connected.
  • FIG. 3A is a front view of the male connector of FIG. 1A.
  • 3B is a right side view of the male connector of FIG. 3A.
  • 3C is a cross-sectional view of the male connector of FIG. 3A.
  • FIG. 4A is a front view of the protective cap of FIG. 1A.
  • 4B is a right side view of the protective cap of FIG. 4A.
  • 4C is a cross-sectional view taken along line AA in FIG. 4A.
  • 4D is a cross-sectional view taken along line BB in FIG. 4B.
  • FIG. 5A is a cross-sectional view showing the male connector and the protective cap in FIG. 1A.
  • FIG. 5B is a front view showing the male connector and the protective cap in FIG. 1B.
  • 5C is a cross-sectional view showing the internal structure of the male connector and the protective cap of FIG. 5B.
  • 6A is a front view of the female connector of FIG. 2A.
  • 6B is a left side view of the female connector of FIG. 6A.
  • FIG. 6C is a right side view of the female connector of FIG. 6A.
  • 6D is a cross-sectional view of the female connector of FIG. 6A.
  • FIG. 7A is a cross-sectional view showing a male connector and a female connector in an exploded state.
  • FIG. 7B is a front view showing the male connector and the female connector in a connected state.
  • FIG. 7C is a cross-sectional view of the male connector and the female connector of FIG. 7B.
  • FIG. 8 is a graph showing experimental results for demonstrating the effect of inhibiting the povidone iodine solution from exuding by the medical connector device according to the first embodiment of the present invention.
  • FIG. 9A is a graph showing experimental results of accelerated storage for demonstrating sterilization ability retention performance by the medical connector device.
  • FIG. 9B is a graph showing experimental results of room temperature storage for demonstrating the bactericidal ability retention performance of the medical connector device.
  • FIG. 10A is a front view showing a connector and a protective cap that constitute the enteral nutrition connector device according to Embodiment 2 of the present invention.
  • FIG. 10B is a cross-sectional view showing the internal structure of the protective cap.
  • FIG. 10C is a front view showing a state where the protective cap is attached to the connector, with only the protective cap shown in cross section.
  • FIG. 11A is a perspective view showing a mixed injection port and a protective cap that constitute the mixed injection port device according to Embodiment 3 of the present invention.
  • FIG. 11B is a cross-sectional view showing the internal structure of the protective cap.
  • FIG. 11A is a perspective view showing a mixed injection port and a protective cap that constitute the mixed injection port device according to Embodiment 3 of the present invention.
  • FIG. 11B is a cross-sectional view showing the internal structure
  • FIG. 12 is a perspective view showing another aspect of the mixed injection port.
  • FIG. 13 is a cross-sectional view showing a configuration of a medical connector device of a conventional example.
  • FIG. 14 is a cross-sectional view showing a configuration of a conventional medical connector device.
  • the medical liquid communication device of the present invention can take the following modes based on the above configuration.
  • one of the coupling members is a male connector and has a mounting portion connected to one of the communication targets at a rear end thereof, and the other of the coupling members is a female connector and a second connector at a rear end thereof. It can be set as the structure which has a mounting part connected with the said 2 communication object.
  • the male connector has an inner cylinder whose lumen forms a flow channel for liquid circulation, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder,
  • the front end of the inner cylinder is located on the inner side of the front end of the outer cylinder, and the protective cap and the female connector can be attached to the outside of the outer cylinder.
  • the male connector has a sealing valve that shields the lumen at the tip
  • the female connector includes an inner cylinder in which the lumen forms a liquid flow path, and an inner diameter of the inner cylinder.
  • An outer cylinder larger than an outer diameter and coaxially coupled to the outer side of the inner cylinder, and the male connector is inserted and connected to the inner side of the outer cylinder, and the male connector and the female connector Are connected, the tip of the inner cylinder of the female connector penetrates the sealing valve to open the flow path.
  • a flange that is formed on the inner surface of the male connector and that has an opening smaller than the outer diameter of the sealing valve is preferably provided on the tip side of the sealing valve.
  • the flange is provided with a rib extending toward the distal end side of the male connector.
  • a configuration may be adopted in which a position restricting portion for restricting the moving position of the male connector toward the inner portion of the protective cap and securing the space is provided inside the protective cap.
  • the position restricting portion is formed by an annular flange, and a contact portion having an outer diameter larger than the inner diameter of the annular flange is formed on the outer surface of the distal end portion of the male connector, and the male connector and the protective cap Can be configured such that the moving position of the male connector toward the inner part of the protective cap is restricted by the contact between the annular flange and the contact portion.
  • the male connector and the protective cap are configured to be coupled by screwing, and the deepest position of the male connector and the protective cap that functions as the position restricting portion functions as the male connector.
  • the moving position toward the back in the protective cap can be configured to be regulated.
  • an inner member can be fitted inside the protective cap, and the disinfectant-impregnated member can be held at the innermost part of the protective cap by the inner member.
  • the inner member may have a position restricting portion that restricts a moving position of the male connector toward the inner portion of the protective cap to secure the space.
  • a reduced diameter part having a smaller diameter than the opening side is provided in the innermost part of the protective cap, and the disinfectant-impregnated member is disposed in the reduced diameter part.
  • one of the communication objects includes a port of a medical container for injecting a nutrient or the like used for enteral nutrition, and the other includes a tube for connecting the medical container and a patient. It can be set as the structure which is an intestinal nutrition set.
  • the connector for enteral nutrition provided at the port of the medical container constitutes one of the coupling members, and the connector provided at one end of the nutrition set and connected to the connector for enteral nutrition, It constitutes the other of the coupling members.
  • One of the coupling members is a mixed injection port
  • the mixed injection port includes a pedestal provided for communication, a disc-shaped valve that is supported on the pedestal from the lower surface side and has an insertion hole formed in the center, and A cover having a fitting hole for exposing an upper surface of a central portion of the valve and covering a peripheral edge of the valve from the upper surface side, and the other of the coupling members can be inserted into the mixed injection port, and a lumen thereof is a liquid flow path It can be set as the structure which is the insert which forms.
  • the protective cap is configured to be attached to the mixed injection port.
  • FIG. 1A is a perspective view showing a male connector 1 and a protective cap 2 constituting the medical connector device in an exploded state.
  • FIG. 1B is a perspective view showing a state where the male connector 1 and the protective cap 2 of FIG. 1A are connected.
  • FIG. 2A is a perspective view showing a female connector 3 constituting the medical connector device.
  • 2B is a perspective view showing a state in which the male connector 1 shown in FIG. 1A and the female connector 3 shown in FIG. 2A are connected.
  • the male connector 1 is used as a patient-side connector
  • the female connector 3 is used as a bag-side connector provided in a dialysate bag.
  • the male connector 1, the protective cap 2, and the female connector 3 are all made of resin.
  • the male connector 1 is fitted with a tube 4 connected to a peritoneal catheter implanted in the abdominal cavity of the patient, for example, at the rear end.
  • a grip portion 5 for operating the male connector 1 is provided at the front portion of the tube 4, and the distal end side forms a coupling portion with the protective cap 2 and the female connector 3.
  • the coupling portion includes a cylindrical portion 6 and a tip small-diameter portion 7 formed to have a slightly smaller diameter than the cylindrical portion 6.
  • a thread groove 6 a is formed on the outer peripheral surface of the cylindrical portion 6.
  • a step is formed at the base end of the cylindrical portion 6 by the large-diameter portion 6b, and an elastic ring 8 that functions as a sealing member is mounted in contact with the large-diameter portion 6b.
  • the protective cap 2 has a substantially cylindrical shape with one end closed, and can be attached to the outer end of the male connector 1 as shown in FIG. 1B. As will be described later with reference to the cross-sectional view, the protective cap 2 holds a disinfectant impregnated member impregnated with a disinfectant (for example, povidone iodine solution) in the innermost part. On the inner peripheral surface of the protective cap 2, an engagement protrusion (described later) for engaging the screw groove 6 a to fix the connection between the male connector 1 and the protective cap 2 when the male connector 1 is mounted. Is provided.
  • the female connector 3 is connected to a circuit tip of a peritoneal dialysis device such as a twin bag, a Y set, or an APD. As shown in FIG. 2A, the tube 9 is attached to the rear end. A grip portion 10 for operating the female connector 3 is provided at the front portion of the tube 9, and the distal end side forms a coupling portion with the male connector 1. This coupling portion is formed inside the outer cylinder 11. On the inner peripheral surface of the outer cylinder 11, when connected to the male connector 1, there is an engagement protrusion 12 that engages with the thread groove 6 a and fixes the connection between the male connector 1 and the female connector 3. Is provided. The engaging protrusion provided on the inner peripheral surface of the protective cap 2 is the same as the engaging protrusion 12.
  • the male connector 1 and the female connector 3 are connected and fixed by inserting the male connector 1 into the outer cylinder 11 and screwing the thread groove 6a and the engaging projection 12 together.
  • the tubes 4 and 9 communicate with each other through a flow path that penetrates the lumens of the connectors 1 and 3.
  • the female connector 3 is depicted as being horizontally reversed with respect to FIG. 2A.
  • the feature of this embodiment is the configuration related to the combination of the male connector 1 and the protective cap 2 as described below. Accordingly, the structure of the male connector 1 and the protective cap 2 will be described in more detail with reference to FIGS. 3A to 5C. First, the structure of the protective cap 2 will be described.
  • FIG. 3A is a front view of the male connector 1 of FIG. 1A
  • FIG. 3B is a right side view of the male connector 1 of FIG. 3A
  • FIG. 3C is a cross-sectional view of the male connector 1 of FIG.
  • the male connector 1 is formed by being divided into a cylindrical portion 6, an inner member 13 attached to the lumen of the cylindrical portion 6, and a grip portion 5 connected to the rear portion of the cylindrical portion 6.
  • the rear part of the inner member 13 extends inside the grip part 5 to form a tube connection part 13a, to which the tube 4 is connected.
  • the inner cavity of the inner member 13 forms a flow path 13b.
  • a sealing valve 14 (for example, a rubber slitted septum) is disposed at the distal end of the lumen of the cylindrical portion 6.
  • a flange 15 that forms an opening smaller than the outer shape of the sealing valve 14 is provided on the inner peripheral surface of the tip of the cylindrical portion 6, and the sealing valve 14 is held between the tip of the inner member 13 and the flange 15.
  • the flange 15 is provided with a rib 15a extending to the tip side.
  • the sealing valve 14 has a function of sealing the flow path of the inner member 13 lumen when the male connector 1 and the female connector 3 are not connected. This prevents bacteria from entering the flow path from the outside of the male connector 1. In addition, the liquid is prevented from leaking from the flexible tube 4 side.
  • the sealing valve 14 is effective to ensure the sealed state of the flow path of the inner member 13 lumen, but is not essential. Moreover, you may ensure a sealed state with another method.
  • the flange 15 provided on the inner peripheral surface of the cylindrical portion 6 makes it easy to hold the sealing valve 14 in the flow path, and suppresses the finger contact with the sealing valve 14 from the distal end side of the male connector 1. Effect is obtained. By providing the rib 15a on the flange 15, the effect can be further improved.
  • FIG. 4A is a front view of the protective cap 2
  • FIG. 4B is a right side view of the protective cap 2 of FIG. 4A
  • FIG. 4C is a cross-sectional view taken along line AA in FIG. 4A
  • FIG. 4D is in FIG. It is sectional drawing along the BB line.
  • the protective cap 2 is formed of a substantially cylindrical outer cylinder 16 whose one end is closed, and an inner member 17 fitted into the outer cylinder 16.
  • a reduced diameter portion 16a having a smaller diameter than the opening side is provided, and a disinfectant-impregnated member 18 is disposed in the reduced diameter portion 16a.
  • the disinfectant-impregnated member 18 is held at the innermost portion by the restriction of the inner end portion 17 a of the inner member 17.
  • the sterilizing agent impregnated member 18 is easily held in the protective cap 2. Furthermore, the effect that the disinfectant-impregnated member 18 is difficult to touch the tip of the male connector 1 is also obtained.
  • An engagement protrusion 17b is formed on the inner peripheral surface of the opening side end of the inner member 17.
  • the connection between the male connector 1 and the protective cap 2 is formed by screwing the thread groove 6a on the outer peripheral surface of the male connector 1 and the engagement protrusion 17b. Further, the deepest position of the connection between the male connector 1 and the protective cap 2 is regulated by this screwing structure. Therefore, when the male connector and the protective cap are connected, the screwing structure functions as a position restricting element that restricts the moving position of the male connector 1 toward the inner part of the protective cap 2.
  • annular flange 17c is formed on the inner peripheral surface of the intermediate portion of the inner member 17, and functions as a similar position restricting portion. That is, a contact portion 6b having an outer diameter larger than the inner diameter of the annular flange 17c is formed on the outer surface of the distal end portion of the male connector 1. Therefore, when the protective cap 2 is attached to the male connector 1, the movement position of the male connector 1 is restricted by the contact between the annular flange 17c and the contact portion 6b.
  • the sterilizing agent-impregnated member 18 can be formed of a material such as a porous body or a fiber body, for example, a sponge.
  • a sterilizing agent other than the povidone iodine solution may be used, but a povidone iodine solution is desirable in consideration of the influence on the human body.
  • FIG. 5A is a sectional view showing the male connector 1 and the protective cap 2 in the exploded state of FIG. 1A
  • FIG. 5B is a front view showing the male connector 1 and the protective cap 2 in the combined state of FIG. 1B
  • FIG. These are sectional drawings of male connector 1 and protective cap 2 of Drawing 5B.
  • the protective cap 2 is attached to the male connector 1 when the male connector 1 and the female connector 3 are not connected to protect the connector tip.
  • the opening of the protective cap 2 is opposed to the tip of the male connector 1, and the male connector 1 is rotated while being pushed in.
  • the protective cap 2 is attached to the tip of the male connector 1 through the engagement between the engaging protrusion 17b provided on the inner surface of the protective cap 2 and the thread groove 6a on the outer peripheral surface of the male connector 1. Fixed.
  • the annular flange 17c formed on the inner peripheral surface of the inner member 17 of the protective cap functions as a position restricting portion, and depends on the deepest position of the male connector 1 and the protective cap 2 to be screwed together.
  • the restriction structure functions as a position restriction part.
  • a space 19 is formed between the periphery of the distal end portion of the male connector 1 and the inner surface of the protective cap 2 (see FIG. 5C). By forming this space, the sterilizing agent-impregnated member 18 held in the protective cap 2 is maintained in a state where it is opposed to the front end of the male connector 1 while maintaining a predetermined interval.
  • the elastic ring 8 is pressed between the outer peripheral surface of the male connector 1 and the inner peripheral surface of the protective cap 3, whereby the airtightness of the space 19 is maintained. Therefore, iodine is sublimated from the sterilizing agent impregnated member 18 impregnated with the povidone iodine solution to fill the space 19, and a sufficient sterilizing effect on the tip of the male connector 1 sealed in the space 19 is obtained.
  • the elastic ring 8 is fitted on the male connector 1, but the elastic ring 8 may be fitted inside the protective cap 3 in order to seal the space 19.
  • the elastic ring 8 may be configured to be pressed from both the protective cap 3 and the male connector 1 when the protective cap 3 is attached to the male connector 1.
  • the elastic ring 8 is externally fitted to the patient-side connector. This is because the protective cap and the connector on the dialysate side can be used only once, whereas the connector on the patient side is replaced once every six months, so that the cost of providing the elastic ring 8 can be reduced. This is not the case as long as the tube is for other purposes.
  • the sterilizing agent impregnated member 18 is not in direct contact with the tip of the male connector 1, but a predetermined interval is provided between the sterilizing agent impregnated member 18 and the tip of the male connector 1. It was confirmed by the results of experiments described later that a sufficient bactericidal effect was obtained.
  • the sterilized state of the distal end portion of the male connector can be easily maintained by attaching the protective cap 2 to the distal end side of the male connector 1.
  • the sterilizing agent since a predetermined interval is provided between the sterilizing agent impregnated member 18 and the tip of the male connector 1, the sterilizing agent is exuded when the sterilizing agent impregnated member 18 receives a pressing force. Is avoided. Therefore, the sterilizing agent that has exuded enters the internal flow path of the connector / conduit from the tip of the connector, or the exuding sterilizing agent leaks to the outside from the joint between the connector and the cap, thereby contaminating the surroundings. Such inconvenience can be avoided.
  • FIG. 6A is a front view of the female connector 3 in FIG. 2A
  • FIG. 6B is a left side view of the female connector 3 in FIG. 6A
  • FIG. 6C is a right side view thereof
  • FIG. 6D is a female connector 3 in FIG. FIG.
  • the female connector 3 has an inner cylinder 20 whose inner cavity forms a flow channel for liquid circulation, and an outer cylinder 11 whose inner diameter is larger than the outer diameter of the inner cylinder 20 and is coaxially coupled to the outside of the inner cylinder.
  • a gripping portion 10 is formed at the rear end portion of the outer cylinder 11 and is coupled to the central portion of the inner cylinder 20.
  • the outer cylinder 11 is open at the tip side, and an inner member 21 is inserted therein.
  • Engagement protrusions 12 are formed on the inner peripheral surface of the inner member 21.
  • the inner cylinder 20 includes an inner cylinder distal end portion 20 a that extends toward the opening inside the outer cylinder 11, and a tube connection portion 20 b that extends rearward of the outer cylinder 11 and is positioned inside the grip portion 10.
  • FIGS. 7A to 7C are sectional views showing the male connector 1 and the female connector 3 in an exploded state
  • FIG. 7B is a front view showing the male connector 1 and the female connector 3 in a connected state
  • FIG. 2 is a cross-sectional view of the male connector 1 and the female connector 3 of FIG.
  • the front end opening of the female connector 3 is opposed to the front end of the male connector 1, and the male connector 1 is rotated while being pushed in.
  • the female connector 3 is attached to the tip of the male connector 1 through the engagement between the engagement protrusion 12 provided on the inner surface of the female connector 3 and the thread groove 6a on the outer peripheral surface of the male connector 1. Installed and fixed.
  • the inner cylinder tip 20 a penetrates the male connector 1 while expanding the slit of the sealing valve 14 attached to the tip of the male connector 1. 1 is reached and the flow path is opened.
  • the male connector 1 may have other forms for mounting the protective cap 2 as described above or for connection with the female connector 3. That is, the male connector is constituted by an inner cylinder whose inner cavity forms a liquid flow path, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder.
  • the tip of the inner cylinder is located on the inner side of the tip of the outer cylinder, and the protective cap and the female connector are attached to the outside of the outer cylinder. According to this configuration, even when the tip of the male connector is accidentally touched, it is possible to avoid touching the inner cylinder through which the liquid flows and to protect the inner cylinder. Since the bacteria attached to the outer cylinder can be sterilized as described above by covering the protective cap, the bacteria do not enter the flow path.
  • the experimental method is as follows. First, five bacterial species of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans were used as evaluation species. In the case of Staphylococcus spp., Physiological saline to which 0.01% of Tween 80 (PolyoxyethylenebitSorbitan Monoleate) was added was prepared, and in the case of other bacterial species, those dissolved in physiological saline were prepared.
  • Tween 80 PolyoxyethylenebitSorbitan Monoleate
  • 10 3 CFU / 20 ⁇ L of the bacterial solution was dispensed at the tip of the male connector 1, and after the protective cap 2 was attached, it was allowed to stand for 3 hours at a body temperature of 30-35 ° C. or a low temperature of 10 ° C. Thereafter, the protective cap 2 was removed, and the male connector 1 was placed in 10 mL of a rinse solution (FLUID D-ST solution / BioMerieux), stirred for 30 seconds, and then filtered through a filter having a diameter of 0.45 ⁇ m. After repeating this three times, this filter was placed on an SCD agar medium and cultured at 30-35 ° C., and the viable cell count was confirmed.
  • a rinse solution FLUID D-ST solution / BioMerieux
  • the fungicide-impregnated member 18 of the protective cap 2 is impregnated with a 10% povidone iodine solution.
  • the fungicide-impregnated member 18 of the protective cap 2 is povidone-iodine solution. Instead, a material impregnated with physiological saline was used.
  • the experimental method is as follows. That is, the protective cap 2 is attached to the tip of the male connector 1 and left for 4 hours, and then the protective cap 2 is removed. After the female connector 3 is connected to the male connector 1, 20 mL of ultrapure water is passed through the tube. Example 2 was obtained. With respect to this ultrapure water, effective iodine was quantified by a redox titration method using a 0.02N sodium thiosulfate solution as a titrant. The same test was performed on the conventional connector as Comparative Example 2 (all of the conventional products were in contact with the povidone iodine solution).
  • Example 2 compared with Comparative Examples 2A to 2D, although the amount of effective iodine in the impregnated member was large, mixing into the liquid passage was not observed. I understand.
  • Example 3 Verification of bactericidal ability retention performance
  • the storage period during which bacteria present at the tip of the male connector 1 can be sterilized was confirmed.
  • the experimental method is as follows. That is, the protective cap 2 is attached to the male connector 1, and after accelerated packaging at 40 ° C / 75% RH after packaging in aluminum packaging material, the water content and effective iodine content in the povidone iodine solution important for sterilization performance The change with time was evaluated. The water content was calculated by measuring the difference between the weight before storage and the weight after storage.
  • the effective iodine amount For the effective iodine amount, after the protective cap 2 was immersed in 99.5% ethanol overnight, povidone iodine was extracted by thorough washing, and then a redox titration method using a 0.01 M sodium thiosulfate solution as a titrant. Quantitative determination of effective iodine. At this time, a calibration curve of the povidone iodine solution was prepared for each test, and the effective iodine amount of the specimen was calculated thereby. At the same time, the samples were stored in the same manner at room temperature, and the relationship between accelerated storage and storage at room temperature was confirmed from the moisture and effective iodine data.
  • the bactericidal ability test was done by the same test as Experiment 1, and the bactericidal ability retention period was examined.
  • the temperature condition was one condition of 30-35 ° C.
  • the bacterial species evaluated was one bacterial species of Staphylococcus epidermidis.
  • Comparative Example 3 a material impregnated with physiological saline instead of the povidone iodine solution impregnated in the impregnated member of the protective cap 2 was used.
  • FIG. 9A The experimental results of accelerated storage are shown in FIG. 9A, and the results of room temperature storage experiments are shown in FIG. 9B. According to the results of this experiment, it can be seen from the comparison between the amount of water and the amount of effective iodine in each storage period that room temperature storage 12M (month) corresponds to accelerated storage 6W (weeks), and room temperature storage 24M corresponds to accelerated storage 12W. . Therefore, it was confirmed that accelerated storage corresponds to a storage period equivalent to eight times storage at room temperature.
  • the accelerated storage 15W is comparable to the room temperature storage equivalent to two and a half years, so that the sterilization ability can be maintained for about two and a half years.
  • Step 1 First, as a step 1, the following experiment was performed. That is, 10% povidone iodine solution was used as a bactericidal agent (Example 4), 10 3 CFU S. epidermidis was used as an evaluation bacterial species, and physiological saline was used for comparison with the evaluation bacterial species (Comparative Example). 4).
  • the sponge was impregnated with 10 ⁇ l, 50 ⁇ l, 150 ⁇ l and 300 ⁇ l of povidone iodine solution, respectively.
  • the sponge impregnated with the povidone iodine solution was attached to the plunger gasket of a 5 ml syringe, and the plunger was adjusted so that the space was 630 ml.
  • the ratio of the povidone iodine solution necessary for killing the bacteria to the enclosed space volume was calculated.
  • the spatial volume is 630 mm 3
  • 10 3 CFU of S. epidermidis can be killed if 50% or more of 10% povidone iodine solution is present.
  • Step 2 Next, as a step 2, the following experiment was performed. That is, sponges were impregnated with 10 ⁇ l, 50 ⁇ l, 150 ⁇ l, and 300 ⁇ l of povidone iodine solution, respectively. The foam impregnated with the povidone-iodine solution was attached to the plunger gasket of a 5 ml syringe, and the plunger was adjusted so that the space was each evaluation volume. Each evaluation volume was 630mm 3, 378mm 3, 189mm 3 , 126mm 3.
  • the medical liquid communication device uses a connector device used for enteral nutrition as an application example.
  • a connector device used for enteral nutrition As an application example.
  • FIG. 10A to FIG. 10B the configuration of the connector device for enteral nutrition in the present embodiment will be described.
  • liquids such as nutrients, liquid foods, or drugs are administered through a tube passed from the patient's nasal cavity to the stomach or duodenum.
  • a nutrient or the like When administering a nutrient or the like, first, the nutrient or the like is injected into a medical container. Next, a connector attached to one end of an injection path set including a tube is connected to a port (liquid passing portion) of the medical container. Further, the medical container is suspended from the hanger with the port to which the injection path set is connected facing downward. With the medical container hung on the hanger, connect the connector attached to the other end of the infusion path set to the connector at the end of the tube attached to the patient. The product is administered to the patient.
  • FIG. 10A shows the port 23 of the medical container 22 to which the injection channel set is connected.
  • the port 23 includes a tubular portion 24 in which a liquid passage hole for allowing a liquid substance to pass therethrough and a enteral nutrition connector 25 that forms the distal end of the tubular portion 24.
  • the connector 25 is connected to a connector (not shown) at one end of the injection path set by a luer connection method. That is, the connector 25 and the connector attached to one end of the injection path set constitute the medical fluid communication device in the present embodiment.
  • This enteral feeding connector device further includes a protective cap 26, and the protective cap 26 is attached to the connector 25 when the medical container 22 is not used.
  • the internal structure of the protective cap 26 is shown in FIG. 10B.
  • the protective cap 26 has a cylindrical shape with one end closed, and a disinfectant-impregnated member 27 is held in the innermost part.
  • a sealing member 28 is attached to the inner peripheral surface of the opening end of the protective cap 26.
  • the protective cap 26 when the protective cap 26 is attached to the connector 25, the protective cap 26 forms a space 29 surrounding the periphery of the tip of the connector 25, and the sterilizing agent impregnated member 27 maintains a predetermined interval so that the connector 25 Opposite the tip. Further, with the protective cap 26 attached to the connector 25, the sealing member 28 is pressed between the outer peripheral surface of the connector 25 and the inner peripheral surface of the protective cap 26, and an airtight structure of the space 29 is formed.
  • the sterilized state of the portion can be easily maintained by attaching the protective cap 26 to the distal end portion of the connector 25.
  • the sterilizing agent is prevented from exuding due to the pressing force of the sterilizing agent impregnating member 27. Accordingly, it is possible to avoid the inconvenience that the exfoliated sterilizing agent enters the internal flow path of the port 23 from the distal end portion of the connector 25 or the exuded sterilizing agent leaks to the outside and contaminates the surroundings. .
  • the protective cap 26 is attached to the enteral nutrition connector 25 provided in the port 23 of the medical container 22, but the protective cap is attached to the connector at the end of the tube attached to the patient.
  • the same effect can also be obtained by configuring as described above.
  • the medical liquid communication device in the third embodiment is an application example of a medical mixed injection port device.
  • FIGS. 11A to 11B the configuration of the co-injection port apparatus according to the present embodiment will be described.
  • the medical co-infusion port is used to administer medicinal solution, etc. to the patient, to mix medicinal solution different from the main medicinal solution into the medicinal solution supply channel, or to sample the liquid flowing in the medicinal solution channel, etc. It is done. Therefore, the mixed injection port is configured such that the above operation can be performed by inserting an insert having a sharp tip into an insertion hole formed in the valve.
  • the mixed injection port 30 shown in FIG. 11A is mounted in the middle of the tube 31 to be communicated.
  • the communication target is not limited to the tube, and may be any other form.
  • a pedestal 32 is provided on the tube 31, and a cover 34 is attached to the pedestal 32.
  • the pedestal 32 and the cover 33 hold a disc-like valve 34 having an insertion hole formed in the center. That is, the valve 34 is supported by the pedestal 32, the cover 33 is in contact with the valve 34, and the valve 34 is sandwiched between the pedestal 32 and the cover 33.
  • the cover 34 has a fitting hole that exposes the upper surface of the central portion of the valve 34 at the central portion.
  • the pedestal 32 has a through hole that communicates with the lumen of the tube 31.
  • the lumen of the insert communicates with the lumen of the tube 31.
  • liquid can be injected and / or collected, and when the lure is removed from the valve 34, the valve 34 closes due to its elasticity. That is, the co-infusion port device composed of the co-infusion port 30 and the insert constitutes the medical liquid communication device in the present embodiment.
  • the mixed injection port device further includes a protective cap 35, and the protective cap 35 is attached to the mixed injection port 30 when the mixed injection port 30 is not used.
  • FIG. 11B shows the internal structure of the protective cap 35.
  • the protective cap 35 has a cylindrical shape with one end closed, and a disinfectant-impregnated member 36 is held at the innermost part.
  • a sealing member 37 is attached to the inner peripheral surface of the opening end of the protective cap 35.
  • the protective cap 35 When the protective cap 35 is attached to the mixed injection port 30, the protective cap 35 forms a space surrounding the periphery of the upper end of the mixed injection port 30, and the disinfectant impregnating member 36 is opposed to the upper end of the mixed injection port 30 while maintaining a predetermined interval. . Further, the sealing member 37 is pressed between the outer peripheral surface of the mixed injection port 30 and the inner peripheral surface of the protective cap 35 in a state where the protective cap 35 is attached to the mixed injection port 30, thereby forming an airtight structure of the space.
  • the sterilized state of the portion can be easily maintained by attaching the protective cap 35 to the upper end portion of the mixed injection port 30.
  • a predetermined space is provided between the sterilizing agent impregnating member 36 and the tip of the co-injecting port 30, exudation of the sterilizing agent due to the pressing force of the sterilizing agent impregnating member 36 is avoided. Therefore, it is possible to avoid the inconvenience that the exfoliated sterilizing agent enters the internal flow path of the tube 31 from the distal end portion of the mixed injection port 30, or the exuded sterilizing agent leaks to the outside and contaminates the surroundings. it can.
  • FIG. 12 is a perspective view showing a mixed injection port device according to another aspect of the present embodiment. Elements similar to those of the mixed injection port apparatus shown in FIG. 11A are denoted by the same reference numerals, and description thereof will not be repeated.
  • the mixed injection port 30 is attached to one end of the tube 31. Even in such an embodiment, the same effect as described above can be obtained by using the same protective cap as described above.
  • the distal end portion of the coupling member can be sufficiently sterilized by attaching the protective cap that holds the sterilizing agent-impregnated member in the back, and the distal end of the coupling member Since the leakage of the sterilizing agent due to the contact of the part with the sterilizing agent-impregnated member is avoided, it is useful for a connector device or the like for channel connection in peritoneal dialysis or infusion.

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Abstract

A medical device for forming a liquid communication path, comprising: joining members (1, 3) for forming the communication flow path between objects to be communicated with each other; and a protective cap (2) having a tubular shape with a closed end, holding a germicide-impregnated member (18) at the deepest end of the protective cap, and capable of being mounted to at least one of the joining members which are being separated from each other. The inner peripheral surface of the protective cap forms a space (19) for surrounding the tip of the joining member, and the dimensional relationship between the joining member and the protective cap is set so that the germicide-impregnated member (18) faces the tip of the joining member with a spacing between the members. A sealing member (8) is mounted to the inner peripheral surface of the opening end of the protective cap or to the outer peripheral surface of that portion of the joining member which corresponds to the opening end of the protective cap, and when the protective cap is in a mounted state, the sealing member is pressed between the outer peripheral surface of the joining member and the inner peripheral surface of the protective cap to form an airtight structure for the space. The mounting of the cap on the joining member effectively sterilizes the tip of the joining member and, in addition, avoids leakage of the germicide due to the contact of the joining member with the germicide-impregnated member.

Description

医療用液体連通装置Medical fluid communication device
 本発明は、例えば医療用のチューブを接続するためのコネクタ装置のような、連通対象の要素に各々装着された結合部材を互いに結合させることにより連通流路を形成するための医療用液体連通装置に関する。特に、互いに分離された状態の結合部材の少なくとも一方に装着可能で殺菌機能を備えた保護キャップを含む構成の液体連通装置に関する。 The present invention relates to a medical fluid communication device for forming a communication flow path by coupling together coupling members respectively attached to elements to be communicated, such as a connector device for connecting a medical tube, for example. About. In particular, the present invention relates to a liquid communication device including a protective cap that can be attached to at least one of the coupling members separated from each other and has a sterilizing function.
 医療用液体連通装置の一例である医療用のコネクタとして、例えば、腹膜透析用の透析液交換に際して患者側トランスファーチューブ(エキステンションチューブ)と透析液の入ったバッグとを接続するためのコネクタが知られている。腹膜透析(PD)療法は、あらかじめ患者の腹腔に外科的に埋植した腹膜カテーテルを介して透析液を腹腔内に貯留し、腹膜の毛細血管を利用して体内に溜まった不純物をろ過する療法である。患者は、腹膜灌流カテーテルの体外側に、連続使用するトランスファーチューブ(エキステンションチューブ)を接続した状態で、日常の生活を送る。そして、患者自身が一日数回、透析液バッグをトランスファーチューブの先端に接続して、腹腔内の透析液を交換する。 As a medical connector which is an example of a medical fluid communication device, for example, a connector for connecting a patient side transfer tube (extension tube) and a bag containing dialysate when exchanging dialysate for peritoneal dialysis is known. It has been. Peritoneal dialysis (PD) therapy is a therapy in which dialysate is stored in the abdominal cavity through a peritoneal catheter that has been surgically implanted in the abdominal cavity of the patient in advance, and impurities accumulated in the body are filtered using peritoneal capillaries. It is. A patient lives a daily life with a transfer tube (extension tube) used continuously connected to the outside of the peritoneal perfusion catheter. Then, the patient himself connects the dialysate bag to the tip of the transfer tube several times a day to exchange dialysate in the abdominal cavity.
 この腹膜透析を行う上で最も問題となるのは、この1日数回行う透析液交換時に、誤って空気中や皮膚に付着した細菌が透析液と共に腹腔内に入ってしまうことである。仮に細菌が腹腔内に入ると、腹膜が炎症を起こし腹膜炎を発症するおそれがある。 The biggest problem in performing this peritoneal dialysis is that bacteria that accidentally adhere to the air or skin enter the peritoneal cavity together with the dialysate during the dialysate exchange performed several times a day. If bacteria enter the abdominal cavity, the peritoneum may become inflamed and peritonitis may occur.
 そこで、腹膜透析を行う場合、透析液バッグとの接続のためにトランスファーチューブの先端に取り付けられたコネクタについて、細菌による汚染を低減することが重要である。器具あるいは組織等を殺菌する場合には、通常、ポビドンヨード溶液が用いられる。その場合、対象物に溶液を塗布して作用させる方法が一般的である。従って、上述のような医療用コネクタの場合にも、トランスファーチューブの先端に設けられたコネクタに、ポビドンヨード等の殺菌剤を含浸したスポンジなどの多孔質物質(以下、含浸部材とする)を備えたキャップを被せることで、コネクタ先端部の殺菌が行なわれてきた(特許文献1~3参照)。 Therefore, when performing peritoneal dialysis, it is important to reduce bacterial contamination of the connector attached to the tip of the transfer tube for connection to the dialysate bag. When sterilizing an instrument or tissue, a povidone iodine solution is usually used. In that case, a method of applying a solution to an object and causing it to act is common. Therefore, even in the case of the medical connector as described above, the connector provided at the tip of the transfer tube is provided with a porous material such as a sponge impregnated with a bactericidal agent such as povidone iodine (hereinafter referred to as an impregnated member). The tip of the connector has been sterilized by applying a cap (see Patent Documents 1 to 3).
 特許文献2に開示された医療用コネクタ装置について、図13、図14に示した断面図を参照して説明する。図13の(a)は、透析液バッグに設けられる雌型コネクタであるバッグ側コネクタ110を示す。図14の(b)は、雄型コネクタとして構成された患者側コネクタ130を示す。図13の(b)はバッグ側コネクタ用キャップ120、図14(a)は患者側コネクタ用キャップ140を示す。 The medical connector device disclosed in Patent Document 2 will be described with reference to the cross-sectional views shown in FIGS. (A) of FIG. 13 shows the bag side connector 110 which is a female connector provided in a dialysate bag. FIG. 14 (b) shows a patient-side connector 130 configured as a male connector. 13B shows a bag-side connector cap 120, and FIG. 14A shows a patient-side connector cap 140. FIG.
 バッグ側コネクタ110は、第1環状ルア-部111と第1先端円筒部112の二重壁からなり、第1環状ルア-部111の基端部115には第1チュ-ブ接続部116が設けられている。第1チュ-ブ接続部116は、透析液バッグに接続されたチュ-ブ119と接続される。基端部115の外周には凹部117が設けられ、第1先端円筒部112の基端には凸部118が設けられている。第1先端円筒部112は基端部115に嵌装され、凹部117と凸部118を介して、第1チュ-ブ接続部116や第1環状ルア-部111に対し独立して回転可能に結合されている。第1先端円筒部112の内周には雌ねじ113が形成されている。また第1環状ルア-部111の先端付近の内周面には、弾性材料からなる封止部材114が埋め込まれている。 The bag-side connector 110 is composed of a double wall of a first annular luer part 111 and a first tip cylindrical part 112, and a first tube connecting part 116 is provided at the base end part 115 of the first annular luer part 111. Is provided. The first tube connection part 116 is connected to a tube 119 connected to the dialysate bag. A concave portion 117 is provided on the outer periphery of the base end portion 115, and a convex portion 118 is provided on the base end of the first tip cylindrical portion 112. The first tip cylindrical portion 112 is fitted to the base end portion 115 and can be rotated independently of the first tube connecting portion 116 and the first annular luer portion 111 via the concave portion 117 and the convex portion 118. Are combined. A female screw 113 is formed on the inner periphery of the first tip cylindrical portion 112. A sealing member 114 made of an elastic material is embedded in the inner peripheral surface near the tip of the first annular luer portion 111.
 一方、患者側コネクタ130は、先端円筒部132と、その内側に形成された第2環状ルア-部131と、第2チュ-ブ接続部135を有する基端部134とからなる。第2チュ-ブ接続部135は、チュ-ブ136と接続される。先端円筒部132の基端は基端部134に結合されており、先端円筒部132は第2環状ルア-部131の先端を覆うように長く延出されている。先端円筒部132の外周には、バッグ側コネクタの先端円筒部112内周に設けられた雌ねじ113と螺合する雄ねじ133が形成されている。また第2環状ルア-部131の外周が、バッグ側コネクタの第1環状ルア-部111の先端部内周に形成された封止部材と液密に周接することができる。 On the other hand, the patient-side connector 130 includes a distal end cylindrical portion 132, a second annular luer portion 131 formed on the inside thereof, and a proximal end portion 134 having a second tube connection portion 135. The second tube connection part 135 is connected to the tube 136. The proximal end of the distal cylindrical portion 132 is coupled to the proximal end portion 134, and the distal cylindrical portion 132 extends long so as to cover the distal end of the second annular luer portion 131. On the outer periphery of the distal end cylindrical portion 132, a male screw 133 is formed to be screwed with the female screw 113 provided on the inner periphery of the distal end cylindrical portion 112 of the bag side connector. Further, the outer periphery of the second annular luer part 131 can be in fluid-tight contact with a sealing member formed on the inner periphery of the tip end part of the first annular luer part 111 of the bag side connector.
 バッグ側コネクタと患者側コネクタを近接させて、先端円筒部112だけを独立に回転させることによって、チュ-ブ119、136を捩れさせることなく、雌ねじ113と雄ねじ133を螺合させて、両コネクタを連結することが可能である。 By bringing the bag-side connector and the patient-side connector close to each other and rotating only the distal end cylindrical portion 112 independently, the female screw 113 and the male screw 133 are screwed together without twisting the tubes 119 and 136. Can be connected.
 患者側コネクタキャップ140は、第3内筒141と、第3内筒141の回りに同心円状に形成された第3外筒142と、第3内筒先端に嵌接した栓146からなる。第3外筒142の内周には、患者側コネクタの先端円筒部132の外周に形成された雄ねじ133に螺合する雌ねじ143が形成され、雌ねじ143が終了する第3外筒先端の内縁部には弾性材料からなる封止部材145が配置されている。第3内筒141の基端には、殺菌剤を含有させた殺菌パッド144が装着されている。 The patient-side connector cap 140 includes a third inner cylinder 141, a third outer cylinder 142 formed concentrically around the third inner cylinder 141, and a plug 146 fitted to the tip of the third inner cylinder. On the inner periphery of the third outer cylinder 142, an internal thread 143 is formed that engages with the external thread 133 formed on the outer periphery of the distal end cylindrical portion 132 of the patient-side connector. Is provided with a sealing member 145 made of an elastic material. A sterilization pad 144 containing a sterilizing agent is attached to the base end of the third inner cylinder 141.
 栓146は弾性材料から形成され、第2環状ルア-部131に押し付けられて液密に封止する。また殺菌パッド144は、患者側コネクタ130を患者側コネクタキャップ140に螺合した際に、先端円筒部132を殺菌する。封止部材145は、患者側コネクタと螺合した患者側コネクタキャップの中を外部からの汚染から保護するように封止する。 The stopper 146 is made of an elastic material, and is pressed against the second annular luer part 131 to seal liquid tightly. The sterilization pad 144 sterilizes the distal end cylindrical portion 132 when the patient side connector 130 is screwed to the patient side connector cap 140. The sealing member 145 seals the patient-side connector cap screwed with the patient-side connector so as to protect it from external contamination.
 バッグ側コネクタキャップ120は、第4先端円筒部121と、第4キャップ基端部123を有する。第4先端円筒部121には、第1先端円筒部112の内周に形成された雌ねじ113に螺合させるための雄ねじ122が形成されている。 The bag-side connector cap 120 has a fourth tip cylindrical portion 121 and a fourth cap base end portion 123. The fourth tip cylindrical portion 121 is formed with a male screw 122 that is screwed into a female screw 113 formed on the inner periphery of the first tip cylindrical portion 112.
 上記構成のコネクタ装置により、透析液の注入が終了し、患者側コネクタ130とバッグ側コネクタ110の結合を解除したときには、患者側コネクタ130には新しい患者側コネクタキャップ140を装着して捩じ込む。この状態において、患者側コネクタ先端円筒部132は、患者側コネクタキャップ140内の殺菌パッド144に押圧されて、殺菌状態が保持される。 When the injection of dialysate is completed by the connector device configured as described above and the coupling between the patient side connector 130 and the bag side connector 110 is released, a new patient side connector cap 140 is attached to the patient side connector 130 and screwed in. . In this state, the patient-side connector distal end cylindrical portion 132 is pressed by the sterilization pad 144 in the patient-side connector cap 140 and the sterilized state is maintained.
特開昭59-500801号公報JP 59-500801 A 特開平8-155025号公報Japanese Patent Laid-Open No. 8-1555025 特開平8-215311号公報Japanese Patent Laid-Open No. 8-215311
 従来医療現場においては、殺菌剤と殺菌対象物とを直接接触させることで殺菌対象物の殺菌を行なうということが一般的であった。そのため、特許文献1、2に記載の構造では、キャップ中の含浸部材がコネクタの先端部と必ず接触する構造となっている。この構造により、コネクタの先端部によって含浸部材が押圧され、含浸部材中の殺菌剤が滲出する。 Conventionally, in a medical field, it is common to sterilize an object to be sterilized by directly contacting the sterilizing agent with the object to be sterilized. Therefore, in the structures described in Patent Documents 1 and 2, the impregnated member in the cap is always in contact with the tip of the connector. With this structure, the impregnating member is pressed by the tip of the connector, and the bactericidal agent in the impregnating member exudes.
 しかし、この構造により、滲出した殺菌剤が、コネクタの先端部からコネクタ・導管の内部流路に浸入したり、出した殺菌剤が、コネクタとキャップの接合部から外部に漏出し、周囲を汚染する、というような問題が発生するおそれがあった。その結果、トランスファーチューブの内部流路を経て患者体内に殺菌剤が浸入し、PD患者の健康に悪影響を及ぼすおそれがある。 However, with this structure, the sterilizing agent that has exuded enters the internal flow path of the connector / conduit from the tip of the connector, or the sterilizing agent that leaks out leaks to the outside from the joint between the connector and the cap, contaminating the surroundings. There was a risk of problems such as. As a result, the disinfectant may enter the patient through the internal flow path of the transfer tube, which may adversely affect the health of the PD patient.
 また、特許文献3に記載の方法でも、保護キャップおよび閉鎖部材を導管から取り外す際に含浸部材(吸収材料10)を押圧する必要があり、その際に滲出した防腐剤が保護キャップと閉鎖部材の間から漏出し、周囲を汚染するおそれがあった。 Also, in the method described in Patent Document 3, it is necessary to press the impregnation member (absorbing material 10) when removing the protective cap and the closing member from the conduit, and the preservative that has oozed out at that time prevents the protective cap and the closing member from There was a risk of leaking from between and contaminating the surroundings.
 このような問題は、腹膜透析用のチューブを接続するコネクタに限らず、輸液チューブ等の、液体流路を接続することを要する箇所に用いられるコネクタについて共通する。更に一般的に言えば、連通対象に各々装着された結合部材により連通流路を形成するための医療用液体連通装置に共通する問題である。より詳しく言えば、互いに分離された状態の結合部材に装着可能で殺菌機能を備えた保護キャップを含む構成に共通する問題である。 Such a problem is not limited to a connector for connecting a peritoneal dialysis tube, but is common to a connector used in a place where a liquid flow path needs to be connected, such as an infusion tube. More generally speaking, this is a problem common to medical fluid communication devices for forming a communication flow path by connecting members respectively attached to communication objects. More specifically, this is a problem common to configurations including a protective cap that can be attached to the coupling members separated from each other and has a sterilizing function.
 そこで本発明は、殺菌剤含浸部材を奥部に保持する保護キャップを装着することにより、結合部材の先端部を十分に殺菌可能であって、しかも、結合部材の先端部が殺菌剤含浸部材に接触することに起因する殺菌剤の漏出を回避可能な医療用液体連通装置を提供することを目的とする。 Therefore, the present invention can sufficiently sterilize the distal end portion of the coupling member by attaching a protective cap that holds the sterilizing agent impregnated member in the back, and the distal end portion of the coupling member becomes the sterilizing agent impregnated member. An object of the present invention is to provide a medical fluid communication device capable of avoiding leakage of a bactericide due to contact.
 本発明の医療用液体連通装置は、連通対象に各々装着され互いに結合されることにより前記連通対象間の連通流路を形成する結合部材と、一端が閉塞された筒形状を有して殺菌剤含浸部材を最奥部に保持し、互いに分離された状態の前記結合部材の少なくとも一方に装着可能な保護キャップとを備える。 The medical liquid communication device of the present invention has a connecting member that forms a communication flow path between the communication objects by being attached to each other and connected to each other, and a sterilizing agent having a cylindrical shape with one end closed And a protective cap that holds the impregnated member in the innermost portion and can be attached to at least one of the coupling members separated from each other.
 上記課題を解決するために、本発明の医療用液体連通装置は、前記保護キャップが前記結合部材に装着された状態において、前記保護キャップの内周面は前記結合部材の先端部を包囲する空間を形成し、前記殺菌剤含浸部材が間隔を保持して前記結合部材の先端部と対向するように、前記結合部材と前記保護キャップの相互の寸法関係が設定され、前記保護キャップの開口端部の内周面または前記結合部材における前記保護キャップの開口端部に対応する部位の外周面に装着された封止部材を備え、前記保護キャップの装着状態で、前記結合部材の外周面と前記保護キャップの内周面間に前記封止部材が押圧されて前記空間の気密構造が形成されることを特徴とする。 In order to solve the above-described problem, in the medical fluid communication device of the present invention, in a state where the protective cap is mounted on the coupling member, an inner peripheral surface of the protective cap surrounds a distal end portion of the coupling member. The dimensional relationship between the coupling member and the protective cap is set so that the disinfectant-impregnated member is opposed to the distal end portion of the coupling member while maintaining a gap, and the opening end portion of the protective cap is formed. A sealing member mounted on an inner peripheral surface of the coupling member or an outer peripheral surface of a portion of the coupling member corresponding to an opening end of the protective cap, and the outer circumferential surface of the coupling member and the protection in a mounted state of the protective cap. The sealing member is pressed between the inner peripheral surfaces of the cap to form an airtight structure of the space.
 上記構成によれば、殺菌剤含浸部材を奥部に保持する保護キャップを装着することにより、殺菌剤含浸部材と結合部材の先端部が接触しなくとも十分な殺菌効果を得ることが可能である。しかも、結合部材の先端部が殺菌剤含浸部材に接触することに起因する殺菌剤の漏出を回避することができる。 According to the above configuration, it is possible to obtain a sufficient sterilizing effect even if the sterilizing agent impregnating member and the tip of the coupling member do not contact with each other by attaching the protective cap that holds the sterilizing agent impregnating member in the back. . Moreover, it is possible to avoid leakage of the sterilizing agent due to the tip of the coupling member coming into contact with the sterilizing agent-impregnated member.
図1Aは、本発明の実施の形態1における医療用コネクタ装置を構成する雄型コネクタ及び保護キャップを分離状態で示す斜視図である。FIG. 1A is a perspective view showing a male connector and a protective cap constituting the medical connector device in Embodiment 1 of the present invention in a separated state. 図1Bは、同医療用コネクタ装置における雄型コネクタに保護キャップが装着された状態を示す斜視図である。FIG. 1B is a perspective view showing a state in which a protective cap is attached to the male connector in the medical connector device. 図2Aは、同医療用コネクタ装置を構成する雌型コネクタを示す斜視図である。FIG. 2A is a perspective view showing a female connector constituting the medical connector device. 図2Bは、図1Aの雄型コネクタと図2Aの雌型コネクタが接続された状態を示す斜視図である。2B is a perspective view showing a state where the male connector of FIG. 1A and the female connector of FIG. 2A are connected. 図3Aは、図1Aの雄型コネクタの正面図である。FIG. 3A is a front view of the male connector of FIG. 1A. 図3Bは、図3Aの雄型コネクタの右側面図である。3B is a right side view of the male connector of FIG. 3A. 図3Cは、図3Aの雄型コネクタの断面図である。3C is a cross-sectional view of the male connector of FIG. 3A. 図4Aは、図1Aの保護キャップの正面図である。FIG. 4A is a front view of the protective cap of FIG. 1A. 図4Bは、図4Aの保護キャップの右側面図である。4B is a right side view of the protective cap of FIG. 4A. 図4Cは、図4AにおけるA-A線に沿った断面図である。4C is a cross-sectional view taken along line AA in FIG. 4A. 図4Dは、図4BにおけるB-B線に沿った断面図である。4D is a cross-sectional view taken along line BB in FIG. 4B. 図5Aは、図1Aにおける雄型コネクタ及び保護キャップを示す断面図である。FIG. 5A is a cross-sectional view showing the male connector and the protective cap in FIG. 1A. 図5Bは、図1Bにおける雄型コネクタ及び保護キャップを示す正面図である。FIG. 5B is a front view showing the male connector and the protective cap in FIG. 1B. 図5Cは、図5Bの雄型コネクタ及び保護キャップの内部構造を示す断面図である。5C is a cross-sectional view showing the internal structure of the male connector and the protective cap of FIG. 5B. 図6Aは、図2Aの雌型コネクタの正面図である。6A is a front view of the female connector of FIG. 2A. 図6Bは、図6Aの雌型コネクタの左側面図である。6B is a left side view of the female connector of FIG. 6A. 図6Cは、図6Aの雌型コネクタの右側面図である。6C is a right side view of the female connector of FIG. 6A. 図6Dは、図6Aの雌型コネクタの断面図である。6D is a cross-sectional view of the female connector of FIG. 6A. 図7Aは、分解状態での雄型コネクタ及び雌型コネクタを示す断面図である。FIG. 7A is a cross-sectional view showing a male connector and a female connector in an exploded state. 図7Bは、接続状態での雄型コネクタ及び雌型コネクタを示す正面図である。FIG. 7B is a front view showing the male connector and the female connector in a connected state. 図7Cは、図7Bの雄型コネクタ及び雌型コネクタの断面図である。FIG. 7C is a cross-sectional view of the male connector and the female connector of FIG. 7B. 図8は、本発明の実施の形態1における医療用コネクタ装置によるポビドンヨード溶液の滲出を抑止する効果を実証するための実験結果を示すグラフである。FIG. 8 is a graph showing experimental results for demonstrating the effect of inhibiting the povidone iodine solution from exuding by the medical connector device according to the first embodiment of the present invention. 図9Aは、同医療用コネクタ装置による殺菌能保持性能を実証するための加速保管の実験結果を示すグラフである。FIG. 9A is a graph showing experimental results of accelerated storage for demonstrating sterilization ability retention performance by the medical connector device. 図9Bは、同医療用コネクタ装置による殺菌能保持性能を実証するための室温保管の実験結果を示すグラフである。FIG. 9B is a graph showing experimental results of room temperature storage for demonstrating the bactericidal ability retention performance of the medical connector device. 図10Aは、本発明の実施の形態2における経腸栄養用コネクタ装置を構成するコネクタ及び保護キャップを示す正面図である。FIG. 10A is a front view showing a connector and a protective cap that constitute the enteral nutrition connector device according to Embodiment 2 of the present invention. 図10Bは、同保護キャップの内部構造を示す断面図である。FIG. 10B is a cross-sectional view showing the internal structure of the protective cap. 図10Cは、コネクタに保護キャップが装着された状態を、保護キャップのみ断面で示す正面図である。FIG. 10C is a front view showing a state where the protective cap is attached to the connector, with only the protective cap shown in cross section. 図11Aは、本発明の実施の形態3における混注ポート装置を構成する混注ポート及び保護キャップを示す斜視図である。FIG. 11A is a perspective view showing a mixed injection port and a protective cap that constitute the mixed injection port device according to Embodiment 3 of the present invention. 図11Bは、同保護キャップの内部構造を示す断面図である。FIG. 11B is a cross-sectional view showing the internal structure of the protective cap. 図12は、混注ポートの他の態様を示す斜視図である。FIG. 12 is a perspective view showing another aspect of the mixed injection port. 図13は、従来例の医療用コネクタ装置の構成を示す断面図である。FIG. 13 is a cross-sectional view showing a configuration of a medical connector device of a conventional example. 図14は、従来例の医療用コネクタ装置の構成を示す断面図である。FIG. 14 is a cross-sectional view showing a configuration of a conventional medical connector device.
 本発明の医療用液体連通装置は、上記構成を基本として、以下のような態様をとることができる。 The medical liquid communication device of the present invention can take the following modes based on the above configuration.
 すなわち、前記結合部材の一方は雄型コネクタであり、その後端部に前記連通対象の一方と連結される装着部を有し、前記結合部材の他方は雌型コネクタであり、その後端部に第2の前記連通対象と連結される装着部を有する構成とすることができる。 That is, one of the coupling members is a male connector and has a mounting portion connected to one of the communication targets at a rear end thereof, and the other of the coupling members is a female connector and a second connector at a rear end thereof. It can be set as the structure which has a mounting part connected with the said 2 communication object.
 前記雄型コネクタは、内腔が液体流通用流路を形成する内筒と、内径が前記内筒の外径よりも大きく前記内筒の外側に同軸に結合された外筒とを有し、前記内筒の先端が前記外筒の先端よりも内部側に位置しており、前記保護キャップ及び前記雌型コネクタは、前記外筒の外側に装着される構成とすることができる。 The male connector has an inner cylinder whose lumen forms a flow channel for liquid circulation, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder, The front end of the inner cylinder is located on the inner side of the front end of the outer cylinder, and the protective cap and the female connector can be attached to the outside of the outer cylinder.
 好ましくは、前記雄型コネクタは、先端部に内腔を遮蔽する密閉弁を有し、前記雌型コネクタは、内腔が液体流通用流路を形成する内筒と、内径が前記内筒の外径よりも大きく前記内筒の外側に同軸に結合された外筒とを有して、前記外筒の内側に前記雄型コネクタが挿入されて接続され、前記雄型コネクタと前記雌型コネクタとが接続されたとき、前記雌型コネクタの前記内筒の先端が前記密閉弁を貫通して流路が開通する。 Preferably, the male connector has a sealing valve that shields the lumen at the tip, and the female connector includes an inner cylinder in which the lumen forms a liquid flow path, and an inner diameter of the inner cylinder. An outer cylinder larger than an outer diameter and coaxially coupled to the outer side of the inner cylinder, and the male connector is inserted and connected to the inner side of the outer cylinder, and the male connector and the female connector Are connected, the tip of the inner cylinder of the female connector penetrates the sealing valve to open the flow path.
 この場合、好ましくは、前記密閉弁よりも先端側に、前記雄型コネクタの内面に形成され前記密閉弁の外径よりも小さい開口を形成するフランジが設けられる。 In this case, a flange that is formed on the inner surface of the male connector and that has an opening smaller than the outer diameter of the sealing valve is preferably provided on the tip side of the sealing valve.
 また、好ましくは、前記フランジに、前記雄型コネクタの先端側に延びるリブが設けられる。 Preferably, the flange is provided with a rib extending toward the distal end side of the male connector.
 また、前記保護キャップの内部に、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置を規制して前記空間を確保する位置規制部が設けられた構成とすることができる。 Further, a configuration may be adopted in which a position restricting portion for restricting the moving position of the male connector toward the inner portion of the protective cap and securing the space is provided inside the protective cap.
 また、前記位置規制部は環状フランジにより形成され、前記雄型コネクタの先端部外面には前記環状フランジの内径よりも大きい外径を有する当接部が形成され、前記雄型コネクタと前記保護キャップとが接続されたとき、前記環状フランジと前記当接部の接触により前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置が規制される構成とすることができる。 The position restricting portion is formed by an annular flange, and a contact portion having an outer diameter larger than the inner diameter of the annular flange is formed on the outer surface of the distal end portion of the male connector, and the male connector and the protective cap Can be configured such that the moving position of the male connector toward the inner part of the protective cap is restricted by the contact between the annular flange and the contact portion.
 また、前記雄型コネクタと前記保護キャップとは螺合により結合するように構成され、前記雄型コネクタと前記保護キャップの前記螺合の最深位置が前記位置規制部として機能し、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置が規制される構成とすることができる。 Further, the male connector and the protective cap are configured to be coupled by screwing, and the deepest position of the male connector and the protective cap that functions as the position restricting portion functions as the male connector. The moving position toward the back in the protective cap can be configured to be regulated.
 また、前記保護キャップの内部にインナー部材が嵌入され、前記インナー部材により前記殺菌剤含浸部材が前記保護キャップの最奥部に保持されている構成とすることができる。 Further, an inner member can be fitted inside the protective cap, and the disinfectant-impregnated member can be held at the innermost part of the protective cap by the inner member.
 また、前記インナー部材は、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置を規制して前記空間を確保する位置規制部を有する構成とすることができる。 Further, the inner member may have a position restricting portion that restricts a moving position of the male connector toward the inner portion of the protective cap to secure the space.
 また、前記保護キャップの最奥部に、開口部側よりも小径になった縮径部が設けられ、前記縮径部に前記殺菌剤含浸部材が配置されている構成とすることができる。 Further, a reduced diameter part having a smaller diameter than the opening side is provided in the innermost part of the protective cap, and the disinfectant-impregnated member is disposed in the reduced diameter part.
 また、前記連通対象の一方は、経腸栄養法に用いられる栄養剤等を注入するための医療用容器のポート、他方は、前記医療用容器と患者の間を接続するためのチューブを含む経腸栄養セットである構成とすることができる。この場合、前記医療用容器のポートに設けられた経腸栄養用コネクタが前記結合部材の一方を構成し、前記栄養セットの一端に設けられ前記経腸栄養用コネクタと接続されるコネクタが、前記結合部材の他方を構成する。 In addition, one of the communication objects includes a port of a medical container for injecting a nutrient or the like used for enteral nutrition, and the other includes a tube for connecting the medical container and a patient. It can be set as the structure which is an intestinal nutrition set. In this case, the connector for enteral nutrition provided at the port of the medical container constitutes one of the coupling members, and the connector provided at one end of the nutrition set and connected to the connector for enteral nutrition, It constitutes the other of the coupling members.
 また、前記結合部材の一方は混注ポートであり、前記混注ポートは、連通対象に設けられる台座と、前記台座に下面側から支持され中央部に挿入孔が形成されたディスク状の弁と、前記弁の中央部の上面を露出させる嵌合孔を有し前記弁の周縁を上面側から覆うカバーとを含み、前記結合部材の他方は、前記混注ポートに挿入可能でその内腔が液体流路を形成している挿入体である構成とすることができる。この場合、前記保護キャップは、前記混注ポートに対して装着されるように構成される。 One of the coupling members is a mixed injection port, and the mixed injection port includes a pedestal provided for communication, a disc-shaped valve that is supported on the pedestal from the lower surface side and has an insertion hole formed in the center, and A cover having a fitting hole for exposing an upper surface of a central portion of the valve and covering a peripheral edge of the valve from the upper surface side, and the other of the coupling members can be inserted into the mixed injection port, and a lumen thereof is a liquid flow path It can be set as the structure which is the insert which forms. In this case, the protective cap is configured to be attached to the mixed injection port.
 以下に、本発明の実施の形態における医療用液体連通装置について、図面を参照して具体的に説明する。 Hereinafter, the medical fluid communication device in the embodiment of the present invention will be specifically described with reference to the drawings.
 (実施の形態1)
 本発明の実施の形態1における医療用液体連通装置は、腹膜透析におけるチューブ接続用の医療用コネクタ装置を適用例としたものである。まず、図1A~図2Bを参照して、本実施の形態の医療用コネクタ装置の概要について説明する。図1Aは、この医療用コネクタ装置を構成する雄型コネクタ1と保護キャップ2を、分解した状態で示す斜視図である。図1Bは、図1Aの雄型コネクタ1と保護キャップ2が接続された状態を示す斜視図である。図2Aは、この医療用コネクタ装置を構成する雌型コネクタ3を示す斜視図である。図2Bは、図1Aに示した雄型コネクタ1と、図2Aに示した雌型コネクタ3が接続された状態を示す斜視図である。
(Embodiment 1)
The medical liquid communication device according to Embodiment 1 of the present invention is an application example of a medical connector device for tube connection in peritoneal dialysis. First, an outline of the medical connector device of the present embodiment will be described with reference to FIGS. 1A to 2B. FIG. 1A is a perspective view showing a male connector 1 and a protective cap 2 constituting the medical connector device in an exploded state. FIG. 1B is a perspective view showing a state where the male connector 1 and the protective cap 2 of FIG. 1A are connected. FIG. 2A is a perspective view showing a female connector 3 constituting the medical connector device. 2B is a perspective view showing a state in which the male connector 1 shown in FIG. 1A and the female connector 3 shown in FIG. 2A are connected.
 本実施の形態では、雄型コネクタ1は患者側コネクタとして使用され、雌型コネクタ3は、透析液バッグに設けられるバッグ側コネクタとして使用される。雄型コネクタ1、保護キャップ2、及び雌型コネクタ3は全て樹脂により形成されている。 In this embodiment, the male connector 1 is used as a patient-side connector, and the female connector 3 is used as a bag-side connector provided in a dialysate bag. The male connector 1, the protective cap 2, and the female connector 3 are all made of resin.
 図1Aに示すように、雄型コネクタ1は後端部に、例えば、患者の腹腔に埋植された腹膜カテーテルに接続されるチューブ4が装着される。チューブ4の前部には、雄型コネクタ1を操作するための把持部5が設けられ、その先端側が保護キャップ2及び雌型コネクタ3との結合部を形成している。この結合部は、円筒部6と、円筒部6よりもやや小径に形成された先端小径部7から構成されている。円筒部6の外周面には、ねじ溝6aが形成されている。円筒部6の基端には大径部6bにより段差が形成され、この大径部6bに当接させて、封止部材として機能する弾性リング8が装着されている。 As shown in FIG. 1A, the male connector 1 is fitted with a tube 4 connected to a peritoneal catheter implanted in the abdominal cavity of the patient, for example, at the rear end. A grip portion 5 for operating the male connector 1 is provided at the front portion of the tube 4, and the distal end side forms a coupling portion with the protective cap 2 and the female connector 3. The coupling portion includes a cylindrical portion 6 and a tip small-diameter portion 7 formed to have a slightly smaller diameter than the cylindrical portion 6. A thread groove 6 a is formed on the outer peripheral surface of the cylindrical portion 6. A step is formed at the base end of the cylindrical portion 6 by the large-diameter portion 6b, and an elastic ring 8 that functions as a sealing member is mounted in contact with the large-diameter portion 6b.
 保護キャップ2は、一端が閉塞された略円筒形状を有し、図1Bに示すように、雄型コネクタ1の先端部外側に装着可能である。断面図を参照して後述するように、保護キャップ2は最奥部に、殺菌剤(例えば、ポビドンヨード溶液)を含浸した殺菌剤含浸部材が保持されている。保護キャップ2の内周面には、雄型コネクタ1に装着される際に、ねじ溝6aと係合して雄型コネクタ1と保護キャップ2の結合を固定するための係合突起(後述)が設けられている。 The protective cap 2 has a substantially cylindrical shape with one end closed, and can be attached to the outer end of the male connector 1 as shown in FIG. 1B. As will be described later with reference to the cross-sectional view, the protective cap 2 holds a disinfectant impregnated member impregnated with a disinfectant (for example, povidone iodine solution) in the innermost part. On the inner peripheral surface of the protective cap 2, an engagement protrusion (described later) for engaging the screw groove 6 a to fix the connection between the male connector 1 and the protective cap 2 when the male connector 1 is mounted. Is provided.
 雌型コネクタ3は、例えばツインバッグ、Yセット、APD等の腹膜透析装置の回路先端等に接続される。図2Aに示すように、後端部に、チューブ9が装着される。チューブ9の前部には、雌型コネクタ3を操作するための把持部10が設けられ、その先端側が雄型コネクタ1との結合部を形成している。この結合部は、外筒11の内部に形成されている。外筒11の内周面には、雄型コネクタ1と接続される際に、ねじ溝6aと係合して雄型コネクタ1と雌型コネクタ3の結合を固定するための係合突起12が設けられている。保護キャップ2の内周面に設けられた係合突起も、この係合突起12と同様である。 The female connector 3 is connected to a circuit tip of a peritoneal dialysis device such as a twin bag, a Y set, or an APD. As shown in FIG. 2A, the tube 9 is attached to the rear end. A grip portion 10 for operating the female connector 3 is provided at the front portion of the tube 9, and the distal end side forms a coupling portion with the male connector 1. This coupling portion is formed inside the outer cylinder 11. On the inner peripheral surface of the outer cylinder 11, when connected to the male connector 1, there is an engagement protrusion 12 that engages with the thread groove 6 a and fixes the connection between the male connector 1 and the female connector 3. Is provided. The engaging protrusion provided on the inner peripheral surface of the protective cap 2 is the same as the engaging protrusion 12.
 外筒11の内部に雄型コネクタ1が挿入され、ねじ溝6aと係合突起12が螺合することにより、図2Bに示すように、雄型コネクタ1と雌型コネクタ3が接続され固定される。雌型コネクタ3と雄型コネクタ1が接続されると、チューブ4、9間が、両コネクタ1、3の内腔を貫通する流路によって連通する。但し、図2Bでは、図2Aに対して雌型コネクタ3が左右反転して描かれている。 As shown in FIG. 2B, the male connector 1 and the female connector 3 are connected and fixed by inserting the male connector 1 into the outer cylinder 11 and screwing the thread groove 6a and the engaging projection 12 together. The When the female connector 3 and the male connector 1 are connected, the tubes 4 and 9 communicate with each other through a flow path that penetrates the lumens of the connectors 1 and 3. However, in FIG. 2B, the female connector 3 is depicted as being horizontally reversed with respect to FIG. 2A.
 本実施の形態の特徴は、以下に説明するとおり、雄型コネクタ1と保護キャップ2の組み合わせに関連した構成にある。従って、図3A~5Cを参照して、雄型コネクタ1と保護キャップ2の構造についてより詳細に説明する。まず、保護キャップ2の構造について説明する。 The feature of this embodiment is the configuration related to the combination of the male connector 1 and the protective cap 2 as described below. Accordingly, the structure of the male connector 1 and the protective cap 2 will be described in more detail with reference to FIGS. 3A to 5C. First, the structure of the protective cap 2 will be described.
 図3Aは、図1Aの雄型コネクタ1の正面図、図3Bは、図3Aの雄型コネクタ1の右側面図、図3Cは、図3Aの雄型コネクタ1の断面図である。図3Cに示されるように、雄型コネクタ1は、円筒部6と、円筒部6の内腔に装着されたインナー部材13と、円筒部6の後部に連結された把持部5に分けて形成されている。インナー部材13の後部は把持部5の内部に延在して、チューブ接続部13aを形成しており、チューブ4が接続されている。また、インナー部材13の内腔は、流路13bを形成している。 3A is a front view of the male connector 1 of FIG. 1A, FIG. 3B is a right side view of the male connector 1 of FIG. 3A, and FIG. 3C is a cross-sectional view of the male connector 1 of FIG. As shown in FIG. 3C, the male connector 1 is formed by being divided into a cylindrical portion 6, an inner member 13 attached to the lumen of the cylindrical portion 6, and a grip portion 5 connected to the rear portion of the cylindrical portion 6. Has been. The rear part of the inner member 13 extends inside the grip part 5 to form a tube connection part 13a, to which the tube 4 is connected. Further, the inner cavity of the inner member 13 forms a flow path 13b.
 円筒部6の内腔の先端部には、内腔を遮蔽する密閉弁14(例えばゴム製のスリット入りセプタム)が配置されている。円筒部6の先端部内周面には、密閉弁14の外形よりも小さい開口を形成するフランジ15が設けられ、インナー部材13の先端とフランジ15の間で、密閉弁14が保持されている。フランジ15には、先端側に延びるリブ15aが設けられている。 A sealing valve 14 (for example, a rubber slitted septum) is disposed at the distal end of the lumen of the cylindrical portion 6. A flange 15 that forms an opening smaller than the outer shape of the sealing valve 14 is provided on the inner peripheral surface of the tip of the cylindrical portion 6, and the sealing valve 14 is held between the tip of the inner member 13 and the flange 15. The flange 15 is provided with a rib 15a extending to the tip side.
 密閉弁14は、雄型コネクタ1と雌型コネクタ3が接続されていないときに、インナー部材13内腔の流路を密閉する機能を有する。それにより、菌が雄型コネクタ1の外部から流路内に侵入することが防止される。また、可撓性のチューブ4側から液が漏出することも防止される。このように、密閉弁14は、インナー部材13内腔の流路の密閉状態を確保するためには有効であるが、必須ではない。また、他の方法で密閉状態を確保してもよい。 The sealing valve 14 has a function of sealing the flow path of the inner member 13 lumen when the male connector 1 and the female connector 3 are not connected. This prevents bacteria from entering the flow path from the outside of the male connector 1. In addition, the liquid is prevented from leaking from the flexible tube 4 side. Thus, the sealing valve 14 is effective to ensure the sealed state of the flow path of the inner member 13 lumen, but is not essential. Moreover, you may ensure a sealed state with another method.
 また、円筒部6の内周面に設けられたフランジ15により、密閉弁14を流路内に保持し易くなるとともに、雄型コネクタ1先端側から密閉弁14に指で接触されることを抑制する効果が得られる。フランジ15にリブ15aが設けられることにより、その効果をより向上させることができる。 Further, the flange 15 provided on the inner peripheral surface of the cylindrical portion 6 makes it easy to hold the sealing valve 14 in the flow path, and suppresses the finger contact with the sealing valve 14 from the distal end side of the male connector 1. Effect is obtained. By providing the rib 15a on the flange 15, the effect can be further improved.
 図4Aは、保護キャップ2の正面図、図4Bは、図4Aの保護キャップ2の右側面図、図4Cは、図4AにおけるA-A線に沿った断面図、図4Dは、図4BにおけるB-B線に沿った断面図である。 4A is a front view of the protective cap 2, FIG. 4B is a right side view of the protective cap 2 of FIG. 4A, FIG. 4C is a cross-sectional view taken along line AA in FIG. 4A, and FIG. 4D is in FIG. It is sectional drawing along the BB line.
 保護キャップ2は、図4C,図4Dに示されるように、一端が閉塞された略円筒形状の外筒16と、外筒16の内部に嵌入されたインナー部材17とから形成されている。保護キャップ2の最奥部には、開口部側よりも小径になった縮径部16aが設けられ、縮径部16a内に殺菌剤含浸部材18が配置されている。殺菌剤含浸部材18は、インナー部材17の内端部17aの規制により最奥部に保持されている。縮径部16aを設け、その中に殺菌剤含浸部材18を挿入することにより、保護キャップ2内に殺菌剤含浸部材18を保持し易くなる。さらに、殺菌剤含浸部材18が雄型コネクタ1の先端部に触れ難くなる効果も得られる。 As shown in FIGS. 4C and 4D, the protective cap 2 is formed of a substantially cylindrical outer cylinder 16 whose one end is closed, and an inner member 17 fitted into the outer cylinder 16. In the innermost part of the protective cap 2, a reduced diameter portion 16a having a smaller diameter than the opening side is provided, and a disinfectant-impregnated member 18 is disposed in the reduced diameter portion 16a. The disinfectant-impregnated member 18 is held at the innermost portion by the restriction of the inner end portion 17 a of the inner member 17. By providing the reduced diameter portion 16 a and inserting the sterilizing agent impregnated member 18 therein, the sterilizing agent impregnated member 18 is easily held in the protective cap 2. Furthermore, the effect that the disinfectant-impregnated member 18 is difficult to touch the tip of the male connector 1 is also obtained.
 インナー部材17の開口側端部の内周面には、係合突起17bが形成されている。雄型コネクタ1と保護キャップ2の結合は、雄型コネクタ1の外周面のねじ溝6aと、係合突起17bとの螺合により形成される。また、この螺合構造により、雄型コネクタ1と保護キャップ2の結合の最深位置が規制される。従って、雄型コネクタと保護キャップとが接続されるとき、螺合構造が、雄型コネクタ1の保護キャップ2内の奥部に向かう移動位置を規制する位置規制要素として機能する。 An engagement protrusion 17b is formed on the inner peripheral surface of the opening side end of the inner member 17. The connection between the male connector 1 and the protective cap 2 is formed by screwing the thread groove 6a on the outer peripheral surface of the male connector 1 and the engagement protrusion 17b. Further, the deepest position of the connection between the male connector 1 and the protective cap 2 is regulated by this screwing structure. Therefore, when the male connector and the protective cap are connected, the screwing structure functions as a position restricting element that restricts the moving position of the male connector 1 toward the inner part of the protective cap 2.
 また、インナー部材17の中間部内周面には環状フランジ17cが形成され、同様の位置規制部として機能する。すなわち、雄型コネクタ1の先端部外面には、環状フランジ17cの内径よりも大きい外径を有する当接部6bが形成されている。そのため、雄型コネクタ1に保護キャップ2が装着されたとき、環状フランジ17cと当接部6bの接触により、雄型コネクタ1の移動位置が規制される。 Further, an annular flange 17c is formed on the inner peripheral surface of the intermediate portion of the inner member 17, and functions as a similar position restricting portion. That is, a contact portion 6b having an outer diameter larger than the inner diameter of the annular flange 17c is formed on the outer surface of the distal end portion of the male connector 1. Therefore, when the protective cap 2 is attached to the male connector 1, the movement position of the male connector 1 is restricted by the contact between the annular flange 17c and the contact portion 6b.
 殺菌剤含浸部材18は、多孔質体、繊維体などの材質、例えばスポンジで形成することができる。含浸させる殺菌剤の例としては、ポビドンヨード溶液以外の殺菌剤を用いても良いが、人体への影響を考慮するとポビドンヨード溶液が望ましい。 The sterilizing agent-impregnated member 18 can be formed of a material such as a porous body or a fiber body, for example, a sponge. As an example of the sterilizing agent to be impregnated, a sterilizing agent other than the povidone iodine solution may be used, but a povidone iodine solution is desirable in consideration of the influence on the human body.
 次に、図5A~図5Cを参照して、雄型コネクタ1に保護キャップ2を装着した時の状態及び作用について説明する。図5Aは、図1Aの分解状態での雄型コネクタ1及び保護キャップ2を示す断面図、図5Bは、図1Bの結合状態での雄型コネクタ1及び保護キャップ2を示す正面図、図5Cは,図5Bの雄型コネクタ1及び保護キャップ2の断面図である。 Next, with reference to FIGS. 5A to 5C, the state and action when the protective cap 2 is attached to the male connector 1 will be described. 5A is a sectional view showing the male connector 1 and the protective cap 2 in the exploded state of FIG. 1A, FIG. 5B is a front view showing the male connector 1 and the protective cap 2 in the combined state of FIG. 1B, and FIG. These are sectional drawings of male connector 1 and protective cap 2 of Drawing 5B.
 保護キャップ2は、雄型コネクタ1と雌型コネクタ3が接続されていないときに雄型コネクタ1に装着され、コネクタ先端を保護する。装着する時には、図5Aに示すように、雄型コネクタ1の先端に保護キャップ2の開口部を対向させて、雄型コネクタ1を押し込みながら回転させる。それにより、保護キャップ2の内面に設けられた係合突起17bと、雄型コネクタ1の外周面のねじ溝6aとの係合を介して、雄型コネクタ1の先端に保護キャップ2が装着され固定される。 The protective cap 2 is attached to the male connector 1 when the male connector 1 and the female connector 3 are not connected to protect the connector tip. When mounting, as shown in FIG. 5A, the opening of the protective cap 2 is opposed to the tip of the male connector 1, and the male connector 1 is rotated while being pushed in. Thereby, the protective cap 2 is attached to the tip of the male connector 1 through the engagement between the engaging protrusion 17b provided on the inner surface of the protective cap 2 and the thread groove 6a on the outer peripheral surface of the male connector 1. Fixed.
 その際、上述のように、保護キャップのインナー部材17の内周面に形成された環状フランジ17cが位置規制部として機能し、また、雄型コネクタ1と保護キャップ2の螺合の最深位置による規制構造が位置規制部として機能する。それにより、雄型コネクタ1の先端部の周辺と保護キャップ2の内面との間に空間19が形成される(図5C参照)。この空間の形成により、保護キャップ2に保持された殺菌剤含浸部材18が、所定の間隔を保持して雄型コネクタ1の先端と接触することなく対向する状態が維持される。 At that time, as described above, the annular flange 17c formed on the inner peripheral surface of the inner member 17 of the protective cap functions as a position restricting portion, and depends on the deepest position of the male connector 1 and the protective cap 2 to be screwed together. The restriction structure functions as a position restriction part. Thereby, a space 19 is formed between the periphery of the distal end portion of the male connector 1 and the inner surface of the protective cap 2 (see FIG. 5C). By forming this space, the sterilizing agent-impregnated member 18 held in the protective cap 2 is maintained in a state where it is opposed to the front end of the male connector 1 while maintaining a predetermined interval.
 また、雄型コネクタ1の外周面と保護キャップ3の内周面の間に弾性リング8が押圧され、それにより空間19の気密が保持される。そのため、ポビドンヨード溶液が含浸された殺菌剤含浸部材18からヨウ素が昇華して空間19内に充満し、空間19内に密閉された雄型コネクタ1の先端部に対する殺菌作用が十分に得られる。なお、上述の例では、弾性リング8は雄型コネクタ1に外嵌されているが、空間19を密閉するためには、弾性リング8は保護キャップ3の内部に嵌入されていてもよい。要するに、保護キャップ3を雄型コネクタ1に装着した際、弾性リング8が保護キャップ3と雄型コネクタ1の双方から押圧される構成であればよい。 Further, the elastic ring 8 is pressed between the outer peripheral surface of the male connector 1 and the inner peripheral surface of the protective cap 3, whereby the airtightness of the space 19 is maintained. Therefore, iodine is sublimated from the sterilizing agent impregnated member 18 impregnated with the povidone iodine solution to fill the space 19, and a sufficient sterilizing effect on the tip of the male connector 1 sealed in the space 19 is obtained. In the above example, the elastic ring 8 is fitted on the male connector 1, but the elastic ring 8 may be fitted inside the protective cap 3 in order to seal the space 19. In short, the elastic ring 8 may be configured to be pressed from both the protective cap 3 and the male connector 1 when the protective cap 3 is attached to the male connector 1.
 但し、弾性リング8は、腹膜透析用チューブのコネクタの場合、患者側のコネクタに外嵌されているほうが望ましい。保護キャップや透析液側のコネクタは1回限り使用であるのに対して、患者側のコネクタは半年に1回交換であるため、弾性リング8を設けるコストを削減できるからである。その他の使用目的のチューブであれば、この限りではない。 However, in the case of a connector for a peritoneal dialysis tube, it is preferable that the elastic ring 8 is externally fitted to the patient-side connector. This is because the protective cap and the connector on the dialysate side can be used only once, whereas the connector on the patient side is replaced once every six months, so that the cost of providing the elastic ring 8 can be reduced. This is not the case as long as the tube is for other purposes.
 このように、殺菌剤含浸部材18が雄型コネクタ1の先端と直接接触するのではなく、殺菌剤含浸部材18と雄型コネクタ1の先端との間に所定の間隔を設けられていても、十分な殺菌効果が得られることが、後述する実験の結果により確認された。 In this way, the sterilizing agent impregnated member 18 is not in direct contact with the tip of the male connector 1, but a predetermined interval is provided between the sterilizing agent impregnated member 18 and the tip of the male connector 1. It was confirmed by the results of experiments described later that a sufficient bactericidal effect was obtained.
 従って、本実施の形態の医療用コネクタ装置によれば、雄型コネクタ1の先端側に保護キャップ2を装着することにより、雄型コネクタの先端部の殺菌状態を容易に保持することができる。しかも、本実施の形態によれば、殺菌剤含浸部材18と雄型コネクタ1の先端との間に所定の間隔が設けられるので、殺菌剤含浸部材18が押圧力を受けることによる殺菌剤の滲出が回避される。従って、滲出した殺菌剤が、コネクタの先端部からコネクタ・導管の内部流路に浸入することや、滲出した殺菌剤が、コネクタとキャップの接合部から外部に漏出して、周囲を汚染するような不都合を回避することができる。 Therefore, according to the medical connector device of the present embodiment, the sterilized state of the distal end portion of the male connector can be easily maintained by attaching the protective cap 2 to the distal end side of the male connector 1. In addition, according to the present embodiment, since a predetermined interval is provided between the sterilizing agent impregnated member 18 and the tip of the male connector 1, the sterilizing agent is exuded when the sterilizing agent impregnated member 18 receives a pressing force. Is avoided. Therefore, the sterilizing agent that has exuded enters the internal flow path of the connector / conduit from the tip of the connector, or the exuding sterilizing agent leaks to the outside from the joint between the connector and the cap, thereby contaminating the surroundings. Such inconvenience can be avoided.
 次に、雌型コネクタ3の構造、及び作用について、図6A~図7Cを参照して説明する。図6Aは、図2Aの雌型コネクタ3の正面図、図6Bは、図6Aの雌型コネクタ3の左側面図、図6Cは同右側面図、図6Dは、図6Aの雌型コネクタ3の断面図である。 Next, the structure and operation of the female connector 3 will be described with reference to FIGS. 6A to 7C. 6A is a front view of the female connector 3 in FIG. 2A, FIG. 6B is a left side view of the female connector 3 in FIG. 6A, FIG. 6C is a right side view thereof, and FIG. 6D is a female connector 3 in FIG. FIG.
 雌型コネクタ3は、内腔が液体流通用流路を形成する内筒20と、内径が内筒20の外径よりも大きく内筒の外側に同軸に結合された外筒11とを有する。外筒11の後端部に把持部10が形成され、また、内筒20の中央部と結合している。外筒11は、先端側が開口しており、内部にインナー部材21が篏込まれている。インナー部材21の内周面には、係合突起12が形成されている。内筒20は、外筒11の内部で開口に向かって延在する内筒先端部20aと、外筒11の後方に延びて把持部10の内側に位置するチューブ接続部20bとを有する。 The female connector 3 has an inner cylinder 20 whose inner cavity forms a flow channel for liquid circulation, and an outer cylinder 11 whose inner diameter is larger than the outer diameter of the inner cylinder 20 and is coaxially coupled to the outside of the inner cylinder. A gripping portion 10 is formed at the rear end portion of the outer cylinder 11 and is coupled to the central portion of the inner cylinder 20. The outer cylinder 11 is open at the tip side, and an inner member 21 is inserted therein. Engagement protrusions 12 are formed on the inner peripheral surface of the inner member 21. The inner cylinder 20 includes an inner cylinder distal end portion 20 a that extends toward the opening inside the outer cylinder 11, and a tube connection portion 20 b that extends rearward of the outer cylinder 11 and is positioned inside the grip portion 10.
 次に、図7A~図7Cを参照して、雄型コネクタ1と雌型コネクタ3を接続した時の状態及び作用について説明する。図7Aは、分解状態での雄型コネクタ1及び雌型コネクタ3を示す断面図、図7Bは、接続状態での雄型コネクタ1及び雌型コネクタ3を示す正面図、図7Cは、図7Bの雄型コネクタ1及び雌型コネクタ3の断面図である。 Next, the state and action when the male connector 1 and the female connector 3 are connected will be described with reference to FIGS. 7A to 7C. 7A is a sectional view showing the male connector 1 and the female connector 3 in an exploded state, FIG. 7B is a front view showing the male connector 1 and the female connector 3 in a connected state, and FIG. 2 is a cross-sectional view of the male connector 1 and the female connector 3 of FIG.
 接続する時には、図7Aに示すように、雄型コネクタ1の先端に雌型コネクタ3の先端開口部を対向させて、雄型コネクタ1を押し込みながら回転させる。それにより、雌型コネクタ3の内面に設けられた係合突起12と、雄型コネクタ1の外周面のねじ溝6aとの係合を介して、雄型コネクタ1の先端に雌型コネクタ3が装着され固定される。 When connecting, as shown in FIG. 7A, the front end opening of the female connector 3 is opposed to the front end of the male connector 1, and the male connector 1 is rotated while being pushed in. Thus, the female connector 3 is attached to the tip of the male connector 1 through the engagement between the engagement protrusion 12 provided on the inner surface of the female connector 3 and the thread groove 6a on the outer peripheral surface of the male connector 1. Installed and fixed.
 その際、雌型コネクタ3への雄型コネクタ1の進入に伴い、内筒先端部20aは、雄型コネクタ1の先端に装着された密閉弁14のスリットを押し広げながら貫通して雄型コネクタ1の内部に達し、流路を開通させる。 At that time, as the male connector 1 enters the female connector 3, the inner cylinder tip 20 a penetrates the male connector 1 while expanding the slit of the sealing valve 14 attached to the tip of the male connector 1. 1 is reached and the flow path is opened.
 なお、以上のような保護キャップ2の装着、あるいは雌型コネクタ3との接続のためには、雄型コネクタ1は、他の形態とすることもできる。すなわち、雄型コネクタを、内腔が液体流通用流路を形成する内筒と、内径が内筒の外径よりも大きく内筒の外側に同軸に結合された外筒とから構成する。内筒の先端は外筒の先端よりも内部側に位置しており、保護キャップ及び雌型コネクタは、外筒の外側に装着される。この構成によれば、誤って雄型コネクタ先端部に触れた場合でも、液体が流通する内筒に触れることは回避でき、内筒を保護することができる。外筒に付着した菌は、保護キャップを被せれば上述のように殺菌することができるので、菌が流路内に侵入することがない。 Note that the male connector 1 may have other forms for mounting the protective cap 2 as described above or for connection with the female connector 3. That is, the male connector is constituted by an inner cylinder whose inner cavity forms a liquid flow path, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder. The tip of the inner cylinder is located on the inner side of the tip of the outer cylinder, and the protective cap and the female connector are attached to the outside of the outer cylinder. According to this configuration, even when the tip of the male connector is accidentally touched, it is possible to avoid touching the inner cylinder through which the liquid flows and to protect the inner cylinder. Since the bacteria attached to the outer cylinder can be sterilized as described above by covering the protective cap, the bacteria do not enter the flow path.
 以下に、本実施の形態における医療用コネクタ装置において、雄型コネクタ1に保護キャップ2を装着した際に得られる効果について確認するための実験の結果について説明する。実験により、雄型コネクタ1の先端部の周辺と保護キャップ2の内面との間に密閉された空間19が形成され、この密閉空間内で、殺菌剤含浸部材18が所定の間隔を保持して雄型コネクタ1の先端と対向する状態が維持されることにより、十分な殺菌効果が得られることが実証された。また、その際、殺菌剤含浸部材18と雄型コネクタ1の先端との接触に起因する殺菌剤の滲出が回避され、殺菌剤がコネクタの先端部からコネクタ・導管の内部流路に浸入する不都合を回避できることが実証された。 Hereinafter, the results of an experiment for confirming the effects obtained when the protective cap 2 is attached to the male connector 1 in the medical connector device according to the present embodiment will be described. As a result of the experiment, a sealed space 19 is formed between the periphery of the front end of the male connector 1 and the inner surface of the protective cap 2, and the sterilizing agent impregnated member 18 maintains a predetermined interval in the sealed space. It has been demonstrated that a sufficient bactericidal effect can be obtained by maintaining the state facing the tip of the male connector 1. Further, at that time, exudation of the sterilizing agent due to contact between the sterilizing agent-impregnated member 18 and the tip of the male connector 1 is avoided, and the sterilizing agent enters the internal flow path of the connector / conduit from the tip of the connector. It was proved that this can be avoided.
 [実験1:殺菌能の検証]
 ポビドンヨード溶液が、雄型コネクタ1の先端部に非接触の状態で対向する構成により、雄型コネクタ1の先端部に存在する菌を殺菌する作用が得られることについて検証した。
[Experiment 1: Verification of bactericidal activity]
It was verified that the povidone-iodine solution is capable of sterilizing bacteria present at the tip of the male connector 1 by the configuration in which the povidone iodine solution faces the tip of the male connector 1 in a non-contact state.
 実験方法は以下のとおりである。まず、評価菌種として、Staphylococcus aureus、Staphylococcus epidermidis、Escherichia coli、Pseudomonas aeruginosa、Candida albicansの5菌種を用いた。ブドウ球菌属の場合は、Tween 80(Polyoxyethylene Sorbitan Monooleate)を0.01%添加した生理的食塩水、その他の菌種の場合は生理的食塩水に溶解させたものを用意した。 The experimental method is as follows. First, five bacterial species of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans were used as evaluation species. In the case of Staphylococcus spp., Physiological saline to which 0.01% of Tween 80 (PolyoxyethylenebitSorbitan Monoleate) was added was prepared, and in the case of other bacterial species, those dissolved in physiological saline were prepared.
 次に、雄型コネクタ1の先端部に10CFU/20μLの菌液を分注し、保護キャップ2を装着後、30-35℃の体温条件あるいは10℃の低温条件で3hr静置した。その後、保護キャップ2を外し、雄型コネクタ1をリンス液(FLUID D-ST液/BioMerieux)10mL中に入れ30sec攪拌後、φ0.45μmのフィルターで濾過を行った。これを3回繰り返した後、このフィルターをSCD寒天培地に載せて30-35℃で培養後、生菌数を確認した。 Next, 10 3 CFU / 20 μL of the bacterial solution was dispensed at the tip of the male connector 1, and after the protective cap 2 was attached, it was allowed to stand for 3 hours at a body temperature of 30-35 ° C. or a low temperature of 10 ° C. Thereafter, the protective cap 2 was removed, and the male connector 1 was placed in 10 mL of a rinse solution (FLUID D-ST solution / BioMerieux), stirred for 30 seconds, and then filtered through a filter having a diameter of 0.45 μm. After repeating this three times, this filter was placed on an SCD agar medium and cultured at 30-35 ° C., and the viable cell count was confirmed.
 本実施の形態に基づく実施例1としては、保護キャップ2の殺菌剤含浸部材18に10%ポビドンヨード溶液を含浸させたもの、比較例1としては、保護キャップ2の殺菌剤含浸部材18にポビドンヨード溶液に代えて生理的食塩水を含浸させたものを使用した。 As Example 1 based on the present embodiment, the fungicide-impregnated member 18 of the protective cap 2 is impregnated with a 10% povidone iodine solution. As Comparative Example 1, the fungicide-impregnated member 18 of the protective cap 2 is povidone-iodine solution. Instead, a material impregnated with physiological saline was used.
 実験の結果について、(表1)を参照して説明する。比較例1については、どちらの温度条件下でも分注した菌数からの変化が認められなかったが、実施例1については、どちらの条件下でも全ての菌種を殺滅することが出来た。従って、ポビドンヨード溶液が雄型コネクタ1の先端部に非接触の状態でも、コネクタ先端部に存在する菌を殺菌可能であることを確認できた。 The results of the experiment will be described with reference to (Table 1). For Comparative Example 1, no change was observed from the number of bacteria dispensed under either temperature condition, but for Example 1, all the bacterial species could be killed under either condition. . Therefore, even if the povidone iodine solution was not in contact with the tip of the male connector 1, it was confirmed that the bacteria present at the connector tip could be sterilized.
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
 [実験2:ポビドンヨード溶液混入試験]
 保護キャップ2を装着し外した後に、コネクタ導管部分に通液を行った場合に、保護キャップ2の殺菌剤含浸部材18中のポビドンヨード溶液が通液内に混入するかどうか確認した。
[Experiment 2: Povidone iodine solution contamination test]
After the protective cap 2 was attached and removed, it was confirmed whether or not the povidone iodine solution in the bactericide-impregnated member 18 of the protective cap 2 was mixed into the liquid flow when the connector conduit portion was passed through.
 実験方法は以下のとおりである。すなわち、雄型コネクタ1の先端部に保護キャップ2を装着し4hr静置後、保護キャップ2を外し、この雄型コネクタ1に雌型コネクタ3を接続後、チューブ内に超純水を20mL通液して、実施例2とした。この超純水について0.02Nチオ硫酸ナトリウム溶液を滴定液として用いた酸化還元滴定法にて有効ヨウ素の定量を行った。従来品のコネクタについて同様の試験を行ったものを、比較例2とした(従来品は全て、ポビドンヨード溶液にコネクタ先端が接触している)。 The experimental method is as follows. That is, the protective cap 2 is attached to the tip of the male connector 1 and left for 4 hours, and then the protective cap 2 is removed. After the female connector 3 is connected to the male connector 1, 20 mL of ultrapure water is passed through the tube. Example 2 was obtained. With respect to this ultrapure water, effective iodine was quantified by a redox titration method using a 0.02N sodium thiosulfate solution as a titrant. The same test was performed on the conventional connector as Comparative Example 2 (all of the conventional products were in contact with the povidone iodine solution).
 実験の結果を示す図8から、実施例2では、比較例2A~2Dと比較して、含浸部材内の有効ヨウ素量が多いにも関わらず、通液内への混入が認められなかったことが判る。 From FIG. 8 showing the results of the experiment, in Example 2, compared with Comparative Examples 2A to 2D, although the amount of effective iodine in the impregnated member was large, mixing into the liquid passage was not observed. I understand.
 この結果により、殺菌剤含浸部材18をコネクタと非接触とすることで、殺菌剤含浸部材18中のポビドンヨード溶液の滲出が回避可能であることを確認できた。 From this result, it was confirmed that exudation of the povidone iodine solution in the sterilizing agent impregnating member 18 can be avoided by making the sterilizing agent impregnating member 18 non-contact with the connector.
 [実験3:殺菌能保持性能の検証]
 雄型コネクタ1の先端部に存在する菌を殺菌可能な保存期間について確認した。実験方法は以下のとおりである。すなわち、雄型コネクタ1に保護キャップ2を装着し、アルミ包材に包装後40℃/75%RHの条件下で加速保管を行い、殺菌能に重要なポビドンヨード溶液中の水分量及び有効ヨウ素量の経時変化の評価を行った。水分量については、保管前重量と保管後重量との差を測定することで算出した。
[Experiment 3: Verification of bactericidal ability retention performance]
The storage period during which bacteria present at the tip of the male connector 1 can be sterilized was confirmed. The experimental method is as follows. That is, the protective cap 2 is attached to the male connector 1, and after accelerated packaging at 40 ° C / 75% RH after packaging in aluminum packaging material, the water content and effective iodine content in the povidone iodine solution important for sterilization performance The change with time was evaluated. The water content was calculated by measuring the difference between the weight before storage and the weight after storage.
 有効ヨウ素量については、保護キャップ2を99.5%エタノールに一晩浸漬後、さらに十分な共洗いによりポビドンヨードを抽出した後、0.01Mチオ硫酸ナトリウム溶液を滴定液として用いた酸化還元滴定法にて有効ヨウ素の定量を行った。この時、試験毎にポビドンヨード溶液の検量線を作成し、これにより検体の有効ヨウ素量を算出した。これと同時に室温条件下でも同様に保管し、水分量・有効ヨウ素量データから加速保管と室温保管との関係を確認した。 For the effective iodine amount, after the protective cap 2 was immersed in 99.5% ethanol overnight, povidone iodine was extracted by thorough washing, and then a redox titration method using a 0.01 M sodium thiosulfate solution as a titrant. Quantitative determination of effective iodine. At this time, a calibration curve of the povidone iodine solution was prepared for each test, and the effective iodine amount of the specimen was calculated thereby. At the same time, the samples were stored in the same manner at room temperature, and the relationship between accelerated storage and storage at room temperature was confirmed from the moisture and effective iodine data.
 また、これについて、実験1と同様の試験により殺菌能試験を行い、殺菌能保持可能期間を検討した。なお、温度条件は30-35℃の1条件とし、評価菌種はStaphylococcus epidermidisの1菌種とした。比較例3としては、保護キャップ2の含浸部材に含浸させているポビドンヨード溶液の代わりに生理的食塩水を含浸させたものを使用した。 Moreover, about this, the bactericidal ability test was done by the same test as Experiment 1, and the bactericidal ability retention period was examined. The temperature condition was one condition of 30-35 ° C., and the bacterial species evaluated was one bacterial species of Staphylococcus epidermidis. As Comparative Example 3, a material impregnated with physiological saline instead of the povidone iodine solution impregnated in the impregnated member of the protective cap 2 was used.
 加速保管の実験結果を図9Aに、室温保管の実験の結果を図9Bに示す。この実験結果によれば、各保管期間の水分量及び有効ヨウ素量の対比から、室温保管12M(月)は加速保管6W(週間)に、室温保管24Mは加速保管12Wにそれぞれ相当することが判る。従って、加速保管は室温保管の8倍相当の保管期間に相当することを確認できた。 The experimental results of accelerated storage are shown in FIG. 9A, and the results of room temperature storage experiments are shown in FIG. 9B. According to the results of this experiment, it can be seen from the comparison between the amount of water and the amount of effective iodine in each storage period that room temperature storage 12M (month) corresponds to accelerated storage 6W (weeks), and room temperature storage 24M corresponds to accelerated storage 12W. . Therefore, it was confirmed that accelerated storage corresponds to a storage period equivalent to eight times storage at room temperature.
 また、殺菌能試験の結果を(表2)に示す。この試験の結果、加速保管18Wで生菌が認められたことから、実施例3の場合は、加速保管15Wまで十分な殺菌能が保持可能であることが確認された。 The results of the bactericidal activity test are shown in (Table 2). As a result of this test, viable bacteria were observed in the accelerated storage 18W, and in the case of Example 3, it was confirmed that sufficient sterilization ability could be maintained up to the accelerated storage 15W.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
 以上の結果により、加速保管15Wは室温保管2年半相当に匹敵するため、殺菌能は約2年半保持することが可能であるということを確認できた。 From the above results, it can be confirmed that the accelerated storage 15W is comparable to the room temperature storage equivalent to two and a half years, so that the sterilization ability can be maintained for about two and a half years.
 [実験4:密閉空間内の殺菌剤濃度と非接触殺菌能の関係の検証]
 密閉空間内での殺菌剤濃度による非接触殺菌能の変化について調べる実験を行った。
[Experiment 4: Verification of relationship between bactericide concentration in closed space and non-contact bactericidal ability]
An experiment was conducted to investigate the change of non-contact sterilization ability due to the concentration of bactericide in a sealed space.
 (1)ステップ1
 先ず、ステップ1として以下の実験を行なった。すなわち、殺菌剤として10%のポビドンヨード溶液を用い(実施例4)、評価菌種として10CFUのS. epidermidisを用い、評価菌種との比較用に生理食塩水をそれぞれ用いた(比較例4)。
(1) Step 1
First, as a step 1, the following experiment was performed. That is, 10% povidone iodine solution was used as a bactericidal agent (Example 4), 10 3 CFU S. epidermidis was used as an evaluation bacterial species, and physiological saline was used for comparison with the evaluation bacterial species (Comparative Example). 4).
 スポンジに、10μl、50μl、150μl、300μlのポビドンヨード溶液をそれぞれ含浸させた。ポビドンヨード溶液が含浸したスポンジを5mlシリンジのプランジャーのガスケットに装着し、空間が630mlとなるようにプランジャーを調節した。 The sponge was impregnated with 10 μl, 50 μl, 150 μl and 300 μl of povidone iodine solution, respectively. The sponge impregnated with the povidone iodine solution was attached to the plunger gasket of a 5 ml syringe, and the plunger was adjusted so that the space was 630 ml.
 フォームと反対側(シリンジ先端細径部)に10CFUの菌液(Tween80を0.01%添加した生理食塩水で希釈)を20μl分注し、密閉した。これを、室温で静置して、1時間後に生菌数を計測した。この実験の結果を(表3)に示す。 20 μl of 10 3 CFU bacterial solution (diluted with physiological saline supplemented with 0.01% Tween 80) was dispensed on the side opposite the foam (small diameter at the tip of the syringe) and sealed. This was left still at room temperature, and the number of viable bacteria was counted after 1 hour. The results of this experiment are shown in (Table 3).
Figure JPOXMLDOC01-appb-T000003
Figure JPOXMLDOC01-appb-T000003
 この実験結果から、菌を殺滅するために必要なポビドンヨード溶液の密閉空間体積に対する割合を算出した。空間体積が630mmの場合、10%のポビドンヨード溶液が50μl以上あれば10CFUのS. epidermidisを殺滅可能であることが判る。 From this experimental result, the ratio of the povidone iodine solution necessary for killing the bacteria to the enclosed space volume was calculated. When the spatial volume is 630 mm 3 , it can be seen that 10 3 CFU of S. epidermidis can be killed if 50% or more of 10% povidone iodine solution is present.
 (2)ステップ2
 次に、ステップ2として以下の実験を行なった。すなわち、スポンジに、10μl、50μl、150μl、300μlのポビドンヨード溶液をそれぞれ含浸させた。ポビドンヨード溶液が含浸したフォームを5mlシリンジのプランジャーのガスケットに装着し、空間が各評価体積となるようにプランジャーを調節した。各評価体積は、630mm、378mm、189mm、126mmとした。
(2) Step 2
Next, as a step 2, the following experiment was performed. That is, sponges were impregnated with 10 μl, 50 μl, 150 μl, and 300 μl of povidone iodine solution, respectively. The foam impregnated with the povidone-iodine solution was attached to the plunger gasket of a 5 ml syringe, and the plunger was adjusted so that the space was each evaluation volume. Each evaluation volume was 630mm 3, 378mm 3, 189mm 3 , 126mm 3.
 フォームと反対側(シリンジ先端細径部)に10CFUの菌液(Tween80を0.01%添加した生理食塩水で希釈)を20μl分注した。室温で静置後、各評価時間毎に生菌数を計測して殺滅完了時間を調べた。その結果を(表4)に示す。評価時間は0.5hr、及び1hrとした。 20 μl of 10 3 CFU bacterial solution (diluted with physiological saline supplemented with 0.01% Tween 80) was dispensed on the opposite side of the foam (small diameter at the tip of the syringe). After standing at room temperature, the number of viable bacteria was counted at each evaluation time to check the killing completion time. The results are shown in (Table 4). Evaluation time was 0.5 hr and 1 hr.
Figure JPOXMLDOC01-appb-T000004
Figure JPOXMLDOC01-appb-T000004
 この実験結果によれば、10%ポビドンヨード溶液が空間体積に対して約8%以上存在すれば、10CFUのS. epidermidisを殺滅可能であることが判る。 According to this experimental result, it is found that 10 3 CFU of S. epidermidis can be killed if a 10% povidone iodine solution is present in an amount of about 8% or more with respect to the space volume.
 (実施の形態2)
 本発明の実施の形態2における医療用液体連通装置は、経腸栄養法に用いられるコネクタ装置を適用例とするものである。図10A~図10Bを参照して、本実施の形態における経腸栄養用コネクタ装置の構成について説明する。
(Embodiment 2)
The medical liquid communication device according to the second embodiment of the present invention uses a connector device used for enteral nutrition as an application example. With reference to FIG. 10A to FIG. 10B, the configuration of the connector device for enteral nutrition in the present embodiment will be described.
 経腸栄養法では、患者の鼻腔から胃又は十二指腸にまで通されたチューブを介して栄養剤、流動食、又は薬剤などの液状物が投与される。栄養剤等を投与する際には、まず、栄養剤等を医療用容器に注入する。次に、医療用容器のポート(通液部)に、チューブを含む注入路セットの一端に装着されたコネクタを接続する。さらに、医療用容器を、注入路セットが接続されたポートを下側にしてハンガーに吊り下げる。医療用容器をハンガーに吊り下げた状態で、注入路セットの他端に装着されたコネクタを、患者に装着されたチューブの端部のコネクタに接続し、医療用容器内の栄養剤等の液状物を患者に投与する。 In enteral nutrition, liquids such as nutrients, liquid foods, or drugs are administered through a tube passed from the patient's nasal cavity to the stomach or duodenum. When administering a nutrient or the like, first, the nutrient or the like is injected into a medical container. Next, a connector attached to one end of an injection path set including a tube is connected to a port (liquid passing portion) of the medical container. Further, the medical container is suspended from the hanger with the port to which the injection path set is connected facing downward. With the medical container hung on the hanger, connect the connector attached to the other end of the infusion path set to the connector at the end of the tube attached to the patient. The product is administered to the patient.
 図10Aは、注入路セットが接続される医療用容器22のポート23を示す。ポート23は、液状物が通過するための通液孔が形成された管状部24と、管状部24の先端を形成する経腸栄養用コネクタ25を有する。コネクタ25は、ルアー接続方式により注入路セットの一端のコネクタ(図示せず)と接続される。すなわち、コネクタ25と注入路セットの一端に装着されたコネクタとが、本実施の形態における医療用液体連通装置を構成する。 FIG. 10A shows the port 23 of the medical container 22 to which the injection channel set is connected. The port 23 includes a tubular portion 24 in which a liquid passage hole for allowing a liquid substance to pass therethrough and a enteral nutrition connector 25 that forms the distal end of the tubular portion 24. The connector 25 is connected to a connector (not shown) at one end of the injection path set by a luer connection method. That is, the connector 25 and the connector attached to one end of the injection path set constitute the medical fluid communication device in the present embodiment.
 この経腸栄養用コネクタ装置は更に、保護キャップ26を含み、医療用容器22が使用されていない状態では、コネクタ25には、保護キャップ26が装着される。保護キャップ26の内部構造を、図10Bに示す。保護キャップ26は、一端が閉塞された筒形状を有しており、最奥部に殺菌剤含浸部材27が保持されている。保護キャップ26の開口端部の内周面には、封止部材28が装着されている。 This enteral feeding connector device further includes a protective cap 26, and the protective cap 26 is attached to the connector 25 when the medical container 22 is not used. The internal structure of the protective cap 26 is shown in FIG. 10B. The protective cap 26 has a cylindrical shape with one end closed, and a disinfectant-impregnated member 27 is held in the innermost part. A sealing member 28 is attached to the inner peripheral surface of the opening end of the protective cap 26.
 図10Cに示すように、保護キャップ26はコネクタ25に装着された状態において、コネクタ25の先端の周囲を包囲する空間29を形成し、殺菌剤含浸部材27が所定の間隔を保持してコネクタ25の先端と対向する。また、保護キャップ26がコネクタ25に装着された状態で、コネクタ25の外周面と保護キャップ26の内周面間に封止部材28が押圧されて、空間29の気密構造が形成される。 As shown in FIG. 10C, when the protective cap 26 is attached to the connector 25, the protective cap 26 forms a space 29 surrounding the periphery of the tip of the connector 25, and the sterilizing agent impregnated member 27 maintains a predetermined interval so that the connector 25 Opposite the tip. Further, with the protective cap 26 attached to the connector 25, the sealing member 28 is pressed between the outer peripheral surface of the connector 25 and the inner peripheral surface of the protective cap 26, and an airtight structure of the space 29 is formed.
 以上のような、本実施の形態の経腸栄養用コネクタ装置によれば、コネクタ25の先端部に保護キャップ26を装着することにより、当該部分の殺菌状態を容易に保持することができる。しかも、殺菌剤含浸部材27と経腸栄養用コネクタ25の先端との間に所定の空間29が設けられるので、殺菌剤含浸部材27が押圧力を受けることによる殺菌剤の滲出が回避される。従って、滲出した殺菌剤が、コネクタ25の先端部からポート23の内部流路に浸入することや、滲出した殺菌剤が外部に漏出して、周囲を汚染するような不都合を回避することができる。 According to the enteral nutrition connector device of the present embodiment as described above, the sterilized state of the portion can be easily maintained by attaching the protective cap 26 to the distal end portion of the connector 25. In addition, since the predetermined space 29 is provided between the sterilizing agent impregnated member 27 and the distal end of the enteral nutrition connector 25, the sterilizing agent is prevented from exuding due to the pressing force of the sterilizing agent impregnating member 27. Accordingly, it is possible to avoid the inconvenience that the exfoliated sterilizing agent enters the internal flow path of the port 23 from the distal end portion of the connector 25 or the exuded sterilizing agent leaks to the outside and contaminates the surroundings. .
 なお、上述の構成では、医療用容器22のポート23に設けられた経腸栄養用コネクタ25に保護キャップ26が装着されるが、患者に装着されたチューブの端部のコネクタに保護キャップを装着するように構成して、同様の効果を得ることもできる。 In the above configuration, the protective cap 26 is attached to the enteral nutrition connector 25 provided in the port 23 of the medical container 22, but the protective cap is attached to the connector at the end of the tube attached to the patient. The same effect can also be obtained by configuring as described above.
 (実施の形態3)
 実施の形態3における医療用液体連通装置は、医療用混注ポート装置を適用例としたものである。図11A~図11Bを参照して、本実施の形態における混注ポート装置の構成について説明する。
(Embodiment 3)
The medical liquid communication device in the third embodiment is an application example of a medical mixed injection port device. With reference to FIGS. 11A to 11B, the configuration of the co-injection port apparatus according to the present embodiment will be described.
 医療用混注ポートは、患者に薬液等を投与する場合に、主たる薬液とは異なる薬液を、薬液供給用送液路に混注し、または、送液路を流れる液体をサンプル採取する場合等に用いられる。そのため、混注ポートは、先端が鋭利ではない挿入体を弁に形成された挿入孔に挿入して上記操作を行なうことができるように構成されている。 The medical co-infusion port is used to administer medicinal solution, etc. to the patient, to mix medicinal solution different from the main medicinal solution into the medicinal solution supply channel, or to sample the liquid flowing in the medicinal solution channel, etc. It is done. Therefore, the mixed injection port is configured such that the above operation can be performed by inserting an insert having a sharp tip into an insertion hole formed in the valve.
 図11Aに示す混注ポート30は、連通対象であるチューブ31の途中に装着されている。なお、連通対象はチューブに限られず、他のどのような形態のものであってもよい。チューブ31には台座32が設けられ、台座32にカバー34が装着されている。台座32とカバー33により、中央部に挿入孔が形成されたディスク状の弁34が保持されている。すなわち、台座32により弁34が支持され、カバー33が弁34に当接して、台座32とカバー33の間に弁34が挟持されている。カバー34は、中央部に弁34の中央部上面を露出させる嵌合孔を有する。台座32は、チューブ31の内腔に通じる貫通孔を有する。 The mixed injection port 30 shown in FIG. 11A is mounted in the middle of the tube 31 to be communicated. The communication target is not limited to the tube, and may be any other form. A pedestal 32 is provided on the tube 31, and a cover 34 is attached to the pedestal 32. The pedestal 32 and the cover 33 hold a disc-like valve 34 having an insertion hole formed in the center. That is, the valve 34 is supported by the pedestal 32, the cover 33 is in contact with the valve 34, and the valve 34 is sandwiched between the pedestal 32 and the cover 33. The cover 34 has a fitting hole that exposes the upper surface of the central portion of the valve 34 at the central portion. The pedestal 32 has a through hole that communicates with the lumen of the tube 31.
 この混注ポート30の弁34を貫通してシリンジ先端部を構成するルアーのような挿入体(図示せず)が挿入されると、挿入体の内腔がチューブ31の内腔と連通する。それにより、液体を注入および/または採取でき、弁34からルアーを抜くと弁34がその弾性により閉じる。すなわち、混注ポート30と挿入体とから構成される混注ポート装置が、本実施の形態における医療用液体連通装置を構成する。 When an insert (not shown) such as a luer that forms the distal end of the syringe is inserted through the valve 34 of the mixed injection port 30, the lumen of the insert communicates with the lumen of the tube 31. Thereby, liquid can be injected and / or collected, and when the lure is removed from the valve 34, the valve 34 closes due to its elasticity. That is, the co-infusion port device composed of the co-infusion port 30 and the insert constitutes the medical liquid communication device in the present embodiment.
 混注ポート装置は更に、保護キャップ35を含み、混注ポート30が使用されていない状態では、混注ポート30には、保護キャップ35が装着される。 The mixed injection port device further includes a protective cap 35, and the protective cap 35 is attached to the mixed injection port 30 when the mixed injection port 30 is not used.
 図11Bに、保護キャップ35の内部構造を示す。保護キャップ35は、一端が閉塞された筒形状を有しており、最奥部に殺菌剤含浸部材36が保持されている。保護キャップ35の開口端部の内周面には、封止部材37が装着されている。 FIG. 11B shows the internal structure of the protective cap 35. The protective cap 35 has a cylindrical shape with one end closed, and a disinfectant-impregnated member 36 is held at the innermost part. A sealing member 37 is attached to the inner peripheral surface of the opening end of the protective cap 35.
 保護キャップ35は混注ポート30に装着された状態において、混注ポート30の上端の周囲を包囲する空間を形成し、殺菌剤含浸部材36が所定の間隔を保持して混注ポート30の上端と対向する。また、保護キャップ35が混注ポート30に装着された状態で、混注ポート30の外周面と保護キャップ35の内周面間に封止部材37が押圧されて、空間の気密構造が形成される。 When the protective cap 35 is attached to the mixed injection port 30, the protective cap 35 forms a space surrounding the periphery of the upper end of the mixed injection port 30, and the disinfectant impregnating member 36 is opposed to the upper end of the mixed injection port 30 while maintaining a predetermined interval. . Further, the sealing member 37 is pressed between the outer peripheral surface of the mixed injection port 30 and the inner peripheral surface of the protective cap 35 in a state where the protective cap 35 is attached to the mixed injection port 30, thereby forming an airtight structure of the space.
 以上のような、本実施の形態の医療用混注ポート装置によれば、混注ポート30の上端部に保護キャップ35を装着することにより、当該部分の殺菌状態を容易に保持することができる。しかも、殺菌剤含浸部材36と混注ポート30の先端との間に所定の空間が設けられるので、殺菌剤含浸部材36が押圧力を受けることによる殺菌剤の滲出が回避される。従って、滲出した殺菌剤が、混注ポート30の先端部からチューブ31の内部流路に浸入することや、滲出した殺菌剤が外部に漏出して、周囲を汚染するような不都合を回避することができる。 According to the medical mixed injection port device of the present embodiment as described above, the sterilized state of the portion can be easily maintained by attaching the protective cap 35 to the upper end portion of the mixed injection port 30. In addition, since a predetermined space is provided between the sterilizing agent impregnating member 36 and the tip of the co-injecting port 30, exudation of the sterilizing agent due to the pressing force of the sterilizing agent impregnating member 36 is avoided. Therefore, it is possible to avoid the inconvenience that the exfoliated sterilizing agent enters the internal flow path of the tube 31 from the distal end portion of the mixed injection port 30, or the exuded sterilizing agent leaks to the outside and contaminates the surroundings. it can.
 図12は、本実施の形態における他の態様の混注ポート装置を示す斜視図である。図11Aに示した混注ポート装置と同様の要素については、同一の参照符号を付して説明の繰り返しを省略する。この態様においては、チューブ31の一端に混注ポート30が装着されている。このような態様でも、上述と同様の保護キャップを用いることにより、上述と同様の効果を得ることができる。 FIG. 12 is a perspective view showing a mixed injection port device according to another aspect of the present embodiment. Elements similar to those of the mixed injection port apparatus shown in FIG. 11A are denoted by the same reference numerals, and description thereof will not be repeated. In this embodiment, the mixed injection port 30 is attached to one end of the tube 31. Even in such an embodiment, the same effect as described above can be obtained by using the same protective cap as described above.
 本発明の医療用液体連通装置によれば、殺菌剤含浸部材を奥部に保持する保護キャップを装着することにより、結合部材の先端部を十分に殺菌可能であって、しかも、結合部材の先端部が殺菌剤含浸部材に接触することに起因する殺菌剤の漏出が回避されるので、腹膜透析や輸液用等における流路接続のためのコネクタ装置等に有用である。 According to the medical fluid communication device of the present invention, the distal end portion of the coupling member can be sufficiently sterilized by attaching the protective cap that holds the sterilizing agent-impregnated member in the back, and the distal end of the coupling member Since the leakage of the sterilizing agent due to the contact of the part with the sterilizing agent-impregnated member is avoided, it is useful for a connector device or the like for channel connection in peritoneal dialysis or infusion.
1 雄型コネクタ
2、26、35 保護キャップ
3 雌型コネクタ
4、9、31 チューブ
5、10 把持部
6 円筒部
6a ねじ溝
6b 当接部
7 先端小径部
8 弾性リング
11、16 外筒
12、17b 係合突起
13、17、21 インナー部材
13a チューブ接続部
13b 流路
14 密閉弁
15 フランジ
15a リブ
16a 縮径部
17a 内端部
17c 環状フランジ
18、27、36 殺菌剤含浸部材
19、29 空間
20 内筒
20a 内筒先端部
20b チューブ接続部
21 インナー部材
22 医療用容器
23 ポート
24 管状部
25 経腸栄養用コネクタ
28、37 封止部材
30 混注ポート
32 台座
33 カバー
34 弁
DESCRIPTION OF SYMBOLS 1 Male connector 2, 26, 35 Protective cap 3 Female connector 4, 9, 31 Tube 5, 10 Holding part 6 Cylindrical part 6a Thread groove 6b Contact part 7 Small end diameter part 8 Elastic ring 11, 16 Outer cylinder 12, 17b Engaging projections 13, 17, 21 Inner member 13a Tube connecting portion 13b Flow path 14 Sealing valve 15 Flange 15a Rib 16a Reduced diameter portion 17a Inner end portion 17c Annular flanges 18, 27, 36 Bactericidal agent impregnated members 19, 29 Space 20 Inner cylinder 20a Inner cylinder tip 20b Tube connection portion 21 Inner member 22 Medical container 23 Port 24 Tubular portion 25 Enteral nutrition connectors 28 and 37 Sealing member 30 Mixed injection port 32 Base 33 Cover 34 Valve

Claims (14)

  1.  連通対象に各々装着され互いに結合されることにより前記連通対象間の連通流路を形成する結合部材と、
     一端が閉塞された筒形状を有して殺菌剤含浸部材を最奥部に保持し、互いに分離された状態の前記結合部材の少なくとも一方に装着可能な保護キャップとを備え、
     前記保護キャップが前記結合部材に装着された状態において、前記保護キャップの内周面は前記結合部材の先端部を包囲する空間を形成し、前記殺菌剤含浸部材が間隔を保持して前記結合部材の先端部と対向するように、前記結合部材と前記保護キャップの相互の寸法関係が設定され、
     前記保護キャップの開口端部の内周面または前記結合部材における前記保護キャップの開口端部に対応する部位の外周面に装着された封止部材を備え、前記保護キャップの装着状態で、前記結合部材の外周面と前記保護キャップの内周面間に前記封止部材が押圧されて前記空間の気密構造が形成されることを特徴とする医療用液体連通装置。
    A coupling member that is mounted on each communication target and coupled to each other to form a communication channel between the communication targets;
    A protective cap that has a cylindrical shape with one end closed, holds the disinfectant-impregnated member at the innermost part, and can be attached to at least one of the coupling members in a state separated from each other;
    In a state in which the protective cap is mounted on the coupling member, an inner peripheral surface of the protective cap forms a space surrounding a front end portion of the coupling member, and the sterilizing agent-impregnated member maintains a gap so that the coupling member The mutual dimensional relationship between the coupling member and the protective cap is set so as to face the tip portion of
    A sealing member mounted on an inner peripheral surface of the opening end portion of the protective cap or an outer peripheral surface of a portion of the coupling member corresponding to the opening end portion of the protective cap; The medical fluid communication device, wherein the sealing member is pressed between an outer peripheral surface of the member and an inner peripheral surface of the protective cap to form an airtight structure of the space.
  2.  前記結合部材の一方は雄型コネクタであり、その後端部に前記連通対象の一方と連結される装着部を有し、
     前記結合部材の他方は雌型コネクタであり、その後端部に第2の前記連通対象と連結される装着部を有する請求項1に記載の医療用液体連通装置。
    One of the coupling members is a male connector, and has a mounting portion connected to one of the communication targets at a rear end portion thereof.
    The medical fluid communication device according to claim 1, wherein the other of the coupling members is a female connector, and has a mounting portion connected to the second communication target at a rear end portion thereof.
  3.  前記雄型コネクタは、内腔が液体流通用流路を形成する内筒と、内径が前記内筒の外径よりも大きく前記内筒の外側に同軸に結合された外筒とを有し、
     前記内筒の先端が前記外筒の先端よりも内部側に位置しており、
     前記保護キャップ及び前記雌型コネクタは、前記外筒の外側に装着される請求項2に記載の医療用液体連通装置。
    The male connector has an inner cylinder whose lumen forms a flow channel for liquid circulation, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder,
    The tip of the inner cylinder is located on the inner side of the tip of the outer cylinder,
    The medical fluid communication device according to claim 2, wherein the protective cap and the female connector are attached to the outside of the outer cylinder.
  4.  前記雄型コネクタは、先端部に内腔を遮蔽する密閉弁を有し、
     前記雌型コネクタは、内腔が液体流通用流路を形成する内筒と、内径が前記内筒の外径よりも大きく前記内筒の外側に同軸に結合された外筒とを有して、前記外筒の内側に前記雄型コネクタが挿入されて接続され、
     前記雄型コネクタと前記雌型コネクタとが接続されたとき、前記雌型コネクタの前記内筒の先端が前記密閉弁を貫通して流路が開通する請求項2に記載の医療用液体連通装置。
    The male connector has a sealing valve that shields the lumen at the tip,
    The female connector has an inner cylinder whose inner cavity forms a liquid flow path, and an outer cylinder whose inner diameter is larger than the outer diameter of the inner cylinder and is coaxially coupled to the outer side of the inner cylinder. , The male connector is inserted and connected to the inside of the outer cylinder,
    The medical fluid communication device according to claim 2, wherein when the male connector and the female connector are connected, a tip of the inner cylinder of the female connector penetrates the sealing valve and a flow path is opened. .
  5.  前記密閉弁よりも先端側に、前記雄型コネクタの内面に形成され前記密閉弁の外径よりも小さい開口を形成するフランジが設けられた請求項4に記載の医療用液体連通装置。 5. The medical fluid communication device according to claim 4, wherein a flange formed on an inner surface of the male connector and having an opening smaller than an outer diameter of the sealing valve is provided on a tip side of the sealing valve.
  6.  前記フランジに、前記雄型コネクタの先端側に延びるリブが設けられた請求項5に記載の医療用液体連通装置。 The medical fluid communication device according to claim 5, wherein the flange is provided with a rib extending toward a distal end side of the male connector.
  7.  前記保護キャップの内部に、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置を規制して前記空間を確保する位置規制部が設けられた請求項2~6のいずれか1項に記載の医療用液体連通装置。 7. The position restricting portion that secures the space by restricting a movement position of the male connector toward the inner portion of the protective cap in the protective cap, according to any one of claims 2 to 6. The medical fluid communication device described.
  8.  前記位置規制部は環状フランジにより形成され、前記雄型コネクタの先端部外面には前記環状フランジの内径よりも大きい外径を有する当接部が形成され、
     前記雄型コネクタと前記保護キャップとが接続されたとき、前記環状フランジと前記当接部の接触により前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置が規制される請求項7に記載の医療用液体連通装置。
    The position restricting portion is formed by an annular flange, and a contact portion having an outer diameter larger than the inner diameter of the annular flange is formed on the outer surface of the distal end portion of the male connector.
    8. When the male connector and the protective cap are connected, the movement position of the male connector toward the inner portion of the protective cap is restricted by the contact between the annular flange and the contact portion. The medical fluid communication device described.
  9.  前記雄型コネクタと前記保護キャップとは螺合により結合するように構成され、
     前記雄型コネクタと前記保護キャップの前記螺合の最深位置が前記位置規制部として機能し、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置が規制される請求項7に記載の医療用液体連通装置。
    The male connector and the protective cap are configured to be coupled by screwing,
    The deepest position of the said screw connection of the said male connector and the said protective cap functions as the said position control part, The movement position toward the back | inner part in the said protective cap of the said male connector is controlled. Medical fluid communication device.
  10.  前記保護キャップの内部にインナー部材が嵌入され、前記インナー部材により前記殺菌剤含浸部材が前記保護キャップの最奥部に保持されている請求項2記載の医療用液体連通装置。 The medical fluid communication device according to claim 2, wherein an inner member is fitted into the protective cap, and the sterilizing agent-impregnated member is held at the innermost part of the protective cap by the inner member.
  11.  前記インナー部材は、前記雄型コネクタの前記保護キャップ内の奥部に向かう移動位置を規制して前記空間を確保する位置規制部を有する請求項10に記載の医療用液体連通装置。 The medical fluid communication device according to claim 10, wherein the inner member has a position restricting portion that restricts a moving position of the male connector toward the inner portion of the protective cap to secure the space.
  12.  前記保護キャップの最奥部に、開口部側よりも小径になった縮径部が設けられ、前記縮径部に前記殺菌剤含浸部材が配置されている請求項2に記載の医療用液体連通装置。 The medical fluid communication according to claim 2, wherein a diameter-reduced portion having a smaller diameter than the opening side is provided at the innermost portion of the protective cap, and the bactericide-impregnated member is disposed in the diameter-reduced portion. apparatus.
  13.  前記連通対象の一方は、経腸栄養法に用いられる栄養剤等を注入するための医療用容器のポート、他方は、前記医療用容器と患者の間を接続するためのチューブを含む経腸栄養セットであり、
     前記医療用容器のポートに設けられた経腸栄養用コネクタが前記結合部材の一方を構成し、
     前記栄養セットの一端に設けられ前記経腸栄養用コネクタと接続されるコネクタが、前記結合部材の他方を構成する請求項1に記載の医療用液体連通装置。
    One of the communication objects is a port of a medical container for injecting a nutrient used in enteral nutrition, and the other is an enteral nutrition including a tube for connecting the medical container and a patient. Set,
    The connector for enteral nutrition provided at the port of the medical container constitutes one of the coupling members,
    The medical fluid communication device according to claim 1, wherein a connector provided at one end of the nutrition set and connected to the enteral nutrition connector constitutes the other of the coupling members.
  14.  前記結合部材の一方は混注ポートであり、前記混注ポートは、連通対象に設けられる台座と、前記台座に下面側から支持され中央部に挿入孔が形成されたディスク状の弁と、前記弁の中央部の上面を露出させる嵌合孔を有し前記弁の周縁を上面側から覆うカバーとを含み、
     前記結合部材の他方は、前記混注ポートに挿入可能でその内腔が液体流路を形成している挿入体であり、
     前記保護キャップは、前記混注ポートに対して装着されるように構成された請求項1に記載の医療用液体連通装置。
    One of the coupling members is a mixed injection port, and the mixed injection port includes a pedestal provided for communication, a disc-like valve supported on the pedestal from the lower surface side and having an insertion hole formed in a central portion thereof, A cover that has a fitting hole that exposes the upper surface of the central portion and covers the periphery of the valve from the upper surface side;
    The other of the coupling members is an insert that can be inserted into the co-injection port and the lumen forms a liquid flow path,
    The medical fluid communication device according to claim 1, wherein the protective cap is configured to be attached to the mixed injection port.
PCT/JP2010/059860 2009-06-12 2010-06-10 Medical device for forming liquid communication path WO2010143693A1 (en)

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